A Randomized Placebo-Controlled Trial of the Efficacy and Tolerability of Etofenamate 70 mg Medicated Plaster for the Treatment of Pain in Acute Sprains, Strains or Bruises of the Soft Tissues Following Blunt Trauma.

IF 3.3 2区医学 Q1 CLINICAL NEUROLOGY

Pain and Therapy Pub Date : 2025-10-01 Epub Date: 2025-07-17 DOI:10.1007/s40122-025-00764-0

Hans-Georg Predel, Andrew C Leary, Roger Imboden, Ralph-Steven Wedemeyer, Bruno M Giannetti

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引用次数: 0

Abstract

Introduction: Topical nonsteroidal anti-inflammatory drug (NSAID) formulations provide significant pain relief with excellent tolerability in the local treatment of soft tissue injuries. This study aimed to assess the efficacy and safety of a novel etofenamate 70 mg medicated plaster for treatment of pain in patients with acute sprains, strains and contusions (bruises).

Methods: In this randomized, placebo-controlled trial patients with acute injuries of recent onset received etofenamate or placebo plasters (2:1) applied once daily for 7 days. Regular clinical assessments were made with focus on pain on movement (POM) in millimetres on a 100-mm visual analogue scale (VAS).

Results: A total of 180 adult patients (mean age 34.5 ± 13.5 years; 49.4% female) were enrolled. Mean VAS values for POM were 70.0 ± 6.3 mm at baseline; at 72 h POM had reduced by 59.0 mm and 33.3 mm in the etofenamate and placebo groups, respectively. Least squares mean treatment difference was 25.0 mm (p value for analysis of covariance < 0.0001). Results were consistent across type of injury (sprain/strain or contusion). Clinically meaningful superiority of etofenamate versus placebo was also seen for POM at the 24-, 48-, 96- and 120-h visits (p < 0.0001). Time to reach meaningful (30%), optimal (50%) and complete (100%) reduction of POM was significantly shorter with etofenamate. A significantly greater proportion of patients using etofenamate rated their progress and/or treatment as 'good' or 'very good'. The responder rate (proportion of patients with at least 50% pain reduction at 72 h) was 98.3% for etofenamate and 38.3% for placebo, resulting in a number needed to treat of 1.7, a value consistent with high effectiveness. The plasters adhered well over the 24-h dosing period and were very well tolerated.

Conclusion: In the setting of acute sprains, strains and contusions (bruises) the etofenamate plaster has therapeutic efficacy that is comparable to that for the best available topical NSAID formulations.

Registration: 2021-003778-30 (EudraCT number).

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醋酸乙酯70 mg药膏治疗钝性外伤后急性扭伤、拉伤或挫伤的疗效和耐受性的随机安慰剂对照试验

外用非甾体抗炎药（NSAID）制剂在软组织损伤的局部治疗中具有良好的耐受性，可显著缓解疼痛。本研究旨在评估一种新型乙托非那酯70 mg药膏治疗急性扭伤、拉伤和挫伤（瘀伤）患者疼痛的疗效和安全性。方法：在这项随机、安慰剂对照试验中，新近发病的急性损伤患者接受依托非甲酸酯或安慰剂膏药（2:1），每天1次，连续7天。定期进行临床评估，重点是在100毫米视觉模拟量表（VAS）上以毫米为单位的运动疼痛（POM）。结果：共180例成人患者(平均年龄34.5±13.5岁；49.4%为女性)。POM的VAS平均基线值为70.0±6.3 mm；在72 h时，乙托非甲酸酯组和安慰剂组的POM分别减少59.0 mm和33.3 mm。最小二乘平均治疗差异为25.0 mm（协方差分析的p值）结论：在急性扭伤、拉伤和挫伤（瘀伤）的情况下，乙托非甲酸酯膏药的治疗效果与现有最佳外用非甾体抗炎药制剂相当。注册号：2021-003778-30（草案号）。

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来源期刊

Pain and Therapy CLINICAL NEUROLOGY-

CiteScore

6.60

自引率

5.00%

发文量

110

审稿时长

6 weeks

期刊介绍： Pain and Therapy is an international, open access, peer-reviewed, rapid publication journal dedicated to the publication of high-quality clinical (all phases), observational, real-world, and health outcomes research around the discovery, development, and use of pain therapies and pain-related devices. Studies relating to diagnosis, pharmacoeconomics, public health, quality of life, and patient care, management, and education are also encouraged. Areas of focus include, but are not limited to, acute pain, cancer pain, chronic pain, headache and migraine, neuropathic pain, opioids, palliative care and pain ethics, peri- and post-operative pain as well as rheumatic pain and fibromyalgia. The journal is of interest to a broad audience of pharmaceutical and healthcare professionals and publishes original research, reviews, case reports, trial protocols, short communications such as commentaries and editorials, and letters. The journal is read by a global audience and receives submissions from around the world. Pain and Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an international and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. This inclusive approach allows the journal to assist in the dissemination of all scientifically and ethically sound research.