Efficacy and safety of sanjiezhentong capsules, a traditional chinese patent medicine, on long-term management of endometriosis: A randomized controlled trial
| Autor: | Xiaofang Yi, Li Wang, Yan Du, Qi Tian, Cong-Jian Xu, Jing-Yao Ruan, Zhi-Ling Zhu, Yunxi Zheng, Jun-Ya Ke |
|---|---|
| Jazyk: | angličtina |
| Rok vydání: | 2021 |
| Předmět: |
medicine.medical_specialty
business.industry Endometriosis Obstetrics and Gynecology Odds ratio alternative medicine endometriosis long-term management sanjiezhentong capsules RC581-607 medicine.disease RC648-665 Confidence interval Diseases of the endocrine glands. Clinical endocrinology law.invention Clinical trial Reproductive Medicine Randomized controlled trial Quality of life law Internal medicine Clinical endpoint Medicine Immunologic diseases. Allergy business Adverse effect |
| Zdroj: | Reproductive and Developmental Medicine, Vol 5, Iss 1, Pp 15-22 (2021) |
| ISSN: | 2589-8728 2096-2924 |
| Popis: | Objective: To compare the efficacy of the traditional Chinese medicine SanJieZhenTong (SJZT) capsules versus gonadotropin-releasing hormone analogs (GnRHa) or oral contraceptives (OCs) in the postoperative treatment of moderate-to-severe endometriosis. Methods: In this prospective clinical trial, women with stage III–IV endometriosis according to the revised American Fertility Society scoring system received three doses of GnRHa immediately after laparoscopic conservative surgery, followed by random assignment to receive treatment with SJZT, GnRHa, or OCs for another 6 months. The primary endpoint was 2-year recurrence, and the secondary endpoints were adverse events, changes in physical function, and quality of life (QoL). Recurrence was assessed using Kaplan–Meier curves and log-rank tests. Generalized estimating equations were used to determine the parameters of the secondary endpoints. Results: A total of 66 women were randomly assigned to the SJZT (n = 21), GnRHa (n = 21), and OCs (n = 24) groups. At a median follow-up of 22 months, no difference in recurrence was found (P = 0.72), with one (4.8%), two (9.5%), and one (4.2%) incidence in the SJZT, GnRHa, and OCs groups, respectively. Expectedly, the incidence of side effects such as hot flush, insomnia, and arthralgia in the SJZT and OCs groups was significantly lower than that in the GnRHa group (P = 0.00). In addition, the female sexual function index was significantly improved in the SJZT group, with a higher value than that in the GnRHa (odds ratio [OR] = 5.25, 95% confidence interval [CI]: 2.09–13.14, P = 0.00) and OCs (OR = 3.94, 95% CI: 1.58–9.83, P = 0.00) groups. Conclusions: SJZT showed more effective pain relief and QoL improvement in patients with moderate-to-severe endometriosis than GnRHa or OCs did. Fewer adverse events than those observed with other agents indicate that this alternative medicine, SJZT, could be a novel option for the long-term management of endometriosis. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
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