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R Andrew Moore

Publications and source records attributed to R Andrew Moore.

29 records · Page 2Linked to original sources
PubMed2003

Single-dose oral naproxen for acute postoperative pain: a quantitative systematic review.

BACKGROUND: Naproxen and naproxen sodium are non-steroidal anti-inflammatory drugs used in a variety of painful conditions, including the treatment of postoperative pain. This review aims to assess the efficacy, safety and duration of action of a single oral dose of naproxen/naproxen sodium for moderate to severe acute postoperative pain in adults, compared with placebo. METHODS: The Cochrane Library (issue 4 2002), EMBASE, PubMed, MEDLINE and an in-house database were searched for randomised, double blind, placebo controlled trials of a single dose of orally administered naproxen or naproxen sodium in adults with acute postoperative pain. Pain relief or pain intensity data were extracted and converted into dichotomous information to give the number of patients with at least 50% pain relief over 4 to 6 hours. Relative benefit and number-needed-to-treat were then calculated. The percentage of patients with any adverse event, number-needed-to-harm, and time to remedication were also calculated. RESULTS: Ten trials with 996 patients in met the inclusion criteria. Six trials compared naproxen sodium 550 mg (252 patients) with placebo (248 patients); the NNT for at least 50% pain relief over six hours was 2.6 (95% confidence interval 2.2 to 3.2). There was no significant difference between the number of patients experiencing any adverse event on treatment compared with placebo. Weighted mean time to remedication was 7.6 hours for naproxen sodium 550 mg (206 patients) and 2.6 hours for placebo (205 patients). Four other trials used lower doses. CONCLUSION: A single oral dose of naproxen sodium 550 mg is an effective analgesic in the treatment of acute postoperative pain. A low incidence of adverse events was found, although these were not reported consistently.

Journal Article↗
PubMed2003

Oral valdecoxib and injected parecoxib for acute postoperative pain: a quantitative systematic review.

BACKGROUND: Clinical trials suggest that cyclo-oxygenase-2 specific inhibitors (coxibs) are an effective treatment for acute postoperative pain. The aims of this systematic review were to examine the evidence for oral valdecoxib and injected parecoxib, and quantify efficacy and adverse effects. METHODS: Information from randomized, double-blind studies in acute postoperative pain was sought. The area under the pain relief versus time curve over four to six hours was dichotomized using validated equations to derive the proportion of patients with treatment and placebo with at least 50% pain relief over four to six hours and calculate the number-needed-to-treat (NNT). Information on duration of analgesia and adverse events was also collected. RESULTS: The NNT for one patient to experience at least 50% relief over six hours following a single oral dose of valdecoxib 20 mg and 40 mg was 1.7 (1.4 to 2.0) and 1.6 (1.4 to 1.8) respectively. The NNT for one patient to have at least 50% relief over four to six hours with parecoxib 20 mg IV and 40 mg IV was 3.0 (2.3 to 4.1) and 2.3 (2.0 to 2.6) respectively. Mean time to remedication (weighted by trial size) was >24 hours with valdecoxib 40 mg, 8.7 hours with parecoxib 40 mg IV and 1.7 to 1.8 hours with placebo. There were no statistical differences between treatment and placebo for any adverse effect. CONCLUSION: Both oral valdecoxib and injected parecoxib are effective treatments for acute postoperative pain.

Journal Article↗
PubMed2002

Finasteride in the treatment of clinical benign prostatic hyperplasia: a systematic review of randomised trials.

BACKGROUND: Benign prostatic hyperplasia affects older men. This systematic review determined efficacy and adverse effects of finasteride. REVIEW METHODS: PubMed, the Cochrane Library, reference lists of reports, and reviews were searched for randomised, double-blind trials of finasteride in benign prostatic hyperplasia. Outcomes included symptom score, urinary flow rate, prostate volume, discontinuation, and adverse effects. Relative risk and NNT or NNH were calculated for dichotomous data. Sensitivity analyses assessed influences of baseline symptom severity, initial prostate volume, a dominating trial, and previous interventions. RESULTS: Three trials had active controls and 19 had placebo. In placebo-controlled trials, 8820 patients received finasteride 5 mg and 5909 placebo over 3-48 months. Over 48 months finasteride produced greater improvements in total symptom score, maximum urinary flow rate, and prostate volume. Significantly more sexual dysfunction, impotence, ejaculation disorder and decreased libido occurred with finasteride at 12 months; the NNH for any sexual dysfunction at 12 months was 14. Significantly fewer men treated with finasteride experienced acute retention or had surgery at 24 or 48 months than with placebo; at 12 months the NNT was 49 (31 to 112) to avoid one acute urinary retention and 31 (21 to 61) to avoid one surgery. Sensitivity analyses showed benefit with finasteride 5 mg to be constant irrespective of the initial prostate volume. CONCLUSIONS: Information from many patients in studies of high quality showed beneficial effects of finasteride in terms of symptoms, flow rate and prostate volume. More utility would result if patient centred outcomes were reported in dichotomous form.

Enzyme Inhibitors↗
PubMed2002

Ibuprofen 400 mg is effective in women, and women are well represented in trials.

BACKGROUND: A recent article in the New Scientist argued that women were under-represented in clinical trials which, until now, had masked the finding that ibuprofen 400 mg was ineffective in women. METHODS: Meta-analysis of randomised, double-blind placebo-controlled trials of ibuprofen 400 mg in acute pain, and use of individual patient information were planned to test the hypothesis that ibuprofen is ineffective in women. For each trial the proportion of women participating, the number of patients with at least 50% pain relief and the overall event rate for ibuprofen 400 mg and placebo was calculated. For each patient percentage pain relief was calculated, and the numbers of women and men achieving at least 50% pain relief used to calculate number-needed-to-treat (NNT) for ibuprofen 400 mg compared to placebo. RESULTS: Thirty-seven included trials had 3,577 patients, 67% of whom were women. The proportion with at least 50% pain relief was unaffected by how many women were included. In an analysis of 678 individual patients the proportion of women and men with at least 50% pain relief was the same, NNT 3.4 (2.6 to 4.6) and 2.5 (2.0 to 3.3) respectively. CONCLUSION: There is no clinically meaningful difference in the efficacy of ibuprofen 400 mg between men and women experiencing moderate to severe postoperative pain and women were well represented.

Journal Article↗
PubMed2002

Single-dose rofecoxib for acute postoperative pain in adults: a quantitative systematic review.

BACKGROUND: Rofecoxib is a cyclo-oxygenase 2 selective inhibitor. This systematic review of rofecoxib in acute pain examined studies in adults of analgesic efficacy over six hours, the amount and quality of the evidence on extended duration of analgesia, and the quality and quantity of evidence on adverse events. METHODS: Cochrane Library (issue 4, 2001), Biological Abstracts (March 2002), MEDLINE (March 2002) and PubMed (March 2002) were searched using rofecoxib as a free text term. The area under the pain relief versus time curve was dichotomized using validated equations to derive the proportion of patients on rofecoxib 50 mg or placebo with at least 50% pain relief over six hours. This was used to calculate the number needed to treat for at least 50% pain relief over six hours for rofecoxib compared with placebo. Information on duration of analgesia and adverse events was also collected. RESULTS: Five included trials investigated 1,118 patients, of whom 211 received placebo and 464 received rofecoxib 50 mg. The NNT for rofecoxib 50 mg was 2.3 (95% confidence interval 2.0 to 2.6). The weighted mean remedication time was 1.9 hours for placebo (126 patients), 7.4 hours for ibuprofen 400 mg (97 patients) and 13.6 hours for rofecoxib 50 mg (322 patients). CONCLUSION: Rofecoxib at 2-4 times the standard daily dose for chronic pain is an effective single dose oral analgesic in acute pain. Limitations in trial reporting constrain conclusions about longer duration of analgesia and adverse event profile.

Journal Article↗
PubMed2002

Pooling data for number needed to treat: no problems for apples.

OBJECTIVE: To consider the problem of the calculation of number needed to treat (NNT) derived from risk difference, odds ratio, and raw pooled events shown to give different results using data from a review of nursing interventions for smoking cessation. DISCUSSION: A review of nursing interventions for smoking cessation from the Cochrane Library provided different values for NNT depending on how NNTs were calculated. The Cochrane review was evaluated for clinical heterogeneity using L'Abbé plot and subsequent analysis by secondary and primary care settings.Three studies in primary care had low (4%) baseline quit rates, and nursing interventions were without effect. Seven trials in hospital settings with patients after cardiac surgery, or heart attack, or even with cancer, had high baseline quit rates (25%). Nursing intervention to stop smoking in the hospital setting was effective, with an NNT of 14 (95% confidence interval 9 to 26). The assumptions involved in using risk difference and odds ratio scales for calculating NNTs are discussed. SUMMARY: Clinical common sense and concentration on raw data helps to detect clinical heterogeneity. Once robust statistical tests have told us that an intervention works, we then need to know how well it works. The number needed to treat or harm is just one way of showing that, and when used sensibly can be a useful tool.

Bias↗
PubMed2002

Combination analgesic efficacy: individual patient data meta-analysis of single-dose oral tramadol plus acetaminophen in acute postoperative pain.

The primary aims of this study were to assess the analgesic efficacy and adverse effects of single-dose oral tramadol plus acetaminophen in acute postoperative pain and to use meta-analysis to demonstrate the efficacy of the combination drug compared with its components. Individual patient data from seven randomized, double blind, placebo controlled trials of tramadol plus acetaminophen were supplied for analysis by the R.W. Johnson Pharmaceutical Research Institute, Raritan, New Jersey, USA. All trials used identical methods and assessed single-dose oral tramadol (75 mg or 112.5 mg) plus acetaminophen (650 mg or 975 mg) in adult patients with moderate or severe postoperative pain. Summed pain intensity and pain relief data over six and eight hours and global evaluations of treatment effect after eight hours were extracted. Number-needed-to-treat (NNT) for one patient to obtain at least 50% pain relief was calculated. NNTs derived from pain relief data were compared with those derived from pain intensity data and global evaluations. Information on adverse effects was collected. Combination analgesics (tramadol plus acetaminophen) had significantly lower (better) NNTs than the components alone, and comparable efficacy to ibuprofen 400 mg. This could be shown for dental but not postsurgical pain, because more patients were available for the former. Adverse effects were similar for the combination drugs and the opioid component alone. Common adverse effects were dizziness, drowsiness, nausea, vomiting, and headache. In sum, this meta-analysis demonstrated analgesic superiority of the combination drug over its components, without additional toxicity.

Acetaminophen↗
PubMedDate not supplied

Evaluating analgesia: the challenges.

Decisions must be made when assigning analgesics, and such decisions involve comparing efficacy and adverse effects. The rules for assessing efficacy by systematic review and by large clinical trials are becoming clearer all the time. It is known, for instance, that trials that are not randomized, are not double-blind, or are too small will exaggerate efficacy. These rules are relatively easy to apply to drug interventions, although there are glaring exceptions, such as in early intra-articular morphine studies. The rules may also be less easy to apply for analgesics available over-the-counter (OTC) if the drugs have not been studied in trials of high quality or if the OTC-recommended doses are below the doses studied in the trials. When there are at least 500 patients studied in trials of high quality, credible efficacy estimates for effective drugs can be derived; more patients are needed for less effective drugs. The number needed to treat and the number needed to harm can be used to compare the efficacy and safety of a treatment with placebo or with other treatments. A recent meta-analysis comparing the number needed to treat for paracetamol 1000 mg and paracetamol 600-650 mg in moderate to severe postoperative pain indicated that paracetamol 1000 mg is likely to be more effective than lower doses. Large data sets allow investigation into dose response, gender differences, and whether particular drugs work better for particular painful conditions. Purists would argue that databases of patient experience should not be used for these efficacy analyses. The rules on how to collect and use evidence on adverse effects are less clearly formulated than they are for efficacy. For safety at or above therapeutic dose, the rules of evidence-gathering are necessarily different, and randomized trials are rarely an adequate or sufficient source. Databases of patient experience, with all the caveats, may be the most reliable data from which to work.

Acetaminophen↗