Published online Jul 27, 2014. doi: 10.5313/wja.v3.i2.181
Revised: June 12, 2014
Accepted: June 14, 2014
Published online: July 27, 2014
Processing time: 370 Days and 9.3 Hours
AIM: To compare the effectiveness and tolerability of paroxetine vs pregabalin for the management of multiple sclerosis (MS)-induced neuropathic pain (NPP).
METHODS: A randomized, flexible-dose open-label 8-wk study involving 21 relapsing-remitting MS patients with MS-induced NPP was conducted to evaluate the effectiveness and tolerability of pregabalin versus paroxetine for pain management. The trial included a 3-wk dose titration phase followed by a 5-wk stable dose phase. Primary outcome measures included daily patient-reported pain intensity as measured using a 100 mm visual analogue scale (VASpain) and daily impact of pain on daily activities (VASimpact). Hierarchical regression modeling was conducted on each outcome to determine if within person VAS trajectory for pain and impact differed across study groups, during 56 d follow-up.
RESULTS: Attrition rates were significantly greater (P < 0.001) in the paroxetine versus pregabalin study group (70% vs 18.2%, respectively). Average study duration between study groups also significantly differed (P < 0.001). Paroxetine participants completed an average of 27.3 d of treatment vs 49.5 d in the pregabalin group, with the majority of patients withdrawing due to adverse events. Due to the high attrition rates in the paroxetine study arm, the investigators stopped the study prior to achieving complete recruitment. As such, no significant differences between pregabalin and paroxetine study arms were noted for the primary outcome measures (VASpain, VASimpact). Comparative assessment of baseline patient characteristics also revealed no significant differences between the study arms.
CONCLUSION: High attrition rates associated with paroxetine use suggest that it be used with caution for MS-induced NPP. Efficacy outcomes could not be assessed due to attrition.
Core tip: The high attrition rates identified in the paroxetine study arm suggest that it be used with caution for multiple sclerosis (MS)-induced neuropathic pain (NPP). Although analysis of the primary endpoint measures revealed no significant differences, there was a trend toward marked improvement for visual analogue scale and daily impact of pain on daily activities in favor of pregabalin. However, due to the premature study cessation, definitive confirmation of pregabalin’s enhanced efficacy was not possible. These results reinforce the recognized challenges clinicians encounter in drug selection for MS-induced NPP. Due to the lack of well-designed controlled NPP trials in this population, effective and well-tolerated treatment selection poses a significant clinical challenge.