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The Boyer et al. paper  diverges, without disclosure, from the registered protocol for this trial. Throughout the paper, the authors stated that quality of life (QOL) was the a priori established primary outcome measure and outlined a case for that decision. This appears as a departure from the www.clinicaltrials.gov register record (NCT00697398) that identifies analgesic efficiency as primary outcome and QOL as secondary outcome. Were the original hypotheses about pain and QOL retained, necessary corrections for multiple testing would likely obviate the significant findings presented in the paper.
The effect on QOL was small and imprecise; not reflected in concomitant change on a different QOL scale or in improvement across any outcomes that might underpin such improvement in QOL. The improvement observed at 11 weeks was not apparent after the initial 2 weeks of intensive stimulation. It is possible that the improvement in QOL was not related to the rTMS treatment. A substantially more conservative interpretation is warranted for a possibly negative trial of rTMS for fibromyalgia.
1.Boyer L, Dousset A, Roussel P, et al. rTMS in fibromyalgia A randomized trial evaluating QoL and its brain metabolic substrate. Neurology 2014; 82: 1231-1238.
For disclosures, please contact the editorial office at [email protected].
We thank Parkitny et al. for their comments. The Fibromyalgia Impact Questionnaire (FIQ) was the primary criterion for our evaluation  since it is the most common instrument used in clinical studies to monitor response to treatment over time, specifically in patients with fibromyalgia (FM). [2,3] Above all, FIQ is the most responsive measure to perceived clinical improvement and has been recommended as a primary endpoint in FM clinical trials .
FIQ evaluates the impact of chronic pain disease on daily life with a multidimensional approach including functioning, symptoms, and pain, anxiety, and depression.  The pain evaluation at this step encompassed both pain and its functional consequences. Secondary outcomes were mono-dimensional evaluations of quality of life (QoL), pain, anxiety and depression using generic scales, nonspecific of FM.
The issues raised by Parkitny et al. were included in the limitations section of the Discussion. Based on our neuroimaging findings, we also proposed changes for future rTMS protocols.We also mentioned that the trial was negative on pain (and also in anxiety and depression), but positive on QoL using multidimensional and mono-dimensional approaches. Randomized controlled trial (RCT) is the gold standard for clinical research, representing the best way to determine efficacy and effectiveness of therapeutic strategies for intervention and prevention programs.
We hope our results, despite limitations, will contribute to the development of more effective therapies.
1. Boyer L, Dousset A, Roussel P, et al. rTMS in fibromyalgia A randomized trial evaluating QoL and its brain metabolic substrate. Neurology 2014;82:1231-1238.
2. Bennett R. The Fibromyalgia Impact Questionnaire (FIQ): a review of its development, current version, operating characteristics and uses. Clin Exp Rheumatol 2005;23:S154-162.
3. Dunkl PR, Taylor AG, McConnell GG, Alfano AP, Conaway MR. Responsiveness of fibromyalgia clinical trial outcome measures. J Rheumatol2000; 27: 2683-2691.
4. Williams DA, Arnold LM. Measures of fibromyalgia: Fibromyalgia Impact Questionnaire (FIQ), Brief Pain Inventory (BPI), Multidimensional Fatigue Inventory (MFI-20), Medical Outcomes Study (MOS) Sleep Scale, and Multiple Ability Self-Report Questionnaire (MASQ). Arthritis Care Res (Hoboken) 2011;63:S86-97.
For disclsoures, please contact the editorial office at [email protected].
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