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

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 significant 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.