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.
OBJECTIVE
this study examined the effect of immune modulation therapy (IMT) on claudication distances.


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.
McGrath
C
C
Department of Vascular Surgery, Bristol Royal Infirmary, Marlborough Street, Bristol BS2 8HW, U.K.
Robb
R
R
Lucas
A J
AJ
Stewart
A H R
AH
Underwood
C L
CL
Horridge
J K
JK
Lamont
P M
PM
Smith
F C T
FC
Baird
R N
RN
D000368:Aged; D001157:Arterial Occlusive Diseases / Q000150:complications / Q000276:immunology* / Q000628:therapy*; D004311:Double-Blind Method; D023381:Endpoint Determination; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007167:Immunotherapy / Q000009:adverse effects; D007383:Intermittent Claudication / Q000209:etiology / Q000276:immunology* / Q000628:therapy*; D008297:Male; D010146:Pain / Q000209:etiology; D059408:Pain Management; D011788:Quality of Life / Q000523:psychology; D012720:Severity of Illness Index; D016896:Treatment Outcome; D006113:United Kingdom / Q000453:epidemiology