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|Title||Standardized cannabis extract in the treatment of postherpetic neuralgia – a randomized, double-blind, placebo-controlled cross-over study.|
|Author(s)||Ernst G, Denke C, Reif M, Schnelle M, Hagmeister H|
|Journal, Volume, Issue||Abstract, IACM 3rd Conference on Cannabinoids in Medicine, September 9-10, 2005, Leiden|
|Major outcome(s)||Cannabis did not reduce pain|
Introduction: Patients with postherpetic neuralgia suffer frequently from spontaneous pain and allodynia and adequate treatment is still a challenge. Approaches with non-opioids, opioids, antidepressants and antiepileptics influence these bothersome symptoms often only to a minor or moderate extent. The aim of this study was to determine the maximal tolerable dose (MTD) of orally administered standardized cannabis extract (2.5 mg THC and 1.2 mg CBD per soft-gelatine capsule) in the treatment of postherpetic pain and allodynia.
Methods: 26 patients who suffered from postherpetic pain for at least 6 months and did not show satisfactory symptom relief during this time have been included into this trial. Basic treatment with analgesics, antidepressants or antiepileptics was maintained during the entire study. Exclusion criteria were neuralgic pain, psychiatric diseases, drug dependency, coronary heart disease and arrhythmias. Concomitant use of analgesics was permitted. After a two-week run-in phase without study medication to measure baseline condition, patients were randomized to arm A (verum first) or arm B (placebo first). Beginning with 2 capsules/d (cannabis extract equivalent to 5 mg THC, or placebo) the dosage was increased every four days up to 8 capsules (20 mg THC/d, or placebo) until symptoms disappeared or adverse effects developed. This optimal dose was maintained for four weeks. A two-week wash-out phase was followed by additional 4-weeks of active, or placebo treatment with an identical dose (sham) escalation pattern. For pain assessment, a validated pain diary (Heidelberger Pain Diary), the McGuill Pain Questionnaire, and daily Visual Analogue Scale (VAS-) Pain Scores were applied. Other secondary parameters were the amount of analgesics used as well as size of the hyperalgesia and allodynia region. To measure health-related quality of life, we used the Medical Outcomes Study (MOS) 36-Item Short Form (SF-36). Physical health was checked with neurological examination including quantitative sensory testing (QST). The study was reviewed and approved by the local ethics committee.
Results: 26 patients were randomized; 3 patients dropped out before commencing the second treatment phase after cross-over due to reasons not related with study medication. No major side effects were reported. Minor adverse events included dizziness, dry mouth, slight tachycardia, nausea and increased appetite. Statistical analysis is pending; main results will be presented at the meeting.
|Type of publication||Meeting abstract|
|Address of author(s)||2University Hospital Charité, Virchow Campus, Pain Clinic, Berlin, Germany|