International Journal of Basic & Clinical Pharmacology
Saji S et al. Int J Basic Clin Pharmacol. 2024 Jul;13(4):493-497
http://www.ijbcp.com
pISSN 2319-2003 | eISSN 2279-0780
DOI: https://dx.doi.org/10.18203/2319-2003.ijbcp20241648
Original Research Article
Comparative study of efficacy and safety of pregabalin and gabapentin
for treatment of neuropathic pain in oral cavity cancer patients:
a comparative, randomized and prospective study
Sreeharsh Saji, Yogendra Singhal, Surendra Kumar Pingoliya*
Department of Palliative Medicine, SMS Medical College Jaipur, Rajasthan, India
Received: 08 April 2024
Accepted: 06 May 2024
*Correspondence:
Dr. Surendra Kumar Pingoliya,
Email: drskpingoliya@gmail.com
Copyright: © the author(s), publisher and licensee Medip Academy. This is an open-access article distributed under
the terms of the Creative Commons Attribution Non-Commercial License, which permits unrestricted non-commercial
use, distribution, and reproduction in any medium, provided the original work is properly cited.
ABSTRACT
Background: Pain in patients with oral cancers can limit the normal functioning and quality of life. Neuropathic pain
raises the anxiety and depression levels, increases the morbidity and decreases the efficiency to work. Neuropathic pain
is frequently diagnosed as a complication of cancer pain due to direct invasion of nerves, plexus or compression, and
side effect of chemotherapy, radiation injury or surgery.
Methods: A total of 60 patients were divided randomly into two groups based on treatment: group P (pregabalin) and
group G (gabapentin). The intensity of pain was measured using visual analog scale (VAS) and DN4 questionnaire
(Douleur Neuropathique 4) was used to evaluate neuropathic component. Changes in pain score and neuropathic
component was assessed at 2nd and 4th week of follow up. Data was collected and analysed using SPSS 20.0 software
at level of significance being p<0.05.
Results: At baseline, the mean±SD of VAS score in group P was 7.20±0.79; in group G was 7.13±0.66. At 2nd week,
the mean±SD of VAS score in group P was 4.5±0.91; in group G was 4.46±0.88. At 4th week, the mean±SD of VAS
score in group P was 3.66±0.69; in group G was 3.83±0.85. At baseline, the mean±SD of DN4 score in group P was
7.13±0.80; in group G was 6.93±0.85. At 2nd week, the mean±SD of DN4 score in group P was 4.73±0.92; in group G
was 4.46±0.82. At 4th week, the mean±SD of DN4 score in group P was 3.73±0.42; in group G was 3.93±0.62.
Conclusions: Pregabalin was found to be more effective with lesser side effects than gabapentin.
Keywords: Gabapentin, Oral cancer, Pain, Palliative care, Pregabalin
INTRODUCTION
Worldwide, oral squamous cell carcinoma (OSCC) is
known to be the sixth most prevalent cancer.1 Although in
past 20 years, there is gross improvement in diagnosis and
treatment modalities of oral cancers, but still outcomes of
treatment and prognosis is compromised.2 Malignancy is
associated with a severity of pain causing extreme
suffering to the patient. Neuropathic pain is frequently
diagnosed as a complication of cancer pain due to direct
invasion of nerves, plexus or compression, and side effect
of chemotherapy, radiation injury or surgery. Radiation
and chemotherapy in patients with oral cancers can cause
prolonged pain. These adverse effects limit the normal
functioning and quality of life. Pain also causes
impairment in speech, eating, swallowing and other motor
activities of the oral cavity.3 Pain in patients with oral
cancer is complex in nature and it generally exists along
with the neuropathic cancer pain (NCP) or nociceptive
pain or mixed pain. NCP can be primary or secondary in
nature, being linked with effect on somatosensory system.
Primary neuropathic pain occurs due to direct infiltration
or compression of nerve, whereas secondary NCP occurs
because of inflammation of tumor affecting secretion of
cytokine and chemokine, leading to changes in pH.4
International Journal of Basic & Clinical Pharmacology | July-August 2024 | Vol 13 | Issue 4 Page 493
Saji S et al. Int J Basic Clin Pharmacol. 2024 Jul;13(4):493-497
The awareness of severity, frequency of neuropathic pain,
its role and utilization of management techniques is still
limited in cancer patients, causing difficulty in managing
the symptoms. Neuropathic pain not only effect quality of
life of patients, but also raises the anxiety and depression
levels, increase the morbidity and decrease the efficiency
to work.5 Management of NCP is observed to be a complex
mechanism. It shows a limited response to treatment done
with opioids alone. Treatment of NCP usually require
combination of various drugs like anticonvulsants,
antiarrhythmic and antidepressants.6
Now-a-days, pregabalin and gabapentin are being used as
the preliminary drugs for management of NCP in cancers.
Pregabalin and gabapentin are anticonvulsants, which
decreases the secretion of excitatory neurotransmitters
which are linked to perception of pain. It acts by binding
to the presynaptic neuronal calcium channels.7
Till now, only few comparative studies have been
conducted assessing the role of pregabalin and gabapentin
in neuropathic pain. In Indian population, no study has
been conducted till date, comparing pregabalin and
gabapentin for treating neuropathic pain in patients with
oral cancer. The present study was conducted with the aim
to assess and compare the efficacy of gabapentin and
pregabalin in managing the neuropathic pain of oral cancer
patients.
METHODS
A prospective, randomised study was conducted in the
Department of Palliative Medicine, SMS Medical College,
Jaipur from May 2023 to December 2023, on patients
suffering from neuropathic pain due to oral cancer.
Inclusion and exclusion criteria
Patients who were registered in palliative care centre, age
between 18-70 years of both sexes, suffering from a
histologically diagnosed advanced oral cavity cancer and
having neuropathic pain were included in the study.
Pregnant and lactating females, patients with known
history of hypersensitivity to study drugs, having severe
renal or liver impairment, taking drugs (antipsychotic,
sedative- psychotropic, atropine and its substitute), those
who were non-cooperative and not giving consent were
excluded from the study.
A total of 60 cases were selected on the basis of inclusion
and exclusion criteria, and were divided randomly into two
groups based on treatment: group P (pregabalin):
pregabalin 75 mg orally twice daily for 4 weeks (n=30);
and group G (gabapentin): gabapentin 300 mg orally twice
daily for 4 weeks (n=30). Randomisation was done on the
basis of closed envelope system. The intensity of pain was
measured and recorded using visual analog scale (VAS) in
quantitative manner using scoring criteria from 0 (no pain)
and 10 (very severe pain). DN4 questionnaire (Douleur
Neuropathique 4) was used to evaluate the neuropathic
component. Changes in pain score and neuropathic
component was also assessed and recorded at 2nd and 4th
week of follow up. Data was collected and analysed using
SPSS 20.0 software at level of significance being p<0.05.
RESULTS
The study comprised of 60 patients, with 30 patients in
each group. Demographic variables were assessed.
Maximum number of patients was aged between 41-60
years of age, with male gender predominance. Most of the
patients resided in rural areas, belonging to Hindu religion
and were illiterate. In both the groups, insignificant
population of patients had habits of tobacco chewing and
smoking (Table 1).
Table 1: Comparison of demographic variable in the
study groups.
Group P
N
%
<20
0
0
Age
20-40
4
13.33
groups
41-60
18
60
(years)
>60
8
26.67
Age mean/SD
52.3±10.2
Female 5
16.67
Gender
Male
25
83.33
Illiterate 17
56.67
Education
Literate 13
43.33
Rural
16
53.33
Area
Urban
14
46.67
Hindu
23
76.67
Religion
Muslim 7
23.33
No
11
36.67
Alcohol 2
6.67
Addiction
Smoking 7
23.33
Tobacco 10
33.33
Mean weight/SD
49.83 7.01
Total
30
100
Parameters
Group G
N
%
0
0
5
16.67
19
63.33
6
20
51.96±9.45
4
13.33
26
86.67
16
53.33
14
46.67
17
56.67
13
43.33
26
86.67
4
13.33
9
30
4
13.33
8
26.67
9
30
52
9.07
30
100
8
7
6
5
4
Pregabalin
3
Gabapentin
2
1
0
Baseline 2 week
4 week
Figure 1: Comparison of mean VAS scores in
both groups.
International Journal of Basic & Clinical Pharmacology | July-August 2024 | Vol 13 | Issue 4 Page 494
Saji S et al. Int J Basic Clin Pharmacol. 2024 Jul;13(4):493-497
We evaluated the improvement in pain score after
treatment with oral pregabalin and gabapentin with VAS
scoring criteria. At baseline, the mean±SD of VAS score in
group P was 7.20±0.79; in group G was 7.13±0.66. At 2nd
week, the mean±SD of VAS score in group P was
4.5±0.91; in group G was 4.46±0.88. At 4th week, the
mean±SD of VAS score in group P was 3.66±0.69; in
group G was 3.83±0.85. It was observed that although pain
score significantly decreased from baseline to 4th week in
both the groups, the mean improvement in pain was found
to be significantly more in patients subjected to pregabalin
than gabapentin (Table 2).
Neurological improvement was assessed using DN4
questionnaire. At baseline, the mean±SD of DN4 score in
group P was 7.13±0.80; in group G was 6.93±0.85. At 2nd
week, the mean±SD of DN4 score in group P was
4.73±0.92; in group G was 4.46±0.82. At 4th week, the
mean±SD of DN4 score in group P was 3.73±0.42; in
group G was 3.93±0.62. It was observed that although the
mean score significantly decreased from baseline to 4th
week in both the groups, the mean improvement in
neurological component was found to be significantly
more in patients subjected to pregabalin than gabapentin
(Table 3).
Table 2: Comparison of VAS scores in the study groups.
Baseline
Mean±SD
7.2±0.79
7.13±0.66
Pregabalin
Gabapentin
2nd week
Mean±SD
4.5±0.91
4.46±0.88
4th week
Mean±SD
3.66±0.69
3.83±0.85
P value
Mean improvement
P<0.0001
P<0.0001
3.54
3.3
Table 3: Comparison of DN4 questionnaire scores in the study groups.
Baseline
Mean±SD
7.13±0.80
6.93±0.85
Pregabalin
Gabapentin
2nd week
Mean±SD
4.73±0.92
4.46±0.82
4th week
Mean±SD
3.73±0.42
3.93±0.62
P value
Mean improvement
P<0.0001
P<0.0001
3.4
3.0
vision with the use of gabapentin as compared to
pregabalin (Table 4).
8
7
6
5
4
3
2
1
0
DISCUSSION
Pregabalin
Gabapentin
Baseline
2 week
4 week
Figure 2: Comparison of mean DN4 questionnaire
scores in both groups.
Table 4: Side effects among the study groups.
Adverse effects
Sedation
Drowsiness
Blurring of vision
Nausea
Headache
Total
Pregabalin
2
1
0
2
1
6
Gabapentin
1
3
1
1
2
8
Besides assessing efficacy of both the drugs, we also
studied their side effects. It was found that patients suffered
from more episodes of drowsiness, headache, blurring of
The present study was conducted to assess and compare
the efficacy of oral 75 mg pregabalin and 300 mg
gabapentin in managing the neuropathic pain in oral cancer
patients. Demographic variables like age, gender, habit,
education, area, weight were evaluated and found to be
comparable in both the groups. We evaluated the
improvement in pain score after using pregabalin and
gabapentin with the help of VAS scoring criteria.
Pregabalin and gabapentin are anticonvulsants that act by
inhibiting the pain sensors and calcium ion channels in the
pain fibres of the postsynaptic dorsal root. They increase
the threshold of pain in patients. We found that both the
drugs significantly reduce the pain score from baseline to
4th week, but the mean improvement in pain was found to
be significantly more in patients subjected to treatment
with pregabalin than with gabapentin. Similar to our study
Mishra et al found that there was a significant difference in
pain score in pregabalin group as compared to other groups
[group amityrptiline (p=0.003), group gabapentin
(p=0.042), group placebo (p=0.024].8 We compared
pregabalin with gabapentin in our study, but it is known
that both act by modulation of alpha-2 delta subunit of
voltage-gated calcium channels. Thus, results of above
studies can be applied and are comparable with our study.
Richter et al reported that pregabalin 300 mg/day provides
International Journal of Basic & Clinical Pharmacology | July-August 2024 | Vol 13 | Issue 4 Page 495
Saji S et al. Int J Basic Clin Pharmacol. 2024 Jul;13(4):493-497
>50% reduction in pain from baseline in about 40% of total
patients.9 In a study by Ghosh et al found that by end of
study pregabalin has significant efficacy in reducing the
quality of pain than gabapentin (p=0.0146) but there was
no significant difference in final VAS scores between both
the groups.10 However, there was no significant difference
in reduction of pain intensity.
In our study, improvement in neuropathic pain was
assessed using DN4 (Douleur Neuropathique 4 questions)
questionnaire.11 This questionnaire comprises of 10 items
that depicts both the signs related to bedside sensory
assessment and sensory descriptors. It is a tool which is
being used for diagnosing the neuropathic pain. Its seven
items are linked to symptoms like tingling, prickling and
cold sensation, burning, electric shocks, itching and
numbness). Rest three items are related to clinical
assessment (hypoesthesia while injecting or touching, and
pain while rubbing). We found that although mean score
of DN4 significantly decrease from baseline to 4th week in
both the groups, but the mean improvement in
neurological component was found to be significantly
more in patients subjected to pregabalin than gabapentin.
Rosenstock et al described a 67% reduction in neuropathic
pain in patients treated with pregabalin.12 Similar to our
study Lamba et al found that the pregabalin is a better
medication for the management of neuropathic pain as
compared to gabapentin.13 Similar to our study Lamba et
al found that in the management of neuropathic pain in
cancer patients who are undergoing palliative care, a
combination of pregabalin with amitriptyline was found to
be more effective in pain relief than gabapentin with
amitriptyline.14
In present study we found that gabapentin had more side
effects than pregabalin in terms of more episodes of
drowsiness, headache, blurring of vision with the use of
gabapentin, whereas with pregabalin few patients suffered
from sedation and nausea. Similar to our study,
Madhanagopal et al stated that pain relief was better in the
pregabalin group than in gabapentin and placebo with an
equal incidence of adverse effects except for nausea which
was more in the pregabalin group.15
The present study reveals that both pregabalin and
gabapentin are well tolerated by patients with oral cancers.
Pregabalin revealed better efficacy in relieving
neuropathic pain and had less side effects than gabapentin.
The present study was a single-center study conducted on
less sample size with a limited follow up of 4 weeks. Thus,
further multi-centre studies should be conducted on large
sample size, and with longer follow up. In future clinical
trials should be conducted to study and compare various
other drugs to manage neuropathic pain in oral cancer
cases. In our study, we used fixed dose of drugs instead of
comparing different dose ranges by dose titration. Thus,
future studies should be conducted assessing efficacy of
drugs at various dose ranges.
CONCLUSION
Both pregabalin and gabapentin are effective in treating the
neuropathic pain in patients with oral cancers. But
pregabalin was found to be more effective with lesser side
effects than gabapentin. We assessed patients using readily
available evaluation scales. In future there is a need to
conduct multicentric studies, having a large sample size
with long follow up period using even better scales, on
different drug combinations to get more authentic,
conclusive and accurate results.
Funding: No funding sources
Conflict of interest: None declared
Ethical approval: The study was approved by the
Institutional Ethics Committee
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Cite this article as: Saji S, Singhal Y, Pingoliya SK.
Comparative study of efficacy and safety of
pregabalin and gabapentin for treatment of
neuropathic pain in oral cavity cancer patients: a
comparative, randomized and prospective study. Int J
Basic Clin Pharmacol 2024;13:493-7.
International Journal of Basic & Clinical Pharmacology | July-August 2024 | Vol 13 | Issue 4 Page 497
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