title: The effect of clove-based herbal mouthwash on radiation-induced oral mucositis in patients with head and neck cancer: a single-blind randomized preliminary study.
abstract: OBJECTIVE
  This study was performed to evaluate the efficacy and safety of clove-based herbal mouthwash in ameliorating radiation-induced oral mucositis in patients with head and neck cancer.
  
  
  METHODS
  Fourteen patients were prospectively enrolled in this study and randomized to either an experimental group or a control group. The patients of the experimental group swished their mouths with a clove-based herbal mouthwash during radiotherapy (RT), while the patients of the control group swished with clear water. The primary end point of this study was incidence of radiation-induced oral mucositis. The secondary end points were time to onset of radiation-induced oral mucositis, duration of radiation-induced oral mucositis, incidence of supplemental nutrition through feeding tube, maximum pain score, body weight loss, incidence of RT interruption, and duration of RT interruption.
  
  
  RESULTS
  The use of clove-based herbal mouthwash shortened the duration of grade ≥2 mucositis (24.3 days vs 37.1 days, P=0.044) and reduced body weight loss during RT (3.1% vs 7.4%, P=0.023) compared with clear water. The use of clove-based herbal mouthwash also reduced the incidence of grade 3 mucositis (28.6% vs 57.1%), supplemental nutrition (0% vs 28.6%), and RT interruption (14.3% vs 28.6%), and reduced the duration of grade 3 mucositis (5.1 days vs 17.7 days) and RT interruption (1 days vs 8.5 days). In addition, clove-based herbal mouthwash delayed the time to onset of mucositis (26.6 days vs 24.5 days) and reduced the maximum pain score (4.1 vs 4.9). However, these differences were not statistically significant.
  
  
  CONCLUSIONS
  Although we could not find significant differences in some end points, this single-blind randomized study showed that a clove-based herbal mouthwash can have a potentially beneficial effect on minimizing or preventing radiation-induced oral mucositis in patients with head and neck cancer. To confirm the results of our study, well-designed randomized studies with large sample sizes will be required.
authors.affiliation: Department of Radiation Oncology, Kyung Hee University Medical Center, Kyung Hee University School of Medicine.
authors.forename: Moonkyoo
authors.initials: M
authors.lastname: Kong
authors.affiliation: Department of Korean Medicine Obstetrics & Gynecology, Kyung Hee University Medical Center.
authors.forename: Deok-Sang
authors.initials: DS
authors.lastname: Hwang
authors.affiliation: Department of Korean Internal Medicine, Korean Medicine Cancer Center, Kyung Hee University Hospital at Gangdong.
authors.forename: Seong Woo
authors.initials: SW
authors.lastname: Yoon
authors.affiliation: Department of Korean Internal Medicine, Kyung Hee University Medical Center, College of Korean Medicine, Kyung Hee University, Seoul, Republic of Korea.
authors.forename: Jinsung
authors.initials: J
authors.lastname: Kim
keywords: clove-based herbal mouthwash; head and neck cancer; mucositis; radiotherapy