ObjectiveTo evaluate the efficacy and safety of traditinal Chinese Medicine (TCM) syndrome classification and intervention for the prophylaxis of menstrual migraine. MethodsPatients consistent with the inclusion criteria from January 2013 to June 2014 were included in the trial. Patients were randomized by their visiting order into two groups:the experimental group was treated with Chinese traditional medicine compound decoctions (two doses for three days), and the control group was treated with vitamin B2 (400 mg once daily). The patients were treated for thirty days consecutively. Efficacy was assessed using the records of the frequency, duration, and severity of migraine attacks. Laboratory tests, vital signs, and adverse events were monitored. ResultsBoth treatments led to a significant reduction in the frequency, duration, and severity of migraine attacks (P<0.05). TCM therapy was significantly better than vitamin B2 for reducing the frequency and the duration of migraine (P<0.05). No serious adverse drug reaction was found in both groups. ConclusionTCM syndrome classification and intervention is effective and relatively safe in the prophylaxis of menstrual migraine attacks.
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.
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 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.
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.
This article introduces a dynamical stratified blocked randomized algorithm when the static stratified blocked randomized algorithm is not suitable to resolve the problem caused by uncertain stratified factors and levels during calculation of the sample size at the stage of clinical trial design. Prior to the start of the clinical trial, a list of random numbers is created by blocked randomized algorithm. During field implementation, a block of random numbers is dynamically allocated to a stratify level. Thereafter, a subject is randomized into different groups in that block. The study of Chinese medicine for gastric cancer anemia and blood hypercoagulability is used as an example to illustrate how to design and implement dynamic stratified block randomized algorithm. The results show that the dynamic stratified block randomized algorithm is more flexible and adaptable than the static stratified blocked randomized algorithm. However, its application is more complex and requires higher standards in clinical trials.
Objective To evaluate the effectiveness and safety of traditional Chinese medicine (TCM) plus transcatheter arterial chemoembolization (TACE) compared with TACE alone, in the treatment of unresectable hepatocellular carcinoma (HCC). Methods The Cochrane Library, MEDLINE, EMBASE, CANCERLIT, CBM, CNKI and VIP were searched electronically. Relevant journals and conference proceedings were also handsearched. The quality of included studies was assessed according to the criteria recommended by the Cochrane Handbook for Systematic Reviews of Interventions, and meta-analyses were performed for homogeneous studies using The Cochrane Collaboration’s RevMan 4.2.10 software. Subgroup analyses by frequency of TACE (lt;3 or ≥3 times) were also performed. Results Thirty seven trials, all published in China, involving 2 653 participants were included. The quality of 2 studies was graded B (medium) and that of the other 35 was graded C (low). Meta-analyses showed that TCM plus TACE, compared with TACE alone, could significantly improve survival, tumor response (complete and partial), quality of life and clinical symptoms, and was also associated with a lower incidence of adverse reactions. Subgroup analyses indicated that, patients with less than three TACE had more significant improvement in survival and clinical symptoms, while patients with three or more TACE had more significant improvement in tumor response and quality of life. The incidence of adverse reactions was similar between these two different frequencies of TACE. Conclusions The treatment regimen of TCM plus TACE is superior to TACE alone in patients with unresectable HCC. As the existing data have a high risk of bias, the current evidence is insufficient to define the efficacy of the combination treatment, and further large-scale, high-quality randomized controlled trials are needed.
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.
Objective To evaluate the efficacy and safety of Chinese herb compared with an analgesic drug in the treatment of cancer pain. Methods We electronically searched CBM (1990 to 2008), CNKI (1990 to 2008), VIP (1990 to 2008), The Cochrane Library (Issue 3, 2008), and MEDLINE (1990 to 2008). Relevant journals and conference proceedings were also handsearched. The quality of the included trials was assessed according to the criteria recommended by the Cochrane Handbook for systematic reviews of interventions and meta-analyses were performed for homogeneous studies using the Cochrane collaboration’s review manager 4.2.2 software. Results Five randomized controlled trails (RCTs), all published in Chinese, involving 590 participants, were included. The quality of all RCTs was graded C (low). Meta-analyses were not performed due to heterogeneity. Instead, descriptive analyses were conducted. The results showed that as for the total effective rate in pain-relieving, Zhentongsan (RR=1.11, 95%CI 1.00 to 1.24, P=0.05) and Xiaozhengzhitong paste (RR=1.35, 95%CI 1.02 to 1.78, P=0.04) were more effective than Indometacin, with significant differences. There were no significant differences between Duyiwei capsule and Indometacin, and so were between Huajianbadumo as well as Shebingzhitong paste and Tramado. In terms of early potency, there were significant differences between Zhentongsan (SMD= –?9.87, 95%CI –10.84 to –8.89, Plt;0.000 01) as well as Xiaozhengzhitong paste (SMD= –8.74, 95%CI –10.164 to –7.32, Plt;0.000?01) and Indometacin, and so were between Shebingzhitong paste and Tramadol (SMD= –2.24, 95%CI –3.00 to –1.49, Plt;0.000?01). There were no significant differences between Huajianbadumo and Tramodo. With regard to the durative effect on pain-relieving, there were significant differences between Xiaozhengzhitong paste and Indometacin (WMD=4.78, 95%CI 2.99 to 6.57, Plt;0.00001), but not between Shebingzhitong paste and Tramadol. Conclusion Because of low quality of the existing studies, the current evidence is insufficient to define the efficacy and safety of compound Chinese herb, and further large-scale and high-quality RCTs are needed.
Traditional Chinese Medicine (TCM) standardization is an important carrier for TCM inheriting and innovating. As an important content of TCM standardization system, TCM clinical practice guidelines' designation and revision play an important role for medical staff to regulate medical behavior, and improve the quality of health services. This paper expounds the significance and function of the TCM guidelines, analyzes the present situation, opportunities and challenges, and puts forward the strategies and suggestions to promote the development of evidence-based TCM guidelines.