After receiving acupuncture treatment 3 days a week during the course of radiation treatment, patients with head and neck cancer experienced less dry mouth, according to study results published by Garcia et al in JAMA Network Open.
The results are from the first randomized, placebo-controlled, phase III trial to evaluate the use of acupuncture during radiation therapy to reduce the incidence and severity of radiation-induced xerostomia, or dry mouth. These results support a 2011 study published by Meng et al in Cancer that found symptoms improved up to 6 months after radiation treatment with concurrent acupuncture sessions in patients with nasopharyngeal carcinoma.
Lorenzo Cohen, PhD
“Dry mouth is a serious concern for [patients with head and neck cancer] undergoing radiation therapy. The condition can affect up to 80% of patients by the end of radiation treatment,” said the study's principal investigator, Lorenzo Cohen, PhD, Professor of Palliative, Rehabilitation, and Integrative Medicine and Director of the Integrative Medicine Program at The University of Texas MD Anderson Cancer Center. “The symptoms severely impact quality of life and oral health, and current treatments have limited benefits.”
Methods
The study included 339 patients with head and neck cancer undergoing radiation treatment at MD Anderson and Fudan University Cancer Center in Shanghai between December 2011 and July 2015. The patients were divided into three groups: one group received true acupuncture; another group received sham acupuncture (the sham procedure in this randomized clinical trial involved a real needle at a real point not indicated for xerostomia, real needles at sham points, and placebo needles at sham points); and the third group, the standard care control group, received radiation and oral health education but no acupuncture. No patients had received acupuncture prior to participating in the study.
Patients assigned to either true or sham acupuncture received acupuncture 3 days a week on the same day as their radiation treatment, which lasted 6 to 7 weeks.
Results were based on data derived from a self-report questionnaire. Patients completed the Xerostomia Questionnaire (XQ), an eight-item survey assessing symptoms of the condition. XQ scores under 30 corresponded to mild or no symptoms of xerostomia. The data was collected at baseline; at the end of radiotherapy; and 3, 6, and 12 months after radiation treatment.
Results
Patients who underwent true acupuncture had significantly lower xerostomia scores than those in the standard care control group and marginally lower scores than the sham acupuncture, with no differences between sham acupuncture and standard care. One year after the end of radiation therapy, the incidence of clinically significant xerostomia was 35% in the true acupuncture group, 48% in the sham acupuncture group, and 55% in the standard care control group.
True acupuncture resulted in significantly fewer and less severe dry mouth symptoms 1 year after treatment. The xerostomia score in the true acupuncture group was 26.6 vs 31.3 in the sham acupuncture group and 34.8 in the standard care control group.
“I think with this study, we can add acupuncture to the list for the prevention and treatment of xerostomia, and the guidelines for the use of acupuncture in the oncology setting should be revised to include this important chronic condition.”— Lorenzo Cohen, PhD
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The Acupuncture Expectancy Scale (AES) was used to measure the relationship between expectations related to acupuncture and clinical response. Patients completed the AES at baseline, after four acupuncture sessions, and at the end of acupuncture treatment. There were no group differences or differences between sites.
“The evidence is to a point where patients should incorporate acupuncture alongside radiation treatment as a way to prevent the severity of dry mouth symptoms,” said Dr. Cohen. “I think with this study, we can add acupuncture to the list for the prevention and treatment of xerostomia, and the guidelines for the use of acupuncture in the oncology setting should be revised to include this important chronic condition.”
A secondary analysis showed a significant difference between sites in response to placebo. The Chinese patients had little to no placebo response to sham acupuncture, whereas the MD Anderson patients had a large placebo response, showing both forms of acupuncture worked. More studies are needed to understand these site differences, but it has been suggested that it could be due to the environment in which the acupuncture is delivered, cultural influences, or the relationship between patient and practitioner.
Future studies will focus on ensuring acupuncture delivery is well controlled and will evaluate inconsistencies in response to sham acupuncture. Additional studies are needed to confirm the trial results and better understand the neurologic mechanisms of acupuncture.
Disclosure: The research was supported in part by the National Cancer Institute (NCI) and the Chinese Science and Technology Commission of Shanghai Municipality. For full disclosures of the study authors, visit jamanetwork.com.
