首页|Can Tibetan medicine Honghua Ruyi pills relieve endometriosis-associated dysmenorrhea?Protocol for a randomized placebo-controlled trial

Can Tibetan medicine Honghua Ruyi pills relieve endometriosis-associated dysmenorrhea?Protocol for a randomized placebo-controlled trial

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  • 国家科技期刊平台
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  • NSTL
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Objective:To provide high-quality clinical evidence of the efficacy of Tibetan medicine Honghua Ruyi(HHRY)pills for endometriosis-associated dysmenorrhea.Methods:This study constitutes a multicenter,randomized,double-blind,placebo-controlled trial encompassing a three-menstrual cycle intervention followed by a three-menstrual cycle follow-up period.A total of 164 eligible females with endometriosis-associated dysmenorrhea were randomly divided into HHRY pills and placebo groups in a 1∶1 ratio.The primary outcome included dysmenorrhea symptoms assessed using Visual Analog Scale(VAS)scores and quality of life,whereas the secondary outcome measures included the maximum VAS for non-menstrual pelvic pain,duration of pain episodes(in days),frequency and quantity of the consumption of ibuprofen sustained-release capsules(or other non-steroidal anti-inflammatory drugs),and days off work/study for staff/student due to dysmenorrhea,ovarian cyst,and/or pelvic nodule size.The safety was monitored throughout the treatment period.All the analyses were based on the intention-to-treat principle.For continuous outcomes,simple or multiple linear regressions were used to estimate the differences between the HHRY pills and placebo groups,with categorical data expressed as the number and percentage of occurrences.Differences were compared using the chi-square test or Fisher's exact test.The predefined analysis was adjusted for concomitant treatment,a variable considered to be associated with outcomes but unaffected by treat-ment allocation.Estimates of treatment effects were reported with 95％confidence intervals.Two-tailed P values ≤.05 were considered statistically significant.Conclusion:Positive results from this trial,upon completion would provide robust evidence for the ef-ficacy and safety of HHRY pills in treating dysmenorrhea in patients with endometriosis.

EndometriosisDysmenorrheaHonghua Ruyi pillsRandomized controlled trialTraditional Chinese medicine

Mei Han、Jiahui Cao、Jiali Wei、Hui Luo、Chaoqin Yu、Xuefang Liang、Nyangmotse、Guoyan Yang、Huilan Du、Jianping Liu

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Centre for Evidence-Based Chinese Medicine,Beijing University of Chinese Medicine,Beijing 102488,China

College of Management,Beijing University of Chinese Medicine,Beijing 102488,China

College of Acupuncture and Moxibustion,Beijing University of Chinese Medicine,Beijing 102488,China

Institute for Tibetan Medicine,China Tibetology Research Center,Beijing 100101,China

Changhai Hospital,Naval Medical University,Shanghai 200433,China

Department of Gynaecology,Guangdong Provincial Hospital of Chinese Medicine,Guangdong 510120,China

Department of Gynaecology,Tibetan Medicine Hospital of Qinghai Province,Xining 810007,China

NICM Health Research Institute,Western Sydney University,Penrith,NSW 2751,Australia

College of Integrated Chinese and Western Medicine,Hebei University of Chinese Medicine,Shijiazhuang 050200,China

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国家自然科学基金

81830115

2024

10.1016/j.jtcms.2023.12.010

中医科学杂志(英文)
北京中医药大学,清华大学出版社有限公司

中医科学杂志(英文)

ISSN：2095-7548
年,卷(期)：2024.11(1)
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