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Bnf8.5
Benfotiamine Research
Likely helpsHigh safety
37 peer-reviewed studies
What the evidence says
Likely helps
Benfotiamine appears to help in 7 of 7 studies with measurable effects — the evidence leans clearly favourable.
Most evidence is from high-quality meta-analyses and randomised trials published 2003–2023 with a typical study size of 39 participants.
Based on 37 studies · 2 meta-analyses · 21 RCTs · 3,508 total participants
Confidence
High
What the studies found
7helped· 30 more without graded effect data
By outcome
Glucose & metabolicReduces AGE formation and supports metabolic resilience · 4-12 weeks
Likely helps32 studies
Therapeutic & clinical
Mostly mechanism / observational6 studies
Safety profile
Mostly mechanism / observational5 studies
Heart & blood pressure
Mostly mechanism / observational4 studies
InflammationReduced glycation and AGE formation · 8-12 weeks
Mostly mechanism / observational4 studies
Neuroprotection & brain aging
Mostly mechanism / observational3 studies
Cognitive function
Too few graded studies1 study
Joint pain & arthritis
Too few graded studies1 study
By the numbers
Pulled from 25 studies with measurable effects
Likely real effects
88%
across studies
People studied
3,508
typical study: 39 people
Strongest designs
23
2 pooled, 21 randomised
Showed benefit
100%
7/7 studies
How long studies ran
Under a week
1
1–4 weeks
1
1–3 months
3
3+ months
5
Populations Studied
Patients with diabetic neuropathy2
Patients with diabetic polyneuropathy2
Diabetes patients with polyneuropathy1
Type 2 diabetes patients with angiopathies1
Steady research
9 studies in the last 5 years · Latest meta-analysis: 2022
200320132023
1Meta-AnalysisCited 28×n=1,354 · large study2015
There is an absence of evidence to recommend the use of vitamin B therapy alone or combination for delaying progression of DKD.
Raval AD et al. · The Cochrane database of systematic reviews (2015)
There is an absence of evidence to recommend the use of vitamin B therapy alone or combination for delaying progression of DKD.
Thiamine was found to be beneficial for reduction in albuminuria in a single study; however, there was lack of any improvement in kidney function or blood pressure following the use of vitamin B preparations used alone or in combination.
These findings require further confirmation given the limitations of the small number and poor quality of the available studies.
Benfotiamine reduced triglyceride level (MD, -1.10; 95% CI: -1.90 to -0.30) in 120 mg/day dose as compared with placebo 150 mg/day, however this was not demonstrated in higher doses.
Muley A et al. · BMJ open (2022)
There was a significant increase in high-density lipoprotein (HDL) (MD, 0.10; 95% CI: 0.10 to 0.20) at 3-month follow-up.
Benfotiamine reduced triglyceride level (MD, -1.10; 95% CI: -1.90 to -0.30) in 120 mg/day dose as compared with placebo 150 mg/day, however this was not demonstrated in higher doses.
Painful DSPN is encountered in 13-26% of diabetes patients, while up to 50% of patients with DSPN may be asymptomatic.
Ziegler D et al. · Diabetes research and clinical practice (2022)
Painful DSPN is encountered in 13-26% of diabetes patients, while up to 50% of patients with DSPN may be asymptomatic.
Considering the individual risk profile, pain management should not only aim at pain relief, but also allow for improvement in quality of sleep, functionality, and general quality of life.
In this review article, the authors discuss the significance of benfotiamine in the prevention of various pathological complications.
Allowitz KV et al. · Future medicinal chemistry (2022)
In addition to potent antioxidative properties, benfotiamine has also been shown to be a strong anti-inflammatory agent with therapeutic significance to several pathological complications.
Specifically, over the past decade or so, benfotiamine has been shown to prevent not only various secondary diabetic complications but also several inflammatory complications such as uveitis and endotoxemia.
Recent studies also demonstrate that this compound could be used to prevent the symptoms associated with various infectious diseases such as HIV and COVID-19.
7Management of diabetic polyneuropathySystematic ReviewCited 73×2021
Journal of Diabetes Investigation
Ziegler D et al. · Journal of diabetes investigation (2021)
Huge benefit
← WorseNo effectBetter →
Painful DSPN might be as frequent as 25% in diabetes patients.
Asymptomatic DSPN might reach 50% among patients with this condition.
Symptomatic therapy uses analgesics, notably antidepressants, opioids and anticonvulsants, reducing pain by ≥50% in approximately 50% of individuals, but might be limited, particularly by central nervous system-related adverse events.
In the present review, we have comprehensively reviewed all the molecular targets modulated by BFT to provide mechanistic perspective to highlight its pleiotropic effects.
Raj V et al. · European review for medical and pharmacological sciences (2018)
The reduction in AGEs subsequently decreases metabolic stress which benefits vascular complications seen in diabetes.
The effects of BFT on the AGE-dependent pathway is well established.
In the present review, we have comprehensively reviewed all the molecular targets modulated by BFT to provide mechanistic perspective to highlight its pleiotropic effects.
9Inflammatory activities in type 2 diabetes with angiopathiesSystematic ReviewCited 18×2020
Conclusion: Inflammatory activities are implicated in diabetes-related angiopathies; regular exercise, the intake of healthy dietary supplements, and medications with anti-inflammatory properties could result in improved protective risk outcome for diabetes patients by suppressing inflammatory activities and elevating anti-inflammatory events.
Nwadiugwu MC · Frontiers in public health (2020)
Borderline
Use of drugs such as salsalate, pioglitazone, simvastatin, and fenofibrate but not glimepiride or benfotiamine reported a significant decrease in inflammatory events.
Results: Data analysis showed that elevated CRP, TNF-α, and IL-6 were the most commonly found inflammatory indicator in diabetes-related angiopathies, while increased IL-10 and soluble RAGE was an indicator for better outcome.
Regular exercise and consumption of dietary supplements such as ginger, hesperidin which have anti-inflammatory properties, and those containing prebiotic fibers (e.g., raspberries) revealed a consistent significant (p < 0.05) reduction in inflammatory activities.
11Pharmacotherapeutic targets for diabetic nephropathySystematic ReviewCited 200×2016
Beside this, some therapeutic agents are still waiting for FDA approval and few drugs without FDA approval are also prescribed in some countries for the management of DN.
Bhattacharjee N et al. · European journal of pharmacology (2016)
Beside this, some therapeutic agents are still waiting for FDA approval and few drugs without FDA approval are also prescribed in some countries for the management of DN.
Despite the medications available in the market to treat DN, the involvement of multiple mechanisms makes it difficult to choose an optimum therapeutic agent.
Therefore, much research is required to find out new therapeutic agent/strategies for an adequate pharmacotherapy of DN.
12Systematic ReviewCited 72×n=741 · large study2008
There are only limited data in randomised trials testing the efficacy of vitamin B for treating peripheral neuropathy and the evidence is insufficient to determine whether vitamin B is beneficial or harmful.
Ang CD et al. · The Cochrane database of systematic reviews (2008)
There are only limited data in randomised trials testing the efficacy of vitamin B for treating peripheral neuropathy and the evidence is insufficient to determine whether vitamin B is beneficial or harmful.
One small trial in alcoholic peripheral neuropathy reported slightly greater improvement in vibration perception threshold with oral benfotiamine for eight weeks than placebo.
In another small study, a higher dose of oral vitamin B complex for four weeks was more efficacious than a lower dose in reducing symptoms and signs.
The present review aims to summarize existing data on the neuroprotective effects of thiamine thioesters and give a comprehensive account.
Bettendorff L · International journal of molecular sciences (2023)
Recent in vitro studies show that another thiamine thioester, O,S-dibenzoylthiamine (DBT), is even more efficient than BFT, especially with respect to its anti-inflammatory potency, and is effective at lower concentrations.
Thiamine thioesters have pleiotropic properties linked to an increase in circulating thiamine concentrations and possibly in hitherto unidentified open thiazole ring derivatives.
The identification of the active neuroprotective metabolites and the clarification of their mechanism of action open extremely promising perspectives in the field of neurodegenerative, neurodevelopmental, and psychiatric conditions.
16Postprandial vascular functionCrossoverCited 10×n=31 · small study2013
In people with Type 2 diabetes and markedly impaired fasting flow-mediated dilatation, a mixed test meal does not further deteriorate flow-mediated dilatation or variables of microvascular or autonomic nervous function.
Stirban A et al. · Diabetic medicine : a journal of the British Diabetic Association (2013)
Participants had an impaired baseline flow-mediated dilatation (2.63 ± 2.49%).
In people with Type 2 diabetes and markedly impaired fasting flow-mediated dilatation, a mixed test meal does not further deteriorate flow-mediated dilatation or variables of microvascular or autonomic nervous function.
17Advanced glycation end-products inhibitionRCTCited 25×n=30 · small study2013
Net change in serum nitrite, -0.15±0.01 versus -0.79±0.12 µmol/L, P<0.001; AGEs, -0.12±0.02 versus -0.99±0.09, arbitrary florescence units, P=0.001; thiobarbituric acid reactive substances, -0.69±0.12 versus -1.80±0.12 nmol/L, P<0.01; C-reactive protein, -0.12±0.35 versus -2.45±0.60 mg/L, P<0.01, were observed in the placebo versus drug group, respectively.
Garg S et al. · The Clinical journal of pain (2013)
18Peripheral nerve functionRCTCited 47×n=67 · small study2012
Our findings suggest that high-dose benfotiamine (300 mg/day) supplementation over 24 months has no significant effects upon peripheral nerve function or soluble markers of inflammation in patients with type 1 diabetes.
Fraser DA et al. · Diabetes care (2012)
Our findings suggest that high-dose benfotiamine (300 mg/day) supplementation over 24 months has no significant effects upon peripheral nerve function or soluble markers of inflammation in patients with type 1 diabetes.
19Pain management in healthy adultsCrossoverCited 3×2020
Pain Bloc-R performed as well as acetaminophen in managing unresolved non-pathological pain in otherwise healthy individuals.
Evans M et al. · Nutrients (2020)
Large benefit
← WorseNo effectBetter →
Likely real
The BPI "pain at its worst" scores were significantly lower when participants took Pain Bloc-R than when they took acetaminophen (21.8% vs. 9.8% decrease, p = 0.026) after seven days of supplementation.
Pain Bloc-R achieved a significant improvement in the "pain at its least" score, significantly decreased the interference of discomfort in walking, and significantly decreased musculoskeletal discomfort total scores (34%, p = 0.040) after seven days.
In a post hoc subgroup analysis based on age and gender, male participants ≤45 years taking Pain Bloc-R reported significant reductions in pain severity and pain interference vs. acetaminophen.