ARIX: A randomized trial of acupuncture versus oral care sessions in patients with chronic radiation-induced xerostomia following treatment for head and neck cancer.

Abstract

5527 Background: Radiation induced xerostomia impairs quality of life of in head and neck cancer survivors. Prior small non-randomised studies suggest that acupuncture may alleviate symptoms. We report the first large randomised trial comparing 8 weeks of group acupuncture with oral care sessions as a control. Methods: 145 patients with radiation induced xerostomia>18 months were recruited from 7 UK Cancer centres. Subjects received standardised group sessions of oral care (OC) education and 8 sessions of weekly group acupuncture (A) in a randomised crossover design with a 4 week washout (Group One OC/A and Group Two A/OC). Acupuncture was standardised to a technique previously piloted (3 auricular points and two distal points bilaterally). Patients completed the EORTC QLQ H&N questionnaire at baseline and weeks 5, 9, 13, 17 and 21 in addition to rating 4 key dry mouth symptoms. The primary outcome was patient reported improvement in dry mouth symptoms. The statistical analysis was longitudinal based on logistic regression models and adjustment for potential carry over. Stimulated and unstimulated saliva was measured. Results: An improvement for 5/7 symptoms was noted following acupuncture. In Group One 24% showed improvement 8 weeks following A (19% after OC). In Group Two 26% reported improvement in severe dry mouth after A (14% after OC). The estimated OR of improved dry mouth 5 weeks after A compared to OC was 2.0 (p=0.031), after adjusting for effects of time, potential carry-over, centre and patient characteristics. The estimated odds ratios of improvement in severity of symptoms for A compared to OC were (OR=1.67, p=0.048) for sticky saliva, (OR=2.08, p=0.011) for needing to sip to swallow food and (OR=1.71, p=0.013) for waking up at night needing to drink. Mean attendance rate for A was 89% and 80% for OC. There was no significant change in saliva production over time or by intervention. Mean global QoL score did not change significantly over time either within or between groups. No adverse events were seen. Conclusions: Eight sessions of weekly group acupuncture provides significantly better relief of radiation induced xerostomia than group oral care education.