Dear Amber Sullivan (ID 70),
We have now completed recruitment and initial analysis for our study “The Influence of Acupuncture on Reproductive Hormones and Ovulation (IRB 12045)”. We have also unblinded the treatment categories for each participant. Based on our records, while you were enrolled in the study, you had 4 periods and ovulated 41% of the months you were in the study.* (A 50% ovulation rate means that you ovulated half the months in the study, 100% means you ovulated every month, and 0% means you never ovulated.) The study arm that you were assigned to was placebo acupuncture*.
On the next page, you will find a summary of the primary study’s findings. As you see, overall, this acupuncture regimen was not particularly effective for treating women with PCOS, although those of you with lower fasting insulin levels were definitely more likely to see a benefit (regular ovulation) than those with higher insulin levels. We’ll be exploring that finding more in the coming months.
It is just as important from a science point-of-view to learn what doesn’t work as what does work, although it sure is more fun to write a scientific article with a “wow!” punch line. I hope you don’t feel discouraged. Your participation in the clinical trial was very important, and we scientists will learn a great deal from your participation in the study. So thanks again, and I’ll send along the scientific papers when they are published, if you indicated that you wanted to see them.
Sincerely,
Lisa M. Pastore, PhD
Assistant Professor
Dept. of OB/GYN
UVA HealthSystem
LPASTORE@virginia.edu
Title: RANDOMIZED CLINICAL TRIAL OF ACUPUNCTURE FOR POLYCYSTIC OVARY SYNDROME (PCOS)
LM Pastore1, CD Williams2, J Jenkins1, J Patrie1
1University of Virginia, Box 800712 Charlottesville, VA, United States, 22908 and 2Reproductive Medicine and Surgery Center of Virginia, 595 Peter Jefferson Way Charlottesville, VA, United States, 22911.
Objective: To determine if acupuncture, compared to sham treatment, normalizes ovarian hormones and increases the ovulation rate in women with PCOS. 3 studies (< 50 acupuncture subjects, not randomized) reported that acupuncture may be an alternative treatment for PCOS.
Design: Randomized, double-blind, 5-month clinical trial.
Materials and Methods: 80 women (+5 women who dropped out during follow-up) completed the study. Eligibility required PCOS diagnosis (NIH criteria) and no hormonal medication 60 days prior to enrollment. Intervention: 12 sessions of true acupuncture or sham procedure (Park Sham Device) for 8 weeks. Biological specimens were collected before the 1st and after the last treatment, plus 3 months later. Ovulation was measured objectively with urine or blood. Analysis, using alpha=0.05, consisted of Wilcoxon tests, ANOVA, and Spearman correlations.
Results: Participants by intervention arm (n=41 true acupuncture, n=44 sham) were similar in demographics, baseline ovarian hormones and androgens, and eligibility criteria. Post-treatment improvement in the LH/FSH ratio was similar by arm (-0.4 and -0.8 in true and sham, respectively, p<0.03). The monthly ovulation rate was similar by arm (34% - 52%), and similar to self-reported pre-study menstrual frequency (most recent 12 months without exogenous hormones). Within the acupuncture arm, the 2 strongest predictors of the ovulation rate were lower fasting insulin (p=0.03) followed by lower insulin area under the curve (p=0.06), controlling for pre-study menstrual frequency and BMI; this pattern was not evident within the sham arm. Neither intervention was associated with any impact to androgen levels, with the exception of decreased SHBG in both arms (p<0.05). There were 7 pregnancies (no difference by arm).
Conclusions: This acupuncture intervention was not effective for increasing the ovulation rate in PCOS overall, although it is possible that acupuncture may be helpful for women with insulin processing closer to normal.
*Emphasis mine (Amber's) - I find this very interesting!! I ovulated 41% of the time!!!! I didn't think I was ovulating at all. :-)
1 comment:
Very interesting and encouraging!
Post a Comment