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

Background

The management of postoperative pain following ambulatory orthopedic surgery is an issue of ongoing concern for patients and for physicians performing these procedures. Numerous studies have found pain control to be inadequate.[1–6] Pain is the most frequent cause of delayed discharge and unanticipated readmission following ambulatory surgery,[7,8] as well as for contacting the family physician after discharge.[9] Nearly a third of patients have moderate to severe pain 24 hours after ambulatory surgery,[10] while eleven percent experience severe pain.[11] Both moderate and severe pain can last for up to a week after surgery.[9] Treatment for post-operative pain typically includes anti-inflammatory medications and opiates, both of which are associated with adverse effects, limiting patient compliance and effectiveness.

Traumeel S® is an over-the-counter homeopathic preparation composed of extracts from a combination of plants and minerals that have been highly- diluted, though not beyond Avogadro's number (see Table 1). It has been widely sold in German, Switzerland and Austria for over 50 years, and is one of the most popular alternative medications in these countries, selling approximately four million doses a year [manufacturer information]. Earlier studies have suggested that Traumeel may be effective in trauma,[12–15] acute tendinopathy[16] and in the spinal syndrome,[17] though these studies were either non-randomized or used poorly chosen controls. A small RCT found Traumeel to be effective in postchemotherapy stomatitis.[18] While the mechanism of action of this preparation remains unknown, recent research has shown that Traumeel reduces secretion of pro-inflammatory cytokines from various human immune cells in vitro, both at rest and when activated by PHA-, PMA-, or TNF-α. Interleukin-1β secretion was reduced by 70%, TNF-α by 65% and 54% (resting and activated), and IL-8 by 50% (P<0.01 for all comparisons).[19] Unpublished data from a manufacturer safety survey indicated adverse events in 0.0035% of 3.5 million cases [personal communication]. These appeared almost entirely in cases where Traumeel was injected, with the most common of these events being local irritation at the site of injection that resolved spontaneously after discontinuation of treatment. No drug interactions are known with this preparation [manufacturer information].

In 2007 we published the results of an open pilot study to evaluate the efficacy of Traumeel in mitigating post-operative pain following ambulatory hallus valgus surgery.[20] In this study, treatment allocation was by week of surgery rather than by strict randomization. This study found significantly lower post-operative pain scores in patients treated with supplementary Traumeel as compared with standard care alone. To the best of our knowledge, no randomized controlled trial has yet assessed the effectiveness of Traumeel for the relief of acute pain in patients following ambulatory surgery. We therefore performed a randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy of Traumeel in controlling post-operative pain after ambulatory hallus valgus correction.

Comments

3090D553-9492-4563-8681-AD288FA52ACE
Comments on Medscape are moderated and should be professional in tone and on topic. You must declare any conflicts of interest related to your comments and responses. Please see our Commenting Guide for further information. We reserve the right to remove posts at our sole discretion.
Post as:

processing....