Chinese herbal medicine for oligomenorrhoea and amenorrhoea in polycystic ovary syndrome: A randomised feasibility study in the United Kingdom
Polycystic ovary syndrome (PCOS) affects 6-18% of women of reproductive age and oligomenorrhoea and amenorrhoea are cardinal symptoms. Conventional management has been associated with side-effects which affects adherence and other alternatives need to be sought. There is anecdotal evidence to suggest Chinese herbal medicine (CHM) can help regulate menses, though this requires rigorous investigation using randomised controlled trials (RCTs). This study explores the feasibility of conducting an RCT in the UK using CHM to regulate menses in PCOS.
This pragmatic, practitioner-blinded feasibility study randomised 40 PCOS participants with oligo- or amenorrhoea into 2 parallel groups - standardised CHM or individualised CHM, prescribed at 16g granules/day as a tea for 6 months.Our primary aim was to evaluate feasibility and collect menstrual data for sample size calculation. Secondary outcomes data was collected on hirsutism, body mass index, weight. Safety data included liver/kidney function and adverse events.
40 participants were recruited within our planned 7-month recruitment period. 29 participants (72.5%) completed the study, 3 were lost-to-follow-up (7.5%) and 8 withdrew (20%). For the 3 lost-to-follow up, issues raised at last point of contact included difficulties with taste (2) and change of job (1). Reasons for withdrawal included pregnancy (2), adverse reactions due to tiredness and skin breakout (2) and difficulties with taste (1). 1 participant was withdrawn at Week 4 since a raised alanine aminotransferase (ALT) result was found. This was later found to be a known response to alcohol intake. 2 withdrawals due to serious adverse events were recorded - nodular goitre and breaking leg whilst abroad, both independently assessed as being unrelated to study medications.Analysis of covariance (ANCOVA) of menstrual rate per month showed statistically significant improvements in standardised CHM (MD 0.18±SE0.06, 95%CI 0.06 to 0.29) and in individualised CHM (MD 0.27±SE0.07, 95%CI 0.15 to 0.39). This did not reach between-group statistical significance (MD 0.10±SE0.08, 95%CI -0.07 to 0.26, p=0.26).Hirsutism scores significantly improved from baseline in both standardised group (MD -2.52, 95% CI -3.40 to -1.65) and individualised group (MD -1.44, 95% CI -2.35 to -0.54) but which did not reach between-group significance, F(1,25)=3.11 (p=0.09). There were no important changes in body mass index or weight. Liver and kidney function at Week 4 was normal (n=35), abnormal ALT (n=1); at final visit was normal (n=30), abnormal (n=0).
We have demonstrated that a CHM RCT for PCOS is feasible in the UK. Preliminary data suggests CHMs are safe and a promising response in terms of menstrual cyclicity. This data will be used to inform sample size calculation and design of a main study that will incorporate an active or placebo-control.
- Lily Lai, University of Southampton, Mathematical Sciences, Southampton, UK
- Andrew Flower, University of Southampton, Mathematical Sciences, Southampton, UK
- Philip Prescott
- Michael Moore, University of Southampton, Mathematical Sciences, Southampton, UK
- George Lewith, University of Southampton, Mathematical Sciences, Southampton, UK