Introduction: Dysphagia is common in head and neck cancer patients after concurrent chemoradiation therapy (CRT). This study evaluated the feasibility of conducting a randomized sham-controlled trial and collected preliminary data on safety and efficacy of acupuncture.
Patients and methods: Head and neck cancer (HNC) patients with stage III-IV squamous cell carcinoma were randomized to 12 sessions of either active acupuncture (AA) or sham acupuncture (SA) during and following CRT. Patients were blinded to treatment assignment. Swallowing-related quality of life (QOL) was assessed using the MD Anderson Dysphagia Inventory (MDADI) total and subscale scores.
Results: Multiple aspects of trial feasibility were confirmed. Forty-two of 196 patients screened (21%) were enrolled and randomized to receive AA (n = 21) or SA (n = 21); 79% completed at least 10 of 12 planned acupuncture sessions; 81% completed the study follow-ups. The majority of patients reported uncertainty regarding their treatment assignment, with no difference between the AA and SA groups. Audits confirmed both AA and SA treatments were delivered with high fidelity. No serious acupuncture-related side effects were observed. MDADI total scores significantly improved from baseline to 12 months post-CRT in both groups (AA: +7.9; SA +13.9; p = .044, p < .001). Similar patterns were observed for the MDADI global subscale (AA: +25.0; SA +22.7; p = .001, p = .002). Intent-to-treat analyses suggested no difference between the treatment groups (p = .17, p = .76 for MDADI total and global scores, respectively).
Conclusion: A sham-controlled randomized trial evaluating acupuncture in dysphagia-related QOL in HNC found the procedure to be feasible and safe. Further investigation is required to evaluate efficacy.
Implications for practice: Dysphagia or swallowing difficulty is an important and common condition after concurrent chemoradiation therapy in head and neck cancer patients. In addition to current available supportive care, acupuncture may offer potential for treating dysphagia. This study demonstrated that both active acupuncture and sham acupuncture are safe and were associated with improved dysphagia-related quality of life from baseline to 12 months after concurrent chemoradiation therapy. This study was not designed to inform underlying specific versus nonspecific effects. Future larger-scale pragmatic clinical trials evaluating the effectiveness of acupuncture versus standard of care are warranted, and further mechanistic research is needed to understand how active versus purportedly sham acupuncture procedures affect dysphagia-related symptoms.
引言. 吞咽困难在接受同步化放疗 (CRT) 的头颈癌患者中很常见。本研究评价了随机假对照临床试验的可行性, 并且收集了针刺治疗安全性和有效性的初步数据。
患者与方法. 对III∼IV期头颈鳞癌 (SCCHN) 患者在CRT期间和之后随机给予12个疗程的针刺治疗 (AA) 或假针刺治疗 (SA) 。患者对治疗分配不知情。使用MD安德森吞咽困难量表 (MDADI) 评估吞咽相关生活质量 (QoL) 总评分和分量表评分。
结果. 我们确认了临床试验的多方面可行性。共筛查196例患者, 42例 (21%) 入选, 随机给予AA (n=21) 或SA (n=21) 治疗。79%的患者至少完成了计划12个针刺疗程中的10个疗程, 81%完成了所有研究随访。大多数患者报告不清楚自己的治疗分组, AA和SA组间无差异。经审查确认AA和SA治疗的实施均具有很高的逼真度。研究未观察到严重针刺相关性不良事件。两组患者基线至CRT后12个月的MDADI总分均显著改善 (AA组: +7.9, SA: +13.9 ; P=0.044, P<0.001) 。MDADI分量表整体评分显示出类似的改善 (AA组: +25.0, SA: +22.7 ; P=0.001, P=0.002) 。意向性治疗分析提示治疗组间无差异 (MDADI总分和整体评分分别为P=0.17和P=0.76) 。
结论. 采用假对照随机临床试验来评价针刺治疗用于头颈癌患者吞咽困难相关性QoL是可行和安全的。需要开展进一步调查以评价有效性。The Oncologist 2016;21:1522–1529
对临床实践的提示: 对于头颈癌患者, 吞咽困难是同步化放疗后的重要和常见问题。除了目前可用的支持治疗外, 针刺在治疗吞咽困难中可能也具有潜力。本研究证实真针刺治疗和假针刺治疗均安全, 且可改善基线至同步化放疗后12个月的吞咽困难相关性生活质量。本研究的设计的目的不包括提供潜在特异性和非特异性作用信息。未来需要开展大型实用性临床试验以评价针刺治疗和标准治疗的有效性, 还需要开展进一步的机制研究以明确真实的针刺以及据信的假针刺操作对吞咽困难相关症状的影响。
Keywords: Acupuncture; Chemoradiation; Dysphagia; Head and neck cancers; Quality of life.