Subcutaneous octreotide in cluster headache: randomized placebo-controlled double-blind crossover study

What Was Tested

The paper reports a study of Octreotide, published as a randomized controlled trial.

Current practical evidence-based acute treatments of cluster headache are limited to subcutaneous and intranasal formulations of sumatriptan, and oxygen.

Patients were instructed to treat two attacks of at least moderate pain severity, with at least a 24-hour break, using subcutaneous octreotide microg or matching placebo.

Who Took Part

The abstract describes 57 patients taking part.

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

Patients with episodic and chronic cluster headache, as defined by the International Headache Society, were recruited to a double-blind placebo-controlled crossover study.

How the Study Was Run

The design is described as randomized, double-blind, placebo-controlled and crossover.

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

As a double-blind Octreotide study, the assignments were hidden from both participants and investigators until the end.

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

Each person switched between Octreotide and the comparison at some point, usually with a gap in between.

What Was Measured

The primary end point was the headache response defined as very severe, severe, or moderate pain becomes mild or nil, at 30 minutes.

The primary end point was examined using a multilevel analysis approach.

PubMed files the paper under topics including Antineoplastic Agents, Hormonal, Cluster Headache, Octreotide and Pain Measurement.

What This Means in Plain Language

The paper is a randomized, double-blind and placebo-controlled study of Octreotide in 57 patients.

The publication is from 2004 (Annals of neurology), a journal based in United States.

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