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A small, widely cited trial of homeopathy with no obvious flaws

PainSci » bibliography » Oberbaum et al 2001
updated
Tags: homeopathy, controversy, random, debunkery

One article on PainSci cites Oberbaum 2001: Does Arnica Gel Work for Pain?

PainSci commentary on Oberbaum 2001: ?This page is one of thousands in the PainScience.com bibliography. It is not a general article: it is focused on a single scientific paper, and it may provide only just enough context for the summary to make sense. Links to other papers and more general information are provided wherever possible.

This is a widely cited study of homeopathy, because its good design and clearly positive results are a rarity. It was a randomized, controlled and blinded trial of Traumeel S for kids with cancer, who get painfully inflamed mouths during stem cell transplants. The results seem happy — statistically significant and clinically meaningful — which makes it the only positive trial of homeopathy I am aware of that has no obvious flaws.

By no means does that guarantee perfection! And with a small sample size — just fifteen kids — even a small mistake in data entry, or a tough choice about how to represent some tricky data, could queer the statistical significance. Science is full of such opportunities to be wrong. It happens even to the best scientists. In any event, “statistically significant” only means that the results probably weren’t a fluke. They still could have been.

And this is why it always takes lots of good quality, bigger trials to come anywhere close to “proving” anything. Although it is a valid test of homeopathy in general, and it is undeniably positive, a test of mouthwash for kids with cancer is too different from an ointment for minor injuries to constitute good evidence in support of Traumeel in the form that most consumers know it.

~ Paul Ingraham

original abstract Abstracts here may not perfectly match originals, for a variety of technical and practical reasons. Some abstacts are truncated for my purposes here, if they are particularly long-winded and unhelpful. I occasionally add clarifying notes. And I make some minor corrections.

BACKGROUND: Stomatitis is a common consequence of chemotherapy and a condition for which there is little effective treatment. Although the management of patients with other chemotherapy-related toxicities has improved in recent years, the incidence of stomatitis is increasing because of more intensive treatment and is often a dose limiting factor in chemotherapy. The authors assessed the efficacy of a homeopathic remedy, TRAUMEEL S(R), in the management of chemotherapy-induced stomatitis in children undergoing bone marrow transplantation.

METHODS: A randomized, placebo-controlled, double-blind clinical trial was conducted in 32 patients ages 3-25 years who had undergone allogeneic (16 patients) or autologous (16 patients) stem cell transplantation. Of the 30 evaluable patients, 15 were assigned placebo, and 15 were assigned TRAUMEEL S both as a mouth rinse, administered five times daily from 2 days after transplantation for a minimum of 14 days, or until at least 2 days after all signs of stomatitis were absent. Stomatitis scores were evaluated according to the World Health Organization grading system for mucositis.

RESULTS: A total of five patients (33%) in the TRAUMEEL S treatment group did not develop stomatitis compared with only one patient (7%) in the placebo group. Stomatitis worsened in only 7 patients (47%) in the TRAUMEEL S treatment group compared with 14 patients (93%) in the placebo group. The mean area under the curve stomatitis scores were 10.4 in the TRAUMEEL S treatment group and 24.3 in the placebo group. This difference was statistically significant (P < 0.01).

CONCLUSIONS: This study indicates that TRAUMEEL S may reduce significantly the severity and duration of chemotherapy-induced stomatitis in children undergoing bone marrow transplantation.

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