Multicenter, Prospective, Controlled Double-Blind Study Comparing Fib-19-01, A Phytotherapy Treatment, To A Dietary Supplement And To Conventional Care In Patients Suffering From Fibromyalgia.

What Was Tested

Researchers studied Copper (Supplement) in this controlled clinical trial publication.

Current therapeutic modalities for fibromyalgia (FM) do not provide satisfactory results and new approaches have to be explored.

Who Took Part

PubMed tags the participants as women only.

Double-blind controlled trial: women with active FM (Fibromyalgia Index Questionnaire FIQ > 40) were randomised to receive Fib-19-01 or a food supplement (FS) undistinguishable from Fib-19-01 or no supplementary treatment (NoST).

Secondary Criteria: variation over time FIQ ( repeated measurements), change in Pichot fatigue scale, Pittsburgh Sleep Quality Index (PSQI), SF-12 and Hospital Anxiety and Depression (HAD) scales.

How the Study Was Run

The design is described as randomized and double-blind.

Because people in this Copper (Supplement) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Blinding on both sides kept the participants and researchers unaware of who received Copper (Supplement).

All continued the conventional therapy throughout the 6 month follow-up.

Primary endpoint: change in FIQ between Day 0 and month 6 (M6).

What Was Measured

The subject headings attached to it are Dietary Supplements, Fibromyalgia, Phytotherapy and Surveys and Questionnaires.

What This Means in Plain Language

The paper is a randomized and double-blind study of Copper (Supplement).

The abstract goes on to report its results in about 8 sentences; this page does not restate them, so read the paper for the findings and their limits.

The publication is from 2019 (Alternative therapies in health and medicine), a journal based in United States.

More context: the Copper (Supplement) compound page, all human trials.