Un nuevo estudio sobre la eficacia del LDN para fibromialgia
Publicado: 08 Feb 2013, 19:41
Aunque sigue siendo un estudio pequeño, es doble ciego contra placebo. Os traduzco la conclusión:
[t]Low-dose naltrexone for the treatment of fibromyalgia: Findings of a small, randomized, double-blind, placebo-controlled, counterbalanced, crossover trial assessing daily pain levels.[/t]
Younger J, Noor N, McCue R, Mackey S.
Source
Stanford University School of Medicine, Palo Alto, California. [email protected].
Abstract
OBJECTIVE:
To determine whether low dosages (4.5 mg/day) of naltrexone reduce fibromyalgia severity as compared with the nonspecific effects of placebo. In this replication and extension study of a previous clinical trial, we tested the impact of low-dose naltrexone on daily self-reported pain. Secondary outcomes included general satisfaction with life, positive mood, sleep quality, and fatigue.
METHODS:
Thirty-one women with fibromyalgia participated in the randomized, double-blind, placebo-controlled, counterbalanced, crossover study. During the active drug phase, participants received 4.5 mg of oral naltrexone daily. An intensive longitudinal design was used to measure daily levels of pain.
RESULTS:
When contrasting the condition end points, we observed a significantly greater reduction of baseline pain in those taking low-dose naltrexone than in those taking placebo (28.8% reduction versus 18.0% reduction; P = 0.016). Low-dose naltrexone was also associated with improved general satisfaction with life (P = 0.045) and with improved mood (P = 0.039), but not improved fatigue or sleep. Thirty-two percent of participants met the criteria for response (defined as a significant reduction in pain plus a significant reduction in either fatigue or sleep problems) during low-dose naltrexone therapy, as contrasted with an 11% response rate during placebo therapy (P = 0.05). Low-dose naltrexone was rated equally tolerable as placebo, and no serious side effects were reported.
CONCLUSION:
The preliminary evidence continues to show that low-dose naltrexone has a specific and clinically beneficial impact on fibromyalgia pain. The medication is widely available, inexpensive, safe, and well-tolerated. Parallel-group randomized controlled trials are needed to fully determine the efficacy of the medication.
Copyright © 2013 by the American College of Rheumatology.
PMID: 23359310 [PubMed - in process]
enlace: http://onlinelibrary.wiley.com/doi/10.1 ... 4/abstract" onclick="window.open(this.href);return false;
Bien por la Universidad de Stanford."La evidencia preliminar sigue mostrando que el LDN tiene un impacto benéfico específico y clínico en el dolor de la fibromialgia. La medicación está ampliamente disponible, es barata, segura y bien tolerada. Son necesarios estudios controlados de grupos paralelos para determinar completamente la eficacia de la medicación."




[t]Low-dose naltrexone for the treatment of fibromyalgia: Findings of a small, randomized, double-blind, placebo-controlled, counterbalanced, crossover trial assessing daily pain levels.[/t]
Younger J, Noor N, McCue R, Mackey S.
Source
Stanford University School of Medicine, Palo Alto, California. [email protected].
Abstract
OBJECTIVE:
To determine whether low dosages (4.5 mg/day) of naltrexone reduce fibromyalgia severity as compared with the nonspecific effects of placebo. In this replication and extension study of a previous clinical trial, we tested the impact of low-dose naltrexone on daily self-reported pain. Secondary outcomes included general satisfaction with life, positive mood, sleep quality, and fatigue.
METHODS:
Thirty-one women with fibromyalgia participated in the randomized, double-blind, placebo-controlled, counterbalanced, crossover study. During the active drug phase, participants received 4.5 mg of oral naltrexone daily. An intensive longitudinal design was used to measure daily levels of pain.
RESULTS:
When contrasting the condition end points, we observed a significantly greater reduction of baseline pain in those taking low-dose naltrexone than in those taking placebo (28.8% reduction versus 18.0% reduction; P = 0.016). Low-dose naltrexone was also associated with improved general satisfaction with life (P = 0.045) and with improved mood (P = 0.039), but not improved fatigue or sleep. Thirty-two percent of participants met the criteria for response (defined as a significant reduction in pain plus a significant reduction in either fatigue or sleep problems) during low-dose naltrexone therapy, as contrasted with an 11% response rate during placebo therapy (P = 0.05). Low-dose naltrexone was rated equally tolerable as placebo, and no serious side effects were reported.
CONCLUSION:
The preliminary evidence continues to show that low-dose naltrexone has a specific and clinically beneficial impact on fibromyalgia pain. The medication is widely available, inexpensive, safe, and well-tolerated. Parallel-group randomized controlled trials are needed to fully determine the efficacy of the medication.
Copyright © 2013 by the American College of Rheumatology.
PMID: 23359310 [PubMed - in process]
enlace: http://onlinelibrary.wiley.com/doi/10.1 ... 4/abstract" onclick="window.open(this.href);return false;