Benfotiamine by XYMOGEN

POSSIBLY EFFECTIVE

• Diabetic neuropathy. Oral benfotiamine might improve symptoms of diabetic neuropathy. Details: Clinical trials in patients with diabetic neuropathy show that taking benfotiamine (Benfogamma, Worwag Pharma) 300-600 mg in divided doses daily for 3-6 weeks and for up to 6 months, might modestly improve neuropathic symptoms when compared with baseline or placebo. Benefit seems to be most notable with the 600 mg daily dose (98030,98032,105468). However, benfotiamine does not seem to improve peripheral nerve function as measured by nerve conduction and vibrational perception in patients with diabetic neuropathy when compared with control (98030,98032,98037). Many of these studies are limited by small sample sizes, lack of intention-to-treat analysis, and a short duration of follow-up, in some cases due to early termination of the clinical trial. Furthermore, many of these studies were funded by the supplement manufacturer. Benfotiamine has also shown symptomatic benefit for diabetic neuropathy when used in combination with other B vitamins. These combination products have combined benfotiamine 50 mg with vitamin B12 250 mcg (Milgamma, Worwag Pharma) (98024); and benfotiamine 40 mg with vitamin B6 90 mg and vitamin B12 250 mcg (Milgamma N, Worwag Pharma) (82799).

POSSIBLY INEFFECTIVE

• Diabetic nephropathy. Oral benfotiamine does not seem to improve markers of diabetic nephropathy. Details: Some clinical research shows that taking benfotiamine (Benfogamma, Worwag Pharma) 300 mg three times daily for 12 weeks does not reduce urinary albumin excretion or improve markers of kidney injury, endothelial dysfunction, or inflammation when compared with placebo in patients with diabetic nephropathy (98035,98039).

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Alcohol use disorder. Small clinical studies suggest that oral benfotiamine may modestly improve symptoms and reduce alcohol consumption in some patients with alcohol use disorder. Details: One clinical trial in alcohol-dependent adults not seeking to quit drinking shows that taking benfotiamine 600 mg daily for 24 weeks decreases total alcohol consumption when compared to baseline; however, there was no difference between treatment and placebo groups. A greater benefit was found in female versus male participants (98046). A follow-up clinical trial in males with severe alcohol use disorder shows that taking benfotiamine 600 mg daily for 6 months does not improve overall psychiatric symptoms associated with alcohol use disorder; however, it might improve obsessive-compulsive and phobic anxiety symptom scores when compared with placebo (98048). Both studies had a drop-out rate above 40%, which is said to be expected in this patient population.
• Alzheimer disease. It is unclear if oral benfotiamine helps to prevent Alzheimer disease onset or progression. Details: One small clinical study in patients with mild Alzheimer disease or amnestic mild cognitive impairment (aMCI) shows that taking benfotiamine 300 mg twice daily for 12 months seems to improve cognition, measured by the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) and the clinical dementia rating (CDR) score, when compared with placebo. The benefit was especially prevalent in patients without the APOE4 genotype. There were no improvements in activities of daily living or neuropsychiatric symptoms (105466). This study was limited by its small size and the lack of certainty that amyloid plaques were the primary cause of cognitive impairment.
• Osteoarthritis. Oral benfotiamine has only been evaluated in combination with other B vitamins; its effect when used alone is unclear. Details: One small clinical trial in adults with osteoarthritis shows that taking a specific combination product containing benfotiamine 50 mg, vitamin B6 50 mg, and vitamin B12 500 mcg (Vonder, Cosme Farma Laboratories) three times daily for 24 weeks modestly decreases pain and stiffness, improves functional ability, and reduces markers of inflammation when compared to baseline (98045). The validity of these findings is limited by the lack of a comparator group. Additionally, the effect of benfotiamine alone in patients with osteoarthritis is unclear.
• Peripheral neuropathy. It is unclear if oral benfotiamine is beneficial in patients with alcohol-induced peripheral neuropathy. Details: One small clinical study in patients with alcohol-induced peripheral neuropathy shows that taking benfotiamine (Benfogamma, Worwag Pharma) 320 mg daily for 4 weeks, followed by 120 mg daily for 4 weeks, improves overall neuropathy symptom scores when compared with placebo or a specific combination product (Milgamma N, Worwag Pharma) containing benfotiamine, vitamin B6, and vitamin B12. However, benfotiamine does not improve pain intensity, coordination, sensory function, or reflexes when compared with placebo or the combination product (98025). It is unclear why benfotiamine alone demonstrated some benefit while the combination product containing the same dose of benfotiamine did not. Further research is needed to determine the effects of benfotiamine, if any, for alcohol-induced peripheral neuropathy.
• Rheumatoid arthritis (RA). Oral benfotiamine has only been evaluated in combination with other B vitamins; its effect when used alone is unclear. Details: One small clinical trial in adults with RA receiving conventional disease-modifying antirheumatic drugs shows that taking a specific combination product containing benfotiamine 50 mg, vitamin B6 50 mg, and vitamin B12 500 mcg (Vonder, ACME Lifescience) twice daily for 12 weeks decreases inflammatory disease activity, improves markers of endothelial dysfunction, and reduces patient-rated disability scores when compared to baseline (98042). The lack of a control group limits the validity of these findings. Additionally, the effect of benfotiamine alone is unclear. More evidence is needed to rate benfotiamine for these uses.

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LIKELY SAFE ...when used orally and appropriately. Benfotiamine has been used safely at doses of 150-600 mg daily for up to 24 weeks (82931,98024,82799,98032,98045,98046). Benfotiamine has also been used safely at doses of 900 mg daily for up to 6 weeks (98031).

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

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General ...Orally, benfotiamine is generally well tolerated. However, a thorough evaluation of safety outcomes has not been conducted.

Dermatologic ...Orally, allergic skin reactions have been reported in two out of 98 patients taking benfotiamine 300-600 mg daily for 6 weeks in one clinical study (98032). The rate of adverse events was not different between treatment and placebo groups.

Gastrointestinal ...Orally, slight gastrointestinal discomfort has been reported in six out of 98 patients taking benfotiamine 300-600 mg daily for 6 weeks in one clinical study (98032). The rate of adverse events was not different between treatment and placebo groups.

Immunologic ...Orally, allergic skin reactions have been reported in two out of 98 patients taking benfotiamine 300-600 mg daily for 6 weeks in one clinical study (98032). The rate of adverse events was not different between treatment and placebo groups.

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