PMID- 17157115
OWN - NLM
STAT- MEDLINE
DCOM- 20070213
LR  - 20131121
IS  - 0149-2918 (Print)
IS  - 0149-2918 (Linking)
VI  - 28
IP  - 10
DP  - 2006 Oct
TI  - Efficacy and tolerability of paracetamol/tramadol (325 mg/37.5 mg) combination 
      treatment compared with tramadol (50 mg) monotherapy in patients with subacute 
      low back pain: a multicenter, randomized, double-blind, parallel-group, 10-day 
      treatment study.
PG  - 1592-606
AB  - BACKGROUND: In various pain studies, the single-dose combination of 
      paracetamol/tramadol (PIT) was found to be more effective than either agent 
      alone. PIT could provide benefit in patients with subacute low back pain (LBP). 
      OBJECTIVE: This study compared the efficacy and tolerability of PIT with tramadol 
      alone (T) in patients with subacute LBP and assessed whether, under comparable 
      analgesic conditions, PIT would be better tolerated. METHODS: This was a 
      multicenter, randomized, double-blind, parallel-group study. Patients were 
      enrolled if they suffered from nonspecific LBP lasting 10 to 42 days and 
      experienced at least moderate pain (> or =40 mm on a 100-mm visual analog scale). 
      Patients were randomized and treated for 10 days with PIT (325 mg/37.5 mg) or T 
      (50 mg). The study outcomes were treatment efficacy (pain intensity, pain relief, 
      patient satisfaction, physicians' assessment of pain control) and tolerability 
      (adverse events [AEs], patients' tolerability judgment). RESULTS: A total of 119 
      patients were enrolled (PIT, n = 59; T, n = 60). Demographic characteristics of 
      patients were comparable between the PIT and T groups in regard to age (mean, 
      56.5 vs 54.1 years, respectively), sex (women/men, 38121 vs 31129), race (white, 
      96.1% vs 94.2%), and body mass index (24.9 vs 26.1 kg/m2). Pain intensity (mean 
      [SD] percentage of worst imaginable pain) improved from nearly identical levels 
      at baseline (P/T, 67.5 [13.0] vs T, 65.3 [14.6]; P = NS) to similarly low levels 
      at the final visit (P/T, 27.9 [22.7] vs T, 24.8 [21.6]; P = NS). The reduction in 
      pain intensity was significant in both treatment groups (P < 0.001). Adequate 
      pain relief (ie, "moderate," "important," or "complete") was observed in 81.6% 
      (40149) of PIT patients versus 82.9% (39147) of T patients (P = NS). Comparably 
      high rates of overall patient satisfaction (72.5% [37151] vs 72.9% [35148], 
      respectively; P = NS) were achieved. Both treatment groups took a comparable 
      number of daily units of study medication, which resulted in significantly (P < 
      0.001) lower daily doses of tramadol in the P/T group (mean [SD], 172.5 [46.6] 
      mg) than in the T group (227.3 [59.7] mg). More P/T patients (84.3%) than T 
      patients (68.8%) judged treatment tolerability as good or very good (P = NS). 
      Significantly fewer AEs (P < 0.001) were observed in PIT patients, and the 
      overall incidence of AEs (mostly opioid-typical AEs [eg, nausea, 
      dizziness/vertigo, sleepiness/drowsiness, constipation, vomiting]) was much lower 
      after P/T compared with T (P = 0.019). The most common AEs in the P/T and T 
      groups were nausea (8159 vs 21160 patients, respectively; P = 0.012) and 
      dizziness (3/59 vs 15/60 patients; P= 0.006). CONCLUSIONS: Tramadol, alone and in 
      combination with paracetamol, provided highly effective analgesia for these 
      patients with subacute LSP However, the combination of PIT, which resulted in 25% 
      less tramadol than equianalgesic daily doses of T alone, considerably reduced the 
      incidence of AEs and improved tolerability.
FAU - Perrot, Serge
AU  - Perrot S
AD  - Service de Medicine Interne et Consultation de la Douleur, Hopital Dieu, Paris, 
      France. serge.perrot@htd.aphp.fr
FAU - Krause, Dirk
AU  - Krause D
FAU - Crozes, Philippe
AU  - Crozes P
FAU - Naim, Claude
AU  - Naim C
CN  - GRTF-ZAL-1 Study Group
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Clin Ther
JT  - Clinical therapeutics
JID - 7706726
RN  - 362O9ITL9D (Acetaminophen)
RN  - 39J1LGJ30J (Tramadol)
SB  - IM
MH  - Acetaminophen/administration & dosage/*therapeutic use
MH  - Double-Blind Method
MH  - Drug Therapy, Combination
MH  - Humans
MH  - Low Back Pain/*drug therapy
MH  - Tramadol/administration & dosage/*therapeutic use
MH  - Treatment Outcome
EDAT- 2006/12/13 09:00
MHDA- 2007/02/14 09:00
CRDT- 2006/12/13 09:00
PHST- 2006/08/16 00:00 [accepted]
PHST- 2006/12/13 09:00 [pubmed]
PHST- 2007/02/14 09:00 [medline]
PHST- 2006/12/13 09:00 [entrez]
AID - S0149-2918(06)00230-X [pii]
AID - 10.1016/j.clinthera.2006.10.001 [doi]
PST - ppublish
SO  - Clin Ther. 2006 Oct;28(10):1592-606. doi: 10.1016/j.clinthera.2006.10.001.