Int J Cancer Manag. In Press(In Press):e8642. Published online 2017 September 30. doi: 10.5812/ijcm.8642. Research Article Efficacy of a Persian Medicine Herbal Compound (Alcea digitata Alef and Malva sylvestris L.) on Prevention of Radiation Induced Acute Mucositis in Patients with Head and Neck Cancer: A Pilot Study Nasser Rezaeipour, 1 Farhad Jafari, 2 Hossein Rezaeizadeh, 3 Mohsen Nasseri, 4 Mohammad Kamalinejad, 5 Ali Ghobadi, 6 Mansour Shamsipour, 7 Arman Zargaran, 8 and Ahmad Ameri 9,* 1 Department of Traditional Medicine, School of Medicine, Shahed University, Tehran, Iran 2 Department of Health and Social Medicine, School of Medicine, Shahed University, Tehran, Iran 3 Department of Traditional Medicine, School of Traditional Medicine, Tehran University of Medical Sciences, Tehran, Iran 4 Traditional Medicine Clinical Trial Research Center, Shahed University, Tehran, Iran 5 Department of Pharmacognosy, School of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran,Iran 6 Department of Traditional Pharmacy, School of Traditional Medicine, Iran University of Medical Sciences, Tehran, Iran 7 Department of Research Methodology and Data Analysis, Institute for Environmental Research, Tehran University of Medical Sciences, Tehran, Iran 8 Department of Traditional Pharmacy, School of Traditional Medicine, Tehran University of Medical Sciences, Tehran, Iran 9 Department of Radiation Oncology, Imam Hossein Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran * Corresponding author: Ahmad Ameri, MD, Department of Radiation Oncology, Imam Hossein Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran. Tel: +98-9123088087, Fax: +98-2177552056, E-mail: a_ameri@sbmu.ac.ir Received 2017 July 03; Revised 2017 August 08; Accepted 2017 September 07. Abstract Background: Mucositis is the most common complication of radiotherapy in patients with head and neck (H and N) cancers. Objectives: This study surveyed the efficacy of a herbal compound containing Alcea digitata Alef and Malva sylvestris L. in prevention of radiation-induced mucositis in patients with head and neck cancer. Methods: In the present study, a total of 23 patients were examined and assigned to 2 groups. The herbal drug and the placebo (provided from Avicel) were administered for 7 weeks, from the beginning of radiotherapy to 2 weeks after the completion of the treatment. During weekly visits, mouth pain score (MPS) was assessed, using visual analog scale (VAS) and severity of mucositis was checked by investigators. Results: Patients in control group showed more severe mucositis from second week, compared with drug group (p < 0.0001). The effect of herbal compound, time and the time-drug’s interaction on mucositis, and MPS were significant (p < 0.0001); hence, the severity of mucositis and the mean of MPS in control group was significantly more severe in comparison with drug group (p < 0.0001) in weekly cut. The effect of time was significant only in control group (p < 0.0001); and in drug group, there was no signifi- cant difference in severity of mucositis and MPS during the study (p = 0.2366). Conclusions: Therefore, not only the severity of mucositis and the average of MPS were significantly lower in drug group compared with control group, but also they were invariant during the study and showed no uptrend. Keywords: Persian Medicine, Traditional Medicine, Mucositis, Head and Neck Cancer 1. Background The patients with head and neck (H and N) cancers in- clude about 5% of cancer cases diagnosed, worldwide. Also, surgery and radiotherapy are curative treatments for only about 3.2% of new cancer cases (1). These cancers lead to about 350,000 deaths, annually (2, 3). Radiotherapy is a common medical procedure used in such patients (4). Mu- cositis is the most common complication of radiotherapy in these patients that is defined as inflammatory and/or ulcerative injuries of oral cavity and/or stomach and in- testines (5). About 83% of patients need radiotherapy and at least 60% of them get mucositis (5). According to world health organization (WHO), in patients with H and N can- cer that received high doses of radiation (6000 - 7000 GY), grade 3 and 4 mucositis reaches to 85%, but all patients get some degrees of mucositis (6). It was reported in a study that the prevalence of severe mucositis was 35% to 65% and these patients are at risk of discontinuing the treatment (7). Ulcerative mucositis of oral cavity is a debilitating and painful condition that causes severe pain, increasing the Copyright © 2017, Cancer Research Center (CRC), Shahid Beheshti University of Medical Sciences. This is an open-access article distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 International License (http://creativecommons.org/licenses/by-nc/4.0/) which permits copy and redistribute the material just in noncommercial usages, provided the original work is properly cited.