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Open Access Highly Accessed Research article

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

Shepherd R Singer1*, Michal Amit-Kohn2, Samuel Weiss2, Jonathan Rosenblum2, Guy Maoz3, Noah Samuels4, Esther Lukasiewicz45, Laurence Freedman4, Ora Paltiel6, Menachem Itzchaki2, Meir Niska and Menachem Oberbaum1

  • * Corresponding author: Shepherd R Singer singer2@013.net

  • † Equal contributors

Author Affiliations

1 The Center for Integrative Complementary Medicine, Shaare Zedek Medical Center, Jerusalem, Israel

2 Department of Orthopedics, Shaare Zedek Medical Center, Jerusalem, Israel

3 Department of Orthopedics, Meir Medical Center, Kfar Saba, Israel

4 Biostatistics Unit, Gertner Institute for Epidemiology and Health Policy Research, Chaim Sheba Medical Center, Tel Hashomer, Israel

5 Faculty of Life Sciences, Bar-Ilan University, Ramat-Gan, Israel

6 Department of Hematology, Hadassah University Hospital, and Hebrew University Hadassah School of Public Health, Jerusalem, Israel

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BMC Clinical Pharmacology 2010, 10:9  doi:10.1186/1472-6904-10-9

Published: 12 April 2010

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