The use of hangeshashinto (HST) in combination with traditional proton-pump inhibitor (PPI) therapy for four weeks may be beneficial for certain patients with PPI-refractory gastroesophageal reflux disease (GERD). A new exploratory Japanese study showed that the combination may be of particular benefit for non-obese and non-elderly patients.
HST is an herbal multicomponent medicine extracted from seven types of crude drugs used in traditional Japanese Kampo Medicine; it is a prescription drug approved by Japanese regulatory authorities for diarrhea, dyspepsia, nervous gastritis, and more.
“Based on the characteristic of patients that responded to HST, the drug may become a new treatment option for PPI-refractory GERD, particularly for patients with acid-related dyspepsia symptoms who are non-obese or non-elderly,” wrote researcher Toshihisa Takeuchi, of Osaka Medical College Hospital Endoscopy Center, Japan, and colleagues.
The study included 78 patients with PPI-refractory GERD and randomly assigned them to either combination of usual dose rabeprazole plus HST or double dose of rabeprazole. The primary endpoints were extent of improvement in Frequency Scale for the Symptoms of GERD (FSSG) score and the change over time in FSSG score.
There was no significant difference in the improvement of the degree of the FSSG score between the two treatment groups.
“We demonstrated that combined HST treatment has a therapeutic effect that is not inferior to that of double-dose PPI treatment, despite the significantly higher number of moderate and severe GERD cases in the HST group,” the researchers noted.
Both groups experienced a significant decrease in total FSSG score and reflux syndrome score over time (P < .001), but patients assigned to HST plus rabeprazole had a significant decrease in acid-related dyspepsia (ARD) from 1 week after drug initiation (P < .05). According to the researchers, this indicated “an improvement in the condition earlier than in the double-dose PPI group.”
A secondary analysis looking at patient characteristics showed that treatment with the double-dose PPI was significantly less effective in those patients with a low body mass index (BMI, < 22 kg/m2) compared with those with a high BMI. Among patients assigned to HST, treatment was significantly more effective in patients aged < 65 years compared with those aged ≥ 65 years. Patient sex did not affect outcomes.
The researchers noted that this was a small exploratory study limited by a lack of restriction by presence or absence of H. pylori and a lack of information about the safety and side effects of HST.