Additive Complex Ayurvedic Treatment in Patients with Fibromyalgia Syndrome Compared to Conventional Standard Care Alone: A Nonrandomized Controlled Clinical Pilot Study (KAFA Trial)

Christian S Kessler, Thomas Ostermann, Larissa Meier, Elmar Stapelfeldt, Silvia Schütte, Joachim Duda, Andreas Michalsen, Christian S Kessler, Thomas Ostermann, Larissa Meier, Elmar Stapelfeldt, Silvia Schütte, Joachim Duda, Andreas Michalsen

Abstract

Background. Fibromyalgia (FMS) is a challenging condition for health care systems worldwide. Only limited trial data is available for FMS for outcomes of complex treatment interventions of complementary and integrative (CIM) approaches. Methods. We conducted a controlled, nonrandomized feasibility study that compared outcomes in 21 patients treated with Ayurveda with those of 11 patients treated with a conventional approach at the end of a two-week inpatient hospital stay. Primary outcome was the impact of fibromyalgia on patients as assessed by the FIQ. Secondary outcomes included scores of pain intensity, pain perception, depression, anxiety, and quality of sleep. Follow-up assessments were done after 6 months. Results. At 2 weeks, there were comparable and significant improvements in the FIQ and for most of secondary outcomes in both groups with no significant in-between-group differences. The beneficial effects for both treatment groups were partly maintained for the main outcome and a number of secondary outcomes at the 6-month followup, again with no significant in-between-group differences. Discussion. The findings of this feasibility study suggest that Ayurvedic therapy is noninferior to conventional treatment in patients with severe FMS. Since Ayurveda was only used as add-on treatment, RCTs on Ayurveda alone are warranted to increase model validity. This trial is registered with NCT01389336.

Figures

Figure 1
Figure 1
Classic Ayurvedic treatment of fibromyalgia (simplified depiction).

References

    1. Häuser W, Eich W, Herrmann M, Nutzinger DO, Schiltenwolf M, Henningsen P. The Fibromyalgia syndrome: classification, diagnosis, and treatment. Deutsches Arzteblatt. 2009;106(23):383–391.
    1. Sommer C, Häuser W, Alten R, et al. Drug therapy of fibromyalgia syndrome. Systematic review, meta-analysis and guideline. Schmerz. 2012;26(3):297–310.
    1. Carville SF, Arendt-Nielsen S, Bliddal H, et al. EULAR evidence-based recommendations for the management of fibromyalgia syndrome. Annals of the Rheumatic Diseases. 2008;67(4):536–541.
    1. Fitzcharles M, Ste-Marie PA, Goldenberg DL, et al. 2012 Canadian guidelines for the diagnosis and management of fibromyalgia syndrome. .
    1. Wolfe F, Ross K, Anderson J, Russell IJ, Hebert L. The prevalence and characteristics of fibromyalgia in the general population. Arthritis and Rheumatism. 1995;38(1):19–28.
    1. Branco JC, Bannwarth B, Failde I, et al. Prevalence of fibromyalgia: a survey in five European countries. Seminars in Arthritis and Rheumatism. 2010;39(6):448–453.
    1. Ngian G, Guymer EK, Littlejohn GO. The use of opioids in fibromyalgia. International Journal of Rheumatic Diseases. 2011;14(1):6–11.
    1. Maletic V, Raison CL. Neurobiology of depression, fibromyalgia and neuropathic pain. Frontiers in Bioscience. 2009;14(14):5291–5338.
    1. Gracely RH, Ambrose KR. Neuroimaging of fibromyalgia. Best Practice and Research. 2011;25(2):271–284.
    1. Jensen KB, Kosek E, Petzke F, et al. Evidence of dysfunctional pain inhibition in fibromyalgia reflected in rACC during provoked pain. Pain. 2009;144(1-2):95–100.
    1. Russell IJ, Larson AA. Neurophysiopathogenesis of fibromyalgia syndrome: a unified hypothesis. Rheumatic Disease Clinics of North America. 2009;35(2):421–435.
    1. Desmeules JA, Cedraschi C, Rapiti E, et al. Neurophysiologic evidence for a central sensitization in patients with fibromyalgia. Arthritis and Rheumatism. 2003;48(5):1420–1429.
    1. Häuser W, Schmutzer G, Brähler E, Glaesmer H. A cluster within the continuum of biopsychosocial distress can be labeled “fibromyalgia syndrome”—Evidence from a representative German population survey. Journal of Rheumatology. 2009;36(12):2806–2812.
    1. Clauw DJ, Arnold LM, McCarberg BH. The science of fibromyalgia. Mayo Clinic Proceedings. 2011;86(9):907–911.
    1. Häuser W, Thieme K, Turk DC. Guidelines on the management of fibromyalgia syndrome—a systematic review. European Journal of Pain. 2010;14(1):5–10.
    1. Langhorst J, Hauser W, Bernardy K, et al. Complementary and alternative therapies for fibromyalgia syndrome: systematic review, meta-analysis and guideline. Schmerz. 2012;26:311–317.
    1. Witt CM, Michalsen A, Roll S, et al. Comparative effectiveness of a complex Ayurvedic treatment and conventional standard care in osteoarthritis of the knee—study protocol for a randomized controlled trial. Trials. 2013;14(1, article 149)
    1. Kessler C, Michalsen A. The role of whole medical systems in global medicine. Forschende Komplementärmedizin. 2012;19:65–66.
    1. World Health Organization. Report by the Secretariat. A 56/18. Geneva, Switzerland: World Health Organization; 2003. Traditional medicine.
    1. World Health Organization. Traditional Medicine in Asia. New Delhi, India: WHO Regional Publications; 2002.
    1. World Health Organization. Traditional Medicine Strategy. Geneva, Switzerland: WHO Regional Publications; 2002.
    1. Association of Ayurvedic Physicians of India (AAPI)
    1. World Health Organization. Benchmarks for Training in Traditional/Complementary and Alternative Medicine: Benchmarks for Training in Ayurveda. Geneva, Switzerland: World Health Organization; 2010.
    1. Furst DE, Venkatraman MM, McGann M, et al. Double-blind, randomized, controlled, pilot study comparing classic ayurvedic medicine, methotrexate, and their combination in rheumatoid arthritis. Journal of Clinical Rheumatology. 2011;17(4):185–192.
    1. Furst DE, Venkatraman MM, Swamy BGK, et al. Well controlled, double-blind, placebo-controlled trials of classical Ayurvedic treatment are possible in rheumatoid arthritis. Annals of the Rheumatic Diseases. 2011;70(2):392–393.
    1. Elder C, Aickin M, Bauer V, Cairns J, Vuckovic N. Randomized trial of a whole-system ayurvedic protocol for type 2 diabetes. Alternative Therapies in Health and Medicine. 2006;12(5):24–30.
    1. DHARA. Tamil Nadu: AVT Institute for Advanced Research,
    1. Universitäres Kompetenznetzwerk für Ayurveda-Medizin (UKAM)
    1. Rasmussen LB, Mikkelsen K, Haugen M, Pripp AH, Fields JZ, Førre ØT. Treatment of fibromyalgia at the Maharishi Ayurveda Health Centre in Norway II-a 24-month follow-up pilot study. Clinical Rheumatology. 2012;31(5):821–827.
    1. Rasmussen LB, Mikkelsen K, Haugen M, Pripp AH, Førre ØT. Treatment of fibromyalgia at the Maharishi Ayurveda Health Centre in Norway. A six-month follow-up study. Clinical and Experimental Rheumatology. 2009;27(5) supplement 56:S46–S50.
    1. Rasmussen LB. Maharishi Ayurveda and unclear conditions. Tidsskrift for den Norske Lægeforening. 2010;130(7):p. 721.
    1. Alampi G, Fischmann K. Types and duration of the effects of ayurvedic treatments (massage and dhara) on 106 patients aged 26 to 88 years. Komplementare und Integrative Medizin. 2008;49(3):37–42.
    1. Clincial Trials.
    1. InEK. German DRG-System. Fallpauschaldenkatalog 2011, .
    1. Wolfe F, Clauw DJ, Fitzcharles M, et al. The American College of Rheumatology preliminary diagnostic criteria for fibromyalgia and measurement of symptom severity. Arthritis Care and Research. 2010;62(5):600–610.
    1. Burckhardt CS, Clark SR, Bennett RM. The fibromyalgia impact questionnaire: development and validation. Journal of Rheumatology. 1991;18(5):728–733.
    1. Offenbaecher M, Waltz M, Schoeps P. Validation of a German version of the fibromyalgia impact questionnaire (FIQ-G) Journal of Rheumatology. 2000;27(8):1984–1988.
    1. Spielberger C. State-Trait Anger. Resarch edition. Odessa, Fla, USA: Psychological Assessment Resources; 1986. (Professional Manual).
    1. Barth J, Martin CR. Factor structure of the Hospital Anxiety and Depression Scale (HADS) in German coronary heart disease patients. Health and Quality of Life Outcomes. 2005;3, article 15
    1. Snaith RP. The hospital anxiety and depression scale. Health and Quality of Life Outcomes. 2003;1, article 29
    1. Lange M, Petermann F. Influence of depression on fibromyalgia. A systematic review. Schmerz. 2010;24(4):326–333.

Source: PubMed

Sponsorer och medarbetare

Medicinska tillstånd

Läkemedelsinterventioner

3
Prenumerera