Objective To learn the current situation of traditional Chinese medicine (TCM) systematic reviews/meta-analyses published in Chinese journals. Methods All TCM systematic reviews/meta-analyses published from 1978 to July 31, 2009 were searched in the Chinese Biomedical Database (CBM). According to the inclusion and exclusion criteria, relevant information was extracted on the basis of research purpose. Meanwhile, publication year, journal name, author’s district, number of authors and their articles, types of diseases and interventions were took as the indexes, and then descriptive analysis was performed using SPSS 15.0 software. Results A total of 245 articles including 238 in Chinese and 7 in English were included. All of them were published in 117 different journals from 1998 to 2008, showing an accelerating growth trend of article number. In addition to only one article with first author from Germany, the first author of other 244 were from 24 domestic provinces (autonomous regions and municipalities); the number of authors ranged from 1 to 11; a total of 186 people had published articles as first author, and the number of their published articles ranged from 1 to 29. There were 16 types of diseases according to the International Classification of Diseases 10th Edition (ICD-10). Totally, 218 articles took drugs as interventions (including 106 listed drugs, 25 self-made prescriptions, 70 related to both listed drugs and self-made prescriptions, and 17 without reporting detailed interventions), accounting for 89%; and 27 articles were about non-drug interventions (including 26 about acupuncture and 1 about massage), accounting for 11%. Most (95.8%) of the articles about self-made prescriptions and listed drugs/self-made prescriptions adopted inappropriate pooled analyses. Conclusion Evidence-based medicine has been spread into the field of TCM, the number of TCM systematic reviews/meta-analyses shows an accelerated growth trend. The types of diseases discussed in the literature were almost the same as the diseases those could be effectively treated by TCM, but there existed imbalance in districts. In the future, systematic review/meta-analysis on drug intervention should aim at Chinese patent medicines and single medicines rather than self-made prescriptions, and should pay more attention to advantageous drugs and advantageous treatments of diseases. Moreover, importance should be also attached to clinical heterogeneity controlling when using acupuncture as a non-drug intervention.
Objective To assess the quality of published systematic reviews and meta-analyses on Traditional Chinese Medicine (TCM) published in Chinese journals. Methods We searched CNKI, CMB from January 1995 to December 2006 and The Cochrane Library (Issue 4, 2006) for systematic reviews and meta-analyses on TCM. We extracted details of the interventions used in the treatment and control groups, analyzed the validity of included studies and investigated whether the reports used QUOROM statement or not. Results We identified 111 reports, of which 1 on prevention, 1 on adverse events, 1 on risk factors and premonitory symptoms, 2 on physiochemical parameters, and 106 on effectiveness and safety assessment. In total, 42 types of diseases were involved, and 41 reports were related to cerebrovascular diseases. As for the investigated interventions, 25 studies assessed TCM and 12 assessed acupuncture. Two had no control intervention design control in the group, 15 did not describe the interventions in the control group, 50 used active control (26 for western medicine, 12 for Chinese medicine, 12 for western plus Chinese medicine), 14 used blank control, 17 used baseline control, 4 used sham acupuncture or acupoint injection control etc., 5 used placebo control and 4 used "mutual control". The interventions used in the treatment and control groups varied widely. The number of trials included in the reviews and meta-analyses ranged from 1 to 35, and 24 studies included non-randomized controlled trials. Of the 111 reports, 14 were Cochrane reviews, 16 did not assess the quality of included randomized trials and a further 22 performed only simple and nonstandard quality assessment of the included trials. None of the reviews or meta-analyses used the QUOROM statement to report their results. Conclusions Because of the unique characteristics of TCM, systematic reviews of TCM should focus on a specific topic, avoid the selection of too many drugs, address the target indications of the test drugs and pay attention on intervention evaluation. High quality systematic reviews of TCM are needed but they will only be produced through the concerted efforts of clinicians, TCM practitioners and methodologists.
Clinical efficacy evaluation is important for the development of traditional Chinese medicine (TCM). In view of the existing accumulation and current situation of the TCM clinical efficacy evaluation, based on the international perspective, and taking the rational and objective evaluation of TCM clinical efficacy and safety as the foundation, in order to enhance TCM evidence level to support clinical decision-making and promote TCM industry and TCM internationalization development, the State Administration of TCM entrusted China Academy of Chinese Medical Sciences to establish China Center for Evidence Based Traditional Chinese Medicine (CCEBTCM). CCEBTCM is expected to optimize the allocation of evidence-based research resources in TCM field to further integrate advantages of evidence-based TCM research teams, promote consensus on evidence-based TCM standards, share evidence-based TCM data or information and lead cultural exchanges between Chinese and overseas. In this way, the status and influence of TCM in the world will be enhanced so that it can better serve global health.
The clinical practice guideline on traditional Chinese medicine alone or combined with antibiotics for patients with acute upper respiratory infection in children was issued by China Association of Chinese Medicine in June 2017. Base on the evidence, consensus and experience, five manage groups, steering committee, consensus expert group, systematic review group, drafting group and secretary group, have promoted the project. The main work process refers to up-to-date clinical practice guideline definitions of institute of medicine and quick recommendations guide of guidelines international network and WHO. In order to provide readers with a better understanding of the guideline, the drafting process of guideline principle, main work process, and basis policy were described in detail in this paper. The guidelines’ scientific characteristics, accuracy and practicability were better exhibited in attempt to enhance its promotion and application.
Objective To assess the efficacy and safety of Chinese herbal medicines for chronic functional constipation. Methods We searched CNKI (1989 to November, 2009), CBM (1989 to November, 2009), VIP (1989 to November, 2009), Cochrane Library (Issue 4, 2009), PubMed (1966 to November, 2009) and EMbase (1986 to November, 2009). All randomized and quasi-randomized clinical trials of treating chronic functional constipation with Chinese herbal medicines versus untreated, placebo or western drug groups were included. Data were extracted independently by two reviewers. The methodological quality of trials was evaluated with Cochrane Handbook 5.0.2 criteria. Meta-analyses were conducted by the RevMan 5.0 software. Results Twenty-one trials involving 2 602 patients were included. The Meta-analysis results showed that: Chinese herbal medicines improved both syndromes and colonic transit function of recipients; moreover, it is superior to both gastrointestinal prokinetic agent in effective rate (RR=1.18, 95%CI 1.12 to 1.25), healing rate (RR=1.59, 95%CI 1.35 to 1.88), and cathartic in effective rate (RR=1.18, 95%CI 1.10 to 1.27), healing rate (RR=1.16, 95%CI 1.29 to 2.10). Integration of Chinese herbal medicines and gastrointestinal prokinetic agent is superior to gastrointestinal prokinetic agent in effective rate (RR=1.21 95%CI 1.09 to 1.34) and healing rate (RR=1.41, 95%CI 1.11 to 1.79). Conclusion Some Chinese herbal medicines may be effective and safe in treating chronic functional constipation, which can not be bly proved at present for lack of studies with high quality.
Objectives
To discuss the methodology of evaluation of traditional Chinese medicine (TCM) placebo simulation effects and the problems of blind implementation and so as to improve the quality of double-blind clinical trials of TCM.
Methods
Focusing on case of placebo preparation of TCM investigational new drug, simulation effects of the placebo were evaluated in terms of shape, color, taste and smell. The possibility of placebo be a drug and the similarity between placebo and drug were tested.
Results
There was no significant difference between placebo and investigational new drug to be judged as a drug (P>0.05). As for the similarity between placebo and drug, there was no significantly difference of the shape (P>0.05), for which the similarity was 100%. The color, taste and smell were significant different between placebo and drug (P<0.05), for which the similarity were 50%, 10% and 15% respectively.
Conclusions
It is very difficult to simulate TCM based on its certain color, taste or smell. Therefore, the subjects and the investigators’ compliance should be kept to avoid breaking the blind intentionally in the process of the trial and the influence of unblinding should be estimated at the end of the trial.
Traditional Chinese Medicine (TCM) clinical practice guidelines play essential roles in the development of TCM. However, the existing TCM guidelines are not effectively used in clinic. Based on this phenomenon, this article addresses the characteristics of clinical practice guidelines of TCM, and analyzes its status, problems and resolutions, providing feasible suggestions for the development of high-quality clinical practice guidelines of TCM which are in accordance with clinical practice.
Objective To assess the efficacy and safety of Chinese medicinal herbs for asymptomatic hepatitis B virus(HBV) infection. Data Source The trials registers of the Cochrane Hepato-Biliary Group, the Cochrane Library and the Cochrane Complementary Medicine Field were searched in combination with MEDLINE, EMBASE, and handsearches of Chinese journals and conference proceedings. Data Selection Randomized clinical trials with 3 months follow-up comparing Chinese medicinal herbs versus placebo, no intervention, non-specific treatment, or interferon treatment for asymptomatic HBV carriers were included. No language and blinding limitations were applied. Data Extraction Data were extracted independently by two reviewers. The methodological quality of trials was assessed by the Jadad-scale plus allocation concealment. Results Three randomized clinical trials (307 patients) with low methodological quality following patients for three months or more after the end of treatment were included. Herbal compound Jianpi Wenshen recipe showed significant effects on clearance of HBV markers compared to interferon: relative risk 2.40 (95 % CI 1.01 to 5.72) for clearance of serum HBsAg, and 2.54 (1.13 to 5.70) for seroconversion of HBeAg to anti-HBe. Phyllanthus amarus and Astragalus membranaceus showed no significant antiviral effect compared with placebo. Analysis of pooling eight randomized clinical trials with less than three months follow-up did not show a significant benefit of Chinese medicinal herbs on viral markers. No serious adverse event was observed. Conclusions There is insufficient evidence for treatment of asymptomatic HBVcarriers using Chinese medicinal herbs due to the low quality of the trials. Further randomized, double blind, placebo-controlled trials are needed.
Objective To analyze the heterogeneity of systematic reviews (SRs)/Meta-analysis on traditional Chinese medicine (TCM), and explore strategies for addressing heterogeneity correctly during the process of conducting TCM related to systematic reviews (SRs). Methods Both electronic and hand searches were used to identify TCM SRs in CBM, CNKI, VIP database, and Chinese Journal of Evidence-Based Medicine. Two researchers performed data extracting and heterogeneity evaluation independently. Results A total of 115 TCM SRs were included, involving 17 types of diseases, among which the cardiovascular and cerebrovascular diseases were the most addressed (n=36, 31.30%). There were 35.65% (n=41) of SRs which integrated two or more types of studies; interventions of the included studies were inconsistent in 53.91% (n=62) of TCM SRs; control groups of the included studies were completely different in 60 (52.17%) SRs; and 8.7% (n=10) of SRs failed to investigate heterogeneity in the process of synthesis analysis. Conclusion The heterogeneity is common in TCM related to SRs, and the most addressed is clinical heterogeneity. Addressing heterogeneity incorrectly would downgrade the quality of TCM related to SRs.
