MD, PhD, MAE, FMedSci, FRCP, FRCPEd.

This double-blind, three-arm randomised trial evaluated the efficacy of homeopathic medication in patients with seasonal allergic rhinitis (SAR). Patients at eleven outpatient clinics and two medical centres were randomised to receive:

  • (1) individualised homeopathic case taking (IHCT) and standardised homeopathic medication with Galphimia Glauca (GG),
  • (2) IHCT and individualised homeopathic treatment (IHG),
  • (3) IHCT and placebo (PG).

The primary outcome was disease-specific quality of life, assessed using the Rhinitis Quality of Life Questionnaire (RQLQ) after three and four weeks. Secondary outcomes included response rate (≥0.5-point change in RQLQ), rescue medication use, and total nasal and non-nasal symptom scores (TNSS, TNNSS).

Sixty-two SAR patients (mean age ± SD: 46.9 ± 14.9; 43.5% female) were recruited, approximately 25% of the planned sample size. After weeks three and four, there were no significant differences in RQLQ (p=0.244) between GG (adjusted mean, 1.2, 95% CI 0.7-1.7), IHG (1.7, 1.2-2.3), and PG (1.4, 0.8-2.0). High response rates were observed (GG: 86.4%, IHG: 66.7%, PG: 81.3%), while RM use was 21.7%, 55.6%, and 29.4%, respectively. There were no relevant differences in RM score, TNSS and TNNSS between the three groups. Eight adverse events but no serious adverse events were reported.

The authors concluded that standardised and individualised homeopathic drugs were not superior compared to placebo suggesting that treatment response was not based on study medication. The validity of the study and its conclusions are limited by the fact that the recruitment target was not achieved.

Multicentre studies like this one are useful for recruiting large numbers of patients. SAR is a common condition; the recruitment of a large sample should therefore have been fairly straight forward. So, why was this study so woefully under-powered? An average of 6 patients per centre is dismal, to put it mildly!

This leaves us with a failed study of a failed (implausible) hypothesis; its negative findings cannot be properly interpreted (other than showing the incompetence of the trialists).

Why publish such a waste of resorces at all?

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