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Efficacy of benzydamine oral rinse in prevention and management of radiation-induced oral mucositis: A double-blind placebo-controlled randomized clinical trial.
Asia Pac J Clin Oncol 2015; 11(1):22-7AP

Abstract

AIM

Several studies have demonstrated positive effects of benzydamine oral rinse in prevention of radiation-induced oral mucositis. The aim of this study was to assess the efficacy of this medication in reducing the signs and symptoms of oral mucositis in patients receiving radiotherapy for head and neck cancer.

METHODS

Fifty-one patients with head and neck carcinoma 2012 received external beam radiotherapy for 5 days/week to total planned cumulative radiotherapy doses of at least 5000 cGy. Patients were randomized to treatment with either benzydamine oral rinse or placebo, initiated the day before radiotherapy and continued for 2 weeks after the end of treatment. Oral cavity was divided into 14 anatomical sites and relevant sites were examined weekly, with a score given to each site based on the degree of mucositis using a 4-point scale, and then a "mean mucositis score" was calculated.

RESULTS

Up to the end of third week, two groups did not show any difference in the severity of mucositis. However, by the end of week 4, the mean score of placebo group was more than that of treatment group (1.81 vs 1.27, P=0.001). This trend continued to end of week 7 (1.98 vs 1.43, P=0.001).

CONCLUSION

Benzydamine oral rinse can be considered as an effective, safe and well-tolerated medication for prevention of radiation-induced oral mucositis and alleviating its symptoms.

Authors+Show Affiliations

Imam Hossein Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

25471468

Citation

Sheibani, Khosro M., et al. "Efficacy of Benzydamine Oral Rinse in Prevention and Management of Radiation-induced Oral Mucositis: a Double-blind Placebo-controlled Randomized Clinical Trial." Asia-Pacific Journal of Clinical Oncology, vol. 11, no. 1, 2015, pp. 22-7.
Sheibani KM, Mafi AR, Moghaddam S, et al. Efficacy of benzydamine oral rinse in prevention and management of radiation-induced oral mucositis: A double-blind placebo-controlled randomized clinical trial. Asia Pac J Clin Oncol. 2015;11(1):22-7.
Sheibani, K. M., Mafi, A. R., Moghaddam, S., Taslimi, F., Amiran, A., & Ameri, A. (2015). Efficacy of benzydamine oral rinse in prevention and management of radiation-induced oral mucositis: A double-blind placebo-controlled randomized clinical trial. Asia-Pacific Journal of Clinical Oncology, 11(1), pp. 22-7. doi:10.1111/ajco.12288.
Sheibani KM, et al. Efficacy of Benzydamine Oral Rinse in Prevention and Management of Radiation-induced Oral Mucositis: a Double-blind Placebo-controlled Randomized Clinical Trial. Asia Pac J Clin Oncol. 2015;11(1):22-7. PubMed PMID: 25471468.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy of benzydamine oral rinse in prevention and management of radiation-induced oral mucositis: A double-blind placebo-controlled randomized clinical trial. AU - Sheibani,Khosro M, AU - Mafi,Ahmad R, AU - Moghaddam,Shiva, AU - Taslimi,Farnaz, AU - Amiran,Ahmadreza, AU - Ameri,Ahmad, Y1 - 2014/12/03/ PY - 2014/09/05/accepted PY - 2014/12/5/entrez PY - 2014/12/5/pubmed PY - 2016/3/24/medline KW - benzydamine KW - oral mucositis KW - radiation therapy SP - 22 EP - 7 JF - Asia-Pacific journal of clinical oncology JO - Asia Pac J Clin Oncol VL - 11 IS - 1 N2 - AIM: Several studies have demonstrated positive effects of benzydamine oral rinse in prevention of radiation-induced oral mucositis. The aim of this study was to assess the efficacy of this medication in reducing the signs and symptoms of oral mucositis in patients receiving radiotherapy for head and neck cancer. METHODS: Fifty-one patients with head and neck carcinoma 2012 received external beam radiotherapy for 5 days/week to total planned cumulative radiotherapy doses of at least 5000 cGy. Patients were randomized to treatment with either benzydamine oral rinse or placebo, initiated the day before radiotherapy and continued for 2 weeks after the end of treatment. Oral cavity was divided into 14 anatomical sites and relevant sites were examined weekly, with a score given to each site based on the degree of mucositis using a 4-point scale, and then a "mean mucositis score" was calculated. RESULTS: Up to the end of third week, two groups did not show any difference in the severity of mucositis. However, by the end of week 4, the mean score of placebo group was more than that of treatment group (1.81 vs 1.27, P=0.001). This trend continued to end of week 7 (1.98 vs 1.43, P=0.001). CONCLUSION: Benzydamine oral rinse can be considered as an effective, safe and well-tolerated medication for prevention of radiation-induced oral mucositis and alleviating its symptoms. SN - 1743-7563 UR - https://www.unboundmedicine.com/medline/citation/25471468/Efficacy_of_benzydamine_oral_rinse_in_prevention_and_management_of_radiation_induced_oral_mucositis:_A_double_blind_placebo_controlled_randomized_clinical_trial_ L2 - https://doi.org/10.1111/ajco.12288 DB - PRIME DP - Unbound Medicine ER -