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the study recruited 67 individuals with type 1 diabetes during routine appointments at the norwegian diabetic centre .
inclusion criteria were 1 ) age 18 to 60 years ( inclusive ) , 2 ) type 1 diabetes ( > 15-year duration ) , and 3 ) normo- or microalbuminuria . all patients provided written informed consent .
the study , which was approved by the regional ethics committee and the norwegian medicines agency , was conducted as a parallel , randomized , double - blind , placebo - controlled prospective trial of 24-month duration .
patients in the active group were given 300 mg benfotiamine per day ( benfogamma , wrwag pharma gmbh ) .
we selected patients with type 1 diabetes of > 15-year duration ( mean 31-year duration ) because we previously showed that these patients have reduced nerve conduction velocity ( ncv ) even if they do not have marked clinical neuropathy ( 6 ) .
nerve conduction studies ( ncs ) were performed with keypoint machines ( medtronic , denmark ) using surface electrodes with > 45-min acclimatization ( room temperature 2224c ) .
abnormal ncs were defined as one or more abnormal z score in two or more nerves , based on sural nerve amplitude ( antidromic stimulation ) , tibial and peroneal ncv , tibial amplitude , increased f - wave minimum latency ( f - min ) , and absent f - waves ( only considered abnormal in tibial nerve ) .
f - wave persistence ( n f - waves / n of stimuli ) was based on 20 consecutive stimulations .
heart - rate response to deep breathing ( 6 breaths / min ; supine position ) relative to the mean heart rate during the same minute and the immediate heart - rate response to standing ( 30:15 ratio ) was also calculated . for clinical assessments ,
peripheral neuropathy was assessed by the diabetic neuropathy symptom score ( dns ) ( 7 ) and the neuropathy disability score ( nds ) ( 8) . this included examination of the ankle reflex , vibration sensation using a 128-hz tuning fork , and pinprick sensation of the great toe .
we assessed cutaneous pressure perception using a 10-g semmes - weinstein monofilament at four validated plantar sites .
blood samples were drawn after an overnight fast ( 0800 and 1000 h ) , prepared within 1 h , and kept frozen at 80c for batch analysis ( except thiamine derivatives and routine analyses ) .
means ( 95% cis ) are given for continuous normally distributed data and medians ( quartiles ) for highly skewed data .
differences between groups over 24 months were tested by two independent sample t tests or mann - whitney u tests .
power calculations based on our primary end point ( peroneal ncv ) indicated that at least 55 patients would be required ( standardized difference 0.75 ; 80% power , 5% significance level ) .
changes from baseline to 24 months within each group were tested by paired t tests for normally distributed data ; otherwise , wilcoxon was used .
means ( 95% cis ) are given for continuous normally distributed data and medians ( quartiles ) for highly skewed data .
differences between groups over 24 months were tested by two independent sample t tests or mann - whitney u tests .
power calculations based on our primary end point ( peroneal ncv ) indicated that at least 55 patients would be required ( standardized difference 0.75 ; 80% power , 5% significance level ) .
changes from baseline to 24 months within each group were tested by paired t tests for normally distributed data ; otherwise , wilcoxon was used .
no significant differences were found between the benfotiamine and placebo groups in any biochemical or neurophysiologic variable at baseline ( supplementary table 1 ) .
of the 59 patients who completed the study , 56% had abnormal ncs ( based on stringent neurophysiologic assessment ) , and 16% had probable diabetic sensorimotor polyneuropathy ( clinical evaluation of both signs and symptoms ) at baseline ( supplementary table 1 ) .
no changes outside of the normal reference ranges were detected in safety parameters ( data not shown ) .
we found a marked increase in thiamine and thiamine diphosphate in all patients who received benfotiamine ( table 1 , both p < 0.001 ) .
diastolic blood pressure ( dbp ) was also significantly increased in the benfotiamine group ( p < 0.01 ) and was significantly different from the change in the placebo group ( p < 0.05 ) .
we found a significant increase in serum folate in the placebo group ( p < 0.05 ) , which was significantly different from the change in the benfotiamine group ( p < 0.05 ) .
changes from baseline to 24 months in the placebo and benfotiamine group ( per - protocol analysis ) no significant differences were noted in changes between the groups for peroneal ncv or any other nerve conduction parameter ( table 1 ) .
peroneal nerve f - wave persistence ( p < 0.05 ) and amplitude ( p = 0.01 ) as well as tibial nerve f - wave persistence ( p < 0.05 ) were significantly reduced in the benfotiamine group .
whereas 56% of all patients had abnormal ncs at baseline , 64% had abnormal scores at 24 months ( four patients in the benfotiamine and one in the placebo group went from normal to abnormal ncs , data not shown ) . there were no significant differences in changes between the groups in any of the inflammatory markers ( table 1 )
no significant differences were found between the benfotiamine and placebo groups in any biochemical or neurophysiologic variable at baseline ( supplementary table 1 ) .
of the 59 patients who completed the study , 56% had abnormal ncs ( based on stringent neurophysiologic assessment ) , and 16% had probable diabetic sensorimotor polyneuropathy ( clinical evaluation of both signs and symptoms ) at baseline ( supplementary table 1 ) .
no changes outside of the normal reference ranges were detected in safety parameters ( data not shown ) .
we found a marked increase in thiamine and thiamine diphosphate in all patients who received benfotiamine ( table 1 , both p < 0.001 ) .
diastolic blood pressure ( dbp ) was also significantly increased in the benfotiamine group ( p < 0.01 ) and was significantly different from the change in the placebo group ( p < 0.05 ) .
we found a significant increase in serum folate in the placebo group ( p < 0.05 ) , which was significantly different from the change in the benfotiamine group ( p < 0.05 ) . changes from baseline to 24 months in the placebo and benfotiamine group ( per - protocol analysis ) no significant differences were noted in changes between the groups for peroneal ncv or any other nerve conduction parameter ( table 1 ) .
peroneal nerve f - wave persistence ( p < 0.05 ) and amplitude ( p = 0.01 ) as well as tibial nerve f - wave persistence ( p < 0.05 ) were significantly reduced in the benfotiamine group .
whereas 56% of all patients had abnormal ncs at baseline , 64% had abnormal scores at 24 months ( four patients in the benfotiamine and one in the placebo group went from normal to abnormal ncs , data not shown ) . there were no significant differences in changes between the groups in any of the inflammatory markers ( table 1 )
no changes outside of the normal reference ranges were detected in safety parameters ( data not shown ) .
we found a marked increase in thiamine and thiamine diphosphate in all patients who received benfotiamine ( table 1 , both p < 0.001 ) .
diastolic blood pressure ( dbp ) was also significantly increased in the benfotiamine group ( p < 0.01 ) and was significantly different from the change in the placebo group ( p < 0.05 ) .
we found a significant increase in serum folate in the placebo group ( p < 0.05 ) , which was significantly different from the change in the benfotiamine group ( p < 0.05 ) . changes from baseline to 24 months in the placebo and benfotiamine group ( per - protocol analysis )
no significant differences were noted in changes between the groups for peroneal ncv or any other nerve conduction parameter ( table 1 ) .
peroneal nerve f - wave persistence ( p < 0.05 ) and amplitude ( p = 0.01 ) as well as tibial nerve f - wave persistence ( p < 0.05 ) were significantly reduced in the benfotiamine group .
whereas 56% of all patients had abnormal ncs at baseline , 64% had abnormal scores at 24 months ( four patients in the benfotiamine and one in the placebo group went from normal to abnormal ncs , data not shown ) .
there were no significant differences in changes between the groups in any of the inflammatory markers ( table 1 ) .
peroneal f - wave persistence and amplitude in addition to tibial nerve f - wave persistence and heart - rate response to standing were significantly reduced in the benfotiamine group , which may indicate a slight deterioration of nerve function .
however , we did not find any significant differences between the benfotiamine and placebo group .
the difference between the current study and former studies that reported a positive effect of benfotiamine may be related to differences in the investigated populations .
symptomatic polyneuropathy was not an inclusion criterion in the current study ( symptom scoring was not meaningful because most patients were asymptomatic ) .
however , because the former studies did not report neurophysiologic function , we can not exclude that the reported effect was related to symptom reduction and not improved nerve function per se . in support of this view
, benfotiamine has been reported to have an antinociceptive effect in inflammatory and neuropathic pain models ( 9 ) . in conclusion , despite a marked improvement in thiamine status , long - term high - dose benfotiamine had no significant effect on peripheral nerve function or inflammatory markers in patients with type 1 diabetes .
objectiveto study the effects of long - term oral benfotiamine supplementation on peripheral nerve function and soluble inflammatory markers in patients with type 1 diabetes.research design and methodsthe study randomly assigned 67 patients with type 1 diabetes to receive 24-month benfotiamine ( 300 mg / day ) or placebo supplementation . 
 peripheral nerve function and levels of soluble inflammatory variables were assessed at baseline and at 24 months.resultsfifty-nine patients completed the study . 
 marked increases in whole - blood concentrations of thiamine and thiamine diphosphate were found in the benfotiamine group ( both p < 0.001 vs. placebo ) . 
 however , no significant differences in changes in peripheral nerve function or soluble inflammatory biomarkers were observed between the groups.conclusionsour 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 .