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To determine the effect of dexamethasone when treating malignant bowel obstruction, 35 patients were randomized to receive intravenous dexamethasone or a placebo, crossing over to the alternate treatment arm if there had been no resolution of obstruction by day 5. This was done in two consecutive studies. Patients were stratified according to whether or not they had received specific anticancer therapy within 28 days of study. In trial 1, 15 out of 22 patients 'responded' (resolution of obstruction by day 5; 10 on dexamethasone, five on placebo). Eleven out of 15 patients were 'on treatment'. In trial 2, six out of 13 responded (three on dexamethasone, three on placebo); three out of six were 'on treatment'. When both studies are combined, 60% (21/35) patients responded (13 on dexamethasone, eight on placebo). Poor patient accrual terminated both studies. Numbers are too small to allow a combination of studies or formal statistical analysis. We are unable to make any conclusion as to the effectiveness of dexamethasone in the palliation of malignant bowel disease.

The relationship between consumption of dietary fiber (DF) from white bread, wholemeal bread, or bran and the development of diverticular disease of the colon has been investigated in a lifespan study using 1800 Wistar rats in nine diet groups. Use of the rat as a model for the human condition was validated by demonstration of significant relationships between fiber intake and fecal output and transit time, and the observation of true acquired diverticula, both single and multiple. Significant inverse relationships (mostly with p less than 0.001) were observed between the incidence of diverticula (and prediverticula) and the concentrations of fiber in the diets, measured by the neutral detergent fiber and Southgate methods. The study offers strong support to the Painter-Burkitt view of human diverticular disease as being due to fiber deficiency, if the extrapolation from rat to man is valid. On the same assumption, the amount of additional fiber required to be consumed in order to achieve a substantial reduction in incidence of the disease is very large. Effects of fiber on body weight, food intake, mineral levels, blood composition and properties, mortality, organ weights, and incidence of tumors and lesions are reported. Significantly fewer mammary tumors were found in rats fed the very high fiber stock diet than in those fed the purified diets.

Nausea and emesis are common side effects of opioid drugs administered for pain relief in cancer patients. The aim of this study was to compare the anti-emetic efficacy and safety of ondansetron, placebo and metoclopramide in the treatment of opioid-induced nausea and emesis (OIE) in cancer patients. This was a multinational, multicentre, double-blind, parallel group study in which cancer patients who were receiving a full opioid agonist for cancer pain were randomised to receive one of oral ondansetron 24 mg once daily, metoclopramide 10 mg three times daily, or placebo. Study medication was started only if the patient experienced nausea and/or emesis following opioid administration. Efficacy and safety assessments were made over a study period of 24 h from the time of the first dose of anti-emetics/placebo. The study was terminated prematurely because of the difficulties in recruiting patients satisfying the stringent entry criteria. Ninety-two patients were included in the intent-to-treat population: 30 patients received placebo, 29 patients ondansetron and 33 patients metoclopramide. There was no statistically significant difference between the groups in the proportion achieving complete control of emesis (33% of patients on placebo, 48% on ondansetron and 52% on metoclopramide) or complete control of nausea (23% of patients on placebo, 17% on ondansetron and 36% on metoclopramide). Rescue anti-emetics were required in 8 of 33 patients on metoclopramide, 4 of 29 on ondansetron, and 3 of 30 on placebo. The incidence of adverse events was very low and similar in all treatment groups. Neither ondansetron 24 mg once daily nor metoclopromide 10 mg t.d.s. given orally was significantly more effective than placebo in the control of OIE in cancer patients.

These results suggest that methotrimeprazine has antiemetic activity.

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Summary This paper describes a randomised clinical trial in patients with advanced breast cancer, comparing the regimen 3M, mitomycin C 7-8 mg m 2 (day 1), mitozantrone 7 -8 mg m-2 (day I and 21), methotrexate 35 mg m-2 (day 1 and 21) given on a 42 day cycle with a standard anthracycline containing regimen, VAC, vincristine 1.4 mg m-2 (day 1), anthracycline (adriamycin or epirubicin) 30 mg m-2 (day 1), cyclophosphamide 400 mg m-2 (day 1) given on a 21 day cycle. Of a total of 217 patients, 107 were randomised to 3M and 110 to VAC and a mean of 5.5 courses was given per patient. The Table 1. A total of 217 patients were entered into the study and after exclusions because of protocol violation (prior chemotherapy) there remained 106 patients who received 3M and 105 patients who received VAC. The median age was 55 (range 36-77) years for 3M and 58 (range 30-76) years for VAC. The median disease-free interval (primary diagnosis to first relapse) was similar for 3M (16 months) and VAC (15 months) and the median time from relapse to start of chemotherapy was also similar (8 months) for both regimens. Most patients (66% for both 3M and VAC) had received prior endocrine therapy consistent with our policy of using endocrine treatment for first relapse.

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