Database Establishment And Analysis Of Polycystic Ovarian Syndrome Treatment Using Chinese Herbal Medicine

Background:Due to the vast array of side effects associated with many western medicines typically prescribed to treat polycystic ovarian syndrome (PCOS), Chinese herbal medicine has been commonly used in China as a less invasive, yet economical approach to treat PCOS or to improve western medicine's treatment effect. To date the application status and clinical outcome of Chinese herbs in treating PCOS in China has not been systematically examined.Objectives:(1) To study the effects of Chinese medical herbs on PCOS treatment by a systematic review and meta-analysis of the literature published between 1980 and 2008. (2) To exam the application status, treatment strategies and clinical outcomes of Chinese medical herbs in PCOS treatment by establishing and analyzing a relational database that collects information of PCOS treatment using Chinese herbs from clinical trials and case serial studies published between 1984 and 2009.Methods:(1)Clinical trials using Chinese herbs to treat PCOS were retrieved from www. ilib.cn and MEDLINE (1980-2008) using key words of "PCOS", "Chinese herbs", "systemic review of literature", "meta-analysis", "data mining", "integral Chinese and western medicine". All case serial studies and randomized trials using Chinese herbs alone, comparing herbs combined with clomiphene citrate and clomiphene citrate alone were studied. (2)Publications were searched and retrieved from www.cnki.net,www.ilib.cn and PUBMED (1984-2009) using key words of "PCOS", "Chinese herbs", "integral Chinese and western medicine", "data-mining", and "literature data analysis". Reference lists of each primary study were hand-searched. Clinical trials and case serial studies using pregnancy rate or confirmed ovulation as primary outcome measures and with treatment durations of at least three months or three menstrual cycles were selected for the study. Microsoft SQL Server program and Microsoft Excel were used as data collection and database management tools. Functions and action sections of Chinese herbs were entered into the database according to Materia Medica, a comprehensive and recognized Chinese herbal medicine textbook in English. Herbal usage frequency, treatment strategies and associated treatment outcomes were analyzed. Most frequently used herbs that were also associated with higher cure rates were screened by data sorting and data-mining using Microsoft SQL Server program and Microsoft Excel. In both studies, the main outcome measures were pregnancy rates or obtaining regular ovulatory cycles of 4 weeks confirmed by biphasic body temperature or transvaginal sonography and midluteal phase progesterone concentration levels after 3-6 months of treatment.Results:In research (1), Meta-analysis of the 38 trials (2883 patients) using . Mantel-Haenszel method (fixed effect model) showed the cure rate of Clomid Citrate (CC) with herbs was 60.39%(927/1535) and the cure rate of CC alone was 34.57% (466/1348). There was a significant increased probability of cured [OR=3.01 (95% CI=2.57/3.52), p=0.00] in favor of the herbal integrated treatment. The test of funnel plot asymmetry showed that the chance of publication bias existed (α=2.05, 95% CI=0.10/3.99, p=0.04. In research (2), a total of 125 relevant publications, 8150 patients were treated with Chinese herbs alone, with integral Chinese herbs and western medicine, or with western medicine alone as controls. According to traditional Chinese medicine (TCM) pattern differentiation theory, a total of 179 herbs from 30 action sections were used by different practitioners. By analyzing database and performing data mining using Microsoft Association Rules algorithm,12 of the 179 herbs were found to be the most frequently used herbs that were also associated with higher cure rates in treating PCOS. These 12 herbs include Chuan Xiong, Dan Shen, Tao Ren, Hong Hua from herbs that invigorate Blood; Xian Mao, Ba Ji Tian, Rou Cong Rong from herbs that tonify the Yang; Nu Zhen Zi from herbs that tonify the Ying; Dang Gui from herbs that tonify the blood; Huang qi from herbs that tonify the Qi; Chai Hu from Cool and acrid herbs that release the exterior (used to remove Liver qi stagnation); and Zhi Ban Xia from herbs that warm and transform phlegmConclusion:Research (1) found that clomiphene citrate treatment outcome of PCOS patients may be significantly improved by using Chinese herbs. Considering the risk of publication bias, double blind randomized trials are needed to further confirm the above conclusion. Research (2) found that the most frequently used herbs which were also associated with higher cure rates in treating PCOS were mostly from herbs that invigorate and tonify the Blood, herbs that tonify the Yang, the Yin and the Qi. These are preliminary findings that need futher supports by more randomized controlled clinical studies.