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

Disclosures

BMC Clin Pharmacol. 2010;10:1-23. 

In This Article

Results

Patient flow throughout the study is presented in Figure 1. Of the 80 patients who participated in the trial, 79 were evaluable for intention-to-treat analysis. The remaining patient withdrew consent on the third day of the trial because of nausea, vomiting and abdominal pain. He did not provide sufficient data points to be included in the final analysis. Patient groups were balanced with respect to all baseline parameters except for laterality of surgery (Table 2).

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.

Overall, the mean area-under-the-curve pain scores during the 14 days of the trial were not significantly different between the groups (55.4 ± 25.5 in Traumeel group vs. 57.4 ± 25.7 for placebo, p=0.89). However, the mean pain score on the day of surgery appeared lower in the Traumeel group than placebo (4.0 vs. 5.6, Figure 2). This difference is supported by the test for interaction between time and treatment group (p=0.04).

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.

When stratified for type of surgery, in the Chevron-only strata the mean pain score appeared lower in the Traumeel group than in the placebo group, however this difference was not found statistically significant (Traumeel - 46.1, Placebo - 61.8, p = 0.35). In the 'Additional osteotomy' and ' Triple or proximal osteotomy' groups, differences in mean pain between the verum and placebo groups were negligible (Table 3).

There was little difference between the two arms in the total number of tablets of primary analgesics consumed (15.6 ± 12.2 for Traumeel vs. 16.0 ± 11.9 for placebo, p=0.74) and in the number of days on which rescue analgesics were required (mean ± SD: 1.0 ± 3.1 for Traumeel and 1.5 ± 2.0 for Placebo, p=0.99).

Four patients in the placebo group (10%) and two in the Traumeel group (5.1%) developed wound infection. Six patients in the Traumeel group (15%) and four patients in the placebo group (10%) developed nausea and/or vomiting, though these differences were not statistically significant (p=0.51 and p=0.68 respectively). In the Traumeel group, one 82- year-old patient with type II diabetes developed cellulitis following wound infection. He was hospitalized for intravenous antibiotic treatment, but did not require further surgery. This was deemed a serious adverse event unrelated to the study medication.

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