Antioxidant Supplementation Reduces Endometriosis-related Pelvic Pain In Humans
Notes for this study:
|Number of Subjects
Pre-surgical endometriosis patients were randomised to take either placebo (13 people) or 1g Vitamin C + 1200 IU Vitamin E (46 people) for 8 weeks prior to laparoscopic surgery. Chronic endometriosis-associated pelvic pain was reduced in significantly more people who took Vitamin C+E than in placebo. Some members of the vitamin group also had less pain during menstruation and sex, but this difference wasn't significant. The treatment and placebo groups were very different sizes with no explanation given, which raises questions about dropouts and study design.
Funding issues for this study:
During surgery, peritoneal fluids were withdrawn to be tested for chemical markers of inflammation. The patients who took Vitamin C+E had significantly lower levels of 3 specific markers of inflammation (RANTES, IL-1, MCP-1) in their peritoneal fluid than the placebo patients. The study tested for other markers of inflammation, but didn't enumerate them or report results, which casts doubt on the statistical significance of these results, since they did not correct for multiple outcomes.
Note: this is a 2013 paper on an unregistered 2003 study, an unusual delay.
The authors acknowledge funding from NIH-NICHD PO1-HD-35276-01A1. The manuscript is based on a clinical trial that was performed and completed prior to 2003 and was not registered under the clinical trial registry at that time.