The "tonifying the kidneys, resolving blood stasis and clearing collaterals" method in polycystic ovary syndrome (PCOS) research: study protocol for a multicentre cohort study nested randomised controlled trials

Abstract

Abstract Introduction: Polycystic ovary syndrome (PCOS) presents as a multi-complicated syndrome and increases the risk of other diseases. Life management is clinically ineffective as a first-line basic treatment for polycystic ovary syndrome. Acupuncture and Chinese herbal medicine (CHM) have excellent clinical efficacy for PCOS. however,there is currently a dearth of high-quality data demonstrating its efficacy.The purpose of this experiment is to assess the safety and efficacy, especially the long-term efficacy,of individualized life management、CHM, acupoint thread-embedding therapy for treating PCOS. Methods and analysis: We present a multicentre, prospective, combined randomised clinical trial and observational cohort study design, with a target sample size of 316 patients with PCOS of the kidney deficiency and blood stasis type aged between 18-45years. Patients were divided into an observational cohort with a renal supplementation and blood-stasis-restoration cohort based on whether or not they were exposed to the tonifying-kidney, resolving-blood stasis-and-tongue method. Based on the examination results, the observation cohort received individualised life management and appropriate pharmacological interventions and was followed up for 6 months. The kidney tonifying and resolving stasis through the channels cohort was randomly divided into A) Kidney tonifying and resolving stasis traditional Chinese medicine group, B) Kidney tonifying and resolving stasis buried under ultrasound in the musculoskeletal bone group, and C) Kidney tonifying and resolving stasis traditional Chinese medicine combined with burying group by the method of randomised numerical table based on the above. The kidney tonifying and resolving stasis through the channels cohort treatment cycle was 3 months, and the follow-up period was 3 months. Main results: (1) the change of menstrual of PCOS patients before and after treatment ; (2) the efficacy of traditional Chinese medicine symptoms. Secondary results: Sex hormones, AMH, ultrasound;changes in scores such as polycystic cognition,PCOSQ-50 score,menstruation,hirsutism,Ffq168,IPAQ-SFHADS etc.All assessments were followed up with redcap questionnaires at baseline at weeks 4, 8, and 12 after the start of the intervention and at weeks 16, 20, and 24 after the end of the intervention. Trial registration number: (2023) Lun Shen No.41; Pre-results.The trial was launched on July 2023 through https://www.chictr.org.cn/ Registrationnumber:ChiCTR2300073832.