| Recently years, the incidence of infertility has increased significantly, which has a big influence on the couples and social stability. Male factors are accounting for half of infertility. Oligoasthenotspermia is the main cause of the male infertility. Its etiology and pathogenesis is not entirely clear, and no exact effect with western medicine treatment up to now. Empirical drugs are commonly used in clinic, including hormones, antioxidant drugs, bromocriptine and zinc preparations. However, clinical research reports were not consistent with each other about the the efficacy.The traditional Chinese medicine in male infertility treatment has a long history which emphasize on kidney's congenital essence. As a result, reinforcing kidney is the main therapeutic method. Our previous studies showed that reinforcing kidney method can significantly improve the quality of sperm in kidney yang-deficiency rats, serum sex hormone levels and spermatogenesis. Moreover, my tutor also found that kidney reinforcing method can better improve the pregnancy rate of the male spouses. Taken the characteristics of significant effects, lower side effects and easily accepted by patients in traditional Chinese medicine therapy into consideration, researches of randomized controlled clinical trials are increasing. Yet, the existing clinical reports are differenent with each other, the evidence of the conclusions are not high and the overall quality of the literature is low.In view of the advantages and the disadvantages, this study is designed to evaluate the effctiveness and safety of reinforcing kidney method in oligoasthenotspermia therapy by a systematic review. Thus, providing a clinical evidence for traditional Chinese medicine in oligoasthenotspermia therapy.Objective:To provide a reliable evidence for clinical application of reinforcing kidney method in oligoasthenotspermia treatment by a systematic review.Methods:1) Searching from the databases such as China Biology Medicine disc(CBM), China National Knowledge Infrastructure(CNKI), VIP, and Pubmed. The search date is from the database construction to July 2015. Both text words and Me SH terms were used by two researchers. Evidence-based research methods were also adopted to obtain the randomized or semi-randomized controlled clinical trials in oligoasthenotspermia treatment using reinforcing kidney method.2) Extraction of information from the included literature.3) Quality evaluation of the literature according to literature reliability and modified Jadad scale.4) A Rev Man 5.3 software was used to statistical analysis.5) Descriptive research method was used to evaluate the clinical safety.Results:1) A totally 431 articles were found while only 25 articles were finally included.2) There are many design flaws after quality assessment of the literature, such as sample size estimating, randomized, blinding and follow-up visit.3) The included articles are all add other therapies based on reinforcing kidney supplying emission. There are 9 articles using combined kidney yin-yang therapy and 7 articles using reinforcing kidney warming yang. In addition, 3 articles are belong to reinforcing kidney dissolving dampness therapy. In addition, reinforcing kidney invigorating spleen, reinforcing kidney activating blood and reinforcing kidney soothing liver therapy are all contain 2 articles, particularly.4) Results show that the total efficiency OR and 95% confidence interval values of reinforcing kidney method in oligoasthenotspermia therapy is 3.17 [2.62, 3.84], and total pregnancy spouse is 2.44 [2.01, 2.97], the difference is statistically significant(P<0.05). Reinforcing kidney method alone or combined with western medicine can improve the overall efficiency and spouse pregnancy, its efficacy is superior to western medicine group, and the security is much better.5) The clinical curative effects of the reinforcing kidney yin-yang alone or combined with western medicine, reinforcing kidney warming yang alone or combined with western medicine, reinforcing kidney dissolving dampness, invigorating spleen and kidney and reinforcing kidney activating blood are higher than western medicine group. The difference is statistically significant(P<0.05). There are no significant difference between reinforcing kidney soothing liver method and western medicine group(P>0.05). Moreover, descriptive analysis is performed to evaluate the semen analysis index, including a sperm motility, a+b sperm motility and semen density. Those indexes in reinforcing kidney method alone or combined with western medicine are improved compare with western medicine group. Statistical significance are found(P<0.05).6) In terms of adverse effects, in addition to a self-created prescription, reinforcing kidney treatment is generally lower than western medicine group.Conclusion:1) The included articles are all add other therapies based on reinforcing kidney supplying emission.2) The clinical total curative effect and pregnant rate of reinforcing kidney method alone or combined with western medicine are much higher than western medicine group. And the same effects are found in the subgroups such as the combined yin-yang alone or combined with western medicine, reinforcing kidney warming yang or combined with western medicine, reinforcing kidney activating blood, invigorating spleen and kidney, reinforcing kidney dissolving dampness and reinforcing kidney soothing liver. In addition, less adverse effects and higher safty are clarified in reinforcing kidney treatment.3) Given the low-quality of the included literature, more multi-center, large sample, reasonable designed, strictly performed and with Chinese characteristics randomized controlled trials should be carried out.4) Taken into consideration the problems of clinical trials and evaluation of curative effect, traditional Chinese medicine clinical evaluation system should be based on to its own characteristics, and made the best use of the advantages and bypass the disadvantages in order to establish a system of evidence-based medicine which combined disease and syndrome. |
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