Standardised versus individualised multiherb Chinese herbal medicine for oligomenorrhoea and amenorrhoea in polycystic ovary syndrome: a randomised feasibility and pilot study in the UK.
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.



Prospective, pragmatic, randomised feasibility and pilot study with participant and practitioner blinding.



2 private herbal practices in the UK.



40 women diagnosed with PCOS and oligomenorrhoea or amenorrhoea following Rotterdam criteria.



6 months of either standardised CHM or individualised CHM, 16 g daily taken orally as a tea.



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.



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.



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.



ISRCTN 31072075; Results.
University of Southampton Primary Care and Population Sciences Aldermoor Health Centre Aldermoor Close, Southampton, UK.
Lily
0000-0001-6611-7234
L
Lai
University of Southampton Primary Care and Population Sciences Aldermoor Health Centre Aldermoor Close, Southampton, UK.
Andrew
A
Flower
University of Southampton, Mathematical Sciences Highfield Southampton, Southampton, UK.
Philip
P
Prescott
Bournemouth University Centre for Ultrasound Studies, Bournemouth, UK.
Trevor
T
Wing
University of Southampton Primary Care and Population Sciences Aldermoor Health Centre Aldermoor Close, Southampton, UK.
Michael
M
Moore
University of Southampton Primary Care and Population Sciences Aldermoor Health Centre Aldermoor Close, Southampton, UK.
George
G
Lewith
D000284:Administration, Oral; D000328:Adult; D000568:Amenorrhea / Q000188:drug therapy* / Q000209:etiology; D015992:Body Mass Index; D001835:Body Weight / Q000187:drug effects; D004311:Double-Blind Method; D004338:Drug Combinations; D004365:Drugs, Chinese Herbal / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D005240:Feasibility Studies; D005260:Female; D006628:Hirsutism / Q000188:drug therapy / Q000209:etiology; D006801:Humans; D008598:Menstruation / Q000187:drug effects; D009839:Oligomenorrhea / Q000188:drug therapy* / Q000209:etiology; D017060:Patient Satisfaction; D008517:Phytotherapy / Q000379:methods*; D010865:Pilot Projects; D011085:Polycystic Ovary Syndrome / Q000150:complications / Q000188:drug therapy*; D011446:Prospective Studies; D006113:United Kingdom; D055815:Young Adult
D004338:Drug Combinations; D004365:Drugs, Chinese Herbal
COMPLEMENTARY MEDICINE; Chinese herbal medicine; PRIMARY CARE; Polycystic Ovary Syndrome; Traditional Chinese Medicine