A multicentre double-blind, placebo-controlled clinical trial, involving 123 patients at 10 centres, was carried out to assess the efficacy of a preparation of lactic acid-producing Enterococcus SF 68 in the prevention of antibiotic-associated diarrhoea and in the treatment of acute diarrhoea. In the prevention study, 45 patients being treated with antibiotics were given, concurrently, one capsule twice daily of either Enterococcus SF68 or placebo. Acute diarrhoea was present in 78 patients who were given the same treatment but three times daily. All treatments were continued for 7 days. Enterococcus SF 68 was shown to be effective in reducing the incidence of antibiotic-associated diarrhoea in comparison with placebo (8.7% compared with 27.2%, respectively). Patients with acute enteritis showed a significantly faster resolution of bowel abnormalities during treatment with Enterococcus SF68 compared with placebo.

The results of clinical trials investigating various therapies in acute ischemic stroke have been inconsistent. The effect of glycerol therapy and a combination therapy of glycerol and dextran was evaluated in a double-blind, placebo-controlled study. Repeated neurologic examinations (Day 0, Weeks 1, 6, 12, and 24) according to a modified Mathew score were performed on 62 patients. Statistical analysis showed no superiority of either treatment compared with placebo in acute ischemic stroke. A retrospective estimation of the Type II error of the study yielded approximately p = 0.25. A major side effect was hemolysis in 98% of patients treated with glycerol. (Stroke 1987; 18:373-379)

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