Long-term effects of goshajinkigan in prevention of diabetic complications

A randomized open-labeled clinical trial

Kenji Watanabe, A. Shimada, K. Miyaki, A. Hirakata, K. Matsuoka, K. Omae, I. Takei

Research output: Contribution to journalArticle

8 Citations (Scopus)

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.

Original languageEnglish
Article number128726
JournalEvidence-based Complementary and Alternative Medicine
Volume2014
DOIs
Publication statusPublished - 2014

Fingerprint

Diabetes Complications
Clinical Trials
Disease Progression
Kampo Medicine
Diabetic Neuropathies
Glycosylated Hemoglobin A
gosha-jinki-gan
Ankle
Powders
Reflex
Fasting
Observation
Glucose
Control Groups
Therapeutics

ASJC Scopus subject areas

  • Complementary and alternative medicine

Cite this

Long-term effects of goshajinkigan in prevention of diabetic complications : A randomized open-labeled clinical trial. / Watanabe, Kenji; Shimada, A.; Miyaki, K.; Hirakata, A.; Matsuoka, K.; Omae, K.; Takei, I.

In: Evidence-based Complementary and Alternative Medicine, Vol. 2014, 128726, 2014.

Research output: Contribution to journalArticle

Watanabe, Kenji ; Shimada, A. ; Miyaki, K. ; Hirakata, A. ; Matsuoka, K. ; Omae, K. ; Takei, I. / Long-term effects of goshajinkigan in prevention of diabetic complications : A randomized open-labeled clinical trial. In: Evidence-based Complementary and Alternative Medicine. 2014 ; Vol. 2014.
@article{58b3976441654e31b5e4c262fe31d481,
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.",
author = "Kenji Watanabe and A. Shimada and K. Miyaki and A. Hirakata and K. Matsuoka and K. Omae and I. Takei",
year = "2014",
doi = "10.1155/2014/128726",
language = "English",
volume = "2014",
journal = "Evidence-based Complementary and Alternative Medicine",
issn = "1741-427X",
publisher = "Hindawi Publishing Corporation",

}

TY - JOUR

T1 - Long-term effects of goshajinkigan in prevention of diabetic complications

T2 - A randomized open-labeled clinical trial

AU - Watanabe, Kenji

AU - Shimada, A.

AU - Miyaki, K.

AU - Hirakata, A.

AU - Matsuoka, K.

AU - Omae, K.

AU - Takei, I.

PY - 2014

Y1 - 2014

N2 - 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.

AB - 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.

UR - http://www.scopus.com/inward/record.url?scp=84900310764&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84900310764&partnerID=8YFLogxK

U2 - 10.1155/2014/128726

DO - 10.1155/2014/128726

M3 - Article

VL - 2014

JO - Evidence-based Complementary and Alternative Medicine

JF - Evidence-based Complementary and Alternative Medicine

SN - 1741-427X

M1 - 128726

ER -