Biomedical subjects

Jayne E Edwards

Publications and source records attributed to Jayne E Edwards.

21 records · Page 2Linked to original sources

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↗

PubMed1999

Oral aspirin in postoperative pain: a quantitative systematic review.

OBJECTIVES: A systematic review of the analgesic efficacy and adverse effects of single-dose aspirin compared with placebo in postoperative pain. DESIGN: Published studies were identified from systematic searching of bibliographic databases and reference lists of retrieved reports. Summed pain intensity and pain relief data were extracted and converted into dichotomous information to yield the number of patients with at least 50% pain relief. This was used to calculate the relative benefit and number-needed-to-treat for one patient to achieve at least 50% pain relief. For adverse effects, relative risk and number-needed-to-harm were calculated. Sensitivity analyses were planned to test the impact of different pain models, pain measurements, sample sizes, quality of study design, and study duration on the results. RESULTS: Seventy-two randomized single-dose trials met our inclusion criteria, with 3253 patients given aspirin, and 3297 placebo. Significant benefit of aspirin over placebo was shown for aspirin 600/650 mg, 1000 mg and 1200 mg, with numbers-needed-to-treat for at least 50% pain relief of 4.4 (4.0-4.9), 4.0 (3.2-5.4) and 2.4 (1.9-3.2) respectively. Single-dose aspirin 600/650 mg produced significantly more drowsiness and gastric irritation than placebo, with numbers-needed-to-harm of 28 (19-52) and 38 (22-174) respectively. Type of pain model, pain measurement, sample size, quality of study design, and study duration had no significant impact on the results. CONCLUSIONS: There was a clear dose-response for pain relief with aspirin, even though these were single dose studies. Adverse effects, drowsiness and gastric irritation were also evident in the single dose studies. The pain relief achieved with aspirin was very similar milligram for milligram to that seen with paracetamol.

Administration, Oral↗

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↗