BMJ 1998;316:1183-1184 ( 18 April )

Editorials

Monitoring randomised controlled trials

Parkinson's disease trial illustrates the dangers of stopping early

Papersp 1191 

The first 150 words of the full text of this article appear below.

The trial of the Parkinson's Disease Research Group reported by Ben-Shlomo et al in this issue (p 1191), which updates the results of a previously curtailed randomised controlled trial,1 raises several methodological issues. The current results relate to an initial three arm trial in which 782 patients with early stage Parkinson's disease were randomised to treatment with either levodopa alone (arm 1), levodopa and selegiline in combination (arm 2), or bromocriptine (arm 3). The first trial report, based on follow up to December 1991, showed no significant differences at the 5% level between arms 1 and 2 in disability levels, but both arms showed significant improvements over baseline.2 At this stage there were too few deaths to assess differences in mortality. The second report was based on follow up to December 1993, resulting in an average 5.6 years follow up.3 As with the earlier report, there continued to be no significant differences between arms 1 and 2 in terms . . . [Full text of this article]
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Relevant Article

Investigation by Parkinson's Disease Research Group of United Kingdom into excess mortality seen with combined levodopa and selegiline treatment in patients with early, mild Parkinson's disease: further results of randomised trial and confidential inquiry
Y Ben-Shlomo, A Churchyard, J Head, B Hurwitz, P Overstall, J Ockelford, and A J Lees
BMJ 1998 316: 1191-1196. [Abstract] [Full Text] [PDF]

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