耳针治疗化疗引起的恶心和呕吐：一项盲法随机临床试验的初步研究

IF 1.7 Q2 Medicine

Advances in integrative medicine Pub Date : 2025-07-25 DOI:10.1016/j.aimed.2025.100559

Eliza Mara das Chagas Paiva , Caroline de Castro Moura , Natália da Silva Martins Fonseca , Ana Cláudia Mesquita Garcia

{"title":"耳针治疗化疗引起的恶心和呕吐：一项盲法随机临床试验的初步研究","authors":"Eliza Mara das Chagas Paiva , Caroline de Castro Moura , Natália da Silva Martins Fonseca , Ana Cláudia Mesquita Garcia","doi":"10.1016/j.aimed.2025.100559","DOIUrl":null,"url":null,"abstract":"<div><h3>Objective</h3><div>Auricular acupuncture (AA) is a promising intervention for managing chemotherapy-induced nausea and vomiting (CINV). However, most randomized clinical trials (RCTs) have methodological limitations and a significant risk of bias, making the evidence inconclusive. This pilot study aimed to assess the feasibility of an AA protocol for controlling CINV in adult cancer patients.</div></div><div><h3>Methods</h3><div>This was a pilot study of a parallel, two-arm, blinded RCT with a 1:1 allocation ratio. Participants were randomized into two study arms: the AA group, which received true auricular acupuncture, or the sham AA group. The evaluated outcomes included preliminary evaluation of the effectiveness of the intervention for the occurrence of CINV, adverse effects of the intervention and study feasibility.</div></div><div><h3>Results</h3><div>Among the participants assessed for eligibility, 50 patients were randomized into the study arms, with 70 % of final evaluations completed. Thirty-five participants completed the study between January and July 2023. No serious adverse events occurred. A significant difference was observed between the AA and sham groups regarding nausea after the last chemotherapy session at follow-up (p = 0.005), suggesting a potential benefit of the intervention.</div></div><div><h3>Conclusion</h3><div>This pilot study demonstrated the feasibility of conducting an RCT on AA for CINV control, highlighting challenges in recruitment and adherence. Preliminary findings suggest that AA is safe and generally associated with few adverse events, which were transient and mild in intensity. These findings reinforce the need for a definitive RCT to confirm efficacy and support the integration of AA into clinical practice.</div></div><div><h3>Trial registration</h3><div>This study is registered in the Brazilian Registry of Clinical Trials (ReBEC): RBR-5rp37x8.</div></div>","PeriodicalId":7343,"journal":{"name":"Advances in integrative medicine","volume":"12 4","pages":"Article 100559"},"PeriodicalIF":1.7000,"publicationDate":"2025-07-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Auricular acupuncture for chemotherapy-induced nausea and vomiting: A pilot study of a blinded randomized clinical trial\",\"authors\":\"Eliza Mara das Chagas Paiva , Caroline de Castro Moura , Natália da Silva Martins Fonseca , Ana Cláudia Mesquita Garcia\",\"doi\":\"10.1016/j.aimed.2025.100559\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Objective</h3><div>Auricular acupuncture (AA) is a promising intervention for managing chemotherapy-induced nausea and vomiting (CINV). However, most randomized clinical trials (RCTs) have methodological limitations and a significant risk of bias, making the evidence inconclusive. This pilot study aimed to assess the feasibility of an AA protocol for controlling CINV in adult cancer patients.</div></div><div><h3>Methods</h3><div>This was a pilot study of a parallel, two-arm, blinded RCT with a 1:1 allocation ratio. Participants were randomized into two study arms: the AA group, which received true auricular acupuncture, or the sham AA group. The evaluated outcomes included preliminary evaluation of the effectiveness of the intervention for the occurrence of CINV, adverse effects of the intervention and study feasibility.</div></div><div><h3>Results</h3><div>Among the participants assessed for eligibility, 50 patients were randomized into the study arms, with 70 % of final evaluations completed. Thirty-five participants completed the study between January and July 2023. No serious adverse events occurred. A significant difference was observed between the AA and sham groups regarding nausea after the last chemotherapy session at follow-up (p = 0.005), suggesting a potential benefit of the intervention.</div></div><div><h3>Conclusion</h3><div>This pilot study demonstrated the feasibility of conducting an RCT on AA for CINV control, highlighting challenges in recruitment and adherence. Preliminary findings suggest that AA is safe and generally associated with few adverse events, which were transient and mild in intensity. These findings reinforce the need for a definitive RCT to confirm efficacy and support the integration of AA into clinical practice.</div></div><div><h3>Trial registration</h3><div>This study is registered in the Brazilian Registry of Clinical Trials (ReBEC): RBR-5rp37x8.</div></div>\",\"PeriodicalId\":7343,\"journal\":{\"name\":\"Advances in integrative medicine\",\"volume\":\"12 4\",\"pages\":\"Article 100559\"},\"PeriodicalIF\":1.7000,\"publicationDate\":\"2025-07-25\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Advances in integrative medicine\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://www.sciencedirect.com/science/article/pii/S2212958825001181\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"Medicine\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Advances in integrative medicine","FirstCategoryId":"1085","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S2212958825001181","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"Medicine","Score":null,"Total":0}

引用次数: 0

摘要

目的耳针治疗化疗引起的恶心呕吐（CINV）是一种很有前景的治疗方法。然而，大多数随机临床试验（RCTs）都有方法学上的局限性和显著的偏倚风险，使得证据不具有结论性。本初步研究旨在评估AA方案控制成人癌症患者CINV的可行性。方法：本研究为一项平行、双臂、盲法随机对照试验，分配比例为1:1。参与者被随机分为两组：AA组，接受真正的耳穴针灸，或假AA组。评估结果包括初步评估干预措施对CINV发生的有效性、干预措施的不良反应和研究可行性。在合格评估的参与者中，50名患者被随机分配到研究组，70% %的最终评估完成。35名参与者在2023年1月至7月期间完成了这项研究。未发生严重不良事件。在随访中，AA组和假手术组在最后一次化疗后的恶心方面有显著差异（p = 0.005），表明干预有潜在的益处。结论：本初步研究证明了进行随机对照试验AA治疗CINV的可行性，强调了招募和依从性方面的挑战。初步研究结果表明，AA是安全的，通常与很少的不良事件相关，这些不良事件是短暂的，强度轻微。这些发现强调了需要一个明确的随机对照试验来确认疗效，并支持将AA纳入临床实践。试验注册本研究已在巴西临床试验注册中心（ReBEC）注册：RBR-5rp37x8。

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

Auricular acupuncture for chemotherapy-induced nausea and vomiting: A pilot study of a blinded randomized clinical trial

Objective

Auricular acupuncture (AA) is a promising intervention for managing chemotherapy-induced nausea and vomiting (CINV). However, most randomized clinical trials (RCTs) have methodological limitations and a significant risk of bias, making the evidence inconclusive. This pilot study aimed to assess the feasibility of an AA protocol for controlling CINV in adult cancer patients.

Methods

This was a pilot study of a parallel, two-arm, blinded RCT with a 1:1 allocation ratio. Participants were randomized into two study arms: the AA group, which received true auricular acupuncture, or the sham AA group. The evaluated outcomes included preliminary evaluation of the effectiveness of the intervention for the occurrence of CINV, adverse effects of the intervention and study feasibility.

Results

Among the participants assessed for eligibility, 50 patients were randomized into the study arms, with 70 % of final evaluations completed. Thirty-five participants completed the study between January and July 2023. No serious adverse events occurred. A significant difference was observed between the AA and sham groups regarding nausea after the last chemotherapy session at follow-up (p = 0.005), suggesting a potential benefit of the intervention.

Conclusion

This pilot study demonstrated the feasibility of conducting an RCT on AA for CINV control, highlighting challenges in recruitment and adherence. Preliminary findings suggest that AA is safe and generally associated with few adverse events, which were transient and mild in intensity. These findings reinforce the need for a definitive RCT to confirm efficacy and support the integration of AA into clinical practice.

Trial registration

This study is registered in the Brazilian Registry of Clinical Trials (ReBEC): RBR-5rp37x8.

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

Advances in integrative medicine INTEGRATIVE & COMPLEMENTARY MEDICINE-

CiteScore

3.20

自引率

11.80%

发文量

审稿时长

15 weeks

期刊介绍： Advances in Integrative Medicine (AIMED) is an international peer-reviewed, evidence-based research and review journal that is multi-disciplinary within the fields of Integrative and Complementary Medicine. The journal focuses on rigorous quantitative and qualitative research including systematic reviews, clinical trials and surveys, whilst also welcoming medical hypotheses and clinically-relevant articles and case studies disclosing practical learning tools for the consulting practitioner. By promoting research and practice excellence in the field, and cross collaboration between relevant practitioner groups and associations, the journal aims to advance the practice of IM, identify areas for future research, and improve patient health outcomes. International networking is encouraged through clinical innovation, the establishment of best practice and by providing opportunities for cooperation between organisations and communities.