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Non-prescription (OTC) oral analgesics for acute pain - an overview of Cochrane reviews

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Moore, R Andrew, Wiffen, Philip J, Derry, Sheena, Maguire, Terry, Roy, Yvonne M, Tyrrell, Laila·2015·Cochrane Database of Systematic Reviews
DOI 10.1002/14651858.cd010794.pub2PMC PMC6485506
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Abstract

BACKGROUND: Non-prescription (over-the-counter, or OTC) analgesics (painkillers) are used frequently. They are available in various brands, package sizes, formulations, and dose. They can be used for a range of different types of pain, but this overview reports on how well they work for acute pain (pain of short duration, usually with rapid onset). Thirty-nine Cochrane reviews of randomised trials have examined the analgesic efficacy of individual drug interventions in acute postoperative pain. OBJECTIVES: To examine published Cochrane reviews for information about the efficacy of pain medicines available without prescription using data from acute postoperative pain. METHODS: We identified OTC analgesics available in the UK, Australia, Canada, and the USA by examining online pharmacy websites. We also included some analgesics (diclofenac potassium, dexketoprofen, dipyrone) of importance in parts of the world, but not currently available in these jurisdictions.We identified systematic reviews by searching the Cochrane Database of Systematic Reviews (CDSR) on The Cochrane Library through a simple search strategy. All reviews were overseen by a single review group, had a standard title, and had as their primary outcome numbers of participants with at least 50% pain relief over four to six hours compared with placebo. From individual reviews we extracted the number needed to treat for an additional beneficial outcome (NNT) for this outcome for each drug/dose combination, and also calculated the success rate to achieve at least 50% of maximum pain relief. We also examined the number of participants experiencing any adverse event, and whether the incidence was different from placebo. MAIN RESULTS: We found information on 21 different OTC analgesic drugs, doses, and formulations, using information from 10 Cochrane reviews, supplemented by information from one non-Cochrane review with additional information on ibuprofen formulations (high quality evidence). The lowest (best) NNT values were for combinations of ibuprofen plus paracetamol, with NNT values below 2. Analgesics with values close to 2 included fast acting formulations of ibuprofen 200 mg and 400 mg, ibuprofen 200 mg plus caffeine 100 mg, and diclofenac potassium 50 mg. Combinations of ibuprofen plus paracetamol had success rates of almost 70%, with dipyrone 500 mg, fast acting ibuprofen formulations 200 mg and 400 mg, ibuprofen 200 mg plus caffeine 100 mg, and diclofenac potassium 50 mg having success rates above 50%. Paracetamol and aspirin at various doses had NNT values of 3 or above, and success rates of 11% to 43%. We found no information on many of the commonly available low dose codeine combinations.The proportion of participants experiencing an adverse event were generally not different from placebo, except for aspirin 1000 mg and (barely) ibuprofen 200 mg plus caffeine 100 mg. For ibuprofen plus paracetamol, adverse event rates were lower than with placebo. AUTHORS' CONCLUSIONS: There is a body of reliable evidence about the efficacy of some of the most commonly available drugs and doses widely available without prescription. The postoperative pain model is predominantly pain after third molar extraction, which is used as the industry model for everyday pain. The proportion of people with acute pain who get good pain relief with any of them ranges from around 70% at best to less than 20% at worst; low doses of some drugs in fast acting formulations were among the best. Adverse events were generally no different from placebo. Consumers can make an informed choice based on this knowledge, together with availability and price. Headache and migraine were not included in this overview.

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  • Both diclofenac and ibuprofen are over-the-counter medicines in the UK, requiring no prescription.

    “Both diclofenac and ibuprofen are over-the-counter medicines in the UK, requiring no prescription (Moore et al., 2015)”

    From Occurrence of emerging and persistent organic pollutants in the rivers Cam, Ouse and Thames, UK (2025) · cites this paper as Moore et al., 2015

    The Methods section says diclofenac potassium was available over the counter in the UK only until early 2015, when its market authorisation was withdrawn. Appendix 1 lists ibuprofen among UK non-prescription analgesics, but labels diclofenac products as ‘not now available in the UK.’ The paper therefore contradicts the claim that both were available without prescription in the UK. (LLM, conf=0.88)

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  • A Cochrane review concluded that the rate of adverse events was similar between higher and lower single doses of paracetamol.

    “In terms of safety, a Cochrane review concluded that the rate of adverse events was similar between the higher and lower single doses of paracetamol.84”

    From An Updated Review on the Metabolite (AM404)-Mediated Central Mechanism of Action of Paracetamol (Acetaminophen): Experimental Evidence and Potential Clinical Impact (2023) · cites this paper as [84]

    Appendix 5 (p. 28) reports similar adverse-event rates for paracetamol 600/650 mg (16%) and 975/1000 mg (18%), but a lower rate for 500 mg (7%). The adverse-events discussion compares single doses with placebo, not higher with lower paracetamol doses, so it does not make the broad conclusion attributed to it. (LLM, conf=0.82)

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Authors
Moore, R. A., Wiffen, P. J., Derry, S., Maguire, T., Roy, Y. M., & Tyrrell, L.
Affiliations
  • Plymouth UK
  • Thame UK
  • Oxford Oxfordshire UK
  • Queen's University Belfast (GB)
  • Churchill Hospital (GB)
ORCID
Venue
Cochrane Database of Systematic Reviews
Publisher
Wiley
Published
2015-11-04
Issue
11
Pages
CD010794-CD010794
ISSN
  • 1361-6137 (ISSN-L)
  • 1465-1858
DOI
10.1002/14651858.cd010794.pub2
PMC
PMC6485506
OpenAlex
W2142451706
Cited by
174
References
94
Citations by year
2026: 4 · 2025: 16 · 2024: 13 · 2023: 17 · 2022: 25 · 2021: 36 · 2020: 13 · 2019: 12 · 2018: 18 · 2017: 10 · 2016: 6 · 2015: 1 · 2014: 1
FWCI
2.23
Type
journal article
Language
en
Open access
Locations
  • Cochrane Database of Systematic Reviews (publishedVersion)
  • PubMed Central (publishedVersion)
  • PubMed (publishedVersion)
Funders
  • National Institute for Health and Care Research
  • National Institutes of Health
Topics
  • Health Sciences › Medicine › Surgery › Anesthesia and Pain Management
  • Health Sciences › Medicine › Anesthesiology and Pain Medicine › Pain Management and Opioid Use
  • Health Sciences › Medicine › Surgery › Nausea and vomiting management
Keywords
over-the-counter analgesics, acute pain, postoperative pain, ibuprofen, paracetamol, diclofenac potassium, dipyrone, caffeine, analgesic efficacy, adverse events, number needed to treat, analgesic combination, placebo comparison, diclofenac sodium, dexketoprofen
MeSH terms
Administration, Oral, Analgesics, Nonprescription Drugs, Humans, Review Literature as Topic, Randomized Controlled Trials as Topic, Acute Pain, Numbers Needed To Treat

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