Effect of Hydroalcoholic Extract of Althaea officinalis Root on Improving Chemotherapy‑Induced Stomatitis: A Randomized, Double‑Blind, Clinical Trial

Background: Stomatitis is a common and serious side effect of chemotherapy. It is associated with multiple consequences such as pain, oral intake disorder, infection, bleeding, and failure of cancer treatments. Objectives: This study aimed to compare the improving effect of mouthwash containing hydroalcoholic extract of Althaea root and routine mouthwash on chemotherapy‑induced stomatitis. Methods: This double‑blind, randomized, controlled clinical trial was conducted on chemotherapy‑induced stomatitis cases (n = 50) in the Oncology Department of Shahid Beheshti Hospital, Kashan, Iran, in 2016. Patients were assigned into two groups through permuted‑block randomization. The control group was treated with 15 mL of routine mouthwash solution 4 times a day for 14 days whereas the experimental group was treated with a mixture of routine solution and Althaea root extract (50/50). The severity of stomatitis was assessed at baseline, 7th, and 14th days of intervention using the Worlds Health Organization’s stomatitis evaluation checklist. Data analysis was conducted using the Chi‑square and Fisher’s exact tests and repeated measure analysis of variance. Results: At baseline, the mean score of stomatitis in the control group was 1.92 ± 0.70, which reduced to 0.96 ± 0.68 and 0.92 ± 0.64 on the 7th and 14th days after the intervention, respectively. In the experimental group, the mean score of stomatitis was 1.84 ± 0.74 at baseline, which reduced to 1.00 ± 0.82 and 0.44 ± 0.76 on the 7th and 14th days after the intervention, respectively (P = 0.015). Conclusion: Mouthwash solution containing Althaea officinalis root extract could improve stomatitis caused by chemotherapy more than the routine mouthwash solution. Thus, the mentioned herb has the potential to be used concurrently with chemotherapy agents to alleviate the occurrence of stomatitis.