Article Publish Status: FREE
Abstract Title:

Clinical Evaluation of a Royal Jelly Supplementation for the Restoration of Dry Eye: A Prospective Randomized Double Blind Placebo Controlled Study and an Experimental Mouse Model.

Abstract Source:

PLoS One. 2017 ;12(1):e0169069. Epub 2017 Jan 6. PMID: 28060936

Abstract Author(s):

Sachiko Inoue, Motoko Kawashima, Ryuji Hisamura, Toshihiro Imada, Yusuke Izuta, Shigeru Nakamura, Masataka Ito, Kazuo Tsubota

Article Affiliation:

Sachiko Inoue


BACKGROUND: Dry eye is a multifactorial disease characterized by ocular discomfort and visual impairment. Lacrimal gland function has been shown to decrease with aging, a known potent risk factor for dry eye. We have previously found that orally administrated royal jelly (RJ) restored tear secretion in a rat model of dry eye.

METHODS AND FINDINGS: We examined the effects of RJ oral administration on dry eye in this prospective, randomized, double-blind, placebo-controlled study. Forty-three Japanese patients aged 20-60 years with subjective dry eye symptoms were randomized to an RJ group (1200 mg/tablet, six tablets daily) or a placebo group for 8 weeks. Keratoconjunctival epithelial damage, tear film break-up time, tear secretion volume, meibum grade, biochemical data, and subjective dry eye symptoms based on a questionnaire were investigated at baseline, and at 4 and 8 weeks after intervention. Adverse events were reported via medical interviews. In the RJ group, tear volume significantly increased after intervention (p = 0.0009). In particular, patients with a baseline Schirmer value of≤10 mm showed a significant increase compared with baseline volume (p = 0.0005) and volume in the placebo group (p = 0.0051). No adverse events were reported. We also investigated the effect of RJ (300 mg/kg per day) administration using a mouse model of dry eye. Orally repeated administration ofRJ preserved tear secretion, potentially through direct activation of the secretory function of the lacrimal glands.

CONCLUSION: Our results suggest that RJ improves tear volume in patients with dry eye.

TRIAL REGISTRATION: Registered NO. the University Hospital Medical Information Network in Japan (UMIN000014446).

Study Type : Animal Study, Human Study

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