Evaluation of safety and effectiveness of gestrinone in the treatment of endometriosis: a systematic review and meta-analysis

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Gestrinone relieved endometriosis pain and increased pregnancy rates, but also increased acne and seborrhea risk compared to other treatments, with limited evidence on overall efficacy.

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This systematic review and meta-analysis evaluated the safety and effectiveness of gestrinone for treating endometriosis by searching six electronic databases and including 16 studies with 1,286 women who received treatment for up to 6 months. Across trials comparing gestrinone with placebo or other interventions (e.g., danazol, mifepristone, leuprolide acetate, and Quyu Jiedu Recipe), gestrinone was associated with relief of dysmenorrhea and pelvic pain and showed favorable ovarian morphologic responses, and the pregnancy rate increased. Adverse events were reported as similar overall to comparator treatments, with increased risk of acne and seborrhea for gestrinone. The authors note that efficacy comparisons are unclear for some drugs due to insufficient data and that the overall evidence quality was generally very low or unclear. This paper is centrally about endometriosis — it evaluates gestrinone’s safety and effectiveness for endometriosis in a systematic review and meta-analysis.

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Abstract

PURPOSE: Endometriosis is a common chronic gynecological disease defined as the presence of endometrial glands and stroma tissue outside the uterus. Gestrinone is an effective antiestrogen that induces endometrial atrophy and/or amenorrhea. The purpose of this systematic review is to provide an evaluation of safety and effectiveness of gestrinone for the treatment of endometriosis. METHODS: We performed a search in six electronic databases: PubMed, MEDLINE (ovid), Embase, Cochrane CENTRAL (clinical trials), Web of Science and Scopus. Our selected primary outcomes were the changes in dysmenorrhea, pain relief including pelvic pain and dyspareunia. The secondary outcomes embrace hormones parameters, pregnancy rate and adverse events. RESULTS: Of 3269 references screened, 16 studies were included involving 1286 women. All studies compared gestrinone with other drugs treatments (placebo, Danazol, Mifepristone tablets, Leuprolide acetate, Quyu Jiedu Recipe) during 6 months. When compared with other drugs treatments, gestrinone relieved dysmenorrhea, pelvic pain, and morphologic response in the ovary. There was an increase on the pregnancy rate. Regarding the side effects observed, gestrinone showed the same adverse events and increased the risk of acne and seborrhea when compared to other treatments. Even if there was any difference in efficacy between gestrinone, danazol, leuprolide acetate, or Quyu Jiedu Recipe Chinese Medicine, it remains unclear due to insufficient data. CONCLUSION: Based limited evidence available suggests that gestrinone appeared to be safe and may have some efficacy advantages over danazol, as well as other therapeutic interventions for treating endometriosis. However, this conclusion should be interpreted with caution, due the quality of the evidence provided is generally very low or unclear. TRIAL REGISTRATION: CRD42021284148.
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Abstract

Purpose Endometriosis is a common chronic gynecological disease defined as the presence of endometrial glands and stroma tissue outside the uterus. Gestrinone is an effective antiestrogen that induces endometrial atrophy and/or amenorrhea. The purpose of this systematic review is to provide an evaluation of safety and effectiveness of gestrinone for the treatment of endometriosis.

Methods

We performed a search in six electronic databases: PubMed, MEDLINE (ovid), Embase, Cochrane CENTRAL (clinical trials), Web of Science and Scopus. Our selected primary outcomes were the changes in dysmenorrhea, pain relief including pelvic pain and dyspareunia. The secondary outcomes embrace hormones parameters, pregnancy rate and adverse events.

Results

Of 3269 references screened, 16 studies were included involving 1286 women. All studies compared gestrinone with other drugs treatments (placebo, Danazol, Mifepristone tablets, Leuprolide acetate, Quyu Jiedu Recipe) during 6 months. When compared with other drugs treatments, gestrinone relieved dysmenorrhea, pelvic pain, and morphologic response in the ovary. There was an increase on the pregnancy rate. Regarding the side effects observed, gestrinone showed the same adverse events and increased the risk of acne and seborrhea when compared to other treatments. Even if there was any difference in efficacy between gestrinone, danazol, leuprolide acetate, or Quyu Jiedu Recipe Chinese Medicine, it remains unclear due to insufficient data.

Conclusion

Based limited evidence available suggests that gestrinone appeared to be safe and may have some efficacy advantages over danazol, as well as other therapeutic interventions for treating endometriosis. However, this conclusion should be interpreted with caution, due the quality of the evidence provided is generally very low or unclear. Trial registration CRD42021284148. Similar content being viewed by others

References

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Pakistan J Pharm Sci 31(5SI):2197–2202 Turnbull AC, Rees MCP (1990) Gestrinone in the treatment of menorrhagia. BJOG 97(8):713–715. https://doi.org/10.1111/j.1471-0528.1990.tb16244.x Giudice LC, Evers JLH, Healy DL (2012) Endometriosis: science and practice. John Wiley & Sons Luo, S., Wang, Y., & HE, J. (2018). Efficacy of high-intensity focused ultrasound ablation combined with gestrinone for treating adenomyosis. Chongqing Medicine, 36:170–172. Ferrari G, Thives Mello A, Melo G, de Mello Roesler CR, Salmoria GV, de Souza Pinto LP, de Mello Gindri I (2022) Polymeric implants with drug-releasing capabilities: a mapping review of laboratory research. Drug Dev Ind Pharm 25:1–11 Funding Conselho Nacional de Desenvolvimento Científico e Tecnológico, 160162/2019-0, Gustavo Ferrari. Author information Authors and Affiliations Contributions GF: study concept, data search and extraction, data analysis, and draft writing. IKS: study concept, conducted protocol, data extraction, data analysis, and draft writing. IMG: study concept, conducted the searchers, resolve conflicts, and draft review. CPMR: study concept and draft review. LPSP: study concept, and draft review. Corresponding author Ethics declarations Conflict of interest All authors declare to have no conflict of interest. Additional information Publisher's Note Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations. Supplementary Information Below is the link to the electronic supplementary material. Rights and permissions Springer Nature or its licensor (e.g. a society or other partner) holds exclusive rights to this article under a publishing agreement with the author(s) or other rightsholder(s); author self-archiving of the accepted manuscript version of this article is solely governed by the terms of such publishing agreement and applicable law. About this article Cite this article de Souza Pinto, L.P., Ferrari, G., dos Santos, I.K. et al. Evaluation of safety and effectiveness of gestrinone in the treatment of endometriosis: a systematic review and meta-analysis. Arch Gynecol Obstet 307, 21–37 (2023). https://doi.org/10.1007/s00404-022-06846-0 Received: Accepted: Published: Version of record: Issue date: DOI: https://doi.org/10.1007/s00404-022-06846-0

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Condition tags

dysmenorrheaendometriosischronic_pelvic_pain

MeSH descriptors

Endometriosis Endometriosis Endometriosis Endometriosis Endometriosis Endometriosis Endometriosis Endometriosis Endometriosis Endometriosis Endometriosis Endometriosis Endometriosis Endometriosis Endometriosis Endometriosis Endometriosis Endometriosis Endometriosis Endometriosis

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