A double-blind, randomized, controlled study of amitriptyline, nortriptyline and placebo in patients with fibromyalgia. An analysis of outcome measures

A double-blind, randomized, controlled study of amitriptyline, nortriptyline and placebo in patients with fibromyalgia. An analysis of outcome measures

Author Heymann, Roberto Ezequiel Autor UNIFESP Google Scholar
Helfenstein Junior, Milton Autor UNIFESP Google Scholar
Feldman, D. Autor UNIFESP Google Scholar
Institution Universidade Federal de São Paulo (UNIFESP)
Abstract Objective To study the efficacy and tolerability of amitriptyline and nortriptyline in a Brazilian population with fibromyalgia and to evaluate the instruments used to measure the efficacy, of the treatment.Methods A total of 118 fibromyalgia patients were randomly assigned to 3 groups: amitripyline (AM, n = 40), nortriptyline (NOR, n = 38) and placebo (PL, n = 40), and were blindly given 25 mg at bedtime of the assigned treatment for 8 weeks. Clinical evaluation before and at the end of the study included the number of tender points (NTP), FIQ score (FIQ), and global improvement as reported by, the patients on a verbal scale (VSGI).Results The 3 groups were comparable at baseline for all the parameters studied. After 8 weeks, the 3 groups improved in all parameters: (36.5% AM, 26.7% NOR and 24% PL patients improved on FIQ; 13.9% AM, 19.5% NOR and 8.57% PL patients improved on NTP; 86.5% AM, 72.2% NOR and 57.6% PL patients improved on VSGI). Only, the AM group differed from the PL group on VSGI Side effects were noted among the groups, but none were serious (16 in the AM group, 31 in the NOR group, and 25 in the PL group).Conclusion All three groups improved after treatment. Only the patient's subjective global assessment of improvement differed between the AM patients and the PL group (p less than or equal to 0.03). In fibromyalgia, placebo groups are important in drug trials. Different measures of therapeutic effect are not better than the patient's self assessment.
Keywords fibromyalgia
clinical trials
pain measures
treatment outcome
Language English
Date 2001-11-01
Published in Clinical And Experimental Rheumatology. Pisa: Clinical & Exper Rheumatology, v. 19, n. 6, p. 697-702, 2001.
ISSN 0392-856X (Sherpa/Romeo, impact factor)
Publisher Clinical & Exper Rheumatology
Extent 697-702
Origin http://www.clinexprheumatol.org/article.asp?a=1199
Access rights Open access Open Access
Type Article
Web of Science ID WOS:000172712100016
URI http://repositorio.unifesp.br/11600/43309

Show full item record




File

File Size Format View

There are no files associated with this item.

This item appears in the following Collection(s)

Search


Browse

Statistics

My Account