rTMS for fibromyalgia: protocol departures and interpretive issues
LukeParkitny, Postdoctoral Research Fellow
Published June 27, 2014
The Boyer et al. paper [1] 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 journal@neurology.org.
The Boyer et al. paper [1] 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 journal@neurology.org.