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

Mario Barmaki , Caroline Maindet-Dominici (1) , Julien Nizard (2) , Dominique Baron , Isabelle Russ , Patrice Fardellone (3, 4) , Patrick Ginies (5) , Jean-Francois Marc , Thierry Conrozier (6) , Philippe Bertin (7, 8)

1 CHU - Centre Hospitalier Universitaire [Grenoble]
2 CHU Nantes - Centre hospitalier universitaire de Nantes
3 Département de Rhumatologie
4 MP3CV - Mécanismes physiopathologiques et conséquences des calcifications vasculaires - UR UPJV 7517
5 CHRU Montpellier - Centre Hospitalier Régional Universitaire [Montpellier]
6 Service de rhumatologie [hôpital Nord-Franche-Comté]
7 Orange Labs [Cesson-Sévigné]
8 Network - Domaine Network (IRT b<>com)

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.

Domaines: Sciences du Vivant [q-bio]

Mario Barmaki, Caroline Maindet-Dominici, Julien Nizard, Dominique Baron, Isabelle Russ, et al.. 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. Alternative Therapies In Health And Medicine, 2019, 25 (4), pp.46-53. ⟨hal-03563950⟩