The efficacy of GnRH-a followed by SanJieZhenTong capsules in long-term management of endometriosis: Study protocol for a multicenter, double-blinded, double-dummy randomized clinical trial

Yunxi Zheng; Ruoyi Guo; Qi Tian; Yan Du; Li Wang; Zhiling Zhu; Erkai Yu; Jing Sun; Xiaofang Yi; Congjian Xu

doi:10.1016/j.conctc.2023.101179

The efficacy of GnRH-a followed by SanJieZhenTong capsules in long-term management of endometriosis: Study protocol for a multicenter, double-blinded, double-dummy randomized clinical trial

Contemp Clin Trials Commun. 2023 Jun 20:34:101179. doi: 10.1016/j.conctc.2023.101179. eCollection 2023 Aug.

Authors

Yunxi Zheng^{1

2

3}, Ruoyi Guo^{1

2

3

4}, Qi Tian^{1

2

3}, Yan Du⁵, Li Wang^{1

2

3

4}, Zhiling Zhu^{1

2

3

4}, Erkai Yu⁶, Jing Sun⁷, Xiaofang Yi^{1

2

3}, Congjian Xu^{1

2

3}

Affiliations

¹ Department of Gynecology, Obstetrics and Gynecology Hospital of Fudan University, Shanghai, 200011, China.
² Department of Obstetrics and Gynecology, Shanghai Medical School, Fudan University, Shanghai, 200011, China.
³ Department of Gynecology, Shanghai Key Laboratory of Female Reproductive Endocrine-Related Diseases, Shanghai, 200011, China.
⁴ Department of Integrated Traditional & Western Medicine, Obstetrics and Gynecology Hospital of Fudan University, Shanghai, 200011, China.
⁵ Office of Clinical Epidemiology, Obstetrics and Gynecology Hospital of Fudan University, Shanghai, China.
⁶ Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, 200011, PR China.
⁷ Department of Obstetrics and Gynecology, Shanghai First Maternity and Infant Hospital, Shanghai, 200011, PR China.

Abstract

Background: Endometriosis is a common benign gynecological disorder with high risk of recurrence and adverse impact on fertility-sparing. This study aims to evaluate the effectiveness and safety of SanJieZhenTong Capsules, a traditional Chinese medicine, in the long-term management of endometriosis postoperatively.

Methods: and analysis: A prospective, double-blinded, double-dummy parallel-group randomized controlled trial will be conducted at three university-based medical centers in China. A total of 600 patients with rAFS III-IV endometriosis diagnosed by laparoscopy will be enrolled. After fundamental treatment (gonadotropin-releasing hormone agonists injection starts on the first day of menstruation postoperatively, and repeats 3 times every 28 days), participants will be randomly allocated to the oral contraceptive group (oral contraceptive + dummy A) or SanJieZhenTong Capsules group (SanJieZhenTong Capsules + dummy B) in a 1:1 ratio. All participants will be treated and followed up for 52 weeks. The primary outcome is a recurrence rate based on endometriosis-related symptoms, physical examination, and/or ultrasound/MRI findings. The secondary outcome includes changes in quality of life and organic function outcome via the 36-item Short-Form scores and gastrointestinal function score.

Conclusion: The current trial could provide rigorous evidence on SanJieZhenTong Capsules application in the long-term management of advanced-stage endometriosis.

Keywords: Endometriosis; Long-term management; Randomized controlled trial; Recurrence; Traditional Chinese medicine.