دورية أكاديمية
Treatment of unfavorable bleeding patterns in contraceptive implant users: a randomized clinical trial of curcumin.
| العنوان: | Treatment of unfavorable bleeding patterns in contraceptive implant users: a randomized clinical trial of curcumin. |
|---|---|
| المؤلفون: | Edelman A; Department of Obstetrics and Gynecology, Oregon Health & Science University, OR. Electronic address: edelmana@ohsu.edu., Boniface E; Department of Obstetrics and Gynecology, Oregon Health & Science University, OR., Schrote K; Department of Obstetrics and Gynecology, Oregon Health & Science University, OR., Messerle-Forbes M; Department of Obstetrics and Gynecology, Oregon Health & Science University, OR., O'Donnell A; Department of Obstetrics and Gynecology, Oregon Health & Science University, OR., Jensen JT; Department of Obstetrics and Gynecology, Oregon Health & Science University, OR., Han L; Department of Obstetrics and Gynecology, Oregon Health & Science University, OR. |
| المصدر: | American journal of obstetrics and gynecology [Am J Obstet Gynecol] 2023 Aug; Vol. 229 (2), pp. 145.e1-145.e9. Date of Electronic Publication: 2023 Apr 26. |
| نوع المنشور: | Randomized Controlled Trial; Journal Article; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't |
| اللغة: | English |
| بيانات الدورية: | Publisher: Elsevier Country of Publication: United States NLM ID: 0370476 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1097-6868 (Electronic) Linking ISSN: 00029378 NLM ISO Abbreviation: Am J Obstet Gynecol Subsets: MEDLINE |
| أسماء مطبوعة: | Publication: <2005->: New York : Elsevier Original Publication: St. Louis. |
| مواضيع طبية MeSH: | Curcumin*/therapeutic use , Contraceptive Agents, Female*/adverse effects , Metrorrhagia*/chemically induced , Metrorrhagia*/drug therapy, Pregnancy ; Female ; Humans ; Uterine Hemorrhage/chemically induced ; Uterine Hemorrhage/drug therapy ; Contraception ; Levonorgestrel/therapeutic use |
| مستخلص: | Background: Some users of the etonogestrel contraceptive implant experience bothersome bleeding, which can reduce contraceptive satisfaction and continuation. Few strategies exist to manage this bleeding. The exact mechanism of progestin-induced bleeding is unknown, but it is likely multifactorial (eg, impaired angiogenesis, "leaky" fragile vasculature, and inflammation). Curcumin, the active ingredient in turmeric, has anti-inflammatory, antiproliferative, and antiangiogenic properties, which may make it a useful agent for implant-associated bothersome bleeding. Objective: This study aimed to evaluate whether curcumin decreases frequent or prolonged bleeding or spotting in contraceptive implant users. Study Design: The study was a randomized, double-blind, placebo-controlled trial. Here, etonogestrel implant users with frequent or prolonged bleeding or spotting were enrolled and randomized to either 600-mg Theracurmin HP (Immunovites, Las Vegas, NV) or placebo daily for 30 days. The term "frequent" was defined as ≥2 independent bleeding or spotting episodes, and the term "prolonged" was defined as ≥7 consecutive days of bleeding or spotting in a 30-day interval. Implant use was confirmed by clinical examination and negative gonorrhea and chlamydia and pregnancy tests. Enrolled participants initiated study treatment after 3 consecutive days of bleeding or spotting; if no bleeding or spotting occurred within 30 days of enrollment, the participants were withdrawn from the study. Study treatments were encapsulated to maintain a similar appearance. Participants used text messages to record daily bleeding patterns and study drug compliance. Bleeding was defined as a day that required the use of protection with a pad, tampon, or liner, and spotting was defined as a day with minimal blood loss that did not require the use of any protection. Our primary outcome was the total number of days without bleeding or spotting during the 30 days of study drug or placebo exposure. The secondary outcomes included total number of bleeding-free days, bleeding episodes, and satisfaction. A sample size of 22 per group provided 80% power at an alpha level of .05 to demonstrate a 6-day difference between groups. Results: From February 2021 to November 2022, 58 individuals enrolled in the study with 54 participants (93%) completing 30 days of treatment (26 in the curcumin group and 28 in the placebo group). Of note, 1 individual in the curcumin arm did not experience a qualifying bleeding event and, thus, never initiated treatment and, per protocol, was withdrawn from the study. Participant characteristics did not differ between groups, including length of implant use at study enrollment (placebo, 521±305 days; curcumin, 419±264 days). The study groups did not differ concerning any bleeding-related outcome (mean days without bleeding or spotting: curcumin, 16.7±6.9; placebo, 17.5±4.8; P=.62; mean bleeding-free days: curcumin, 23.4±4.9; placebo, 22.4±4.5; P=.44; bleeding episodes: curcumin, 2.0±0.8; placebo, 2.1±0.8; P=.63). In addition, satisfaction with the implant as contraception and acceptability of bleeding over the study period did not differ by study group (P=.54 and P=.30, respectively). Conclusion: Daily use of curcumin did not improve bleeding patterns in users of the etonogestrel contraceptive implant experiencing frequent or prolonged bleeding patterns. (Copyright © 2023 The Author(s). Published by Elsevier Inc. All rights reserved.) |
| فهرسة مساهمة: | Keywords: Nexplanon; contraceptive implant; contraceptive-induced menstrual changes; curcumin; implant-related bleeding; turmeric |
| سلسلة جزيئية: | ClinicalTrials.gov NCT04205929 |
| المشرفين على المادة: | IT942ZTH98 (Curcumin) 0 (Contraceptive Agents, Female) 5W7SIA7YZW (Levonorgestrel) |
| تواريخ الأحداث: | Date Created: 20230428 Date Completed: 20230724 Latest Revision: 20230724 |
| رمز التحديث: | 20240628 |
| DOI: | 10.1016/j.ajog.2023.04.028 |
| PMID: | 37116825 |
| قاعدة البيانات: | MEDLINE |
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