ABSTRACT
<p><b>BACKGROUND</b>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.</p><p><b>OBJECTIVE</b>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.</p><p><b>DESIGN, SETTING, PARTICIPANTS AND INTERVENTIONS</b>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.</p><p><b>MAIN OUTCOME MEASURES</b>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.</p><p><b>RESULTS</b>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).</p><p><b>CONCLUSION</b>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.</p><p><b>TRIAL REGISTRATION</b>Iranian Registry of Clinical Trials IRCT2016061428469N1.</p>
ABSTRACT
<p><b>BACKGROUND</b>Xerostomia is one of the most common side effects of radiation therapy among patients with head and neck cancers (HNC). However, conventional medicine lacks an effective treatment for radiation-induced xerostomia.</p><p><b>OBJECTIVE</b>Synthesizing the traditional use of Alcea digitata and Malva sylvestris with their known beneficial effects from recent studies, we evaluated the efficacy of the herbs in the quality of life (QOL) of HNC patients with radiation-induced xerostomia.</p><p><b>DESIGN, SETTING, PARTICIPANTS AND INTERVENTIONS</b>This study is a randomized, double-arm, open-label active-controlled clinical trial. We evaluated the effect of A. digitata and M. sylvestris on QOL of HNC patients with radiation-induced xerostomia compared with Hypozalix (artificial saliva). Patients were enrolled from the Imam Hossein Hospital's oncology clinic in Shahid Beheshti University of Medical Sciences, Tehran, Iran.</p><p><b>MAIN OUTCOME MEASURES</b>Primary outcome measures in this trial were changes in patients' QOL assessed by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, Head and Neck Module (EORTC QLQ-H&N 35).</p><p><b>RESULTS</b>Between-group analysis showed that the intervention group patients obtained significantly lower (better) total EORTC QLQ-H&N 35 scores as compared to the control group at the end of the intervention period (P = 0.007). Mean scores of dry mouth of EORTC QLQ-H&N 35 was also significantly lower (better) in the intervention group as compared to the control group (P = 0.017).</p><p><b>CONCLUSION</b>Traditional Persian medicine preparation of hollyhocks and common mallow should be considered as a suitable treatment for xerostomia and improving QOL in HNC patients with radiation-induced xerostomia.</p><p><b>TRIAL REGISTRATION</b>The trial was registered in ClinicalTrials.gov with Identifier: NCT02854358.</p>