Efficacy and safety of hangeshashinto for treatment of GERD refractory to proton pump inhibitors

Abstract

BackgroundProton pump inhibitor (PPI)-refractory gastroesophageal reflux disease (GERD) leads to a clinical decline in the quality of life (QOL). Therefore, new treatment options are needed. We performed a multicenter, randomized, parallel-group exploratory trial to determine the efficacy of hangeshashinto (HST) in patients with PPI-refractory GERD.MethodsWe enrolled 78 patients with PPI-refractory GERD for standard PPI regimens for at least 4\xa0weeks and randomly assigned patients to receive either a combination of usual dose of rabeprazole (10\xa0mg/day)\u2009+\u2009HST (7.5\xa0g/day; HST group) or a double dose of rabeprazole (20\xa0mg/day; double-dose PPI group). The primary end points were the extent of improvement in FSSG (Frequency Scale for the Symptoms of GERD) score and the change over time in FSSG score.ResultsThere was no significant difference in terms of the improvement degree of the FSSG score between the two groups. Although the total FSSG score and reflux syndrome score decreased significantly for both groups over time (p\u2009<\u20090.001), the acid-related dyspepsia (ARD) score decreased significantly in the HST group from 1\xa0week after drug administration (p\u2009<\u20090.05), indicating an improvement in the condition earlier than in the double-dose PPI group. Moreover, in examinations concerning BMI and age, the HST group had a significantly higher improvement degree of ARD score in patients with BMI\u2009<\u200922 (p\u2009<\u20090.05) and aged\u2009<\u200965\xa0years (p\u2009<\u20090.05) than the double-dose PPI group.ConclusionsHST may be beneficial for patients with PPI-refractory GERD, particularly in non-obese and non-elderly patients with dyspepsia symptoms.