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Quantitive Systematic Review of Topically Applied Non-Steroidal Anti-Inflammatory Drugs R a Moore, M R Tramèr, D Carroll, P J Wiffen, H J Mcquay

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Quantitive Systematic Review of Topically Applied Non-Steroidal Anti-Inflammatory Drugs R a Moore, M R Tramèr, D Carroll, P J Wiffen, H J Mcquay Papers BMJ: first published as 10.1136/bmj.316.7128.333 on 31 January 1998. Downloaded from Quantitive systematic review of topically applied non-steroidal anti-inflammatory drugs R A Moore, M R Tramèr, D Carroll, P J Wiffen, H J McQuay Abstract Despite licensed status, there is scepticism that topical Pain Research and Nuffield non-steroidal anti-inflammatory drugs have any action Department of Objective: To review the effectiveness and safety of 23 other than as rubefacients. This systematic review Anaesthetics, topical non-steroidal anti-inflammatory drugs in acute was undertaken to examine the evidence that topical University of Oxford, The and chronic pain conditions. non-steroidal anti-inflammatory drugs are effective Design: Quantitive systematic review of randomised Churchill, Oxford and safe and to determine whether there is evidence Radcliffe Hospital, controlled trials. for differences between topical preparations. Headington, Data sources: 86 trials involving 10 160 patients. Oxford OX3 7LJ Main outcome measures: Measures of treatment R A Moore, Methods consultant biochemist success approximating at least 50% reduction in pain, M R Tramèr, local and systemic adverse effects. Analysis at 1 week Criteria for inclusion research fellow for acute and 2 weeks for chronic conditions with We sought reports of randomised controlled trials of D Carroll, relative benefit and number needed to treat. topical non-steroidal anti-inflammatory drugs in which senior research nurse P J Wiffen, Results: In acute pain conditions (soft tissue trauma, pain was an outcome and included those that regional strains, and sprains) placebo controlled trials had a compared topical non-steroidal anti-inflammatory pharmaceutical relative benefit of 1.7 (1.5 to 1.9), the number needed drug(s) with placebo, with another topical non- adviser to treat was 3.9 (3.4 to 4.4). With analysis by drug (at HJMcQuay, steroidal, or with an oral non-steroidal. A number of clinical reader in pain least three trials), ketoprofen (number needed to treat different search strategies in Medline (1966 to Septem- relief 2.6), felbinac (3.0), ibuprofen (3.5), and piroxicam (4.2) ber 1996), Embase (1981 to September 1996), and the Correspondence to: 4 had significant efficacy. Benzydamine and Oxford Pain Relief Database (1950-94) were used to Dr Moore http://www.bmj.com/ indomethacin were no different from placebo. In locate reports by using individual drug name (generic andrew.moore@ pru.ox.ac.uk chronic pain conditions (osteoarthritis, tendinitis) and proprietary) together with the words “administra- placebo controlled trials had a relative benefit of 2.0 tion, topical,” “gel,” “ointment,” “aerosol,” “cream,” and BMJ 1998;316:333–8 (1.5 to 2.7); the number needed to treat was 3.1 (2.7 to combinations of these, without restriction to English 3.8). Small trials ( < 40 treated patients) exaggerated language. Additional reports were identified from effectiveness of topical non-steroidals by 33% in acute reference lists of retrieved reports and review articles. conditions but not in chronic conditions. There was Librarians and medical directors of the 12 pharmaceu- on 28 September 2021 by guest. Protected copyright. no relation between trial quality and treatment effect. tical companies in the United Kingdom identified as In both acute and chronic pain local and systemic marketing topical non-steroidal anti-inflammatory adverse events and withdrawal from the study related products were asked for reports of randomised to the drug had a low incidence and were no different controlled trials of their products, including any from placebo. unpublished reports. Abstracts were not sought. Conclusion: Topical non-steroidal anti-inflammatory Authors were not contacted. drugs are effective in relieving pain in acute and We included randomised controlled trials of chronic conditions. non-steroidal anti-inflammatory drugs with pain as an outcome in acute conditions (strains, sprains, sports Introduction injuries) or chronic conditions (arthritis, rheumatism). Those in vaginitis, oral or buccal conditions, thrombo- Some topical non-steroidal drugs are available without phlebitis, or experimental pain settings were not prescription and are widely advertised for acute and included. chronic painful conditions. There are 20-24 million Two of us screened reports to eliminate those with- prescriptions (predominantly oral) for non-steroidal out pain outcomes, that were definitely not ran- anti-inflammatory drugs in the United Kingdom each domised, or that were abstracts or reviews. Each report year, 5% of the NHS total prescriptions. The was read by all of the authors independently to assess attributable risk of going to hospital with gastrointesti- adequacy of randomisation and blinding and to assess nal problems is 1.3 to 1.6% annually for regular users description of withdrawals.5 The authors met to agree of oral non-steroidals.1 This raises the question of consensus. Reports that were described as randomised whether for some patients using oral non-steroidal were given 1 point, plus a further point if the method anti-inflammatory drugs is worse than the disease.2 of randomisation was described and adequate (such as BMJ VOLUME 316 31 JANUARY 1998 333 Papers Table 1 Summary of randomised studies of topical non-steroidal anti-inflammatory drugs in acute and chronic painful conditions Quality score (1-5) Trials No of trials* No of patients 12345 BMJ: first published as 10.1136/bmj.316.7128.333 on 31 January 1998. Downloaded from Acute pain: Placebo controlled 37 (34) 3556 1 6 10 13 7 Active controlled 24 (21) 4171 4 11 4 5 0 Chronic pain: Placebo controlled 13 (12) 1161 0 3 5 5 0 Active controlled 12 (9) 1272 2 5 3 2 0 *Numbers in parentheses are those reports with dichotomous outcomes. a table of random numbers). There had been an earlier assumed when P < 0.1. This was done by pooling all agreement that trials without randomisation or with an data, pooling data for an individual drug for which inadequate randomisation method (without conceal- there were at least three trials, and, for sensitivity analy- ment of treatment allocation) would be excluded from sis, by quality score and size of treatment group. We further analysis. Reports that were described as blinded used a fixed effect model8 for the (homogeneous) were given 1 point, plus a further point if the method adverse effect data. A significant improvement over of blinding was described and adequate (such as iden- control was assumed when the lower 95% confidence tical appearance of preparation). Reports that limit of the relative benefit was > 1. described the number of and reasons for withdrawals Number needed to treat (95% confidence interval) were given 1 point. Thus the minimum score of an was calculated for effect data.910The number needed to included randomised controlled trial was 1, the treat indicates how many patients with acute or chronic maximum score 5. pain have to be treated with topical non-steroidal for one of them to achieve a successful outcome who Data collected would not have done so with placebo. A significant dif- Information about treatment(s) and control(s), condi- ference between numbers needed to treat was assumed tion studied, number of patients randomised and ana- when confidence intervals did not overlap. Calcula- lysed, study design, observation periods, outcome tions were performed by using excel v 5.0 on a Macin- measures used for pain or global evaluation, results of tosh 8500/150. analgesic outcome, local skin irritation, systemic adverse effects, and study withdrawal due to adverse Results effects was taken from each report by authors meeting to concur. Searches found 86 reports (10 160 patients) that We defined a clinically relevant successful outcome. fulfilled inclusion criteria, 76 of which had dichoto- A hierarchy of measures was used for extraction which mous pain outcomes, including three unpublished reports with 1695 patients from a pharmaceutical approximated (in order of preference), firstly, patient http://www.bmj.com/ global judgment (excellent/good); secondly, pain on company. The number of reports, patients, and the dis- movement (no pain/slight pain); thirdly, spontaneous tribution of quality scores is divided by acute or chronic pain or pain at rest (no pain/slight pain); and finally, conditions, both placebo controlled and active control- physician global judgment (excellent/good) if defined led, in table 1. Over 75% of placebo controlled trials against a stated scale. had quality scores of 3 or more. Conversely 60% of Outcomes not in these categories were defined as active controlled trials had scores of 2 or less. Full “failures.” Only information that was available in details of trial design, outcome measures, and results dichotomous form was used for analysis. The denomi- can be found on the world wide web (http://www. on 28 September 2021 by guest. Protected copyright. nator was taken as the number of patients jr2.ox.ac.uk/Bandolier/painres/topic/topic.html). randomised—that is, an intention to treat analysis. For acute conditions we took the effectiveness measure Acute conditions nearest to 1 week after start of treatment and for Thirty seven reports of 40 placebo controlled trials of chronic conditions 2 weeks. Our prior hypotheses were topical non-steroidal anti-inflammatory drugs were that topical non-steroidals were no better than placebo found. The mean size of the group treated with topical and that there was no difference between them. drug was 47 patients (median 32). Studies were conducted in recent soft tissue injury, sprains, strains, Analysis or trauma. Dichotomous pain outcomes were available The scatter of success rates with topical non-steroidal from 1747 patients with active treatment and 1492 on against success rate with placebo6 was used as a graphi- placebo. An additional 24 reports of 24 trials cal means of exploring the consistency of efficacy and compared different topical non-steroidal anti- the homogeneity of the data.
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