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Example 1.4 Small dose–response design – pain prevention following hand surgery

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Stevinson, Devaraj, Fountain‐Barber, et al. (2003) conducted a randomised double‐blind, placebo‐controlled trial to compare placebo with homoeopathic arnica 6C and arnica 30C to determine the degree of pain prevention in patients with carpel tunnel syndrome undergoing elective surgery for their condition. Pain was assessed postoperatively with the short‐form McGill Pain Questionnaire (SF‐MPQ) at four days. A total of 64 patients were randomised to the three groups resulting in median scores of 16.0 (range 0–69), 10.5 (0–76) and 15.0 (0–82) for the respective groups. From these results, the authors suggest that homoeopathic arnica has no advantage over placebo in reducing levels of postoperative pain.

Key features include the following:

 Design: Single‐centre, randomised double‐blind, placebo‐controlled, three‐group dose response,

 Endpoint: Pain using the SF‐MPQ,

 Size: 64 patients undergoing hand surgery for carpal tunnel syndrome,

 Analysis: Kruskal–Wallis test,

 Conclusion: Irrespective of dose homoeopathic arnica has no advantage over placebo.

Randomised Clinical Trials

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