Does drug treatment have a placebo effect on programmed training in intermittent claudication? A randomized clinical trial

Abstract

We have previously observed that programmed physical training improved walking tolerance in intermittent claudication, even after temporary discontinuation of the training programme, in the presence both of active drug and placebo treatment. We therefore established the effect of physical training alone and in combination with placebo on intermittent claudication. Of the 23 patients recruited forthe study aged 47-76 years, 17 completed the six-month supervised training programme. In this randomized parallel group study the treatment with placebo did not appear to affect the overall improvement in walking tolerance achieved during the programmed training; the mean final pain-free walking distance was 4.2 times the initial level. Furthermore, when retrospectively comparing those who increased their physical activity including submaximal walking and dynamic leg exercises more than one hour daily to those whose increase was one hour or less a clear trend towards further improvement in walking tolerance could be observed. Thus our present results corroborate the beneficial effect of programmed training and emphasize the significance of patient compliance, although we are unable to disclose any placebo effect attributable to drugs in the conservative treatment of intermittent claudication - this is at least partly due to the small size of the patient sample.