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Randomized double-blind placebo-controlled trial to evaluate the effect of the ACTH4-9 analogue ORG 2766 in IDDM patients with neuropathy.

Plain-language guide to PMID 8063043 (1994): double-blind randomized controlled trial of Anticonvulsants in 2766 patients.

Key Facts

PMID
8063043
Journal
Diabetologia
Year
1994
Study type
Randomized Controlled Trial
Authors
Bravenboer B et al. (7 authors)
DOI
10.1007/BF00408479

What This Study Did, in Plain Language

What Was Tested

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

In this study the researchers report a randomized double-blind, placebo-controlled trial to evaluate the effect of ORG 2766 in IDDM patients with peripheral neuropathy.

Why It Was Studied

Sixty-two patients were selected based on the following criteria: abnormal vibration perception threshold above the 95th-percentile adjusted for age and/or abnormal warm temperature threshold, both measured in the right hand.

The total study period was 1 year.

Who Took Part

According to the abstract, 2766 patients were involved.

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

How the Study Was Run

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

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

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

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

What Was Measured

Sixty-two patients were selected based on the following criteria: abnormal vibration perception threshold above the 95th-percentile adjusted for age and/or abnormal warm temperature threshold, both measured in the right hand.

The subject headings attached to it are Adrenocorticotropic Hormone, Anticonvulsants, Diabetes Mellitus, Type 1, Diabetic Neuropathies, Peptide Fragments, Perceptual Disorders and Psychomotor Performance.

What This Means in Plain Language

The paper is a randomized, double-blind and placebo-controlled study of Anticonvulsants in 2766 patients.

With several hundred people or more, it is a fairly large study for this kind of research.

The publication is from 1994 (Diabetologia), a journal based in Germany.

More context: all human trials.

Related Pages

Source: PubMed record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.