Wasana KGP, Attanayake AP, Weerarathna TP, Jayatilaka KAPW. Efficacy and safety of a herbal drug of Coccinia grandis (Linn.) Voigt in patients with type 2 diabetes mellitus: a double-blind randomized placebo controlled clinical trial. Phytomedicine. January 2021;81:153431. doi: 10.1016/j.phymed.2020.153431.
A global increase in the prevalence of diabetes mellitus is attributed to several factors including, an increased aging population, sedentary lifestyle, and poor diet. Hypoglycemic agents help control blood glucose levels in patients with type 2 diabetes mellitus (T2DM); however, they can produce adverse effects. Several phytomedicines have been studied for their mechanisms of action in the pathophysiology of diabetes. Ivy gourd (Coccinia grandis, Cucurbitaceae) has been used widely in Sri Lankan traditional herbal medicine to treat diabetes, among other diseases. These authors, from the University of Ruhuna in Galle, Sri Lanka, conducted a randomized, double-blind, placebo-controlled clinical trial to investigate the efficacy and safety of an herbal formulation of ivy gourd in patients newly diagnosed with T2DM.
Ivy gourd leaves were collected from southern Sri Lanka. Previously standardized refluxed ivy gourd extract was freeze-dried to obtain a powder yielding 30% per weight. Each capsule contained 100% freeze-dried ivy gourd (500 mg per capsule) powder, and each placebo capsule contained 500 mg corn (Zea mays, Poaceae) starch.
Patients with newly diagnosed T2DM who visited the University Medical Clinic at the Teaching Hospital in Karapitiya, Galle, Sri Lanka, were screened for the study. The study was conducted from February 2018 to September 2019. Patients with fasting plasma glucose (FPG) concentrations of 126-159 mg/dL and/or glycated hemoglobin (HbA1c) of 6.3-7.5% were eligible. None of the 158 enrolled patients received any other antidiabetic drugs during the trial. They were given recommendations on physical activity and diet during the study.
Six study visits were scheduled within 14 days of each other. Socioeconomic and demographic data were collected at baseline, and each patient was given a diary to record any adverse effects. Eligible patients were randomly assigned to the treatment (n = 79) or placebo (n = 79) group and instructed to take one study capsule daily after lunch for 12 weeks.
The patients were aged 48.41 ± 6.97 years in the treatment group and 48.87 ± 7.20 years in the placebo group. Body mass index was calculated to be 25.55 ± 3.91 kg/m2 in the treatment group and 24.95 ± 3.93 kg/m2 in the placebo group.
Study outcome measures included HbA1c, insulin, lipid profiles, fructosamine, the homeostatic model assessment for insulin resistance (HOMA-IR), atherogenic index, cardioprotective index, and coronary risk index. FPG concentrations, renal and liver toxicity parameters, hematological parameters, and blood pressure were also monitored.
Six patients in the treatment group were lost to follow-up because of protocol violations, family problems, relocation, or surgery for an accidental injury. In the placebo group, seven patients were lost to follow-up due to protocol violation, family problems, relocation, or pregnancy. The final analysis included 73 patients in the treatment group and 72 patients in the placebo group. All patients had good compliance to the study protocol, and no adverse effects were reported.
After 12 weeks, greater improvements were observed in the treatment group compared with the placebo group in HbA1c, fructosamine, FPG, insulin, HOMA-IR, triglycerides, and very low-density lipoprotein cholesterol (P < 0.001 for all).
Safety assessments, blood pressure measures, and anthropometric characteristics did not change significantly in either group throughout the study.
Limitations of this study include its short duration, the lack of efficacy comparison between the ivy gourd extract and an active agent, and the fact that the glycemic parameters were not measured with an oral glucose tolerance test.
In this study, the use of the ivy gourd extract for three months improved glycemic indices and some lipid profile parameters in patients who were newly diagnosed with T2DM. "This dual therapy of action by means of antihyperglycemic activity and improvement of lipid profile together with safety and tolerability of the herbal drug of C. grandis could be beneficial as a new therapeutic approach for the early management of patients with T2DM," write the authors.
This study was supported by the National Research Council of Sri Lanka. The authors declare no conflicts of interest.