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Journal of Integrative Medicine: Volume 16, 2018   Issue 2,  Pages: 126-131

DOI: 10.1016/j.joim.2018.02.008
Original Clinical Research
Efficacy and safety of Amla ( Phyllanthus emblica L.) in non-erosive reflux disease: a double-blind, randomized, placebo-controlled clinical trial
1. Shahnaz Karkon Varnosfaderani (Department of Traditional Medicine, School of Traditional Medicine, Tehran University of Medical Sciences, Tehran 1416663361, Iran )
2. Fataneh Hashem-Dabaghian (Research Institute for Islamic and Complementary Medicine, Iran University of Medical Sciences, Tehran 1145847311, Iran )
3. Gholamreza Amin (Department of Traditional Pharmacy, Faculty of Traditional Medicine, Tehran University of Medical Sciences, Tehran 1416663361, Iran )
4. Mahbubeh Bozorgi (Department of Traditional Pharmacy, Faculty of Traditional Medicine, Tehran University of Medical Sciences, Tehran 1416663361, Iran )
5. Ghazaleh Heydarirad (Department of Traditional Medicine, School of Traditional Medicine, Shahid Beheshti University of Medical Sciences, Tehran 1516745811, Iran )
6. Esmaeil Nazem (Department of Traditional Medicine, School of Traditional Medicine, Tehran University of Medical Sciences, Tehran 1416663361, Iran )
7. Mohsen Nasiri Toosi (Department of Gastroenterology, Imam Khomeini Hospital, Tehran University of Medical Sciences, Tehran 1419733141, Iran )
8. Seyed Hamdollah Mosavat (Research Centre for Traditional Medicine and History of Medicine, Shiraz University of Medical Sciences, Shiraz 7135644144, Iran )

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.

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Please cite this article as:
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. J Integr Med. 2018; 16(2): 126-131.
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