| KCD (13) | Author | Year | Country | Condition | Included Studies (n) | Inclusion Criteria | Exclusion Criteria | Intervention (Regimen) | Comparison (Regimen) | Outcome | Result | Conclusions |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| A00-B99 특정 감염성 및 기생충성 질환 | Li | 2020 | China | Hepatitis C | 28 | 1) Randomized controlled trials (RCTs) 2) Availability of clear diagnostic criteria for patients 3) Control group treated with a PR regimen and intervention group with TCM+PR regimen 4) Evaluation indicators included liver function indicators from serum, fibrosis indicators from serum, Comprehensive Clinical Efficacy, and HCV-RNA negative rate 5) The clinical types of hepatitis C were not limited. | 1) Control group treated with a non-PR program 2) The subjects were non-HCV patients 3) Lack of conformity to the principles of RCT 4) Errors in and/or lack of data 5) RCT not explicitly described 6) Lack of patient information 7) Reviews 8) Duplicate reports | Traditional Chinese medicine (TCM) + Western medicine(PR) | Wetsern medicine pegylated interferon (Peginterferon) AND/OR ribavirin | 1) Liver function testing 2) Comprehensive 3) Clinical Efficacy 4) Viral clearance 5) Liver fibrosis indicators | Twenty-eight RCTs met the inclusion criteria. The combination therapy or intervention group showed significantly greater HCV-RNA negative rate post-treatment compared to the monotherapy or the control group (P<.05). In addition, the serum levels of the liver function indicators alanine aminotransferase (ALT), aspartate aminotransferase (AST), and albumin (ALB) were significantly improved after the combination therapy compared to PR alone (P<.05), while total bilirubin (TB) and r-glutamyltransferase (GGT) levels were not affected by TCM (P>.05). Finally, the parameters of liver fibrosis were also reduced by the combination therapy more effectively than the monotherapy. | The combination of TCM and PR can improve the Comprehensive Clinical Efficacy of hepatitis C and have a better negative rate of HCV-RNA with a better benefit in the liver function. The effect of TCM+PR is better than that of PR alone in treating hepatitis C. |
| C00-D48 신생물 | Deng | 2019 | China | Breast Cancer | 13 | 1) Pathological or cellular Clinically diagnosed as breast cancer 2) Kamofsky score of quality of life >60 points 3) Heart, liver, and kidney functions are basically normal 4) No obvious complications 5) No chemotherapy prohibition Indications | 1) Concurrent radiotherapy 2) Drug intolerance of this research drug | Kang’ai Injection+cytotoxic drugs + chemo therapy | Cytotoxic drugs + chemo therapy | 1) Efficient rate 2) Quality of life improvement rate 3) Weight gain | Meta-analysis showed that there were no significant differences in the main outcome indicators between the research group and the control group in the efficiency of chemotherapy, the improvement rate of quality of life, weight gain and stability. Secondary outcome indicators included reduced incidence of grade Ⅰ-Ⅳ leukopenia (RR=0.78, 95% CI=0.70~0.86, P<0.00001), decreased incidence of grade Ⅱ-Ⅳ leukopenia (RR=0.61, 95% CI=0.43~0.88, P=0.009), decreased incidence of thrombocytopenia (RR=0.24, 95% CI=0.12~0.50, P=0.0001), and decreased incidence of liver injury (RR=0.59, 95% CI=0.44~0.80, P=0.0007). There was no significant difference in the incidence of renal function injury, gastrointestinal adverse reactions and alopecia | Kang'ai injection in adjuvant treatment of breast cancer can decrease part of toxic and side-effects, but it also need high-quality large-scale long-term studies for further validation |
| C00-D48 신생물 | Wu | 2019 | China | Breast Cancer | 20 | 1) The type of patient was diagnosed by pathology/cytology Breast cancer patients (quality of life score ＞ 60 points, heart, liver, Kidney function is basically normal, no obvious comorbidities, no contraindications to chemotherapy) 2) Intervention measures: Patients in the experimental group received chemotherapy and Shenqi Fuzheng injection Treatment, the control group received chemotherapy alone, and the chemotherapy regimen in the two groups remained consisten 3) Clinical trial and a randomized controlled trial 4) The outcome refers to the standard must include at least one of the following: Efficient According to World Health Tissue (WHO) solid tumor curative effect evaluation standard judged as complete remission and partial remission; KPS score; blood picture analysis; immune function index Mark; Adverse reactions. | 1) The trial did not meet the inclusion criteria 2) Overview, team listed studies, case-control studies and other non-randomized controlled trials 3) Repeatability literature or plagiarism | Shenqi Fuzheng Injection+chemotherapy | Chemotherapy | 1) Effective rate 2) KPS score 3) Blood picture analysis 4) Adverse reactions | The results of meta-analysis showed that: compared with control group, Shenlingbaizhusan could improve the efficiency of gastric cancer patients (RR=1.55, 95%CI 1.31 to 1.84, P<0.000 01) and the living quality of patients (RR=1.70, 95%CI 1.39 to 2.07, P<0.000 01), and reduce the side effects such as nausea, vomiting, diarrhea and the the possibilities of recurrence. However there was no difference between two groups in bone marrow suppression | this study has systemically evaluated the efficacy and safety of Shenqi Fuzheng Injection combined with chemotherapy in treatment of breast cancer and provided the reference of evidence-based medicine for safe and effective clinical application of medicines. |
| C00-D48 신생물 | Chen | 2019 | China | Gastric cancer | 14 | 1) Diagnosed as gastric cancer by pathological examination (staging is no limitation) 2) No other serious organs and systemic Disease 3) No radiotherapy or chemotherapy in the past 3 months before enrollment 4) Expected survival period over than 3 months. | NR | Shenlingbaizhusan+conventional western medicine treatment for gastric cancer | Conventional western medicine treatment | 1) Efficient rate 2) Quality of life (KPS score) 3) Adverse reaction rate 4) Recurrence rate 5) 2-year survival rate | Meta analysis showed that as compared with control group of chemotherapy alone,Shenqi Fuzheng Injection combined with chemotherapy could improve the clinical curative efficiency,the KPS score,and immune function indexes such as total T cells,Th cells and Ts cells; inhibit the decline of white blood cells ( WBC) ,platelets in blood system,T-lymphocyte subsets such as CD3 + ,CD4 + ,CD4 + /CD8 + ,alleviate myelosuppression and reduce the incidence of side effects such as gastrointestinal adverse reaction,liver and kidney dysfunction and abnormal electrocardiogram. The results revealed that for clinical breast cancer patients,Shenqi Fuzheng Injection combined with chemotherapy could significantly improve its clinical efficacy and reduce adverse reactions.However,the conclusions still need to be verified by high- quality,multi-center,large-sample,prospective,randomized and double-blind clinical trials | The current evidence shows that Shenlingbaizhusan as adjuvant therapy has better curative effect on gastric cancer, which can improve the efficiency of treatment and quality of life, and reduce some adverse reactions of chemotherapy. Due to limited quality and quantity of the included studies, more high quality studies are needed to verify above conclusions |
| C00-D48 신생물 | Liu | 2019 | China | Primary Liver Cancer | 24 | 1) Studies of patients with PLC confirmed by pathology, cytology or imaging, according to National Comprehensive Cancer Network (NCCN) clinical guidelines for hepatobiliary cancers 2) RCTs 3) Studies comparing the effects of AD plus Western medical therapy (WMT) with WMT alone in the treatment of PLC 4) Studies including data on patient QOL and short-term response rates of chemotherapy. | 1) Studies including patients with liver metastases or those with incomplete or inconsistent data | Aidi Injection(AD) + Western medical therapies (WMT) | Western medical therapies (WMT) | 1) Rate of short-term response to chemotherapy 2) QOL: karnofsky performance status 2) Survival 3) Improvement of clinical symptoms 4) Adverse events (AEs) | The risk ratio (RR) and 95% confidence intervals (CI) of ORR, DCR, QOL, neutropenia, thrombocytopenia, gastrointestinal toxicity and liver injury were as following: 1.32 (1.20 to 1.46), 1.14 (1.09 to 1.20), 1.89 (1.66 to 2.16), 0.61 (0.51 to 0.74), 0.62 (0.45 to 0.87), 0.59 (0.49 to 0.72) and 0.52 (0.36 to 0.75). Compared to chemotherapy alone, all differences were statistically significant. Subgroup analysis showed that only with the TP, Aidi injection could increase the ORR and DCR. Treatment with 100 ml, 80 ml or 50 ml/time, and 14 days/2 cycles or 21 days/2-4 cycles, Aidi injection could increase the ORR and DCR, respectively. Sensitivity analysis showed that the results had good robustness. None of the trials reported the overall survivals (OS), progression free survival (PFS). The quality of evidences was moderate. | AD in combination with WMT improves QOL in patients with PLC. Considering the inherent limitations of the included studies, further well-designed, rigorously performed, high-quality, and double-blinded RCTs with large sample sizes are needed. |
| C00-D48 신생물 | Zhang | 2019 | China | Esophageal cancer | 55 | 1) The study included patients affected by esophageal cancer, without limitations on gender, age, race, region, or nationality. 2) The interventions involved the administration of CHIs combined with radiotherapy in either arm of treatment, and the CHIs used (such as Aidi injection, Compound kushen injection, and Kangai injection) were authorized by the China Food and Drug Administration and applied in clinics for treating tumors. 3) The study performed a comparison with esophageal cancer patients receiving only radiotherapy, regardless of its course or dosage. 4) The study described efficacy outcomes, such as the clinical effectiveness rate, performance status, and 1-year and 2-year survival rate, and the safety outcomes were ADRs, such as leucopenia, gastrointestinal reactions, and radiation esophagitis. 5) The study was a RCT that compared the relative outcomes of CHIs combined with radiotherapy. | 1) Patients were with other tumors. 2) The interventions included surgery chemotherapy or other cancer treatments; CHIs were not combined with radiotherapy in either arm; arms from the same trials were different in their therapy duration or drug administration 3) Relevant outcome indexes were not reported or estimated 4) The study designs and publication types were non-RCT or were duplicates, and or the full text was unavailable. | Chinese herbal injections (CHIs) + radiotherapy | Radiotherapy | 1) Clinical effectiveness rate 2) Performance status 3) Adverse reactions (ADRs) 4) Survival rate | The clinical response rate (relative risk (RR) = 1.21, 95% confidence interval (CI): 1.06 to 1.37; P = 0.003), KPS (RR = 2.18, 95% CI: 1.49 to 3.17; P < 0.0001), immune function (mean differences (MD) = 0.82, 95% CI: 0.12 to 1.52; P = 0.02) and adverse effects (RR = 0.67, 95% CI: 0.60 to 0.74; P < 0.00001) in the CKI plus chemo group showed significant differences when compared with chemo alone. | The current clinical evidence indicated that Compound kushen injection combined with radiotherapy is the most preferable and beneficial option for patients with esophageal cancer in terms of efficacy and safety. However, the results of our study should be interpreted with caution given the limitations of the sample size and the methodological quality of the included trials. |
| C00-D48 신생물 | Shen | 2019 | China | Non-small cell lung cancer | 41 | 1) Randomized controlled trial 2) The research objects were patients with NSCLC 3) The therapy used in the treatment group was the supplementing Qi and nourishing Yin method combined with chemotherapy, and the therapy used in the control group was chemotherapy 4) The study included only English and Chinese articles. | 1) It was a repeat published article, or the content and result were same as that of some other study 2) It was a case report, theoretical research, conference report, systematic review, metaanalysis, expert comment, or economic analysis 3) The outcomes were not what we needed. | Chemotherapy + Tonifying Qi and Yin (supplementing Qi, nourishing Yin and detoxifying compound; Yiqiyangyin decoction; Yiqi nourishing Yin and uzheng solid prescription) | Chemotherapy | 1) Effective rate 2) Karnofsky score 3) TCM symptom | TRR of the group with TCMs combined with 5-FU-based regimens was higher than that in the group with 5-FU regimens alone (risk ratio [RR] 1.36 [1.25-1.49], I2 = 0%). Furthermore, both nonoral administration (RR 1.51 [1.29-1.76], I2 = 0%) and oral administration (RR 1.31 [1.18-1.45], I2 = 0%) of TCMs showed benefits to the CRC treatment. Further sensitivity analysis of specific plant-based TCMs found that fuling, sheshecao, banzhilian, eshu, baizhu, huangqi, yiyiren, and dangshen had significantly higher contributions to the results of the risk ratio. | These results demonstrated that supplementing Qi and nourishing Yin combined with chemotherapy would have better clinical efficacy in effective rate, the Karnofsky score, and TCM symptom. Most of the included studies had a low Jadad score; however, there is still a need for high‐quality, larger‐sample, multicentric, and long‐term follow‐up randomized controlled trials to confirm our conclusion |
| C00-D48 신생물 | Chen(2) | 2019 | China | Colorectal Cancer | 45 | 1) Disorder: colorectal cancer and related terms 2) Intervention: fluorouracil (5-FU), herbal medicine, traditional medicine, and related terms 3) Study type: randomized controlled trial and related terms. The test arm and the control arm of the randomized controlled trials that are involved in the meta-analyses were fluorouracil regimens combined with TCM intervention and fluorouracil regimen alone, respectively. | NR | Traditional Chinese medicines (TCMs) + 5-fluorouracil (5-FU)-based chemotherapy | 5-FU-based chemotherapy | 1) Tumor response rate (TRR) | The combination of Astragalus-based Chinese medicines and chemotherapy may increase the efficiency of tumor response rate (TRR) for the treatment of CRC patients (RR: 1.52; 95% CI: 1.24–1.87; p < 0.0001), improve their life quality based on KPS (RR: 2.51; 95% CI: 1.85–3.42; p < 0.00001 and WMD: 10.96; 95% CI: 9.45–12.47; p < 0.00001), and reduce the adverse reactions, including neutropenia (RR: 0.52; 95% CI: 0.44–0.62; p < 0.00001), anemia (RR: 0.49; 95% CI: 0.34–0.70; p < 0.0001), thrombocytopenia (RR: 0.59; 95% CI: 0.46–0.77; p = 0.0001), nausea and vomiting (RR: 0.56; 95% CI: 0.46–0.68; p < 0.00001), diarrhea (RR: 0.55; 95% CI: 0.40–0.75; p = 0.0001), and neurotoxicity (RR: 0.56; 95% CI: 0.49–0.65; p < 0.00001). Hepatic dysfunction (RR: 0.76; 95% CI: 0.53–1.09; p = 0.13) and renal dysfunction (RR: 0.95; 95% CI: 0.51–1.76; p =0.87) were similar between two groups. | TCMs may have the potential to improve the efficacy of 5-FU-based chemotherapy for CRC. |
| C00-D48 신생물 | Wu | 2019 | China | Advanced Gastric Cancer | 14 | 1) RCT of XAPI combined with chemotherapy, regardless of blindness and language. 2) Patients were diagnosed with advanced gastric cancer by pathology or cytology and had lost the opportunity for surgical treatment. There were no restrictions on gender, age, nationality, etc. 3) The control group was treated with chemotherapy alone, regardless of the chemotherapy regimen. The experimental group was treated with XAPI combined with chemotherapy, and the chemotherapy regimen was consistent with the control group 4) one or more of the folliwng outcome indicators: 1> Tumor objective response rate (ORR) and disease control rate (DCR) 2> Qulity of life: KPS 3> Survival data: PFS and OS 4> Drugrelated adverse events | 1) Other Chinese herbal medicines, Chinese patent medicines, and acupuncture were combined in the treatment 2) Other chemotherapy regimens have been applied before enrollment 3) There were repeated publications 4) There were data that cannot be obtained. | Chemotherapy + Xiao Ai Ping injection (XAPI) | Chemotherapy | 1) Tumor objective response rate (ORR) and disease control rate (DCR) 2) Qulity of life: KPS 3) Survival data:PFS and OS 4) Drug related adverse events | Significant differences in total effectiveness between WM and TCM or combination of TCM with WM {(OR = 2.63, 95 % CI = 1.37, 5.03), test of the combined effect (Z = 2.91, p ˂ 0.005)}. | The findings of the present systematic review and metaanalysis indicate that XAPI combined with chemotherapy may represent a beneficial treatment strategy in patients with advanced gastric cancer, particularly the combination pf XAPI with XELOX. However, further high-quality randomized controlled trials of standardized design and following the principles of evidence-based medicine are needed to validate this conclusion. |
| C00-D48 신생물 | Liu | 2019 | China | Advanced pancreatic cancer | 16 | 1) Controlled trials conducted with patients with advanced PC 2) Studies comparing the clinical outcomes of radiochemotherapy and KLT injection adjuvant therapy (experimental group) with radiochemotherapy alone (control group) 3) Studies that included >30 patients with PC. | 1) Non-contrast articles, case studies, review articles 2) Patients with mixed malignancies. | Kanglaite (KLT) injection + radiochemotherapy | Radiochemotherapy | 1) Treatmen efficacy 2) Quality of life (QoL) 3) Adverse events | A total of 41 studies were involved in the meta‐analysis with 1335 objects in the treatment group and 1272 objects in the control group. Compared with chemotherapy, supplementing Qi and nourishing Yin combined with chemotherapy significantly increased the effective rate (RR: 1.37, 95% CI: 1.24‐1.51), increased the Karnofsky score (RR: 1.50, 95% CI: 1.39‐1.61), and improved the TCM symptom (RR: 1.69, 95% CI: 1.55‐1.85). | Evidence from the Meta-analysis suggested that the combinational treatment of radiochemotherapy and KLT injection is more effective in advanced PC treatment than radiochemotherapy alone. Additionally, the combination therapy improved QoL of the patients. KLT injection can alleviate the adverse effects associated with the radiochemotherapy. |
| C00-D48 신생물 | Lin | 2019 | China | Colorectal Cancer | 22 | 1) Outcomes of chemotherapy with or without Astragalus-based herbal therapy for CRC treatment were analyzed 2) At least one of the outcomes was reported 3) Check whether dual or multiple studies were reported by the same institution and/or authors, either the one of higher quality or the most recent publication was included in the analysis | 1) Non-randomized control trials, letters, editorials, abstracts and expert opinions, reviews without original data 2) Studies or case reports lacking control groups 3) It was impossible to extract the appropriate data from the published results; the outcomes and parameters of patients were not clearly reported [e.g., with no clearly reported outcomes or standard deviations (SD)]; or there was overlap between authors or centers in the published literature. | Astragalus-based Chinese medicines + chemotherapy | Chemotherapy | 1) Tumor response rate (TRR) 2) Quality of life (QOL) 3) Drug toxic effects (DTE) | Twenty-four RCTs were included in this study. Compared with WMT used alone, AD as additional intervention was more effective on improving QOL (P<0.01), increasing short-term effifi cacy (P<0.01), prolonging life (P<0.05 or P<0.01), relieving clinical symptoms (P<0.01), and reducing adverse events (e.g. reduce white blood cell counts, P=0.002; reduce in platelet counts, P<0.01). Subgroup analysis showed that the hepatic artery interventions with AD was superior in improving QOL (P<0.01) and enhancing short-term response rates (P=0.007) and reducing white blood cell counts (P=0.0004) than hepatic artery interventions alone (P<0.01). The chemoembolization plus AD or the chemotherapy plus AD were both better than chemoembolization or the chemotherapy alone in improving the QOL and short-term response rate (P<0.05 or P<0.01). | Astragalus-based Chinese medicines combined with chemotherapy in the treatment of CRC may increase the efficiency of TRR, reduce chemotherapeutic agents-associated adverse reactions, and improve their life quality when comparedwith chemotherapy alone, but further randomized studies arewarranted. |
| C00-D48 신생물 | Pu | 2019 | China | Non-Small-Cell Lung Cancer | 10 | 1) Research Object. All patients enrolled in this study, regardless of gender and age, were diagnosed by histopathological examination and were expected to survive for more than 3 months, as well as in line with the relevant standards for NSCLC developed by the International Union Against Cancer (UICC) in 1997) 2) Type of Study. In all the included RCTs, the control group was treated with chemo and the experimental group was given CKI on the basis of the control group. In brief, the requirement of the experimental design should reflect the individual effects of CKI. And there were no limits to the treatment dose and duration in both groups. | 1) Research Object. Chemotherapy contraindications and other systemic acute diseases affecting the test results were excluded. 2) Type of Study. All observational and cohort studies were excluded. | Compound Kushen injection (CKI)+chemo treatment (chemo) | Chemo treatment | 1) Clinical Efficiency 2) KPS 3) Immune Function 4) Adverse Event | Fourteen studies, representing 1097 enrolled patients, were included in our analysis. Compared with chemotherapy alone, combination treatment with XAPI and the XELOX regimen (capecitabine plus oxaliplatin) was found to improve the objective response rate (ORR) [RR=1.36; 95%CI (1.10, 1.70); P=0.006], disease control rate (DCR) [RR=1.15; 95% CI (1.04, 1.28); P=0.010], and Karnofsky Performance Status (KPS) improvement rate [RR=1.51; 95%CI (1.14, 2.00); P=0.004] and to reduce the incidence of leukopenia [RR=0.68; 95%CI (0.55,0.84); P=0.0005], liver damage [RR=0.59; 95% CI (0.37, 0.92); P=0.02], renal impairment [RR=0.39; 95% CI (0.18, 0.85); P=0.02], and hand-foot syndrome [RR=0.56; 95%CI (0.35,0.90); P=0.02]. However, median progression-free survival (PFS), 1-year survival rate, andmedian overall survival (OS)were not extended byXAPI plusXELOX.Combination treatmentwithXAPI and the SOXregimen (tegafur plus oxaliplatin) did not improve ORR or DCR, but it did enhance the KPS improvement rate [RR=1.73; 95%CI (1.23,2.43); P=0.002] and reduce the incidence of nausea and vomiting [RR=0.66; 95% CI (0.50, 0.88); P=0.004]. XAPI in combination with the FOLFOXregimen (fluorouracil/calciumfolinate/oxaliplatin) enhanced only theKPS improvement rate [RR=1.68; 95%CI (1.18,2.39); P=0.004] and had no significant effect on ORR or DCR or the incidence of adverse events. A single study reported that XAPI combined with the CPT-11 regimen (irinotecan) was superior to chemotherapy alone with respect to DCR and also reduced the incidence of leukopenia, liver damage, and hand-foot syndrome during chemotherapy, while prolonging PFS. Finally, one study reported that XAPI combined with the TP regimen (palitaxel plus cisplatin) improved ORR and KPS improvement rate to a greater extent than TP alone. Although the present review has some limitations, the findings suggest that XAPI combined with chemotherapymay represent a beneficial treatment strategy, particularly the combination of XAPI and XELOX. | CKI combined with chemo can improve clinical efficiency, KPS, and immune function and reduce adverse reactions in patients with NSCLC when compared with chemo alone. However, more rigorously designed RCTs are needed to validate this benefit, as some of the included RCTs are of low methodological quality |
| C00-D48 신생물 | Xiao | 2020 | China | Advanced non–small-cell lung carcinoma | 54 | 1) Patients had stage III-IV NSCLC and were diagnosed using the histopathological and cytological diagnostic criteria and the TNM staging system; all patients were intolerant for surgery 2) The intervention studied was Aidi injection administered via intravenous injection 3) The experimental group was administered Aidi injection with NP, and the control group was administered NP alone 4) No patients had received chemotherapy, radiotherapy, targeted therapy or TCM within one month before treatment. 5) The primary outcomes were tumor response and survival, and the secondary outcomes were quality of life (QOL), ADRs, and levels of peripheral blood lymphocytes. 6) All RCTs. There was no limit to follow-up procedures or types of settings. | 1) Duplicated records 2) Studies regarding non-NSCLC, non-Aidi injection or Aidi injection alone 3) Aidi injection combined with other chemotherapy, targeted therapy, or radiotherapy 4) Cohorts, casecontrol studies, and case reports 5) Meeting abstracts and reviews without usable data 6) Unrelated systematic reviews or meta-analyses 7) Studies without data on tumor response, survival, QOL, ADRs, or levels of peripheral blood lymphocytes. | Aidi injection combination + vinorelbine + cisplatin | Vinorelbine and cisplatin (NP) | 1) Tumor response 2) Survival 3) Quality of life (QOL) 4) ADRs 5) Levels of peripheral blood lymphocytes. | Of 685 identified trials, 55 were eligible for inclusion in the study. These 55 trials included 12 CHIs and 4,114 participants. The cluster analysis results suggested that Compound kushen injection therapy is the optimal CHI treatment for patients with esophageal cancer in terms of improving the clinical effectiveness rate and performance status. Huachansu and Kangai injection are superior in improving 1-year and 2-year survival rates. Lentinan injection may be considered a favorable choice for reliving ADRs, and Compound kushen injection may provide treatment benefits by reducing both gastrointestinal reaction and radiation esophagitis. | The results suggest that administration of the Aidi injection and concomitant NP is beneficial to NSCLC, and provide evidence for the optimal threshold and treatment regimen that may improve tumor response with a good safety level. |
| C00-D48 신생물 | Feng | 2020 | China | Advanced non-small-cell lung cancer | 24 | 1) Only clinical randomized controlled trials (RCTs) 2) Studies in which diagnosis of NSCLC had been verified by cytology or tissue biopsy. Furthermore, only patients with pathologically documented NSCLC of stage III or IV, according to the tumor-node-metastasis (TNM)- based staging of lung cancer were included 3) Studies where the treatment involved platinum-based chemotherapy with or without XAPI 4) Objective tumor response rate (ORR) and improvement of Karnofsky performance score (KPS) were regarded as the primary outcome measures. The adverse side effects and indicators of immune function were considered as secondary outcome measures. | 1) review articles, animal experiments, duplicated publications, inappropriate interventions, or they if did not present sufficient data. | Xiao-ai-ping injection + platinum-based chemotherapy | Platinum-based chemotherapy | 1) ORR 2) KPS 3) reduction in grade 3)4 myelosuppression, nausea and vomiting, other adverse side effects 4) Indicators of immune function | Data from 16 trials with 960 patients with advanced PC were included. Compared with radiochemotherapy alone, the combination of KLT injection and radiochemotherapy significantly improved the 1-year overall survival (OS, odds ratio [OR] = 2.58 95% CI: 1.12–5.93 P = .03), overall response (ORR, OR = 2.16 95% CI: 1.58–2.94 P <.00001) and disease control rates (DCR, OR = 2.50 95% CI: 1.84–3.38 P <.00001). The QoL of patients, who received a combination of radiochemotherapy and KLT injection, also improved compared with radiochemotherapy treatment alone as indicated by the increased quality of life improved rate (QIR, OR = 3.68 95%CI: 2.36–5.75 P <.00001), pain relief rate (PRR, OR = 3.70 95% CI: 2.23–6.14 P <.00001) and weight gain rate (WGR, OR = 3.69 95% CI: 2.22–6.13 P <.00001). Adverse events related to radiochemotherapy including gastrointestinal side effects, nephrotoxicity, leukopenia, thrombocytopenia, and myelosuppression were alleviated (P <.05) when KLT was injected to patients with PC. | Our meta-analyses demonstrated that XAPI in combination with platinum-based chemotherapy had a better tumor response, improved the quality of life, attenuated adverse side effects, and enhanced immune function, which suggests that it might be used for advanced NSCLC. Moreover, low dosage (< 60 ml/d) and longterm treatment of XAPI might be a choice for advanced NSCLC patients. |
| C00-D48 신생물 | Chen | 2020 | China | Non-small cell lung cancer, stage III/IV | 37 | 1) The participants: Diagnosis of stage III-IV NSCLC using the 2) Histopathological/cytological diagnostic criteria and TNM staging system at least one bi-dimensionally measurable lesion 3) Karnofsky performance status (KPS) score of at least 60 4) The range of Performance Status score from 0 to 2 5) Life expectancy at least 3 months. | 1) The trials were not RCTs 2) Sample size of either group was less than 30 patients 3) Diagnosis was not NSCLC 4) The staging was not at stage III/IV 5) The NSCLC diagnosis was not specified accurately 6) The trials in which baseline data of the participants were inconsistent 7) There were no relevant outcome measures 8) The chemotherapy regimen was not platinum-based chemotherapy (PBC) or not clarified 9) Radiotherapy, surgery, chemotherapy, immunotherapy, or Chinese medicine therapy other than CKI had been administered within three months before randomization; 10) Full-text articles or data was not available. | Compound Kushen injection (CKI) + platinum-based chemotherapy (PBC) | Platinum-based chemotherapy (PBC | 1) Disease control rate (DCR) 2) Objective response rate (ORR) 3) Quality of life (QOL) 4) Survival rate 5) Toxicities | Thirty-seven trials, recruiting 3,272 patients with stage III/IV NSCLC, were included. The results showed that, CKI combined with PBC resulted in significant improvements in DCR (RR = 1.11, 95% CI 1.07 to 1.15, P < 0.00001), ORR (RR = 1.30, 95% CI 1.20 to 1.40, P < 0.00001), QOL (RR = 1.73, 95% CI 1.55 to 1.92, P < 0.00001), 1-year survival rate (RR = 1.51, 95% CI 1.18 to 1.94, P = 0.001), and a 58% decline in the incidence of severe toxicities (RR = 0.42, 95% CI 0.37 to 0.49, P < 0.00001). | From the available evidence, our data indicate that CKI plus platinum-based chemotherapy is more effective in improving clinical efficacy and alleviating the toxicity of chemotherapy than platinum-based chemotherapy alone in the treatment of stage III/IV NSCLC. However, considering the intrinsic limitations of the included trials, high-quality RCTs with survival outcomes are still needed to further confirm our findings. |
| C00-D48 신생물 | Yang | 2020 | China | Non-small cell lung cancer | 20 | 1) RCT 2) Patients of non-small cell lung cancer were included, regardless of age, gender, ethnicity, or profession. 3) Studies conducting a comparison between the combination treatment with TCM and chemotherapy and the same chemotherapy alone were included. 4) The main therapeutic indicators were clinical efficacy and quality of life. Effective = CR (complete remission) + PR (partial remission). Secondary efficacy indicators were KPS score (including score stability and improvement), Adverse Drug reactions, QOL(qulity of life). | 1) Animal experiments, review, and other irrelevant studies 2) Patient without interventions of TCM 3) Non-RCTs studies 4) No detailed data about KPS score, QOL, and reduction of ADRs or no indicators for them 5) Lack of comparable control group 6) Single-arm study. | Traditional Chinese Medicine (TCM) + chemotherapy | Chemotherapy | 1) Total effective rate of clinical efficacy 2) Quality of life (QOL), 3) Karnofsky Performance Status (KPS) score 4) Adverse drug reactions (ADRs) | A total of 20 RCTs were included, with a total sample of 1669 cases, including 845 in the experimental group (TCM combined with chemotherapy) and 824 in the control group (chemotherapy alone). Compared with the control group, the experimental group significantly improved patients’ QOL [OR = 2.79, 95% CI (1.87, 4.16), P < 0.00001], improved clinical efficacy [OR = 2.88, 95%CI (2.32, 3.58), P < 0.00001], increased KPS score [OR = 2.88, 95%CI (1.79, 4.62), P < 0.00001], and reduced the incidence of leukopenia [OR = 0.21, 95%CI (0.12, 0.37), P < 0.0001], thrombocytopenia [OR = 0.23, 95%CI (0.13, 0.40), P < 0.00001], hemoglobin reduction [OR = 0.17, 95% CI (0.10, 0.30), P < 0.00001], myelosuppression [OR = 0.24, 95% CI (0.10, 0.58), P < 0.001], nausea and vomiting [OR = 0.16, 95% CI (0.11, 0.22), P < 0.00001], diarrhea [OR = 0.21, 95% CI (0.12, 0.37), P < 0.00001], liver damage [OR = 0.17, 95%CI (0.10, 0.27), P < 0.00001], and kidney damage [OR = 0.30, 95%CI (0.10, 0.90), P = 0.03]. | TCM combined with chemotherapy can improve clinical efficacy and KPS score, as well as improve patients’ QOL and reduce ADRs caused by chemotherapy drugs. |
| C00-D48 신생물 | Chen(2) | 2020 | China | Small cell lung cancer | 22 | 1) Participants: Adult patients diagnosed with small cell lung cancer regardless of age, gender, and chemotherapy regimen. The diagnosis must have been confirmed by pathological or cytology diagnosis. 2) Based on the Pharmacopoeia of the People’s Republic of China 2010, decoctions, tablets, pills, powders, granules, capsules, oral liquids, and injections are all formulations of TCM (Committee CP 2010), which, typically consisting of two or more herbs to achieve specific effects under specific conditions, are all determined by physicians according to TCM diagnostic and therapeutic theory. 3) Participants in the TCM-C group should receive the conventional chemotherapy and TCM for at least 28 days during or after chemotherapy. Participants in the C group should be treated by the conventional chemotherapy alone. There is no limit to the number of TCM herbs and formulas. 4) Outcome: therapeutic effect, Survival time, quality of life evaluated with Karnofsky score, adverse events 5) Only RCTs | 1) Adult patients diagnosed with non-small cell lung cancer 2) Patients did not receive TCM 3) Patients did not receive chemotherapy 4) Patients received tumor resection or targeted therapy 5) Duplicate publications (only the largest publication kept) 6) Case reports, letters, reviews, conference abstracts, animal experiments, and expert opinions | TCM + chemotherapy | Conventional chemotherapy | 1) Therapeutic effect 2) Survival time 3) Quality of life evaluated: Karnofsky score 4) Adverse events | We included 54 trials containing 4,053 patients for analysis. Combining the Aidi injection with NP significantly increased the objective response rate (odds ratio [OR], 1.32; confidence interval [CI], 1.23, 1.42), disease control rate (OR, 1.14; CI, 1.11, 1.18), and quality of life (OR, 1.80; CI, 1.61, 1.98), with decreased risks of myelosuppression, neutropenia, thrombocytopenia, anemia, gastrointestinal reaction, and liver dysfunction. For patients with a Karnofsky Performance Status score of ≥60, the Aidi injection (50 mL/day, two weeks/cycle, with two to three cycles) treatment with vinorelbine (25 mg/m2) and cisplatin (30–35 mg/m2 or 40–50 mg/m2) might be the optimal regimen for producing the desired tumor response and achieving a good safety level. Most results were robust, and their quality was moderate. | The systematic review indicated that TCM combined with chemotherapy may improve therapeutic effect, quality of life, and prolong survival time. More large-scale and higher quality RCTs are warranted to support our findings. |
| C00-D48 신생물 | Wang | 2020 | Taiwan | Advanced non-small cell lung cancer | 14 | 1) Patients diagnosed with advanced NSCLC (stage III-IV) using histopathological and cytological diagnostic criteria 2) Randomized controlled trial (RCT), regardless of blinding 3) An experimental group that received CHMs plus platinum-based chemotherapy, and a control group that received platinum-based chemotherapy alone 4) Dosage forms of CHM given as decoction, ground powders, capsules, pills or injections. | 1) Traditional non.CHM therapies 2) Systematic and narrative reviews, case reports, case controls, cohorts, cross-sectional studies, editorials, commentaries, and letters to the editor 3) The absence of specific data or statistical data, or significant inconsistencies in the baseline data of the patients. | Chinese herbal medicines (CHMs) + platinum-based chemotherapy | Platinum-based chemotherapy | 1) Objective response rate (ORR) 2) Disease control rate (DCR) 3) Quality of life (QOL) 4) Tumor response 5) Progression- free survival 6) Median survival time 7) 1-year overall survival rate | 22 RCTs involving 1887 patients were included in this study. Compared with patients treated with chemotherapy alone, those with Chinese herbal medicine and chemotherapy (TCM-C) had better therapeutic effects (RR = 1.295, 95% CI 1.205–1.391, P < 0.001), KPS scores (RR = 1.310, 95% CI 1.210–1.418, P < 0.001), 1-year survival rate (RR = 1.282, 95% CI 1.129–1.456, P < 0.001), 3-year survival rate (RR = 2.109, 95% CI 1.514–2.939, P < 0.001), and 5-year survival rate (RR = 2.373, 95% CI 1.227–4.587, P = 0.01). The incidence of gastrointestinal reaction (RR of = 0.786, 95% CI 0.709–0.870, P < 0.000) and bone marrow depression (RR = 0.837, 95% CI 0.726–0.965, P = 0.014) in TCM-C group were lower than that in the C group. | Our study found that higher ORR, DCR, QOL, mST and 1-year OS rate were associated with CHM use as an adjuvant to chemotherapy. Although these results require further confirmation, CHMs apparently have potential therapeutic value for patients with advanced NSCLC. |
| C00-D48 신생물 | Xiao | 2018 | China | Non-small cell lung cancer | 31 | 1) The patients were diagnosed with stage III-IV NSCLC in accordance with histopathological and cytological diagnostic criteria and TNM staging system (Mountain, 1989). 2) Randomized controlled trials (RCTs) 3) Experimental groups were treated with Aidi injection plus paclitaxel-based chemotherapy, and the control groups were treated with chemotherapy alone that included the TP, TO and TC. 4) Previously being recruited in the study, the participants did not receive the radiotherapy, docetaxel and other chemotherapies and traditional Chinese herbs. | 1) Duplicated citations, irrelevant citations including studies about in-vitro, animal, and/or conditions such as subjects receiving surgery, radiotherapy, docetaxel, other chemotherapies and traditional Chinese herbs 2) Non-randomized controlled studies including case control, cohort and case report study 3) Meeting abstracts and reviews without usable data, and irrelevant SRs and meta-analyses, studies without the tumor responses, survivals, QOL and ADRs. | Aidi injection + paclitaxel-based chemotherapy | Chemotherapy alone | 1) Objective response rate (ORR) 2) Disease control rate (DCR) 3) Survivals 4) Quality of life (QOL) 5) Adverse drug reactions (ADRs) | Reports of 14 randomized controlled trials involving 1451 patients were included in the analysis. Among them, 739 patients received CHMs, and 712 patients received chemotherapy alone. The ORR (RR=1.37, 95 % CI [1.20‐1.58], p= .000), DCR (RR = 1.13, 95 % CI [1.07‐1.21], p = 0.000), QOL (SMD=1.47; 95 % CI [0.30–2.64]; p = 0.014), mST (SMD=1.62; 95 % CI [1.15‐2.08];p= .000), and 1-year OS rate (RR = 1.24, 95 % CI [1.05‐1.47], p= 0.01) were higher in patients with NSCLC who received CHMs than in those who received only chemotherapy. However, the CHM group was not found to have a higher median PFS (SMD=1.27, 95 % CI [-0.22‐2.78], p= .095) than the chemotherapy group. Publication bias for ORR and DCR was indicated by funnel plot. For the efficacy endpoint, no evidence of a lack of robustness was found, according to the sensitivity analysis. These results must be interpreted with caution due to differences in the designs of the trials and patients’ characteristics, and also due to the presence of missing data. | Current moderate evidence revealed that Aidi injection plus paclitaxel-based chemotherapy, especially TP can significantly improve the clinical efficacy and QOL for patients with stage III/IV NSCLC. Aidi injection can relieve the risk of hematotoxicity, gastrointestinal toxicity and liver injury in patient with NSCLC receiving paclitaxel-based chemotherapy. The optimal usage may be 50 ml/time and 14 days/2 cycles. |
| C00-D48 신생물 | Yukun | 2019 | China | Triple negative breast cancer | 16 | 1) Diagnostic criteria postoperative pathological examination resulting in diagnosis of breast cancer, and immunohistochemistry showing negative expressions of ER, PR and HER-2) 2) Intervention treatment with TCM or combination of TCM and WM in which the TCM was given through oral administration, external application and emotional therapy. studies in which the control group used WM treatment methods such as surgery, WM, and radiotherapy, and combination treatment studies involving use of both TCM and strategies. 3) Study indices Studies in which clinical remission was evaluated according to WHO evaluation criteria; studies in which total effectiveness was evaluated as the sum of complete responses and partial responses, with secondary observation indicators such as quality of life, immune indicators and survival rates | 1) Non-RCT literature, 2) Randomized controlled trials involving different Chinese medicine or integrated TCM and WM treatment regimens in the control-group and the treatment-group 3) Non-clinical studies 4) Studies without clinical observation 5) Studies involving animal experiments, reviews, and clinical studies without statistical analysis. | Traditional Chinese Medicine (TCM) | Western Medicine treatment | 1) Immune function 2) Quality of life 3) Survival rate | We included and analyzed 24 randomized controlled trials. The meta-analysis showed that XAPI adjunctive to platinum-based chemotherapy had better outcomes in objective tumor response rate (ORR) (RR: 1.27, 95% CI, 1.14–1.40); improved Karnofsky performance scores (KPS) (RR: 1.70, 95% CI, 1.48–1.95); reduction in occurrence of grade 3/4 leukopenia (RR: 0.49, 95% CI, 0.38–0.64), anemia (RR: 0.63, 95% CI, 0.46–0.87) and thrombocytopenia (RR: 0.53, 95% CI, 0.38–0.73), nausea and vomiting (RR: 0.57, 95% CI, 0.36–0.90); and enhanced immune function (CD8+ [MD: 4.96, 95% CI, 1.16–8.76] and CD4+/CD8+ [MD: 2.58, 95% CI, 1.69–3.47]). However, it did not increase dysregulated liver and kidney function, diarrhea, constipation, and fatigue. Subgroup analysis of ORR and KPS revealed that dosage, treatment duration, and methodological quality did not affect the outcome significantly. | The results show that TCM is effective in the treatment TNBC. |
| C00-D48 신생물 | Wu | 2019 | China | Any Cancers | 4 | 1) They claimed RCTs with baseline data without significant differences in clinical characteristics, among both the experimental and the control groups. 2) The subjects of both groups were patients diagnosed with cancer. 3) The experimental group received CHM combined with other active treatments, which was the same as was given to the control group. 4) Studies investigated at least one of the outcomes listed below: (I) Clinical benefit, evaluated with the WHO scale. (II) Conventional therapy-induced toxicity events, | NR | Traditional Chinese Medicine + chemotherapy | Chemotherapy | 1) Disease control rate 2) Objective response rate 3) Bone marrow suppression 4) Gastrointestinal reactions | Four RCTs were included in this review, comprising 256 subjects. The majority of the RCTs were judged as being of poor methodological quality. Meta-analysis showed that the combination of traditional Chinese medicine preparation and chemotherapy appeared to be more effective than chemotherapy alone, for the treatment of cancer, as assessed by the disease control rate (RR: 1.41, 95% CI: 1.11 to 1.79) and the objective response rate (RR: 2.71, 95% CI: 1.28 to 5.77).There were no statistically significant differences between the groups in terms of bone marrow suppression (RR: 0.88, 95% CI: 0.57 to 1.37) or gastrointestinal reaction (RR: 1.12, 95% CI 0.75 to 1.69). | Traditional Chinese medicine preparation combined with chemotherapy may improve objective response rates and disease control rates more than chemotherapy alone.The evidence that combined traditional Chinese medicine preparation can reduce the side effects of chemotherapy is insufficient. More rigorous randomized controlled trials are needed to confirm these conclusions. |
| C00-D48 신생물 | Zhang | 2019 | China | Advanced non-small cell lung cancer | 29 | 1) RCT: with reference to advanced NSCLC, in which patients in the experimental groups were treated by CFI (intravenous infusion) and chemo-combined therapy, and patients in the control groups were treated by solely chemotherapy. | NR | Cinobufotalin injection (CFI) + chemotherapy | Chemotherapy | 1) Therapeutic effects, (overall survival rate(ORR) and disease-control rate(DCR)) 2) QoL 3) Adverse events. | Nine RCTs involving 963 patients were included for meta-analysis. More concretely, the combination therapy showed the risk ratio (RR) and 95% confidence intervals (CI) of ORR and ADRs as (RR, 1.21 [95% CI, 1.15, 1.28]) and (RR, 0.37 [95% CI, 0.27, 0.51]), respectively. And other major outcomes were as follows: hospitalization durations (standard mean difference (SMD), − 1.32 [95% CI, − 1.48, − 1.16]), antipyretic time (SMD, − 1.26 [95% CI, − 1.70, − 0.83]), cough disappearance time (SMD, − 1.07 [95% CI, − 1.38, − 0.75]), and the disappearance time of lung wet Rales (SMD, − 0.83 [95% CI, − 1.07, − 0.60]). With statistically significant differences in various aspects, the combination therapy plus XYP displayed obvious advantages in contrast to AZM alone. | The combination of CFI and chemotherapy is safe, and is more effective in treating NSCLC than chemotherapy alone. Therefore, CFI mediated therapy could be recommended as an adjuvant treatment method for NSCLC. |
| E00-E90 내분비, 영양 및 대사질환 | Lian | 2018 | China | Type 2 diabetes | 15 | 1) Randomized controlled trial (RCT) of Jinlida granules in with combination antidiabetic agents to control glucose levels in patients with T2D 2) Participants of any ethnic origin, sex, and age, with the definition of T2D based on 1999 World Health Organization (WHO) criteria or 2017 ADA criteria 3) Jinlida used in combination with antidiabetic agents for the treatment of T2D patients, with the intervention lasting at least 12 weeks and compared with treatment with antidiabetic agents alone or with placebo 4) Primary outcome measures of HbA1c (considered the gold standard for glucose monitoring in T2D), fasting blood glucose (FBG), and 2-hour postprandial blood glucose (2hPG), and secondary outcome measure including homeostasis model assessment of insulin resistance (HOMA-IR), homeostatic model assessment of β-cell function (HOMA-β), body mass index (BMI), and adverse events (AEs). | NR | Jinlida+ antidiabetic agents | Antidiabetic agents | 1) Glycosylated hemoglobin 2) Fasting blood glucose 3) 2-Hour postprandial glucose 4) Homeostatic model assessment of β-cell function 5) HOMA-IR 6) Body mass index 7) Adverse events | Decreases in HbA1c were greater in groups receiving Jinlida granules as add-on therapy compared with control groups (n = 1820; mean difference - 0.66; 95% confidence interval - 0.72, - 0.60; P < 0.00001; I2 = 38%). In addition, Jinlida granules reduced body mass index and had beneficial effects on homeostatic model assessment of β-cell function and homeostasis model assessment of insulin resistance. No obvious adverse events were reported. | Findings from this meta-analysis demonstrate additional benefits of Jinlida granules as an add-on therapy for T2D and that Jinlida granules are generally safe. Treatment with Jinlida granules provided clinically and statistically significant reductions in fasting plasma glucose, 2-hour post-load glucose, and HbA1c levels in patients with T2D. However, the findings should be interpreted with caution due to the small sample size and study limitations. |
| G00-G99 신경계통의 질환 | Han | 2019 | China | Post-stroke dysarthria | 72 | 1) Patients with first-onset stroke 2) Combined with dysarthria those who are obstructed 3) Age ≥50 years old 4) Patient is conscious and able to cooperate in articulationTraining and acupuncture treatment 5) Patients and their families informed and signed the treatment plan | 1) Patients with mental illnesses such as post-stroke depression and unable to cooperate with articulation training and acupuncture treatment 2) Combined with the risk of other organs in the body Severely ill 3) Severe or advanced to advanced disease 4) Incomplete medical records those who cannot perform statistical analysis | Acupuncture treatment(fengchi, gongxie, yiming, zhichong, tunyan, juquan, jinjin, yuye) + speech-language training | Speech-language training | 1) Clinical efficacy evaluation | One hundred and twenty-one Chinese articles were retrieved. There was 1 article published in 2004, total 14 articles by the end of 2018. The articles (n=5) are mainly form Chengdu University of Traditional Chinese Medicine by Hu Kaming team. Sixty percent of the first ten affiliations and the first eight authors were form the Chinese Medicine Universities or their affiliated hospitals. Of them, 72 articles addressed acupuncture and moxibustion, including 7 in acupuncture at tongue, 8 in acupuncture at tongue and neck, 7 in acupuncture at tongue and head, 12 in acupuncture and electrostimulation, 3 in acupuncture and hyperbaric oxygen therapy, and 35 in acupuncture and rehabilitation training. (2) The total effctiveness rate in the treatment group (92%) was significantly higher than that in the control group (54%) (P < 0.05) | In China, studies on the treatment of post-stroke dysarthria are mainly from Chinese Medicine Universities and their affiliated hospitals. Chinese medicine, especially acupuncture and moxibustion (acupuncture at tongue and neck mostly used) is an important means in the treatment of post-stroke dysarthria. Clinical trial results suggest that post-stroke dysarthria treated by acupuncture at tongue and neck combined with speech-language training can obtain satisfactory outcomes. |
| G00-G99 신경계통의 질환 | Li | 2019 | China | Poststroke dysphagia | 17 | 1) Patients: all of the participants had been diagnosed with ischaemic or haemorrhagic stroke by CT or MRI and were clinically confirmed to have dysphagia 2) Study design: the trials had to be randomised controlled trials (RCTs, not including quasi-RCTs) that aimed to compare combination therapy with swallowing training alone 3) Outcomes: the primary outcomes were the clinical effective rate (ER), swallowing function assessment (SFA), individual activity (IA; eg, the modified Barthel index (MBI)) and QOL (eg, swallowing-related QOL (S-QOL)) | 1) Non-original research articles 2) Studies that were not published in English or Chinese 3) Studies in which the required data were unavailable. | Manual acupuncture + swallowing training | Swallowing training | 1) Clinical effective rate (ER) 2) Swallowing function assessment (SFA) 3) Individual activity (IA; eg, the modified Barthel index (MBI)) 4) QOL (eg, swallowing-related QOL (S-QOL)) 5) Adverse events | Acupuncture may have a superior effect on GCS score (MD=2.03, 95% CI :1.92 2.43, Z=16.54, and P<0.00001); GOS score (RR=1.23, 95%CI: 1.18 1.35, Z=6.65, and P<0.00001); efficacy rate (RR=1.48, 95%CI: 1.40 1.56, Z=13.49, and P<0.00001); ADL (MD=9.20, 95% CI:8.19 10.21, Z=17.84, and P<0.00001); and mortality (RR=0.50, 95% CI:0.38 0.67, Z=4.70, and P<0.00001). | This study showed that acupuncture combined with swallowing training may improve the ER, swallowing function and activities of daily life of patients with poststroke dysphagia compared with conventional swallowing training alone. |
| G00-G99 신경계통의 질환 | Tan | 2019 | China | Disorder of consciousness after Traumatic Brain Injury(TBI) | 49 | 1) All trials in which the intervention involved acupuncture or electroacupuncture separately, or acupuncture combined with other interventions, such as hyperbaric oxygen (HPO), traditional Chinese medicine (TCM) rehabilitation, and electrical stimulation. 2) There was no distinction for acupoints, manipulation, stimulation intensity, or the course of treatment. 3) It is available for basic treatment or combined with rehabilitation training in the control group. 4) The trials’ outcome indicators had to include at least one of the following: Glasgow Coma Scale (GCS) or Glasgow Outcome Scale(GOS). | 1) Trials that used transcutaneous electrical nerve stimulation and/or manual acupressure and DOC results from nontraumatic diseases, such as cerebrovascular disease, tumor, or toxicosis, were excluded. 2) Trials without a nonacupuncture group were also excluded.le (GCS) or Glasgow Outcome Scale(GOS). | Acupuncture (electroacupuncture) OR acupuncture + other interventions | Basic treatment | 1) Glasgow Coma Scale (GCS) 2) Glasgow Outcome Scale (GOS) 3) Mortality 4) Efficacy rate 5) Activities of daily living 6) Functional comprehensive assessment | The pooled ER (RR 1.26, 95% CI 1.19 to 1.34, P<0.001, 14 studies) and SFA (SMD 1.06, 95% CI 0.79 to 1.32, P<0.001, five studies) suggested that combination therapy yielded a significantly higher ER and improved the SFA scores to a greater degree than swallowing training alone in patients with poststroke dysphagia. The pooled QOL score (SMD 1.06; 95% CI -0.04 to 2.17, P=0.06, two studies) did not differ between groups. The MBI data (SMD 1.47, 95% CI 1.07 to 1.87, P<0.001, one study) showed significant improvement in IA. Some evidence of publication bias was observed for the ER, although the trim-and-fill analysis and fail-safe number indicated no influence of publication bias on its pooled effect size. There was no evidence of publication bias of any other outcome measures | the acupuncture group fared better than the control group in the treatment of DOC after TBI. However, studies were generally of poor quality, and publication bias favoring positive studies was obvious. Therefore, rigorous evaluation standards and well-designed studies are necessary in future studies. |
| G00-G99 신경계통의 질환 | Cai | 2019 | China | Post-stroke spasticity | 24 | 1) Randomized controlled trials (RCTs) or quasi RCTs 2) Patients with one or multiple strokes that were confirmed by computed tomography or magnetic resonance imaging 3) Ashworth Scale (AS) or Modified Ashworth Scale (MAS) of any joint ≥1 4) Comparison of any type of RC with or without CHM, or with placebo, with co-intervention being allowed as long as it was incorporated into all arms 5) Studies that reported at least one of the following outcome measures: AS or MAS for spasticity severity as the primary outcome measure, Fugl-Meyer Assessment of Sensorimotor Recovery (FMA) for motor function and Barthel Index (BI) for assessment of activities of daily living as secondary outcome measures, and reporting of adverse events as a safety outcome. | 1) Studies of patients with stroke symptoms caused by trauma, tumor, infection, and subdural hemorrhage 2) The add-on effects of CHM could not be estimated due to the involvement of other interventions | Chinese herbal medicine (CHM) + routine care (RC: including pharmacotherapy and/or rehabilitation therapies) | Routine care (RC) | 1) Ashworth Scale (AS or MAS) 2) Fugl-Meyer Assessment of Sensorimotor Recovery (FMA) 3) Barthel Index (BI). 4) Adverse events | Thirty-five trials involving 2,457 patients were included. For upper-limb AS or MAS, the estimated add-on effects of CHM to RC were significantly better when using oral (SMD -1.79, 95% CI: -3.00 to -0.57) or topical CHM (SMD -1.06, 95% CI: -1.40 to -0.72). For lower-limb AS or MAS, significant add-on benefits to RC were also detected (SMD -1.01, 95% CI: -1.43 to -0.59 and SMD -1.16, 95% CI: -1.83 to -0.49) using oral and topical CHM, respectively. For FMA and BI, better results were detected when adding CHM to RC, except for the subgroup of oral CHM for upper-limb FMA. Ten of the 35 included studies reported safety information, with two of them mentioning two mild adverse events | Noting the quality concerns of the included trials, this review suggests that CHM appears to be a well-tolerated therapy for patients with PSS, and the potential add-on effects of CHM in reducing spasticity and improving the daily activities of patients with PSS require further rigorous assessment. |
| G00-G99 신경계통의 질환 | Zhang | 2019 | China | Limb spasticity reduction in post-stroke | 31 | 1) RCTs of EA with rehabilitation training for limb spasticity reduction in post-stroke patients 2) Clear diagnostic criteria and diagnosis of stroke confirmed by craniocerebral magnetic resonance imaging (MRI) or computed tomography (CT); increased muscle tension of paralyzed limbs 3) Control group used EA alone or rehabilitation training alone, experiment group used EA + rehabilitation training (i.e., combined with another therapy based on the treatment of the control group) | 1) Patients with severe complications or mental and cognitive impairment that prevents them from receiving treatment 2) No EA intervention or rehabilitation training, 3) Non-invasive therapies, 4) With other confounding factors, | Electroacupuncture (EA) + rehabilitation training + © | EA alone OR rehabilitation training alone | 1) Clinical efficiency 2) Modified Ashworth Scale (MAS) classification 3) MAS score 4) Clinical spasticity index (CSI) score | Thirty studies were included in this systematic review, 23 of which were pooled in meta-analysis. Acupuncture combined with speech rehabilitation training is likely beneficial for was response rate (n = 1685; RR = 1.37; 95% CI [1.29, 1.46], P < 0.01, I2 = 34%; 17 studies, low CoE) compared to speech rehabilitation treatment alone. | EA with rehabilitation training could be a good strategy for reducing limb spasticity after stroke and is better than EA alone or rehabilitation training alone. However, its effectiveness remains to be further verified by large-sample and high-quality RCTs. |
| G00-G99 신경계통의 질환 | Xie | 2019 | China | Post-stroke dysarthria | 23 | 1) RCTs with parallel-group or crossover designs 2) Participants in eligible studies were adults who suffereddysarthria following stroke, regardless of sex, age, or duration ofthe disease. 3) Intervention group received ACWSRT, regardless of fre-quency, intensity, or duration of the interventions. patients receiving either manual acupuncture or electroacupunc-ture, using conventional acupoints. acupuncture therapies that focused on specific parts of the body, such as nape,scalp, or tongue acupuncture. 4) The comparator was speech rehabilitation training alone (SRTA) 5) Outcome measure was the clinical response rate measured with the Frenchay Dysarthria Assessment (FDA) tool. The secondary outcomes were speech intelligibility and qualityof life (measured using a validated questionnaire). Adverse events and serious adverse events were also summarized. | 1) All non-RCT studies 2) Individuals diagnosed with dysarthria resulting fromother conditions (e.g., Parkinson’s disease or brain tumors), or fromaphasia 3) RCTs that combined ACWSRT withherbal medicine, moxibustion, tuina, auricular therapy, or otheralternative complementary treatments | Acupuncture + speech rehabilitation | Speech rehabilitation | 1) Clinical response rate: FDA 2) Speech intelligibility 3) Qualityof life 4) Adverse events | A total of 31 RCTs (including 2488 participants) were included. Except for Cai et al.’s study, the quality of other RCTs was not high. All studies performed a descriptive analysis, and 29 RCTs conducted a meta-analysis. The odds ratio (OR) for marked efficiency was 2.35 (95% confidence interval [CI] 1.68, 3.27, Z = 5.03, P < .00001). The OR for Modified Ashworth Scale (MAS) classification was 2.42 (95% CI 1.89, 3.10, Z = 7.03; P < .00001). The weighted mean difference (WMD) for MAS score was -0.68 (95% CI -0.79, -0.56, Z = 11.24, P < .00001). The WMD for clinical spasticity index score was -1.50 (95% CI -2.28, -0.72, Z = 3.79, P = .0002). | The combination of acupuncture and speech rehabilitation training may improve total response rate of stroke patients with dysarthria. However, more RCTs with rigorous study design and validated outcome measures are needed to confirm the evidence. |
| I00-I99 순환계통의 질환 | Yang | 2020 | China | Bradycardia combined with premature beat | 9 | 1) The type of trial is a randomized controlled clinical trial, whether it is used or not Blind method. 2) Test subject: Diagnosed with bradyarrhythmia at the same time (the types of premature beats, brady arrhythmias and premature beats are not limited. 3) Intervention : The treatment group used Shensong Yangxin Capsule alone; the control measure was placebo or blank control. 4) Outcome indicators: The main outcome indicator is average heart rate; secondary outcome indicators include effective rate of premature beats and effective bradycardia Rate and clinical effectiveness. The safety outcome is an adverse reaction | 1) Research that cannot accurately extract data or data is missing 2) Duplication Published | Shensong Yangxin Capsules | Placebo or blank control | 1) Average heart rate; 2) Effective rate of premature beats and effective bradycardia Rate and clinical effectiveness. 3) Adverse reaction | The results of Meta-analysis showed that in terms of decrease of total cholesterol(MD=-0. 15,95%CI[-0.25, -0.05],P=0.004) ,decrease of triglycerides improvement(MD=-0.16, 95%CI[-0.23, -0.10], P＜0. 000 01) ,decrease of low-density lipoprotein(MD = -0.08, 95% CI[-0. 15,-0. 01], P=0. 03) ,and increase of high-density lipoprotein(MD=0.06, 95% CI[0.03, 0.10], P=0.0002) ,experimental group was better than control group.At the same time,the incidence of adverse reactions were low in the experimental group (OR= 0.40, 95%CI[0.18, 0.85],P= 0. 02) .As a result,in treatment of coronary heart disease,the therapeutic efficacy of Zhibitai Capsules combined with statins is better than statins alone in lowering total cholesterol level,triglyceride level,low-density lipoprotein level,and increasing high-density lipoprotein level. | In conclusion,the single administration with Shensong Yangxin Capsules may have a certain effect in improving heart rate,controlling premature beats and alleviating clinical symptoms in patients with bradycardia combined with premature beat,with no obvious adverse reaction. Shensong Yangxin Capsules can be used in clinic. |
| I00-I99 순환계통의 질환 | Li | 2020 | China | Coronary heart disease | 11 | 1) Study type is the randomization of Zhibitai combined with statin in the treatment of coronary heart disease Controlled Trials (RCT), 2) The language are limited to Chinese and English. 3) The research subjects definition should meet any of the following criteria :The relevant provisions of coronary heart disease "Ischemic heart disease naming and diagnostic criteria Standard" , "Guiding Principles for Clinical Research of New Chinese Medicines" , " Practical inernal medicine" . 4) Sex, age, and comorbidities are not limited. Intervention measures 5) The test group used Zhibitai capsules combined with statins, and the control group used statins. 6) Outcome indicators include at least the following Item : a.Blood lipid level (total cholesterol, triglycerides, low-density lipoprotein White, high-density lipoprotein); b.Inflammation indicators (hs-CRP, CT-1);c.Integral of TCM syndromes; d.Safety indicators (liver and kidney function, muscleEnzymes, blood sugar, gastrointestinal discomfort, etc.) | 1) Non-RCT 2) Research objects, control measures, intervention measures, outcome indicators do not match the requirements 3) Data are incorrect 4) Incomplete, and unavailable and repeated publications. | Zhibitai Capsules + statin | Statin | 1) At least one outcome as follow :Blood lipid levels (total cholesterol, triglycerides, low-density fat White, high-density lipoprotein), Inflammation indicators (hs-CRP, CT-1), Integral of TCM syndromes, Safety indicators (liver and kidney function, muscle Enzymes, blood sugar, gastrointestinal discomfort, etc.) | The results showed that Shensong Yangxin Capsules had an obvious effect on average heart rate (MD= 6. 59,95%CI[3. 87, 9. 31], I2 = 90%) ,premature beat efficacy ( ＲR=1. 72,95%CI[1. 53, 1. 93], I2 = 0%) ,heart rate efficacy ( ＲＲ = 1. 74,95%CI[1. 40, 2. 17], I2 = 47%) ,and objective efficacy( ＲＲ= 1. 50,95%CI[1. 31, 1. 70], I2 = 31%) . Eight studies reported safety events,with no significant adverse reaction. | Patients in the experimental group had a low incidence of adverse events,but the heterogeneity was slightly higher,and the result had a poor stability. However,due to the small sample size of studies included,some experimental designs were not perfect,which reduces the recommendation level and evidence intensity of this system evaluation. Therefore,high-quality multi-center,large-sample,randomized,double-blind randomized controlled trials are needed for providing more reliable basis. |
| I00-I99 순환계통의 질환 | Chen | 2019 | China | Deep vein thrombosis | 16 | 1) Study design: randomized controlled trials (RCTs) 2) Treatments: patients in the combination group had received TCM prescription and LMWH treatment, while those in the control group only had taken LMWH 3) Study subject: orthopedics major operation (total hip arthroplasty [THA], total knee arthroplasty [TKA], or hip fractures surgery) 4) Relevant to the prevention of DVT after orthopedics major surgery 5) Only included English and Chinese articles. | 1) Preoperative thrombosis 2) Literature lack of data integrity 3) Non-RCTs 4) Repeated publications 5) Meeting reports, system evaluation, or summary articles. | Traditional chinese medicine(TCM) + low-molecular-weight heparin(LMWH) | LMWH | 1) Incidence of DVT 2) APTT 3) PT 4) FIB 5) D-D levels | The results indicated that in the combination group, the incidence of DVT (RR: 0.34, 95% CI: 0.23-0.50, P < .00001) and D-dimer levels (standardized mean difference: -1.19, 95% CI: -1.80 to -0.58, P ¼ .0001) was significantly lower than that in the LMWH group. Furthermore, the combination treatment obviously decreased the concentration of fibrinogen (MD: -1.19, 95% CI: -2.13 to -0.25, P ¼ .01). | The combination of TCM prescription and LMWH could significantly reduce the incidence of DVT, suggesting that it may be a more effective prophylaxis measure for DVT after major orthopedics surgery. |
| I00-I99 순환계통의 질환 | Lyu | 2019 | China | Acute Cerebral Infarction | 14 | 1) Participants diagnosed as ACI or Acute Ischemic Stroke (AIS) 2) Randomized controlled trials (RCTs) 3) SAFI plus CT versus CT, including statins, aspirin, edaravone, clopidogrel, citicoline sodium, nitrate esters, cerebrolysin vial 4) Primary outcome is total effective rate, total effective rate=(number of effective cases)/total number of cases×100%; and 5) Secondary outcomes including NIHSS score, ability of daily living (ADL: Barthel index, BI; modified Rankin Scale, MRS score), hemorheology (LBV, HBV, PV), mini-mental state examination (MMSE) score, Montreal cognitive assessment (MoCA) score, C-reactive protein (CRP) and any adverse drugs events/reactions (ADEs/ADRs). | 1) There was a serious error in the research data 2) Unable to obtain full text 3) Duplicate data 4) Intervention included other Chinese medicines, acupuncture, or massage. | Salvianolic acids for injection (SAFI) + conventional treatment (CT) | Conventional treatment (CT) | 1) Total effective rate of NIHSS score 2) NIHSS 3) Barthel Index 4) Hemorheology 5) MRS 6) MMSE 7) MOCA 8) CRP 9) ADEs/ADRs; | A total of 14 RCTs involving 1309 patients were included. Meta-analysis showed that SAFI plus CT was bet-ter than CT alone in improving the total effective rate (RR=1.35, 95% CI 1.25 to 1.44, P<0.00001), reducing the National Institutes of Health Stroke Scale (NIHSS) score (130 mg: WMD=–3.31, 95% CI –3.80 to –2.47, P<0.00001; 100 mg: WMD=–1.91, 95% CI –2.28 to –1.54, P<0.00001), improving the activity of daily living and cognitive function of ACI, and improving the hemorheology (HBV: high shear rate blood viscosity, LBV: low shear rate blood viscosity, PV: plasma viscosity) and C-reactive protein (CRP). | SAFI plus CT in the treatment of ACI can improve the total effective rate, neurological deficit, and ability to perform activities of daily living, and there is no serious adverse reaction. Based on the GRADE system, the evidence quality is low. More large-scale, well-designed, and high-quality RCTs are required to confirm the positive results. |
| I00-I99 순환계통의 질환 | Tai | 2019 | China | Hypertension | 14 | 1) Patients: diagnosed as having primary hypertension by meeting the criteria of Guide to Prevention and Treatment of Hypertension 2010, Guiding Principles for Clinical Research of New Drugs in Traditional Chinese Medicine, Chinese Medicine Dialectical Diagnosis Efficacy Standard, Chinese Medicine Diagnosis and Treatment of Heart Disease Efficacy Standards and Norms, or Guide to Prevention and Treatment of Hypertension in China. 2) Randomized control trials (RCTs). 3) Intervention: TGD combined with nifedipine in the experimental group and only nifedipine in the control group. 4) Outcome: total antihypertensive efficacy. The following indices in the articles must contain at least one of the following: blood pressure, TCMs, serum creatinine, adverse events, and blood urea nitrogen. | 1) Non-randomized controlled trials 2) Secondary hypertension 3) Hypertension and other illnesses 4) Patients received drugs other than TGD and nifedipine in RCTs 5) Studies such as reviews, animal experiments, and case report that were considered to be irrelevant to the theme. | Tianma Gouteng Decoction (TGD) + Nifedipine | Nifedipine | 1) Anti-hypertensive efficacy 2) Blood pressure 3) TCMs 4) Serum creatinine 5) Adverse events 6) Blood urea nitrogen | Eleven RCTs with 1149 participants were included in this study. It has been identified that Wenxin granules combined with propafenone have better clinical efficacy than the use of propafenone alone in the treatment of APB (OR = 3.89, 95% CI (2.03, 7.44), P < 0.0001, low-dose propafenone; OR= 4.24, 95% CI (1.32, 13.60), P = 0.02, high-dose propafenone). There is no difference in clinical efficacy between the Wenxin granules alone and high-dose propafenone in the treatment of APB (OR = 1.17, 95% CI (0.65, 2.11), P = 0.60), and Wenxin granules alone are superior to the low-dose propafenone in the treatment of APB (OR = 2.56, 95% CI (1.34, 4.89), P = 0.004). Wenxin granules combined with propafenone can reduce the incidence of sinus bradycardia caused by propafenone (OR = 0.15, 95% CI (0.03, 0.70), P = 0.02). There was no significant difference between Wenxin granules combined with propafenone and propafenone alone in causing the atrioventricular block, dizziness, xerostomia, gastrointestinal symptoms, and tongue paresthesia. There was no significant difference between Wenxin granules alone and propafenone alone in causing dizziness, xerostomia, gastrointestinal symptoms, tongue paresthesia, frequent premature ventricular contractions, and prolongation of R-R interval. | The combination of TGD and nifedipine has a better effect in the treatment of hypertension, including blood pressure lowering and patients’ TCMs improving. However, our findings must be handled with care because of the small sample size and low quality of clinic trials cited. Other rigorous and large-scale RCTs are in need to confirm these results. |
| I00-I99 순환계통의 질환 | Yuan | 2019 | China | Atrial Premature Beats | 11 | 1) Randomized controlled trial(RCTs) 2) Chinese and English 3) Participants. Diagnostic criteria in line with arrhythmias (atrial premature beats), regardless of gender, race, and age, with or without organic heart disease 4) Interventions: Three specific comparisons including Wenxin granules will be taken into account: Wenxin granules, Wenxin granules compared with low-dose propafenone, and Wenxin granules compared with high-dose propafenone. The control intervention included low-dose propafenone and high-dose propafenone (same dose as propafenone in the experimental group). 5) Outcomes: Clinical efficiency, Adverse reaction rate | NR | Wenxin granules OR Wenxin granules + propafenone | Propafenone | 1) Clinical efficacy 2) Adverse Effects Rate | A total of 1,537 (769 cases in the experimental group and 768 cases in the control group) patients were enrolled. The total efficacy rate was improved significantly for the combination of nifedipine with TGD compared to nifedipine treatment alone (I² = 22%, RR = 1.17, and 95% CI: 1.12 to 1.22). Traditional Chinese medicine (TCM) symptoms of patients were obviously improved in the experimental group than in the control group (I² = 44%, RR = 1.26, and 95% CI: 1.17 to 1.36). TGD combined with nifedipine shows a better effect than nifedipine in decreasing diastolic blood pressure (I² = 95%,MD= - 5.32, and 95% CI: - 8.19 to - 2.45) and systolic blood pressure (I² = 98%, MD= - 9.35, and 95% CI: - 15.03 to - 3.67) of patients. A sensitivity analysis was conducted for SBP and DBP by removing 2 studies and recalculated the combined estimate on remaining studies. The results of SBP showed a small heterogeneity (I² =17%, MD= - 13.95, 95% CI: - 14.86 to - 13.05, and P < 0.00001) when two studies (shicaihong 2017 and xiaoyugao 2017) were removed. And the results of DBP showed no heterogeneity (I² = 0, MD= - 8.36, 95% CI: - 8.91 to - 7.81, and P < 0.00001) when two studies (panzhixiong 2019 and shicaihong 2017) were removed. | Very low-quality evidence showed that Wenxin granules may be superior to low-dose propafenone in the treatment of APB. Wenxin granules may reduce the incidence of sinus bradycardia caused by propafenone. Limited by the quality of included RCTs, the conclusions of this study still need further verification. |
| J00-J99 호흡계통의 질환 | Gao | 2019 | China | Acute exacerbation of chronic bronchitis | 23 | 1) Randomized controlled trial 2) Patients who are clearly diagnosed as chronic bronchitis in the acute stage | 1) The intervention group and the control group are inconsistent with the conventional treatment of western medicine 2) Unable to accurately extract data, missing data, or incomplete reporting of the outcome | Tanreqing injection + western medicine as control group | Western medicine(including levofloxa, Cefoperazone, Cefuroxime, Cefoperazone Sodium, Sulbactam Sodium, Cefoperazone) | 1) Time to stop cough 2) Antipyretic time, phlegm disappearance time 3) Total effective rate 4) Lungs Reduced rales 5) Adverse reactions | The Meta-analysis demonstrated that in terms of the disappearance time of fever,the group of Tanreqing Injection combined with the conventional therapy was superior to conventional therapy group (RR= -1.03, 95%CI[-1.45,-0.62],P＜0. 000 01); compared with the conventional therapy group,the group of Tanreqing Injection combined with conventional therapy had a higher cure rate for AECB (RR= 1.17, 95% CI[1.13,1.23],P＜ 0. 000 01) . The group of Tanreqing Injection combined with levofloxacin had a higher cure rate for AECB than the levofloxacin group (RR = 1. 23, 95% CI[1. 08,1.41], P = 0.002) . The group of Tanreqing Injection combined with cefuroxime had a higher cure rate for AECB than the cefuroxime group (RR= 1. 22, 95%CI [1.05,1.42], P= 0. 01) .The group of Tanreqing Injection combined with cefoperazone sodium and sulbactam sodium had a higher cure rate for AECB than the group of cefoperazone sodium and sulbactam sodium (RR= 1. 22,95%CI[1. 04,1. 44], P = 0. 02) | The outcomes of disappearance time of cough and expectoration had a huge heterogeneity,so were used for descriptive analysis. The adverse reactions mainly included skin rash,dizziness,gastrointestinal reactions. Based on the available data and the results of the analysis,the group of TaNReqing Injection combined with Western medicine has a higher cure rate for acute exacerbation of chronic bronchitis,and the effect in reducing symptoms disappearance time. In view of the limited number of included studies,small sample size and low methodological quality,the results of this study need to be confirmed with high-level clinical trials. |
| J00-J99 호흡계통의 질환 | Jiang | 2019 | China | Asthma | 9 | 1) Randomized controlled trial(RCTs) were published in English or Chinese, with the full text available. 2) Diagnostic criteria for bronchial asthma. 3) RCTs compared conventional treatments plus acupuncture with conventional treatments alone. 4) Studies measured at least one of the following end points: symptom response rate, forced expiratory volume in one second (FEV1), FEV1/forced vital capacity (FVC), and interleukin-6 (IL-6) levels. | 1) Studies only involved cells or animals or were case reports, letters, reviews, observational studies, or nonrandomized clinical trials. 2) Younger than 12 years of age. 3) Trials in which acupuncture therapies were used with other therapies. | Conventional treatments + acupuncture | Conventional treatments | 1) FEV1 2) FEV1/FVC 3) IL-6 | CHIs combined with azithromycin had superior effects than azithromycin only among overall outcomes. Yanhuning injection combined with azithromycin ranked highest in four different outcomes and second in two based on surface under the cumulative ranking probabilities (SUCRA). Meanwhile, the results of MD and 95% CIs of concerned outcomes indicated that only Yanhuning injection combined with azithromycin had better response than other CHIs combined with azithromycin. Moreover, cluster analysis results revealed Reduning injection combined with azithromycin was associated with a positive effect on the three group outcomes. Similarly, it was found to be the top three ranking in all outcomes based on SUCRA | Conventional treatments plus acupuncture are associated with significant benefits for adult and adolescent patients with asthma.Therefore, we suggest the use of conventional treatments plus acupuncture for asthma patients. |
| J00-J99 호흡계통의 질환 | Haung | 2019 | China | Chronic obstructive pulmonary disease | 23 | 1) RCTs that assessed the combination of Shengmai injection and WM relative to drugs alone for COPD were included. 2) COPD, which is diagnosed by explicit criteria,11was the target disease. The participants had no limitations in terms of age, gender, race and disease severity. 3) The control treatments were any kind of WM for the treatment of COPD, including oxygen intake, anti-inflammatories, relief of cough and asthma, reduction of phlegm and so on. The experimental interventions were the combination of Shengmai injection and the controls. | 1) No available data were obtained after contact with the original authors 2) Plagiarism | Shengmai injection + Western medicin(WM) | Western medicine | 1) Clinical total effective rate 2) CAT score and mMRC score 3) Average hospitalization time 4) Pulmonary function index (FEV1 (L), FEV1 (%)) 5) Blood gas index (PaO2 (mmHg), PaCO2 (mmHg)) 6) Immunoglobulin index (IgG (g)L), IgA (g)L), IgM (g)L) and T cell subsets) 7) C-reactive protein (CRP (mg)L)) 8) Lung rale disappearance time (d) 9) Adverse drug reactions)adverse drug events (ADRs)ADEs) | conventional treatments plus acupuncture as a complementary therapy could improve the symptom response rate (OR = 7.87, 95% CI = [4.13, 14.99], p < 0.00001) and significantly decrease interleukin-6 (IL-6) levels (MD = -11.42; 95% CI = [-15.28, -7.56], p < 0.00001). However, indices of pulmonary function, including the forced expiratory volume in one second (FEV1) (MD = 0.22, 95% CI = [-0.11, 0.56], p = 0.19) and FEV1/forced vital capacity (FVC) (MD = 8.62, 95% CI = [-0.35, 17.59], p = 0.06), failed to be improved with conventional treatments plus acupuncture. | Shengmai injection may positively influence COPD in combination with WM. However, firm conclusions could not be draw due to the low quality of the evidence. Further high-quality studies are still required to test the efficacy of Shengmai injection for this condition. |
| J00-J99 호흡계통의 질환 | Duan | 2019 | China | Mycoplasma pneumonia | 167 | 1) Population. Patients were under 15 years old and received definitive diagnosis of mycoplasma pneumonia. 2) Intervention and Control. After the preanalysis, the following interventions were included: Azithromycin, Reduning injection combined with azithromycin, Tanreqing injection combined with azithromycin, Xixinnao injection combined with azithromycin, Xiyanping injection combined with azithromycin, Yanhuning injection combined with azithromycin. Basic therapies were given if necessary, including abatement of fever, relieving a cough, preventing asthma, reducing phlegm. 3) Outcomes. The following outcomes attracted our attention: clinical effective rate, disappearance time of fever, disappearance time of cough, disappearance time of pulmonary rale, average hospitalization time, disappearance time of pulmonary shadows in X‐ray, serum level of TNF‐α and IL‐6) Clinical effective rate = (number of total patients – number of invalid patients)/number of total patients × 100%. The patients whose clinical symptoms were unchanged and objective indicators were not adjusted were deemed as invalid. 4) Study design. Only randomized controlled trials (RCTs) were enrolled. | NR | Chinese herbal injection(CHI) + azithromycin | Azithromycin | 1) Clinical effective rate 2) Disappearance time of cough fever 3) Disappearance time of cough 4) Disappearance time of pulmonary rale 5) Average hospitalization time 6) Disappearance time of pulmonary shadows in X‐ray 7) TNF‐α 8) IL‐6 | Shengmai injection and western medicine (WM) could achieve a better effect than WM alone in terms of improving the clinical total effective rate (RR=1.20, 95% CIs: 1.15–1.24), pulmonary function (FEV1(L): MD=0.41, 95% CIs 0.32 to 0.49; FEV1(%): MD=6.21, 95% CIs: 2.72–9.71), blood gas index (PaO2: MD=6.13, 95% CIs: 2.93–9.32; PaCO2: MD=-6.2, 95% CIs: -11.63 to -0.77), immunoglobulin levels (IgG: MD=3.55, 95% CIs: 3.10–3.99; IgA: MD=0.34, 95% CIs: 0.31to 0.38; IgM: MD=0.35, 95% CIs: 0.27 to 0.42), C-reactive protein levels (MD=-8.05, 95% CIs: -10.11 to -6.00) and the lung rale disappearance time (MD=-2.57, 95% CIs: -3.19 to -1.95). Additionally, the CAT score, mMRC and average hospitalization time were also reduced significantly by Shengmai injection plus WM. Among 11 RCTs that mentioned safety issues, 6 RCTs found no adverse events, and the other 5 RCTs reported the details of adverse events. | Yanhuning injection combined with azithromycin and Reduning injection combined with azithromycin were found to be preferable treatments based on the data of this study. |
| J00-J99 호흡계통의 질환 | Li | 2019 | China | Mycoplasma pneumoniae Pneumonia | 9 | 1) Prospective, randomized controlled trial 2) Patients with p-MPP 3) It randomized patients to a strategy of XYP plus AZM therapy and the parallel control group using AZM alone 4) The outcome indicators measured for efficacy and safety evaluation included ORR, ADRs, hospitalization durations, antipyretic time, cough disappearance time, and lung wet Rales disappearance time. | 1) The study design did not have a clear standard of diagnosis and treatment 2) There were no the control groups or the control groups using interventions other than AZM in the study 3) Literature on nonclinical studies such as reviews, pharmacological experiments, and animal experiments 4) Clinical studies with unsatisfactory results of efficacy assessment or with unclear statistical analysis 5) Clinical studies that did not explicitly describe randomized grouping methods. Their design was a prospective, randomized controlled trial. | Xiyanping injection (XYP) + azithromycin (AZM) chemotherapy | Azithromycin (AZM) chemotherapy | 1) Overall response rate (ORR) 2) Adverse drug reactions (ADRs) 3) Hospitalization duration 4) Antipyretic time 5) Cough disappearance time 6) Lung wet Rales disappearance time, 7) Symptom-disappearing time | The 29 trials including 2300 advanced NSCLC patients were involved in this study. Compared with chemotherapy alone, its combination with CFI significantly prolonged the patients’ 1-, 2- and 3-year overall survival rate (OS) (1-year OS, OR=1.94, 95% CI=1.42–2.65, P<.0001; 2-year OS, OR=2.31, 95% CI=1.55–3.45, P<.0001; 3-year OS, OR=4.69, 95% CI=1.78–12.39, P=.002) and improved patients’ overall response (ORR, OR=1.84, CI=1.54–2.18, P<.00001), disease control rate (DCR, OR= 2.09, 95% CI=1.68–2.60, P<.00001) and QoL (quality of life improved rate, QIR, OR=2.64, 95% CI=1.98–3.52, P<.00001; karnofsky performance score, KPS, OR=10.97, 95% CI=5.48–16.47, P<.0001). Most adverse events caused by chemotherapy were obviously alleviated (P<.05) when CFI was also applied to patients. | Overall, XYP might reduce the incidence of ADRs and significantly improve the clinical efficacy for p-MPP receiving AZM chemotherapy. |
| J00-J99 호흡계통의 질환 | Gao | 2020 | China | Acute exacerbation of chronic obstructive pulmonary disease | 38 | 1) Randomized controlled trial(RCT) 2) Patients with diagnosed acute exacerbation of COPD, who received XQLD combined with conventional therapy as treatment compared with those receiving conventional therapy alone. participants irrespective of gender, age, or ethnicity, who were diagnosed with COPD using clearly defined or internationally recognized criteria 3) An herbal formula that must include XQLD was used in the experiment group. no limitation on the form of the drug, dosage, frequency, or duration of the treatment. 4) Outcomes: total clinical efficacy rate (TCER), TCM symptom scores, TCM symptom relief time (TCMsrt), lung function, blood gas analysis, inflammatory cytokines, and C-reactive protein (CRP). | 1) Non-RCTs and quasi-RCTs 2) One of the following conditions: duplicated publications; case series, reviews, observation study, animal researches, and pharmacological experiments 3) TCM that were used in both treatment group and control group 4) Combined with other TCM therapy | Xiaoqinglong decoction + conventional treatment | Conventional therapy (CT) | 1) Total clinical efficacy rate (TCER) 2) TCM symptom scores 3) TCM symptom relief time (TCMsrt) 4) Lung function, blood gas analysis 5) Inflammatory cytokines, and C-reactive protein (CRP) | 15 trials and 1500 patients were involved in this review. It showed that clinical efficacy of trial group was more superior than control group at the outcome measures of cough disappearance time, lung rale disappearance time, fever subsidence time, total effective rate, lung X-ray infiltrates disappearing time, reduction of hospital stay, immunological indexes, and some other measures. And the differences between groups were statistically significant. /ere was no statistical difference in the adverse effects between two groups. Lung X-ray infiltrates disappearing time and cough disappearance time were separately high- and moderatequality evidences while lung rale disappearance time and fever subsidence time were all low in accordance with GRADE criteria. | XQLD plus CT was more effective than CT alone for treating chronic obstructive pulmonary disease. Further higher quality trials are needed. The safety of XQLD remained uncertain. |
| J00-J99 호흡계통의 질환 | Zhang | 2020 | China | Mycoplasma pneumoniae Pneumonia | 15 | 1) Regarding types of studies design, all included studies in the present systematic review about the treatment of Xiao’er Xiaoji Zhike oral liquid for MPP in children were randomized controlled trials (RCTs), regardless of the methods of blinding 2) Languages:Chinese and English. 3) Participants: children within 15 years old met the clinical diagnostic criteria for MPP. There was no limitation to the race, gender, or the intensity and course of the disease. 4) Intervention: children in control group were treated with azithromycin and symptomatic treatment of relieving cough and asthma, correcting water and electrolyte balance, keeping breath flowing, or oxygen as needed. trial group was treated with the same methods as control group and Xiao’er Xiaoji Zhike oral liquid at the same time. 5) Outcomes: at least one of the following: cough disappearance time, lung rale disappearance time, fever subsidence time, total effective rate, hospitalization time, lung X-ray infiltrates disappearing time and immunological indexes, adverse reaction rate. 6) Regarding evaluation criteria, curative effects of studies were judged by special effect, valid, and invalid. | 1) The studies were not RCTs 2) Reviews, meta-analysis, meeting abstracts, nonclinical studies, or case reports werev included 3) Duplicate studies, retrospective studies, and studies without data or with poor design were included 4) The data was statistically flawed and studies reported improper outcome measures; 5) Xiao’er Xiaoji Zhike oral liquid was administered as a control. | Xiao’er Xiaoji Zhike Oral Liquid + Azithromycin | Azithromycin | 1) Cough disappearance time 2) Lung rale disappearance time 3) Fever subsidence time 4) Total effective rate 5) Lung X-ray infiltrates disappearing time 6) Immunological indexes 7) Adverse reaction | Thirty-eight trials were identified. Compared with conventional therapy (CT), XQLD plus CT significantly improve the total clinical efficacy rate (Risk Ratio [RR]=1.22, 95% confidence interval [CI]=1.18–1.26, P<.00001). Forced expiratory volume in the first second (FEV1) (mean difference [MD]=0.37, 95% CI=0.27–0.46; P<.00001), FEV1%pre (MD=4.52, 95% CI=2.42–6.62; P<.00001), FEV1/forced vital capacity (MD=5.11, 95% CI=4.21–6.00; P<.00001), PaO2 (MD=7.17, 95% CI=4.80–9.54; P<.00001); lowered cough symptom score (MD=0.65; 95% CI=0.70 to 0.59;P<.00001), sputum symptom score (MD= 0.41; 95% CI=0.45 to 0.37; P<.00001), wheezing symptom score (MD=0.49; 95% CI=0.60 to 0.38; P<.00001); reduce cough relief time(MD=1.28; 95% CI=1.53 to 1.02; P<.00001), sputum relief time (MD=1.19; 95% CI=1.42 to 0.96;P<.00001), wheezing relief time (MD=1.65; 95% CI=2.63 to 0.68; P=.0009), lassitude relief time (MD=2.16; 95% CI=3.44 to 0.89; P=.0009), and PaCO2 (MD=7.63, 95% CI=9.62 to 5.63; P<.00001). Benefit for interleukin (IL)-4(MD=9.20, 95% CI=13.59 to 4.81; P<.00001), IL-6 (MD=5.07, 95% CI=8.14 to 2.01; P=.001), IL-8 (MD=5.59, 95% CI=6.09 to 5.08; P<.00001), tumor necrosis factor (TNF)-a (MD=5.93, 95% CI=6.97 to 4.89; P<.00001), Interferon (INF)-g (MD=18.03, 95% CI=13.22–22.84; P<.00001), and C-reactive protein (MD=3.93, 95% CI=5.97 to 1.89; P=.0002). For adverse events, there were no difference between XILD plus CT and CT. | In accordance with trials with low methodological quality, Xiao’er Xiaoji Zhike oral liquid combined with azithromycin seems to be safe and superior to azithromycin alone for the treatment of MPP in children. However, further trials with rigorous methodology need to be implemented for these potential benefits. |
| K00-K93 소화계통의 질환 | Chen | 2019 | China | Postoperative ileus | 15 | 1) Participants aged > 18 years and undergoing abdominal surgery including open and laparoscopic surgery 2) Intervention consisting of perioperative EA or TEA at single or combined acupoints, with or without acupoint drug injection 3) The control group receiving no EA, sham EA or drug therapy 4) Outcomes evaluating time to first flatus and/or defecation and/or bowel sound recovery, and/or time to first oral feeding, and/or length of hospital stay, and/or postoperative analgesic consumption 5) Only randomized controlled trials (RCTs). | 1) Animal studies 2) Reviews, letters or protocols 3) Duplicate articles 4) No sufficient outcomes related to POI. | electroacupuncture (EA) OR transcutaneous electroacupuncture(TEA) | Routine treatment OR Sham EA on bilateral sham ST36 | 1) Time to first flatus 2) Time to first 3) Defecation Time to bowel sound recovery 4) Time to first oral feeding 5) Length of hospital stay 6) Postoperative analgesics consumption | A total of 15 trials involving 965 participates were included. Meta-analysis results favored EA/TEA treatment for POI by analysis of time to first flatus [mean difference (MD) -11.60 h, I²=94%, REM)], time to first defecation (MD -12.94 h, I²=90%, REM), time to bowel sound recovery (MD -7.25 h, I²=85%, REM), time to first oral feeding (MD -15.76 h, I²=47%, REM) and length of hospital stay (MD -1.19 d, I²=44%, REM). Subgroup analysis of laparoscopic surgery patients also favored EA/TEA by analysis of time to first flatus (MD -2.46 h, I²=0%, FIXED), time to first oral feeding (MD -10.73 h, I²=0%, FIXED) and length of hospital stay (MD-1.30 d, I²=32%, REM). ST36 (Zusanli), ST37 (Shangjuxu) and ST39 (Xiajuxu) are preferred EA/TEA acupoints for treating POI. There was no significant difference in postoperative analgesic consumption between EA and control groups (P=0.39). No severe adverse events associated with EA/TEA were reported. | This meta-analysis suggests that EA/TEA is a safe, effective treatment for POI after abdominal surgeries including laparoscopic surgery, and that EA/TEA does not relieve postoperative pain after abdominal surgery. There is significant heterogeneity of research on this subject, thus, a professional consensus is needed to establish a standard protocol for use of this technique. |
| K00-K93 소화계통의 질환 | Qin | 2020 | China | Postoperative pain after hemorrhoidectomy | 107 | 1) Participants included were those with acute postoperative pain after receiving hemorrhoidectomy; the surgery type was not limited 2) RCTs with parallel design comparing one of acupuncture related techniques with placebo pills, sham procedure, active controls (opioids, NSAIDs, or analgesics), usual care, or one of the other treatments 3) Outcome of responder rate or pain intensity and used the definition of responder as reported in each RCT | 1) Participants receiving both hemorrhoidal surgery and other anorectal surgery 2) RCTs with parallel design 3) RCTs published in the form of letters-to-the-editor or conference abstracts and presented without data | Acupuncture related techniques | Placebo pills, sham procedure, active controls (opioids, NSAIDs, or analgesics), usual care, or one of the other treatments | 1) Responder rate 2) VAS | We included 107 RCTs (n=10,972) for network meta-analysis assessing the relative effectiveness of 40 treatments and 48 RCTs (n=5226) to analyse responder rate. Auricular acupressure plus acupuncture (RR, 1.44 [95 %CI, 1.15–1.81], P-score=0.923), acupuncture (RR, 1.23, [95 %CI, 1.04–1.45], P-score=0.723), other acupuncture techniques (RR, 1.22, [95 %CI, 1.04–1.44], P-score=0.727) and auricular acupressure (RR, 1.22, [95 %CI, 1.09–1.36], P-score=0.720) were significantly superior over usual care, and auricular acupressure plus acupuncture ranked the most effective. 72 RCTs (n=7220) were analysed for pain intensity. Providing eight treatments was significantly superior compared with usual care. Auricular acupressure plus acupuncture (SMD, -1.82 [95 %CI, -3.33 to -0.31], P-score=0.799) ranked the most effective. | Auricular acupressure plus acupuncture provided the best outcomes but findings were limited by the quality of the evidence. |
| M00-M99 근골격계통 및 결합조직의 질환 | 2020 | China | Rheumatoid Arthritis | 20 | 1) English or Chinese language 2) Participating patients diagnosed with RA in accordance with the 1987 American Rheumatism Association (1987 ARA) or the 2010 American College of Rheumatology and European Union League Against Rheumatism (2010 ACR/EULAR) diagnostic criteria 3) Experimental groups (EGs) treated with a combination of TCM and WM, while control groups (CGs) treated only with WM 4) RCTs 5) Detailed data of at least 1 relevant outcome. | 1) Participants not diagnosed with RA according to the diagnostic criteria mentioned inclusion criteria. 2) Participants restricted to special crowd (e.g., the elderly and juveniles) 3) EGs treated only with TCM 4) Duplicative data 5) Incomplete or unavailable data 6) Reviews, conference abstracts, and case reports. | Traditional Chinese medicine (TCM) + Western medicine (WM) | Western medicine (WM) | 1) Therapeutic effects (TEs) 2) Adverse events (AEs) 3) Tender joint count (TJC) 4) Swollen joint count (SJC) 5) Duration of morning stiffness (DMS) 6) Grip strength (GS) 7) Disease activity score in 28 joints (DAS28) 8) Rheumatoid factor (RF) 9) Anti-cyclic peptide containing citrulline (anti-CCP) 10) Erythrocyte sedimentation rate (ESR) 11) C-reactive protein (CRP) | A total of 20 RCTs with 2269 patients met the inclusion criteria. TCM used in these studies included Chinese herbal decoctions and tablets or capsules made from herbs and their extracts, while WM included disease-modifying antirheumatic drugs (DMARDs), nonsteroidal anti-inflammatory drugs (NSAIDs), and glucocorticoids (GC). Compared with patients receiving WM treatment alone, patients with integrative TCM-WM treatment showed better TEs (OR = 3.03, 95% CI [2.36, 3.88]). -e integrative treatment group showed reductions in TJC (MD = -1.17, 95% CI [-2.12, -0.21]), SJC (MD = -0.87, 95% CI [-1.85, 0.10]), DMS (SMD = -0.69, 95% CI [-0.98, -0.41]), DAS28 (MD = -0.43, 95% CI [-0.57, -0.29]), RF (SMD = -0.59, 95% CI [-0.91, -0.27]), anti-CCP (SMD = -0.21, 95% CI [-0.36, -0.06]), ESR (MD = -8.36, 95% CI [-12.60, -4.12]), and CRP (MD = -6.73, 95% CI [-9.38, -4.08]), and increment in GS (SMD = 0.12, 95% CI [-0.63, 0.87]). AEs, especially gastrointestinal disorders, abnormal liver function, leukopenia, skin allergies and rashes, headaches and dizziness, and alopecia, significantly decreased (OR = 0.37, 95% CI [0.29, 0.47]) in the integrative treatment group. | The findings of this metaanalysis indicate that integrative TCM-WM could obtain effective and safe results in the treatment of RA. Using TCM as an adjunctive therapy in RA has great prospects for further development. | |
| M00-M99 근골격계통 및 결합조직의 질환 | Yin | 2020 | China | Lumbar disc herniation | 18 | 1) Patients who were diagnosed with LDH, regardless of gender, age, race, region, etc. 2) Experimental group: acupuncture or moxibustion alone or in combination with other treatment. Control group: drugs, placebo, sham acupuncture, etc. 3) Outcomes: Total effective rate, VAS, Japanese orthopaedic association scores (JOA), and Oswestry disability index (DOI). | 1) Articles that was duplicated 2) Articles that was ont found 3) Articles that was not related to acupuncture, moxibustion, or LDH, 4) Not SRs or meta-analyses and articles that were SRs but did not include RCTs. | Acupuncture or moxibustion alone or in combination with other treatment | Drugs, placebo, sham acupuncture, etc. | 1) Total effective rate 2) VAS 3) Japanese orthopaedic association scores (JOA) 4) Oswestry disability index (DOI) | A total of 18 systematic reviews were included, and the conclusion is that acupuncture and/or moxibustion have some advantages in terms of efficacy and safety with regard to LDH treatment. According to the AMSTAR score, there were 4 high-quality studies, 13 moderate-quality studies, and 1 low-quality study. GRADE showed that quality of evidence such as total effective rate of LDH and VAS was low and that of other forms of evidence was lower. The PRISMA statement showed that 8 articles were in line with 20 or more of the 27 items, and 10 articles were in line with 10-19 of the 27 items. | At present, acupuncture and/or moxibustion for LDH has a good curative effect. More importantly, its methodological quality was of moderate level and the report quality was generally good and relatively complete. However, the poor quality of the original research results was reflected in the quality of evidence. More studies are needed to make sure whether acupuncture is more effective than other treatment methods. |
| N00-N99 비뇨생식계통의 질환 | Wang | 2020 | China | Erectile dysfunction | 11 | 1) The included subjects met the definition of ED: The penis could not achieve and maintain enough erection to gain a satisfactory sexual life. The course of illness shall not be less than three months 2) Study type: All clinical randomized controlled trials published from January 1, 2003, to October 30, 2018, whether blind or not 3) Intervening measure: The treatment group was treated with traditional Chinese medicine combined with tadalafil, and the control group was treated with tadalafil. The tadalafil schemes include: once-a-day (OAD) and step-down treatment, regardless of each oral dose of tadalafil 4) Observation targets: IIEF-5, effective rate, SEPQ2, SEP-Q3, and side effects. | 1) Animal experiments and fundamental research 2) Studies using self-controlled or without control group 3) Incomplete data or incorrect data. | Traditional Chinese medicine (TCM) + Tadalafil | Tadalafil | 1) IIEF-5 2) Effective rate 3) SEPQ2 4) SEP-Q3 5) Side effects | A total of 8 RCTs comprising 790 patients with ALUTIs were included in the present meta-analysis. The cure rate of SJTs combined with gatifloxacin tablets (GTs) was higher than that of GTs alone [relative ratio (RR)=1.30, 95% CI=1.07-1.57, P=0.009]. The cure rate of SJTs combined with levofloxacin tablets (LTs) was higher than that of LTs alone (RR=1.13, 95% CI=1.04-1.24, P=0.006). SJTs combined with LTs was better in improving the total effective rate than LTs alone (RR=1.11, 95% CI=1.03-1.19, P=0.005). The recurrence rate for SJTs combined with antibiotics was lower than that associated with antibiotics alone (RR=0.35, 95% CI=0.13-0.97, P=0.04). The bacterial clearance rate achieved with SJTs combined with antibiotics was higher than that obtained with antibiotics alone (RR=1.41, 95% CI=1.09-1.84, P=0.009). | Traditional Chinese medicine combined with tadalafil has significant efficacy in the treatment of ED with no increase in side effects. The specific implementing regulations and effect of de-escalation therapy still need more long-term, multicenter, randomized, and double-blind clinical trials. |
| N00-N99 비뇨생식계통의 질환 | Lyu | 2020 | China | Acute lower urinary tract infections | 8 | 1) Participants were diagnosed with ALUTIs 2) The study was performed as a randomized controlled trial (RCT) 3) Efficacy of SJT combined with antibiotics vs. antibiotics, including levofloxacin tablets (LTs), gatifloxacin tablets (GTs) and ofloxacin tablets (OTs); 4) Primary outcomes were the cure rate and the recurrence rate 5) Secondary outcomes included the total effective rate, bacterial clearance rate, incidence of adverse reactions (ADRs) and any adverse events (ADEs). | 1) Insufficient data (miscalculation or missing data) 2) The full text was not available 3) Duplicated data 4) The intervention included other Chinese drugs, acupuncture and massag | Sanjin tablets (SJTs) + antibiotics | Antibiotics OR placebo + antibiotics | 1) Cure rate 2) Total effective rate. 3) Recurrence rate 4) Incidence of ADRs 5) ADRs/ADEs | A total of 11 studies including 451 cases in the treatment group and 452 cases in the control group were obtained. Compared with tadalafil alone, meta-analysis suggests there were statistically significant differences in International Index of Erectile Function-5 (IIEF-5), effective rate, Sexual Encounter Profile questions 2 and 3 (SEP-Q2, SEP-Q3) between traditional Chinese medicine combined with tadalafil, and no statistically significant differences in side effects between the two groups. All included studies were tested for publication bias, and the results indicated that there was no significant bias. Two of the articles mentioned the scheme that traditional Chinese medicine combined with low-dose tadalafil for erectile dysfunction by down stairs. | The present meta-analysis demonstrated that, compared with the effects of antibiotics treatment, SJTs combined with antibiotics improved the cure rate, total effective rate and bacterial clearance rate, and decreased the recurrence rate. In addition, no serious adverse reactions were observed in patients with ALUTIs. However, the GRADE quality of evidence was low. Thus, further large scale and rigorously designed clinical trials are required to improve the quality of evidence. |
| O00-O99 임신, 출산 및 산후기 | Meng | 2018 | China | Post-partum blood loss | 8 | 1) RCT comparing prophylactic use of motherwort injection plus carboprost tromethamine for prevention of post-partum blood loss 2) outcome measures included blood loss during post-partum 2 h and 24 h period, incidence of PPH, length of the third stage of labor, duration of lochia and adverse events. | 1) Motherwort was not used as an adjunctive therapy 2) Any different regimen except for motherwort treatment 3) Self-control trial. | Motherwort (YiMuCao) + carboprost | Carboprost | 1) Post-partum 2 h blood loss 2) Post-partum 24 h blood loss 3) Incidence of blood loss 4) Length of the third stage of labor 5) Duration of lochia 6) Adverse events | Meta-analyses showed that GZFL plus mifepristone was superior to mifepristone in reducing the recurrence of endometriosis (RR 0.40; 95% CI 0.27–0.59) and improving the pregnancy (risk ratio [RR] 1.74; 95% confidence intervals [CI] 1.40–2.17). Moreover, adjuvant treatment with GZFL also significantly reduced serum level of estradiol (mean difference [MD] 20.83 pmol/L; 95% CI 34.01 to 7.65) and progesterone (MD 0.18mmol/L; 95% CI 0.23 to 0.12). However, there were no significant differences in serum level of follicle-stimulating hormone (MD 0.42 U/L; 95% CI 1.16 to 0.31) and luteinizing hormone (MD 0.04 U/L; 95% CI 0.43 to 0.34). | Prophylactic use of motherwort injection add-on therapy to carboprost tromethamine could reduce post-partum blood loss. However, more well-designed trials are necessary to confirm the findings of this study due to the methodological flaws of the included trials. |
| O00-O99 임신, 출산 및 산후기 | Chen | 2019 | China | Postpartum Hemorrhage after Cesarean Section | 48 | 1) Patients with cesarean section 2) Studies compared the effectiveness and safety of Yimucao injection combined with western medicine 3) Randomized controlled trials (RCTs) 4) Clinical outcomes which the estimated blood loss. | NR | Yimucao injection + western medicine | Western medicine | 1) Total Effective Rate. 2) Intraoperative Blood Loss 3) Blood Loss within 2 Hours after Delivery 4) Blood Loss within 24 Hours after Delivery | The overall response rate of Yimucao injection combined with western medicine as a class (OR=4.19, 95%CI=2.83, 6.20, P<0.00001) was found to be significantly improved than western medicine alone. Yimucao injection combined with western medicine group could significantly reduce blood loss in intraoperative (SMD= -1.15, 95%CI= -1.43, -0.87, P<0.00001), compared with control group. The treatment group could significantly reduce postpartum blood loss within 2 hours (SMD= -1.73, 95%CI= -2.01, -1.46, P<0.00001) and had a significantly lower blood loss within 24 hours (SMD= -1.92, 95%CI= -2.21, -1.63, P<0.00001) than control group. Additionally, in terms of the safety, Yimucao injection group reduced the risk of adverse events in the course of prevention than the western medicine group. | This study demonstrated that Yimucao injection combined with western medicine may be more effective for preventing postpartum hemorrhage after cesarean section. However, high-quality and large multicenter randomized clinical trials will be needed to prove the consequence in the further. |
| O00-O99 임신, 출산 및 산후기 | Xie | 2019 | China | In vitro fertilization | 27 | 1) RCTs that evaluated the effects of acupuncture on IVF outcomes in women undergoing IVF, with or without ICSI. Namely, women in intervention groups received both IVF and acupuncture and control groups received IVF with or without sham/placebo acupuncture 2) no restriction on objective of study, meaning we included studies where acupuncture was administered for pain relief during oocyte retrieval, or for anxiety relief during IVF-ET, or for improving IVF outcomes 3) any of three types of acupuncture: manual (MA), electrical (EA), and auricular acupuncture techniques 4) studies using either traditional acupuncture, in which needles were inserted in classical meridian points, or western medical acupuncture, in which the needles were inserted in non-meridian or trigger points 5) a clear description of acupuncture time. That is, we included studies which give an equal number of acupuncture treatments for women within a group 6) needling in the control groups could be either no acupuncture or sham (placebo) acupuncture 7) Both fresh and frozen–thawed embryo transfer cycles reporting at least one of the following outcomes: clinical pregnancy rates (CPR - a pregnancy diagnosed by ultrasonographic visualization of one or more gestational sacs or definitive clinical signs of pregnancy), or live birth rates (LBR - the complete expulsion or extraction from a woman of a product of fertilization, after 22 completed weeks of gestational age; which, after such separation, breathes or shows any other evidence of life, such as heart beat, umbilical cord pulsation or definite movement of voluntary muscles, irrespective of whether the umbilical cord has been cut or the placenta is attached) 8) No restrictions on publication type or language. Where studies had multiple publications, the main trial report was used as the reference and additional details were derived from secondary papers. studies of acupuncture treatments without needling; retrospective studies, case series, and studies with a crossover design. | 1) Studies of acupuncture treatments without needling 2) Retrospective studies, case series, and studies with a crossover design. | Acupuntrue(MA OR EA) | No acupuncture(no treatment OR Alfentanil + PCB) OR sham (placebo) acupuncture | 1) Clinical pregnancy rate (CPR) 2) Live birth rate (LBR) 3) Miscarriage rate (MR: [CPR-LBR])CPR) and any reported side effects | Twenty-seven studies with 6116 participants were included. The pooled clinical pregnancy rate (CPR) from all of acupuncture groups was significantly greater than that of control groups (RR 1.21, 95% CI: 1.07–1.38), whereas the pooled live birth rate (LBR) was not. Meta-regression subgroup analysis showed a more significant benefit of acupuncture for repeated IVF cycle proportion (number of women with a history of prior unsuccessful IVF attempt divided by number of women included in each trial) ≥ 50% group (CPR: RR 1.60, 95% CI: 1.28–2.00; LBR: RR 1.42, 95% CI: 1.05–1.92), and this covariate explained most of the heterogeneity (CPR and LBR: adjusted R2 = 100 and 87.90%). Similar results were found between CPR and number of acupuncture treatments (CPR: p = 0.002, adjusted R2 = 51.90%), but not LBR. | Our analysis finds a benefit of acupuncture for IVF outcomes in women with a history of unsuccessful IVF attempt, and number of acupuncture treatments is a potential influential factor. Given the poor reporting and methodological flaws of existing studies, studies with larger scales and better methodologies are needed to verify these findings. |
| O00-O99 임신, 출산 및 산후기 | Gu | 2019 | China | In vitro fertilization with embryo transfer | 31 | 1) Randomized controlled trials (RCTs) 2) Intervention groups received acupuncture as an adjunctive of IVF-ET 3) At least one of the following two IVF outcomes: clinical pregnancy (detection of one or more fetal heartbeats or gestational sacs, ensured by transvaginal ultrasound), or live birth (presence of live birth after 24 weeks of pregnancy). | NR | Acupuncture | No acupuncture OR sham (placebo) acupuncture | 1) IVF outcomes (CPR, OPR, IR, MR, BPR, LBR, IR) | Twelve RCTs involving 1178 patients were included. Regarding the therapeutic effects, total effective treatment ratewas higher for theKTC+HT groups compared to theHT-only groups. Furthermore, compared with HT, KTC+HR effectively altered endocrine indexes involving serum levels of luteinizing hormone (weighted mean difference [WMD]=-3.47, 95% CI [5.68, -1.26], P=0.002]), follicle-stimulating hormone [WMD=-8.15, 95% CI [- 10.44, -5.86], P<0.00001], estrogen [WMD=17.21, 95% CI [10.16, 24.26], P<0.00001], and anti-M¨ullerian hormone [WMD=1.07, 95% CI [0.78, 1.36], P<0.00001]; blood lipid indexes involving serum levels of triglyceride (WMD=-0.55, 95% CI [-0.76, -0.43], P<0.00001), total cholesterol (WMD=-0.63, 95% CI [-0.74, -0.52], P<0.00001), and low-density lipoprotein cholesterol (WMD=- 0.62, 95% CI [-0.75, -0.49], P<0.00001); and B-ultrasound results involving ovarian resistance index (WMD=-0.20, 95% CI [- 0.35, -0.04], P=0.01), perfusion index (WMD=-0.41, 95% CI [-0.57, -0.24], P<0.00001), peak systolic velocity (WMD=2.43, 95% CI [1.52, 3.34], P<0.00001), antral follicle count (WMD=1.20, 95% CI [0.41, 2.00], P=0.003), and mean ovarian diameter in the plane containing the longest axis of the ovary (WMD=4.34, 95% CI [2.94, 5.74], P<0.00001).There were no serious adverse events in either group. | This system review indicated that acupuncture appears to be beneficial to women with poor ovarian reserve or with previous unsuccessful attempts of IVF-ET. The great heteroge- neity and different levels of methodological quality among RCTs may account for variations in outcomes reported by them. Large-size, standardized, TCM theory-based, randomized, and multicenter trials should be conducted in order to gather sufficient evidence to allow relevant governing bodies to make an informed choice on whether or not acupuncture can improve IVF outcomes. |
| O00-O99 임신, 출산 및 산후기 | Liu | 2019 | China | Premature Ovarian Failure | 12 | 1) Study design was an RCT (with no restrictions regarding language, blinding, or publication type) 2) POF was diagnosed according to Chinese and international standards 3) Patients treated with KTC combined with HT were defined as the trial group; patients treated with HT alone were defined as the control group 4) Information about the therapeutic effects of KTC combined with HT was included 5) Data could be extracted for a meta-analysis. | 1) Study design was a non-RCT (without randomization or a control group), review, animal study, case report, report of specialist experiences, etc. 2) Publication was a duplicate article 3) Data could not be extracted 4) Sample size <30 cases 5) Treatment measurements did not meet the predetermined inclusion criteria. | Kuntai capsules (KTC) plus hormone therapy (HT) | HT | 1) Total effective treatment rate 2) Luteinizing hormone (LH) + follicle-stimulating hormone (FSH) + estrogen (E2) levels 3) Lipid index levels 4) Ovarian resistance index (RI), perfusion index (PI), and peak systolic velocity (PSV) 5) Antral follicle count (AFC) 6) Anti-M¨ullerian hormone (AMH) 7) Kupperman score 8) Mean ovarian diameter (MOD) in the plane containing the longest axis of the ovary | The overall response rate of Yimucao injection combined with westernmedicine as a class (OR=4.19, 95%CI=2.83, 6.20, P<0.00001) was found to be significantly improved than western medicine alone. Yimucao injection combinedwith western medicine group could significantly reduce blood loss in intraoperative (SMD= -1.15, 95%CI= -1.43, -0.87, P<0.00001), compared with control group.The treatment group could significantly reduce postpartum blood loss within 2 hours (SMD= -1.73, 95%CI= -2.01, -1.46, P<0.00001) and had a significantly lower blood loss within 24 hours (SMD= -1.92, 95%CI= -2.21, -1.63, P<0.00001) than control group. Additionally, in terms of the safety, Yimucao injection group reduced the risk of adverse events in the course of prevention than the western medicine group. | There is evidence that KTC+HT ismore effective and safer than HT alone for treating POF. However, the trials had low methodological quality and small samples, so further standardized research is required. |
| O00-O99 임신, 출산 및 산후기 | Gao | 2019 | China | Anovulatory infertility | 9 | 1) RCT design 2) Patients diagnosed with anovulatory infertility 3) Treatment groups that received acupuncture only or acupuncture combined with CC and control groups that were given CC 4) Outlined clear endpoints for assessment and pregnancy outcomes 5) Contained sufficient data to enable the calculation of odds ratios (ORs) or mean differences (MDs) and their 95% confidence intervals (95% CI) | 1) Non-RCTs 2) Not include patients who met the diagnostic criteria for anovulatory infertility 3) No information concerning pregnancy outcomes 4) Not contain a treatment group using acupuncture only or acupuncture combined with CC and a control group using CC 5) Included other drugs that may have affected ovulation 6) Used Chinese herbal medicine 7) Not clearly identify the location of needles being stimulated 8) Missing data 9) Duplicate publications of previously identified studies. | Acupuncture, acupuncture + clomiphene citrate (CC) | Clomiphene citrate | 1) Pregnancy 2) Ovulation 3) Follicular diameter 4) Pregnancy loss | Eight trials including 1276 pregnant women fulfilled the inclusion criteria. Prophylactic use of motherwort injection add-on therapy significantly reduced the post-partum 2 h (MD -127.5 mL; 95% CI -149.13 to -105.88) and 24 h (MD -146.85 mL; 95% CI -179.77 to -113.94) blood loss and incidence of post-partum hemorrhage (RR 0.28; 95% CI 0.17–0.45) than carboprost. Moreover, adjunctive treatment with motherwort injection significantly decreased the length of the third stage of labor (MD -3.41 min; 95% CI -4.33 to -2.49) and duration of lochia (MD -7.13 days; 95% CI -8.49 to -5.76). There was no statistical significant difference in the incidence of adverse events (RR 0.76; 95% CI 0.50–1.16). | Based on the above pooled results of the studies, the use of acupuncture as a monotherapy significantly improved the rate of pregnancy among the study participants compared with the use of CC alone. However, any results drawn from these studies should be interpreted with caution when considering the context of clinical practice. |
| O00-O99 임신, 출산 및 산후기 | Meng | 2019 | China | Endometriosis | 10 | 1) RCT as study design 2) Participants were women with confirmed endometriosis 3) GZFL formula (pill, capsule, decoction, or tablet) plus mifepristone versus mifepristone alone as intervention 4) Outcome measures were pregnancy rate and recurrence of endometriosis (Secondary outcomes were serum level of follicle-stimulating hormone (FSH), luteinizing hormone, estradiol or progesterone, and adverse events including irregular vaginal bleeding, gastrointestinal reaction, hot flashes or abnormal liver function) | 1) Non-randomized trials and suspected plagiarism 2) Modified Guizhi Fuling formula as intervention 3) Any different interventions except for GZFL 4) Outcome measures were not of interests | Guizhi Fuling formula + Mifepristone | Mifepristone | 1) Pregnancy rate 2) Recurrence rate 3) Follicle-stimulating hormone 4) Luteinizing hormone 5) Estradiol 6) Progesterone 7) Adverse events | Nine trials including 1441 women were included in the meta-analysis. There were no significant differences in the rates of pregnancy (odds ratio (OR) 1.18, 95% CI 0.83 to 1.69), ovulation (OR 2.57, 95% CI 0.59 to 11.29) or pregnancy loss (OR 0.98, 95% CI 0.59 to 1.63) when acupuncture was used as an adjuvant therapy alongside CC. Although acupuncture alone did not increase the ovulation rate (OR 0.41, 95% CI 0.11 to 1.49), our review demonstrated superior effects in patients who received acupuncture as a separate treatment modality with respect to both the pregnancy rate (OR 2.34, 95% CI 1.76 to 3.10) and the maximum follicular diameter (mean difference 0.50 mm, 95% CI 0.44 to 0.56 mm) when compared with CC alone. Statistical analysis also showed a reduction in the rate of pregnancy loss when acupuncture was used as a separate treatment compared with CC alone (OR 0.19, 95% CI 0.08 to 0.45). | GZFL as adjuvant therapy to mifepristone appears to have additional benefits in preventing recurrence of endometriosis and improving pregnancy among women with endometriosis. However, these conclusions should be interpreted with caution due to the methodological flaws of the included trials. |
| S00-T98 손상, 중독 및 외인에 의한 ... | Cao | 2019 | China | Acute Alcohol Intoxica- tion | 35 | 1) Randomized controlled trials (RCTs) which compared XNJ with naloxone for patients with AAI were included in this review. AAI is diagnosed according to a recognized criterion (e.g., DSM-Ⅳ- TDR), and the patients have symptoms of ataxia or coma, regardless to their age or gender. 2) Routine therapy was used in both groups, including diuretic, rehydration, vitamin supplement, and maintain of electrolyte balance. Combination of XNJ and naloxone compared with naloxone alone was also included to determine the add-on effect of XNJ for AAI. 3) The included trials report at least one of the following: The primary outcome is the patients' conscious recovery time. The secondary outcomes include length of stay time in emergency department, ataxia symptom disappearance time (defined by the doctor in charge of the case), severity of the symptoms [assessed by recognized scales, e.g., the International Classifi cation of Diseases, 10th Revision, Australian Modification (ICD-10-AM)], BAL and AEs. | NR | Xingnaojing Injection(XNJ) + Routine Therapy OR XNJ + Naloxone + Routine Therapy OR XNJ | Naloxone + Routine Therapy OR Naloxone + Routine Therapy OR Naloxone | 1) Patients' conscious recovery time, 2) Stay length in emergency department, 3) Disappearance time of the ataxia symptom, 4) Severity of the symptoms, 5) Blood alcohol content 6) Adverse events | Totally 141 trials with 13,901 patients were included in this review, all of them were assessed as unclear or high risk of bias. Results showed that on the basis of routine therapy, standard dose XNJ (10–20 mL) may have similar results with naloxone on the recovery time of consciousness (MD 12 min, 95% CI 7.2–17.4 min) and disappearance time of symptoms (MD 6 min, 95% CI –13.8–25.8 min) for patients with AAI. Larger dose of XNJ Injection (21–40 mL) may speed up the time (almost 1 h earlier). Combination of XNJ and naloxone seemed superior to the naloxone alone for all the relevant outcomes. The average difference of time in consciousness recovery was 2 h and the number of AAI patients whose consciousness recovery within 1 h was above 50% the combination group than in the control group (RR 1.42, 95% CI 1.29 to 1.56). No severe adverse events or adverse reactions of XNJ were reported in the included trials. | Low quality of evidence showed XNJ may have equal effect as naloxone and may achieve better effect as add-on intervention with naloxone for patients with AAI. We failed to evaluate the safety of XNJ Injection due to the insuffi cient evidence in this review. |
| U00-U99 특수목적 코드 | Wang | 2020 | China | Corona Virus Disease 2019 | 7 | 1) 研究类型:临床疗效研究。 2) 研究对象：COVID-19 患者。 3) 诊断标准:根据国家卫健委 发布的《新型冠状病毒感染的肺炎诊疗方案》。 4) 患者基线均衡可比。 5) 干预措施:治疗组在对照组 的基础上给予连花清瘟或与其方剂成分相同的治疗，包括连花清瘟单独及联合其他中药治疗。对照组采用对症支持治疗、抗病毒和抗菌等西医单独治疗方案。 6) 结局指标:包括主要临床症 状(发热、乏力及咳嗽)有效率, CT 好转情况,临床转重型 情况,发热持续时间,临床症状消失时间及住院时间。 | 1) 非临床疗效 研究，如个案报告、病例系列研究等。 2) 研究对象为 疑似COVID-19患者。 3) 重复(病例 发表文献。 4) 无法获得全 文进行数据提取的文献。 | Lianhua Qingwen + Western Medicine | Western medicine | 1) 主要临床症状 (发热,乏力及咳嗽)有效率 2) CT 好转情况 3) 临床转重型情况 4) 发热持续时间 5) 临床症状消失时 间及住院时间 | Seven clinical trials were included with 665 COVID-19 patients. Compared with Western medicine alone, integrated Lianhua Qingwen significantly improved the effective rate of clinical symptoms [RR = 1.24, 95% CI (1.12, 1.38), P < 0.05] of COVID-19, increased CT improvement [RR = 1.14, 95% CI (1.02, 1.28), P < 0.05] and reduced the proportion of progressing into sever clinical level [RR = 0.48, 95% CI (0.31, 0.72), P < 0.05]; In addition, integrated Lianhua Qingwen could effectively shorten the duration of fever [SMD = -0.87, 95% CI (-1.22,-0.52), P < 0.05], time of clinical symptoms disappearance [SMD = -1.19, 95% CI (-1.56, -0.82), P < 0.05] and hospital stay [SMD = -0.61, 95% CI (-0.91, -0.30), P < 0.05]. | Lianhua Qingwen could be used as adaptive and complementary medicine to improve clinical symptoms and CT for COVID-19. |
| U00-U99 특수목적 코드 | Liu | 2020 | China | Corona virus disease (COVID-19) | 11 | 1) Patients: confirm diagnosed COVID-19 patients (Age≥18 years) by laboratory 2) Intervention: patients in treatment groups were given TCM therapy in addition to the baseline medication similar to the control group (the TCM therapy included Chinese medicine compound drugs, Chinese patent medicine) 3) Comparison: the patients of the control group were given modern Western conventional treatments 4) Outcomes: a. clinical efficacy, b. clinical symptoms, c. laboratory indicators, d. adverse drug reactions 5) Study types: randomized controlled trials (RCTs) and case-control studies (CCSs) | 1) Review, abstract, letter, case reports, case series reports, and animal experiments | TCM +Western conventional treatments | Western conventional treatments | 1) Clinical Efficacy 2) Symptoms disappearance rate or time 3) Laboratory indicators 4) Adverse Drug Reaction | A total of 11 studies were included. Four were RCTs and seven were CCSs. The sample size of including studies ranged from 42 to 200 (total 982). The traditional Chinese medicine included Chinese medicine compound drugs (QingFei TouXie FuZhengFang) and Chinese patent medicine (e.g. Shufeng Jiedu Capsule, Lianhua Qingwen granules). Compared with the control group, the overall response rate [RR=1.230, 95%CI (1.113, 1.359), P=0.000], cure rate [RR=1.604, 95%CI (1.181, 2.177), P=0.002], severity illness rate [RR=0.350, 95%CI (0.154, 0.792), P=0.012], and hospital stay [WMD=-1.991, 95%CI (-3.278, -0.703), P=0.002] of the intervention group were better. In addition, Integrated Medicine can improve the disappearance rate of fever, cough, expectoration, fatigue, chest tightness and anorexia and reduce patients’ fever, and fatigue time (P < 0.05). | This review found that Integrated Medicine had better effects and did not increase adverse drug reactions for COVID-19. More high-quality RCTs are needed in the future. |
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