Pitfalls in placebo-controlled trials in palliative care: dexamethasone for the palliation of malignant bowel obstruction

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 st...

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Bibliographic Details
Published in:Palliative medicine 1998-11, Vol.12 (6), p.437-442
Main Authors: Hardy, Janet, Ling, Julie, Mansi, Janine, Isaacs, Richard, Bliss, Judith, A'Hern, Roger, Blake, Peter, Gore, Martin, Shepherd, John, Hanks, Geoff
Format: Article
Language:English
Subjects:
Abdomen
Adult
Aged
Aged, 80 and over
Anesthesia. Intensive care medicine. Transfusions. Cell therapy and gene therapy
Anti-Inflammatory Agents - therapeutic use
Biological and medical sciences
Bowel cancer
Cancer
Clinical death. Palliative care. Organ gift and preservation
Cross-Over Studies
Dexamethasone - therapeutic use
Double-Blind Method
Female
Gastroenterology. Liver. Pancreas. Abdomen
Humans
Intestinal obstruction
Intestinal Obstruction - drug therapy
Medical sciences
Middle Aged
Other diseases. Semiology
Palliative Care
Patients
Placebos
Randomized controlled trials
Steroids
Stomach. Duodenum. Small intestine. Colon. Rectum. Anus
Treatment
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Summary: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.
ISSN:0269-2163
1477-030X
DOI:10.1191/026921698666334766