Comparison of the efficacy and safety of tramadol/acetaminophen combination therapy and gabapentin in the treatment of painful diabetic neuropathy.
OBJECTIVE
This study compared the efficacy and safety of tramadol/acetaminophen (T/A) and gabapentin in the management of painful diabetic neuropathy.


METHODS
An open, randomized, comparative study was conducted. Subjects with painful symmetric neuropathy in the lower limbs and mean pain-intensity score > or = 4 on a numeric rating scale were eligible. Subjects were randomized to receive either tramadol (37.5 mg)/acetaminophen (325 mg) or gabapentin (300 mg) for 6 weeks. After 2 weeks of the titration period (1200 mg/day for gabapentin and three tablets/day for T/A), the doses were maintained if the pain was relieved. The primary efficacy outcome was a reduction in pain intensity. Secondary measures evaluated a pain relief scale, a Brief Pain Inventory, a 36-item Short Form Health Survey, average pain intensity and sleep disturbance.


RESULTS
One hundred and sixty-three subjects (T/A 79; gabapentin 84) were included. At the final visit, the mean doses were 1575 mg/day for gabapentin and 4.22 tablets/day for T/A. Both groups were similar in terms of baseline pain intensity (mean intensity: T/A 6.7 +/- 1.6; gabapentin 6.3 +/- 1.6, P = 0.168). At the final visit, the mean reductions in pain intensity were similar in both groups (T/A -3.1 +/- 2.0; gabapentin -2.7 +/- 2.1, P = 0.744). Both groups had similar improvements in every Short Form Health Survey category and Brief Pain Inventory subcategory, and in the mean pain relief scores.


CONCLUSIONS
This study suggests that the T/A combination treatment is as effective as gabapentin in the treatment of painful diabetic neuropathy in patients with Type 2 diabetes.
Ko
S-H
SH
The Catholic University of Korea, Seoul, Korea.
Kwon
H-S
HS
Yu
J-M
JM
Baik
S-H
SH
Park
I-B
IB
Lee
J-H
JH
Ko
K-S
KS
Noh
J-H
JH
Kim
D-S
DS
Kim
C-H
CH
Mok
J-O
JO
Park
T-S
TS
Son
H-S
HS
Cha
B-Y
BY
D000082:Acetaminophen / Q000008:administration & dosage*; D000328:Adult; D000368:Aged; D000588:Amines / Q000008:administration & dosage*; D000701:Analgesics, Opioid / Q000008:administration & dosage*; D003509:Cyclohexanecarboxylic Acids / Q000008:administration & dosage*; D003924:Diabetes Mellitus, Type 2 / Q000150:complications / Q000188:drug therapy* / Q000503:physiopathology; D003929:Diabetic Neuropathies / Q000188:drug therapy* / Q000503:physiopathology; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D000077206:Gabapentin; D006801:Humans; D008297:Male; D008875:Middle Aged; D010146:Pain / Q000188:drug therapy; D014147:Tramadol / Q000008:administration & dosage*; D016896:Treatment Outcome; D005680:gamma-Aminobutyric Acid / Q000008:administration & dosage*
D000588:Amines; D000701:Analgesics, Opioid; D003509:Cyclohexanecarboxylic Acids; D000082:Acetaminophen; D014147:Tramadol; D005680:gamma-Aminobutyric Acid; D000077206:Gabapentin