Nabilone as an Adjunctive to Gabapentin for Multiple Sclerosis-Induced Neuropathic Pain: A Randomized Controlled Trial
Turcotte et al.·Pain MedicineImpact 1.4
Klarer NutzenGRADEModerat121 Zitate
Stichproben = 15 Pat.
Dauer9 Wochen, 63-Tage Follow-up
KontrollePlacebo oral als Adjunkt zu Gabapentin
EndpunktVAS
Verblindungdoppelblind
DesignRCT (doppelblind, placebokontrolliert)
Cannabinoidthc
Max. Dosis2.0 mg
Applikationoral
”Kernaussage
Nabilone als Zusatztherapie zu Gabapentin zeigte eine statistisch signifikant größere Reduktion von Schmerzintensität (VASpain) und Auswirkungen auf alltägliche Aktivitäten (VASimpact) im Vergleich zu Placebo (beide P < 0,01).
Zusammenfassung
n=15 MS-Patienten mit neuropathischem Schmerz unter Gabapentin (≥1.800 mg/Tag), Nabilon (1 mg 2×/Tag) als Add-on vs. Placebo über 9 Wochen (4 Wochen Titration + 5 Wochen Erhaltung); signifikant stärkere Abnahme von VASpain (p<0.01) und VASimpact (p<0.01) unter Nabilon nach Adjustierung für Kovariaten. Nabilon gut verträglich, häufigste Nebenwirkungen Schwindel/Schläfrigkeit.
P
PopulationErwachsene mit schubförmig remittierender MS und MS-induziertem neuropathischem Schmerz, stabil auf Gabapentin ≥1.800 mg/Tag, n=15
I
InterventionNabilon oral 1 mg zweimal täglich (Titration über 4 Wochen, dann 5 Wochen Erhaltung) als Adjunkt zu Gabapentin
C
KontrollePlacebo oral (identisches Schema) als Adjunkt zu Gabapentin
O
OutcomeSignifikant stärkere Abnahme von VASpain und VASimpact in der Nabilon-Gruppe vs. Placebo (Gruppe × Zeit²-Interaktion, p<0,01 für beide Outcomes)
Vertrauen in die Evidenz
Sehr niedrigNiedrigModeratHoch
Moderat
Dritte von vier GRADE-Stufen, die Effektschätzung ist wahrscheinlich verlässlich.
Background: Neuropathic pain (NPP) is a chronic syndrome suffered by patients with multiple sclerosis (MS), for which there is no cure. Underlying cellular mechanisms involved in its pathogenesis are multifaceted, presenting significant challenges in its management.
Methods: A randomized, double-blind, placebo-controlled study involving 15 relapsing-remitting MS patients with MS-induced NPP was conducted to evaluate nabilone combined with gabapentin (GBP). Eligible patients stabilized on GBP (>/=1,800 mg/day) with inadequate pain relief were recruited. Nabilone or placebo was titrated over 4 weeks (0.5 mg/week increase) followed by 5-week maintenance of 1 mg oral nabilone (placebo) twice daily. Primary outcomes included two daily patient-reported measures using a 100-mm visual analog scale (VAS), pain intensity (VASpain), and impact of pain on daily activities (VASimpact). Hierarchical regression modeling was conducted on each outcome to determine if within-person pain trajectory differed across study groups, during 63-day follow-up.
Results: After adjustment for key patient-level covariates (e.g., age, sex, Expanded Disability Status Scale, duration of MS, baseline pain), a significant group x time(2) interaction term was reported for both the VASpain (P < 0.01) and VASimpact score (P < 0.01), demonstrating the adjusted rate of decrease for both outcomes was statistically greater in nabilone vs placebo study group. No significant difference in attrition rates was noted between treatments. Nabilone was well tolerated, with dizziness/drowsiness most frequently reported.
Conclusion: Nabilone as an adjunctive to GBP is an effective, well-tolerated combination for MS-induced NPP. The results of this study identify a novel therapeutic combination for use in this population of patients predisposed to tolerability issues that may otherwise prevent effective pain management.