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 language | English |
|---|---|
| Article number | 128726 |
| Journal | Evidence-based Complementary and Alternative Medicine |
| Volume | 2014 |
| DOIs | |
| Publication status | Published - 2014 |
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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 journal › Article
}
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
AN - SCOPUS:84900310764
VL - 2014
JO - Evidence-based Complementary and Alternative Medicine
JF - Evidence-based Complementary and Alternative Medicine
SN - 1741-427X
M1 - 128726
ER -