Chagas' cardioneuropathy: Effects of ganglioside treatment on stress-induced arrhythmias. A randomized, double-blind, placebo-controlled study

Chagas' disease is manifested by cardiovascular and autonomic nervous system disorders with arrhythmias and sudden death. This paper reports the results of an analysis of the mean total arrhythmias (MTA), calculated as the sum of arrhythmias counted after cough, hyperventilation, and postural stress tests, that was conducted as part of a randomized, double-blind, placebo-controlled study. This analysis evaluated the effect on MTA of eight weeks of treatment with Cronassial® (mixed gangliosides) in a 58-patient study, conducted under a U.S. Food and Drug Administration-approved investigational New Drug Application. Results demonstrated the following: (1) patients receiving placebo during the first four weeks increased in MTA from 0.39 to 1.69, then decreased to 0.69 following four weeks of ganglioside therapy; (2) patients receiving gangliosides in the first four weeks decreased in MTA from 2.70 to 0.41; and (3) the subset of these latter patients who continued with ganglioside therapy for an additional four weeks had a further decrease to 0.36 after a total of eight weeks of ganglioside treatment, while the remaining patients who changed from gangliosides to placebo after week 4 returned to a higher MTA of 1.15. Comparisons between ganglioside- and placebo-treated patients were statistically significant (p<0.05) at both four and eight weeks, favoring ganglioside therapy. In conclusion, gangliosides reduced the mean number of stress-induced arrhythmias in chronic chagasic patients. This effect may be due to gangliosides' ability to stabilize autonomic control of the heart.