IMR Press / CEOG / Volume 50 / Issue 5 / DOI: 10.31083/j.ceog5005107
Open Access Original Research
Effect of Traditional Chinese Formula Dingkun Pill on Primary Dysmenorrhea: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial
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1 National Clinical Research Center for Obstetric & Gynecologic Diseases, Department of Obstetrics and Gynecology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, 100730 Beijing, China
2 Department of Gynecology and Obstetrics, Key Laboratory of Obstetrics and Gynecologic and Pediatric Diseases and Birth Defects of the Ministry of Education, West China Second University Hospital, Sichuan University, 610041 Chengdu, Sichuan, China
*Correspondence: (Aijun Sun)
These authors contributed equally.
Clin. Exp. Obstet. Gynecol. 2023, 50(5), 107;
Submitted: 22 November 2022 | Revised: 15 January 2023 | Accepted: 17 January 2023 | Published: 22 May 2023
(This article belongs to the Special Issue Complementary and Integrative Therapies for Women’s Health)
Copyright: © 2023 The Author(s). Published by IMR Press.
This is an open access article under the CC BY 4.0 license.

Background: Primary dysmenorrhea (PD) afflicts many childbearing-age women, with a high prevalence ranging from 17% to 90%. The Dingkun pill (DKP), a traditional Chinese medicine formula, has been prescribed for managing menstrual disorders empirically in clinical practice for a long time, but there are very few high-quality studies supporting this practice. Therefore, this trial aimed to assess the efficacy and safety of DKP in patients with PD. Methods: Our study was a multicenter, prospective, randomized, double-blind, placebo-controlled study. DKP or placebo was prescribed to participants from the 5th to 14th day of each menstrual cycle for 12 weeks. Changes in pain intensity were measured by a visual analog scale (VAS) and were compared between groups using repeated measures analysis. The pain mediators and sex hormones were also assessed before and after the treatment, and their intergroup changes from the baseline were analysed by student t-test. The hemodynamic indices and safety profile of DKP were also investigated. Results: A total of 156 women were recruited and randomly allocated to receive either DKP or placebo, of whom 142 (73 in DKP and 69 in sham control) completed the study. A more distinctive reduction in VAS scores was observed in the DKP group, compared with placebo (–2.68 ± 0.21 vs. –1.29 ± 0.14, p < 0.001). Compared to placebo, DKP treatment resulted in a pronounced suppression of serum PGF2α, oxytocin and vasopressin, along with a significant increase in beta-endorphin level (p < 0.001). Moreover, uterine artery flow measured by ultrasonography indicated increased blood perfusion after DKP treatment (p < 0.01), while no change was detected in the placebo group. Additionally, except for an inhibited serum follicular stimulating hormone (FSH) (p = 0.037), no statistical difference in hormonal status and safety indicators was detected before and after the treatment. Conclusions: DKP treatment attenuated pain severity in patients with primary dysmenorrhea, and no harmful side effect was observed during 12 weeks of treatment. Clinical Trial Registration:, NCT03953716. Registered 17 May 2019.

primary dysmenorrhea
Dingkun pill
traditional Chinese medicine
alternative therapy
pain management
2020-2-40113/Capital’s Funds for Health Improvement and Research
82074143/Natural Science Foundation of China
2020-PT320-003/Non-profit Central Research Institute Fund of Chinese Academy of Medical Sciences
Fig. 1.
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