Abstract

Objective: Verify if L-carnitine associated with Piracetam in fixed dose combination improves fatigue and muscular strength (MS) in Post-Poliomyelitis Syndrome (PPS)patients and verify the tolerability and safety of the combination.

Methods:a randomized clinical study, double-blind, placebo-controlled was conducted, comparing the use of three tablets of the fixed dose combination (L-Carnitine 330mg, Piracetam 270 mg) twice a day, to your placebo.94 patients were evaluated over 180 days, where three evaluations (3 visits) took place; MS was assessedthrough the Medical Research Council Manual Muscular Test (MMT), the fatigue through the Fatigue Severity Scale (FSS) and Piper’s Revised Fatigue Scale (PRFS).

Results:Only the group that received the active medication presented significant improvement in fatigue, both in the PRFS (V1: 5.73, V3: 4.36, p = 0.001) and FSS (V1: 53.1, V3: 49, 4, p = 0.002). A statistically significant improvement was observed in the proximal musculature of the lower limbs of the activr group (AG) (V1 78.99%; V 3 81.10%, p = 0.040). As in the MS of the proximal muscles of the right lower limb AG (V1 77.86% V3 81.69%, p = 0.008), the group that received the placebo (V1 79.67% V3 78.83%, p = 0.035). The placebo group (PG) had the highest MS decrease.Possible AE related to AG when compared to PG highlighted the high presence of headache and dry mouth that occurred more frequently in the PG. The other events reported didn’t presented significant differences between the groups.

Conclusion:The combination of the drugs has shown to be effective for improving fatigue and MS in PPS patients, as well as delaying the progression of muscle weakness. The trial monitoring demonstrated safety and tolerability for this combination.

Keywords

fatigue, l-carnitine, muscle strength, post- poliomyelitis syndrome, debilitating late symptoms, metabolic demand, muscular glycogen, cerebral metabolism, mitochondrial dysfunction, neuromuscular diseases, electrocardiogram, cognitive, mood, behavioural, severity