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.
<h4>Background</h4>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) rest...
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Public Library of Science (PLoS)
2017-01-01
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| Series: | PLoS ONE |
| Online Access: | https://journals.plos.org/plosone/article/file?id=10.1371/journal.pone.0169069&type=printable |
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| author | Sachiko Inoue Motoko Kawashima Ryuji Hisamura Toshihiro Imada Yusuke Izuta Shigeru Nakamura Masataka Ito Kazuo Tsubota |
| author_facet | Sachiko Inoue Motoko Kawashima Ryuji Hisamura Toshihiro Imada Yusuke Izuta Shigeru Nakamura Masataka Ito Kazuo Tsubota |
| author_sort | Sachiko Inoue |
| collection | DOAJ |
| description | <h4>Background</h4>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.<h4>Methods and findings</h4>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 of RJ preserved tear secretion, potentially through direct activation of the secretory function of the lacrimal glands.<h4>Conclusion</h4>Our results suggest that RJ improves tear volume in patients with dry eye.<h4>Trial registration</h4>Registered NO. the University Hospital Medical Information Network in Japan (UMIN000014446). |
| format | Article |
| id | doaj-art-d0b8909224834490924cd391a5fd991f |
| institution | OA Journals |
| issn | 1932-6203 |
| language | English |
| publishDate | 2017-01-01 |
| publisher | Public Library of Science (PLoS) |
| record_format | Article |
| series | PLoS ONE |
| spelling | doaj-art-d0b8909224834490924cd391a5fd991f2025-08-20T02:28:58ZengPublic Library of Science (PLoS)PLoS ONE1932-62032017-01-01121e016906910.1371/journal.pone.0169069Clinical 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.Sachiko InoueMotoko KawashimaRyuji HisamuraToshihiro ImadaYusuke IzutaShigeru NakamuraMasataka ItoKazuo Tsubota<h4>Background</h4>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.<h4>Methods and findings</h4>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 of RJ preserved tear secretion, potentially through direct activation of the secretory function of the lacrimal glands.<h4>Conclusion</h4>Our results suggest that RJ improves tear volume in patients with dry eye.<h4>Trial registration</h4>Registered NO. the University Hospital Medical Information Network in Japan (UMIN000014446).https://journals.plos.org/plosone/article/file?id=10.1371/journal.pone.0169069&type=printable |
| spellingShingle | Sachiko Inoue Motoko Kawashima Ryuji Hisamura Toshihiro Imada Yusuke Izuta Shigeru Nakamura Masataka Ito Kazuo Tsubota 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. PLoS ONE |
| 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. |
| title_full | 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. |
| title_fullStr | 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. |
| title_full_unstemmed | 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. |
| title_short | 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. |
| title_sort | 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 |
| url | https://journals.plos.org/plosone/article/file?id=10.1371/journal.pone.0169069&type=printable |
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