[48]
EFFECTS OF NEUROTROPIN®
ON POST-HERPETIC NEURALGIA: DOUBLE-BLIND
PLACEBO-CONTROLLED CLINICAL TRIAL
*K. Dan (1) and H. Yamamura
(2)
(1) Fukuoka Tokusyukai Hospital, Fukuoka,
Japan; (2) Kosaikai Hospital, Tokyo, Japan
Introduction:
Neurotropin® (NT), a non-protein extract
from inflamed rabbit dermis inoculated
with vaccinia virus that has been shown
to facilitate descending pain inhibitory
system in animal studies, is widely used
for the treatment of chronic pain in Japan
and China. It has been reported that NT
tablets cured neuropathic pain such as
Post-Herpetic Neuralgia (PHN) and Complex
Regional Pain Syndrome I and II. To clarify
the efficacy of NT on PHN, we conducted
a randomized, double-blind, placebo-controlled
clinical study of NT tablets in the treatment
of PHN at
27 pain clinics in Japan.
Method:
Patients with PHN were instructed to take
two tablets of NT or Placebo (PL) orally
twice a day for 4 weeks (NT group: 111
patients; PL group: 117 patients). The
intensity of pain was evaluated as severe
(intolerable), moderate (capable of self
care but work significantly affected),
mild (tolerable), slight (so mild that
it is occasionally forgotten) and nil
at 0, 2, and 4 weeks of treatment. The
patients also recorded pain relief, mood
improvement, and sleeping status during
the trial, and the data were calculated
as scores.
Results:
NT improved the pain intensity score,
pain relief score, total mood improvement,
and sleep rating score at 4 weeks, as
shown below.
Moderate improvement or better (%)
| Item |
NT |
PL |
x²-test |
| Pain intensity score |
34.3 |
19.6 |
P<0.05 |
| Pain relief score |
42.4 |
24.7 |
P<0.05 |
| Total mood improvement |
30.3 |
10.3 |
P<0.01 |
| Sleep rating score |
16.9 |
3.9 |
P<0.05 |
A global improving rating
of moderate improvement or better was
obtained in 40.4% (NT) and 18.6% (PL)
of patients at 4 weeks (p<0.01, x²-test).
No significant adverse reactions were
observed in the NT-group, compared with
the PL group.
Conclusion:
NT tablet is considered to be a useful
medication for the treatment of PHN.
Corresponding Author: K.
Dan, MD., Fukuoka Tokusyukai Hospital,
4-5, Sukukita, Kasuga-shi, Fukuoka, Japan
816-0864, Fax +81-92-573-1733, Tel: +81-92-573-6622