Research Council for Complementary Medicine, 27a Devonshire Street, London W1G 6PN, UK
The paper by Stevinson and co-workers (February 2003 JRSM1) suggests that people undergoing carpal tunnel surgery are not helped by homeopathic arnica. The authors themselves describe the study as preliminary, and it has several important methodological flaws. To begin with, they failed to carry out a power calculation before conducting the research. They suggest that there were no reliable data on which to base a formal sample size calculation. However, they could have used the data from this pilot study to calculate a post-hoc power analysis in order to establish the robustness of their conclusions and determine the appropriate sample size for a full study.
Secondly, poor adherence to the treatment and the fact that the data were not normally distributed (the actual distributions are not presented in the paper) make it difficult to determine whether their results are influenced by outliers. Furthermore, Stevinson et al. do not report how outliers were dealt with, which is particularly relevant in small studies.
The researchers claim that the randomization procedure resulted in similar patient characteristics in each group for most variables, but they did not compare patient characteristics using statistical apalysis. In their Table 1 the preoperative pain for the arnica 6C group is reported as 3, with a range of 0-70. If this is not an error, then the patients in the arnica 6C group appear to be very different from the other two groups. The researchers also say that there were more male patients in the arnica 6C group. This suggests that there are systematic differences between the groups on characteristics that may have affected the outcome.
Furthermore, although the researchers report that oral analgesic medication (paracetamol or diclofenac) was prescribed, the actual use of these agents is not adequately presented in the study. Table 5 gives the numbers of tablets taken, but paracetamol and diclofenac (different types of analgesic) are grouped together, rather than presented separately, and details of dosages are not provided. This is a serious omission.
There is no doubt that rigorous studies are required to assess the usefulness and effectiveness of homeopathy. Unfortunately, rather than provide any clear evidence for or against the use of arnica postoperatively in carpal tunnel surgery, this article will simply be added to the list of homeopathic studies that raise questions about methodological rigour and practical relevance.
REFERENCES
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||