Conclusions
The homeopathic complex Traumeel S ® was not found superior to placebo in mitigating post-operative pain or analgesic consumption over the 14 days of the trial. A transient reduction in the daily maximum post-operative pain score, observed on the day of surgery, is of questionable importance. We recommend repetition of this trial, but using injected Traumeel and focusing on the early post-operative period.
This study was registered at ClinicalTrials.gov. # NCT00279513
Abbreviations
CONSORT - Consolidated Standards of Reporting Trials, MMC – Meir Medical Center, Kefar Saba, Israel, NRS – Numerical Rating Scale, SZMC – Shaare Zedek Medical Center, Jerusalem, Israel
Competing Interests
The HEEL Company (Baden-Baden, Germany) has funded previous research at the Shaare Zedek Center for Integrative Complementary Medicine, and provided funding for the performance and monitoring of this project, supplied the study medication and placebo, and prepared the randomization list. However, it had by contractual agreement no control over the flow of the study, the data analysis, or the decision when and where to publish the study findings. The authors have full control over the primary data, and agree to allow the journal to review the data if requested.
Author Contributions
MO conceived the trial, and was central to its design, performance, and reporting. SRS was PI, participated in drafting the protocol, oversaw performance of the trial and participated in drafting the manuscript. NS and OP participated in study design and drafting of protocol and manuscript. MAK, SW, JR, GM, MI and MN screened patients and performed surgery and follow-ups. EL and LF participated in design of the trial, data management and analysis. All authors have read and approved the final manuscript.
BMC Clin Pharmacol. 2010;10:1-23. © 2010 Singer et al.; licensee BioMed Central Ltd.
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