Traumeel was not superior to placebo in minimizing pain or analgesic consumption over the 14 days of the trial, however a transient reduction in the daily maximum post-operative pain score was observed on the day of surgery. Our statistical design did not allow for a significance test specific to that day, however a test for interaction was significant. Stratification by type of surgery did not alter these results. Because post-operative pain is maximal in the period immediately following surgery, this finding may be of clinical importance. Wound infection was more prevalent in the placebo group, but the difference was not statistically significant. Other adverse effects were too rare to analyze statistically.
Our findings do not support those of a pilot study published in 2007 that suggested a 30% improvement in pain over 14 post-operative days, and a non-significant trend towards lower analgesic consumption. In that non-blinded study, 30 subjects were allocated by week of surgery to intraoperative injection of Traumeel, injection plus oral Traumeel, or no treatment. Both treatment arms were found superior to no treatment [20
]. Differences in study methodology could explain the differences in outcome. We believe that future research should focus on the early post-operative period.
Homeopathy is frequently attacked for its use of solutions diluted beyond Avogadro's number, and hence physical-chemical implausibility. That criticism was circumvented in this trial by employing a preparation of solutions that were dilute, but well within the material range.
Relief of post-operative pain remains an ongoing challenge. While other treatment modalities have been examined, each has its own limitations. Valdecoxib and rofecoxib have both been found effective for relief of pain following hallux valgus surgery [22
] but were removed from the market amid concerns of excessive risk of heart attack and stroke. Betamethasone has been found to reduce post-operative pain and nausea [24
], but concerns remain regarding the effect of corticosteroids on post-operative healing [25
]. Parenteral routes for delivery of opiates are available, but they entail greater cost, complexity, and possible need for hospitalization [26
This trial has several limitations. By choosing a cumulative 14-day measure for our primary outcome, we may have inadvertently diluted any effect that may have been present in the first days after surgery - those with the greatest pain. Homeopathic purists may find fault in the administration of a standardized combination homeopathic formula to all patients, based upon clinical diagnosis - as opposed to the individualized manner dictated by standard homeopathic practice. We were aware of this limitation at the outset; however, performing an individualized RCT would be far more complex, time-consuming, and fraught with methodological pitfalls. The mode of administration of the remedy may have played a role as well. In contrast to our pilot study, in the current study, for the sake of simplicity we chose to use only oral administration of the study medication, under the assumption that its effect would be similar to that of injection followed by oral therapy. In retrospect, that assumption may have been mistaken.