The Probiotic VSL#3 Does Not Seem to Be Efficacious for the Treatment of Gastrointestinal Symptomatology of Patients with Fibromyalgia: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial
Metadatos
Mostrar el registro completo del ítemAutor
Pita Calandre, Elena; Hidalgo Tallon, Javier; Molina-Barea, Rocío; Rico-Villademoros, Fernando; Molina Hidalgo, Cristina; García-Leiva, Juan Miguel; Carrillo Izquierdo, Antonio; Slim, MahmoudEditorial
MDPI
Materia
Fibromyalgia Gastrointestinal symptoms Probiotics VSL#3® Efficacy Tolerability
Fecha
2021Referencia bibliográfica
Calandre, E.P.; Hidalgo-Tallon, J.; Molina-Barea, R.; Rico-Villademoros, F.; Molina-Hidalgo, C.; Garcia-Leiva, J.M.; Carrillo-Izquierdo, D.; Slim, M. The Probiotic VSL#3® Does Not Seem to Be Efficacious for the Treatment of Gastrointestinal Symptomatology of Patients with Fibromyalgia: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial. Pharmaceuticals 2021, 14, 1063. https://doi.org/10.3390/ ph14101063
Patrocinador
Actial Farmaceutica Srl (Rome, Italy); Ferring SAU (Madrid, Spain); Neither Actial Farmaceutica Srl nor Ferring SAU; Actial Farmaceutica SrlResumen
Background: Gastrointestinal symptomatology is frequent among patients with fibromyalgia, which increases disease burden and lacks specific treatment, either pharmacological or nonpharmacological. We aimed to evaluate the efficacy and tolerability of a multi-strain probiotic,
VSL#3®, for the treatment of fibromyalgia-associated gastrointestinal manifestations. Methods: This
randomized, placebo-controlled trial included 12 weeks of probiotic or placebo treatment followed
by 12 weeks of follow up. The primary outcome variable was the mean change from the baseline to
the endpoint in the composite severity score of the three main gastrointestinal symptoms reported
by patients with fibromyalgia (abdominal pain, abdominal bloating and meteorism). Secondary
outcome variables were the severity of additional gastrointestinal symptoms, fibromyalgia severity,
depression, sleep disturbance, health-related quality of life and patients’ overall impression of improvement. Results: No differences were found between VSL#3® (n = 54) and the placebo (n = 56) in
the primary outcome (estimated treatment difference: 1.1; 95% confidence interval [CI]: −2.1, 4.2; p
= 0.501), or in any of the secondary outcomes. However, responders to VSL#3 were more likely to
maintain any improvement during the follow-up period compared to responders in the placebo
arm. Overall, VSL#3 tolerability was good. Conclusion: Our data could not demonstrate any beneficial effects of VSL#3® either on the composite score of severity of abdominal pain, bloating and
meteorism or in any of the secondary outcome variables. More research is needed to elucidate specific factors that may predict a favourable response to treatment in patients with fibromyalgia.