Traumeel S for pain relief following hallux valgus surgery: a randomized controlled trial

Shepherd R Singer, Michal Amit-Kohn, Samuel Weiss, Jonathan Rosenblum, Guy Maoz, Noah Samuels, Esther Lukasiewicz, Laurence Freedman, Ora Paltiel, Menachem Itzchaki, Meir Niska, Menachem Oberbaum, Shepherd R Singer, Michal Amit-Kohn, Samuel Weiss, Jonathan Rosenblum, Guy Maoz, Noah Samuels, Esther Lukasiewicz, Laurence Freedman, Ora Paltiel, Menachem Itzchaki, Meir Niska, Menachem Oberbaum

Abstract

Background: In spite of recent advances in post-operative pain relief, pain following orthopedic surgery remains an ongoing challenge for clinicians. We examined whether a well known and frequently prescribed homeopathic preparation could mitigate post-operative pain.

Method: We performed a randomized, double blind, placebo-controlled trial to evaluate the efficacy of the homeopathic preparation Traumeel S in minimizing post-operative pain and analgesic consumption following surgical correction of hallux valgus. Eighty consecutive patients were randomized to receive either Traumeel tablets or an indistinguishable placebo, and took primary and rescue oral analgesics as needed. Maximum numerical pain scores at rest and consumption of oral analgesics were recorded on day of surgery and for 13 days following surgery.

Results: Traumeel was not found 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 favoring the Traumeel arm was observed on the day of surgery, a finding supported by a treatment-time interaction test (p = 0.04).

Conclusions: Traumeel was not superior to placebo in minimizing pain or analgesic consumption over the 14 days of the trial. A transient reduction in the daily maximum post-operative pain score on the day of surgery is of questionable clinical importance.

Trial registration: This study was registered at ClinicalTrials.gov. # NCT00279513.

Figures

Figure 1
Figure 1
Flow chart of patients through study. 172 patients were screened for participation in the trial. Of 80 patients randomized, one discontinued treatment and was excluded from analysis.
Figure 2
Figure 2
Mean pain score over the 14 days of the trial. Mean NRS pain scores over 14 days for 79 patients receiving Traumeel S® or Placebo. The error bars indicate the mean plus or minus 1 standard error.

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Source: PubMed

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