Sulbutiamine treatment for chronic postinfectious fatigue (CPIF): a double-blind study.

Purpose. - Chronic fatigue remains a medical mystery and a therapeutic failure. The subgroup of chronic fatigue postinfection fatigue (CPlF) is an interesting one since it is quite frequent in general practice. Methods. - We studied sulbutiamine (Su), isobutyryl- thiamine disulfide in this context. We included 326 general-practice patients suffering from CPlF: they received randomly either Su, 400 mg daily (n = 105), 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. Results. - 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. Conclusion. - 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.