Abstract
Background and Objectives
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.
Study Design and Setting
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.
Results
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.
Conclusion
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.
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Article info
Publication history
Published online: November 10, 2006
Accepted:
July 3,
2006
Identification
Copyright
© 2007 Elsevier Inc. Published by Elsevier Inc. All rights reserved.
