A research paper by Susan Arentz, et al titled ‘Combined Lifestyle and Herbal Medicine in Overweight Women with Polycystic Ovary Syndrome (PCOS): A Randomized Controlled Trial’ has shown promise when using multiple therapies in a clinic setting as well as indicating that multiple therapies can be clinically trialed in a single trial. This has been a common argument against the use of clinical trials using natural remedies as natural remedies use multiple constituents as well as often multiple remedies and usually includes diet and lifestyle modifications. This means there are many variables to test.
This trial has done it cleverly.
122 women meeting the eligibility criteria were randomized in parallel groups to herbal medicine plus a lifestyle intervention or the lifestyle intervention alone. This study included women aged 18–44 years with a confirmed diagnosis of PCOS according to the Rotterdam criteria (ESHRE, 2004) and a body mass index (BMI) greater than or equal to 24.5 kg/m2 (the category of overweight for women). The interventions were administered for 3 months.
The lifestyle intervention was guided by the evidence-based guidelines for the management of PCOS (Teede et al.,2010; AAPCOS, 2011) defined as dietary and exercise behaviours that induce weight loss or prevent weight gain. The evidence-based guidelines recommend a calorie-controlled diet within a healthy food choice setting (AAPCOS, 2011) and exercise for at least 150 min per week including 90 min of aerobic activity (60–90% of maximum heart rate) and participants were supported to do so.
Herbal medicine was administered in the form of two types of herbal medicine tablets each containing different herbal ingredients and two 30-min consultations at trial weeks 4 and 8. During the consultations, women were asked about their well-being and assessed for adverse effects by a qualified naturopath. The herbal ingredients were selected based on the evidence for reproductive endocrine effects (Arentz et al., 2014a, 2014b) and tailored to wider presentations of PCOS guided by naturopathic principles indicated by commonly observed clinical signs and symptoms of overweight women with PCOS (ESHRE, 2012). Three tablets once a day were administered throughout the trial which is a common dosing schedule for herbal medicines.
This study was looking for several outcomes. Evidence from women with PCOS show the most important outcomes associated with PCOS was oligomenorrhoea defined as irregular menstruation or 35 to 179 days between menstrual periods. Secondary study end points set by the researchers included serum concentration of reproductive hormones; glucose and insulin sensitivity; anthropometric characteristics; health-related quality of life (HRQoL) and depression, anxiety and stress; pregnancy and birth outcomes; and safety of the herbal medicine assessed as increased blood pressure and adverse reactions.
The mean number of days in the menstrual cycle for women assigned to the herbal medicine plus lifestyle group was 106.0 days at baseline and for women allocated to the lifestyle intervention only group 109.5 days. At 3 months, there was a statistically significant difference in oligomenorrhoea for women in the herbal medicine plus lifestyle group compared with controls with the mean menstrual cycle length shortening to 43 days. The proportion of women with ‘normal’ menstrual cycle length (20–34 days) in the herbal medicine plus lifestyle group was significantly greater compared with controls 33 of 60 (55.0%) compared with 15 of 62. Secondary outcomes at 3 months found a statistically significant difference between groups for women taking herbal medicine plus lifestyle compared with controls in body weight and BMI kg/m2. Waist circumference was also significantly lower in herbal medicine group but there was no statistically significant difference between groups for waist-to-hip ratio.
Secondary outcomes relating to reproductive hormonal concentrations for 64 women at 3 months were statistically different for two of the hormones. Follicular phase oestradiol was increased in the test group and LH was lowered. Fasting insulin was significantly lower for women taking herbal medicine in addition to lifestyle compared with controls. Women’s use of hypoglycaemic medication (metformin) was reduced at end point with no significant difference between groups. There was a significant improvement for systolic and diastolic blood pressure for women taking the herbal medicine compared with controls. Women assigned to the herbal medicine plus lifestyle group reported significantly improved HRQoL compared with controls for the total PCOSQ score and for the domains of concerns about body hair, infertility, body weight, menstrual problems and emotions. Participants taking the herbal medicine tablets plus lifestyle recorded a significantly greater reduction in depression, anxiety and stress scores compared with controls.
These are amazing results for a herbal medicine. The findings from this study compare favourably with published data comparing metformin and the oral contraceptive pill Diane Nova for menstrual regularity over 3 months. There were no serious adverse events during the trial, and non-serious adverse effects were substantially fewer compared with the pharmaceutical interventions clomiphene and metformin for managing PCOS.
This gives some hope for PCOS sufferers that menstrual cycle regularity and feelings of wellbeing can be improved with the use of quality herbal medicines which treat the whole person alongside dietary, lifestyle and motivational changes that accompany seeing a qualified Naturopath or Herbalist.
- Combined Lifestyle and Herbal Medicine in Overweight Women with Polycystic Ovary Syndrome (PCOS): A Randomized Controlled Trial. Phytother Res. 2017 Sep;31(9):1330-1340. https://pubmed.ncbi.nlm.nih.gov/28685911/