Probiotics for chronic low back pain with type 1 Modic changes: a randomized double-blind, placebo-controlled trial with 1-year follow-up using Lactobacillus Rhamnosis GG

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Purpose To investigate whether treatment by lactic acid bacteria for 100 days is associated with change of disability and pain in chronic low back pain (CLBP) patients with type 1 or mixed Modic changes (MC) during one year follow-up.
Methods Eighty-nine patients with CLBP and type 1 MC or mixed MC were randomized to receive either one capsule Lactobacillus Rhamnosis GG (6 billion colony-forming unit per capsule) twice daily or placebo capsules for 100 days.
Results Missing values at one year were 4% and 3% in the disability and pain variables, respectively. The predefined outcomes disability and back+leg pain only changed little during follow-up with no statistically significant differences between groups. At one year, back pain had on average decreased by 1.1 more on a 0-10 scale (95% confidence interval 0.20- 1.97) in the group treated by lactic acid bacteria than in the control group. There were no differences regarding other predefined outcomes, i.e. global effect or percentage with minimal disability at one year. Nine percent of the patients reported gastrointestinal side-effects without difference between groups.
Conclusions No differences were found regarding the predefined outcomes. Overall, there was little improvement during the one-year observation period. A small, though hardly clinically relevant, effect on back pain was seen after treatment by Lactobacillus Rhamnosis GG, and the treatment was without side-effects in comparison with the control group.
OriginalsprogEngelsk
TidsskriftEuropean Spine Journal
Vol/bind28
Nummer11
Sider (fra-til)2478-2486
Antal sider9
ISSN0940-6719
DOI
StatusUdgivet - nov. 2019

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