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Trial of traumeel for sports injuries

PainSci » bibliography » Böhmer et al 1992
Tags: homeopathy, controversy, inflammation, debunkery, pain problems

One article on PainSci cites Böhmer 1992: Does Arnica Gel Work for Pain?

PainSci commentary on Böhmer 1992: ?This page is one of thousands in the 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 very old German experiment, in a journal owned by Traumeel’s manufacturer, straightforwardly claims to have found clear evidence that Traumeel is better than a placebo by several measures (very similar to Thiel). It has a reasonably strong design. Böhmer and Ambros compared two types of Traumeel to a placebo in 100 freshly injured patients. Swelling, skin temperature, strength, pain, and recovery time. They report excellent, clinically significant superiority of Traumeel with a high statistical confidence.

Across the board, I dispute the authors claim that the differences were “clinically significant.” For instance, the number of days until resumption of training differed by less than a day and a half in a two week period — hardly a miracle drug there. The reported pain differences were not large either: less than a 16% of their scale.

If they’re real, these are worthwhile differences — just really clearly not impressive. But their reality must be questioned as well, due to the overwhelming risk of (unacknowledged) bias.

The paper is amusingly lacking in references to support its assumptions.

This is one of ten studies cited on to substantiate that Traumeel has therapeutic effects. See Does Arnica Gel Work for Pain? for a full discussion of these references as a set.

~ 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.

A controlled double-blind study was conducted on outpatients with sports injuries, to compare with a placebo the effectiveness of Traumeel ointment in its normal commercially available form (Traumeel S), and in a form of this preparation containing only six constituents (Traumeel Sine). The primary criteria employed to assess medication effectiveness were regression of swelling and reduction in skin temperature. Secondary criteria for effectiveness were the following: increase in maximum muscle force, reduction of pain intensity (pain index), time until resumption of training, and overall evaluation of effectiveness by patient and physician.

A total of 102 patients was included in this study, with breakdown into groups of 34 patients each. It was possible to evaluate data for all patients except one (who was disqualified for not satisfying criteria for acceptance into the study). All other patients completed the study in compliance with the criteria for conduct of the study. With respect to the main criteria of skin temperature, no differences became apparent among the three treatment groups; variance was determined, however, for swelling. Convincing evidence has been obtained that there is no difference between the effectiveness of Traumeel S and Traumeel Sine, but that the effectiveness of both differs from that of the placebo. Purely formally, however, in the sense of control of multiple-level alpha, only the difference between Traumeel Sine and the placebo was able to be verified.

All secondary criteria such as maximum muscle force, pain index, resumption of training, and overall evaluation confirm without exception, and with low P values, that there is no difference in effectiveness between the two Traumeel preparations, but that a great difference does exist between these preparations and the placebo. The values of P on the 15th day were smaller than 0.001 for the pain index and the overall evaluation. In addition, the Mann-Whitney characteristic P(X<Y) reveals that these differences are of considerable clinical significance. At the end of the study, the patients and the physician evaluated the tolerance of the tested substances as good to very good. No undesired side effects were observed in any of the three treatment groups.

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