Co esponding au ho : Vaishna S R
Copy igh © 2025 Au ho (s) e ain he copy igh o his a icle. This a icle is published unde he e ms o he C ea i e Commons A ibu ion Liscense 4.0.
An obse a ional compa a i e s udy o e alua e he e icacy and sa e y o p egabalin
and gabapen in in neu opa hic pain- a a Te i ia y Ca e Cen e
Vaishna S R 1, *, Bhagya S Kuma 1, Rabiya Shajihan 1, D . Chi a C Nai 2 and D . Beena P 3
1 Pha m. D In e n, KVM College o Pha macy, Che hala, Ke ala, India.
2 P o esso and HOD, Depa men o Pha macy P ac ice, KVM College o Pha macy, Che hala, Ke ala, India.
3 P incipal, KVM College o Pha macy, Che hala, Ke ala, India.
Wo ld Jou nal o Biology Pha macy and Heal h Sciences, 2025, 21(01), 335-342
Publica ion his o y: Recei ed on 02 Decembe 2024; e ised on 08 Janua y 2025; accep ed on 10 Janua y 2025
A icle DOI: h ps://doi.o g/10.30574/wjbphs.2025.21.1.0036
Abs ac
Backg ound: Millions o people a ound he wo ld su e om Neu opa hic pain (Nep), a p e alen and debili a ing
condi ion. T ea men o NeP ypically includes an icon ulsan s, an idep essan s, opioids, opical medica ions, and local
anes he ics. Al hough P egabalin and Gabapen in a e commonly used o his pu pose, he e is a lack o conclusi e
e idence suppo ing hei e icacy. NeP signi ican ly diminishes pa ien s' quali y o li e. This s udy aims o e alua e he
sa e y and e ec i eness o Gabapen in and P egabalin in ea ing pa ien s wi h NeP.
Me hods: Among a o al o 100 pa ien s 50 pa ien s (G oup A) we e gi en Gabapen in and 50 Pa ien s (G oup B) we e
gi en P egabalin. The e icacy o d ug was measu ed on he basis o dec ease in NeP based on Douleu Neu opa hique
4 ques ions (DN4) pain scale measu ed a baseline, a e one mon h and a e wo mon hs. Ad e se d ug eac ion (ADR)
epo ed by he pa ien o obse ed by he clinician du ing he s udy was epo ed using ADR epo ing o m.
Resul : The mean educ ion o he neu opa hic pain sco e in G oup A om baseline o 2 mon hs was 2.15, while in
G oup B i was 3.49. Hence, p egabalin showed compa able pain educ ion o gabapen in a he end o he 2-mon hs
s udy.
Conclusion: P egabalin 100 mg once daily b ough be e imp o emen o symp oms and signs han Gabapen in 300
mg adminis e ed once daily. The s udy ound ha P egabalin is a be e d ug o he ea men o neu opa hic pain han
Gabapen in. Gabapen in had ewe ad e se e ec s han P egabalin.
Keywo ds: Neu opa hic Pain; P egabalin; Gabapen in; Ad e se d ug eac ion
1. In oduc ion
Pain is an unpleasan senso y and emo ional expe ience o en esul ing om in ense o po en ially ha m ul s imuli. Pain
hus se es as a wa ning sign o issue damage, con eyed h ough speci ic ecep o s and ibe sys ems spanning om
he pe iphe y o he b ain. Dis up ion o hese no mal pa hways due o inju y esul s in immedia e loss o educ ion o
unc ion, o en accompanied by pain. Howe e , in ce ain ins ances, such as when a lesion occu s, neu opa hic pain
(NeP) may de elop. The In e na ional Associa ion o he S udy o Pain de ines NeP as "an unpleasan senso y and
emo ional expe ience associa ed wi h, o esembling ha associa ed wi h, ac ual o po en ial issue damage." [1]
Neu opa hic pain (NeP) esul s om a lesion o disease a ec ing he soma osenso y ne ous sys em, leading o
s uc u al and unc ional changes ha cause spon aneous pain and abno mally ampli ied esponses o bo h pain ul and
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non-pain ul s imuli. Pe iphe al causes o NeP include condi ions such as polyneu opa hy, pos he pe ic neu algia,
pos ope a i e pain, and pos auma ic neu algia, while cen al causes include spinal co d inju ies and s oke.[2] NeP is
commonly desc ibed as bu ning, shoo ing, p icking, pins and needles, squeezing, o eezing sensa ions. Spon aneous
pain may be occasionally o e shadowed by in e mi en elec ic-shock-like pa oxysms, ei he independen ly o in
conjunc ion wi h ongoing discom o .
NeP managemen p ima ily ocuses on alle ia ing symp oms, wi h ea men o he unde lying e iological causes being
possible only in ce ain pa hological condi ions, leading o pain elie . The Special In e es G oup on Neu opa hic Pain
(NeuPSIG) has ecommended gabapen inoids, icyclic an idep essan s (TCAs) and selec i e se o onin–no epineph ine
eup ake inhibi o s (SNRIs) as i s -line d ugs o NeP. Lidocaine, Capsaicin, and T amadol a e sugges ed as second-line
ea men s, while s ong opioids (such as Mo phine and Oxycodone) and Bo ulinum oxin-A (BTX-A) a e conside ed
hi d-line ea men s o pe iphe al NeP. Gabapen in and P egabalin ha e ecei ed app o al om he Food and D ug
Adminis a ion (FDA) o NeP managemen . Thei s uc u al simila i y o he GABA neu o ansmi e enables hem o
bind o he α2-δ subuni o ol age- dependen calcium channels, he eby educing calcium in lux in o cells. Bo h
gabapen in and p egabalin ha e shown signi ican e icacy in ea ing Diabe ic neu opa hy, Pos he pe ic neu algia,
spinal co d inju y (SCI), and phan om limb synd ome.[3]
P egabalin is a well-es ablished an icon ulsan and analgesic agen and was he i s d ug app o ed by he FDA o
ea ing neu opa hic pain and pos he pe ic neu algia. P eclinical and clinical s udies ha e demons a ed p egabalin's
e ec i eness in managing neu opa hic pain, wi h animal s udies cla i ying i s an i-hype algesic and an i-allodynic
mechanisms. Clinical esea ch also suppo s he e icacy and dose-dependen e ec s o p egabalin, whe he used as
mono he apy o alongside o he analgesics, in alle ia ing pain and ela ed symp oms. I s main ad an ages include
eliabili y, ease o use, and high ole ance in pa ien s wi h neu opa hic pain.
Gabapen in (GBP) is commonly used o pos he pe ic neu algia (PHN). I s mechanism o ac ion in ol es binding wi h
high a ini y o he alpha-2-del a subuni o ol age-ga ed calcium channels in he pe iphe al and cen al ne ous
sys em, modi ying neu o ansmi e elease and educing ne e cell exci abili y. This ac ion likely con ibu es o i s
analgesic e ec in neu opa hic pain pa ien s.[4]
2. Me hods
• S udy design: P esen s udy was p ospec i e, obse a ional, compa a i e s udy, single cen e s udy.
• S udy cen e and du a ion: S udy was conduc ed a ou pa ien and inpa ien o Neu ology depa men a SH
medical cen e, Ko ayam, Ke ala o a pe iod o 6 mon hs.
• S udy design: To al pa ien s we e 100 and we e andomised in o 2 g oups. G oup A pa ien s ecei ed
Gabapen in 300 mg. G oup B pa ien s ecei ed P egabalin 100 mg.
• Inclusion c i e ia: Pa ien s o ei he sex wi h age >18 yea s, Inpa ien s and ou pa ien s o neu ology
depa men wi h NeP based on clinical p esen a ion, Those who a e ecei ing P egabalin 100 mg o Gabapen in
300 mg o NeP, Those who a e willing o gi e consen we e included in he s udy.
• Exclusion c i e ia: In pa ien wi h o he ypes o pain no con i med o be NeP, Pa ien s who p e iously did
ecei e any o he d ug ha will be used in he s udy, Pa ien wi h his o ies o li e diso de s, hea condi ions,
enal diso de s, p egnancy /lac a ion.
• P ocedu e: The pa ien s we e e alua ed on basis o p ope his o y, p esen ing complain s and pas symp oms.
Pa ien s diagnosed as a case o NeP a ending inpa ien and ou pa ien depa men o neu ology, SH medical
cen e . Pa ien s we e en olled in he s udy a e signing he consen o m which we e p o ided in Malayalam
and English. A e ge ing en olled and p io o he commencemen o he ea men , he ollowing we e
eco ded in he case eco d o m-physical examina ion, pas medical his o y, concomi an medica ions i any i
any, clinical es o neu opa hic pain, diagnosis and pain assessmen was done using Douleu Neu opa hique
4 ques ions.
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Table 1 Douleu neu opa hic 4 ques ionnai e (DN4)
DOULEUR NEROPATHIC SCALE 4 QUESTIONS
Please comple e his ques ionnai e by icking one answe o each i em in he
Ques ions below
INTERVIEW OF THE PATIENT
QUESTION NO 1: Does you pain p esen by one o mo e o he
ollowing cha ac e is ics.
Pain eels like bu ning
Sensa ion o pain ul cold
Pain eels like elec ic shocks
QUESTION NO 2: Is he pain associa ed wi h one o mo e o he
Following symp oms in same a ea?
Tingling
Pins and needles Numbness I ching
PATIENTEXAMINATION
QUESTION NO3: Is he pain loca ed in an a ea whe e he physical
Examina ion had one o bo h o he ollowing cha ac e is ics?
1.Hypoes hesia o ouch?
2.Hypoes hesia o pinp ick?
QUESTION NO 4: Is he pain p o oked o inc eased by?
1.B ushing?
Yes=1/No= 0 pa ien ’s Sco e: /10Sco es≥4/10indica e NeP
• ADR epo ing: Ad e se d ug eac ion epo ed by he pa ien o obse ed by he clinician du ing he s udy was
epo ed using he ADR epo ing o m.
• S a is ical analysis: Fo analysis o his da a S a is ical package o social science (SPSS) so wa e e sion 20 h
was used. Quali a i e da a we e ep esen ed in he o m o alues and pe cen ages. Quan i a i e we e
ep esen ed in he o m o mean±S anda ed De ia ion (SD). An ANOVA es was conduc ed o compa e he
mean sco es o he Douleu Neu opa hique 4 ques ionnai e be ween he wo g oups. Addi ionally, a Chi-squa e
es was used o assess ad e se d ug eac ions in he wo s udy g oups.
3. Resul s
Table 2 Dis ibu ion o pa ien s acco ding o age g oup
Age in yea s
GROUP A (Gabapen in) (n=50)
GROUP B (P egabalin) (n=50)
To al (N=100)
F equency
Pe cen age (%)
F equency
Pe cen age (%)
F equency
Pe cen age (%)
≤50
4
8.0
4
8.0
8
8.0
51-60
14
28.0
11
22.0
25
25.0
61-70
18
36.0
14
28.0
32
32.0
71-80
12
24.0
18
36.0
30
30.0
>80
2
4.0
3
6.0
5
5.0
In his s udy, pa ien s we e mo e in he age g oup 61-70 yea s ollowed by 71-80 and 51-60. The mean age o pa ien s
in he s udy is 65 yea s. In g oup A, pa ien s we e mo e in he age g oup 61- 70 yea s and he mean age is 64 yea s. In
g oup B, pa ien s we e mo e in he age g oup 71 -80 yea s and he mean age is 66 yea s.
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In each g oup o al 100 pa ien s we e he e. In g oup A o al emales we e 42 (84%) and 8 (16%) we e males and in
g oup B, emales we e 22 (56%) and males we e 28 (44%).
Table 3 Dis ibu ion o pa ien s acco ding o gende
Sex
G oup A Gabapen in (n=50)
(G oup B) P egabalin (n=50)
To al (N=100)
F equency
Pe cen age (%)
F equency
Pe cen age (%)
F equency
Pe cen age (%)
Male
8
16.0
28
56.0
36
36.0
Female
42
84.0
22
44.0
64
64.0
A baseline, he mean±SD o DN4 sco e in G oup A was 6.57±0.81and G oup B was 7.14±0.74 espec i ely wi h alue
o 3.486 and p alue o <0.001 which was s a is ically signi ican . A one mon h, he mean±SD o DN4 pain sco e in G oup
A was 5.70±0.70 and G oup B was 5.23±0.77 espec i ely wi h an alue o 2.689 and p alue o 0.009 which was no
s a is ically signi ican . A wo mon hs, he mean±SD o DN4 pain sco e in G oup A was 4.41±1.15 and G oup B we e
3.65±1.00 espec i ely wi h alue o 3.335 and p alue o <0.001 which was s a is ically signi ican .
Table 4 Compa ison o neu opa hic pain sco e in G oup A and G oup B a baseline, a e one mon h and a e 2 mon hs
Time
G oup
Mean
SD
Mean di e ence
alue
p alue
Baseline
G oup A (Gabapen in) (n=46)
6.57
0.81
0.57
3.486
<0.001***
G oup B (P egabalin) (n=43)
7.14
0.74
Fi s ollow up
G oup A (Gabapen in) (n=46)
5.70
0.70
0.42
2.689
0.085
G oup B (P egabalin) (n=43)
5.28
0.77
Second ollow up
G oup A (Gabapen in) (n=46)
4.41
1.15
0.76
3.335
<0.001***
G oup B (P egabalin) (n=43)
3.65
1.00
In G oup A, he mean di e ence in DN4 sco e om baseline o one mon h o ea men was 0.89, wi h a p- alue o
<0.001, indica ing s a is ical signi icance. F om baseline o he second ollow-up, he mean di e ence in DN4 sco e was
2.15, wi h a p- alue o 0.01, which was s a is ically signi ican . The mean di e ence in DN4 sco e be ween he i s and
second ollow-up was 1.28, wi h a p- alue o 0.001, which was also s a is ically signi ican as shown in able 8.5 and
igu e 8.5.
Table 5 Compa ison o neu opa hic pain sco e in G oup A a baseline, a e one mon h and a e wo mon hs
G oup
Mean
SD
Mean di e ence
alue
p alue
Baseline
6.57
0.81
0.89
10.882
<0.001***
Fi s ollow up
5.70
0.70
Baseline
6.57
0.81
2.15
13.857
0.01**
Second ollow up
4.41
1.15
Fi s ollow up
5.70
0.70
1.28
8.668
0.001***
Second ollow up
4.41
1.15
In G oup B, he mean di e ence in DN4 sco e om baseline o one mon h was 1.86, wi h a p- alue o <0.001, which was
s a is ically signi ican . F om baseline o he second ollow-up, he mean di e ence in DN4 sco e was 3.49, wi h a p-
alue o <0.001, which was s a is ically signi ican . The mean di e ence in DN4 sco e om he i s ollow-up o he
second ollow-up was 1.63, wi h a p- alue o <0.001, indica ing s a is ical signi ican .
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Table 6 Compa ison o neu opa hic pain sco e in G oup B a baseline, a e one mon h and a e wo mon hs
G oup
Mean
SD
Mean di e ence
alue
p alue
Baseline
7.14
0.74
1.86
12.034
<0.001***
Fi s ollow up
5.28
0.77
Baseline
7.14
0.74
3.49
20.036
<0.001***
Second ollow up
3.65
1.00
Fi s ollow up
5.28
0.77
1.63
11.523
<0.001***
Second ollow up
3.65
1.00
The mean educ ion o he neu opa hic pain sco e in G oup A om baseline o 2 mon hs was 2.15, while in G oup B i
was 3.49. Hence, p egabalin showed compa able pain educ ion o gabapen in a he end o he 2-mon hs s udy.
Table 7 Compa ison o mean educ ion o neu opa hic pain sco e in g oup A and g oup B a baseline s a e 2 mon hs
GROUP
MEAN REDUCTION
G oup A a baseline Vs G oup A a 2 mon hs
2.15
G oup B a baseline Vs G oup B a 2 mon hs
3.49
Figu e 1 Compa ison o mean educ ion o neu opa hic pain sco e in g oup A and g oup B a baseline s a e 2
mon hs
Table 8 Ad e se d ug eac ion in pa ien s in g oup A and g oup B
Ad e se e ec s
G oups
P alue
Chi-squa e
GROUP A
GROUP B
Seda ion
4
8
0.202 (NS)
1.613
Dizziness
0
1
0.309 (NS)
1.033
D owsiness
0
2
0.148 (NS)
2.088
Somnolence
0
1
0.309(NS)
1.033
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The occu ence o seda ion was highe in G oup B, wi h 8 pa ien s, compa ed o G oup A, wi h 4 pa ien s. Howe e , his
di e ence was no s a is ically signi ican . Addi ionally, dizziness and somnolence was obse ed in one pa ien in G oup
B, and d owsiness was obse ed in wo pa ien s in G oup B, none o which we e s a is ically signi ican .
4. Discussion
A p ospec i e obse a ional compa a i e s udy was conduc ed a he depa men o Neu o-medicine, SH Medical
Cen e , Ko ayam, o e a pe iod o six mon hs om 2023 o 2024. The s udy ocused on e alua ing he e icacy and
sa e y o p egabalin and gabapen in, which a e commonly used o NeP in bo h he OPD and inpa ien depa men s o
neu o-medicine a he a o emen ioned hospi al. Pa ien s a ending he OPD and inpa ien depa men s a SHMedical
Cen e , Ko ayam, we e diagnosed wi h NeP based on he c i e ia es ablished by he DN4 ques ionnai e, de eloped by
he F ench NeP Pain G oup. The DN4 ques ionnai e aids in dis inguishing NeP om non-NeP and is a s aigh o wa d,
objec i e ool ha includes bo h an in e iew and a pa ien examina ion.
The e icacy o he d ug was e alua ed based on he dec ease in neu opa hic pain (NeP) using he DN4 scale, measu ed
a speci ic in e als. The pa icipan s we e andomly assigned o wo g oups. G oup A ecei ed Gabapen in (300 mg)
and G oup B ecei ed P egabalin (100 mg) as a single daily dose o a pe iod o wo mon hs. Obse a ions we e made
a baseline, one mon h, and wo mon hs.
The pain educ ion in pa ien s ea ed wi h p egabalin was 3.49 and gabapen in i was 2.15 a he end o 2 mon hs.
Hence p egabalin shown s a is ically signi ican pain educ ion as compa ed o gabapen in a he end o 2 mon hs o he
s udy. Mohi Shukla e al. epo ed ha esul s om a andomized ial suppo he supe io e icacy o p egabalin
compa ed o gabapen in, which is consis en wi h he indings o he p esen s udy.[3]
The esul s o he p esen s udy indica e a emale p eponde ance in bo h ea men g oups, which con as s wi h o he
s udies ha ha e epo ed male p edominance. This disc epancy could be due o geog aphical a ia ions o he lowe
pain h eshold and g ea e emo ional labili y o emales.[7]
Du ing he s udy, i was obse ed ha ADR we e mo e p e alen in he p egabalin ea ed g oup compa ed o he
gabapen in g oup. Speci ically, he occu ence o seda ion was highe in g oup B, wi h 8 pa ien s a ec ed, compa ed o
g oup A, which had 4 pa ien s a ec ed. Only a ew pa ien s who ook p egabalin epo ed d owsiness, and jus 1 ou o
46 pa ien s expe ienced dizziness and somnolence.
Va ious s udies on he e icacy and sa e y o d ugs o NeP ha e been conduc ed. A al e al. ound ha p egabalin is
mo e e icacious han gabapen in in pa ien s wi h spinal co d inju y expe iencing ch onic NeP.[8] A p ospec i e,
andomized, double-blind, placebo-con olled s udy conduc ed by Mish a e al. on 120 pa ien s compa ed he e icacy
o ami ip yline, gabapen in, and p egabalin in neu opa hic cance pain, demons a ing ha all h ee d ugs a e e ec i e
in elie ing cance - ela ed NeP.[9] P egabalin showed a s a is ically and clinically signi ican mo phine-spa ing e ec in
elie ing neu opa hic cance pain and symp oms compa ed o o he an i-neu opa hic d ugs. Kiss e al. published an
a icle summa izing, p esen ing, and e alua ing na ional and in e na ional guidelines issued in he pas i e yea s.[10]
The mos equen ly ecommended d ugs in all guidelines a e ami ip yline, duloxe ine, gabapen in, and p egabalin.
P egabalin is he only d ug ecommended as a i s -line ea men in all e e enced guidelines. Ma kman e al. analyzed
da a om 18 andomized, double-blind, placebo-con olled ials o p egabalin in pa ien s wi h NeP p e iously ea ed
wi h gabapen in and concluded ha p egabalin can success ully ea pa ien s who a e e ac o y, espond
inadequa ely, o a e in ole an o gabapen in.[11] Kopel e al. published a case epo desc ibing a pa ien success ully
ea ed o PHN wi h p egabalin a e ailing gabapen in. P egabalin is sugges ed as an e ec i e i s -line he apy o
PHN and o he o ms o neu opa hic and ch onic pain.[12] Tong e al. comple ed a ne wo k me a-analysis o eigh
andomized con olled ials examining p egabalin, gabapen in, ca bamazepine, and ami ip yline.[13] The analysis
ound ha , based on a e age pain in ensi y a e ea men , he e icacy o de om highes o lowes was p egabalin,
gabapen in, ami ip yline, ca bamazepine, and placebo in pa ien s wi h spinal co d inju y- ela ed NeP.
Limi a ions
The cu en s udy was conduc ed o e a limi ed pe iod o 6 mon hs. Some die a y and li es yle pa ame e changes migh
ha e in luenced he esul s. The e may also be conce ns abou compliance wi h he s udy d ugs among some subjec s.
Ano he limi a ion o his s udy is he a iabili y in indi idual pain pe cep ion due o he subjec i e na u e o pain.
P ima y ou comes in e ms o e icacy and ad e se e ec s should be assessed by conduc ing long- e m s udies, using
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di e en doses o p egabalin and gabapen in, and conside ing he ecu ence o disease a e discon inua ion o
medica ion, as ecu ence is a majo ac o in cu en ea men op ions o neu opa hic pain
5. Conclusion
In summa y, he obse a ional compa a i e s udy, conduc ed a a e ia y ca e cen e , e alua ed he e icacy and sa e y
o p egabalin and gabapen in in ea ing NeP. Ou indings sugges ha while p egabalin demons a ed supe io e icacy
compa ed o gabapen in, i also showed a highe incidence o ADR, pa icula ly seda ion. Con e sely, gabapen in
exhibi ed a lowe incidence o ADR, ende ing i a po en ially sa e op ion o ce ain pa ien s. Fu he mo e, ou esul s
e ealed a emale p eponde ance in bo h ea men g oups, con as ing wi h s udies epo ing male p edominance.
This incong ui y may s em om geog aphical a ia ions o di e ences in pain h eshold and emo ional esponse
be ween gende s. The subjec i e na u e o pain and indi idual a iances in pain pe cep ion p esen limi a ions o ou
s udy. Addi ionally, he s udy's du a ion limi s ou abili y o asce ain he long- e m e ec s and sa e y o hese
medica ions. Consequen ly, u u e esea ch wi h la ge pa ien coho s and p olonged ollow-up pe iods is impe a i e
o o e mo e comp ehensi e insigh s in o he sus ained e icacy and sa e y o p egabalin and gabapen in o NeP
managemen .
Compliance wi h e hical s anda ds
Acknowledgmen s
We ake his oppo uni y o exp ess ou deep sense o g a i ude and espec ul ega ds o D . S eeji h V Ra i MBBS MD
(Gene al medicine) DM (Neu ology) D NB (Neu ology), SH Medical Cen e, Ko ayam o hei immense suppo ,
encou agemen and c edible ideas which ha e been g ea con ibu o s in comple ion o his esea ch wo k. We a e also
hank ul o he Managemen , Nu sing S a and all o he S a s o SH Medical Cen e, Ko ayam, o hei immense
suppo .
Disclosu e o con lic o in e es
No con lic o in e es o be disclosed.
S a emen o e hical app o al
The s udy was app o ed by he Ins i u ional E hics Commi ee
S a emen o in o med consen
In o med consen was ob ained om all indi idual pa icipan s included in he s udy.
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