Clinical effects of octreotide compared to placebo in patients with gastrointestinal neuroendocrine tumours. Report on a double-blind, randomized trial

What Was Tested

This randomized controlled trial looks at Octreotide.

To compare the effect of octreotide with f placebo on symptoms, tumour marker and quality of life in patients with gastrointestinal neuroendocrine tumours and liver metastases.

Who Took Part

The age groups tagged for this paper are adults, middle-aged adults and older adults, both men and women.

Quality of life was registered with the Psychosocial Adjustment to Illness Scale (PAIS) and 5-HIAA measured by high-performance chromatography with electrochemical detection. 5-HIAA values exceeding 45 mumol 24 h-1 were considered to be elevated.

Twelve patients were approached; eleven patients were included, with a mean age of 56.5 (range 30-72) years.

How the Study Was Run

The researchers set it up as a randomized, double-blind, placebo-controlled and crossover study.

Random assignment meant chance, not the researchers, decided who got Octreotide and who got the comparison, which limits bias.

Neither the participants nor the staff measuring them knew who was on Octreotide, so expectations could not easily colour the readings.

Some participants received a placebo instead of Octreotide, giving a reference point.

In the crossover set-up each of the participants took both Octreotide and the comparison in turn, acting as their own control.

A blinded, placebo-controlled, cross-over study was performed.

Quality of life and 24-h urinary 5-hydroxyindoleacetic acid (5-HIAA) excretion were measured before the start, and at 4 and 8 weeks.

The study was performed in a tertiary referral centre.

The primary tumour originated from the small intestine in nine and from the pancreas in two patients.

The main symptoms were diarrhoea, flushing and nausea.

What Was Measured

Topics PubMed links to this paper include Adaptation, Psychological, Biomarkers, Tumor, Gastrointestinal Neoplasms, Hydroxyindoleacetic Acid, Liver Neoplasms, Neuroendocrine Tumors and Octreotide.

What This Means in Plain Language

The paper is a randomized, double-blind and placebo-controlled study of Octreotide.

The abstract goes on to report its results in about 4 sentences; this page does not restate them, so read the paper for the findings and their limits.

The publication is from 1995 (Journal of internal medicine), a journal based in England.

More context: the Octreotide compound page, all human trials.