Zusammenfassung
Fragestellung
Eine interdisziplinäre Leitlinie zur Therapie des Fibromyalgiesyndroms (FMS) und chronischer Schmerzen in mehreren Körperregionen (engl. „chronic widespread pain“, CWP) wurde in Kooperation von 10 medizinischen bzw. psychologischen Fachgesellschaften und 2 Patientenselbsthilfeorganisationen erstellt.
Methodik
Eine Literatursuche über alle kontrollierten Studien (engl. „randomized controlled trial“, RCT) zur medikamentösen Therapie des FMS bzw. von CWP wurde unter Benutzung der Cochrane Collaboration Reviews (1993–12/2006), Medline (1980–12/2006), PsychInfo (1966–12/ 2006) und Scopus (1980–12/ 2006) durchgeführt. Für die Vergabe von Evidenzklassen wurde das System des Oxford Centre for Evidence-Based Medicine verwendet. Für die Vergabe von Empfehlungsgraden wurde die Empfehlungsgraduierung der nationalen Versorgungsleitlinien verwendet. Die Erstellung der Empfehlungen erfolgte in einem mehrstufigen nominalen Gruppenprozess.
Ergebnisse
Die zeitlich befristete Verwendung von Amitriptylin erhielt den Empfehlungsgrad A. Den Empfehlungsgrad B für die zeitlich befristete Verwendung erhielten Fluoxetin und Duloxetin.
Schlussfolgerung
Die Empfehlungen zur medikamentösen Therapie des FMS werden durch die kurze Studiendauer sowie fehlende Untersuchungen nach Therapieende und zur Kosteneffektivität eingeschränkt.
Abstract
Background
An interdisciplinary guideline for the treatment of fibromyalgia syndrome (FMS) and chronic widespread pain (CWP) was developed in cooperation with ten German medical and psychological associations and two patients’ self-help organizations.
Methods
Using the Cochrane Collaboration Reviews (1993–12/2006), Medline (1980–2006), PsychInfo (1966–12/2006), and Scopus (1980–12/ 2006) a systematic literature search was performed, which included all randomised controlled trials (RCT) evaluating multicomponent therapy in FMS and CWP. Levels of evidence were assigned according to the classification system of the Oxford Centre for Evidence-Based Medicine. The strength of recommendation was graded according to the German program for disease management guidelines. Consensus was achieved using a multi-step nominal group procedure.
Results
The short-term use of amitriptyline is strongly recommended (grade A) and the short-term use of fluoxetine und duloxetine is recommended (grade B).
Conclusions
The recommendations regarding pharmacological treatment of FMS are limited by the short duration of the RCT, the lack of follow-ups and absence of cost-effectiveness studies.
Literatur
Anderberg UM, Marteinsdottir I, von Knorring L (2000) Citalopram in patients with fibromyalgia – a randomized, double-blind, placebo-controlled study. Eur J Pain 4: 27–35
Arnold LM, Hess EV, Hudson JI et al. (2002) A randomized, placebo-controlled, double-blind, flexible-dose study of fluoxetine in the treatment of women with fibromyalgia. Am J Med 112: 191–197
Arnold LM, Keck PE jr, Welge JA (2000) Antidepressant treatment of fibromyalgia. A meta-analysis and review. Psychosomatics 41: 104–113
Arnold LM, Lu Y, Crofford LJ et al. (2004) A double-blind, multicenter trial comparing duloxetine with placebo in the treatment of fibromyalgia patients with or without major depressive disorder. Arthritis Rheum 50: 2974–2984
Arnold LM, Rosen A, Pritchett YL et al. (2005) A randomized, double-blind, placebo-controlled trial of duloxetine in the treatment of women with fibromyalgia with or without major depressive disorder. Pain 119: 5–15
Ataoğlu S, Ataoğlu A, Erdoğan F et al. (1997) Comparison of paroxetine, amitriptyline in the treatment of fibromyalgia. Turk J Med Sci 27: 535–539
Backman E, Bengtsson A, Bengtsson M et al. (1988) Skeletal muscle function in primary fibromyalgia. Effect of regional sympathetic blockade with guanethidine. Acta Neurol Scand 77: 187–191
Bengtsson M, Bengtsson A, Jorfeldt L (1989) Diagnostic epidural opioid blockade in primary fibromyalgia at rest and during exercise. Pain Clin 39: 171–180
Bennett RM, Clark SC, Walczyk J (1998) A randomized, double-blind, placebo-controlled study of growth hormone in the treatment of fibromyalgia. Am J Med 104: 227–231
Bennett RM, Gatter RA, Campbell SM et al. (1988) A comparison of cyclobenzaprine and placebo in the management of fibrositis. A dou-ble-blind controlled study. Arthritis Rheum 31: 1535–1542
Bennett RM, Jones J, Turk DC et al. (2007) An internet survey of 2,596 people with fibromyalgia. BMC Musculoskelet Disord 8: 27
Bennett RM, Kamin M, Karim R et al. (2003) Tramadol and acetaminophen combination tablets in the treatment of fibromyalgia pain: a double-blind, randomized, placebo-controlled study. Am J Med 114: 537–545
Bennett RM, Schein J, Kosinski MR et al. (2005) Mpact of fibromyalgia pain on health-related quality of life before and after treatment with tramadol/acetaminophen. Arthritis Rheum 53: 519–527
Bentsson A, Bengtsson M (1988) Regional sympathetic blockade in primary fibromyalgia. Pain Clin 33: 161–167
Bessette L, Carette S, Fosse A et al. (1998) A placebo controlled crossover trial of subcutaneous salmon calcitonin in the treatment of patients with fibromyalgia. Scand J Rheumatol 27: 112–116
Biasi G, Manca S, Manganelli S et al. (1998) Tramadol in the fibromyalgia syndrome: a controlled clinical trial versus placebo. Int J Clin Pharmacol Res 13–19
Bibolotti E, Borghi C, Pasculli E (1986) The management of fibrositis: a double-blind comparison of maprotiline (ludiomil), chlor-imipramine, and placebo. J Clin Trials 23: 269–280
Cantini F, Bellandi F, Niccoli L et al. (1994) Fluoxetin combined with cyclobenzaprine in the treatment of fibromyalgia. Minerva Med 85: 97–100
Çapaci K, Hepgüler S (2002) Comparison of the effect of amitriptyline and paroxetine in the treatment of fibromyalgia syndrome. Pain Clin 14: 223–228
Carette S, Bell MJ, Reynolds WJ et al. (1994) Comparison of amitriptyline, cyclobenzaprine, and placebo in the treatment of fibromyalgia. A randomized, double-blind clinical trial. Arthritis Rheum 37: 32–40
Carette S, McCain GA, Bell DA et al. (1986) Evaluation of amitriptyline in primary fibrositis. A double-blind, placebo-controlled study. Arthritis Rheum 29: 655–659
Carette S, Oakson G, Guimont C et al. (1995) Sleep electroencephalography and the clinical response to amitriptyline in patients with fibromyalgia. Arthritis Rheum 38: 1211–1217
Clark S, Tindall E, Bennett RM (1985) A double blind crossover trial of prednisone versus placebo in the treatment of fibrositis. J Rheumatol 12: 980–983
Crofford LJ, Rowbotham MC, Mease PJ et al. (2005) Pregabalin 1008–105 Study Group. Pregabalin for the treatment of fibromyalgia syndrome: results of a randomized, double-blind, placebo-controlled trial. Arthritis Rheum 52: 1264–1273
Drewes HM (1991) Zopiclone in the treatment of sleep abnormalities in fibromyalgia. Scand J Rheumatol 20: 288–293
Dwight MM, Arnold LM, O’Brien H et al. (1998) An open clinical trial of venlafaxine treatment of fibromyalgia. Psychosomatics 39: 14–17
Färber L, Stratz TH, Bruckle W et al. (2001) German Fibromyalgia Study Group. Short-term treatment of primary fibromyalgia with the 5-HT3-receptor antagonist tropisetron. Results of a randomized, double-blind, placebo-controlled multicenter trial in 418 patients. Int J Clin Pharmacol Res 21: 1–13
Finckh A, Berner IC, Aubry-Rozier B et al. (2005) A randomized controlled trial of de-hydroepiandrosterone in postmenopausal women with fibromyalgia. J Rheumatol 32: 1336–1340
Freedenfeld RN, Murray M, Fuchs PN et al. (2006) Decreased pain and improved quality of life in fibromyalgia patients treated with olanzapine, an atypical neuroleptic. Pain Pract 6: 112–118
Gendreau RM, Thorn MD, Gendreau JF et al. (2005) Efficacy of milnacipran in patients with fibromyalgia. J Rheumatol 32: 1975–1985
Ginsberg F, Joos E, Geczy J et al. (1998) A pilot randomized placebo-controlled study of pirlindole in the treatment of primary fibromyalgia. J Musculoskel Pain 6: 6–17
Ginsberg F, Mancaux A, Joos E et al. (1996) A randomized placebo-controlled trial of sustained-release amitriptyline in primary fibromyalgia. J Musculoskel Pain 4: 37–47
Giordano N, Geraci S, Santacroce C et al. (1999) Efficacy and tolerability of paroxetine in patients with fibromyalgia syndrome: a single-blind study. Curr Ther Res 60: 696–702
Goldenberg D, Mayskiy M, Mossey C et al. (1996) A randomized, double-blind crossover trial of fluoxetine and amitriptyline in the treatment of fibromyalgia. Arthritis Rheum 39: 1852–1859
Goldenberg DL, Felson DT, Dinerman H (1986) A randomized, controlled trial of amitriptyline and naproxen in the treatment of patients with fibromyalgia. Arthritis Rheum 29: 1371–1377
Gonzalez-Viejo MA, Avellanet M, Hernandez-Morcuende MI (2005) A comparative study of fibromyalgia treatment: ultrasonography and physiotherapy versus sertraline treatment. Ann Readapt Med Phys 48: 610–615
Gronblad M, Nykanen J, Konttinen Y et al. (1993) Effect of zopiclone on sleep quality, morning stiffness, widespread tenderness and pain and general dis-comfort in primary fibromyalgia patients. A double-blind randomized trial. Clin Rheumatol 12: 186–191
Gür A, Karakoç M, Nas K et al. (2002) Effects of low power laser and low dose amitriptyline therapy on clinical symptoms and quality of life in fibromyalgia: a single-blind, placebo-controlled trial. Rheumatol Int 22: 188–193
Hannonen P, Malminiemi K, Yli-Kerttula U et al. (1998) A randomized, double-blind, placebo-controlled study of moclobemide and amitriptyline in the treatment of fibromyalgia in females without psychiatric disorder. Br J Rheumatol 37: 1279–1286
Häuser W, Musial F, Kopp I et al. (2008) Methodische Grundlagen für die Entwicklung der Leitlinienempfehlungen (Methodenreport). Schmerz, im Druck
Häuser W, Wilhelm R, Klein W et al. (2006) Subjektive Krankheitsattributionen und Inanspruchnahme medizinischer Leistungen von Patienten mit Fibromyalgiesyndrom. Schmerz 20: 119–127
Heymann RE, Helfenstein M, Feldman D (2001) A double-blind, randomized, controlled study of amitriptyline, nortriptyline and placebo in patients with fibromyalgia. An analysis of outcome measures. Clin Exp Rheumatol 19: 697–702
Holman AJ, Myers RR (2005) A randomized, double-blind, placebo-controlled trial of pramipexole, a dopamine agonist, in patients with fibromyalgia receiving concomitant medications. Arthritis Rheum 52: 2495–2505
Hrycaj P, Stratz T, Mennet P et al. (1996) Pathogenetic aspects of responsiveness to ondansetron (5-hydroxytryptamine type 3 receptor antagonist) in patients with primary fibromyalgia syndrome – a preliminary study. J Rheumatol 23: 1418–1423
Isomeri R, Mikkelson M, Latikka P et al. (1993) Effects of amitriptyline and cardiovascukar fitness training on patients with primray fibromyalgia. J Musculoscelet Pain 253–260
Jacobsen S, Danneskiold-Samsoe B, Andersen RB (1991) Oral S-adenosylmethionine in primary fibromyalgia. Double-blind clinical evaluation. Scand J Rheumatol 20: 294–302
Jaeschke R, Adachi J, Guyatt G et al. (1991) Clinical usefulness of amitriptyline in fibromyalgia: the results of 23 N-of-1 randomized controlled trials. J Rheumatol 18: 447–451
Janzen VD, Scudds RA (1997) Sphenopalatine blocks in the treatment of pain in fibromyalgia and myofascial pain syndrome. Laryngoscope 107: 1420–1422
Kempenaers C, Simenon G, Vander Elst M et al. (1994) Effect of an antidiencephalon immune serum on pain and sleep in primary fibromyalgia. Neuropsychobiology 30: 66–72
Kendall SA, Schaadt ML, Graff LB et al. (2004) No effect of antiviral (valacyclovir) treatment in fibromyalgia: a double blind, randomized study. J Rheumatol 31: 783–784
Kiser RS, Cohen HM, Freedenfeld RN et al. (2001) Olanzapine for the treatment of fibromyalgia symptoms. J Pain Symptom Manage 22: 704–708
McCleane G (2000) Does intravenous lidocaine reduce fibromyalgia pain? A randomized, double-blind, placebo controlled cross-over study. Pain Clin 12: 181–185
McKenzie R, O’Fallon A, Dale J et al. (1998) Low-dose hydrocortisone for treatment of chronic fatigue syndrome: a randomized controlled trial. JAMA 280: 1061–1066
Moldofsky H, Lue FA, Mously C et al. (1996) The effect of zolpidem in patients with fibromyalgia: a dose ranging, double blind, placebo con-trolled, modified crossover study. J Rheumatol 23: 529–533
Müller A, Hartmann M, Eich W (2000) Health care utilization in patients with fibromyalgia syndrome (FMS). Schmerz 14: 77–83
Nagaoka S, Ohno M, Sekiguchi A (2004) An open-label clinical trial of milnacipran in fibromyalgia syndrome with co-morbid depressive symptoms. Psychiatry Clin Psycho 8: 47–51
Nørregaard J, Volkmann H, Danneskiold-Samsoe B (1995) A randomized controlled trial of citalopram in the treatment of fibromyalgia. Pain 61: 445–449
O’Malley PG, Balden E, Tomkins G et al. (2000) Treatment of fibromyalgia with antidepressants: a meta-analysis. J Gen Intern Med 15: 659–666
Offenbaecher M, Waltz M, Schoeps P (2000) Validation of a German version of the Fibromyalgia Impact Questionnaire (FIQ-G). J Rheumatol 27: 1984–1988
Olin R, Klein R, Berg PA (1998) A randomised double-blind 16-week study of ritanserin in fibromyalgia syndrome: clinical outcome and analysis of autoantibodies to serotonin, gangliosides and phospholipids. Clin Rheumatol 17: 89–94
Özerbil O, Okudan N, Gökbel H et al. (2006) Comparison of the effects of two antidepressants on exercise performance of the female patients with fibromyalgia. Clin Rheumatol 25: 495–497
Pattrick M, Swannell A, Doherty M (1993) Chlormezanone in primary fibromyalgia syn-drome: a double blind placebo controlled study. Br J Rheumatol 32: 55–58
Posner IA (1994) Treatment of fibromyalgia syndrome with intravenous lidocaine: a prospective, randomized pilot study. J Musculoskelet Pain 2: 55–65
Quijada-Carrera J, Valenzuela-Castano A, Povedano-Gomez J et al. (1996) Comparison of tenoxicam and bromazepan in the treatment of fi-bromyalgia: a randomized, double-blind, placebo-controlled trial. Pain Pract 65: 221–225
Quimby LG, Gratwick GM, Whitney CD et al. (1989) A randomized trial of cyclobenzaprine for the treatment of fibromyalgia. J Rheumatol 19 [suppl]: 140–143
Raphael JH, Southall JL, Treharne GJ et al. (2002) Efficacy and adverse effects of intravenous lignocaine therapy in fibromyalgia syndrome. BMC Musculoskelet Disord 3: 21
Reynolds WJ, Moldofsky H, Saskin P et al. (1991) The effects of cyclobenzaprine on sleep physiology and symptoms in patients with fibromyalgia. J Rheumatol 18: 452–454
Rico-Villademoros F, Hidalgo J, Dominguez I et al. (2005) Atypical antipsychotics in the treatment of fibromyalgia: a case series with olanzapine. Prog Neuropsychopharmacol Biol Psychiatry 29: 161–164
Robinson RL, Jones ML (2006) In search of pharmacoeconomic evaluations for fibromyalgia treatments: a review. Expert Opin Pharmacother 7: 1027–1039
Russell IJ, Fletcher EM, Michalek JE et al. (1991) Related articles, treatment of primary fibrositis/fibromyalgia syndrome with ibuprofen and alprazolam. A double-blind, placebo-controlled study. Arthritis Rheum 34: 552–560
Russell IJ, Kamin M, Bennett RM et al. (2000) Efficacy of tramadol in treatment of pain in fibromyalgia. J Clin Rheumatol 6: 250–257
Samborski W, Lezanska-Szpera M, Rybakowski JK (2004) Open trial of mirtazapine in patients with fibromyalgia. Pharmacopsychiatry 37: 168–170
Santandrea S, Montrone F, Sarzi-Puttini P et al. (1993) A double-blind crossover study of two cyclobenzaprine regimens in primary fibromyalgia syndrome. J Int Med Res 21: 74–80
Sayar K, Aksu G, Ak I et al. (2003) Venlafaxine treatment of fibromyalgia. Ann Pharmacother 37: 1561–1565
Scharf MB, Baumann M, Berkowitz DV (2003) The effects of sodium oxybate on clinical symptoms and sleep patterns in patients with fibromyalgia. J Rheumatol 30: 1070–1074
Scudds RA, McCain GA, Rollman GB et al. (1989) Improvements in pain responsiveness in patients with fibrositis after successful treatment with amitriptyline. J Rheumatol 19 [suppl]: 98–103
Şencan S, Ak S, Karan A et al. (2004) A study to compare the therapeutic efficacy of aerobic exercise and paroxetine in fibromyalgia syndrome. J Back Musculoskelet Rehabil 17: 57–61
Sörensen J, Bengtsson A, Ahlner J et al. (1997) Related articles, Fibromyalgia – are there different mechanisms in the processing of pain? A double blind crossover comparison of analgesic drugs. J Rheumatol 24: 1615–1621
Sörensen J, Bengtsson A, Backman E et al. (1995) Pain analysis in patients with fibromyalgia. Effects of intravenous morphine, lidocaine, and ketamine. Scand J Rheumatol 24: 360–365
Späth M, Stratz T, Neeck G et al. (2004) Related articles, efficacy and tolerability of intravenous tropisetron in the treatment of fibromyalgia. Scand J Rheumatol 33: 267–270
Stoll LA (2000) Fibromyalgia symptoms relieved by flupirtine: an open-label case series. Psychosomatics 41: 371–372
Tavoni A, Vitali C, Bombardieri S et al. (1987) Evaluation of S-adenosylmethionine in primary fibromyalgia. A double-blind crossover study. Am J Med 83: 107–110
Tofferi JK, Jackson JL, O’Malley PG (2004) Treatment of fibromyalgia with cyclobenzaprine: a meta-analysis. Arthritis Rheum 51: 9–13
Üçeyler N, Häuser W, Sommer C (2008) A systematic review of the effectiveness of treatment with antidepressants in fibromyalgia syndrome. Arthritis Care Res, in press
Vitton O, Gendreau M, Gendreau J et al. (2004) A double-blind placebo-controlled trial of milnacipran in the treatment of fibromyalgia. Hum Psychopharmacol 19(1): 27–35
Wolfe F, Cathey MA, Hawley DJ (1994) A double-blind placebo controlled trial of fluoxetine in fibromyalgia. Scand J Rheumatol 23: 255–259
Wörz R (1991) Flupirtin bei chronischen myofasziellen Schmerzzuständen. Fortschr Med 109: 158–160
Yavuzer G, Küçükdeveci A, Arasli T et al. (1998) Moclobemid treatment in primary fibromyalgia syndrome. Eur J Phys Med Rehabil 8: 35–38
Yunus MB, AT M, Aldağ JC (1989) Short term effects of ibuprofen in primary fibromyalgia syndrome: a double blind, placebo controlled trial. J Rheumatol 16: 527–532
Interessenkonflikt
Die korrespondierende Autorin gibt an, dass kein Interessenkonflikt besteht.
Author information
Authors and Affiliations
Corresponding author
Additional information
Die Mitgliedschaften der Autoren in Fachgesellschaften sind in Infobox 1 aufgelistet.
Rights and permissions
About this article
Cite this article
Sommer, C., Häuser, W., Berliner, M. et al. Medikamentöse Therapie des Fibromyalgiesyndroms. Schmerz 22, 313–323 (2008). https://doi.org/10.1007/s00482-008-0676-2
Published:
Issue Date:
DOI: https://doi.org/10.1007/s00482-008-0676-2