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Twelve patients with refractory chronic congestive heart failure (Class IV NYHA), related to idiopathic dilated cardiomyopathy (10 patients); previous myocardial infarction (one patient) and peripartum cardiomyopathy (one patient), received Terminalia Arjuna, an Indian medicinal plant, as bark extract (500 mg 8-hourly) or matching placebo for 2 weeks each, separated by 2 weeks washout period, in a double blind cross over design as an adjuvent to maximally tolerable conventional therapy (Phase I). The clinical, laboratory and echocardiographic evaluation was carried out at baseline and at the end of Terminalia Arjuna and placebo therapy and results were compared. Terminalia Arjuna, compared to placebo, was associated with improvement in symptoms and signs of heart failure, improvement in NYHA Class (Class III vs. Class IV), decrease in echo-left ventricular enddiastolic (125.28 ± 27.91 vs. 134.56 ± 29.71 ml/m2; P < 0.005) and endsystolic volume (81.06 ± 24.60 vs. 94.10 ± 26.42 ml/m2; P < 0.005) indices, increase in left ventricular stroke volume index (44.21 ± 11.92 vs. 40.45 ± 11.56 ml/m2; P < 0.05) and increase in left ventricular ejection fractions (35.33 ± 7.85 vs. 30.24 ± 7.13%; P < 0.005). On long term evaluation in an open design (Phase II), wherein Phase I participants continued Terminalia Arjuna in fixed dosage (500 mg 8-hourly) in addition to flexible diuretic, vasodilator and digitalis dosage for 20–28 months (mean 24 months) on outpatient basis, patients showed continued improvement in symptoms, signs, effort tolerance and NYHA Class, with improvement in quality of life. One patient died of cerebrovascular accident while another had sudden cardiac death, 16 months and 14 months after entry into Phase II, respectively. No significant clinical untoward effect occurred during Terminalia Arjuna or placebo therapy. The mechanism of beneficial effects of Terminalia Arjuna needs evaluation but it could be related to one or more of the constituents which have cardiotonic (glycosides) or free radicle scavenger (tannins, flavones) properties. In conclusion, adjuvent Terminalia Arjuna therapy in our patients with refractory congestive heart failure, mostly related to idiopathic dilated cardiomyopathy, appeared safe and caused long lasting improvement in symptoms and signs of heart failure along with improvement in left ventricular ejection phase indices with definite improvement in quality of life. We believe that these preliminary observations open a new vista for future research in therapy of myocardial failure.
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Accepted: February 24, 1995
Received: August 15, 1994
© 1995 Published by Elsevier Inc.