Heart palpitation relief with Melissa officinalis leaf extract: double blind, randomized, placebo controlled trial of efficacy and safety.

Fatemeh Alijaniha, Mohsen Naseri, Suleiman Afsharypuor, Faramarz Fallahi, Ahmadali Noorbala, Mahmood Mosaddegh, Soghrat Faghihzadeh, Sima Sadrai

Journal: Journal of ethnopharmacology 2016;164():378-84

PMID: 25680840

Full Text on Elsevier Science View on PubMed

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.

Address: Department of Traditional Pharmacy, School of Traditional Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran. Electronic address: [email protected].; Traditional Medicine Clinical Trial Research Center, Shahed University, Tehran, Iran. Electronic address: [email protected].; Faculty of Pharmacy and Pharmaceutical Sciences, Isfahan University of Medical Sciences, Isfahan, Iran. Electronic address: [email protected].; Cardiology Department, Shahed University, Tehran, Iran. Electronic address: [email protected].; Psychosomatic Ward Imam Khomeini Hospital, Tehran University of Medical Sciences, Tehran, Iran. Electronic address: [email protected].; Dean Traditional Medicine and Materia Medica Research Center (TMRC) Shahid Beheshti University of Medical Sciences, Tehran, Iran. Electronic address: [email protected].; Department of Biostatistic and Epidemiology, School of Medicine, Zanjan University of Medical Science, Zanjan, Iran. Electronic address: [email protected].; Division of Biopharmaceutics and Pharmacokinetics, Department of Pharmaceutics, Faculty of Pharmacy, Tehran University of Medical Sciences, Tehran, Iran. Electronic address: [email protected].

DOI: 10.1016/j.jep.2015.02.007

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MeSH Terms: Adult, Arrhythmias, Cardiac, Double-Blind Method, Female, Humans, Male, Melissa, Middle Aged, Phytotherapy, Plant Extracts, Plant Leaves, Treatment Outcome