Clinical trial: acupuncture vs. doubling the proton pump inhibitor dose in refractory heartburn R. DICKMAN*,  , E. SCHIFF à ,§, A. HOLLAND à , – , C. WRIGHT – , S. R. SARELA*, B. HAN* & R. FASS* *The Neuroenteric Clinical Research Group, Section of Gastroenterology, Southern Arizona VA Health Care System and University of Arizona Health Sciences Center, Tucson, AZ, USA;  Department of Gastroentero- logy and Oncology, Rabin Medical Center, Petach-Tikva, Israel; àDepart- ment of Integrative Medicine, Univer- sity of Arizona Health Sciences Center, Tucson, AZ, USA; §Bnai Zion Medical Center, Internal Medicine Division, Haifa, Israel; –Asian Insti- tute of Medical Studies, Tucson, AZ, USA Correspondence to: Prof. R. Fass, University of Arizona, Head, Neuroenteric Clinical Research Group, Southern Arizona VA Health Care System, GI Section (1-111G-1), 3601 S. 6th Avenue, Tucson, AZ 85723-0001, USA. E-mail: ronnie.fass@va.gov Publication data Submitted 20 July 2007 First decision 12 August 2007 Resubmitted 21 August 2007 2nd decision 30 August 2007 Resubmitted 12 September 2007 Accepted 12 September 2007 SUMMARY Background The current standard of care in proton pump inhibitor failure is to dou- ble the proton pump inhibitor dose, despite limited therapeutic gain. Aims To determine the efficacy of adding acupuncture vs. doubling the pro- ton pump inhibitor dose in gastro-oesophageal reflux disease patients who failed symptomatically on proton pump inhibitors once daily. Methods Thirty patients with classic heartburn symptoms who continued to be symptomatic on standard-dose proton pump inhibitors were enrolled into the study. All participants underwent upper endoscopy while on proton pump inhibitors once daily. Subsequently, patients were ran- domized to either adding acupuncture to their proton pump inhibitor or doubling the proton pump inhibitor dose over a period of 4 weeks. Acupuncture was delivered twice a week by an expert. Results The two groups did not differ in demographic parameters. The acupunc- ture + proton pump inhibitor group demonstrated a significant decrease in the mean daytime heartburn, night-time heartburn and acid regurgi- tation scores at the end of treatment when compared with baseline, while the double-dose proton pump inhibitor group did not demonstrate a significant change in their clinical endpoints. Mean general health score was only significantly improved in the acupuncture + proton pump inhibitor group. Conclusion Adding acupuncture is more effective than doubling the proton pump inhibitor dose in controlling gastro-oesophageal reflux disease-related symptoms in patients who failed standard-dose proton pump inhibitors. Aliment Pharmacol Ther 26, 1333–1344 Alimentary Pharmacology & Therapeutics ª 2007 The Authors 1333 Journal compilation ª 2007 Blackwell Publishing Ltd doi:10.1111/j.1365-2036.2007.03520.x