Sham-controlled, randomised, feasibility trial of acupuncture for prevention of radiation-induced xerostomia among patients with nasopharyngeal carcinoma

Abstract

Background: Xerostomia (dry mouth) after head/neck radiation is a common problem among cancer patients. Quality of life (QOL) is impaired, and available treatments are of little benefit. This trial determined the feasibility of conducting a sham-controlled trial of acupuncture and whether acupuncture could prevent xerostomia among head/neck patients undergoing radiotherapy.

Methods: A sham controlled, feasibility trial was conducted at Fudan University Shanghai Cancer Center, Shanghai, China among patients with nasopharyngeal carcinoma undergoing radiotherapy. To determine feasibility of a sham procedure, 23 patients were randomised to real acupuncture (N=11) or to sham acupuncture (N=12). Patients were treated three times/week during the course of radiotherapy. Subjective measures were the Xerostomia Questionnaire (XQ) and MD Anderson Symptom Inventory for Head and Neck Cancer (MDASI-HN). Objective measures were unstimulated whole salivary flow rates (UWSFR) and stimulated salivary flow rates (SSFR). Patients were followed for 1 month after radiotherapy.

Results: XQ scores for acupuncture were significantly lower than sham controls starting in week 3 and lasted through the 1-month follow-up (all P's <0.001 except for week 3, which was 0.006), with clinically significant differences as follows: week 6 - RR 0.28 [95% confidence interval, 0.10, 0.79]; week 11 - RR 0.17 [95%CI, 0.03, 1.07]. Similar findings were seen for MDASI-HN scores and MDASI-Intrusion scores. Group differences for UWSFR and SSFR were not found.

Conclusions: In this small pilot study, true acupuncture given concurrently with radiotherapy significantly reduced xerostomia symptoms and improved QOL when compared with sham acupuncture. Large-scale, multi-centre, randomised and placebo-controlled trials are now needed.

Conflict of interest statement

CONFLICT OF INTEREST STATEMENT

None declared.

Copyright © 2012 Elsevier Ltd. All rights reserved.

Figures

Figure 1

Patient flow diagram.

Figure 2

Xerostomia Questionnaire raw means and standard error bars over time. P values at each time point are based on the LSMEAN group comparison analyses from the mixed model analyses.

Figure 3

MD Anderson Symptom Inventory raw means and standard error bars over time (a. Symptom Severity; b. Interference; c. Head and Neck Subscale). P values at each time point are based on the LSMEAN group comparison analyses from the mixed model analyses.

Figure 3

MD Anderson Symptom Inventory raw means and standard error bars over time (a. Symptom Severity; b. Interference; c. Head and Neck Subscale). P values at each time point are based on the LSMEAN group comparison analyses from the mixed model analyses.

Figure 3

MD Anderson Symptom Inventory raw means and standard error bars over time (a. Symptom Severity; b. Interference; c. Head and Neck Subscale). P values at each time point are based on the LSMEAN group comparison analyses from the mixed model analyses.

Figure 4

Stimulated and unstimulated whole salivary flow rates raw means and standard error bars over time. P values at each time point are based on the LSMEAN group comparison analyses from the mixed model analyses.