title: Long-term effects of goshajinkigan in prevention of diabetic complications: a randomized open-labeled clinical trial.
abstract: Objective. This clinical trial was designed to investigate whether goshajinkigan reduces the onset of diabetic complications or not. Materials and Methods. A total of 332 type 2 diabetic mellitus patients were registered from 9 clinical centers from March 2000 to August 2007. Patients were randomly assigned to take goshajinkigan extract powder, 2.5 grams for 3 times a day or no kampo therapy, additionally to the regular treatment. The primary endpoints were the onset of macrovascular diseases or progression of nephropathy or retinopathy. Statistical analysis was performed by the intention-to-treat method. Results. After 5 years of observation, 116 patients were submitted to analysis. Among them, no macrovascular events were observed in both groups. Although 43 participants had upstaging of retinopathy or nephropathy in total, there was no significant difference between goshajinkigan group and control group. Deterioration of ankle reflex was suppressed in goshajinkigan group. Also glycated hemoglobin, and fasting plasma glucose were decreased in the goshajinkigan group. Conclusion. Although the power of analysis was too low to demonstrate any effects of goshajinkigan on the progression of macrovascular diseases, retinopathy or nephropathy, goshajinkigan may be beneficial for diabetic neuropathy and glycemic control.
authors.affiliation: Center for Kampo Medicine, Faculty of Environment and Information Study, Keio University School of Medicine, 5322 Endo, Fujisawa, Kanagawa 252-0882, Japan.
authors.forename: K
authors.initials: K
authors.lastname: Watanabe
authors.affiliation: Division of Internal Medicine, Saiseikai Central Hospital, 1-14-17 Mita, Minato-ku, Tokyo 108-0073, Japan.
authors.forename: A
authors.initials: A
authors.lastname: Shimada
authors.affiliation: Department of Clinical Research and Informatics, National Center for Global Health and Medicine, 1-21-1 Toyama, Shinjuku-ku, Tokyo 162-8655, Japan.
authors.forename: K
authors.initials: K
authors.lastname: Miyaki
authors.affiliation: Department of Ophthalmology, Kyorin University School of Medicine, 6-20-2 Shinkawa, Mitaka, Tokyo 181-8611, Japan.
authors.forename: A
authors.initials: A
authors.lastname: Hirakata
authors.affiliation: Division of Internal Medicine, Saiseikai Central Hospital, 1-14-17 Mita, Minato-ku, Tokyo 108-0073, Japan.
authors.forename: K
authors.initials: K
authors.lastname: Matsuoka
authors.affiliation: Department of Preventive Medicine and Public Health, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan.
authors.forename: K
authors.initials: K
authors.lastname: Omae
authors.affiliation: Tokyo Dental College, Ichikawa General Hospital, 5-11-13 Sugano, Ichikawa, Chiba 272-8513, Japan.
authors.forename: I
authors.initials: I
authors.lastname: Takei