WellBetX Mulberry Extract by Natural Factors Nutritional Products Inc

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Diabetes. It is unclear if oral black mulberry leaf extract is beneficial in patients with diabetes. Details: A small clinical study in patients with type 2 diabetes shows that taking black mulberry leaf extract 3 mL three times daily for 3 months reduces fasting plasma glucose by around 9 mg/dL and glycated hemoglobin (HbA1c) by around 0.6% when compared with placebo (105797).
• Menopausal symptoms. It is unclear if oral black mulberry leaf is beneficial in patients with menopausal symptoms. Details: A small clinical study in menopausal patients shows that taking black mulberry leaf powder 250 mg daily for 60 days improves menopausal symptom scores and some quality-of-life measures when compared with placebo. Improvements were similar to those reported in patients taking estradiol 1 mg daily (103280).
• Oral mucositis. Small clinical studies suggest that rinsing with black mulberry molasses or syrup reduces symptoms and improves healing of lesions in patients with oral mucositis from various causes. Details: A small clinical study in patients with head and neck cancer receiving radiotherapy shows that rinsing the mouth with black mulberry molasses for 1-3 minutes and then swallowing three times daily reduces pain from oral mucositis by approximately 38% when compared with no treatment (96981). Another small clinical study in patients with chronic obstructive pulmonary disease and oral mucositis shows that rinsing the mouth with 5 mL of black mulberry syrup for 1 minute and then swallowing three times daily after meals for 15 days improves the severity of oral mucositis and reduces the time to lesion healing by 3 days when compared with no treatment (105798). The validity of these findings is limited by a lack of placebo control. Additionally, a small clinical study in adults with cancer receiving methotrexate conducted in Turkey shows that rinsing with black mulberry extract syrup 5 mL for 60 seconds three times daily for 15 days marginally improves oral mucositis and dry mouth when compared with sodium bicarbonate mouthwash (112367). The validity of this study is limited by poor methodology. In addition, it is unclear whether any improvement is clinically significant. More evidence is needed to rate black mulberry for these uses.

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POSSIBLY SAFE ...when used orally in food amounts. The fruit is commonly used in foods (96981,96982). ...when the leaf is used orally in medicinal amounts, short-term. Black mulberry leaf powder has been used with apparent safety at a dose of 250 mg daily for up to 60 days (103280).

PREGNANCY AND LACTATION:
Insufficient reliable information available; avoid using.

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ANTIDIABETES DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, black mulberry leaf might increase the risk of hypoglycemia when taken with antidiabetes drugs.  Details One small clinical study shows that black mulberry leaf extract has hypoglycemic effects (105797). This is supported by in vitro research which also suggests that constituents in black mulberry twigs and leaves might have hypoglycemic effects (19,103801).

MIDAZOLAM (Versed) Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, black mulberry might inhibit the metabolism of midazolam.  Details In vitro research shows that black mulberry juice can inhibit midazolam 1'-hydroxylation, a reaction that is catalyzed by cytochrome P450 3A4 (36010). This effect has not been reported in humans.

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General ...Orally, black mulberry leaf extracts and black mulberry molasses seem to be generally well tolerated. However, a thorough evaluation of safety outcomes has not been conducted.
Most Common Adverse Effects:
Topically: Contact dermatitis in sensitive individuals.

Dermatologic ...Topically, black mulberry leaf may cause contact dermatitis. A case of lichenoid contact dermatitis was reported in a 68-year-old male who came into contact with black mulberry leaves while picking black mulberries (105799).

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