This study aimed to assess the feasibility of a future definitive trial, with a preliminary assessment of differences between effects of individualized homeopathic (IH) medicines and placebos in the treatment of cutaneous warts.
A double-blind, randomized, placebo-controlled trial (n = 60) was conducted at the dermatology outpatient department of the Homoeopathic Medical College and Hospital, West Bengal. Patients were randomized to receive either IH (n = 30) or identical-looking placebos (n = 30). The primary outcome measures were numbers and sizes of warts; the secondary outcome measure was the Dermatology Life Quality Index (DLQI) questionnaire measured at baseline, and every month up to 3 months. Group differences and effect sizes were calculated on the intention-to-treat sample.
Attrition rate was 11.6% (IH, 3; placebo, 4). Intra-group changes were significantly greater in the IH group than in the placebo group. Inter-group differences were statistically non-significant (all p > 0.05, Mann-Whitney U tests) with small effect sizes, both in the primary outcomes (number of warts after 3 months: IH median [interquartile range; IQR] 1 [1, 3] vs. placebo 1 [1, 2]; p = 0.741; size of warts after 3 months: IH 5.6 mm [2.6, 40.2] vs. placebo 6.3 [0.8, 16.7]; p = 0.515) and in the secondary outcomes (DLQI total after 3 months: IH 4.5 [2, 6.2] vs. placebo 4.5 [2.5, 8]; p = 0.935). Thuja occidentalis (28.3%), Natrum muriaticum (10%), and Sulphur (8.3%) were the most frequently prescribed medicines. No homeopathic aggravations or serious adverse events were reported.
The authors concluded that, as regards efficacy, the preliminary study was inconclusive, with a statistically non-significant direction of effect favoring homeopathy. The trial succeeded in showing that an adequately powered definitive trial is both feasible and warranted.
Partly the same group of authors recently published another trial of homeopathy with similar findings. At the time, I commented as follows:
We have come across this terminology before; homeopaths seem to like it. It prevents them from calling a negative trial by its proper name: A NEGATIVE TRIAL. In their view
- a positive trial is a study where homeopathy yields better results than placebo,
- a negative trial is a study where placebo yields better results than homeopathy,
- an inconclusive trial is a study where homeopathy yields results that are not significantly different from placebo.
Is this silly?
Yes, it is completely bonkers!
Is it dishonest?
Yes, in my view, it is.
Why is it done nonetheless?
Perhaps a glance at the affiliations of the authors provides an answer. And here is the list of the affiliations of the trialists of the present cutaneous wart study:
- 1Department of Repertory, D.N. De Homoeopathic Medical College and Hospital, Govt. of West Bengal, Tangra, Kolkata, West Bengal, India.
- 2D.N. De Homoeopathic Medical College and Hospital, Govt. of West Bengal, Tangra, Kolkata, West Bengal, India.
- 3Department of Organon of Medicine and Homoeopathic Philosophy, The Calcutta Homoeopathic Medical College and Hospital, Kolkata, West Bengal, India.
- 4Department of Practice of Medicine, The Calcutta Homoeopathic Medical College and Hospital, Kolkata, West Bengal, India.
- 5Department of Repertory, National Institute of Homoeopathy, Ministry of AYUSH, Govt. of India, Kolkata, West Bengal, India.
- 6Department of Organon of Medicine and Homoeopathic Philosophy, D.N. De Homoeopathic Medical College and Hospital, Govt. of West Bengal, Tangra, Kolkata, West Bengal, India.
- 7Department of Pediatrics, National Institute of Homoeopathy, Ministry of AYUSH, Govt. of India, Salt Lake, Kolkata, West Bengal, India.
- 8Department of Organon of Medicine and Homoeopathic Philosophy, State National Homoeopathic Medical College and Hospital, Lucknow, Uttar Pradesh.
- 9Independent Researcher; Champsara, Baidyabati, Hooghly, West Bengal, India.
- 10Independent Researcher, Shibpur, Howrah, West Bengal, India.
And, as before, this paper also contains this statement:
Conflict of interest statement
The conclusion translates to
“We tried as hard as we could to bring this blasted p-value down below 0.05 – but whatever we tried, it would not do as we would have wished. This is the best we can get, meagre as it is. Sorry. Hopefully our text sounds nice and somehat convincing for marketing purposes.”
What foolishness. Everyone knows that the application of the fluid of the milkweed plant cures warts. None of this homeopathy mumble jumble.
Nonsense: You need to bury a black cat at full moon near a graveyard-wall.
So you say that all trials that have inconclusive results are negative. Well, you’ll have no problem acknowledging that more than 90% of medical treatments don’t work because their results are inconclusive, and I’m not saying that, Cochrane review analysis says so. This also applies to vaccines, it is a wonder that Edzard Ernst recognizes that most conventional medical treatments are placebos and that they should not be offered or justified in hospitals or by governments. This should cause you to retract all your articles and your twitter trolls friends (pharmacists, doctors and so on) to start quitting their jobs to do no more harm than good.
“So you say that all trials that have inconclusive results are negative.”
I say that all trials that show the experimental treatment is not better than placebo are ‘negative’
TRIALS NOT REVIEWS!!!