Comparative evaluation of fosinopril and herbal drug Dioscorea bulbifera in patients of diabetic nephropathy.

2013
Saudi journal of kidney diseases and transplantation : an official publication of the Saudi Center for Organ Transplantation, Saudi Arabia 24(4)
- R G Singh
- M Rajak
- B Ghosh
- A Agrawal
- G P Dubey

PubMed: 23816723
DOI: 10.4103/1319-2442.113866

Study Design

Type: Randomized Controlled Trial (RCT)
Sample size: n = 137
Population: 137 patients (M:F 2.61:1) with diabetic nephropathy, proteinuria >500 mg/day or albuminuria >300 mg/day, S Cr ≤2.5 mg/dL and hypertension controlled with a single drug, age range 19-76 years
Methods: hospital-based single-center prospective open-label randomized case-control interventional study; three groups: group A (n=46) on fosinopril (5-40 mg/day), group B (n=45) on Dioscorea bulbifera (500 mg BD), group C (n=46) on neither drug
Blinding: Open-label
Duration: six months

Large Human Trial

Worldwide, diabetic nephropathy is one of the leading causes of end-stage renal failure. This hospital-based single-center prospective open-label randomized case-control interventional study was performed to evaluate and compare the native drug Dioscorea bulbifera with fosinopril in the management of diabetic nephropathy. Patients with diabetic nephropathy with proteinuria >500 mg/day or albuminuria >300 mg/ day, S Cr ≤2.5 mg/dL and hypertension controlled with a single drug were included into the study and were divided into three groups according to the interventional drugs that they were given; group A (n = 46) on fosinopril (5-40 mg/day), group B (n = 45) on Dioscorea bulbifera (500 mg BD) and group C (n = 46) on neither of these drugs. All necessary laboratory investigations needed to assess the effect of both the drugs were carried out. Patients were followed-up for six months. The study included 137 patients (M:F 2.61:1) with an age range of 19-76 years. At the sixth-month follow-up, a significant decrease in the systolic blood pressure was noted in all three groups whereas the diastolic blood pressure decreased significantly only in group B. There was significantly better control of both systolic and diastolic blood pressures in group B than in the other groups. Although fasting blood sugar was poorly controlled in the initial visit in all three groups, there was a significant decrease at the sixth-month follow-up in all three groups. Moreover, the decrease was significantly more pronounced in group B than in the other two groups. Low-density lipoprotein decreased significantly only in group B. Proteinuria, serum transforming growth factor-β, interleukin-6 (IL-6) and C-reactive protein decreased in both group A and group B, more so in the latter, but the differences between the groups were not statistically significant. Importantly, proteinuria and serum IL-6 showed an increasing trend in group C. It can be concluded that Dioscorea bulbifera was more effective than fosinopril in controlling blood pressure, glycemia, cholesterolemia and inflammatory state in diabetic nephropathy. Both agents decreased proteinuria. However, creatinine clearance significantly decreased with both the drugs, more so with Dioscera, and thus further evaluation with a larger trial is needed.

Research Insights

air potato→Reduced Blood Pressure
There was significantly better control of both systolic and diastolic blood pressures in group B than in the other groups.
Effect
Beneficial
Effect size
Moderate
Dose
500 mg BD
air potato→Reduced C-Reactive Protein Levels
Proteinuria, serum transforming growth factor-β, interleukin-6 (IL-6) and C-reactive protein decreased in both group A and group B, more so in the latter, but the differences between the groups were not statistically significant.
Effect
Neutral
Effect size
Small
Dose
500 mg BD
air potato→Reduced Creatinine Clearance
However, creatinine clearance significantly decreased with both the drugs, more so with Dioscera, and thus further evaluation with a larger trial is needed.
Effect
Harmful
Effect size
Small
Dose
500 mg BD
air potato→Reduced Diastolic Blood Pressure
whereas the diastolic blood pressure decreased significantly only in group B. There was significantly better control of both systolic and diastolic blood pressures in group B than in the other groups.
Effect
Beneficial
Effect size
Moderate
Dose
500 mg BD
air potato→Reduced Fasting Blood Glucose Levels
Although fasting blood sugar was poorly controlled in the initial visit in all three groups, there was a significant decrease at the sixth-month follow-up in all three groups. Moreover, the decrease was significantly more pronounced in group B than in the other two groups.
Effect
Beneficial
Effect size
Moderate
Dose
500 mg BD
air potato→Reduced Interleukin-6 Levels
Proteinuria, serum transforming growth factor-β, interleukin-6 (IL-6) and C-reactive protein decreased in both group A and group B, more so in the latter, but the differences between the groups were not statistically significant.
Effect
Neutral
Effect size
Small
Dose
500 mg BD
air potato→Reduced Low-Density Lipoprotein Level
Low-density lipoprotein decreased significantly only in group B.
Effect
Beneficial
Effect size
Small
Dose
500 mg BD
air potato→Reduced Proteinuria
Proteinuria, serum transforming growth factor-β, interleukin-6 (IL-6) and C-reactive protein decreased in both group A and group B, more so in the latter, but the differences between the groups were not statistically significant.
Effect
Beneficial
Effect size
Small
Dose
500 mg BD
air potato→Reduced Systolic Blood Pressure
At the sixth-month follow-up, a significant decrease in the systolic blood pressure was noted in all three groups... There was significantly better control of both systolic and diastolic blood pressures in group B than in the other groups.
Effect
Beneficial
Effect size
Moderate
Dose
500 mg BD
air potato→Reduced Transforming Growth Factor-β Level
Proteinuria, serum transforming growth factor-β, interleukin-6 (IL-6) and C-reactive protein decreased in both group A and group B, more so in the latter, but the differences between the groups were not statistically significant.
Effect
Neutral
Effect size
Small
Dose
500 mg BD