Effects of Bunium persicum and Piper nigrum in the Treatment of Patients With Alzheimer's Disease: A Double-Blinded Randomised Clinical Trial

Abstract

Introduction: Alzheimer's disease (AD), a common form of dementia, is a rapidly growing disease worldwide with a high financial burden that leads to morbidity and mortality. Current medications focus on symptom therapy and preventing disease progression. No curative management has been established for the disease till now. Persian medicine (PM) suggests various natural medications for what we know as AD in today's medicine. The goal of the present study is to assess the efficacy and safety of a memory enhancer formulation from PM. Methods: A formulation from PM containing Bunium persicum (Boiss.) B.Fedtsch. and Piper nigrum L. (1:1) was selected and evaluated using a fixed dose (1 g/d) in patients with mild to moderate AD for 6 months in a double-blinded randomised clinical trial. Results: Among 63 patients who completed the study, the drug group (33 patients) showed remarkable improvement (P-value < 0.001) in Persian clinical dementia rating scores, including memory, orientation, judgement/problem-solving, and home and hobbies domains. Moreover, medication has also reduced aggression, restlessness, insomnia, and impaired concentration during the study interval in the drug group. No adverse reaction was reported during the study interval. Conclusions: This simple natural formulation can be considered a traditional-based product and used as a memory enhancer supplement in AD.