Effects of goshajinkigan on corneal sensitivity, superficial punctate keratopathy and tear secretion in patients with insulin-dependent diabetes mellitus.
Goshajinkigan (niu-che-shen-qi-wan in Chinese), a traditional herbal medicine, has been used in Japan to treat clinical symptoms of diabetic neuropathy. A double-masked study was performed to evaluate its effects on corneal sensitivity, superficial punctate keratopathy and tear production in patients with insulin-dependent diabetes mellitus. Fifty diabetic patients were randomized into two groups: Group A, in which 25 patients received goshajinkigan orally, 7.5 g/day for 3 months; Group B, in which 25 patients were orally administered placebo, 6.0 g/day for 3 months; and in Group C, 25 non-diabetic subjects were orally administered goshajinkigan, 7.5 g/day for 3 months. Corneal sensitivity was measured with an aesthesiometer. The area of superficial punctate keratopathy was expressed as a fluorescein staining score. Reflex tearing was determined with a Schirmer test without anesthesia goshajinkigan was analyzed by high-performance liquid chromatography. Corneal thresholds after treatment with goshajinkigan (2.03 g/mm2) in Group A were significantly lower than those before treatment (2.47 g/mm2). Those in Groups B and C did not change after treatment. Fluorescein staining scores after administration of Goshajinkigan (0.64) in Group A were significantly lower than those before treatment (1.32). Those in Groups B and C did not change after treatment. Schirmer test results after goshajinkigan administration (11.0 mm/5 min) in Group A were significantly higher than those before treatment (9.3 mm/5 min). Those in Groups B and C did not change after treatment. Hemoglobin A1c levels in Groups A, B,and C did not change after treatment. Several components in goshajinkigan were found on high performance liquid chromatography. In conclusion, goshajinkigan improved ocular surface disorders in patients with insulin-dependent diabetes mellitus.
Nagaki
Yasunori
Y
Department of Ophthalmology, Faculty of Medicine Toyama Medical and Pharmaceutical University, Toyama, Japan. ophthal@ms.toyama-mpu.ac.jp
Hayasaka
Seiji
S
Hayasaka
Yoriko
Y
Kadoi
Chiharu
C
Sekiya
Nobuyasu
N
Terasawa
Katsutoshi
K
Sakakibara
Iwao
I
D000328:Adult; D002851:Chromatography, High Pressure Liquid; D003315:Cornea / Q000187:drug effects* / Q000503:physiopathology; D003922:Diabetes Mellitus, Type 1 / Q000503:physiopathology*; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D004365:Drugs, Chinese Herbal / Q000494:pharmacology*; D015352:Dry Eye Syndromes / Q000188:drug therapy* / Q000503:physiopathology; D006801:Humans; D013666:Tears / Q000187:drug effects* / Q000378:metabolism / Q000502:physiology
D004365:Drugs, Chinese Herbal; C119642:gosha-jinki-gan