By Carrie Decker, ND
Founder and Medical Director
Synopsis: This 8-week, randomized, double-blind, placebo-controlled study demonstrates that proper dosage of the probiotic strain Lactobacillus casei 01 was provided to women with rheumatoid arthritis at a dosage of 108 colony forming unit significantly lowers disease activity score and levels of proinflammatory cytokines tumor necrosis factor-α, interleukin-6, and interleukin-12. Additionally, the characteristics of state and trait anxiety were shown to be not significantly altered by therapies.
Source: Vaghef-Mehrabany E, et al. Probiotic supplementation improves inflammatory status in patients with rheumatoid arthritis. Nutrition 2014;30:430-435.
There is certainly precedence for probiotics’ efficacy in altering immune system function—with aims to reduce inflammation being among the most common. Different strains of probiotics are used to achieve different effects: some are used to stimulate the immune system; others are used to suppress hyperactive immune responses. Prior studies have investigated the effects of many lactobacillus strains in both animals and humans—particularly focusing on the strains’ interaction with inflammatory markers and immune responses of patients with rheumatoid arthritis.
Sixty women afflicted with inactive to moderate RA in this double blind-placebo controlled study were randomly assigned to either a regimen of the lactobacillus strain or a regimen of maltodextrin, which acted as a placebo. The instructions and delivery mechanisms of the treatment were otherwise identical. The daily dose of L. casei was 108 CFU.
Prerequisites for study participation included subjects having been diagnosed with RA for at least a year and on active treatment for at least 3 months leading up to the study. Individuals were not allowed to take non-steroidal anti-inflammatories, and were excluded if they were pregnant, on hormonal treatments, had previously suffered from other inflammatory or gastrointestinal disorder, or had recently taken other anti- and pro-biotics.
The study focused on the assessment of patients’ cytokine and tumor necrosis factor-α (TNF-α) levels, while also closely monitoring the progression of each patient’s disease activity score. Disease scores were assessed by a separate rheumatologist, while state and trait anxiety levels were calculated with the Spielberger State-Trait Inventory Form Y. Each parameter was determined twice, first at the outset of the trial and then after the 8-week period of intervention and trial.
The subjects report no adverse effects during the trial. Of the 30 initial subjects in each group, 22 and 24 of the intervention and placebo groups respectively completed the study. Those that did not complete the study chose so for a variety of reasons, including vacation, medical changes or general unwillingness.
Disease activity state in the probiotic group was significantly lower when compared with the initial testing—which stood in stark contrast to the placebo group, which registered no significant change. The parameters considered during the DAS calculation fell across the board; the actual values, however, were unreported in the study. Serum levels of the aforementioned inflammatory cytokines also drastically decreased in the test group, but the levels actually increased in the placebo group; confidence intervals for these changes were also not calculated. Again, neither group displayed observable change in state or trait anxiety; and there were no adverse effects reported.