Efficacy of a traditional Persian medicine preparation for radiation-induced xerostomia: a randomized, open-label, active-controlled trial.

BACKGROUND: 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.

OBJECTIVE: 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.

DESIGN, SETTING, PARTICIPANTS AND INTERVENTIONS: 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.

MAIN OUTCOME MEASURES: 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).

RESULTS: 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).

CONCLUSION: 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.

TRIAL REGISTRATION: The trial was registered in ClinicalTrials.gov with Identifier: NCT02854358.