Muscular dystrophy: A RANDOMIZED TRIAL OF BEMITHYL IN MUSCULAR DYSTROPHIES

[STEMC]

      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