Validity of conclusions on treatment efficacy: Difficulties in patient recruitment and a large number of drop-outs may lead to bias

Validity of conclusions on treatment efficacy: Difficulties in patient recruitment and a large... Hougaard etal. [1] in this issue of the Scandinavian Journal of Pain report on a randomised, double blind, placebo controlled cross-over study in the aura phase of migraine from which we can learn a great deal about trial design and generalisability of trial results.NXN-188 is an oral dual action nNOS-inhibitor and 5HT1B/1D receptor agonist. A total of 50 patients were randomised between two different sequences of NXN-188 and placebo. However, only 18 patients completed the trial and were available for the planned analysis. No statistically significant difference between NXN-188 and placebo was demonstrated. As stated by the authors, the low number of patients completing the study prevents a firm conclusion on lack of efficacy. Nevertheless, the results presented do not seem very promising.The authors have experienced large problems recruiting patients to the trial and have faced an unexpectedly high propor-tion of drop-outs before the second treatment period. Probably they would have been hesitant to initiate this trial had they known that the final statistical analysis would include only 18 completers. The figure illustrating patient disposition illustrates their challenge. Out of 615 patients contacted by telephone 563 did not meet entry criteria or did not wish to participate in the http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Scandinavian Journal of Pain de Gruyter

Validity of conclusions on treatment efficacy: Difficulties in patient recruitment and a large number of drop-outs may lead to bias

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Publisher
de Gruyter
Copyright
© 2012 Scandinavian Association for the Study of Pain
ISSN
1877-8860
eISSN
1877-8879
D.O.I.
10.1016/j.sjpain.2012.09.006
Publisher site
See Article on Publisher Site

Abstract

Hougaard etal. [1] in this issue of the Scandinavian Journal of Pain report on a randomised, double blind, placebo controlled cross-over study in the aura phase of migraine from which we can learn a great deal about trial design and generalisability of trial results.NXN-188 is an oral dual action nNOS-inhibitor and 5HT1B/1D receptor agonist. A total of 50 patients were randomised between two different sequences of NXN-188 and placebo. However, only 18 patients completed the trial and were available for the planned analysis. No statistically significant difference between NXN-188 and placebo was demonstrated. As stated by the authors, the low number of patients completing the study prevents a firm conclusion on lack of efficacy. Nevertheless, the results presented do not seem very promising.The authors have experienced large problems recruiting patients to the trial and have faced an unexpectedly high propor-tion of drop-outs before the second treatment period. Probably they would have been hesitant to initiate this trial had they known that the final statistical analysis would include only 18 completers. The figure illustrating patient disposition illustrates their challenge. Out of 615 patients contacted by telephone 563 did not meet entry criteria or did not wish to participate in the

Journal

Scandinavian Journal of Painde Gruyter

Published: Jan 1, 2013

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