Clinical and metabolic response to probiotic supplementation in patients with rheumatoid arthritis: a randomized, double-blind, placebo-controlled trial
Authors: Mohsen Taghizadeh
Zatollah Asemi
Mohammad R Memarzadeh
Shima Farshbaf
Reyhaneh Akhavan
Maryam Tajabadi-Ebrahimi
Batol Zamani
Hamid R Golkar
Modjtaba Emadi-Baygi
Parvaneh Jafari
Journal: International Journal of Rheumatic Diseases (2016)
Discipline: CLINICAL MEDICINE
Keywords: metabolic profiles; probiotic; rheumatoid arthritis; supplementation.
Affiliations: Department of Internal Medicine, Autoimmune diseases research center, Kashan University of Medical Sciences, Kashan, I.R. Iran., Department of Genetics, School of Basic Sciences, Shahrekord University, Shahrekord, I.R. Iran., Research Institute of Biotechnology, School of Basic Sciences, Shahrekord University, Shahrekord, I.R. Iran., Science Department, Science Faculty, Islamic Azad University, Tehran Central Branch, Tehran, I.R. Iran., Department of Microbiology, Science Faculty, Islamic Azad University, Arak Branch, Arak, I.R. Iran., Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, I.R. Iran., Barij Medicinal Plants Research Center, Kashan, I.R. Iran., Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, I.R. Iran. .

Abstract:  Objective: This study was performed to determine the effects of probiotic supplementation on clinical and metabolic status of patients with rheumatoid arthritis (RA). Methods: Sixty patients with RA aged 25-70 years were assigned into two groups to receive either probiotic capsules (n = 30) or placebo (n = 30) in this randomized, double-blind, placebo-controlled trial. The patients in the probiotic group received a daily capsule that contained three viable and freeze-dried strains: Lactobacillus acidophilus (2 × 10(9) colony-forming units [CFU]/g), Lactobacillus casei (2 × 10(9) CFU/g) and Bifidobacterium bifidum (2 × 10(9) CFU/g) for 8 weeks. The placebo group took capsules filled with cellulose for the same time period. Fasting blood samples were taken at the beginning and the end of the study to quantify related markers. Results: After 8 weeks of intervention, compared with the placebo, probiotic supplementation resulted in improved Disease Activity Score of 28 joints (DAS-28) (-0.3 ± 0.4 vs. -0.1 ± 0.4, P = 0.01). In addition, a significant decrease in serum insulin levels (-2.0 ± 4.3 vs. +0.5 ± 4.9 μIU/mL, P = 0.03), homeostatic model assessment-B cell function (HOMA-B) (-7.5 ± 18.0 vs. +4.3 ± 25.0, P = 0.03) and serum high-sensitivity C-reactive protein (hs-CRP) concentrations (-6.66 ± 2.56 vs. +3.07 ± 5.53 mg/L, P &lt; 0.001) following the supplementation of probiotics compared with the placebo. Subjects who received probiotic capsules experienced borderline statistically significant improvement in total- (P = 0.09) and low-density lipoprotein-cholesterol levels (P = 0.07) compared with the placebo. Conclusion: Overall, the results of this study indicated that taking probiotic supplements for 8 weeks among patients with RA had beneficial effects on DAS-28, insulin levels, HOMA-B and hs-CRP levels. 

Retracted: No

PubPeer comments:
 There are many concerns about the integrity of 172 publications by this research group, including this one. Some of the concerns are published 1. Anaesthesia 2020;75:1683u201392, see Supplementary data. This paper is A81 2. Account Res 2020;28:149-61. 3. J Clin Epidemiol 2021;131:22-29. Journals and publishers were notified of these concerns in July 2019. 23 publications have an expression of concern. To our knowledge there has been no public response about any of the concerns. We think these publications are unreliable ,