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Background <p>Oral mucositis is a common debilitating complication of radiotherapy and chemotherapy in patients with head and neck cancer, often leads to severe pain and impaired quality of life (QOL). Despite the availability of various treatment strategies, managing oral mucositis effectively remains a clinical challene. This study aimed to compare the efficacy of 0.5% doxepin mouthwash and Persica herbal mouthwash in alleviating oral mucositis pain in patients undergoing radiochemotherapy.</p> Methods <p>A double-blind, randomized, parallel-group clinical trial was conducted on 56 eligible patients diagnosed with oral mucositis following treatment for head and neck cancer. Participants were randomly assigned to receive either 0.5% doxepin mouthwash or Persica herbal mouthwash. Each patient used 5&#xa0;mL thrice daily of the assigned formulation as a gargle. Pain intensity was assessed using the Visual Analog Scale (VAS) at baseline and at multiple time points following administration: 5, 15, 30, 60, 120, and 240&#xa0;min, as well as 24&#xa0;h post-gargling. The incidence of adverse effects, including burning sensation and drowsiness, were also monitored and recorded. Statistical analyses were performed using SPSS version 19 repeated measures ANOVA, independent t-tests, and chi-square tests were used as appropriate to compare outcomes between the groups.</p> Results <p>Both interventions significantly reduced mucositis-associated pain over time (<i>P</i> &lt; 0.001), with no statistically significant difference in analgesic efficacy between doxepin and Persica mouthwashes (<i>P</i> &gt; 0.05). However, doxepin was associated with a significantly higher incidence of drowsiness (<i>P</i> &lt; 0.001), while the Persica mouthwash demonstrated lower taste acceptability (<i>P</i> &lt; 0.001). No significant differences were observed in other adverse effects between the groups.</p> Conclusion <p>Both 0.5% doxepin and Persica mouthwashes were effective in alleviating oral mucositis pain in patients undergoing radiochemotherapy for head and neck cancer. Although doxepin demonstrated better taste acceptability, its sedative side effects should be taken into account in clinical decision-making.</p>

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Evaluation of Analgesic Effect of Doxepin versus Persica on Radiochemotherapy-Related Oral Mucositis: A Double-Blind, Randomized Clinical Trial

  • 期刊论文

  • 发表日期：

    2025年8月26日

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  • Behrooz Heydari,
  • Pegah Mahjour,
  • Hassan-Ali Vahedian-Ardakani,
  • Masood Shabani,
  • Mohsen Nabi-Meybodi,
  • Farahnaz Pouyanfar,
  • Fatemeh Saghafi

摘要

Background

Oral mucositis is a common debilitating complication of radiotherapy and chemotherapy in patients with head and neck cancer, often leads to severe pain and impaired quality of life (QOL). Despite the availability of various treatment strategies, managing oral mucositis effectively remains a clinical challene. This study aimed to compare the efficacy of 0.5% doxepin mouthwash and Persica herbal mouthwash in alleviating oral mucositis pain in patients undergoing radiochemotherapy.

Methods

A double-blind, randomized, parallel-group clinical trial was conducted on 56 eligible patients diagnosed with oral mucositis following treatment for head and neck cancer. Participants were randomly assigned to receive either 0.5% doxepin mouthwash or Persica herbal mouthwash. Each patient used 5 mL thrice daily of the assigned formulation as a gargle. Pain intensity was assessed using the Visual Analog Scale (VAS) at baseline and at multiple time points following administration: 5, 15, 30, 60, 120, and 240 min, as well as 24 h post-gargling. The incidence of adverse effects, including burning sensation and drowsiness, were also monitored and recorded. Statistical analyses were performed using SPSS version 19 repeated measures ANOVA, independent t-tests, and chi-square tests were used as appropriate to compare outcomes between the groups.

Results

Both interventions significantly reduced mucositis-associated pain over time (P < 0.001), with no statistically significant difference in analgesic efficacy between doxepin and Persica mouthwashes (P > 0.05). However, doxepin was associated with a significantly higher incidence of drowsiness (P < 0.001), while the Persica mouthwash demonstrated lower taste acceptability (P < 0.001). No significant differences were observed in other adverse effects between the groups.

Conclusion

Both 0.5% doxepin and Persica mouthwashes were effective in alleviating oral mucositis pain in patients undergoing radiochemotherapy for head and neck cancer. Although doxepin demonstrated better taste acceptability, its sedative side effects should be taken into account in clinical decision-making.