ABSTRACT
Introduction:
Diabetes mellitus frequently leads to development of
peripheral neuropathies in almost 30-50% of
patients and the most common type of neuropathy associated with this condition is Distal Symmetric Sensorimotor
Polyneuropathy (DSPN).
Gabapentin and
Amitriptyline are two
drugs frequently used for the
treatment of
neuropathic pain associated with
type 2 diabetes. Aim of the study The aim of this study was to compare
efficacy and
safety of
Gabapentin and
Amitriptyline in subjects of
Type 2 diabetes mellitus with peripheral
neuropathic pain. Material and
Methods:
A prospective, open, randomized, parallel group,
comparative study was conducted in 60
patients coming to Department of
Medicine, Rajindra
Hospital attached to
Government Medical College Patiala, to evaluate the
efficacy and
safety of
Gabapentin and
Amitriptyline in
patients with diabetic peripheral
neuropathic pain. The
patients fulfilling the inclusion criteria were included in the study after taking written
informed consent. The
patients were divided into two groups of 30 cases each by simple
randomization. Group I
patients received
Gabapentin 300 mg HS by oral route. Group II
patients received
Amitriptyline 25 mg HS by oral route.
Therapeutic efficacy of both
drugs, by using
Michigan Neuropathy
Screening Instrument (MNSI) was compared at the baseline and at the end of 4 months. Any
adverse drug reactions of the respective
drug observed in
patient were also noted. All the observations thus made were statistically analysed using appropriate tests.
Results:
Baseline characteristics of the
patients in two groups such as age,
sex, duration of diabetes were
similar (p>0.05). The mean age in group I and group II were 53.40±8.41 years and 57.17±8.55 years, respectively. There was statistically significant reduction in mean MNSI scores in
questionnaire part and
physical examination part in both the groups. Also, there was statistically significant difference between the two
drugs in reducing mean MNSI score. Mean difference between two
drugs in reducing MNSI score in
history part (0.77±0.16, p<0.01) and
physical examination part (0.75±0.19, p<0.01) favoured
Gabapentin. No. of
adverse drug reactions reported were significantly higher in
Amitriptyline group, p value (<0.05) for the difference in ADRs between two
drugs was statistically significant.
Conclusion:
In this study, we concluded that both
drugs lead to improvement in
signs and symptoms of
diabetic neuropathy.
Gabapentin was proved to be more efficacious than
Amitriptyline.
Gabapentin treated
patient’s mean MNSI score at the study end point was significantly lower as compared to the
Amitriptyline treated
patient’s end-point score.
Adverse drug reactions reported in our study were mild in both the groups and a significantly higher number of
adverse effects were reported in the
amitriptyline group.
Dizziness and
somnolence were two most commonly reported
adverse drug reactions.