Pharmacy World and Science

, Volume 18, Issue 4, pp 130–136 | Cite as

Health-related quality of life assessments in osteoarthritis during NSAID treatment

  • G. H. de Bock
  • J. Hermans
  • H. W. J. van Marwijk
  • A. A. Kaptein
  • J. D. Mulder


There is some evidence that nabumetone (1000 mg once daily) in comparison with piroxicam (20 mg once daily) in patients with OA in general practice is associated with a lower incidence and less severe occurrence of stomach pain but with more withdrawals due to lack of efficacy. The aim of this analysis was to investigate whether these differences are reflected in health-related quality of life assessments. Patients (n=198) included in this study were selected in general practice according to a protocol. The patients were randomized and treated for a period of six weeks. Clinical assessments were performed by the general practitioner (GP) during treatment. The Sickness Impact Profile (SIP), the Activities of Daily Living (ADL), and a pain questionnaire were filled out by the patients before and after treatment. As measured with the SIP, the ADL and the pain questionnaire, there were no significant differences between nabumetone and piroxicam. The comelations between (changes in) patient assessments and (changes in) clinical assessments were low. The differences between the two drugs regarding withdrawals and adverse events were not reflected by patient health-related quality of life assessments. There was a low correlation between patient health-related quality of life assessment and clinical assessments. To get a complete picture of the efficacy and safety of a drug, patient health-related quality of life assessments should be a part of a clinical trial.


Nabumetone Piroxicam osteoarthritis Randomized controlled trials Sickness Impact Profile Activities of daily living 


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  1. 1.
    Scott JC, Hochberg MC. Osteoarthritis I: epidemiology. Md State Med J 1984;33:712–6.Google Scholar
  2. 2.
    Pincus T, Mitchell JM, Burkhauser RV. Substantial work disability and earnings losses in individuals less than age 65 with osteoarthritis: comparisons with rheumatoid arthritis. J Clin Epidemiol 1989;42:449–57.Google Scholar
  3. 3.
    Yelin E, Lubeck D, Holman H, Epstein W. The impact of rheumatoid arthritis and osteoarthritis: the activities of patients with rheumatoid arthritis and osteoarthritis compared to controls. J Rheumatol 1987;14:710–7.Google Scholar
  4. 4.
    Lubeck DP, Yelin EH. A question of value: measuring the impact of chronic disease. Milbank Quart 1988;66:444–64.Google Scholar
  5. 5.
    Leigh TJ, Hindmarch I, Bird HA, Wright V. Comparison of sleep in osteoarthritic patients and age and sex matched healthy controls. Ann Rheum Dis 1988;47:40–2.Google Scholar
  6. 6.
    Davis MA, Ettinger WH, Neuhaus JM, Mallon KP. Knee osteoarthritis and physical functioning: evidence from the NHANES I epidemiologic follow-up study. J Rheumatol 1991;18:591–8.Google Scholar
  7. 7.
    DeBock GH, Kaptein AA, Touw-Otten FWMM, Mulder JD. Health-related quality of life in patients with osteoarthritis in a family practice setting. Arthritis Care Res 1995;8:88–93.Google Scholar
  8. 8.
    Wood PHN, Badley E. Rheumatic disorders In. Epidemiology of diseases. Miller DL, Farmer RDT (eds). Oxford: Blackwell Scientific Publication, 1982:333–46.Google Scholar
  9. 9.
    Voorn TB. Chronic diseases in general practice [Chronische ziekten in de huisartspraktijk]. Utrecht: Wetenschappelijke Uitgeverij Bunge, 1983.Google Scholar
  10. 10.
    DeBock GH, Kaptein AA, Mulder JD. Dutch general practitioner's management of patients with distal osteoarthritic symptoms. Scand J Prim Health Care 1992;10:42–6.Google Scholar
  11. 11.
    Steele K, Mills KA, Gilliland AEW, Irwin WG, Taggart A. Repeat prescribing of non-steroidal anti-inflammatory drugs excluding aspirin: how careful are we? Brit Med J 1987; 295: 962–4.Google Scholar
  12. 12.
    Committee on the Safety of Medicines. CSM update: nonsteroidal anti-inflammatory drugs and serious gastrointestinal adverse reactions 1. Brit Med J 1986;292:614.Google Scholar
  13. 13.
    Vermeulen HN, Stricker BHCh, DeKoning GHP, Porsius AJ. A comparison of reported suspected adverse drug reactions between a regional centre and a national centre [Een vergelijking van de meldingen van vermoedelijke bijwerkingen bij een regionaal en een landelijk meldingssysteem]. Pharm Weekbl 1990;125:931–6.Google Scholar
  14. 14.
    Roth SH. Endoscopy controlled study of the safety of nabumetone compared with naproxen in arthritis therapy. Am J Med 1987;30(4B):25–30.Google Scholar
  15. 15.
    Greb WH, VonSchrader HW, Cerlek S, Dominis M, Hauptmann E, Zenic N. Endoscopic studies of nabumetone in patients with rheumatoid arthritis: a comparative endoscopic and histologic evaluation. Am J Med 1987;30(4B):19–24.Google Scholar
  16. 16.
    Lussie A, LeBel E. Radiochromium (chromium-51) evaluation of gastrointestinal blood loss associated with placebo, aspirin, and nabumetone. Am J Med 1987;30(4B):15–8.Google Scholar
  17. 17.
    Friedel HA, Langtry HD, Buckley MM. Nabumetone: a reappraisal of its pharmacology and therapeutic use in rheumatic diseases. Drugs 1993;45:131–56.Google Scholar
  18. 18.
    Roth SH. Nabumetone: a new NSAID for rheumatoid arthritis and osteoarthritis. Orthop Rev 1992;21:223–7.Google Scholar
  19. 19.
    Verbruggen LA, Pintens H. Efficacy and safety of nabumetone in long-term treatment of osteoarthritis. Int J Tissue React 1984;6:339–42.Google Scholar
  20. 20.
    Verbruggen LA, Cytryn E, Pintens H, Double-blind cross-over study of nabumetone versus naproxen in the treatment of osteoarthritis. J Int Med Res 1982;10:214–8.Google Scholar
  21. 21.
    DeBock GH, Hermans J, Mulder JD. Randomized doubleblind study of nabumetone and piroxicam in the treatment of osteoarthritis in Dutch general practice: efficacy and tolerability. Pharm World Sci 1993;15:132–8.Google Scholar
  22. 22.
    The Classification Committee of WONCA (World Organization of National Colleges, Academies, and Academic Associations of General Practitioners/Family Physicians) in collaboration with the World Health Organization. ICHPPC-2-Defined (International Classification of Health Problems in Primary Care). Oxford: Oxford University Press, 1983.Google Scholar
  23. 23.
    Steinbrocker O, Traeger CH, Batterman RC. Therapeutic criteria in rheumatoid arthritis J Am Med Assoc 1949;140:659–62.Google Scholar
  24. 24.
    Bergner M, Bobbitt RA, Carter WB, Gilson BS. The Sickness Impact Profile: development and revision of a health status measure. Med Care 1981;19:787–805.Google Scholar
  25. 25.
    Katz S, Ford AB, Moskowitz RW, Jackson BA, Jaffe MW. Studies of illness in the aged. The index of ADL: a standardized measure of biological and psychosocial function. J Am Med Assoc 1963;185:914–9.Google Scholar
  26. 26.
    Katz S, Akpom CA. Index of ADL. Med Care 1976;14:116–8.Google Scholar
  27. 27.
    Katz S, Akpom CA. A measure of primary sociobiological functions. Int J Health Serv 1976;6:493–508.Google Scholar
  28. 28.
    Culpepper L. Symptoms, measures of the mind. In: Tools of primary care research. Stewart M, Tudiver F, Bass MJ, Dunn EV, Norton PG (ed). Research methods for primary care: 2. Newbury Park: SAGE publications 1992: 113–23.Google Scholar
  29. 29.
    Hunt S, McEwen J, McKenna S. Measuring health status: a new tool for clinicians and epidemiologists. J R Coll Gen Pract 1985;35:185–8.Google Scholar
  30. 30.
    Fitzpatrick R, Fletcher A, Gore S, Jones D, Spiegelhalter D, Cox D. Quality of life measures in health care. I: Applications and issues in assessment. Brit Med J 1992;305:1074–7.Google Scholar
  31. 31.
    Wilkin D, Hallam L, Doggett M-A Measures of need and outcome for primary health care. Oxford Oxford University Press, 1993 [revised edition].Google Scholar
  32. 32.
    The SIP (Dutch version) is available from Department of General Practice, University of Utrecht, The Netherlands. Tel-31-30-2538188.Google Scholar
  33. 33.
    Luttik A, Jacobs HM, DeWitte LP. The Sickness-Impact-Profile. Utrecht: Department of Family Medicine, University of Utrecht, 1987.Google Scholar
  34. 34.
    Jacobs HM, Luttik A, Touw-Otten FWMM, DeMelker RA. The ‘Sickness Impact Profile’: results of a validation study of the Dutch version [De ‘Sickness Impact Profile; resultaten van een valideringsonderzoek van de Nederlandse versie]. Ned Tijdschr Geneeskd 1990;134:1950–4.Google Scholar
  35. 35.
    DeBruin AF, DeWitte LP, Stevens F, Diederiks JPM. Sickness Impact Profile: the state of the art of a generic functional status measure. Soc Sci Med 1992;35:1003–14.Google Scholar
  36. 36.
    The ADL (Dutch version) is available from Department of Psychiatry, Leiden University, The Netherlands. Tel-31-71-5275237.Google Scholar
  37. 37.
    Kaptein AA, Dekker FW, Dekhuijzen PNR, Wagenaar JPM, Janssen PJ. The value of the 12-minute walking sest in patients with chronic obstructive pulmonary disease. II. Walking in the laboratory and walking in daily life [De 12-minuten-looptest bij patiënten met een chronische uitademingsstoornis. II. Lopen in het laboratorium en lopen in het leven]. Ned Tijdschr Geneeskd 1987;131:1717–21.Google Scholar
  38. 38.
    Huskisson EC. Measurement of pain. Lancet 1974; ii: 1127–31.Google Scholar
  39. 39.
    Cohen J. Statistical power analysis for the behavioral sciences. New York: Lawrence Erlbaum Associates, 1977.Google Scholar
  40. 40.
    Deyo RA. Measuring the quality of life of patients with rheumatoid arthritis. In: Quality of life assessment: key issues in the 1990s. Walker SR, Rosser RM (Eds). Lancaster, UK: Kluwer Academic Publishers 1993.Google Scholar
  41. 41.
    DeBock GH, VanMarwijk HWJ, Kaptein AA, Mulder JD. Osteoarthritis pain assessment in general practice. Arthritis Care Res 1994;7:40–5.Google Scholar

Copyright information

© Kluwer Academic Publishers 1996

Authors and Affiliations

  • G. H. de Bock
    • 1
  • J. Hermans
    • 2
  • H. W. J. van Marwijk
    • 1
  • A. A. Kaptein
    • 3
  • J. D. Mulder
    • 1
  1. 1.Department of General PracticeLeiden UniversityLeidenNetherlands
  2. 2.Department of Medical StatisticsLeiden UniversityLeidenNetherlands
  3. 3.Department of PsychiatryLeiden UniversityLeidenNetherlands

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