The objectives of the study were (1) to carry out a systematic review to assess the analgesic efficacy and the adverse effects of acupuncture compared with placebo for back and neck pain and (2) to develop a new tool, the Oxford Pain Validity Scale (OPVS), to measure validity of findings from randomized controlled trials (RCTs), and to enable ranking of trial findings according to validity within qualitative reviews. Published RCTs (of acupuncture at both traditional and non-traditional points) were identified from systematic searching of bibliographic databases (e.g. MEDLINE) and reference lists of retrieved reports. Pain outcome data were extracted with preference given to standardized outcomes such as pain intensity. Information on adverse effects was also extracted. All included trials were scored using a five-item 0-16 point validity scale (OPVS). The individual RCTs were ranked according to their OPVS score to enable more weight to be placed on the trials of greater validity when drawing an overall conclusion about the efficacy of acupuncture for relieving neck and back pain. Statistical analyses were carried out on the OPVS scores to assess the relationship between trial finding (positive or negative) and validity. Thirteen RCTs met the inclusion criteria. Five trials concluded that acupuncture was effective, and eight concluded that it was not effective for relieving back or neck pain. There was no obvious difference between the findings of trials using traditional and non-traditional points. Using the new OPVS scale, the validity scores of the included trials ranged from 4 to 14. There was no significant relationship between OPVS score and trial finding (positive versus negative). Authors' conclusions did not always agree with their data. We drew our own conclusions (positive/negative) based on the data presented in the reports. Re-analysis using our conclusions showed a significant relationship between OPVS score and trial finding, with higher validity scores associated with negative findings. OPVS is a useful tool for assessing the validity of trials in qualitative reviews. With acupuncture for chronic back and neck pain, we found that the most valid trials tended to be negative. There is no convincing evidence for the analgesic efficacy of acupuncture for back or neck pain.
We wanted to compare the analgesic efficacy and adverse effects of pharmacological treatments for acute migraine through a systematic review of randomised controlled trials in patients with acute migraine pain of moderate to severe intensity. Trials were identified from systematic searching of bibliographic databases. For eletriptan information from all trials was supplied by Pfizer Inc. Outcomes sought were headache relief at 1 and 2h, patients pain free at 2h and sustained relief over 24h for treatments compared with placebo. Numbers-needed-to-treat (NNTs) were calculated, together with relative benefit. Information on adverse effects was also collected. Comparisons of relative efficacy used the same definition of headache, the same degree of pain at the start of treatment and the same definitions of outcomes, and always compared with placebo. Forty-eight publications reporting on 54 trials were included in the meta-analyses, with 79 placebo comparisons for the primary outcome of headache relief at 2h. Information on any outcome was available for nine oral medications, two intranasal medications and subcutaneous sumatriptan in 21,022 patients. For headache relief at 2h NNTs ranged from 2.0 for subcutaneous sumatriptan 6mg to 5.4 for naratriptan 2.5mg. For patients pain free at 2h NNTs ranged from 2.1 for subcutaneous sumatriptan 6mg to 8.6 for aspirin 900mg plus metoclopramide 10mg. For sustained relief over 24h NNTs ranged from 2.8 for eletriptan 80mg to 8.3 for rizatriptan 5mg. It was not possible to systematically review adverse effects data. Most interventions are effective. There is considerable information on relative efficacy for a number of outcomes.
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