This observational study examined the outcome of two different therapeutic strategies in the treatment of chronic
neuropathic pain by including
pregabalin (
PGB) as mono- or add-on
therapy in one of two treatment options. Patients with a
pain score of > or =4, refractory to usual care for
neuropathic pain for at least 6 months, were allocated consecutively to one of two treatment strategies according to the decision of the physician: complete switch to a flexible-dosage, monotherapeutic or add-on
therapy with
pregabalin (
PGB group), or change established doses and combinations of pre-existing mono- or combination
therapy without
pregabalin (non-
PGB group). After 4 weeks (primary endpoint) a significant improvement in
pain reduction was documented in both intention-to treat (ITT) analysis (
PGB group, n = 85: mean
pain score reduction of 3.53, SD 2.03, p < 0.001; non-
PGB group, n = 102; mean
pain score reduction of 2.83, SD 2.23, p < 0.001) and per-protocol (PP) analysis (
PGB group, n = 79: mean
pain score reduction 3.53 vs. 2.83, p < 0.05; non-
PGB group, n = 81; 3.5 vs. 2.9, p < 0.05) compared to baseline. Comparison of the results observed in the two groups shows that patients in the
PGB group achieved significantly greater
pain reduction. These results demonstrate that
PGB administered twice daily is superior to treatment regimes without
PGB in reducing
pain and
pain-related interference in quality of life.