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Slb3.0

Sulbutiamine Research

Mostly mechanism / observational

5 peer-reviewed studies

What the evidence says

Mostly mechanism / observational

Most Sulbutiamine studies are mechanism or observational rather than RCTs that measure a clinical effect — keep findings provisional.

Most evidence is from high-quality randomised trials published 1999–2026 with a typical study size of 315 participants.

Based on 5 studies · 3 RCTs · 791 total participants

Confidence

Moderate confidence

By outcome

Energy & fatigueMay reduce fatigue/asthenia — but human evidence is weak and mixed · 1-4 weeks
Mostly mechanism / observational3 studies
Cognitive function
Too few graded studies2 studies
Safety profile
Too few graded studies1 study

Steady research

1 study in the last 5 years

199920122026

1RCT2000

Lôo H, Poirier MF, Ollat H, Elatki S · Encephale (2000)

2RCTn=450 · medium study2026

In plain English: These findings suggest that sulbutiamine may represent a safe and effective alternative or adjunct in the pharmacologic management of primary nocturnal enuresis.

Ahmed Mahmoud T, Mohamed Abdelhamied L, Badawy AA, El Din Salem Morsy E, Mahmoud Mohammed A, Rashed Mohamed E, Reyad AM. · Journal of pediatric urology (2026)

The mean duration to achieve successful therapy was shorter with sulbutiamine (3.2 ± 1.9 months) and combination therapy (3.3 ± 1.8 months) than with imipramine alone (3.8 ± 1.9 months; p = 0.017).
After six months, complete response occurred in 60% of the combination group, 52.7% of the sulbutiamine group, and 37.3% of the imipramine group (p = 0.003).
Relapse rates were markedly lower with sulbutiamine (28.7%) and combination therapy (24.8%) compared with imipramine (43.6%) (p = 0.01).

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3RCTn=315 · medium study1999

In plain English: The evaluation of fatigue, by multiple means including mainly MFI, a validated multidimensional fatigue scale, showed overall no significant difference between the groups.

Tiev KP et al. · Rev Med Interne (1999)

Tested for chronic post-infectious fatigue (n=315, randomized double-blind)
No overall significant difference between groups; only a transient day-7 effect in women on 600 mg, not persistent at day 28
A lipophilic thiamine derivative that crosses the blood-brain barrier

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4Review2020

In plain English: There is some evidence that sulbutiamine can have anti-fatigue, nootropic, and antioxidant effects, which led to its use as a sport supplement.

Starling-Soares B et al. · J Nutr Metab (2020)

Synthetic, lipophilic thiamine (B1) derivative
Proposed effects on fatigue, memory, and mood
Human evidence is sparse and generally low-quality

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5Open-Labeln=26 · very small study2017

In plain English: Sulbutiamine intake resulted in a significant reduction on the total score of FIS and on all three subscales assessing physical, cognitive, and psychosocial functioning (all p-values < 0,01).

Sevim S et al. · Mult Scler Relat Disord (2017)

Reduced Fatigue Impact Scale scores in MS patients (n=26)
Benefit mainly in patients on disease-modifying therapy (13/23 vs 0/5)
Small, open, uncontrolled study

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View in Research Library

Sulbutiamine Research

Mostly mechanism / observational

[Effects of sulbutiamine (Arcalion 200) on psycho-behavioral inhibition in major depressive episodes].

Comparative evaluation of sulbutiamine and imipramine in the treatment of primary nocturnal enuresis: A randomized controlled clinical study

[Treatment of chronic postinfectious fatigue: randomized double-blind study of two doses of sulbutiamine (400-600 mg/day) versus placebo].

Role of the Synthetic B1 Vitamin Sulbutiamine on Health.

Sulbutiamine shows promising results in reducing fatigue in patients with multiple sclerosis.