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Amitriptyline in the treatment of fibromyalgia: A systematic review of its efficacy – Source: Rheumatology, Aug 12, 2008

  [ 78 votes ]   [ 2 Comments ]
By B Nishishinya, G Urrutia, et al. • • August 16, 2008

[Note: Amitriptyline (brand name ElavilR) is a type of tricyclic antidepressant that has been tested in trials to determine its efficacy for improving sleep, pain and fatigue in non-depressed patients with Fibromyalgia - and has been prescribed off label for this purpose.]

The objective of this study was to assess the efficacy and safety of amitriptyline as a treatment of FM. A comprehensive computerized search in Medline (Pubmed), EMBASE and The Cochrane Library was performed. Randomized controlled trials (RCTs) comparing amitriptyline vs placebo in adult patients suffering from FM were identified, the methodological quality was assessed and the results of the main outcomes were evaluated.

Ten RCTs were identified. Large clinical variability and statistical heterogeneity precluded quantitative meta-analysis. Overall, the study quality was moderate to high.

  • Amitriptyline 25 mg/day (six RCTs) demonstrated a therapeutic response compared with placebo in the domains of pain, sleep, fatigue and overall patient and investigator impression.
  • This benefit was generally seen at 6-8 weeks of treatment but no effect was noted at 12 weeks.
  • Amitriptyline 50 mg/day (four RCTs) did not demonstrate a therapeutic effect compared with placebo.
  • Neither dose of amitriptyline had an effect on tender points count.
  • No clear statements on adverse events with amitriptyline can be made due to inconsistencies in data among the studies.

A definitive clinical recommendation regarding the efficacy of amitriptyline for FM symptoms cannot be made.

  • There is some evidence to support the short-term efficacy of amitriptyline 25 mg/day in FM.
  • There is no evidence to support the efficacy of amitriptyline at higher doses or for periods [more than] >8 weeks.

More stringent RCTs with longer follow-up periods are required to determine the long-term efficacy and safety of the amitriptyline and define its role in the multidisciplinary management of FM.

Source: Rheumatology (Oxford), Aug 12, 2008. [E-pub ahead of print] PMID: 18697829, by Nishishinya B, Urrútia G, Walitt B, Rodriguez A, Bonfill X, Alegre C, Darko G. Iberoamerican Cochrane Center, Universitat Autònoma de Barcelona, Spain; Kovacs Foundation, Palma de Mallorca; CIBER Epidemiología y Salud Pública, Spain; Washington Hospital Center, Washington DC, USA; Hospital de la Vall d'Hebron, Barcelona, Spain. [E-mail:]

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Article Comments Post a Comment

Posted by: elbow
Aug 22, 2008
This is not a good drug to take if you have heart beat irregularities. I makes them much worse. Also one can gain a lot of weight on this drug. I take Trazodone at bedtime; half of a 25mg tablet. It deepens my sleep and I get a lot less pain now.
Reply Reply

Posted by: tebeling-siravo
Sep 1, 2008
I agree. The Amitriptyline made my shaking worse and did not help with sleep. I also have been taking Trazadone for the last year and have found that it works for me. I take between 100-250 mg depending on my sleep and pain patterns. I started at 50 mg and the dosage was increased and regulated under medical supervision.
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