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This double-blind, placebo-controlled study evaluated the efficacy of oral α-amylase enzyme replacement therapy in treating early-stage diabetic polyneuropathy (DPN). The study was conducted at Al-Azhar University Hospitals with 83 diabetic patients randomized to receive either fermented deglycyrrhizinated licorice extract (FDGL) containing α-amylase enzyme (2500 IU/gm) or placebo for 6 months. Primary outcomes measured improvements in nerve conduction velocity and vibration perception threshold.
Diabetes mellitus complications continue to develop despite optimal glycemic control with insulin. Recent studies suggest that serum amylase deficiency correlates with the severity of diabetic complications. This study hypothesizes that α-amylase enzyme deficiency represents an enzymatic defect in the cascade between activated insulin receptors and mitochondrial energy liberation, contributing to diabetic complications.
α-amylase is a glycolytic enzyme that undergoes entero-pancreatic circulation and is proposed to be a precursor to key phosphorylating enzymes (glycogen phosphorylase, glucokinase, and hexokinase) essential for glycolysis. Supplementation with α-amylase may restore normal carbohydrate metabolism and prevent diabetic complications.
The study drug is a formulation rich in α-amylase enzyme prepared from fermented deglycyrrhizinated licorice root extract, also containing acid-lipase enzyme and naturally occurring flavonoids. The intervention was administered as 500mg capsules twice daily, one hour before meals, for 6 months alongside regular antidiabetic medications.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fermented Deglycyrrhizinated Licorice | Active Comparator | Oral capsules containing 500 mg of fermented deglycyrrhizinated licorice root extract standardized to 2500 IU/gm of α-amylase enzyme and naturally occurring flavonoids and acid-lipase. Administered twice daily (1000 mg/day). |
|
| Placebo Comparator | Placebo Comparator | 500 mg non-fermented deglycyrrhizinated licorice root extract capsules, matching FDGL in appearance, color, weight, and excipients. Administered twice daily. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fermented Deglycyrrhizinated Licorice | Drug | Oral capsules containing 500 mg of fermented deglycyrrhizinated licorice root extract standardized to 2500 IU/gm of α-amylase enzyme and naturally occurring flavonoids and acid-lipase. Administered twice daily (1000 mg/day). |
| Measure | Description | Time Frame |
|---|---|---|
| Sensory Nerve Conduction Velocity (SCV) | Measurement of nerve conduction velocity in sural nerve using digital electromyography equipment | Baseline, 3 months, 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Motor Nerve Conduction Velocity (MCV) | Measurement of nerve conduction velocity in peroneal nerve using digital electromyography equipment | Baseline, 3 months, 6 months |
| Vibration Perception Threshold (VPT) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ahmed Aly Massoud, PhD | Department of Hepato-gastroenterology and Infectious Diseases, Faculty of Medicine, Al-Azhar University, Cairo, Egypt | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Al-Azhar University | Cairo | Nasr City | 11651 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41627541 | Derived | Massoud AMA, Massoud HMA, El-Shawarby AA, Elseidy MI. Randomized Double-blind Placebo-controlled study to evaluate the efficacy of fermented deglycyrrhizinated licorice for treatment of diabetic polyneuropathy. Endocrine. 2026 Feb 2;91(1):51. doi: 10.1007/s12020-025-04476-5. |
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| ID | Term |
|---|---|
| D003929 | Diabetic Neuropathies |
| D048909 | Diabetes Complications |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D003920 | Diabetes Mellitus |
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| Non-fermented Deglycyrrhizinated Licorice | Dietary Supplement | 500 mg non-fermented deglycyrrhizinated licorice root extract capsules, matching FDGL in appearance, color, weight, and excipients. Administered twice daily. |
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Measurement using biothesiometer at six points on each foot (big toe, metatarsal bases, instep, heel)
| Baseline, 3 months, 6 months |
| Serum α-amylase Levels | Measurement of serum α-amylase concentration as marker of compliance and drug efficacy | Baseline, 3 months, 6 months |
| Sensory Nerve Action Potential Amplitude (SNAP) | Amplitude measurement in sural nerve | Baseline, 3 months, 6 months |
| Compound Muscle Action Potential Amplitude (CMAP) | Amplitude measurement in peroneal nerve | Baseline, 3 months, 6 months |
| D004700 | Endocrine System Diseases |