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

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

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.

Lai, Lily
4ad55f3d-3e0c-4faa-a981-cbbbb4319811
Flower, Andrew
5256a2c8-6e74-49be-acc8-463ed3c18c6a
Prescott, Philip
cf0adfdd-989b-4f15-9e60-ef85eed817b2
Wing, Trevor
dfa5ef97-7d6e-42aa-8ed1-8c6861badd60
Moore, Michael
1be81dad-7120-45f0-bbed-f3b0cc0cfe99
Lewith, George
0fc483fa-f17b-47c5-94d9-5c15e65a7625
Lai, Lily
4ad55f3d-3e0c-4faa-a981-cbbbb4319811
Flower, Andrew
5256a2c8-6e74-49be-acc8-463ed3c18c6a
Prescott, Philip
cf0adfdd-989b-4f15-9e60-ef85eed817b2
Wing, Trevor
dfa5ef97-7d6e-42aa-8ed1-8c6861badd60
Moore, Michael
1be81dad-7120-45f0-bbed-f3b0cc0cfe99
Lewith, George
0fc483fa-f17b-47c5-94d9-5c15e65a7625

Lai, Lily, Flower, Andrew, Prescott, Philip, Wing, Trevor, Moore, Michael and Lewith, George (2017) Standardised versus individualised multiherb Chinese herbal medicine for oligomenorrhoea and amenorrhoea in polycystic ovary syndrome: a randomised feasibility and pilot study in the UK. BMJ Open, 7 (2), [e011709]. (doi:10.1136/bmjopen-2016-011709).

Record type: Article

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.

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Accepted/In Press date: 12 January 2017
e-pub ahead of print date: 3 February 2017
Published date: 3 February 2017
Organisations: Primary Care & Population Sciences

Identifiers

Local EPrints ID: 406417
URI: http://eprints.soton.ac.uk/id/eprint/406417
PURE UUID: 03ba3153-19b0-4737-bf2d-4eab4e887865
ORCID for Michael Moore: ORCID iD orcid.org/0000-0002-5127-4509

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Date deposited: 10 Mar 2017 10:46
Last modified: 16 Mar 2024 03:43

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Contributors

Author: Lily Lai
Author: Andrew Flower
Author: Philip Prescott
Author: Trevor Wing
Author: Michael Moore ORCID iD
Author: George Lewith

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