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. 2004 Sep;63(9):1028–1034. doi: 10.1136/ard.2003.011403

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

F Boureau 1, H Schneid 1, N Zeghari 1, R Wall 1, P Bourgeois 1
PMCID: PMC1755112  PMID: 15308513

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.

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Figure 1.

Figure 1

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 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 missing (9 in the ibuprofen group, 12 in the paracetamol group), a second drug intake started before the end of the first 6 hours (3 in the ibuprofen group, 5 in the paracetamol group), study treatment started before the first pain evaluation (4 in the ibuprofen group, 1 in the paracetamol group), forbidden concomitant treatment started (2 in the ibuprofen group); some patients had more than one reason.

Figure 2.

Figure 2

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 Evolution of the pain intensity during 6 hours after the first dose. *p<0.05, Student's t test.

Figure 3.

Figure 3

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 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.

Figure 4

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 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.

Figure 5

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 Global efficacy assessment at the end of the study using a four point verbal scale. Ibuprofen versus paracetamol: p = 0.001, Wilcoxon test.

Selected References

These references are in PubMed. This may not be the complete list of references from this article.

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