Traditional Chinese Medicine Treatment Of Recurrent Miscarriage System And Methodology Are Reviewed

Background Recurrent miscarriage is a common clinical problem in reproduction. It is defined as the loss of two or three or more consecutive spontaneous abortions, affecting approximately5%of all couples trying to conceive. Risk factors for recurrent vary widely, such as maternal age, number of previous miscarriages, antiphospholipid syndrome, genetic factors, anatomical deformity of reproductive organs, endocrine disorders, immune factors, and infective agents, but in more than half of such patients, no certain diagnosis could be identified. Various interventions have been used in clinical practice, but for the majority of which, there is still insufficient evidence to evaluate the effect of preventing a miscarriage in women with recurrent miscarriage. In China and other Asian countries, traditional Chinese medicine (TCM) has been widely used for the treatment of recurrent miscarriage for thousands of years. During the past two decades, a series of trials conducted to evaluate the effectiveness and safety of Chinese herbal medicine (CHM) for recurrent miscarriage, but the findings have not yet been systematically summarized.Objectives To critically appraise the existing randomized controlled trials (RCTs) and controlled clinical trials (CCTs) on CHM for recurrent miscarriage, provide evidence-based evaluation on the effectiveness and safety of CHM for this disease, and offer the suggestions for Chinese medicine researchers to perform good clinical researches by conducting this systematic review.Material and methods A literature search was conducted in PubMed, Cochrane Library (Issue12,2011), CNKI, CBM and VIP databases until January12,2012. RCTs and CCTs of CHM or CHM plus conventional medicine for recurrent miscarriage patients comparing with placebo or conventional medicine or other CHMs were included. Two reviewers searched literature and extracted data independently. Cochrane Handbook and the Consolidated Standards for Reporting of Trials (CONSORT) statement were used to assess the methodological quality in the design and reporting of included trials. RevMan5.1.4software was used for data analyses. Risk ratio (RR) with a95%confidence interval (CI) was used as effect measure. Meta-analysis was to be used if the trials had a good homogeneity of study design, participants, interventions, control, and outcome measures.Results A total of63trials (49RCTs and14CCTs) involving5266recurrent miscarriage patients were indentified and included in this systematic review. The majority of trials were of high risk of bias due to poor methodological quality. Live birth rate was reported in26trials, of which13trials showed the superior of CHM or CHM plus conventional medicine over the conventional medicine, while9trials showed no significant statistical difference, and outcomes were not assessed in4trials due to the CHM interventions were used in both groups. The status of embryonic development was reported in32trials, of which10trials showed the superior of CHM or CHM plus conventional medicine over the conventional medicine;13trials found no significant statistical difference; one trial showed the superior of conventional medicine over CHM; and outcomes were not assessed in8trials due to the CHM interventions were received in both groups. Laboratory parameters related to recurrent miscarriage were reported in15trials, of which3trials found that CHM treatment could benefit patients in improving immune parameters or virus-negative rate, while other12trials found no difference between CHM group and control group.21trials reported adverse events (AEs), and no severe AEs were reported in CHM group. Meta-analysis could not be conducted due to clinical heterogeneity.Conclusion Overall, there is limited good quality evidence for CHMs for managing recurrent miscarriage. Some CHMs demonstrated potential positive effect and safety for recurrent miscarriage. At the moment the evidence of clinical trials is not sufficient to draw definitive conclusions because most trials are of low methodological quality and lack of large RCTs. Therefore, it is not possible to recommend any kind of CHMs in treating recurrent miscarriage. Further studies with rigorous design and standardized report are needed to evaluate the effectiveness and safety of CHM. We highlighted that four issues should be taken into consideration for Chinese medicine researches:1) basic principles of clinical research in design and reporting of RCTs,2) definite diagnosis criteria and baseline data should be reported in detail,3) appropriate treatment and control interventions should be selected according to the assumption and objective of research,4) clinical endpoint (live birth rate) should be reported and assessed.