title: Acupuncture for Chemoradiation Therapy-Related Dysphagia in Head and Neck Cancer: A Pilot Randomized Sham-Controlled Trial.
abstract: 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.
  
  
  
  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.
  
  
  
  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).
  
  
  
  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.
  
  
  
  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.
authors: Leonard P. Zakim Center for Integrative Therapies, Dana-Farber Cancer Institute, Boston, Massachusetts, USA weidong_lu@dfci.harvard.edu.
authors: Weidong
authors: W
authors: Lu
authors: Osher Center for Integrative Medicine, Division of Preventive Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, USA.
authors: Peter M
authors: PM
authors: Wayne
authors: Department of Medicine, Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA.
authors: Roger B
authors: RB
authors: Davis
authors: Osher Center for Integrative Medicine, Division of Preventive Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, USA.
authors: Julie E
authors: JE
authors: Buring
authors: Dana-Farber/Harvard Cancer Center, Boston, Massachusetts, USA.
authors: Hailun
authors: H
authors: Li
authors: Biostatistics Center, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA.
authors: Eric A
authors: EA
authors: Macklin
authors: Head and Neck Oncology Program, Dana-Farber Cancer Institute, Boston, Massachusetts, USA.
authors: Jochen H
authors: JH
authors: Lorch
authors: Head and Neck Oncology Program, Dana-Farber Cancer Institute, Boston, Massachusetts, USA.
authors: Elaine
authors: E
authors: Burke
authors: Head and Neck Oncology Program, Dana-Farber Cancer Institute, Boston, Massachusetts, USA.
authors: Tyler C
authors: TC
authors: Haddad
authors: Head and Neck Oncology Program, Dana-Farber Cancer Institute, Boston, Massachusetts, USA.
authors: Laura A
authors: LA
authors: Goguen
authors: Leonard P. Zakim Center for Integrative Therapies, Dana-Farber Cancer Institute, Boston, Massachusetts, USA.
authors: David S
authors: DS
authors: Rosenthal
authors: Head and Neck Oncology Program, Dana-Farber Cancer Institute, Boston, Massachusetts, USA.|Department of Radiation Oncology, Dana-Farber Cancer Institute/Brigham and Women's Hospital, Boston, Massachusetts, USA.
authors: Roy B
authors: RB
authors: Tishler
authors: Head and Neck Oncology Program, Dana-Farber Cancer Institute, Boston, Massachusetts, USA.|Head and Neck Oncology Center, Mount Sinai Medical Center, New York, New York, USA.
authors: Marshall R
authors: MR
authors: Posner
authors: Head and Neck Oncology Program, Dana-Farber Cancer Institute, Boston, Massachusetts, USA.
authors: Robert I
authors: RI
authors: Haddad
mesh_terms: D015670:Acupuncture Therapy / Q000009:adverse effects; D000368:Aged; D059248:Chemoradiotherapy / Q000009:adverse effects*; D003680:Deglutition Disorders / Q000209:etiology / Q000523:psychology / Q000628:therapy*; D005260:Female; D006258:Head and Neck Neoplasms / Q000473:pathology / Q000628:therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D011788:Quality of Life
keywords: Acupuncture; Chemoradiation; Dysphagia; Head and neck cancers; Quality of life