The effect of Momordica charantia capsule preparation on glycemic control in type 2 diabetes mellitus needs further studies. Evaluation of the efficacy of bitter gourd (momordica charantia) as an oral hypoglycemic agent--a randomized controlled clinical trial. Metformin-pioglitazone and metformin-rosiglitazone effects on non-conventional cardiovascular risk factors plasma level in type 2 diabetic patients with metabolic syndrome.
Momordica charantia, locally known as Ampalaya, is being widely used and advertised for its hypoglycemic effects. However, to date, no large clinical trial has been published on the efficacy of any type of preparation. The main objective of this study is to determine if addition of M. charantia capsules to standard therapy can decrease glycosylated hemoglobin (hemoglobin A1c or HbA1c) levels in diabetic patients with poor sugar control.
                A randomized, double-blind, placebo-controlled trial was conducted between April and September 2004 at the outpatient clinics of the Philippine General Hospital. The trial included 40 patients, 18 years old and above, who were either newly diagnosed or poorly controlled type 2 diabetics with A1c levels between 7% and 9%. On top of the standard therapy, the patients were randomized to either M. charantia capsules or placebo. The treatment group received two capsules of M. charantia three times a day after meals, for 3 months. The control group received placebo at the same dose. The primary efficacy endpoint was change in the A1c level in the two groups. The secondary efficacy endpoints included its effect on fasting blood sugar, serum cholesterol, and weight. Safety endpoints included effects on serum creatinine, hepatic transaminases (Alanine aminotransferase/ALT and Aspartate aminotransferase/AST), sodium, potassium, and adverse events.
                Baseline characteristics between the treatment and control groups were similar. The difference in mean change in A1c between the two groups was 0.22% in favor of M. charantia (95% CI: -0.40 to 0.84) with P=0.4825. There was no significant effect on mean fasting blood sugar, total cholesterol, and weight or on serum creatinine, ALT, AST, sodium, and potassium. There were few adverse events and these were generally mild.
                This is the first randomized controlled trial to shed light on the issue concerning the hypoglycemic effects of M. charantia. The investigators targeted a 1% decline in A1c at the outset with an estimated power of 88%. With the observed decline of 0.24%, the achieved power was only 11%. For this reason, we are unable to make a definite conclusion about the effectiveness of M. charantia. However, the results of this study can be used estimate the sample size for bigger studies. nan Metformin is considered the gold standard for type 2 diabetes treatment as monotherapy and in combination with sulphonylureas and insulin. The combination of metformin with thiazolidinediones is less well studied. The aim of the present study was to assess the differential effect, and tolerability, of metformin combined with pioglitazone or rosiglitazone on glucose, coagulation and fibrinolysis parameters in patients with type 2 diabetes mellitus and metabolic syndrome.
                This 12-month, multicentre, double-blind, randomized, controlled, parallel-group trial was conducted at three study sites in Italy. We assessed patients with type 2 diabetes mellitus (duration >or=6 months) and with metabolic syndrome. All patients were required to have poor glycaemic control with diet, or experienced adverse effects with diet and metformin, administered up to the maximum tolerated dose. Patients were randomized to receive either pioglitazone or rosiglitazone self-administered for 12 months. We assessed body mass index (BMI), glycaemic control [glycosylated haemoglobin (HbA(1c)), fasting and postprandial plasma glucose and insulin levels (FPG, PPG, FPI, and PPI respectively), homeostasis model assessment (HOMA) index], lipid profile [total cholesterol (TC), low-density lipoprotein-cholesterol (LDL-C), high-density lipoprotein-cholesterol (HDL-C) and triglycerides (TG)], lipoprotein (a) [Lp(a)] and homocysteine (HCT) at baseline and at 3, 6, 9 and 12 months of treatment.
                No BMI change was observed at 3, 6, 9 and 12 months in either group. Significant HbA(1c) decreases were observed at 9 and 12 months in both groups. After 9 and 12 months, mean FPG and PPG levels decreased in both groups. Decreases in FPI and PPI were observed at 9 and 12 months compared with the baseline in both groups. Furthermore, in both groups, the HOMA index improved but only at 12 months. Significant TC, LDL-C, HDL-C, TG improvement was present in the pioglitazone group at 12 months compared with the baseline values, and these variations were significantly different between groups. No TC, LDL-C, TG improvement was present in the rosiglitazone group after 12 months. Significant Lp(a) and HCT improvement was present in the pioglitazone group at 12 months compared with the baseline values, and Lp(a) change was significant compared with the rosiglitazone group. Significant HCT decrease was observed in the rosiglitazone group at the end of the study. In our type 2 diabetic patients, both drugs were safe and effective for glycaemic control and improving HCT plasma levels. However, long-term treatment with metformin plus pioglitazone significantly reduced Lp(a) plasma levels, whereas metformin + rosiglitazone did not.
                For patients with type 2 diabetes mellitus and metabolic syndrome, combined treatment with metformin and rosiglitazone or pioglitazone is safe and effective, However, the pioglitazone combination also reduced the plasma Lp(a) levels whereas the rosiglitazone combination did not.
There is insufficient evidence on the effects of momordica charantia for type 2 diabetes mellitus. Further studies are therefore required to address the issues of standardization and the quality control of preparations. For medical nutritional therapy, further observational trials evaluating the effects of momordica charantia are needed before RCTs are established to guide any recommendations in clinical practice.