The herbal formula has significantly reduced glycosylated haemoglobin (HbA1c), fasting blood sugar, and postprandial blood sugar levels in both prediabetic and newly diagnosed diabetic patients suffering from type II diabetes.
This is according to a 120-day randomised, double-blind, two-arm study sponsored by Sabinsa Corporation.
Findings of the RCT were recently published in Diabetology & Metabolic Syndrome.
Taking place in India, 29 prediabetic and 40 newly diagnosed diabetic patients were recruited into the study.
Both prediabetic and diabetic patients were randomised into two intervention and two control groups.
The intervention groups took GlycaCare-II tablets twice a day, while the control groups took Metformin (500mg) twice daily as well.
GlycaCare-II is an herbal supplement containing extracts of Cinnamomum cassia, Momordica charantia, Pterocarpus marsupium, Gymnema sylvestre, Salacia reticulata, Eugenia jambolana, and a bioavailability enhanced piperine from Piper nigrum.
Of which, cinnamon, Momordica charantia, and Pterocarpus marsupium extracts exist in the largest quantity, with a tablet containing 150mg of each of these extracts.
Cinnamon polyphenols have shown insulin-like activities, while charantin from Momordica charantia exhibits antihyperglycemic effects with a mechanism similar to insulin.
On the other hand, C-glycosides from Pterocarpus marsupium could increase glucose uptake by skeletal muscles, said the researchers, citing findings from existing studies.
“Although various herbal products are in use for T2DM, only a few products have been compared with metformin, and even in the comparison, the outcome of antihyperglycemic activity was lower than that of metformin.
“Hence, the purpose of this study was to evaluate and compare the efficacy and safety of GlycaCare-II against metformin for the management of T2DM in prediabetic and newly diagnosed patients,” the researchers said.
The subjects’ HbA1c, fasting blood sugar, and postprandial blood sugar were measured, and the differences between the effects of metformin and GlycaCare-II were compared.
Effects on HbA1C
Findings showed that both the herbal formula and metformin were equivalently effective in reducing HbA1c in both prediabetics and diabetic patients.
In the diabetic patients, the HbA1c levels of the intervention and control groups have significantly reduced to 6.52 ± 0.19 per cent and 6.53 ± 0.26 per cent respectively.
The baseline HbA1C levels for the intervention and control groups were 6.99 ± 0.32 per cent and 6.99 ± 0.38 per cent respectively.
“The mean changes in HbA1c were not significantly different in metformin & GlycaCare-II groups, suggesting equivalent efficacy,” the researchers highlighted.
A similar trend was seen in the prediabetic patients.
In the intervention group, the mean HbA1c level has reduced from 6.16 ± 0.21 per cent to 5.87 ± 0.15 per cent.
This was also seen in the control group, in which mean HbA1c has dropped down from 6.2 ± 0.24 per cent to 5.97 ± 0.21 per cent.
Effects on fasting blood sugar
The effects of the herbal formula on fasting blood sugar was more significant in the prediabetic patients.
By the end of the study, fasting blood sugar level was down 15 per cent for prediabetic patients and 11 per cent for diabetic patients who took the herbal formula.
A slightly lower reduction was seen in both groups taking metformin.
For diabetic patients, their fasting blood sugar level was down 10 per cent, while a reduction of 11 per cent was seen in the prediabetic patients.
Effects on postprandial blood sugar
Lastly, the herbal formula showed a greater effect on postprandial blood sugar as compared to metformin in both prediabetic and diabetic patients.
Postprandial blood sugar in diabetic patients who took the intervention had decreased by 32.75 mg/dl by the end of the study.
This was a greater amount of change as compared to those who took metformin, where a reduction of 21.06 mg/dL was seen.
Similarly, the postprandial blood sugar of prediabetic patients who took the intervention also saw a greater change – from 169.59 ± 16.35 mg/dl at baseline to 146 ± 8.66 mg/dl by the end of the study
The group taking metformin also reported a comparable change – from 165.67 ± 14.89 mg/dl to 148 ± 8.31 mg/dl.
“The findings in this randomized clinical study demonstrate the potential of GlycaCare-II as an alternative safe medication in the treatment of T2DM. It was also evident that GlycaCare-II possesses a similar therapeutic response as compared to metformin,” the researchers concluded.
Source: Diabetology & Metabolic Syndrome
A randomized, double-blind clinical trial of a herbal formulation (GlycaCare-II) for the management of type 2 diabetes in comparison with metformin
DOI: 10.1186/s13098-021-00746-0
Authors: Shaji Paulose et al