Fatigue was not improved among patients with inflammatory bowel disease (IBD) after daily thiamine treatment. These findings, from a randomized, open-label, controlled long-term extension (LTE) trial, were published in the Scandinavian Journal of Gastroenterology.
This analysis was of LTE data from participants of the TARIF trial, which was a randomized, double-blind, placebo-controlled, cross-over study conducted from 2019 to 2020. Patients (N=40) with IBD who were in remission and had symptoms of fatigue were recruited from Aarhus University Hospital in Denmark.
In the original study, patients were randomly assigned to receive 600 to 1800 mg/day thiamine or placebo for 4 weeks. After a 4-week washout period, the assignments were reversed. All participants entered the LTE, during which they were randomly assigned to receive 300 mg/day thiamine or no thiamine for 12 weeks and allowed to self-treat with thiamine for 6 months thereafter. At 52 weeks, participants were evaluated for fatigue.
The cohorts who received thiamine (n=20) or not (n=20) during the LTE were aged mean 36 (SD, 14) and 38 (SD, 11) years, 5 and 0 were men, 9 and 11 had ulcerative colitis, 10 and 11 were using anti-tumor necrosis factor treatment, IBD-Fatigue (F) severity scores were 9.7 (SD, 3.8) and 10.5 (SD, 3.8) points, and IBD-F impact scores were 31.3 (SD, 24.6) and 39.3 (SD, 22.9) points, respectively.
Between weeks 12 and 24, the mean change in IBD-F severity was 1.4 (SD, 3.5) points among the thiamine and 1.9 (SD, 4.4) points among the no thiamine cohorts (P =.75). Similarly, there were no significant group differences for IBD-F impact (P =.24), European Quality of Life Five Dimension visual analogue scale (P =.50), or short health scale (P =.54).
Stratified by which treatment the participants received first during the TARIF trial, no significant differences were observed for IBD-F severity scores between weeks 12 and 24 (both P ³.42). Stratified by fatigue score at week 12, neither those with lower fatigue (P =.94) nor higher fatigue (P =.57) exhibited significant changes in their symptoms.
A single participant reported the adverse effect of oral blisters and discontinued thiamine use.
This study was limited by its small sample size and may have been underpowered.
The study authors concluded that there was little evidence that 300 mg daily thiamine reduced symptoms of fatigue among patients with IBD.
Bager P, Hvas CL, Rud CL, Dahlerup JF. Long-term maintenance treatment with 300 mg thiamine for fatigue in patients with inflammatory bowel disease: results from an open-label extension of the TARIF study. Scand J Gastroenterol. 2021;1-7. doi:10.1080/00365521.2021.1983640