K. Pavelka et al., Intraindividual differences in pain relief and functional improvement in osteoarthritis with diclofenac or tramadol, CLIN DRUG I, 16(6), 1998, pp. 421-429
Objectives: To investigate how individual patients with painful osteoarthri
tis (OA) respond to the non-steroidal anti-inflammatory drug (NSAID) diclof
enac and the centrally acting analgesic tramadol when individual on-demand
dose titration is allowed. In addition, we studied whether the differences
in the mode of action of the different analgesics were important for functi
onal outcome in OA patients.
Methods: This was performed as a double-blind, crossover: randomised study
in 60 patients with OA of the hip (19 patients) or knee (41 patients) witho
ut clinical joint inflammation. Patients received either tramadol (50 to 10
0mg up to three times daily, on demand) for 4 weeks, followed by diclofenac
(25 to 50mg up to three times daily, on demand) for 4 weeks, or vice versa
. The multidimensional 'Western Ontario and McMaster Universities Osteoarth
ritis Index' (WOMAC) questionnaire (pain, stiffness and functional impairme
nt) was used to assess the effect of the drugs on pain and functional capab
ility.
Results: 54 patients completed both study periods. The mean (+/- SD) daily
dose of tramadol consumed was 164.8mg (+/- 54.1 mg) and that of diclofenac
was 86.9mg (+/- 21.4mg). Both treatments modestly improved median pain inte
nsity, paralleled by an improvement in functional parameters, and there wer
e no statistically significant differences between the groups. However, ind
ividual treatment effects varied greatly, and within individual patients th
ere were considerable variations in analgesic effectiveness between the two
treatments. Consistently, pain relief correlated linearly with functional
improvement. More patients reported adverse events with tramadol than with
diclofenac (20 vs 3%, p = 0.0056), but there was no difference in adverse e
vent-related withdrawals (p = 0.69).
Conclusion: OA patients' response to analgesic treatment was highly individ
ual and the response to one drug was not predictive of that to another drug
. A significant proportion of patients were not treated satisfactorily with
diclofenac or tramadol alone. The results obtained from a descriptive anal
ysis of group effects (means, medians) were inappropriate for drawing concl
usions on individual treatment benefits. Improvement of functional capabili
ty apparently was a consequence of pain relief. Effective pain relief shoul
d therefore be the main therapeutic goal in patients with OA where inflamma
tion is less prominent.