Efficacy and safety of willow bark extract in the treatment of osteoarthritis and rheumatoid arthritis: Results of 2 randomized double-blind controlled trials

Journal of Rheumatology

Volumn 31, Issue 11, 2004, Pages 2121-2130

  Biegert, Claudia ^a   Wagner, Irmela ^a   Lüdtke, Rainer ^c   Kötter, Ina ^b   Lohmüller, Claudia ^b   Günaydin, Ilhan ^b   Taxis, Katja ^a   Heide, Lutz ^a  

^a UNIVERSITY OF TÜBINGEN   (Germany)

^b UNIVERSITY HOSPITAL TÜBINGEN   (Germany)

^c Karl und Veronica Carstens Stiftung   (Germany)

Author keywords

Diclofenac; Drug therapy; Osteoarthritis; Rheumatoid arthritis; Willow bark

Indexed keywords

DICLOFENAC; PLACEBO; PLANT EXTRACT; SALICIN; UNCLASSIFIED DRUG; WILLOW BARK EXTRACT;

ADULT; ARTICLE; BLOOD CLOTTING DISORDER; CARDIOVASCULAR DISEASE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DEEP VEIN THROMBOSIS; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; DYSPNEA; FEMALE; FOLLOW UP; GASTRITIS; GASTROINTESTINAL HEMORRHAGE; GASTROINTESTINAL SYMPTOM; HEARTBURN; HEMATURIA; HUMAN; INDIGESTION; MAJOR CLINICAL STUDY; MALE; MENTAL DISEASE; MUSCULOSKELETAL DISEASE; OSTEOARTHRITIS; OUTCOMES RESEARCH; PAIN; PAIN ASSESSMENT; PRIORITY JOURNAL; PRURITUS; RANDOMIZED CONTROLLED TRIAL; RASH; RESPIRATORY TRACT DISEASE; RHEUMATOID ARTHRITIS; SCORING SYSTEM; SIDE EFFECT; SKIN DISEASE; TISSUE INJURY; TREATMENT OUTCOME; VASCULAR DISEASE; VISUAL DISORDER; WILLOW;

ADMINISTRATION, ORAL; ANTI-INFLAMMATORY AGENTS, NON-STEROIDAL; ANTIRHEUMATIC AGENTS; ARTHRITIS, RHEUMATOID; DICLOFENAC; DOUBLE-BLIND METHOD; FEMALE; HEALTH STATUS; HUMANS; MALE; MIDDLE AGED; OSTEOARTHRITIS; PLANT BARK; PLANT EXTRACTS; SALIX; SEVERITY OF ILLNESS INDEX; TREATMENT OUTCOME;

EID: 7544249711     PISSN: 0315162X     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (36)

1. Eisenberg DM, Davis RB, Ettner SL, et al. Trends in alternative medicine use in the United States, 1990-1997: results of a follow-up national survey. JAMA 1998;280:1569-75.
2. Tyler VE. Foreword. In: Blumenthal M, editor. The complete German Commission E monographs: therapeutic guide to herbal medicines. Austin, Texas: American Botanical Council; 1998.
3. Angell M, Kassirer JP. Alternative medicine - the risks of untested and unregulated remedies [editorial]. N Engl J Med 1998;339:839-41.
4. De Smet PA. Herbal remedies. N Engl J Med 2002;347:2046-56.
5. Straus SE. Herbal medicines - what's in the bottle? N Engl J Med 2002;347:1997-8.
6. Wolfe MM, Lichtenstein DR, Singh G. Gastrointestinal toxicity of nonsteroidal antiinflammatory drugs. N Engl J Med 1999;340:1888-99.
7. FitzGerald GA, Patrono C. The coxibs, selective inhibitors of cyclooxygenase-2. N Engl J Med 2001;345:433-42.
8. Chrubasik S, Eisenberg E, Balan E, Weinberger T, Luzzati R, Conradt C. Treatment of low back pain exacerbations with willow bark extract: a randomized double-blind study. Am J Med 2000;109:9-14.
9. Chrubasik S, Künzel O, Model A, Conradt C, Black A. Treatment of low back pain with a herbal or synthetic anti-rheumatic: a randomized controlled study. Willow bark extract for low back pain. Rheumatology Oxford 2001;40:1388-93.
10. Schmid B, Lüdtke R, Selbmann HK, et al. Effectiveness and tolerance of standardized willow bark extract in osteoarthritis patients. Randomized, placebo controlled double-blind study. Z Rheumatol 2000;59:314-20.
11. Temple R, Ellenberg SS. Placebo-controlled trials and active-control trials in the evaluation of new treatments. Part 1: ethical and scientific issues. Ann Intern Med 2000;133:455-63.
12. European Agency for the Evaluation of Medicinal Products - Committee for Proprietary Medicinal Products. Points to consider on clinical investigation of medicinal products used in the treatment of osteoarthritis. CPMP/EWP/784/97. London: EMEA; 1998. Internet. [cited July 14, 2004]. Available from: http://www.emea.eu.int/pdfs/human/ewp/078497en.pdf
13. Altman R, Brandt K, Hochberg M, et al. Design and conduct of clinical trials in patients with osteoarthritis: recommendations from a task force of the Osteoarthritis Research Society. Results from a workshop. Osteoarthritis Cartilage 1996;4:217-43.
14. Food and Drug Administration. Guidance for industry: Clinical development programs for drugs, devices, and biological products intended for the treatment of osteoarthritis (OA). Washington, DC: Federal Register 64 (135), July 15, 1999; docket 98D-0077.
15. Meier B, Sticher O, Bettschart A. Weidenrinden-Qualität. Deutsche Apotheker Zeitung 1985;125:341-7.
16. US Pharmacopeia 25. Diclofenac sodium delayed release tablets. In: The United States Pharmacopeia. Philadelphia: National Publishing; 2002:554-5.
17. Altman R, Alarcon G, Appelrouth D, et al. The American College of Rheumatology criteria for the classification and reporting of osteoarthritis of the hip. Arthritis Rheum 1991;34:505-14.
18. Altman R, Asch E, Bloch D, et al. Development of criteria for the classification and reporting of osteoarthritis. Classification of osteoarthritis of the knee. Diagnostic and Therapeutic Criteria Committee of the American Rheumatism Association. Arthritis Rheum 1986;29:1039-49.
19. Bellamy N, Buchanan WW, Goldsmith CH, Campbell J, Stitt LW. Validation study of WOMAC: a health status instrument for measuring clinically important patient relevant outcomes to antirheumatic drug therapy in patients with osteoarthritis of the hip or knee. J Rheumatol 1988;15:1833-40.
20. Bellamy N. WOMAC Osteoarthritis Index - A user guide. London, ON: University of Western Ontario; 1995.
21. Cockcroft DW, Gault MH. Prediction of creatinine clearance from serum creatinine. Nephron 1976;16:31-41.
22. Stucki G, Meier D, Stucki S, et al. Evaluation of a German version of WOMAC (Western Ontario and McMaster Universities) Osteoarthritis Index. Z Rheumatol 1996;55:40-9.
23. Bullinger M. German translation and psychometric testing of the SF-36 Health Survey: preliminary results from the IQOLA Project. International Quality of Life Assessment. Soc Sci Med 1995;41:1359-66.
24. WHO. Adverse reaction terminology. Geneva: World Health Organization, The Uppsala Monitoring Centre; 2001.
25. Arnett FC, Edworthy SM, Bloch DA, et al. The American Rheumatism Association 1987 revised criteria for the classification of rheumatoid arthritis. Arthritis Rheum 1988;31:315-24.
26. Hochberg MC, Chang RW, Dwosh I, Lindsey S, Pincus T, Wolfe F. The American College of Rheumatology 1991 revised criteria for the classification of global functional status in rheumatoid arthritis. Arthritis Rheum 1992;35:498-502.
27. Felson DT, Anderson JJ, Boers M, et al. The American College of Rheumatology preliminary core set of disease activity measures for rheumatoid arthritis clinical trials. The Committee on Outcome Measures in Rheumatoid Arthritis Clinical Trials. Arthritis Rheum 1993;36:729-40.
28. Fuchs HA, Brooks RH, Callahan LF, Pincus T. A simplified twenty-eight-joint quantitative articular index in rheumatoid arthritis. Arthritis Rheum 1989;32:531-7.
29. Fries JF, Spitz P, Kraines RG, Holman HR. Measurement of patient outcome in arthritis. Arthritis Rheum 1980;23:137-45.
30. Lautenschlager J, Mau W, Kohlmann T, et al. Comparative evaluation of a German version of the Health Assessment Questionnaire and the Hannover Functional Capacity Questionnaire. Z Rheumatol 1997;56:144-55.
31. Felson DT, Anderson JJ, Boers M, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum 1995;38:727-35.
32. Mills SY, Jacoby RK, Chacksfield M, Willoughby M. Effect of a proprietary herbal medicine on the relief of chronic arthritic pain: a double-blind study. Br J Rheumatol 1996;35:874-8.
33. Bellamy N. Musculoskeletal clinical metrology. Dordrecht: Kluwer Academic Publishers; 1993.
34. Schmid B, Kötter I, Heide L. Pharmacokinetics of salicin after oral administration of a standardised willow bark extract. Eur J Clin Pharmacol 2001;57:387-91.
35. Fiebich BL, Chrubasik S. Effects of an ethanolic salix extract on the release of selected inflammatory mediators in vitro. Phytomedicine 2004;11:135-8.
36. Wagner I, Greim C, Laufer S, Heide L, Gleiter CH. Influence of willow bark extract on cyclooxygenase activity and on tumor necrosis factor alpha or interleukin 1 beta release in vitro and ex vivo. Clin Pharmacol Ther 2003;73:272-4.