Trial reportAnnals of the rheumatic diseases2011
A randomised controlled trial of ibuprofen, paracetamol or a combination tablet of ibuprofen/paracetamol in community-derived people with knee pain.
Trial report in Annals of the rheumatic diseases, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 55 papers, 4 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
55 citing papers in PubMed, 4 syntheses or guidelines pooled it, 162 citations in OpenAlex.
- Paracetamol Combination Therapy for Back Pain and Osteoarthritis: A Systematic Review and Meta-Analyses.Drugs · 2024Pooled it
- Paracetamol: not as safe as we thought? A systematic literature review of observational studies.Annals of the rheumatic diseases · 2016Pooled it
- Adverse events associated with single dose oral analgesics for acute postoperative pain in adults - an overview of Cochrane reviews.The Cochrane database of systematic reviews · 2015Pooled it
- A systematic review of the effect of paracetamol on blood pressure in hypertensive and non-hypertensive subjects.British journal of clinical pharmacology · 2013Pooled it
- Evaluation of Fixed-Dose Combinations of Ibuprofen and Acetaminophen in the Treatment of Postsurgical Dental Pain: A Pilot, Dose-Ranging, Randomized Study.Drugs in R&D · 2020Trial
- Bio-optimized Curcuma longa extract is efficient on knee osteoarthritis pain: a double-blind multicenter randomized placebo controlled three-arm study.Arthritis research & therapy · 2019Trial
- Hyaluronan derivative HYMOVIS® increases cartilage volume and type ii collagen turnover in osteoarhritic knee: data from MOKHA study.BMC musculoskeletal disorders · 2019Trial
- Effects of Lactobacillus coryniformis K8 CECT5711 on the immune response to influenza vaccination and the assessment of common respiratory symptoms in elderly subjects: a randomized controlled trial.European journal of nutrition · 2019Trial
- Responsiveness of SF-36 Health Survey and Patient Generated Index in people with chronic knee pain commenced on oral analgesia: analysis of data from a randomised controlled clinical trial.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2017Trial
- Combined glucosamine and chondroitin sulfate, once or three times daily, provides clinically relevant analgesia in knee osteoarthritis.Clinical rheumatology · 2015Trial
- Effectiveness and Safety of the Combination of Paracetamol 1000 mg and Ibuprofen 300 mg Versus Ibuprofen 600 mg in Monotherapy in Acute Low Back Pain: Results from a Phase IV Randomized Study.Journal of clinical medicine · 2026Article
- Article
- Incidence of Side Effects Associated With Acetaminophen in People Aged 65 Years or More: A Prospective Cohort Study Using Data From the Clinical Practice Research Datalink.Arthritis care & research · 2025Article
- Efficacy and Safety of Fixed-Dose Combinations for Pain in Older Adults.Drugs & aging · 2024Review
- Model-Based Meta-Analysis Supporting the Combination of Acetaminophen and Topical Diclofenac in Acute Pain: A Therapy for Mild-to-Moderate Osteoarthritis Pain?Pain and therapy · 2024Article
- Model-Based Assessment of the Liver Safety Profile of Acetaminophen to Support its Combination Use with Topical Diclofenac in Mild-to-Moderate Osteoarthritis Pain.Pain and therapy · 2024Article
- Therapeutic Efficacy of Medicinal Plants with Allopathic Medicine in Musculoskeletal Diseases.International journal of plant, animal and environmental sciences · 2024Article
- Parenteral Ready-to-Use Fixed-Dose Combinations Including NSAIDs with Paracetamol or Metamizole for Multimodal Analgesia-Approved Products and Challenges.Pharmaceuticals (Basel, Switzerland) · 2023Review
- Balancing the evidence: An update on analgesic use in rheumatic and musculoskeletal diseases.Frontiers in drug safety and regulation · 2023Review
- Review
Corrections and comments
- Commented on by
- Commented on by
- Commented on by[Not Available].2012
Authors and funding
7 authors at 4 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesTo compare the efficacy and safety of single versus combination non-prescription oral analgesics in community-derived people aged 40 years and older with chronic knee pain.
methodsA randomised, double-blind, four-arm, parallel-group, active controlled trial investigating short-term (day 10) and long-term (week 13) benefits and side-effects of four regimens, each taken three times a day: ibuprofen (400 mg); paracetamol (1000 mg); one fixed-dose combination tablet (ibuprofen 200 mg/paracetamol 500 mg); two fixed-dose combination tablets (ibuprofen 400 mg/paracetamol 1000 mg).
resultsThere were 892 participants (mean age 60.6, range 40-84 years); 63% had radiographic knee osteoarthritis and 85% fulfilled American College of Rheumatology criteria for osteoarthritis. At day 10, two combination tablets were superior to paracetamol (p<0.01) for pain relief (determined by mean change from baseline in WOMAC pain; n=786). At 13 weeks, significantly more participants taking one or two combination tablets rated their treatment as excellent/good compared with paracetamol (p=0.015, p=0.0002, respectively; n=615). The frequency of adverse events was comparable between groups. However, by 13 weeks, decreases in haemoglobin (≥1 g/dl) were observed in some participants in all groups. Twice as many participants taking two combination tablets had this decrease compared with those on monotherapy (p<0.001; paracetamol, 20.3%; ibuprofen, 19.6%; one or two combination tablets, 24.1%, 38.4%, respectively).
conclusionsIbuprofen/paracetamol combination analgesia, at non-prescription doses, confers modest short-term benefits for knee pain/osteoarthritis. However, in this population, paracetamol 3 g/day may cause similar degrees of blood loss as ibuprofen 1200 mg/day, and the combination of the two appears to be additive. Study no ISRCTN77199439.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.