Effect of prebiotic and probiotic supplementation on reduced pain in patients with fibromyalgia syndrome: a double-blind, placebo-controlled randomized clinical trial

ABSTRACT

It has recently been observed that microorganisms in the gut can regulate brain processes through the gut microbiota-brain axis, affecting pain, depression, and sleep quality. Consequently, prebiotics and probiotics may potentially improve physical, psychological, and cognitive states in those with fibromyalgia syndrome (FMS) who have an altered microbiota balance. In a randomised, double-blind, placebo-controlled clinical trial to determine the effects of probiotic and prebiotic treatments on pain, sleep, quality of life, and psychological distress (depression and anxiety) in FMS, 53 female participants with FMS were randomised to receive either: 1) 4 × 10¹⁰ CFUs per day for the 18 patients in the probiotics group; 2) 10 g dose inulin per day for the 17 patients in the prebiotic group; or 3) a placebo for 8 weeks for the 18 patients in this group. The mean ages of the groups were similar and there was no significant difference between the groups. The impact of FMS on pain, sleep quality, quality of life, anxiety, and depressive symptoms were measured at baseline, 4 weeks, and 8 weeks post-intervention. Probiotic supplementation significantly decreased the Beck Depression Index (BDI), Beck Anxiety Index (BAI), and Pittsburgh Sleep Quality Index (PSQI) scores compared to baseline, while prebiotic supplementation only significantly decreased PSQI scores. Moreover, participants who received probiotic treatment presented a significantly reduced Visual Analogue Scale (VAS) score compared with those who received placebo treatment, after the interventions. Probiotic supplementation significantly improved sleep quality, depression, anxiety, and pain scores compared to those at baseline in FMS patients, while prebiotic supplementation significantly improved pain scores and sleep quality. The potential benefits of using probiotics for treatment management in FMS patients is supported by the results of the current study and might provide an important strategy to combat FMS-associated diseases.

KEYWORDS:

• Probiotics
• prebiotics
• fibromyalgia syndrome
• pain
• depression

Abbreviations

(5-HT), 5-hydroxytryptamine; BAI, Beck Anxiety Index; BDI, Beck Depression Index; BMI, Body Mass Index; CFS, Chronic Fatigue Syndrome; CRF, Corticotrophin-Releasing Factor; FIQ, Fibromyalgia Impact Questionnaire; FMS, Fibromyalgia Syndrome; GABA, Gamma-Amino Butyric Acid; GI, Gastrointestinal; HPA, Hypothalamic-Pituitary-Adrenal; IBS, Inflammatory Bowel Syndrome; ANOVA, One-Way Analysis Of Variance; PSQI, Pittsburgh Sleep Quality Index; SF-36, Quality of Life; SMD, Standard Mean Deviation; SES, Socioeconomic Status; VAS, Visual Analogue Scale.

Acknowledgments

The authors thank iHealth Nutritional Products Ltd. for providing the Pro-Probiotics capsules. Moreover, the authors are grateful women with fibromyalgia women for participating in this study.

Disclosure statement

No potential conflict of interest was reported by the authors.

Clinical trial registration

www.ClinicalTrials.gov NCT04607278

Additional information

Funding

The funders had no role in the design, analysis or writing of this article.