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Effectiveness
of Different Benfotiamine Dosage Regimens in the
Treatment of Painful Diabetic Neuropathy
Winkler
G, Pal B, Nagybeganyi E, Ory I, Porochnavec M,
Kempler P.
2nd
Department of Internal Medicine,
Municipal St. John's Hospital,
Budapest, Hungary.
Arzneimittelforschung. 1999 Mar;49(3):220-4.
Abstract
The
therapeutic effectiveness of a benfotiamine vitamin B
combination, administered in high (4 x 2 capsules/day,
= 320 mg benfotiamine/day) and medium doses (3 x 1
capsules/day), was compared to a monotherapy with
benfotiamine (3 x 1 tablets/day, = 150 mg benfotiamine/day)
in diabetic patients suffering from painful peripheral
diabetic neuropathy (DNP). In a 6-week open clinical
trial, 36 patients (aged 40 to 70 yrs) having
acceptable metabolic control (HbA1c < 8.0%) were
randomly assigned to three groups, each of them
comprising 12 participants. Neuropathy was assessed by
five parameters: the pain sensation (evaluated by a
modified analogue visual scale), the vibration
sensation (measured with a tuning fork using the
Riedel-Seyfert method) and the current perception
threshold (CPT) on the peroneal nerve at 3
frequencies: 5, 250 and 2000 Hz). Parameters were
registered at the beginning of the study and at the
end of the 3rd and 6th week of therapy. An overall
beneficial therapeutic effect on the neuropathy status
was observed in all three groups during the study, and
a significant improvement in most of the parameters
studied appeared already at the 3rd week of therapy (p
< 0.01). The greatest change occurred in the group
of patients receiving the high dose of benfotiamine (p
< 0.01 and 0.05, resp., compared to the other
groups). Metabolic control did not change over the
study. It is concluded that benfotiamine is most
effective in large doses, although even in smaller
daily dosages, either in combination or in monotherapy,
it is effective.
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