A randomized, double-blinded, placebo-controlled pilot study of probiotics in active rheumatoid arthritis.

Abstract:

BACKGROUND:To examine the effect of probiotics as adjunctive therapy for the treatment of rheumatoid arthritis (RA). A sample size of 30 subjects was calculated to determine a moderate effect. MATERIAL/METHODS:A three month double-blind, placebo-controlled study was performed using probiotic Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14 capsules administered orally. Inclusion criteria required at least 4 swollen and 4 tender joints and stable medications with no steroids for at least 1 month prior to and during the study. Twenty-nine patients with RA were randomized to treatment. ACR20 responses, serum cytokine levels and safety parameters were assessed. RESULTS:Fifteen patients were randomized to the probiotic group, and 14 to placebo. Three subjects in the probiotic (20%) and one in the placebo group (7%) achieved an ACR20 response (p= 0.33). There was no statistically significant difference between individual components of the ACR20 criteria. Changes in cytokines favored placebo over probiotic. There was a significant improvement in the Health Assessment Questionnaire (HAQ) score in the probiotic group from visit 1 to visit 3 (p=0.02) but no between-group differences. CONCLUSIONS:Due to inclusion criteria, patients selected for the study had stable RA with chronic synovitis, and thus it may have been difficult for an adjunctive therapy to demonstrate improvement within 3 months. Although probiotics did not clinically improve RA as measured by the ACR20, it is interesting that there was functional improvement seen within the probiotic group compared to placebo.

journal_name

Med Sci Monit

authors

Pineda Mde L,Thompson SF,Summers K,de Leon F,Pope J,Reid G

doi

10.12659/msm.881808

subject

Has Abstract

pub_date

2011-06-01 00:00:00

pages

CR347-54

issue

6

eissn

1234-1010

issn

1643-3750

pii

881808

journal_volume

17

pub_type

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