Summary and Conclusions

Summary and
Conclusions
The present study was a randomized, prospective, double blind, placebo

controlled, cross over, single dose study of the effect of gabapentin, vigabatrin

and sodium valproate on psychomotor functions in twenty four healthy

volunteers using a battery of subjective and objective tests for the assessment

of these functions.

The sensory processing, motor component, central integration of central

nervous system and test for memory and learning in addition to the subjective

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 Summary and Conclusions

component was evaluated in the study. The various test used were Six digit

cancellation test (6DCT), Digit symbol substitution test (DSST), Critical flicker

fusion test (CFFT), Arithmetic ability test (AAT), Digital span test (DST), Hand

steadiness test (HST) which are the objective tests and Visual analogue scale

(VAS) for subjective component. The dose used was gabapentin (300mg),

vigabatrin (500mg) and sodium valproate (200mg) in a single dose. The

volunteers were tested at the baseline just before administration of the drug (0

hour) and then at first hour, second hour and third hour in all above tests. The

side effects reported by the volunteers were also noted.

Within group comparison showed statistically significant difference on all

the objective scales for the assessment of cognitive and psychomotor functions

at the end of third hour of the study in sodium valproate group. DSST (p<0.001),

6DCT (p<0.01), AAT (p<0.001), CFFT (p<0.001), DST (p<0.001), HST (p<

0.01) ,VAS for sedation (p<0.05),VAS for concentration (p<0.001) and VAS for

alertness (p<0.001).

Both gabapentin and vigabatrin, did not impair objective tests in the study.

When compared with placebo, sodium valproate showed statistically

significant difference in all objective tests at the end of third hr. DSST (p<0.05),

6DCT (p<0.05), AAT (p<0.01), CFFT (p<0.001), DST (p<0.01), HST (p< 0.01).

No significant difference was observed when gabapentin and vigabatrin

was compared to placebo.

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 Summary and Conclusions

Statistically significant difference was observed when gabapentin is

compared with sodium valproate at the end of third hour. DSST (p<0.01), 6DCT

(p<0.01), AAT (p<0.001), CFFT (p<0.001), DST (p<0.05), HST (p< 0.01).

Statistically significant difference was observed when vigabatrin is compared

with sodium valproate at the end of third hour. DSST (p<0.05), 6DCT (p<0.01),

AAT (p<0.001), CFFT (p<0.001), DST (p<0.01), HST (p< 0.05).

Volunteers marked sedation on VAS in all three groups at the end of

third hour, gabapentin (p<0.05), vigabatrin (p<0.05) and valproate at second

hour (p<0.05) and third hour (p<0.001).

In VAS rating for alertness, statistically significant difference was

observed in sodium valproate group at the end of third hour (p<0.05). No

difference was observed with gabapentin and vigabatrin.

In VAS for concentration, statistically significant difference was observed

in sodium valproate group at the end of third hour (p<0.01). No difference was

observed with gabapentin and vigabatrin.

Sodium valproate caused nausea (p< 0.01) and abdominal pain

(p< 0.05). Adverse events were not significant in gabapentin and vigabatrin

when compared to placebo.

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 Summary and Conclusions

The following conclusions were drawn from the study:

1. In all the subjective tests for the assessment of cognitive and

psychomotor function, no difference was found when gabapentin is

compared with placebo suggesting that the drug has no effect to on

these functions. Sedation is observed with gabapentin with no effect on

concentration and alertness.

2. Similarly, when vigabatrin is compared to placebo, similar results were

obtained as for gabapentin.

3. When valproate is compared with placebo, impairment in all tests is

observed. The drug also causes sedation, dullness and inability to

concentrate as noted by visual analogue scale.

4. Gabapentin and vigabatrin have no difference in performance on

psychomotor tests when compared to each other either in subjective or

objective tests.

5. Valproate causes impairment in all the tests when compared to

gabapentin.

6. Likewise, valproate cause decrease performance in all tests when

compared to vigabatrin.

7. Valproate caused increased nausea and abdominal pain as compared to

placebo.

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 Summary and Conclusions

Valproate, among conventional anti epileptic causes cognitive and

psychomotor impairment while gabapentin and vigabatrin have no effect on

these functions.

The present study provides information on cognitive and psychomotor

effects of some new anti epileptic drugs which will assist physician and their

patients on making treatment decision. The clinicians’ goal for the individual

patient is to balance a variety of factors in order to obtain seizure control,

minimise the adverse effects and maintain the quality of life of patients.

However further studies measuring serum concentration of the drug, using dose

variation and studying the molecular mechanism of cognitive and psychomotor

impairment of the drug are required.

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