褪黑素漱口水对预防化疗所致口腔黏膜炎的作用，一项随机双盲安慰剂对照临床试验

IF 1.9 4区医学 Q3 INTEGRATIVE & COMPLEMENTARY MEDICINE

European Journal of Integrative Medicine Pub Date : 2025-07-04 DOI:10.1016/j.eujim.2025.102523

Aida Abdi , Zaynab Sadeghi Ghadi , Maryam Daei , Elliyeh Ghadrdan

{"title":"褪黑素漱口水对预防化疗所致口腔黏膜炎的作用，一项随机双盲安慰剂对照临床试验","authors":"Aida Abdi , Zaynab Sadeghi Ghadi , Maryam Daei , Elliyeh Ghadrdan","doi":"10.1016/j.eujim.2025.102523","DOIUrl":null,"url":null,"abstract":"<div><h3>Introduction</h3><div>Chemotherapy can induce a range of unpleasant adverse effects, with oral mucositis being one of the most common. This condition significantly impacts patients' quality of life and can disrupt their adherence to treatment protocols. Oral mucositis serves as an important limiting factor in chemotherapy, often necessitating dose reductions or treatment delays, which in turn can compromise the overall effectiveness of the therapy. This study was conducted to investigate the effect of melatonin mouthwash on the prevention of chemotherapy-induced oral mucositis.</div></div><div><h3>Methods</h3><div>Following the preparation of melatonin and placebo mouthwashes, a randomized, double-blinded, placebo-controlled clinical trial was conducted on patients with solid tumor malignancies who had no oral lesions and were treated with chemotherapy regimens. The patients began using the mouthwash on the first day of their corresponding chemotherapy course, continuing for six weeks with a frequency of three times daily, 4mL per application. At the end of each week, the patients were evaluated for the severity and duration of mucositis, as well as the associated pain. Quality of life was assessed at the study's start and weekly thereafter.</div></div><div><h3>Results</h3><div>Seventy patients were randomized into melatonin (<em>n</em> = 35) and placebo (<em>n</em> = 35) groups. The melatonin group had a lower incidence of mucositis (11.43 % versus 34.28 %), with a relative risk of 0.74 (95 % confidence interval (CI): 0.56 to 0.96). The severity of mucositis showed statistically significant differences between the melatonin and placebo groups at the end of the fifth week (<em>P</em> = 0.003) and the sixth week (<em>P</em> = 0.002). Additionally, the intensity of pain caused by mucositis demonstrated statistically significant differences at the end of the third week (<em>P</em> = 0.021), the fifth week (<em>P</em> = 0.001), and the sixth week (<em>P</em> = 0.001). There was also a significant difference in the overall duration of mucositis between the melatonin and placebo groups (mean difference -8.83, 95 %CI: -14.54 to -3.12). The mouthwash was well tolerated in both groups.</div></div><div><h3>Conclusion</h3><div>The findings of this study suggest that melatonin mouthwash is effective in preventing chemotherapy-induced mucositis. A six-week regimen of melatonin mouthwash significantly reduces the severity and duration of mucositis, as well as the associated pain intensity.</div></div>","PeriodicalId":11932,"journal":{"name":"European Journal of Integrative Medicine","volume":"78 ","pages":"Article 102523"},"PeriodicalIF":1.9000,"publicationDate":"2025-07-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"The effect of melatonin mouthwash on prevention of chemotherapy-induced oral mucositis, a randomized double blinded placebo controlled clinical trial\",\"authors\":\"Aida Abdi , Zaynab Sadeghi Ghadi , Maryam Daei , Elliyeh Ghadrdan\",\"doi\":\"10.1016/j.eujim.2025.102523\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Introduction</h3><div>Chemotherapy can induce a range of unpleasant adverse effects, with oral mucositis being one of the most common. This condition significantly impacts patients' quality of life and can disrupt their adherence to treatment protocols. Oral mucositis serves as an important limiting factor in chemotherapy, often necessitating dose reductions or treatment delays, which in turn can compromise the overall effectiveness of the therapy. This study was conducted to investigate the effect of melatonin mouthwash on the prevention of chemotherapy-induced oral mucositis.</div></div><div><h3>Methods</h3><div>Following the preparation of melatonin and placebo mouthwashes, a randomized, double-blinded, placebo-controlled clinical trial was conducted on patients with solid tumor malignancies who had no oral lesions and were treated with chemotherapy regimens. The patients began using the mouthwash on the first day of their corresponding chemotherapy course, continuing for six weeks with a frequency of three times daily, 4mL per application. At the end of each week, the patients were evaluated for the severity and duration of mucositis, as well as the associated pain. Quality of life was assessed at the study's start and weekly thereafter.</div></div><div><h3>Results</h3><div>Seventy patients were randomized into melatonin (<em>n</em> = 35) and placebo (<em>n</em> = 35) groups. The melatonin group had a lower incidence of mucositis (11.43 % versus 34.28 %), with a relative risk of 0.74 (95 % confidence interval (CI): 0.56 to 0.96). The severity of mucositis showed statistically significant differences between the melatonin and placebo groups at the end of the fifth week (<em>P</em> = 0.003) and the sixth week (<em>P</em> = 0.002). Additionally, the intensity of pain caused by mucositis demonstrated statistically significant differences at the end of the third week (<em>P</em> = 0.021), the fifth week (<em>P</em> = 0.001), and the sixth week (<em>P</em> = 0.001). There was also a significant difference in the overall duration of mucositis between the melatonin and placebo groups (mean difference -8.83, 95 %CI: -14.54 to -3.12). The mouthwash was well tolerated in both groups.</div></div><div><h3>Conclusion</h3><div>The findings of this study suggest that melatonin mouthwash is effective in preventing chemotherapy-induced mucositis. A six-week regimen of melatonin mouthwash significantly reduces the severity and duration of mucositis, as well as the associated pain intensity.</div></div>\",\"PeriodicalId\":11932,\"journal\":{\"name\":\"European Journal of Integrative Medicine\",\"volume\":\"78 \",\"pages\":\"Article 102523\"},\"PeriodicalIF\":1.9000,\"publicationDate\":\"2025-07-04\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"European Journal of Integrative Medicine\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://www.sciencedirect.com/science/article/pii/S1876382025000745\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q3\",\"JCRName\":\"INTEGRATIVE & COMPLEMENTARY MEDICINE\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"European Journal of Integrative Medicine","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S1876382025000745","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"INTEGRATIVE & COMPLEMENTARY MEDICINE","Score":null,"Total":0}

引用次数: 0

摘要

化疗可引起一系列不良反应，口腔黏膜炎是最常见的不良反应之一。这种情况会严重影响患者的生活质量，并可能破坏他们对治疗方案的依从性。口腔黏膜炎是化疗的一个重要限制因素，通常需要减少剂量或延迟治疗，这反过来又会损害治疗的整体有效性。本研究旨在探讨褪黑素漱口水对化疗所致口腔黏膜炎的预防作用。方法在制备褪黑素和安慰剂漱口水后，随机、双盲、安慰剂对照的临床试验，对无口腔病变的恶性实体瘤患者进行化疗。患者在相应化疗疗程的第一天开始使用漱口水，持续六周，频率为每天三次，每次4毫升。在每周结束时，评估患者的严重程度和持续时间，以及相关的疼痛。在研究开始时和之后每周对生活质量进行评估。结果70例患者随机分为褪黑素组（n = 35）和安慰剂组（n = 35）。褪黑素组的黏膜炎发生率较低（11.43%对34.28%），相对危险度为0.74（95%可信区间（CI）： 0.56 ~ 0.96）。在第5周末（P = 0.003）和第6周末（P = 0.002），褪黑素组与安慰剂组的粘膜炎严重程度有统计学差异。此外，粘膜炎引起的疼痛强度在第3周末（P = 0.021）、第5周末（P = 0.001）和第6周末（P = 0.001）差异有统计学意义。褪黑素组和安慰剂组在粘膜炎的总持续时间上也有显著差异（平均差异为-8.83,95% CI: -14.54至-3.12）。两组对漱口水的耐受性都很好。结论褪黑素漱口水对化疗引起的黏膜炎有一定的预防作用。六周的褪黑素漱口水疗法显著降低了黏膜炎的严重程度和持续时间，以及相关的疼痛强度。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

查看原文本刊更多论文

The effect of melatonin mouthwash on prevention of chemotherapy-induced oral mucositis, a randomized double blinded placebo controlled clinical trial

Introduction

Chemotherapy can induce a range of unpleasant adverse effects, with oral mucositis being one of the most common. This condition significantly impacts patients' quality of life and can disrupt their adherence to treatment protocols. Oral mucositis serves as an important limiting factor in chemotherapy, often necessitating dose reductions or treatment delays, which in turn can compromise the overall effectiveness of the therapy. This study was conducted to investigate the effect of melatonin mouthwash on the prevention of chemotherapy-induced oral mucositis.

Methods

Following the preparation of melatonin and placebo mouthwashes, a randomized, double-blinded, placebo-controlled clinical trial was conducted on patients with solid tumor malignancies who had no oral lesions and were treated with chemotherapy regimens. The patients began using the mouthwash on the first day of their corresponding chemotherapy course, continuing for six weeks with a frequency of three times daily, 4mL per application. At the end of each week, the patients were evaluated for the severity and duration of mucositis, as well as the associated pain. Quality of life was assessed at the study's start and weekly thereafter.

Results

Seventy patients were randomized into melatonin (n = 35) and placebo (n = 35) groups. The melatonin group had a lower incidence of mucositis (11.43 % versus 34.28 %), with a relative risk of 0.74 (95 % confidence interval (CI): 0.56 to 0.96). The severity of mucositis showed statistically significant differences between the melatonin and placebo groups at the end of the fifth week (P = 0.003) and the sixth week (P = 0.002). Additionally, the intensity of pain caused by mucositis demonstrated statistically significant differences at the end of the third week (P = 0.021), the fifth week (P = 0.001), and the sixth week (P = 0.001). There was also a significant difference in the overall duration of mucositis between the melatonin and placebo groups (mean difference -8.83, 95 %CI: -14.54 to -3.12). The mouthwash was well tolerated in both groups.

Conclusion

The findings of this study suggest that melatonin mouthwash is effective in preventing chemotherapy-induced mucositis. A six-week regimen of melatonin mouthwash significantly reduces the severity and duration of mucositis, as well as the associated pain intensity.

求助全文

通过发布文献求助，成功后即可免费获取论文全文。去求助

来源期刊

European Journal of Integrative Medicine INTEGRATIVE & COMPLEMENTARY MEDICINE-

CiteScore

4.70

自引率

4.00%

发文量

102

审稿时长

33 days

期刊介绍： The European Journal of Integrative Medicine (EuJIM) considers manuscripts from a wide range of complementary and integrative health care disciplines, with a particular focus on whole systems approaches, public health, self management and traditional medical systems. The journal strives to connect conventional medicine and evidence based complementary medicine. We encourage submissions reporting research with relevance for integrative clinical practice and interprofessional education. EuJIM aims to be of interest to both conventional and integrative audiences, including healthcare practitioners, researchers, health care organisations, educationalists, and all those who seek objective and critical information on integrative medicine. To achieve this aim EuJIM provides an innovative international and interdisciplinary platform linking researchers and clinicians. The journal focuses primarily on original research articles including systematic reviews, randomized controlled trials, other clinical studies, qualitative, observational and epidemiological studies. In addition we welcome short reviews, opinion articles and contributions relating to health services and policy, health economics and psychology.