A meta-analysis of the efficacy of fibromyalgia treatment according to level of care

Javier Garcia-Campayo, Jesus Magdalena, Rosa Magallón, Esther Fernández-García, Montserrat Salas, Eva Andrés, Javier Garcia-Campayo, Jesus Magdalena, Rosa Magallón, Esther Fernández-García, Montserrat Salas, Eva Andrés

Abstract

Introduction: The aim of this paper was to compare the efficacy of the treatments for fibromyalgia currently available in both primary care and specialised settings.

Methods: Published reports of randomised controlled trials (RCTs) researching pharmacological and non-pharmacological treatments in patients with fibromyalgia were found in the MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials and PsychInfo databases. The most recent electronic search was undertaken in June 2006.

Results: We identified a total of 594 articles. Based on titles and abstracts, 102 full articles were retrieved, 33 of which met the inclusion criteria. These RCTs assessed 120 treatment interventions in 7789 patients diagnosed with primary fibromyalgia. Of them, 4505 (57.8%) were included in the primary care group of our study and 3284 (42.2%) in the specialised intervention group. The sample was mostly made up of middle-aged women, who have had fibromyalgia for a mean period of 6 to 10 years. The mean effect size of the efficacy of the 120 treatment interventions in patients with fibromyalgia compared with controls was 0.49 (95% confidence interval [CI] = 0.39 to 0.58; p < 0.001). In the primary care group it was 0.46 (95% CI = 0.33 to 0.58) while in specialised care it was 0.53 (95% CI = 0.38 to 0.69), with no statistical significance in the differences. We analysed the efficacy of treatments by comparing primary and specialised care in the different fibromyalgia groups and there were no significant differences. The variables of the studies that affected the improvements in the efficacy of fibromyalgia treatment were low quality of the studies and a shorter duration of treatment. However, both factors were biased by the heterogeneity of the studies. Other variables that also improved outcome and were not biased by the heterogeneity of the studies, were younger age of the patients and shorter duration of the disorder. On the contrary, gender and type of treatment (pharmacological vs. psychological) did not affect outcome.

Conclusion: Based on this meta-analysis and despite the heterogeneity of specialised care studies and of the other limitations described in this article, treating fibromyalgia in specialised care offers no clear advantages.

Figures

Figure 1
Figure 1
Flowchart showing the process of study selection.
Figure 2
Figure 2
Efficacy of the treatments allocated to both levels of care according to the type of pain in patients with fibromyalgia.

References

    1. Wolfe F, Smythe HA, Yunus MB, Bennet RM, Bombardier C, Goldenberg DL, Tugwell P, Campbell SM. The American College of Rheumatology 1990 Criteria for the classification of fibromyalgia. Report of the Multicenter Criteria Committee. Arthritis Rheum. 1990;33:160–172. doi: 10.1002/art.1780330203.
    1. Hudson JI, Pope HG., Jr The relationship between fibromyalgia and major depressive disorder. Rheum Dis Clin North Am. 1996;22:285–303. doi: 10.1016/S0889-857X(05)70273-8.
    1. Wolfe F, Ross K, Anderson J, Russell IJ. The prevalence and characteristics of fibromyalgia in the general population. Arthritis Rheum. 1995;38:19–28. doi: 10.1002/art.1780380104.
    1. Wolfe F. Fibromyalgia, the clinical syndrome. Rheum Dis Clin NA. 1989;15:1–18.
    1. Wolfe F, Anderson J, Harkness D, Bennet RM, Caro XJ, Goldenberg DL, Russell IJ, Yunus MB. Health status and disease severity in fibromyalgia: results of a six-center longitudinal study. Arthritis Rheum. 1997;40:1571–1579. doi: 10.1002/art.1780400905.
    1. Arnold LM, Keck PE, Welge JA. Antidepressant treatment of fibromyalgia. A meta-analysis and review. Psychosomatics. 2000;41:104–113. doi: 10.1176/appi.psy.41.2.104.
    1. O'Malley PG, Balden E, Tomkins G, Santoro J, Kroenke K, Jackson JL. Treatment of fibromialgia with antidepressants. A meta-analysis. J Gen Intern Med. 2000;15:659–666. doi: 10.1046/j.1525-1497.2000.06279.x.
    1. Tofferi JK, Jackson JL, O'Malley PG. Treatment of fibromialgia with cyclobenzaprine: a meta-analysis. Arthritis Rheum. 2004;51:9–13. doi: 10.1002/art.20076.
    1. Sim J, Adams N. Systematic review of randomized controlled trials of nonpharmacological interventions for fibromialgia. Clin J Pain. 2002;18:324–336. doi: 10.1097/00002508-200209000-00008.
    1. Mayhew E, Ernst E. Acupuncture for fibromialgia – a systematic review of randomized clinical trials. Rheumatology. 2007;46:801–804. doi: 10.1093/rheumatology/kel406.
    1. Moher D, Cook DJ, Eastwood S, Olkin I, Rennie D, Stroup DF. Improving the quality of reports of meta-analyses of randomised controlled trials: the QUOROM statement. Quality of Reporting of Meta-analyses. Lancet. 1999;354:1896–1900. doi: 10.1016/S0140-6736(99)04149-5.
    1. Pasquina P, Tramer MR, Walder B. Prophylactic respiratory physiotherapy after cardiac surgery: systematic review. BMJ. 2003;327:1379. doi: 10.1136/bmj.327.7428.1379.
    1. Elia N, Tramer MR. Ketamine and postoperative pain – a quantitative systematic review of randomised trials. Pain. 2005;113:61–70. doi: 10.1016/j.pain.2004.09.036.
    1. Carette S, Bell MJ, Reynols WJ, Haraqui B, McCain G, Bykerk V, Edworthy SM, Baron M, Koehler BE, Fam AG. Comparison of amitriptyline, cyclobenzaprine, and placebo in the treatment of fibromyalgia. A randomized, double-blind clinical trial. Arthritis & Rheumatism. 1994;37:32–40. doi: 10.1002/art.1780370106.
    1. Russell IJ, Michael JE, Flechas JD, Abraham GE. Treatment of fibromyalgia syndrome with super malic: A randomized, double blind, placebo controlled, crossover pilot study. J Rheumatol. 1995;22:953–958.
    1. Wolfe F, Cathey MA, Hawley DJ. A double-blind placebo controlled trial of fluoxetine in fibromyalgia. Scand J Rheumatol. 1994;23:255–259. doi: 10.3109/03009749409103725.
    1. Carette S, Oakson G, Guimont CH, Steriade M. Sleep electroencephalography and the clinical response to amitriptyline in patients with fibromyalgia. Arthritis & Rheumatism. 1995;38:1211–1217. doi: 10.1002/art.1780380906.
    1. Chesky KS, Russell IJ, Lopez Y, Kondraske GV. Fibromyalgia tender point pain: A double blind, placebo-controlled pilot study of music vibration using the music vibration table. J Musculosk Pain. 1997;5:33–52. doi: 10.1300/J094v05n03_04.
    1. Goldenberg D, Maysky M, Mossey C, Ruthazer R, Schmid C. A randomized double-blind crossover trial of fluoxetine and amitriptyline in the treatment of fibromyalgia. Arthritis & Rheumatism. 1996;39:1852–1859. doi: 10.1002/art.1780391111.
    1. Ginsberg F, Mancaux A, Joos E, Vanhove Ph, Famacy JP. A randomized placebo-controlled trial of sustained-release amitriptyline in primary fibromyalgia. J Musculosk Pain. 1996;4:37–47. doi: 10.1300/J094v04n03_05.
    1. Moldofsky H, Lue F, Mously C, Rhot-Schechter R, Reynolds WJ. The effect of zolpidem in patients with fibromyalgia: A dose ranging, double blind, placebo controlled, modified crossover study. J Rheumatol. 1996;23:529–533.
    1. Vlaeyen JW, Teeken-Gruben NJ, Goosens EJ, Ritten M, Pelt R, Hugo van Eek Heuts P. Cognitive-educational treatment of fibromyalgia: A randomized clinical trial. I. Clinical effects. J Rheumatol. 1996;23:1237–1245.
    1. Wigers SH, Stiles TC, Vogel A. Effects of aerobic exercise versus stress management treatment in fibromylgia. Scand J Rheumatol. 1996;25:77–86. doi: 10.3109/03009749609069212.
    1. Pearl S, Lue F, McLean A, Heslegrave R, Reynolds WL, Moldofsky H. The effects of bright light treatment on the symptoms of fibromyalgia. J Rheumatol. 1996;23:896–902.
    1. Kelli L, Moez H, Rajwani H, Rocco C. The efficacy of chiropractic management of fibromyalgia patients: a pilot study. J Manipul Physiol Ther. 1997;20:389–399.
    1. Hannonen P, Malminiemi K, Yli-Kerttula U, Isomeri R, Roponen P. A randomized, double-blind, placebo-controlled study of moclobemide and amitriptyline in the treatment of fibromyalgia in females without psychiatric disorder. Br J Rheumatol. 1998;37:1279–1286. doi: 10.1093/rheumatology/37.12.1279.
    1. Yavuzer G, Küçükdeveci A, Arasil T, Elhan A. Moclobemide treatment in primary fibromyalgia syndrome. Eur J Phys Med Rehabil. 1998;8:35–38.
    1. Ginsberg F, Joos E, Géczy J, Bruhwyler J, Vanderkerckhove K, Famaey JP. A pilot randomized placebo-controlled study of pirlindole in the treatment of fibromyalgia. J Musculosk Pain. 1998;6:5–17. doi: 10.1300/J094v06n02_02.
    1. Russel J, Kamin M, Bennett R, Schnitzer T, Grenn J, Katz W. Efficacy of tramadol in treatment of pain in fibromyalgia. J Clin Rheumatol. 2000;6:250–257. doi: 10.1097/00124743-200010000-00003.
    1. Heyman RE, Helfenstein M, Feldman D. A double-blind, randomized, controlled study of amitriptyline, nortriptyline and placebo in patients with fibromyalgia. An analysis of outcome measures. Clin Experiment Rheumatol. 2001;19:697–702.
    1. Färber L, Stratz TH, Brückle W, Späth M, Pongratz D. Short-term treatment of primary fibromyalgia whit the 5-HT3-receptor antagonist tropisetron. Results of a randomized double-blind, placebo-controlled multicenter trial in 418 patients. Int J Clin Pharm Res. 2001;21:1–13.
    1. Gowans SE, Hueck A, Voss S, Silaj A, Abbey SE, Reynolds WJ. Effect of randomized, controlled trial of exercise on mood and physical function in individuals with fibromyalgia. Arthrit Care & Res. 2001;45:519–529. doi: 10.1002/1529-0131(200112)45:6<519::AID-ART377>;2-3.
    1. Mannerkorpi K, Nyberg B, Ahlmen M, Ekdahi Ch. Pool exercise combined with an education program for patients with fibromyalgia syndrome. A prospective, randomized study. J Rheumatol. 2000;27:2473–2481.
    1. Gür A, Karakoc M, Nas K, Cevik R, Sarac AJ, Ataoglu S. 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. 2002;22:188–193. doi: 10.1007/s00296-002-0221-z.
    1. Joaquim J, Soares F, Grossi G. A randomized, controlled comparison of educational and behavioural interventions for women with fibromyalgia. Scand J Occupat Ther. 2002;9:35–45. doi: 10.1080/110381202753505845.
    1. King S, Wessel J, Bhambhani Y, Sholter D, Maksymowych W. The effects of exercise and education, individually or combined, in women with fibromyalgia. J Rheumatol. 2002;29:2620–2627.
    1. Lemstra M, Olszynski P. The efficacy of multidisciplinary rehabilitation in the treatment of fibromyalgia. Clin J Pain. 2005;21:166–174. doi: 10.1097/00002508-200503000-00008.
    1. Schachter C, Busch A, Peloso P, Sheppard MS. Effects of short versus long bouts of aerobic exercise in sedentary women with fibromyalgia: A randomized controlled trial. Phys Ther. 2003;83:340–358.
    1. Arnold L, Lu L, Crofford L, Wohlreich M, Detke M, Iyengar S, Goldstein D. Double-blind, multicenter trial comparing duloxetine with placebo in the treatment of fibromyalgia patients with or without major depressive disorder. Arthrit & Rheum. 2004;50:2974–2984. doi: 10.1002/art.20485.
    1. Yildiz S, Kiralp M, Akin A, Keskin I, Ay H, Dursun H, Cimsit M. A new treatment modality for fibromyalgia syndrome: hyperbaric oxygen therapy. J Internat Med Res. 2004;32:263–267.
    1. Crofford L, Rowbotham M, Mease P, Russell I, Dworkin R, Corbin A, Young J, LaMoreaux L, Martin S, Sharma U, the pregabalin 1008-105 Study group Pregabalin for the treatment of fibromyalgia syndrome. Arthritis & Rheumatim. 2005;52:1264–1273. doi: 10.1002/art.20983.
    1. Arnold L, Rosen A, Pritchett Y, D'Souza D, Goldstein D, Iyengar S, Wernicke J. A randomized, double blind, placebo-controlled trial of duloxetine in the treatment of women with fibromyalgia with or without major depressive disorder. Pain. 2005;119:5–15. doi: 10.1016/j.pain.2005.06.031.
    1. Gendreau M, Thorn M, Gendreau J, Kranzler J, Ribeiro S, Gracely R, Wiliams D, Mease P, McLean S, Lauw D. Efficay of milnacipran in patients with fibromyalgia. J Rheumatol. 2005;32:1975–1985.
    1. Finckh A, Berner I, Aubry-Rozier B, Kai-Lik So A. A randomized controlled trial of dehydroepiandrosterona in menopausal women with fibromyalgia. J Rheumatol. 2005;32:1336–1340.
    1. Holman A, Myers R. A randomized, double-blind, placebo-controlled trial of pramipexole, a dopamine agonist, in patients with fibromyalgia receiving concomitant medications. Arthitis & Rheumatism. 2005;5:2495–2505. doi: 10.1002/art.21191.
    1. Edinger J, Wohlgemuth , Krystal A, Rice J. Behavioral insomnia therapy for fibromyalgia patients. Arch Intern Med. 2005;165:2527–2535. doi: 10.1001/archinte.165.21.2527.
    1. Buskila D, Abu-Shakra M, Neumann L, Odes L, Shneider E, Fkusser D, Sukenik S. Balneotherapy for fibromyalgia at the Dead Sea. Rheumatol Int. 2001;21:105–108. doi: 10.1007/s002960000085.
    1. Melzack R. The McGill Pain Questionnaire: major properties and scoring methods. Pain. 1975;1:277–299. doi: 10.1016/0304-3959(75)90044-5.
    1. Cleeland CS, Ryan KM. Pain assessment: global use of the Brief Pain Inventory. Ann Acad Med Singapore. 1994;23:129–138.
    1. Sriwatanakul K, Kelvie W, Lasagna L. Studies with different types of visual analog scales for measurement of pain. Clin Pharmacol Ther. 1983;34:234–239.
    1. Ware JE, Snow KK, Kosinski M, Grandek B. SF-36 health survey manual and interpretation guide. Boston: The Health Institute, New England Medical Center; 1993.
    1. Buckhardt CS, Archenholtz B, Bjelle A. Measuring the quality of life of women with rheumatoid arthritis of systemic lupus erythematosus: a Swedish version of the quality of life scale. Scand J Rheumatol. 1992;21:190–195. doi: 10.3109/03009749209099220.
    1. Beck AT, Steer RA, Ball R, Rainieri W. Comparison of Beck Depression Inventories IA and II in psychiatric outpatient. J Pers Asses. 1996;67:588–597. doi: 10.1207/s15327752jpa6703_13.
    1. Zigmond A, Snaith RP. The Hospital anxiety and depression scale. Acta Psychiatric Scand. 1983;67:361–370. doi: 10.1111/j.1600-0447.1983.tb09716.x.
    1. Hamilton M. A rating scale for depression. J Neurol Neurosurg Psychiatric. 1960;23:56–62.
    1. Speilberger CD. State-trait Anxiety Inventory for adults. Palo Alto: Mind Garden; 1980.
    1. Guy W, ECDEU . Assessment Manual for Psychopharmacology Revised. Rockville: US Department of Health, Education and Welfare publication (ADM), National Institute of Mental Health; 1976. pp. 218–22.
    1. Russell IJ, Viprao GA, Morgan WW, Bowden CL. Is there a metabolic basis for the fibrositis syndrome? Am J Med. 1986;81:50–56. doi: 10.1016/0002-9343(86)90874-0.
    1. Belza B, Henke C, Epstein W, Gilliss C. Correlates of fatigue in older adults with rheumatoid arthritis. Nurs Res. 1993;42:93–99. doi: 10.1097/00006199-199303000-00006.
    1. Burckhardt CS, Clarck SR, Bennet RM. The fibromyalgia impact questionnaire: development and validation. J Rheumatol. 1991;18:728–733.
    1. Bergner M, Bobbitt RA, Carter WB, Bilson BS. The Sickness Impact Profile: development and final revision of a health status measure. Med Care. 1981;19:787–805. doi: 10.1097/00005650-198108000-00001.
    1. Cohen J. Statistical power analysis for the behavioural sciences. 2. Hillsdale: Lawrence Erlbaum Associates; 1988.
    1. Higgins JPT, Thompson SG, Deeck JJ, Altman DG. Measuring inconsistency in meta-analysis. BMJ. 2003;327:557–560. doi: 10.1136/bmj.327.7414.557.
    1. Van Wilgen CP, Bloten H, Oeseburg B. Results of a multidisciplinary program for patients with fibromyalgia implemented in the primary care. Disabil Rehabil. 2007;29:1207–1213. doi: 10.1080/09638280600949860.
    1. Alamo MM, Moral RR, Pérula de Torres LA. Evaluation of a patient-centred approach in generalized musculoskeletal chronic pain/fibromyalgia patients in primary care. Patient Educ Couns. 2002;48:23–31. doi: 10.1016/S0738-3991(02)00095-2.
    1. Giesecke T, Williams DA, Harris RE, Cupps TR, Tian X, Tian TX, Gracely RH, Clauw DJ. Subgrouping of fibromyalgia patients on the basis of pressure-pain thresholds and psychological factors. Arthrit Rheum. 2003;48:2916–2922. doi: 10.1002/art.11272.

Source: PubMed

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