Objective To examine concordance between treatment effects in animal experiments and clinical trials. Study design Systematic review. Data sources Medline, Embase, SIGLE, NTIS, Science Citation Index, CAB, BIOSIS. Study selection Animal studies for interventions with unambiguous evidence of a treatment effect (benefit or harm) in clinical trials: head injury, antifibrinolytics in haemorrhage, thrombolysis in acute ischaemic stroke, tirilazad in acute ischaemic stroke, antenatal corticosteroids to prevent neonatal respiratory distress syndrome, and bisphosphonates to treat osteoporosis. Review methods Data were extracted on study design, allocation concealment, number of randomised animals, type of model, intervention, and outcome. Results Corticosteroids did not show any benefit in clinical trials of treatment for head injury but did show a benefit in animal models (pooled odds ratio for adverse functional outcome 0.58, 95% confidence interval 0.41 to 0.83). Antifibrinolytics reduced bleeding in clinical trials but the data were inconclusive in animal models. Thrombolysis improved outcome in patients with ischaemic stroke. In animal models, tissue plasminogen activator reduced infarct volume by 24% (95% confidence interval 20% to 28%) and improved neurobehavioural scores by 23% (17% to 29%). Tirilazad was associated with a worse outcome in patients with ischaemic stroke. In animal models, tirilazad reduced infarct volume by 29% (21% to 37%) and improved neurobehavioural scores by 48% (29% to 67%). Antenatal corticosteroids reduced respiratory distress and mortality in neonates whereas in animal models respiratory distress was reduced but the effect on mortality was inconclusive (odds ratio 4.2, 95% confidence interval 0.85 to 20.9). Bisphosphonates increased bone mineral density in patients with osteoporosis. In animal models the bisphosphonate alendronate increased bone mineral density compared with placebo by 11.0% (95% confidence interval 9.2% to 12.9%) in the combined results for the hip region. The corresponding treatment effect in the lumbar spine was 8.5% (5.8% to 11.2%) and in the combined results for the forearms (baboons only) was 1.7% ( − 1.4% to 4.7%). Conclusions Discordance between animal and human studies may be due to bias or to the failure of animal models to mimic clinical disease adequately.

Objective To evaluate factors predisposing women to chronic and recurrent pelvic pain. Design, data sources, and methods Systematic review of relevant studies without language restrictions identified through Medline, Embase, PsycINFO, Cochrane Library. SCISEARCH, conference papers, and bibliographies of retrieved primary and review articles. Two reviewers independently extracted data on study characteristics, quality, and results. Exposure to risk factors was compared between women with and without pelvic pain. Results were pooled within subgroups defined by type of pain and risk factors. Results There were 122 studies (in 111 articles) of which 63 (in 64 286 women) evaluated 54 risk factors for dysmenorrhoea, 19 (in 18 601 women) evaluated 14 risk factors for dyspareunia, and 40 (in 12 040 women) evaluated 48 factors for non-cyclical pelvic pain. Age < 30 years, low body mass index, smoking, earlier menarche ( < 12 years), longer cycles, heavy menstrual flow, nulliparity, premenstrual syndrome, sterilisation, clinically suspected pelvic inflammatory disease, sexual abuse, and psychological symptoms were associated with dysmenorrhoea. Younger age at first childbirth, exercise, and oral contraceptives were negatively associated with dysmenorrhoea. Menopause, pelvic inflammatory disease, sexual abuse, anxiety, and depression were associated with dyspareunia. Drug or alcohol abuse, miscarriage, heavy menstrual flow, pelvic inflammatory disease, previous caesarean section, pelvic pathology, abuse, and psychological comorbidity were associated with an increased risk of non-cyclical pelvic pain. Conclusion Several gynaecological and psychosocial factors are strongly associated with chronic pelvic pain. Randomised controlled trials of interventions targeting these potentially modifiable factors are needed to assess their clinical relevance in chronic pelvic pain.

Background Episiotomy is done to prevent severe perineal tears, but its routine use has been questioned. The relative effects of midline compared with midlateral episiotomy are unclear. Objectives The objective of this review was to assess the effects of restrictive use of episiotomy compared with routine episiotomy during vaginal birth. Search methods We searched the Cochrane Pregnancy and Childbirth Group’s Trials Register (March 2008). Selection criteria Randomized trials comparing restrictive use of episiotomy with routine use of episiotomy; restrictive use of mediolateral episiotomy versus routine mediolateral episiotomy; restrictive use of midline episiotomy versus routine midline episiotomy; and use of midline episiotomy versus mediolateral episiotomy. Data collection and analysis The two review authors independently assessed trial quality and extracted the data. Main results We included eight studies (5541 women). In the routine episiotomy group, 75.15% (2035/2708) of women had episiotomies, while the rate in the restrictive episiotomy group was 28.40% (776/2733). Compared with routine use, restrictive episiotomy resulted in less severe perineal trauma (relative risk (RR) 0.67, 95% confidence interval (CI) 0.49 to 0.91), less suturing (RR 0.71, 95% CI 0.61 to 0.81) and fewer healing complications (RR 0.69, 95% CI 0.56 to 0.85). Restrictive episiotomy was associated with more anterior perineal trauma (RR 1.84, 95% CI 1.61 to 2.10). There was no difference in severe vaginal/perineal trauma (RR 0.92, 95% CI 0.72 to 1.18); dyspareunia (RR 1.02, 95% CI 0.90 to 1.16); urinary incontinence (RR 0.98, 95% CI 0.79 to 1.20) or several pain measures. Results for restrictive versus routine mediolateral versus midline episiotomy were similar to the overall comparison. Authors’ conclusions Restrictive episiotomy policies appear to have a number of benefits compared to policies based on routine episiotomy. There is less posterior perineal trauma, less suturing and fewer complications, no difference for most pain measures and severe vaginal or perineal trauma, but there was an increased risk of anterior perineal trauma with restrictive episiotomy.

EBM CONNECT Collaboration.

No abstract