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
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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.

Abstract Image

Abstract Image

用于缓解拇指外翻术后疼痛的 Traumeel S:随机对照试验。
背景:尽管近来在术后止痛方面取得了进展,但骨科手术后的疼痛仍是临床医生面临的一项持续挑战。我们研究了一种众所周知的常用顺势疗法制剂能否减轻术后疼痛:方法:我们进行了一项随机、双盲、安慰剂对照试验,以评估顺势疗法制剂 Traumeel S 在最大程度地减轻术后疼痛和减少外翻矫正手术后镇痛药用量方面的疗效。连续 80 名患者被随机分配接受 Traumeel 药片或无差别安慰剂,并根据需要服用主要口服镇痛药和救援口服镇痛药。记录了手术当天和术后13天内休息时的最大疼痛数字评分和口服镇痛药的用量:在14天的试验中,Traumeel在减轻疼痛或减少镇痛药用量方面未发现优于安慰剂,但在手术当天观察到Traumeel治疗组的术后每日最大疼痛评分出现短暂下降,治疗-时间交互检验(P = 0.04)支持了这一结果:结论:在14天的试验中,曲美在减轻疼痛或减少镇痛药用量方面并不优于安慰剂。试验注册:本研究已在 ClinicalTrials.gov 注册。# NCT00279513。
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