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Abstract
Objectives To explore feasibility of a randomised study using standardised or individualised multiherb Chinese herbal medicine (CHM) for oligomenorrhoea and amenorrhoea in women with polycystic ovary syndrome (PCOS), to pilot study methods and to obtain clinical data to support sample size calculations.
Design Prospective, pragmatic, randomised feasibility and pilot study with participant and practitioner blinding.
Setting 2 private herbal practices in the UK.
Participants 40 women diagnosed with PCOS and oligomenorrhoea or amenorrhoea following Rotterdam criteria.
Intervention 6 months of either standardised CHM or individualised CHM, 16 g daily taken orally as a tea.
Main outcome measures Our primary objective was to determine whether oligomenorrhoea and amenorrhoea were appropriate as the primary outcome measures for the main study. Estimates of treatment effects were obtained for menstrual rate, body mass index (BMI), weight and hirsutism. Data were collected regarding safety, feasibility and acceptability.
Results Of the 40 participants recruited, 29 (72.5%) completed the study. The most frequently cited symptoms of concern were hirsutism, weight and menstrual irregularity. Statistically significant improvements in menstrual rates were found at 6 months within group for both standardised CHM (mean difference (MD) 0.18±0.06, 95% CI 0.06 to 0.29; p=0.0027) and individualised CHM (MD 0.27±0.06, 95% CI 0.15 to 0.39; p<0.001), though not between group (p=0.26). No improvements were observed for BMI nor for weight in either group. Improvements in hirsutism scores found within group for both groups were not statistically significant between group (p=0.09). Liver and kidney function and adverse events data were largely normal. Participant feedback suggests changing to tablet administration could facilitate adherence.
Conclusions A CHM randomised controlled trial for PCOS is feasible and preliminary data suggest that both individualised and standardised multiherb CHMs have similar safety profiles and clinical effects on promoting menstrual regularity. These data will inform the design of a study in primary care that will incorporate an appropriate control.
Trial registration number ISRCTN 31072075; Results.
- Polycystic Ovary Syndrome
- Chinese herbal medicine
- Traditional Chinese Medicine
- COMPLEMENTARY MEDICINE
- PRIMARY CARE
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Contributors All authors have made important and impactful contributions to the present manuscript. LL is the primary author of this research study and was granted the funding to conduct this work as part of her research training fellowship. She has made substantial contributions to the study design, acquisition of data, analysis and interpretation and in writing and preparing the manuscript. AF made a substantial contribution to the concept and design of this research and provided mentorship throughout the process. PP has provided statistical guidance throughout the project with input into randomisation, data collection and planned and eventual data analysis. TW has made important contributions to the design of this research study and supporting recruitment and screening of participants. MM has had an integral role in this project by providing guidance in study design, recruitment of participants and providing critical comments on data interpretation and manuscript preparation. GL has made a substantial contribution to this project by providing mentorship and guidance in study concept, design, participant eligibility and data interpretation and manuscript preparation. All authors have approved of the final version of this manuscript.
Funding This study is supported by a PhD research training fellowship (RCS Ref 10-0894) awarded to the main author by the National Institute for Health Research (NIHR) School for Primary Care Research.
Disclaimer The views expressed are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health. Other than the role stated, those named have had no other contribution to the study design, analysis or writing of the protocol and of this report.
Competing interests None declared.
Patient consent Obtained.
Ethics approval Ethical approval was granted in December 2012 from the University of Southampton Faculty of Medicine Research Ethics Committee; Register of Chinese Herbal Medicine Research Ethics Committee (Approvals ID 3977).
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement No additional data are available.