Recombinant human relaxin in the treatment of scleroderma. A randomized, double-blind, placebo-controlled trial

What Was Tested

The paper reports a study of Relaxin (Serelaxin), published as a randomized controlled trial.

Relaxin is a pregnancy-related hormone that has tissue remodeling and antifibrotic effects.

Systemic sclerosis (scleroderma) is characterized by fibrosis of the skin, vasculature, and internal organs.

Who Took Part

According to the abstract, 68 patients were involved.

PubMed indexes the participants as teenagers, adults, middle-aged adults and older adults, both men and women.

68 patients who had had stable, diffuse scleroderma (moderate to severe) for less than 5 years.

Secondary measurements were pulmonary function, the Health Assessment Questionnaire, and other measures of scleroderma that reflected fibrosis.

How the Study Was Run

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

The patients were allocated by chance, so the Relaxin (Serelaxin) group and the comparison group should start out alike.

As a double-blind Relaxin (Serelaxin) study, the assignments were hidden from both participants and investigators until the end.

A placebo (an inactive look-alike) gave the Relaxin (Serelaxin) group a baseline to be compared against.

More than one site took part, so the patients came from several places.

Multicenter, parallel-group, randomized, double-blind, placebo-controlled trial.

What Was Measured

The subject headings attached to it are Analysis of Variance, Anemia, Drug Eruptions, Exanthema, Menorrhagia, Recombinant Proteins and Relaxin.

What This Means in Plain Language

The paper is a randomized, double-blind and placebo-controlled study of Relaxin (Serelaxin) in 68 patients.

Results are reported in around 5 sentences of the abstract; we leave them to the paper itself rather than summarise them.

The publication is from 2000 (Annals of internal medicine), a journal based in United States.

More context: the Relaxin (Serelaxin) compound page, all human trials.