Most chronic pain patients with insomnia are currently not well-managed using existing medications. If found to safely improve sleep with chronic pain patients, nabilone could be added to the treatment options available in the management of fibromyalgia and associated symptoms.
The principle hypothesis of this study is that nabilone at a dose of 0.5-1mg is as efficacious as amitriptyline at a dose of 10-20mg, in improving sleep quality in patients with fibromyalgia.
Conferencia»American College of Rheumatology/Association of Rheumatology Health Professionals Annual Scientific Meeting. Published in: Arthritis Rheum. 2009;60:1429
Objective: Fibromyalgia (FM) is a chronic pain syndrome associated with dysregulation of central nervous system pain processing. Insomnia affects over 75% of patients, and tricyclic antidepressants are the mainstay of treatment. Cannabis is used by some patients with FM to help sleep. We evaluated the safety and efficacy of nabilone, a synthetic cannabinoid, on sleep disturbance in FM. Methods: We conducted a randomized double-blind active control equivalency crossover trial to compare nabilone (0.5-1.0mg before bedtime) to amitriptyline (10-20mg before bedtime) in FM patients with chronic insomnia. Subjects received each drug for two weeks with a two-week washout period. The primary outcome was sleep quality, measured by the Insomnia Severity Index (ISI) and the Leeds Sleep Evaluation Questionnaire (LSEQ). Secondary outcomes included pain, mood, quality of life and adverse events (AEs). Results: Thirty-one subjects were enrolled and 29 completed the trial (26 female, mean age 49.5 years). While sleep was improved by both amitriptyline and nabilone, nabilone was superior to amitriptyline (ISI difference=3.2, 95% CI 1.2-5.3). Nabilone was marginally better on the restfulness (LSEQ difference=0.5 (0.0-1.0) but not on wakefulness (difference=0.3 (-0.2, 0.8)). Adverse events (AEs) were mostly mild to moderate and were more frequent with nabilone. Most common AEs for nabilone were dizziness, nausea and dry mouth. Conclusion: Nabilone is effective in improving sleep in patients with FM and is well tolerated. Low dose nabilone given once daily at bedtime may be considered as an alternative to amitriptyline. Longer trials are needed to determine the duration of effect and to characterize long-term safety. The trial was conducted following Good Clinical Practice guidelines and was registered at www.clinicaltrials.gov (registration number NCT00381199).
Purpose: Fibromyalgia (FM) is a chronic pain syndrome with generalized tender points. Insomnia affects over 75% of patients with FM, and tricyclic antidepressants are the mainstay of treatment. Cannabis has been used by patients with FM to help sleep. We evaluated nabilone, a synthetic cannabinoid, for insomnia in FM. Method: We conducted a randomized double-blind active control equivalency crossover trial to compare nabilone (0.5-1.0mg qHS) to amitriptyline (10-20mg qHS) in FM patients with chronic insomnia. Subjects received each drug for two weeks with a two-week washout. The primary outcome was sleep quality using the Insomnia Severity Index (ISI) and the Leeds Sleep Evaluation Questionnaire (LSEQ); secondary outcomes included pain, mood, quality of life and adverse events (AEs). Results: Thirty-one subjects were enrolled and 29 completed the trial (26 female, mean age 49.5y). While sleep was improved by both nabilone and amitriptyline, nabilone was superior to amitriptyline (ISI difference=3.2, 95%CI 1.2-5.3). Nabilone was marginally better on the restfulness LSEQ sleep quality scale (difference=0.5 (0.0-1.0) but not on wakefulness (difference=0.3 (-0.2, 0.8)). Adverse events were all mild-moderate and were more frequent with nabilone (102) than amitriptyline (53). Most common AEs for nabilone were dizziness (10), nausea (9) and dry mouth (7). Conclusion: Nabilone is effective in improving sleep in patients with FM and is well tolerated. Low dose nabilone given once daily at night may be considered as an alternative to amitriptyline. Longer trials are needed to determine the duration of effect and to characterize long-term safety.
ANTECEDENTES: Los trastornos del sueño afectan a muchos pacientes con condiciones de dolor crónico. El cannabis ha sido reportado por varias poblaciones de pacientes para ayudar a dormir. Se evaluó la seguridad y eficacia de la nabilona, un cannabinoide sintético, en los trastornos del sueño en la fibromialgia (FM), una enfermedad caracterizada por dolor crónico generalizado y el insomnio.
MÉTODOS: Se realizó un estudio doble ciego, control activo, ensayo cruzado equivalencia aleatorio para comparar la nabilona (0,5-1,0 mg antes de acostarse) a la amitriptilina (10-20 mg antes de acostarse) en pacientes con FM con insomnio crónico. Los sujetos recibieron cada fármaco durante 2 semanas con un período de lavado de 2 semanas. El resultado primario fue la calidad del sueño, medida por el Índice de Severidad Insomnio y el Cuestionario de Evaluación Leeds sueño. Los resultados secundarios incluyeron dolor, estado de ánimo, calidad de vida, y los acontecimientos adversos (AA).
Resultados: Treinta y un sujetos fueron inscritos y 29 completaron el ensayo (26 mujeres, edad media 49,5 años). Aunque el sueño se mejoró tanto la amitriptilina y la nabilona, nabilona fue superior a la amitriptilina (diferencia Insomnia Severity Index = 3,2; intervalo de confianza del 95% = 1.2 a 5.3). La nabilona era ligeramente mejor en el sosiego (diferencia Leeds sueño Cuestionario de Evaluación = 0,5 [0,0-1,0]), pero no en la vigilia (diferencia = 0,3 [-0,2 a 0,8]). No se observaron efectos sobre el dolor, estado de ánimo o la calidad de vida. AEs eran en su mayoría leves a moderados y fueron más frecuentes con nabilona. Los acontecimientos adversos más comunes para la nabilona fueron mareos, náuseas y sequedad de boca.
CONCLUSIONES: La nabilona es eficaz para mejorar el sueño en pacientes con FM y es bien tolerado. Nabilona Bajas dosis una vez al día al acostarse puede ser considerada como una alternativa a la amitriptilina. Se necesitan ensayos más largos para determinar la duración del efecto y caracterizar la seguridad a largo plazo.
Most chronic pain patients with insomnia are currently not well-managed using existing medications. If found to safely improve sleep with chronic pain patients, nabilone could be added to the treatment options available in the management of fibromyalgia and associated symptoms.
The principle hypothesis of this study is that nabilone at a dose of 0.5-1mg is as efficacious as amitriptyline at a dose of 10-20mg, in improving sleep quality in patients with fibromyalgia.
Diseño del estudio»Ensayo controlado aleatorizado (ECA)
