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Randomized Controlled Trial
. 2015 Apr 22;164:378-84.
doi: 10.1016/j.jep.2015.02.007. Epub 2015 Feb 11.

Heart Palpitation Relief With Melissa Officinalis Leaf Extract: Double Blind, Randomized, Placebo Controlled Trial of Efficacy and Safety

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Randomized Controlled Trial

Heart Palpitation Relief With Melissa Officinalis Leaf Extract: Double Blind, Randomized, Placebo Controlled Trial of Efficacy and Safety

Fatemeh Alijaniha et al. J Ethnopharmacol. .

Abstract

Ethnopharmacological relevance: In Traditional Iranian Medicine (TIM), Melissa officinalis L. is commonly regarded as an effective therapy for heart palpitations.

Objective: Heart palpitation is a common complaint that is often benign and associated with a marked distress that makes the condition difficult to treat. Herbal medicines provide an alternative to conventional drugs for treating various kinds of diseases. This study was done as a double blind randomized placebo-controlled clinical trial to evaluate the efficacy and safety of the dried extract of M. officinalis on adults suffering from benign palpitations.

Materials and methods: Eligible volunteers were randomly assigned as outpatients to a 14 day treatment with 500 mg twice a day of lyophilized aqueous extract of M. officinalis leaves (or placebo). Participants in the tests, physicians and researchers were blind to group assignments. Both primary and secondary outcomes were patient-reported. Primary outcomes were obtained from two measures: mean frequency of palpitation episodes per week, derived from patients׳ diaries, and mean intensity of palpitation estimated through Visual Analogue Scale (VAS) in a self-report questionnaire. Psychiatric symptoms (somatization, anxiety and insomnia, social dysfunction and severe depression) were evaluated as secondary outcomes by General Health Questionnaire-28 (GHQ-28), before and after intervention.

Results: Fifty-five volunteers out of 71 recruited study subjects completed the trial. Results showed that 14-day of treatment with lyophilized aqueous extract of M. officinalis leaves reduced frequency of palpitation episodes and significantly reduced the number of anxious patients in comparison to the placebo (P=0.0001, P=0.004 resp.). Also, M. officinalis extract showed no indication of any serious side effects.

Conclusion: Lyophilized aqueous extract of M. officinalis leaves may be a proper and safe herbal drug for the treatment of benign palpitations.

Keywords: Aqueous extract; Lemon balm; Melissa officinalis; Palpitations; Traditional Iranian Medicine (TIM).

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