In a controlled multicenter study 70 patients with chronic
arterial occlusive disease stage IV according to Fontaine's classification were randomised to treatment with
prostaglandin E1 (
PGE1) or
pentoxifylline (PX), administered over 4 weeks. Parameters of effectiveness were the reduction of
analgesics, the relief of rest
pain according to an analogue scale, the improvement of the ulceration according to an
ulcer score and the healing of necrotic area. The results show that both forms of treatment produced a significant reduction in
analgesic consumption and rest
pain. Moreover in both groups a significant reduction of the
ulcer score and healing of the necrotic area were observed. Side effects occurred in six patients of the PGE1-group and in ten patients of the PX-group, which required premature discontinuation of treatment in four patients of the PX-group. The study also demonstrated that
PGE1 is more effective in the treatment of severe
arterial occlusive disease than PX. With respect to the
analgesic consumption, the reduction of
ulcer score and the healing of necrotic area a significant difference was found in favour of
PGE1. In accordance the six months follow-up examinations showed a marked deterioration in the PX-group opposed to the PGE1-group. The intravenous application of
PGE1 over a period of 4 weeks in patients with severe
arterial occlusive disease seems to be an effective therapeutical principle.