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Logo of annrheumdAnnals of the Rheumatic DiseasesCurrent TOCInstructions for authors
Ann Rheum Dis. Sep 2004; 63(9): 1028–1034.
PMCID: PMC1755112

The IPSO study: ibuprofen, paracetamol study in osteoarthritis. A randomised comparative clinical study comparing the efficacy and safety of ibuprofen and paracetamol analgesic treatment of osteoarthritis of the knee or hip

Abstract

Objective: To compare the analgesic efficacy of single and multiple doses of ibuprofen with that of paracetamol in patients with knee or hip osteoarthritis (IPSO study).

Method: 222 patients were randomised in a double blind, multicentre study—156 (70%) had a painful knee joint and 66 (30%) a painful hip joint. The main efficacy criterion was pain intensity assessment after a single dose (ibuprofen 400 mg, paracetamol 1000 mg). Functional disability assessment and patient global assessment were carried out over 14 days.

Results: The sum of the pain intensity difference over 6 hours after the first administration was significantly higher (p = 0.046) in the ibuprofen group than in the paracetamol group. Over 14 days pain intensity decreased from the first day and was significantly lower in the ibuprofen group than in the paracetamol group (p<0.05). The functional disability of the patient was assessed using the WOMAC; the ibuprofen group improved significantly over 2 weeks compared with the paracetamol group for each of the subscales: stiffness (p<0.002), pain (p<0.001), physical function (p<0.002). The drugs were equally safe.

Conclusion: The IPSO study shows that for the treatment of osteoarthritic pain, ibuprofen 400 mg at a single and multiple dose (1200 mg/day) for 14 days is more effective than paracetamol, either as a single dose of 1000 mg or a multiple dose (3000 mg/day). Because ibuprofen and paracetamol have similar tolerability, this study indicates that the efficacy/tolerability ratio of ibuprofen is better than that of paracetamol in this indication over 14 days.

Full Text

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Selected References

These references are in PubMed. This may not be the complete list of references from this article.
  • Cooper SA, Schachtel BP, Goldman E, Gelb S, Cohn P. Ibuprofen and acetaminophen in the relief of acute pain: a randomized, double-blind, placebo-controlled study. J Clin Pharmacol. 1989 Nov;29(11):1026–1030. [PubMed]
  • Zhang WY, Li Wan Po A. Efficacy of minor analgesics in primary dysmenorrhoea: a systematic review. Br J Obstet Gynaecol. 1998 Jul;105(7):780–789. [PubMed]
  • Felson DT, Lawrence RC, Dieppe PA, Hirsch R, Helmick CG, Jordan JM, Kington RS, Lane NE, Nevitt MC, Zhang Y, et al. Osteoarthritis: new insights. Part 1: the disease and its risk factors. Ann Intern Med. 2000 Oct 17;133(8):635–646. [PubMed]
  • Schachtel BP, Furey SA, Thoden WR. Nonprescription ibuprofen and acetaminophen in the treatment of tension-type headache. J Clin Pharmacol. 1996 Dec;36(12):1120–1125. [PubMed]
  • Behotas S, Chauvin A, Castiel J, Martin A, Boureau F, Barrat J, Lienhart A. Effets antalgiques de l'ibuprofène dans les douleurs après épisiotomie. Ann Fr Anesth Reanim. 1992;11(1):22–26. [PubMed]
  • Mehlisch DR, Jasper RD, Brown P, Korn SH, McCarroll K, Murakami AA. Comparative study of ibuprofen lysine and acetaminophen in patients with postoperative dental pain. Clin Ther. 1995 Sep-Oct;17(5):852–860. [PubMed]
  • Bradley JD, Brandt KD, Katz BP, Kalasinski LA, Ryan SI. Comparison of an antiinflammatory dose of ibuprofen, an analgesic dose of ibuprofen, and acetaminophen in the treatment of patients with osteoarthritis of the knee. N Engl J Med. 1991 Jul 11;325(2):87–91. [PubMed]
  • Pendleton A, Arden N, Dougados M, Doherty M, Bannwarth B, Bijlsma JW, Cluzeau F, Cooper C, Dieppe PA, Günther KP, et al. EULAR recommendations for the management of knee osteoarthritis: report of a task force of the Standing Committee for International Clinical Studies Including Therapeutic Trials (ESCISIT). Ann Rheum Dis. 2000 Dec;59(12):936–944. [PMC free article] [PubMed]
  • Altman R, Asch E, Bloch D, Bole G, Borenstein D, Brandt K, Christy W, Cooke TD, Greenwald R, Hochberg M, 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 Aug;29(8):1039–1049. [PubMed]
  • Altman R, Alarcón G, Appelrouth D, Bloch D, Borenstein D, Brandt K, Brown C, Cooke TD, Daniel W, Feldman D, et al. The American College of Rheumatology criteria for the classification and reporting of osteoarthritis of the hip. Arthritis Rheum. 1991 May;34(5):505–514. [PubMed]
  • 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 Dec;15(12):1833–1840. [PubMed]
  • Pelletier JP, Yaron M, Haraoui B, Cohen P, Nahir MA, Choquette D, Wigler I, Rosner IA, Beaulieu AD. Efficacy and safety of diacerein in osteoarthritis of the knee: a double-blind, placebo-controlled trial. The Diacerein Study Group. Arthritis Rheum. 2000 Oct;43(10):2339–2348. [PubMed]
  • Altman RD. Review of ibuprofen for osteoarthritis. Am J Med. 1984 Jul 13;77(1A):10–18. [PubMed]
  • Williams HJ, Ward JR, Egger MJ, Neuner R, Brooks RH, Clegg DO, Field EH, Skosey JL, Alarcón GS, Willkens RF, et al. Comparison of naproxen and acetaminophen in a two-year study of treatment of osteoarthritis of the knee. Arthritis Rheum. 1993 Sep;36(9):1196–1206. [PubMed]
  • March L, Irwig L, Schwarz J, Simpson J, Chock C, Brooks P. n of 1 trials comparing a non-steroidal anti-inflammatory drug with paracetamol in osteoarthritis. BMJ. 1994 Oct 22;309(6961):1041–1046. [PMC free article] [PubMed]
  • Davies GM, Watson DJ, Bellamy N. Comparison of the responsiveness and relative effect size of the western Ontario and McMaster Universities Osteoarthritis Index and the short-form Medical Outcomes Study Survey in a randomized, clinical trial of osteoarthritis patients. Arthritis Care Res. 1999 Jun;12(3):172–179. [PubMed]
  • Fries JF, Spitz PW, Young DY. The dimensions of health outcomes: the health assessment questionnaire, disability and pain scales. J Rheumatol. 1982 Sep-Oct;9(5):789–793. [PubMed]
  • Bradley JD, Brandt KD, Katz BP, Kalasinski LA, Ryan SI. Treatment of knee osteoarthritis: relationship of clinical features of joint inflammation to the response to a nonsteroidal antiinflammatory drug or pure analgesic. J Rheumatol. 1992 Dec;19(12):1950–1954. [PubMed]
  • Moskowitz RW. Osteoarthritis: simple analgesics versus nonsteroidal antiinflammatory drugs. J Rheumatol. 2001 May;28(5):932–934. [PubMed]
  • Pincus T, Swearingen C, Cummins P, Callahan LF. Preference for nonsteroidal antiinflammatory drugs versus acetaminophen and concomitant use of both types of drugs in patients with osteoarthritis. J Rheumatol. 2000 Apr;27(4):1020–1027. [PubMed]
  • Wolfe F, Zhao S, Lane N. Preference for nonsteroidal antiinflammatory drugs over acetaminophen by rheumatic disease patients: a survey of 1,799 patients with osteoarthritis, rheumatoid arthritis, and fibromyalgia. Arthritis Rheum. 2000 Feb;43(2):378–385. [PubMed]
  • Cicuttini FM, Spector TD. Osteoarthritis in the aged. Epidemiological issues and optimal management. Drugs Aging. 1995 May;6(5):409–420. [PubMed]
  • Le Parc JM, Van Ganse E, Moore N, Wall R, Schneid H, Verrière F. Comparative tolerability of paracetamol, aspirin and ibuprofen for short-term analgesia in patients with musculoskeletal conditions: results in 4291 patients. Clin Rheumatol. 2002 Feb;21(1):28–31. [PubMed]
  • Doyle G, Furey S, Berlin R, Cooper S, Jayawardena S, Ashraf E, Baird L. Gastrointestinal safety and tolerance of ibuprofen at maximum over-the-counter dose. Aliment Pharmacol Ther. 1999 Jul;13(7):897–906. [PubMed]
  • Hochberg MC, Altman RD, Brandt KD, Clark BM, Dieppe PA, Griffin MR, Moskowitz RW, Schnitzer TJ. Guidelines for the medical management of osteoarthritis. Part I. Osteoarthritis of the hip. American College of Rheumatology. Arthritis Rheum. 1995 Nov;38(11):1535–1540. [PubMed]
  • Hochberg MC, Altman RD, Brandt KD, Clark BM, Dieppe PA, Griffin MR, Moskowitz RW, Schnitzer TJ. Guidelines for the medical management of osteoarthritis. Part II. Osteoarthritis of the knee. American College of Rheumatology. Arthritis Rheum. 1995 Nov;38(11):1541–1546. [PubMed]

Figures and Tables

Figure 1
 Disposition of the patients. *Patients excluded because of missing values for pain assessment on VAS scale: 3 in the ibuprofen group, 2 in the paracetamol group; †patients excluded because pain assessment values were not available or ...
Figure 2
 Evolution of the pain intensity during 6 hours after the first dose. *p<0.05, Student's t test.
Figure 3
 Evolution of the pain intensity over 14 days of treatment assessed by a VAS. *p<0.05; **p<0.005, Student's t test.
Figure 4
 Evolution of the pain intensity during 14 days of treatment assessed by a four point verbal scale. Ibuprofen versus paracetamol: p<0.001, Wilcoxon test.
Figure 5
 Global efficacy assessment at the end of the study using a four point verbal scale. Ibuprofen versus paracetamol: p = 0.001, Wilcoxon test.

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