The Effect of Additional Acupuncture Versus Doubling the Proton Pump Inhibitor (PPI) Dose on Symptoms Report of Patients Who Continued To Be Symptomatic on Standard Dose PPI - A Randomized Trial

Purpose: To determine the efficacy of adding acupuncture as compared to doubling the PPI dose in GERD patients unresponsive to standard dose PPI. Methods: Thirty consecutive patients with classic heartburn symptoms unresponsive to standard dose PPI were enrolled into the study. Patients were evaluated by a demographics questionnaire, the validated GERD Symptom Checklist, GERD Symptom Assessment Score (GSAS) and the quality of life questionnaire (SF-36). All participants underwent an upper endoscopy on PPI once a day. Patients were excluded if erosive esophagitis or GERD-related complications were documented. Patients were randomized to either adding acupuncture or doubling the PPI dose over a period of 4 weeks. Acupuncture was delivered twice a week by an expert. Patients filled diary on a daily basis that documented severity and frequency of GERD-related symptoms. Symptom score (frequency x severity) was calculated for previous 7 days at baseline and at 2 and 4 weeks of treatment in both groups. Results: The two groups did not differ in gender (M/F), age and BMI (High PPI dose - 10/5, 48.9 ± 8.11, 31.4 ± 8.7, acupuncture group −9/6, 52.7 ± 10.8, 32.3 ± 6.2, respectively, p= NS). The acupuncture group demonstrated a significant decrease in the mean daytime heartburn scores from baseline to week 2 and 4 as compared to the high-dose PPI group (18.3, 8.5, 3.2, p < 0.05 versus 12.8, 11.9, 16.4, p= NS, respectively). Mean nighttime heartburn scores were significantly improved only in the acupuncture group as compared to the high PPI dose group (18.07, 7.2, 3.6, p < 0.05 versus 12.8, 14.4,15.6, p= NS, respectively). Mean regurgitation scores were significantly improved only in the acupuncture group as compared to the high PPI dose group (14.8, 7.3, 3.67, p < 0.05 versus 8.9, 6.2, 7.4, p= NS, respectively). Conclusions: Adding acupuncture as compared to doubling the PPI dose was more effective in controlling GERD-related symptoms in GERD patients unresponsive to standard dose PPI.