Sulbutiamine Reduces MS Fatigue: Clinical Trial Results

clinical-trial PMID: 28755683

Quick Summary: A study found that sulbutiamine may help reduce fatigue in people with multiple sclerosis (MS). However, this benefit was only seen in those already taking medication for their MS.

What The Research Found

This research looked at how sulbutiamine affects fatigue in people with MS. The study showed that taking sulbutiamine for two months helped reduce fatigue. However, this improvement was only seen in people who were already using other medications to treat their MS.

Study Details

Who was studied: 26 people with MS who reported fatigue as a main symptom.

How long: The study lasted for 2 months (60 days).

What they took: Participants took 400mg of sulbutiamine once a day.

What This Means For You

If you have MS and experience fatigue, this research suggests sulbutiamine might help, but only if you're already taking other MS medications. It's important to talk to your doctor before trying sulbutiamine. They can help you understand if it's right for you and how it might interact with your current treatments.

Study Limitations

It's important to know that this study has some limitations:

There was no comparison group (like a placebo).

The study included a small number of people.

The study only included people without depression.

The study did not follow people for a long time.

The study only showed that sulbutiamine worked with other MS medications.

Key Findings

Sulbutiamine (400mg/day for 60 days) significantly reduced fatigue in multiple sclerosis (MS) patients as measured by the Fatigue Impact Scale (FIS), but only in patients concurrently using disease-modifying therapy (DMT). The average FIS score decreased from 77 (SD: 30.5) at baseline to 60.5 (SD: 29.7) on Day 60 (p<0.01). Improvement occurred across physical, cognitive, and psychosocial subscales (all p<0.01). Crucially, 13 of 23 DMT-treated patients showed improvement, while none of the 5 non-DMT patients improved. No serious adverse events were reported.

Study Design

This was an open-label, single-group clinical trial (no control or placebo group) conducted in 2017. It enrolled 26 MS patients (18 female, 8 male; mean age 37.2 years, range 18-57) with mean Expanded Disability Status Scale (EDSS) score of 2.71. Inclusion required fatigue as a top-3 symptom, FIS score >20, Beck Depression Inventory score <17, and no relapse in the prior 3 months. The 60-day intervention assessed FIS score changes as the primary outcome.

Dosage & Administration

Participants received 400 mg of sulbutiamine orally, once daily, for 60 consecutive days. Administration was as a monotherapy adjunct to existing MS management, with no specified timing relative to meals.

Results & Efficacy

Sulbutiamine produced a statistically significant mean reduction of 16.5 points in total FIS scores (77 → 60.5; p<0.01). Significant improvements were also observed in all FIS subscales (physical, cognitive, psychosocial; p<0.01 each). The effect was exclusively observed in patients using DMTs: 56.5% (13/23) of DMT users improved, while 0% (0/5) of non-DMT users showed improvement. The study did not report effect sizes (e.g., Cohen's d) or confidence intervals beyond p-values.

Limitations

Major limitations include the absence of a control or placebo group, small sample size (n=26), and very small non-DMT subgroup (n=5), making the DMT interaction finding preliminary. The open-label design introduces performance and expectation bias. Exclusion of patients with depression (BDI ≥17) limits generalizability, as depression and MS fatigue often co-occur. Lack of long-term follow-up and no assessment of sulbutiamine's mechanism in MS fatigue are additional constraints. The observed DMT dependency requires rigorous validation in larger, controlled trials.

Clinical Relevance

This study suggests sulbutiamine may be a well-tolerated adjunct option for reducing MS-related fatigue specifically in patients already using DMTs. However, the lack of a control group and small size mean these results are preliminary and insufficient to support clinical adoption. Patients should not self-treat MS fatigue with sulbutiamine based solely on this trial. The strong association with DMT use implies sulbutiamine might modulate fatigue pathways linked to MS disease activity rather than acting as a standalone fatigue treatment. Further research must confirm efficacy in randomized, placebo-controlled trials with larger cohorts and explore the DMT interaction mechanism. Medical supervision is essential due to MS complexity.

Sulbutiamine Reduces MS Fatigue: Clinical Trial Results