A randomized, double-blind, placebo-controlled trial of a traditional herbal formula, Yukmijihwang-tang in elderly subjects with xerostomia.
ETHNOPHARMACOLOGICAL RELEVANCE
Yukmijihwang-tang (YMJ) is a typical herbal formula to treat Yin-deficiency (YD) syndrome by enriching the fluid-humor of the body. YMJ has been used to treat dry mouth symptoms for hundreds of years in traditional East Asian medicine. Xerostomia, a subjective oral dryness, is common in the elderly and results in impaired quality of life. Many conventional treatments for xerostomia provide only temporary symptom relief, and have side effects. The aim of this study is to investigate the efficacy and safety of YMJ for the treatment of xerostomia in the elderly.


METHODS
This study was designed as a randomized, placebo-controlled, double-blinded, two center trial. Ninety-six subjects aged 60-80 years who had experienced xerostomia for at least 3 months and presented with score>40 on the visual analog scale (VAS) for subjective oral dryness were recruited and randomly allocated to YMJ and placebo groups. YMJ or placebo was administered to each group for 8 weeks (3g of YMJ or placebo, three times per day). The primary outcome was change of VAS for xerostomia from 0 to 8 weeks.


RESULTS
VAS for xerostomia was decreased by 22.04±22.76 in the YMJ group and 23.58±23.04 in the placebo group. YMJ had no effect on xerostomia. However, participants with BMIs lower than 29.37kg/m(2) showed improvement of xerostomia after 8 weeks of treatment with YMJ compared to placebo. In addition, YMJ improved oral moisture, which is associated with subjective oral dryness in the YMJ group, and the relationship between VAS for xerostomia and YD was significant.


CONCLUSION
A trend was observed in which YMJ improved oral moisture status and subjective oral dryness in elderly subjects with lower BMI and greater tendency toward YD.
['Han|Gajin|G|', 'Ko|Seok-Jae|SJ|', 'Kim|Juyeon|J|', 'Oh|Ja-Young|JY|', 'Park|Jae-Woo|JW|', 'Kim|Jinsung|J|']
D000368:Aged D000369:Aged, 80 and over D015992:Body Mass Index D004311:Double-Blind Method D004365:Drugs, Chinese Herbal D005260:Female D006801:Humans D008297:Male D008516:Medicine, Chinese Traditional D016896:Treatment Outcome D014987:Xerostomia
Yukmijihwang-tang Xerostomia Oral moisture 5-hydroxymethyl-2-furaldehyde (PubChem CID: 237332) Gallic acid (PubChem CID: 370) Herbal medicine Salivary flow Yin deficiency acetic acid (PubChem CID: 176) acetonitrile (PubChem CID: 6342) alisol B acetate (PubChem CID: 3084460) allantoin (PubChem CID: 204) loganin (PubChem CID: 87691) paeoniflorin (PubChem CID: 442534) paeonol (PubChem CID: 11092)