The safety profile of GH replacement therapy in adults.

What Was Tested

The paper reports a study of Human Growth Hormone, published as a randomized controlled trial.

The GH deficiency in adults may have arisen i either childhood or during adult life and these two groups differ with regard to history of disease.

The aid of the present report was to study differences in safety profile between these two groups during long-term replacement therapy with recombinant human GH (hGH).

Possible factors which placed a patient at risk of experiencing an adverse event were also examined.

Who Took Part

The study group was 98 patients.

By PubMed's age tags, the people studied were adults, both men and women.

GH-deficient adult patients were randomized into two study protocols, differing only in age of onset of the GH deficiency syndrome.

There were 98 patients with adult-onset and 67 patients with childhood-onset GH deficiency.

How the Study Was Run

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

The patients were allocated by chance, so the Human Growth Hormone group and the comparison group should start out alike.

Neither the patients nor the staff measuring them knew who was on Human Growth Hormone, so expectations could not easily colour the readings.

Being open-label, the Human Growth Hormone study did not mask who received what.

A placebo (an inactive look-alike) gave the Human Growth Hormone group a baseline to be compared against.

Each study consisted of a 6-month double-blind placebo-controlled phase followed by an open-label hGH treatment phase.

What Was Measured

PubMed files the paper under topics including Age of Onset, Arthralgia, Blood Glucose, Growth Hormone, Human Growth Hormone, Muscular Diseases and Pain.

What This Means in Plain Language

The paper is a randomized, double-blind and open-label study of Human Growth Hormone in 98 patients.

Results are reported in around 9 sentences of the abstract; we leave them to the paper itself rather than summarise them.

The publication is from 1997 (Clinical endocrinology), a journal based in England.

More context: the related Exogenous HGH, sermorelin & older GHRPs (why they're passed over) library page, all human trials.