WHO monographs on selected medicinal plants - travolekar.ru

<strong>WHO</strong> <strong>monographs</strong> on selected medicinal plants
studies were small and were not randomized or double-blinded. Most of
them assessed the anti-diabetic effects of the crude drug in both noninsulin-dependent
diabetes mellitus (type II) and insulin-dependent
(type I) diabetes.
In a pilot study, the efficacy of the powdered fruit was assessed in
41 patients with diabetes. The patients were treated with varying doses of
the fruit for 6 months and the blood glucose level was reduced by up to
25% from a baseline value of 200 mg/dl and glycosylated haemoglobin
was lowered by an average of 0.5% (27).
The effects of the fruit on blood glucose levels were assessed in patients
with diabetes (26). Nineteen subjects were enrolled in the study,
including 14 patients with type I or type II diabetes mellitus, and five
healthy volunteers. The preparation used in this investigation was a protein
isolated from the crude drug and termed “vegetable insulin”. The
protein extract was suspended in sterile water and administered subcutaneously
at a concentration of 1.8 mg of protein per 40-unit dose. Nine of
the diabetic patients received 10 units of the formulation if their fasting
blood sugar was less than 180 mg/dl; 20 units when it was 180–250 mg/dl;
and 30 units when it was > 250 mg/dl. Five patients with diabetes and five
healthy volunteers received a placebo (sterile water). The primary endpoint
was a decrease in fasting blood glucose, which was measured over
12 hours after administration. The results showed a mean decrease in serum
glucose levels for the diabetic patients receiving treatment as early as
30 minutes after administration, a 21.5% decrease from mean baseline of
295 mg/dl. After 4 hours, a maximum decrease of 49.2% in serum glucose
was observed, and at 12 hours a 28% drop persisted. In contrast, patients
administered the placebo had a 5% decrease in serum glucose over the
study period. The patients with diabetes who received treatment had substantially
reduced mean baseline serum glucose concentrations, 295 mg/dl
versus a concentration in the placebo group of 210 mg/dl. No blinding,
randomization or statistical analyses were performed (26).
One investigation reports a series of case-studies in Asian patients with
type II diabetes (n = 9), of whom eight were taking concomitant sulfonylurea
drugs (29). After undergoing a baseline glucose tolerance test, the
test was repeated after oral administration of the fruit juice (50 ml), and
then again after oral ingestion, approximately 0.23 kg/day, of the fried
fruit for 8–11 weeks. The glucose tolerance test performed after ingestion
of the fruit showed a reduction in glucose levels of approximately 6%
after 1 hour, but this finding was not statistically significant. The glucose
tolerance test, done after consumption of the juice, showed a significant
decrease in glucose levels of 12% after 1 hour (p < 0.05) and in conjunc-
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