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Editor's Correspondence |

Intention-to-Treat Analysis May Better Represent the Actual Efficacy

Steven C. Vlad, MD; Michael P. LaValley, PhD
Arch Intern Med. 2008;168(11):1228. doi:10.1001/archinte.168.11.1228-a.
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Rooks et al1 report that patients with fibromyalgia syndrome experienced a meaningful improvement in physical function and well-being after undergoing a program of aerobic and flexibility exercise, strength training, and a self-help course (the Arthritis Foundation's Fibromyalgia Self-Help Course). This is a finding with important treatment implications for this difficult-to-treat syndrome.

The authors' conclusions were based on the findings of an analysis of subjects who completed treatment, and they did a laudable job of fully and transparently describing withdrawals. They also indicated that they performed an intention-to-treat analysis; however, the results of this do not appear to have been reported. The intention-to-treat result may be especially important. First, high dropout rates can destroy the similarities between treatment groups that result from randomization and produce overestimates of the effects of an intervention.2 Because this trial had a high dropout rate (35%), the results may apply only to patients with sufficient motivation to complete the treatment regimens. The especially high dropout rate in the self-help–only group (46%) supports the idea that only those who perceived a benefit were likely to complete the trial. Second, the intention-to-treat analysis is more likely to reflect the actual efficacy of an intervention in clinical practice.2

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