A phase I/II study of Ling Zhi mushroom Ganoderma lucidum (W.Curt.:Fr.)Lloyd (Aphyllophoromycetideae) extract in patients with type II Diabetes Mellitus

Animal studies have demonstrated that the polysaccharide fractions of Ganoderma lucidum (Ling Zhi, reishi mushroom) have potential hypoglycemic and hypolipidemic activities. This clinical study aimed to evaluate the efficacy and safety of Ganopoly (polysaccharide fractions extracted from G. lucidum by patented technique) in 71 patients with confirmed type II diabetes mellitus (DM). Eligibility criteria included type II DM of >3 months' duration for which patients were not receiving insulin; age >18 years; normal vital signs for age and disease state; normal electrocardiogram (ECG); and fasting plasma glucose (FPG) level of 8.9.16.7 mmol/L in sulfonylurea-naive patients or an FPG <10 mmol/L before washout in sulfonylurea-treated patients. Patients were randomly grouped to be given either Ganopoly or placebo orally at 1800 mg three times daily for 12 weeks. Patients underwent 4 weeks of dose adjustment followed by 8 weeks of dose maintenance. Fasting and stimulated glycosylated hemoglobin (HbA1c), plasma glucose, insulin, and C-peptide were monitered at predetermined intervals. Adverse events and hypoglycemic episodes were recorded. The treatment of Ganopoly significantly decreased the mean HbA1c from 8.4 at baseline to 7.6% at 12 weeks. Significant changes in mean FPG and PPG levels at the last visit paralleled the changes in mean HbA1c levels. At baseline, the mean FPG and PPG values in patients treated with Ganopoly were 12.0 and 13.6 mmol/L, respectively. At week 12, mean PPG values had decreased to 11.8 mmol/L. However, these parameters did not change or slightly increased in patients receiving placebo. The between-group difference in PPG levels at week 12 was significant (p < 0.05). Changes in fasting insulin, 2-hour post-prandial insulin, fasting C-peptide, and 2-hour post-prandial C-peptide were consistent, with the between-group differences in these end points being significant at the last visit. Overall, Ganopoly was well tolerated.