We previously prepared and pharmaceutically evaluated ginger orally disintegrating (OD) tablets, opti- mized the base formulation, and carried out a clinical trial in healthy adults in their 20s and 50s to measure their effect on salivary substance P (SP) level and improved swallowing function. In this study, we conducted clinical trials using the ginger OD tablets in older people to clinically evaluate the improvements in swallow- ing function resulting from the functional components of the tablet. The ginger OD tablets were prepared by mixing the excipients with the same amount of mannitol and sucrose to a concentration of 1% ginger. Eigh- teen healthy older adult volunteers aged 63 to 90 were included in the swallowing function test. Saliva was collected before and 15min after administration of the placebo and ginger OD tablets. Swallowing endoscopy was performed by an otolaryngologist before administration and 15min after administration of the ginger OD tablets. A scoring method was used to evaluate the endoscopic swallowing. Fifteen minutes after taking the ginger OD tablets, the salivary SP amount was significantly higher than prior to ingestion or after tak- ing the placebo (p<0.05). Among 10 subjects, one scored 1–3 using the four evaluation criteria. Overall, no aspiration occurred and a significant improvement in the swallowing function score was observed (p<0.05) after taking the ginger OD tablets. Our findings showed that the ginger OD tablets increased the salivary SP amount and improved swallowing function in older people with appreciably reduced swallowing function.
a Department of Pharmacy, Kochi Medical School Hospital; 185–1 Kohasu, Oko-cho, Nankoku, Kochi 783–8505, Japan: b Kochi Medical Graduate School; 185–1 Kohasu, Oko-cho, Nankoku Kochi 783–8505, Japan: and
c Department of Otolaryngology, Head and Neck Surgery, Kochi Medical School; 185–1 Kohasu, Oko-cho, Nankoku, Kochi 783–8505, Japan.
Received December 28, 2015; accepted March 21, 2016