Fagorutin by GlaxoSmithKline Consumer Healthcare

POSSIBLY EFFECTIVE

• Chronic venous insufficiency (CVI). Oral butcher's broom extract, taken in combination with hesperidin and vitamin C, seems to improve symptoms of CVI. It is unclear if oral butcher's broom alone is beneficial in these patients. Details: One clinical trial in females with CVI shows that taking a specific butcher's broom rhizome extract (Fagorutin Ruscus Kapseln, GlaxoSmithKline Consumer Healthcare) 36-37.5 mg twice daily for 12 weeks reduces leg edema and symptoms of fatigue, heaviness, and tension of the leg when compared with placebo (9932). A specific combination product (Cyclo 3 Fort, Pierre Fabre Laboratories) containing butcher's broom has also been evaluated. Several clinical studies and meta-analyses of clinical research in patients with CVI show that taking this product, providing butcher's broom root extract 150 mg, hesperidin methyl chalcone 150 mg, and vitamin C 100 mg per capsule, at a dose of 1-3 capsules, 1-3 times daily for up to 3 months, can reduce edema, fatigue, pain, paresthesia, pruritus, and leg fatigue when compared with baseline or placebo (10068,10070,37483,37498,94779). It is unclear if these findings are due to butcher's broom, other ingredients, or the combination.

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Diabetic retinopathy. It is unclear if oral butcher's broom extract is beneficial in patients with diabetic retinopathy. Details: A small clinical study in patients with diabetic retinopathy shows that taking a specific butcher's broom extract (Fagorutin-Ruscus, Fink GmbH) 37.5 mg orally twice daily for 3 months does not improve visual acuity when compared to baseline. However, there does appear to be some regression of changes in the fundus in 23% of patients, and an increase in oscillatory potentials, suggesting improvement in retinal blood circulation, in 15% of patients (37502).
• Hemorrhoids. Although there has been interest in using oral and topical butcher's broom for hemorrhoids, there is insufficient reliable information about the clinical effects of butcher's broom for this purpose.
• Lymphedema. Oral butcher's broom extract has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A small clinical study in females with arm lymphedema following breast cancer treatment shows that taking a specific combination product (Cyclo 3 Fort, Pierre Fabre Laboratories) providing butcher's broom root extract 150 mg, hesperidin methyl chalcone 150 mg, and vitamin C 100 mg per capsule, in a dose of three capsules three times daily for 90 days, reduces swelling in the arms and improves mobility and heaviness when compared with placebo. Edema was reduced by around 13% when compared with placebo (37494).
• Orthostatic hypotension. Although there has been interest in using oral butcher's broom for orthostatic hypotension, there is insufficient reliable information about the clinical effects of butcher's broom for this purpose.
• Varicose veins. Oral butcher's broom extract has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A small, uncontrolled study in 12 males aged 34 -75 years with varicose veins suggest that taking a specific combination product (Cyclo 3 Fort, Pierre Fabre Laboratories) containing butcher's broom root extract 150 mg, hesperidin methyl chalcone 150 mg, and vitamin C 100 mg per capsule in a dose of three capsules in the morning on the first day, followed by one capsule three times daily for 5-7 days, decreases the diameter of some veins in the leg while standing and increases flow rates in these veins when compared to baseline (37499). It is unclear whether these changes improve the appearance of varicose veins. More evidence is needed to rate butcher's broom for these uses.

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POSSIBLY SAFE ...when used orally and appropriately short-term. A specific butcher's broom rhizome extract (Fagorutin Ruscus Kapseln, GlaxoSmithKline Consumer Healthcare) has been used with apparent safety at a dose of 75 mg daily for up to 3 months (9932,37502). A specific combination product (Cyclo 3 Fort, Pierre Fabre Medicament) containing butcher's broom root extract, hesperidin methyl chalcone, and vitamin C has been used with apparent safety in doses providing butcher's broom root extract 150 mg twice daily for up to 3 months or 300 mg three times daily for up to 1 month (10068,37494,94779). There is insufficient reliable information available about the safety of butcher's broom when used topically.

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

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ALPHA-ADRENERGIC AGONISTS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, butcher's broom might increase the effects and adverse effects of alpha-adrenergic agonists.  Details Animal and in vitro studies show that butcher's broom has alpha-adrenergic agonist effects (10069,94784).

ALPHA-ADRENERGIC ANTAGONISTS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, butcher's broom might reduce the effects of alpha-adrenergic antagonists.  Details Animal and in vitro studies show that butcher's broom has alpha-adrenergic agonist effects (10069,94784).

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General ...Orally, butcher's broom seems to be well tolerated, short-term.
Most Common Adverse Effects:
Orally: Diarrhea, dyspepsia, gastritis, heartburn, nausea, and vomiting.
Topically: Contact dermatitis in sensitive individuals.

Dermatologic ...Topically, butcher's broom may cause contact dermatitis (37487,94780). A 30-year-old female developed an erythematous, papular, pruritic rash on both legs after applying a cream containing butcher's broom root extract (Fabroven, Pierre Fabre Iberica) to varicose veins for 2 months. The rash spread to the entire body, and the patient had positive patch tests to ethanol extracts of butcher's broom (37487). In another report, a 34-year-old female developed pruritic eczematous lesions in the perianal area after using an antihemorrhoidal cream containing a butcher's broom extract (Proctolog, Desma Pharmaceutical). Several months later, the patient developed a generalized eczematous rash after applying another cream containing butcher's broom extract to the legs. The patient had positive patch tests to ruscogenins, which are constituents of butcher's broom (94780).

Gastrointestinal ...Orally, butcher's broom may cause nausea, vomiting, diarrhea, dyspepsia, heartburn, and gastritis (10068,37494,37498,94778). A 39-year-old female with poorly-controlled diabetes reported severe vomiting and diarrhea after taking butcher's broom for 5 days and was ultimately hospitalized with dehydration, hyperkalemia, acidosis, and sinus tachycardia (94778).

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