Aim: The effectiveness of propionyl-L-carnitine (PLC) monotherapy regimen alone or in association with pulsed muscular compression was compared to the physical therapy by itself against obliterant arteriopathy Leriche Fontaine stage II. PLC is involved in cellular metabolism and is transformed into two active substances, free L-carnitine and propionyl-coenzyme A in the mitochondria, which take part in fatty acid transfer and in the citric acid cycle, respectively.
Methods: Forty-two patients with arterial disease were selected (22 males and 20 females; mean age: 62+/-8 years; 21 type 2 diabetic [DB] and 21 non-DB [NDB]). At enrollment all patients completed a symptoms questionnaire enabling both clinical and social evaluation of the impact of the arteriopathy on the quality of life. Then, patients had: routine blood samples, echo duplex scan; evaluation of the ankle/arm (Winsor) index; impedance plethysmography (Rheoscreen) to measure the crest time (CT), index of the pathological changes due to the sclerosis on the vascular wall, and measurement of walking distance by means of treadmill test. Patients were randomized in three groups, each of them composed by 14 patients (7 DB and 7 NDB): the first group was submitted to infusional PLC therapy at a dosage of 4 fl (total: 1,200 mg PLC) in 250 cc of physiological solution for 5 days a week for 4 weeks; the second group was treated with PLC in association with pulsed muscular compression therapy by Vascupump (5 sessions a week for 4 weeks); the third group was submitted only to Vascupump.
Results: The efficacy of both PLC and Vascupump in the treatment of the peripheral vasculopathies was confirmed. From a subjective point of view, patients referred benefits both in clinical terms, i.e. increased walking distance (average increaseaegroup I: DB 102%, NDB 118%; group II: DB 94%, NDB 193%; group III: DB 33%, NDB 67%) and of decreased intensity of the calf pain from the quality of life questionnaire (21.5 to 10.7). The instrumental parameters showed a trend towards normality, i.e decrease in CT and an increase of the Winsor index, indicators of increased peripheral blood circulation.
Conclusion: Combined pharmaco- and physical therapy was most efficient treatment regime and best results were seen in NDB compared to the DB patients.