Multicenter, Prospective, Controlled Double-Blind Study Comparing Fib-19-01, A Phytotherapy Treatment, To A Dietary Supplement And To Conventional ...

A new interesting article has been published in Altern Ther Health Med. 2019 Jul;25(4):46-53. Controlled Clinical Trial; Multicenter Study and titled:

Multicenter, Prospective, Controlled Double-Blind Study Comparing Fib-19-01, A Phytotherapy Treatment, To A Dietary Supplement And To Conventional …

Authors of this article are:

Barmaki M, Maindet-Dominici C, Nizard J, Baron D, Russ I, Fardellone P, Ginies P, Marc JF, Conrozier T, Bertin P.

A summary of the article is shown below:

Background: Current therapeutic modalities for fibromyalgia (FM) do not provide satisfactory results and new approaches have to be explored.Objectives: To assess efficacy and safety of adding a phytotherapy treatment (Fib-19-01) to the current therapeutic regimen in patients with FM.Methods: 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). All continued the conventional therapy throughout the 6 month follow-up. Primary endpoint: change in FIQ between Day 0 and month 6 (M6). 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.Results: 100 patients (Intent-To-Treat population) were analyzed. FIQ decreased significantly only in the Fib-19-01 group (P < .001) at both week 12 and 24. Improvement was higher for Fib-19-01 (-13.4 ± 18.9) than in the 2 other groups (-5.5 ± 15.6 and -5.6 ± 11.3) despite there was no statistical between-group difference at week 24 in FIQ score (P = .08 and P = .09 respectively). Analysis of variance in repeated measurements of FIQ showed a significant difference between Fib-19-01 and FS throughout the follow-up period (P = .03). Fib-19-01 was superior to both FS and NoST for Pichot scale decrease over time: -4.6 (range -6.9; -2.28), -0.29 (-2.7; 2.1) and -0.72 (-3.1; 1.66) (P = .013 and 0.023 respectively), mental and social SF12 [+8.1 (range 3.5; 12.6), -0.27(range -5.3; 4.8 ) and -0.02 (range -5.0; 4.9 ) P = .02 and 0.018)],HAD depression [-2.0 (range -3.3; -0.7), +0.5 (range -0.9; 1.9 ) and +0.71 (range -0.7; 2.1) P = .013 and 0.007]. No significant difference was found between FS and NoST groups for any outcome. All treatments were well and similarly tolerated.Conclusions: In patients with FM taking conventional therapy, Fib-19-01 has a therapeutic effect on fatigue, emotion and social life, and depression associated with the disease.
Check out the article’s website on Pubmed for more information:

[link-preview url=https://www.ncbi.nlm.nih.gov/pubmed/31202211 forceshot=true]

This article is a good source of information and a good way to become familiar with topics such as: Double-Blind Method;Female;Fibromyalgia;Humans;Phytotherapy;Prospective Studies;Surveys and Questionnaires;Treatment Outcome.

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