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 degrees C, 10 ml 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%) (Placebo 12/33, 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. Copyright 2002 Elsevier Science Ltd.
RCT Entities:
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 degrees C, 10 ml 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%) (Placebo 12/33, 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. Copyright 2002 Elsevier Science Ltd.
Authors: Mei Luo Zhang; Jie Mei; Lori Anne Archer; Masakazu Obayashi; Ni Diao; Bruno Stuyvers; Henk E D J ter Keurs Journal: Can J Cardiol Date: 2009-07 Impact factor: 5.223
Authors: Guillermo Torre-Amione; Robert C Bourge; Wilson S Colucci; Barry Greenberg; Craig Pratt; Jean-Lucien Rouleau; Francois Sestier; Lemuel A Moyé; John A Geddes; Agnes J Nemet; James B Young Journal: Can J Cardiol Date: 2007-04 Impact factor: 5.223