Polycystic Ovary Disease (PCOS) is the most common endocrine disorder among reproductive age women, and is the most common cause of irregular cycles and anovulatory infertility. Acupuncture may represent an alternative to hormonal treatment for these women, based on three studies with positive findings with fewer than 50 acupuncture subjects and no control group. The best of these studies examined 24 PCOS women and found that 38% of the women had restored ovulation (2+ ovulations) during the treatment plus follow-up time period. The proposed research will be a double-blind, placebo-controlled, randomized clinical trial to assess if acupuncture restores ovulation (2+ ovulations) and normalizes ovarian hormones in women v/ith PCOS. Participants (n=78 completers) will be randomized to receive either acupuncture treatment or a sham procedure (Park Sham Device) for a standard 8-week period of time. All participants will provide blood samples through the University of Virginia General Clinical Research Center before treatment, after treatment, and three months later from which reproductive hormones, androgens and insulin/glucose will be assayed. Urine samples will be provided weekly throughout the treatment and follow-up periods to determine if ovulation has occurred. To collect data on potential confounders, weight will be measured and questionnaires administered at the same three time periods as the blood samples. Results will be analyzed with a combination of odds ratios, multiple logistic regression, repeated measures analyses, generalized estimating equations, and analysis of covariance. This study will be a clear enhancement compared to the existing literature by inclusion of a sham treatment control group, rigorous diagnosis of PCOS, and collection of blood samples timed to the menstrual cycle (applicable when there is an ovulatory cycle). This research will assess within our PCOS population whether acupuncture increases ovulatory frequency, causes the ratio of follicle simulating hormone (FSH) to luteinizing hormone (LH) to normalize, and causes the mean levels of FSH and LH to adjust towards normal levels (increase and decrease, respectively). Toward future research, an exploratory analysis will also be conducted to estimate if some patient groups (e.g., normal insulin, smaller body mass index) are more responsive to acupuncture therapy. We will also compare enrollment strategies for population-based recruitment of women into an acupuncture clinical trial. ? ?
