Efficacy and Safety of SanJieZhenTong Capsules, a Traditional Chinese Patent Medicine, on Long-term Management of Endometriosis: A Randomized Controlled Trial

摘要

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.