DOI: 10.5281/zenodo.17844278
title: An Exquisite Appraisal of the Efficacy, Safety, and Pharmacoeconomic Value of Honghua Ruyi Pills in Alleviating Secondary Dysmenorrhea Induced by Ovarian Endometriosis

description: Objective To delve into the therapeutic potency, safety profile, and pharmacoeconomic ramifications of Honghua Ruyi Pills in alleviating secondary dysmenorrhea stemming from ovarian endometriosis. 

Methods This study enrolled primiparous women who underwent vaginal deliveries at the Qinghai Red Cross Hospital between January 2018 and January 2019 as research participants. All subjects received comprehensive diagnosis, standardized treatment, and continuous follow-up monitoring throughout the study period at their respective medical institutions. Following the signing of informed consent, participants were randomly assigned via a random number table method into three cohorts: the immersive control group (administered a simulated Honghua Ruyi Pill placebo), the observation group (treated with authentic Honghua Ruyi Pills), and the standard therapy group (receiving Dienogest—a first-line agent recommended by current clinical guidelines). A comparative analysis was conducted across all groups, evaluating key dimensions including clinical efficacy, drug safety profiles, and pharmacoeconomic indicators to illuminate the holistic therapeutic value of Honghua Ruyi Pills.

Results Among the efficacy evaluation metrics, both the observation group and the standard drug group exhibited marked improvements across all parameters relative to the control group following treatment, with results reaching statistical significance. A comparative analysis was then conducted between the observation group and the standard drug group. With regard to subjective indicators, the observation group demonstrated superior performance over the standard drug group in key domains: the VAS pain score, the duration subscale of the CMSS, and the peak intensity of non-menstrual pelvic pain as measured by the BPI’s severity dimension. For the remaining subjective measures, no statistically significant differences were observed between the two groups. In terms of objective biomarkers, the observation group outperformed the standard therapy group in the modulation of inflammatory and immunological mediators—including TNF-α, IL-6, IL-1β, IL-10—as well as in the regulation of CA125, COX-2, and PGE2 levels. Conversely, the standard drug group showed greater efficacy in reducing endometriosis cyst volume and suppressing PGF2α concentrations. Regarding neurochemical markers—5-HT, NE, SP, and ENK—no significant intergroup disparities were detected. Concerning safety assessment parameters, routine laboratory tests—including hematology, urinalysis, stool examination, biochemical profiles, coagulation function, and electrocardiographic findings—remained within normal limits for all participants across the three groups before and after intervention, with no clinically or statistically meaningful alterations. Furthermore, the incidence of adverse events did not differ significantly among the groups throughout the study period. In pharmacoeconomic evaluation, the total health expenditure incurred by the observation group was substantially lower than that of the standard drug group, underscoring a compelling advantage in clinical cost-effectiveness and highlighting the economic sustainability of Honghua Ruyi Pills in long-term management. 

Conclusion Honghua Ruyi Pills effectively alleviate secondary dysmenorrhea induced by ovarian endometriosis, significantly enhance clinical outcomes, and offer exceptional safety profiles alongside remarkable pharmacoeconomic benefits.