The following is a summary of “Treatment of unfavorable bleeding patterns in contraceptive implant users: a randomized clinical trial of curcumin,” published in the AUGUST 2023 issue of Obstetrics and Gynecology by Edelman, et al.
Certain users of the etonogestrel contraceptive implant encounter bothersome bleeding, potentially affecting contraceptive satisfaction and continuation. Existing strategies to manage the bleeding were limited. The underlying mechanism of progestin-induced bleeding remained unclear, likely involving various factors such as impaired angiogenesis, fragile vasculature, and inflammation. Curcumin, found in turmeric, possesses anti-inflammatory, antiproliferative, and antiangiogenic properties, which could make it a promising agent for managing implant-related troublesome bleeding. For a study, researchers sought to assess whether curcumin reduces frequent or prolonged bleeding or spotting in etonogestrel contraceptive implant users.
A randomized, double-blind, placebo-controlled trial was conducted. Participants were etonogestrel implant users experiencing frequent or prolonged bleeding or spotting. They were randomly assigned to receive either 600 mg Theracurmin HP (Immunovites, Las Vegas, NV) or a placebo daily for 30 days. “Frequent” bleeding referred to ≥2 independent bleeding or spotting episodes, while “prolonged” bleeding indicated ≥7 consecutive days of bleeding or spotting within a 30-day period. Implant usage was confirmed through clinical examination and negative gonorrhea, chlamydia, and pregnancy tests. Treatment initiation occurred after 3 consecutive days of bleeding or spotting; participants were withdrawn if no bleeding or spotting occurred within 30 days of enrollment. Encapsulated study treatments maintained a similar appearance. Daily bleeding patterns and drug compliance were recorded through text messages. Bleeding was categorized as requiring pad, tampon, or liner usage while spotting was minimal blood loss, not necessitating protection. The primary outcome was total bleeding or spotting-free days during the 30-day exposure to the study drug or placebo. Secondary outcomes encompassed bleeding-free days, bleeding episodes, and satisfaction. A sample size of 22 per group was determined to provide 80% power at an alpha level of .05 to detect a 6-day difference between groups.
Between February 2021 and November 2022, 58 participants enrolled, with 54 (93%) completing the 30-day treatment (26 in the curcumin group and 28 in the placebo group). Notably, 1 individual in the curcumin group did not experience qualifying bleeding and, therefore, never initiated treatment and was withdrawn per protocol. Participant characteristics, including length of implant use at study enrollment (placebo: 521±305 days; curcumin: 419±264 days), did not vary between groups. No bleeding-related outcomes differed significantly between study groups (mean days without bleeding or spotting: curcumin: 16.76.9; placebo: 17.54.8; P=.62; mean bleeding-free days: 23.44.9; placebo: 22.44.5; P=.44; bleeding episodes: 2.00.8; placebo: 2.10.8; P=.63). Additionally, there was no difference in study group satisfaction with the implant’s effectiveness as a contraceptive method or acceptance of bleeding during the trial period (P=.54 and P=.30, respectively).
Daily curcumin use did not demonstrate an improvement in bleeding patterns among users of the etonogestrel contraceptive implant experiencing frequent or prolonged bleeding.
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