This study was conducted on 30 diabetic patients with diabetic peripheral neuropathy on carbamazepine and they were divided in to three equal groups with add-on duloxetine gabapentin and intradermal Botox injection.
Table 1 shows the demographic and clinical characteristics of the studied groups. All three groups were matched regarding age and sex and duration of diabetes. Mean age was 59.5 years for duloxetine 58 years for gabapentin and 63 years in Botulinum toxin A group. With no statistically significant difference among the three groups at p = 0.900.
Oral hypoglycemic drugs were the main line of treatment of diabetes in the studied groups. 60% of patients on oral hypoglycemic drugs in the duloxetine group 90% for gabapentin group and 80% in Botulinum toxin A group with no statistically significant difference among the three groups at p = 0.430.
Regarding the duration of diabetes, mean duration of diabetes was 9.2 ± 6.4 years for duloxetine group 6.4 ± 4.4 years for gabapentin group and 9.6 ± 6.2 years in Botulinum toxin A group. With no statistically significant difference among the three groups at p = 0.425.
Table 2 shows the VAS at 0, 1, 4, 12 weeks comparing duloxetine, gabapentin and Botulinum toxin A injection.
Baseline mean VAS was 8 ± 1.1 in the duloxetine group 7.5 ± 1.1 in the gabapentin and 8.1 ± 0.7 in the Botulinum toxin A group. There was no statistically significant difference among the three groups at p = 0.348.
VAS decreased in the three groups, yet it was not a statistically significant difference between the three groups at p = 0.316.
Table 3 and Figure 1 show that duloxetine, gabapentin and Botulinum toxin significantly decreased the VAS along week 0 to 12.
Comparison between the different studied periods according to VAS
Duloxetine add-on therapy decreased the VAS from a mean of 8 ± 1.1 to 5.8 ± 0.9 after 12 weeks and this was statistically significant at p < 0.001*
While gabapentin add-on therapy decreased the VAS mean from 7.5 ± 1.1 to a mean of 5.5 ± 1.1 after 12 weeks, this was statistically significant at p < 0.001*
Botulinum A intradermal injection also decreased the mean of VAS from 8.1 ± 0.7 to 6.2 ± 1 in 12 weeks and this was statistically significant at p < 0.001*
When comparing VAS 0 to VAS 1, 4, 12 among each patient group Botulinum toxin A was the only drug that caused statistically significant difference all along the study duration p1 = 0.019*, < 0.001*, 0.004*, respectively.
When comparing PSQ1 among different add-on therapy, Table 4 shows that baseline mean PSQ1 was 17.4 ± 2.21 in the duloxetine group 16.2 ± 2.7 in the gabapentin and 17.3 ± 1.8 in the Botulinum toxin A group with no statistically significant difference among the groups at p = 0.437.
PSQ1 at week 4 was lowest in the Botulinum A intradermal group mean = 9.9 ± 3.6 and this was statistically significant at p = 0.001*
This decline was confirmed even further when comparing duloxetine and gabapentin p1 = 0.891 which was statistically insignificant.
p value when comparing duloxetine and Botox was p2 = 0.002* which was statistically significant, p value when comparing between gabapentin and Botox was p3 = 0.005* which was statistically significant.
Table 5 and Figure 2 show that duloxetine add-on therapy decreased the PSQ1 from a mean of 17.4 ± 2.2 to 13.8 ± 2.4 after 12 weeks and this was statistically significant at p < 0.001*.
Comparison between the different studied periods according to PSQI
While gabapentin add-on therapy decreased the PSQ1 mean from 16.2 ± 2.7 to 13.3 ± 3 after 12 weeks, this was statistically significant at p < 0.001*.
Botulinum A intradermal injection also decreased the mean of PSQ1 from 17.3 ± 1.8 to 10.9 ± 3.1 in 12 weeks constituting the highest decline in PSQ1 among the three groups and this was statistically significant at p < 0.001*.
When comparing PSQ1 0 to of PSQ1 1, 4, 12 weeks among each patient group, Botulinum toxin A was the only drug that caused statistically significant difference all along the study duration, p1 = 0.016**, < 0.001*, < 0.001**, respectively.
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