Efficacy and safety of Amla (Phyllanthus emblica L.) in non-erosive reflux disease: a double-blind, randomized, placebo-controlled clinical trial

doi:10.1016/j.joim.2018.02.008

Journal of Integrative Medicine ›› 2018, Vol. 16 ›› Issue (2): 126-131.doi: 10.1016/j.joim.2018.02.008

• Original Clinical Research • Previous Articles Next Articles

Efficacy and safety of Amla (Phyllanthus emblica L.) in non-erosive reflux disease: A double-blind, randomized, placebo-controlled clinical trial

Shahnaz Karkon Varnosfaderani ^a, Fataneh Hashem-Dabaghian ^b, Gholamreza Amin ^c, Mahbubeh Bozorgi ^c, Ghazaleh Heydarirad ^d, Esmaeil Nazem ^a, Mohsen Nasiri Toosi ^e, Seyed Hamdollah Mosavat ^f

^aDepartment of Traditional Medicine, School of Traditional Medicine, Tehran University of Medical Sciences, Tehran 1416663361, Iran
^b Research Institute for Islamic and Complementary Medicine, Iran University of Medical Sciences, Tehran 1145847311, Iran
^cDepartment of Traditional Pharmacy, Faculty of Traditional Medicine, Tehran University of Medical Sciences, Tehran 1416663361, Iran
^dDepartment of Traditional Medicine, School of Traditional Medicine, Shahid Beheshti University of Medical Sciences, Tehran 1516745811, Iran
^eDepartment of Gastroenterology, Imam Khomeini Hospital, Tehran University of Medical Sciences, Tehran 1419733141, Iran
^fResearch Centre for Traditional Medicine and History of Medicine, Shiraz University of Medical Sciences, Shiraz 7135644144, Iran

Received:2017-10-29 Accepted:2018-01-06 Online:2018-03-10 Published:2018-02-13
Contact: Seyed Hamdollah Mosavat; E-mail: hamdi_88114@yahoo.com

Abstract

Background
Gastroesophageal reflux disease (GERD) is one of the most common gastrointestinal complaints. GERD, caused by the reflux of stomach contents into the esophagus, leads to troublesome symptoms such as heartburn and regurgitation. It is classified into two types: erosive esophagitis, characterized by visible esophageal mucosa erosion in endoscopy, and non-erosive reflux disease (NERD). GERD is a chronic and recurrent disease that impairs the quality of life and imposes socioeconomic and therapeutic burdens to both patients and society.

Objective

Due to the failure of the conventional treatments for GERD and to the traditional use of Amla (Phyllanthus emblica L.), in addition to beneficial effects shown in recent studies, we evaluated the safety and efficacy of Amla tablet for improvement of symptoms of patients with NERD.

Design, setting, participants and interventions

We designed a double-arm, randomized, double-blind, placebo-controlled clinical trial. Sixty-eight patients who had classic symptoms of GERD (heartburn, regurgitation and epigastralgia) for at least three months before the start of the trial were randomized in two parallel groups. Patients in the Amla group received two 500?mg Amla tablets twice a day, after meals, for 4?weeks. In the control group, patients received placebo tablets similar to the Amla prescription.

Main outcome measures

The patients were visited at baseline, and at the end of the 2nd and 4th weeks of intervention; their symptoms were measured on a frequency and severity scale for the symptoms of NERD, according to the quality of life in reflux-associated disease questionnaire.

Results

Frequencies of heartburn and regurgitation in both groups of the study were significantly reduced after intervention (P?<?0.001). Repeated measures logistic regression analysis showed that, in the Amla group, there was a more significant reduction in regurgitation frequency, heartburn frequency, regurgitation severity and heartburn severity during the study period, compared with the placebo group (P?<?0.001).

Conclusion

This randomized double-blind, placebo-controlled clinical trial demonstrated that Amla could reduce frequencies of heartburn and regurgitation and improve heartburn and regurgitation severity in patients with NERD.

Trial registration

Iranian Registry of Clinical Trials IRCT2016061428469N1.

Key words: Gastroesophageal reflux, Non-erosive reflux disease, Amla, Phyllanthus emblica, Phytotherapy, Randomized clinical trials

Shahnaz Karkon Varnosfaderani, Fataneh Hashem-Dabaghian, Gholamreza Amin, Mahbubeh Bozorgi, Ghazaleh Heydarirad, Esmaeil Nazem, Mohsen Nasiri Toosi, Seyed Hamdollah Mosavat. Efficacy and safety of Amla (Phyllanthus emblica L.) in non-erosive reflux disease: A double-blind, randomized, placebo-controlled clinical trial. Journal of Integrative Medicine, 2018, 16(2): 126-131.

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Efficacy and safety of Amla (Phyllanthus emblica L.) in non-erosive reflux disease: A double-blind, randomized, placebo-controlled clinical trial

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