Abstract

This study aimed to evaluate the clinical analgesic efficacy and identify the molecular targets of XGDP for treating primary dysmenorrhea (PD) by a network pharmacology approach. Analysis of pain disappearance rate of XGDP in PD treatment was conducted based on data from phase II and III randomized, double-blind, double-simulation, and positive parallel controlled clinical trials. The bioactive compounds were obtained by the absorption, distribution, metabolism, and excretion processes with oral bioavailability (OB) and drug-likeness (DL) evaluation. Subsequently, target prediction, pathway identification, and network construction were employed to clarify the mechanisms of the analgesic effect of XGDP on PD. The pain disappearance rates in phase II and III clinical trials of XGDP in PD treatment were 62.5% and 55.8%, respectively, yielding a significant difference (P < 0.05) when compared with the control group using Tongjingbao granules (TJBG). Among 331 compounds, 53 compounds in XGDP were identified as the active compounds related to PD through OB, DL, and target prediction. The active compounds and molecular targets of XGDP were identified, and our study showed that XGDP may exert its therapeutic effects on PD through the regulation of the targets related to anti-inflammation analgesia and central analgesia and relieving smooth muscle contraction.

Highlights

  • Primary dysmenorrhea (PD) is a common gynecological complaint in adolescent girls and young women

  • We proposed its mechanisms of action on analgesia, which may provide a basis for an in-depth understanding of the mechanisms of action of Xuangui Dropping Pill (XGDP) for treating PD

  • A total of 240 patients with PD were enrolled in the phase II clinical trial. 120 patients were randomized into the XGDP group; 116 of them completed the study and 4 of them dropped out

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Summary

Introduction

Primary dysmenorrhea (PD) is a common gynecological complaint in adolescent girls and young women. It is characterized by lower abdominal pain and often accompanied by symptoms such as sweating, headache, nausea, vomiting, diarrhea, and tremulousness [1, 2]. Nonsteroid anti-inflammatory drugs (NSAIDs) are very effective for treating dysmenorrhea; NSAIDs are usually associated with many adverse effects including indigestion, headaches, and drowsiness [4]. Traditional Chinese Medicine (TCM) has been widely used in China to prevent, diagnose, and treat diseases over 2,000 years. Xuangui Dropping Pill (XGDP), which is a Chinese patent medicine, has been approved by China Food and Drug Administration (approval number Z20130008) and is widely used for treating dysmenorrhea in China

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