High-dose oral thiamine versus placebo for chronic fatigue in patients with primary biliary cholangitis: A crossover randomized clinical trial.
PLoS One
; 19(3): e0301354, 2024.
Article
in En
| MEDLINE
| ID: mdl-38551983
ABSTRACT
BACKGROUND & AIMS:
Fatigue has high negative impact on many patients with primary biliary cholangitis (PBC) and treatment options are limited. Recently we showed favorable effects of four weeks of high-dose thiamine treatment on fatigue in patients with inflammatory bowel disease. We aimed to investigate the effect and safety of high-dose (600-1800 mg daily) oral thiamine treatment on chronic fatigue in patients with PBC.METHODS:
Randomized, double-blinded, placebo-controlled crossover trial including patients with severe PBC-related fatigue. Participants were allocated 11 to either group 1) 4 weeks of high-dose thiamine, 4 weeks of washout, and 4 weeks of placebo; or group 2) 4 weeks of placebo, washout, and high-dose thiamine, respectively. Fatigue severity was quantified using the fatigue subscale of the PBC-40 questionnaire. The primary outcome was a fatigue reduction of ≥ 5 points after 4 weeks of high-dose thiamine treatment.RESULTS:
We enrolled 36 patients; 34 completed the study. The overall mean reduction in fatigue was 5.0 points (95% CI 2.5 to 7.5; p < 0.001) for the combined group 1 and group 2. Crossover analysis showed a mean increase in fatigue of 0.3 points (95% CI -4.2 to 3.8) after high-dose thiamine treatment compared to a 1.4 points (95% CI 6.2 to -3.4) mean reduction after placebo (p = 0.55). Only mild and transient adverse events were recorded.CONCLUSION:
Four weeks of high-dose oral thiamine treatment in patients with PBC was well tolerated and safe. However, high-dose thiamine was not superior to placebo in reducing PBC-related fatigue. TRIAL REGISTRATION The trial was registered in the ClinicalTrials.gov (NCT04893993) and EudraCT (2020-004935-26).
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Thiamine
/
Fatigue Syndrome, Chronic
/
Liver Cirrhosis, Biliary
Limits:
Humans
Language:
En
Journal:
PLoS One
Journal subject:
CIENCIA
/
MEDICINA
Year:
2024
Document type:
Article
Affiliation country:
Country of publication: