A RANDOMIZED TRIAL OF BEMITHYL IN MUSCULAR DYSTROPHIES
V. Pustozerov and L.A. Saikova
Medical Academy of Postgraduate Education, St. Petersberg, Russia
Introduction
Bemithyl (2-ethyl benzamidazole hydrobromide monohydrate) is a compound which
stimulates
gluconeogenesis. It has been used to improve performance during physical
activity in animals and
human volunteers.
We report a prospective randomized trial of Bemithyl in patients with muscular
dystrophy.
Methods
Patients with muscle weakness caused by a variety of myopathic conditions were
allocated to two
groups. One group received Bemithyl (0.5 - 1.0 g/day), the other had
traditional treatment involving
massage, anabolic steroids and physiotherapy, both for 30 days. Assessments
were performed pre
and post treatment by a measure incorporating ADL and muscle strength, the
Movement Capacity
Index (see attached handout). Each group was subdivided by diagnosis and
severity.
Results
All patients in the mild to moderate groups improved significantly during the
30-day period. In
patients severely affected, independent of the disease process, the Bemithyl
produced more
improvement.
Total score of all groups combined
Pre Post p value
Bemithyl 22.3 2.0 28.8 1.9 0.001
Control 21.3 2.3 21.5 2.5 ns
Dystrophy Severity n Bemithyl Traditional p
Pre Post Pre Post
Duchenne Mild 4:3 72.4 2.3 91.6 2.1 73.8 1.8 86.2 2.4 .0246
Moderate 10:9 45.6 4.1 59.7 3.2 44.9 3.2 51.7 2.9 .0001
Severe 6:6 12.4 2.2 17.6 1.8 13.8 3.4 15.6 4.5 .16
Erb's Mild 8:6 21.5 1.5 28.5 1.7 74.6 1.8 86.7 3.3 .0025
Moderate 40:27 47.7 4.1 61.3 2.2 46.9 3.4 54.3 1.7 .0001
Severe 17:12 12.4 2.2 17.6 1.8 22.4 3.0 22.7 12.6 .0618
Dejerine Mild 5:7 73.3 3.8 95.1 1.3 73.6 2.4 89.2 2.7 .0012
Moderate 32:21 48.7 4.2 64.3 3.7 45.9 2.2 55.7 3.6 .0001
Severe 18:12 19.8 3.6 27.2 2.4 21.2 1.9 20.4 3.1 .0001
Scapulo- Mild 10:5 73.1 2.9 95.3 3.1 72.8 1.7 85.8 2.2 .0001
peroneal Moderate 28:15 55.4 2.9 70.4 4.8 52.9 2.1 61.4 2.7 .0001
Severe 2:3 28.2 0.6 35.2 1.8 26.7 1.2 25.9 1.7 .0098
Conclusion
Bemithyl seems to have an effect on muscle strength and ADL in patients with
weakness due to myopathy of
various types. This may be due to its effect on gluconeogenesis. Such an
effect may be of use clinically. Further
controlled blinded studies with proper randomization are necessary to support
this finding.
Presentation is moderated by M. Gawel and A. Alexandrov,
Sunnybrook Health Science Centre, University of Toronto, Canada
For further information regarding Bemithyl, including availablity, please
contact STEMC (Toronto, Canada) 416-250-0442.
E-mail: stemc at interlog.com
