|
| Study | Type | Patients | Tramadol/paracetamol
mean daily dose | Comparator
mean daily dose |
|
| Musculoskeletal pain |
|
|
Mullican and Lacy, 2001 [85] | 4-week double-blind, double-dummy, active-control, multicenter, randomized | 462
Mean age 57.6 years
Chronic nonmalignant low back pain, osteoarthritis pain, or both | 131 mg/1133 mg | Codeine/paracetamol 105 mg/1054 mg |
| Serrie et al., 2011 [86] | Observational, prospective, open-label, in clinical practice
37.6% first-line treatment
62.4% following treatment failure of mainly paracetamol or analgesics containing dextropropoxyphene | 5495
Mean age 53.2 ± 15.9 years
Mainly musculoskeletal pain | 139 mg/1203 mg
Mean treatment duration 16.6 ± 9.8 days | None |
| Mejjad et al., 2011 [87] | Observational, prospective, open-label, in clinical practice
30% first-line treatment
70% after treatment failure/safety problems with at least one other analgesic | 2,663
≥65 years old; mean age 73.6 ± 6.6 years
Primarily musculoskeletal pain | 143 mg/1235 mg
Mean treatment duration 23.2 ± 9.2 days | None |
|
| Osteoarthritis |
|
| Silverfield et al., 2002 [96] | 10-day multicenter, double-blind, placebo-controlled, randomized
Add-on treatment | 308
Mean age 60.1 ± 9.9 years
Hip or knee flare pain | 37.5 mg/325 mg
1-2 tablets qid | Placebo |
| Emkey et al., 2004 [97] | 3-month multicenter, double-blind, randomized
Add-on to celecoxib or rofecoxib | 306
Mean age 61 ± 9 years
Hip or knee pain | 154 mg/1332 mg | Placebo |
| Park et al., 2012 [98] | Multicenter, randomized, comparative
8-week monotherapy after 4-week add-on to meloxicam or aceclofenac | 97
Knee OA > 1 year | 121 mg/1050 mg
Mean age 60 ± 7.4 years | Meloxicam or aceclofenac
Mean age 61.2 ± 7.5 years |
| Choi et al., 2007 [99] | 2-week multicenter, double-blind, double-dummy add-on to NSAIDs
Safety study
Randomization to titration and nontitration group | 250
Mean age 60.2 ± 7.8 years
Knee OA on stable NSAID therapy | 37.5 mg/325 mg tid
Titration over 7 days for titration group | None |
|
| Low back pain |
|
| Ruoff et al., 2003 [106] | 3-month double-blind, multicenter, randomized, placebo-controlled | 318
Mean age 53.9 years
At least moderate chronic lower back pain | 158 mg/1365 mg | Placebo |
| Peloso et al., 2004 [107] | 3-month double-blind, multicenter, randomized, placebo-controlled | 336
Mean age 57.5 ± 12.6 years
At least moderate chronic lower back pain | 158 mg/1369 mg | Placebo |
|
| Rheumatoid arthritis |
|
| Lee et al., 2006 [108] | 1-week, double-blind, randomized, placebo-controlled
Add-on treatment | 277
Inadequate pain control by conventional NSAIDs and DMARDs | 112.5 mg/975 mg
Mean age 51.6 ± 11.7 years | Placebo
Mean age 52 ± 12 years |
|
| Painful diabetic neuropathy |
|
| Freeman et al., 2007 [109] | 66-day double-blind, multicenter, randomized, placebo-controlled | 313
Mean age 55.7 ± 10.3 years
94% type 2 diabetics
Neuropathy symptoms for a mean
3.7 ± 2.6 years | 158 mg/1365 mg | Placebo |
| Ko et al., 2010 [110] | 6-week, open-label, randomized | 163
25–75 years
Type 2 diabetes | Mean dose at final visit
158 mg/1371 mg
Mean age 58.6 ± 7.5 years | Gabapentin
Mean dose at final visit 1575 mg
Mean age 57.1 ± 9.3 years |
|
