It is time, I think, to express my gratitude to Dr Jens Behnke, a German homeopath employed by the pro-homeopathy lobby group the ‘Carstens Stiftung’, who diligently tweets trials of homeopathy which he obviously believes prove the value of his convictions.
The primary objective of this new study was to evaluate the efficacy of homoeopathy for women suffering from polycystic ovary syndrome. This condition is characterised by:
- irregular periods which means your ovaries don’t regularly release eggs,
- abnormally high levels of male hormones in the body, which may cause physical signs such as excess facial or body hair,
- polycystic ovaries – ovaries become enlarged and contain many fluid-filled sacs (follicles) which surround the eggs.
There’s no cure for PCOS, but the symptoms can usually be treated. As so often in such situations, homeopaths are happy to step into the fray.
This single-blind, randomised, placebo-controlled pilot study was conducted at two research centres in India. The cases fulfilling the eligibility criteria were enrolled (n = 60) and randomised to either the homoeopathic intervention (HI) (n = 30) or placebo (P) (n = 30) with uniform lifestyle modification (LSM) for 6 months.
The menstrual regularity with improvement in other signs/symptoms was observed in 60% of the cases (n = 18) in HI + LSM group and none (n = 0) in control group. Statistically significant difference was observed in the reduction of intermenstrual duration in HI + LSM in comparison to placebo + LSM group. Significant improvements were also observed in HI+LSM group in domains of weight, fertility, emotions and menstrual problems. No change was observed in respect of improvement in the ultrasound findings. Pulsatilla was the most frequently indicated homeopathic remedy.
The authors concluded that HI along with LSM has shown promising outcome; further comparative study with standard conventional treatment on adequate sample size is desirable.
This trial might convince believers (mostly because they do not even need convincing), but it cannot convince anybody capable of critical thinking. Here is why:
- According to its authors, this trial was a pilot study; this means it should not report any results and merely focus on the feasibility of a definitive trial.
- Researchers were not blinded, meaning that they might have influenced the outcome in more than one way.
- The primary endpoint was subjective and could have been influenced by the non-blinded researchers.
- 0% success rate in achieving the primary endpoint in the placebo group is not plausible.
- Compliance to LSM was not checked; as the homeopathy group lost more weight, these patients seemed to have complied better (probably due to being better motivated by the non-blinded researchers).
So?
My conclusion is not very original but all the more true: POORLY DESIGNED STUDIES USUALLY GENERATE UNRELIABLE RESULTS.
I seem to remember from my days as an endocrinology SHO that weight loss does improve the symptoms of polycycstic ovary disease, so this may explain much of the reported improvement in the treated group. Certainly the women I encountered with it were all somewhat overweight, though this was a limited sample.
On the other hand, as you say, the numbers are too small to draw any strong conclusion.