Is individualized Chinese herbal formula effective in treating oligomenorrhoea and amenorrhoea among female with polycystic ovary syndrome as compared to standardized Chinese herbal formula?
Date of publication of randomized controlled trial: February 2017
Design
Pragmatic randomized controlled trial (RCT).
Participants
40 women presented with oligomenorrhoea or amenorrhoea with a diagnosis of polycystic ovary syndrome consistent with the Rotterdam criteria (age range: 18 to 44 years).
Intervention
Individualized Chinese herbal medicine (CHM), 16 g daily taken orally as a decoction. Duration of treatment lasted for 6 months. The treatment was given by a practitioner who was registered with a professional Chinese medicine organization in the UK, and has been practicing for at least 5 years. At baseline, weeks 4, 8 and 12, participants were asked to meet the practitioner. An individualized prescription was formulated by practitioner for every participant at each visit and practitioner might prescribe treatment in an individualized manner from a range of 270 different CHMs.
Comparator
Comparison: Individualized CHM versus standardized CHM. The standardized prescription was fixed, which contained 14 CHMs derived from expert consensus process. Duration of treatment lasted for 6 months, with CHMs taken orally as decoction.
Major Outcomes
Outcome 1: Change in mean menstrual rate at 6 months;
Outcome 2: Hirsutism as measured by the change in modified Ferriman-Gallwey (mFG) score at 6 months;
Outcome 3: Change in waist-to-hip ratio (WHR) at 6 months;
Outcome 4: Change in quality of life as measured by Polycystic Ovary Syndrome (PCOS) total scores at 6 months.
Settings
The trial was conducted in outpatient settings.
Comparison    Individualized CHM versus standardized CHM
Main Results
Compared to standardized CHM, individualized CHM did not show significant improvement in the mean menstrual rate (mean differences (MD): 0.10, 95% CI: -0.07 to 0.26), mFG scores (p= 0.09) and PCOS total scores (p= 0.33) at 6 months among women with polycystic ovary syndrome. However, individualized CHM showed significant reduction in WHR when compared to standardized CHM (p=0.02). Both standardized and individualized CHM conferred benefits to patients across all outcomes.
Comparison: Individualized CHM versus standardized CHM among female with polycystic ovary syndrome
Outcomes No. of studies (Total number of participants) Mean (SE)/ No. of participants Heterogeneity test (I2) MD (95% CI) p value Overall quality of evidence*
Intervention Comparator
1 (menses/ 28 days) 1(37) 0.71 (0.06)/ 18 0.62 (0.06)/ 19 Not applicable as there is only 1 trial 0.10 (-0.07 to 0.26) 0.26 Moderate
2 (NA) 1(29) -1.44 (0.44)/14 −2.52 (0.42)/ 15 Not applicable as there is only 1 trial Not reported 0.09 Moderate
3 (NA) 1(27) -0.04 (0.01)/ 12 0.002 (0.01)/ 15 Not applicable as there is only 1 trial Not reported 0.02 High
4 (NA) 1(35) 3.74 (1.00)/ 18 5.17 (1.00)/ 17 Not applicable as there is only 1 trial Not reported 0.33 Low
Keys: SE= standard error; MD: mean difference; CI: confidence interval.
Comparison    Individualized CHM versus standardized CHM
Main Results
Compared to standardized CHM, individualized CHM did not show significant improvement in the mean menstrual rate (mean differences (MD): 0.10, 95% CI: -0.07 to 0.26), mFG scores (p= 0.09) and PCOS total scores (p= 0.33) at 6 months among women with polycystic ovary syndrome. However, individualized CHM showed significant reduction in WHR when compared to standardized CHM (p=0.02). Both standardized and individualized CHM conferred benefits to patients across all outcomes.
Comparison: Individualized CHM versus standardized CHM among female with polycystic ovary syndrome
Outcomes 1 (menses/ 28 days) 2 (NA) 3 (NA) 4 (NA)
No. of studies (Total number of participants) 1(37) 1(29) 1(27) 1(35)
Mean (SE)/ No. of participants Intervention 0.71 (0.06)/ 18 -1.44 (0.44)/14 -0.04 (0.01)/ 12 3.74 (1.00)/ 18
Comparator 0.62 (0.06)/ 19 −2.52 (0.42)/ 15 0.002 (0.01)/ 15 5.17 (1.00)/ 17
MD (95% CI) 0.10 (-0.07 to 0.26) Not reported Not reported Not reported
p value 0.26 0.09 0.02 0.33
Overall quality of evidence* Moderate Moderate High Low
Keys: SE= standard error; MD: mean difference; CI: confidence interval.
Conclusion
Benefits
This study showed that both individualized and standardized CHM can improve outcomes of patients with polycystic ovary syndrome. There were no significant differences on the mean menstrual rate, mFG scores and PCOS total scores at 6 months between individualized CHM and standardized CHM groups. However, individualized CHM significantly reduced WHR when compared to standardized CHM. . For outcomes 1 and 2, the overall quality of evidence is moderate. Further research is fairly likely to have an important impact on our confidence in this estimate of effect. For outcome 3, the overall quality of evidence is high. Further research is unlikely to have an important impact on our confidence in this estimate of effect. For outcome 4, the overall quality of evidence is low. Further research is likely to have an important impact on our confidence in this estimate of effect.
Harms
Two serious adverse events were reported. One patient in individualized CHM group was diagnosed with nodular goitre and one in standardized CHM group experienced a leg fracture. Both events were confirmed to be not related to study treatments. Adverse events were minor with 9 reactions reported among six patients in standardized CHM group and four in individualized CHM group. The 9 events were assessed as mild, expected, not serious and having a reasonable causal relationship with treatment. The most commonly reported symptoms are gastrointestinal symptoms, including bloating, nausea, loose stools and vomiting while the remaining consist of tiredness, skin breakout, ovulation pain and headache.
Link to Original Article
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5293993/
The synopsis is based on the following article:
Lai L, Flower A, Prescott P, Wing T, Moore M, Lewith G. 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. 2017 Feb 1;7(2):e011709.


* Interpretation of quality assessment results:
• Very low: Further research is most likely to have an important impact on our confidence in this estimate of effect.
• Low: Further research is likely to have an important impact on our confidence in this estimate of effect.
• Moderate: Further research is fairly likely to have an important impact on our confidence in this estimate of effect.
• High: Further research is unlikely to have an important impact on our confidence in this estimate of effect.
• Very high: Further research is most unlikely to have an important impact on our confidence in this estimate of effect.

Details of assessment method can be found at Chung VC, Wu XY, Ziea ET, Ng BF, Wong SY, Wu JC. Assessing internal validity of clinical evidence on effectiveness of CHinese and integrative medicine: Proposed framework for a CHinese and Integrative Medicine Evidence RAting System (CHIMERAS). European Journal of Integrative Medicine. 2015 Aug 31;7(4):332-41.