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[Benefits of an add-on treatment with the synthetic cannabinomimetic nabilone on patients with chronic pain--a randomized controlled trial].

Abstract

OBJECTIVE

The aim of this study was to investigate the efficacy and efficiency of an add-on treatment with the synthetic cannabinomimetic nabilone on patients with chronic pain. Of major interest were the evaluation of the influence the treatment had on pain and on quality of life as well as the subjective assessment of positive effects and side effects by the study participants.

METHODS

The placebo-controlled double-blinded pilot study was divided into a 14 week cross-over period (two 4 week medication phases plus wash-out phases) followed by a 16 week medication switch period with free choice of the study drugs (drug A and drug B) by the study participants. The principal inclusion criterion was chronic therapy-resistant pain in causal relationship with a pathologic status of the skeletal and locomotor system. The study participants chose the dosage of the study drug themselves (between 1 und 4 capsules/day, in the case of nabilone this corresponds to (1/4)-1 mg/day). Pain intensity was assessed by a visual analogue scale (VAS), quality of life by the Mezzich and Cohen QOL-score.

RESULTS

Altogether, 30 patients were included and analyzed. From the results, it is obvious that throughout the cross-over periods the nabilone treatment was superior (medians [25%-; 75%-percentiles]: nabilone/placebo): decrease of the average spinal pain intensity within the last 4 weeks (DeltaVAS) 0.9 [0.0; 2.0] / 0.5 [0.0; 1.7], decrease of the current spinal pain intensity (DeltaVAS) 0.6 [0.0; 2.5] / 0.0 [-1.0, 1.0] (p = .006), decrease of the average headache intensity within the last 4 weeks (DeltaVAS) 1.0 [-1.0; 2.4] / 0.2 [-0.9; 1.0], increase of the number of days without headache within the last 4 weeks 2.0 [0.0; 6.5] / 0.0 [-5.0; 4.0], increase of the quality of life (DeltaQOL-Score) 5.0 [0.8; 10.8] / 2.0 [-2.3; 8.0]. In the medication switch period, the number of study participants who favoured nabilone (nabilone intake > or =85% of all medication days) was more than 4 times higher than those who favoured placebo. The number of days with nabilone intake was clearly higher than the number with placebo intake (medians: 89% vs. 11% of all medication days, p = .003).

CONCLUSION

In summary, the study results allow the conclusion that a majority of patients with chronic pain classify nabilone intake in addition to the standard treatment as a measure with a positive individual benefit-riskratio. Thus, this kind of treatment may be an interesting and attractive enrichment of analgetic therapy concepts.

Links

  • Publisher Full Text
  • Authors+Show Affiliations

    ,

    Confraternität, Privatklinik Josefstadt, Wien, Austria. m.pinsger@nextra.at

    , , , ,

    Source

    Wiener klinische Wochenschrift 118:11-12 2006 Jun pg 327-35

    MeSH

    Anti-Anxiety Agents
    Cannabinoids
    Chemotherapy, Adjuvant
    Chronic Disease
    Cross-Over Studies
    Double-Blind Method
    Dronabinol
    Female
    Humans
    Male
    Middle Aged
    Pain
    Pain Measurement
    Placebo Effect
    Quality of Life
    Treatment Outcome

    Pub Type(s)

    English Abstract
    Journal Article
    Randomized Controlled Trial

    Language

    ger

    PubMed ID

    16855921

    Citation

    Pinsger, Martin, et al. "[Benefits of an Add-on Treatment With the Synthetic Cannabinomimetic Nabilone On Patients With Chronic Pain--a Randomized Controlled Trial]." Wiener Klinische Wochenschrift, vol. 118, no. 11-12, 2006, pp. 327-35.
    Pinsger M, Schimetta W, Volc D, et al. [Benefits of an add-on treatment with the synthetic cannabinomimetic nabilone on patients with chronic pain--a randomized controlled trial]. Wien Klin Wochenschr. 2006;118(11-12):327-35.
    Pinsger, M., Schimetta, W., Volc, D., Hiermann, E., Riederer, F., & Pölz, W. (2006). [Benefits of an add-on treatment with the synthetic cannabinomimetic nabilone on patients with chronic pain--a randomized controlled trial]. Wiener Klinische Wochenschrift, 118(11-12), pp. 327-35.
    Pinsger M, et al. [Benefits of an Add-on Treatment With the Synthetic Cannabinomimetic Nabilone On Patients With Chronic Pain--a Randomized Controlled Trial]. Wien Klin Wochenschr. 2006;118(11-12):327-35. PubMed PMID: 16855921.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - [Benefits of an add-on treatment with the synthetic cannabinomimetic nabilone on patients with chronic pain--a randomized controlled trial]. AU - Pinsger,Martin, AU - Schimetta,Wolfgang, AU - Volc,Dieter, AU - Hiermann,Erich, AU - Riederer,Franz, AU - Pölz,Werner, PY - 2005/09/11/received PY - 2006/05/09/accepted PY - 2006/7/21/pubmed PY - 2006/10/6/medline PY - 2006/7/21/entrez SP - 327 EP - 35 JF - Wiener klinische Wochenschrift JO - Wien. Klin. Wochenschr. VL - 118 IS - 11-12 N2 - OBJECTIVE: The aim of this study was to investigate the efficacy and efficiency of an add-on treatment with the synthetic cannabinomimetic nabilone on patients with chronic pain. Of major interest were the evaluation of the influence the treatment had on pain and on quality of life as well as the subjective assessment of positive effects and side effects by the study participants. METHODS: The placebo-controlled double-blinded pilot study was divided into a 14 week cross-over period (two 4 week medication phases plus wash-out phases) followed by a 16 week medication switch period with free choice of the study drugs (drug A and drug B) by the study participants. The principal inclusion criterion was chronic therapy-resistant pain in causal relationship with a pathologic status of the skeletal and locomotor system. The study participants chose the dosage of the study drug themselves (between 1 und 4 capsules/day, in the case of nabilone this corresponds to (1/4)-1 mg/day). Pain intensity was assessed by a visual analogue scale (VAS), quality of life by the Mezzich and Cohen QOL-score. RESULTS: Altogether, 30 patients were included and analyzed. From the results, it is obvious that throughout the cross-over periods the nabilone treatment was superior (medians [25%-; 75%-percentiles]: nabilone/placebo): decrease of the average spinal pain intensity within the last 4 weeks (DeltaVAS) 0.9 [0.0; 2.0] / 0.5 [0.0; 1.7], decrease of the current spinal pain intensity (DeltaVAS) 0.6 [0.0; 2.5] / 0.0 [-1.0, 1.0] (p = .006), decrease of the average headache intensity within the last 4 weeks (DeltaVAS) 1.0 [-1.0; 2.4] / 0.2 [-0.9; 1.0], increase of the number of days without headache within the last 4 weeks 2.0 [0.0; 6.5] / 0.0 [-5.0; 4.0], increase of the quality of life (DeltaQOL-Score) 5.0 [0.8; 10.8] / 2.0 [-2.3; 8.0]. In the medication switch period, the number of study participants who favoured nabilone (nabilone intake > or =85% of all medication days) was more than 4 times higher than those who favoured placebo. The number of days with nabilone intake was clearly higher than the number with placebo intake (medians: 89% vs. 11% of all medication days, p = .003). CONCLUSION: In summary, the study results allow the conclusion that a majority of patients with chronic pain classify nabilone intake in addition to the standard treatment as a measure with a positive individual benefit-riskratio. Thus, this kind of treatment may be an interesting and attractive enrichment of analgetic therapy concepts. SN - 0043-5325 UR - https://www.unboundmedicine.com/medline/citation/16855921/[Benefits_of_an_add_on_treatment_with_the_synthetic_cannabinomimetic_nabilone_on_patients_with_chronic_pain__a_randomized_controlled_trial]_ L2 - https://dx.doi.org/10.1007/s00508-006-0611-4 DB - PRIME DP - Unbound Medicine ER -