sulbutiamine and Fatigue

Chronic fatigue remains a medical mystery and a therapeutic failure. The subgroup of chronic fatigue postinfectious fatigue (CPIF) is an interesting one since it is quite frequent in general practice.. We studied sulbutiamine (Su), isobutyryl-thiamine disulfide in this context. We included 326 general-practice patients suffering from CPIF: they received randomly either Su, 400 mg daily (n = 106), or Su, 600 mg daily (n = 111), or placebo (n = 109) for 28 days in a double-blind, parallel-group study. 315 patients completed the study.. The evaluation of fatigue, by multiple means including mainly MFI, a validated multidimensional fatigue scale, showed overall no significant difference between the groups. On the 7th day, however, women receiving Su, 600 mg had less fatigue (P < 0.01), but the figures were quite diverse and no persistent effect was noted at the 28th day.. Thus, we showed for the first time that a high level general-practice study of fatigue is feasible using specific tools. Whether the effect observed after 1 week in women represents a true finding needs additional research. Further studies are in progress in order to characterize better the potential usefulness of Su in chronic fatigue.

Topics: Adult; Antidepressive Agents; Bacterial Infections; Chronic Disease; Dose-Response Relationship, Drug; Double-Blind Method; Fatigue; Female; Humans; Male; Middle Aged; Thiamine; Treatment Outcome

Fatigue is the most frequent and often debilitating symptom for patients with multiple sclerosis (MS). There are no available effective therapies for fatigue associated with MS, and it is unclear whether a successful therapy of MS leads to clinical improvement. Sulbutiamine is a lipophilic compound that crosses the blood-brain barrier more readily than thiamine and increases the levels of thiamine and thiamine phosphate esters in the brain. Whereas several clinical trials have demonstrated the beneficial effects of sulbutiamine in patients with asthenia, there have been no reports on the effects of sulbutiamine on fatigue in patients with MS.. Our study was designed to evaluate the short-term effects of sulbutiamine on fatigue in patients with MS.. Patients were included if fatigue was one of their three predominant symptoms. They were required to have a total score on the Fatigue Impact Scale (FIS) of >20, and on the Beck Depression Inventory of <17, and no relapse in the last 3 months prior to onset of the study. Patients were advised to receive 400mg orally of sulbutiamine once daily for two months. The outcome of the study was in the changes of FIS.. Twenty-six patients with MS (18 females and 8 males) were selected. The patients were 18-57 years of age (mean:37,2). The average score of Expanded Disability Status Scale (EDSS) of the patients was 2,71. A significant number of the subjects who were on some kind of disease modifying treatment (DMT) demonstrated obvious improvement in their total FIS scores, whereas none of the subjects who were not on any DMT improved (13/23 vs. 0/5). The average fatigue score was 77 (SD:30,5) at the baseline and 60,5 (SD:29,7) on Day 60, respectively. 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). There were no serious adverse events.. Sulbutiamin appears to be effective in treating fatigue in MS; particularly in patients who were on some DMT, but not on those who were not. It is well-tolerated by all. This observation may encourage further evaluations of the efficacy of sulbutiamine on fatigue in MS.

Topics: Adolescent; Adult; Central Nervous System Agents; Disability Evaluation; Fatigue; Female; Humans; Immunologic Factors; Male; Middle Aged; Multiple Sclerosis; Psychiatric Status Rating Scales; Thiamine; Treatment Outcome; Young Adult