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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.
The
therapeutic effectiveness of a benfotiamine (CAS 22457-89-2)-vitamin B
combination (Milgamma-N), 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 (Benfogamma) (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 bneneficial 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 othr
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.
Publication Types:
- Clinical Trial
- Randomized Controlled Trial
PMID: 10219465 [PubMed -
indexed for MEDLINE]
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