Abstract
BackgroundDry 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 FindingsWe 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 of RJ preserved tear secretion, potentially through direct activation of the secretory function of the lacrimal glands.ConclusionOur results suggest that RJ improves tear volume in patients with dry eye.Trial RegistrationRegistered NO. the University Hospital Medical Information Network in Japan (UMIN000014446)
Highlights
Dry eye is a common disease and recognized as a growing public health problem that degrades daily quality of life [1, 2] It is a multi-factorial disease characterized by ocular discomfort and visual impairment
Our results suggest that royal jelly (RJ) improves tear volume in patients with dry eye
The values ware statistically significant between RJ group and placebo group (p = 0.0054)
Summary
Dry eye is a common disease and recognized as a growing public health problem that degrades daily quality of life [1, 2] It is a multi-factorial disease characterized by ocular discomfort and visual impairment. The use of digital devices is a risk factor for dry eye [6]. The incidence of this condition has been increasing in the ageing modern society, including Japan [1]. The main products of beekeeping include honey, royal jelly (RJ), propolis, pollen, and bee larva produced or collected by Apidae. The efficacy of these products in the field of ophthalmology has been demonstrated [14,15]. 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
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