Benefit of an add-on-treatment with a synthetic cannabinomimeticum on patients with chronic back pain-a randomized controlled trial

INTRODUCTION:

Even the use of strong opioids and antirheumatics on patients with back pain leads in many cases only to a limited reduction of the strong initial pain. Although only Great Britan has a drug permit for Nabilone, the often desperate situations of patients with therapy refractory pain on one hand and the good effects on the patients problems on the other hand, justify the systematic validation on its efficacy. Goals of the Study were: To verify the subjective valuation of effects- and side effects relation (number of days with Nabilone or Placebo with freedom of choice of the study participants)

MATERIAL AND METHODS:

It's a prospective placebo-controlled randomized doubeblind pilot study (modified early-escape-design with tested change of medication), clinical trail phase II. In this study 30 cases were included and evaluated. Characterizing the Intent-To-Treat (ITT)-Collective (Medians or % of the ITT-Collective): Age 55 years, sex (m/f) 23%/77%, BMI 25,8kg/m2, height 165cm, headache 80%, duration of back pain 20 years, current back pain intensity (VAS) 7,8, number of headache free days in the past 4 weeks 7,0, opioid medication 63%, antirheumatic medication 50%

RESULTS:

(ITT) of the Cross-Over-Section (Medians: Nabilone/Placebo): Change of average back pain intensity in the past 4 weeks (DVAS) -0,9/-0,5, change of current back pain intensity (DVAS) -0,6/0,0 (p=0,006), change of average headache intensity in the past 4 weeks (DVAS) -1,0/-0,2, change of number of headache free days in the past 4 weeks 2,0/0,0, change of life quality (DQOL-Score) 5,0/2,0. Results: (ITT) of the change-of-medication-Section (Medians: Nabilone/Placebo): Number of days of taking Nabilone or Placebo 83/29 (p=0,003). A majority of patients of the change-of-medication-Section (85% of days with Medication) chose Nabilone.

CONCLUSION:

The results of the study allow to conclude that using Nabilone in addition to standard therapy is seen as a positive benefit-risk-profile by the patients and therefore illustrates an interesting and attractive enrichment to the current analgetic concept to treat.