Sulbutiamine Reduces Infection-Related Weakness - Study

Key Findings

The study reported 51.7% (916/1772; 95% CI: 49.4–54.0) of patients achieved complete resolution of asthenic symptoms (weakness) when sulbutiamine was added to standard anti-infective treatment. Residual severe asthenia persisted in 0.6% (11 patients; 95% CI: 0–26) and moderate asthenia in 5.3% (94 patients; 95% CI: 0–17.6). Symptom improvement was reportedly more pronounced in acute infections and symptoms linked to cerebral function. Side effects occurred in 0.6% of patients, with overall well-being significantly improved. The authors concluded sulbutiamine may be a useful adjunct to anti-infective therapy.

Study Design

This was a prospective, uncontrolled, non-randomized, commercial observational study conducted in India. It enrolled 1,772 patients with infectious diseases and asthenic symptoms, treated by 350 randomly selected physicians. No control group received anti-infectives alone. The study duration was 15 days of sulbutiamine administration alongside standard anti-infective treatment. Demographics were not specified beyond the Indian practice setting.

Dosage & Administration

The study summary does not specify the sulbutiamine dosage, formulation, or exact administration schedule (e.g., frequency, timing). It only states patients received "vitamin B analogue (sulbutiamine)" as an adjunct for 15 days concurrently with physician-determined anti-infective treatment.

Results & Efficacy

Primary outcome (complete symptom resolution) occurred in 51.7% of patients (916/1772; 95% CI: 49.4–54.0). The confidence intervals for residual severe (0–26) and moderate (0–17.6) asthenia suggest imprecise estimates due to low event counts. Statistical significance testing (e.g., p-values) for efficacy comparisons was not reported, consistent with the uncontrolled design. The study noted greater subjective response in acute infections and cerebral-function-related symptoms but provided no quantitative effect sizes or significance measures for these subgroups.

Limitations

Major limitations include the absence of a control group, non-randomization, and commercial sponsorship, introducing high risk of selection and performance bias. The uncontrolled design prevents causal attribution of symptom resolution to sulbutiamine versus anti-infectives, placebo effects, or natural recovery. Confidence interval upper bounds (e.g., 54.0 for primary outcome) appear inconsistent with standard calculation methods, suggesting potential reporting errors. Subgroup observations lacked statistical validation. The observational nature and lack of blinding further limit reliability. No follow-up data beyond 15 days was provided.

Clinical Relevance

This single low-quality observational study provides weak evidence for sulbutiamine's adjunctive use in infection-related weakness. The 51.7% symptom resolution rate cannot be compared to anti-infectives alone due to the lack of a control group. The low side effect rate (0.6%) suggests short-term tolerability, but efficacy claims remain unsubstantiated by rigorous evidence. Supplement users should not replace standard anti-infective treatment with sulbutiamine. These results do not support clinical recommendations; high-quality randomized controlled trials are essential before considering sulbutiamine for this indication. Current evidence is insufficient to guide supplementation decisions.