A randomised, double blind, placebo-controlled study to determine the efficacy of immune modulation therapy in the treatment of patients suffering from peripheral arterial occlusive disease with intermittent claudication

C. McGrath, R. Robb, A. J. Lucas, A. H. R. Stewart, C. L. Underwood, J. K. Horridge, P. M. Lamont, F. C. T. Smith, R. N. Baird, J. J. F. Belch

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    Abstract

    Objectives: this study examined the effect of immune modulation therapy (IMT) on claudication distances

    Materials and methods: a double-blind placebo controlled trial was performed on patients with disabling intermittent claudication with randomisation stratified for short and long distance IC. For IMT, following exposure to UV light, oxidisation and 42.5°C, 10ml of citrated autologous blood was administered by intra-muscular injection. One course consisted of 6 injections in 3-weeks followed by 3-weeks rest. Patients received 2, 3 or 4 courses depending on response. The primary end-point was the number of responders (>50% increase in initial claudication distance (ICD)) in each group. Secondary end-points included percentage changes in ICD and change in quality of life.

    Results: at week 24, there were more responders in the IMT group (20/31, 65%) compared to placebo (16/39, 41%) (p=0.06). In the subgroup of short distance claudicants this difference reached significance (IMT 17/26, 65%) (Placebo12/33, 36%) (p=0.04). The median increase in ICD was significantly greater in the IMT group (81%) compared to placebo (44%, p=0.04). These results were supported by quality of life measurements.

    Conclusions: IMT is a safe and apparently effective treatment for patients with short distance claudication.
    Original languageEnglish
    Pages (from-to)381-387
    Number of pages7
    JournalEuropean Journal of Vascular and Endovascular Surgery
    Volume23
    Issue number5
    DOIs
    Publication statusPublished - 2002

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