Evaluation methods of clinical efficacy of traditional Chinese medicine / 中国中药杂志

Clinical efficacy is the basis for the development of traditional Chinese medicine(TCM), and the evaluation of clinical efficacy of TCM has always been the focus of attention. The technical and methodological difficulties in the evaluation process often restrict the generation of high-level evidence. Therefore, methodological research should be deepened and innovative practice should be carried out to study the application of scientific research methods in the evaluation of the advantages of TCM. After more than ten years of development, the clinical efficacy evaluation of TCM, on the basis of the initially classic placebo randomized controlled trials, has successively carried out a series of meaningful attempts and explorations in N-of-1 trials, cohort studies, case-control studies, cross-sectional studies, real world studies, narrative medicine studies, systematic evaluation, and other aspects, laying the foundation for the transformation of TCM from "experience" to "evidence". This paper focused on the clinical efficacy evaluation of TCM, summarized the main connotation and development status of efficacy evaluation indicators, standards, and methods, and put forward corresponding countermeasures and suggestions for the problems of indicator selection, standard formulation, and methodology optimization in the research process. It is clear that scientific and objective evaluation of the efficacy of TCM is an urgent problem to be solved at present.

Problems and thoughts in clinical safety evaluation of traditional Chinese medicine / 中国中药杂志

Amid the modernization and internationalization of traditional Chinese medicine(TCM), the safety of TCM has attracted much attention. At the moment, the government, scientific research teams, and pharmaceutical enterprises have made great efforts to explore methods and techniques for clinical safety evaluation of TCM. Although considerable achievements have been made, there are still many problems, such as the non-standard terms of adverse reactions of TCM, unclear evaluation indicators, unreasonable judgment methods, lack of evaluation models, out-of-date evaluation standards, and unsound reporting systems. Therefore, it is urgent to further deepen the research mode and method of clinical safety evaluation of TCM. Based on the current national requirements for the life-cycle management of drugs, this study focused on the problems in the five dimensions of clinical safety evaluation of TCM, including normative terms, evaluation modes, judgment methods, evaluation standards, and reporting systems, and proposed suggestions on the development of a life-cycle clinical safety evaluation method that conformed to the characteristics of TCM, hoping to provide a reference for future research.

Clinical efficacy of Yougui capsules and Wuziyanzong pills on oligoasthenospermia / 中华男科学杂志

<p><b>OBJECTIVE</b>To investigate the clinical effects of the Chinese traditional medicine Yougui Capsules and Wuziyanzong Pills on sperm viability and motility in patients with oligoasthenospermia.</p><p><b>METHODS</b>A total of 80 infertile men oligoasthenospermia were equally randomized into a trial and a control group, the former treated with Yougui Capsules at 1.68 g tid, while the latter with Wuziyanzong Pills at 6 g bid, both for a course of 12 weeks. The sperm viability and motility of the patients were detected and compared before and after medication.</p><p><b>RESULTS</b>After 12 weeks of medication, the sperm viability and percentages of grade a and grade a + b sperm were (65.7 +/- 13.1), (22.5 +/- 9.1) and (47.6 +/- 15.8)% in the trial group, significantly higher than (38.1 +/- 11.1), (13.2 +/- 6.8) and (24.1 +/- 10.9)% in the control (P<0.05). What's more, the above three parameters of the two groups were also significantly higher than those before medication, which were (31.9 +/- 16.9), (8.2% +/- 3.7) and (15.7 +/- 13.9)% in the former and (31.7 +/- 17.0), (7.9 +/- 4.5) and (16.9 +/- 13.6)% in the latter (P<0.05).</p><p><b>CONCLUSION</b>Both Yougui Capsules and Wuziyanzong Pills can improve sperm viability and motility in patients with oligoasthenospermia, and the former is even more efficacious than the latter.</p>

Acupuncture for chronic prostatitis: a meta-analysis / 中华男科学杂志

<p><b>OBJECTIVE</b>To determine the effect of acupuncture on chronic prostatitis.</p><p><b>METHODS</b>We retrieved all the case-control studies on acupuncture for chronic prostatitis before August 2007 in MEDLINE and CNKI databases, screened the eligible literature according to the selection and exclusion criteria, and performed meta-analyses of the included studies with the software Revman 4. 2.</p><p><b>RESULTS</b>Thirteen eligible reports were identified in this study, including 861 cases and 738 controls. The effectiveness and cure rates were significantly higher in the acupuncture therapy group than in the control, with pooled RR as 1.20 (95% CI, 1.14, 1.25; P < 0.01) and 1.85 (95% CI, 1.63, 2.11; P < 0.01), respectively.</p><p><b>CONCLUSION</b>Acupuncture therapy exhibited a definite effect in the treatment of chronic prostatitis.</p>