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A randomised controlled trial of empowerment training for Chinese abused pregnant women in Hong Kong.

OBJECTIVE: To evaluate the effectiveness of an empowerment intervention in reducing intimate partner violence (IPV) and improving health status. DESIGN: Randomised controlled trial. SETTING: Antenatal clinic in a public hospital in Hong Kong. SAMPLE: One hundred and ten Chinese pregnant women with a history of abuse by their intimate partners. METHODS: Women were randomised to the experimental or control group. Experimental group women received empowerment training specially designed for Chinese abused pregnant women while the control group women received standard care for abused women. Data were collected at study entry and six weeks postnatal. MAIN OUTCOMES MEASURES: IPV [on the Conflict Tactics Scale (CTS)], health-related quality of life (SF-36) and postnatal depression [Edinburgh Postnatal Depression Scale (EPDS)]. RESULTS: Following the training, the experimental group had significantly higher physical functioning and had significantly improved role limitation due to physical problems and emotional problems. They also reported less psychological (but not sexual) abuse, minor (but not severe) physical violence and had significantly lower postnatal depression scores. However, they reported more bodily pain. CONCLUSION: An empowerment intervention specially designed for Chinese abused pregnant women was effective in reducing IPV and improving the health status of the women.

Adult↗

Comparison of the maternal experience and duration of labour in two upright delivery positions--a randomised controlled trial.

OBJECTIVE: To compare two upright delivery positions at the second stage of labour in healthy primiparous women with regard to duration of the second stage of labour and maternal experience. DESIGN: A randomised controlled trial. SETTING: A county hospital delivery ward. SAMPLE: Primiparous subjects (n=271) were randomly allocated to a kneeling (n=138) or a sitting (n=133) position during the second stage of labour. A postpartum questionnaire was answered by 264/271 women (97%) participating in the trial. METHODS: Primiparous subjects were randomised to a kneeling or sitting delivery position during second stage of labour. Analysis was performed on an intention-to-treat basis. MAIN OUTCOME MEASURE: Duration of the second stage of labour. RESULTS: A comparison of the duration of the second stage of labour (kneeling 48.5 minutes+/-27.6 SD, sitting 41 minutes+/-23.4 SD) revealed no significant difference between the groups. A sitting position during the second stage of labour was associated with a higher level of delivery pain (P<0.01), a more frequent perception of the second stage as being long (P=0.002), less comfort for giving birth (P=0.03) and more frequent feelings of vulnerability (P=0.05) and exposure (P=0.02). There were no significant differences in the frequency of sphincter ruptures although a sitting position was associated with a higher degree of postpartum perineal pain (P<0.001) (Table 3). CONCLUSIONS: Kneeling and sitting upright during the second stage of labour do not significantly differ from one another in duration of the second stage of labour. In healthy primiparous women, a kneeling position was associated with a more favourable maternal experience and less pain compared with a sitting position.

Attitude to Health↗

Textured or smooth implants for breast augmentation? Three year follow-up of a prospective randomised controlled trial.

Silicone breast implant surface texturing has been shown to reduce the short-term incidence of adverse (Baker III/IV) capsular contracture in augmentation mammaplasty in double-blind randomised controlled trials. It is, however, undetermined whether the textured surface merely delays the onset of severe contracture or its effect on capsular contraction is persistent. The current study reviewed, after three years, 49 of the 53 patients who had undergone subglandular breast augmentation mammaplasty in a randomised double-blind study with textured or smooth silicone gel-filled implants in 1989. The incidence of adverse capsular contracture was 59% for smooth implants and 11% for textured ones (P = 0.001; chi 2 = 10.60). Eight patients (31%) with smooth prostheses underwent breast implant exchange for severe capsular contracture between the one and three year assessments, compared with a revisional surgery rate of only 7.4% (2/27 patients) for the textured group (P < 0.04). These adverse capsular contracture and revisional breast implant surgery rates clearly demonstrate that the effect of textured implants in reducing capsular contracture in augmentation mammaplasty found at one year is maintained at three years, and suggest that it may be long lasting.

Breast Implants↗

Surgical stabilisation of the spine compared with a programme of intensive rehabilitation for the management of patients with chronic low back pain: cost utility analysis based on a randomised controlled trial.

OBJECTIVE: To determine whether, from a health provider and patient perspective, surgical stabilisation of the spine is cost effective when compared with an intensive programme of rehabilitation in patients with chronic low back pain. DESIGN: Economic evaluation alongside a pragmatic randomised controlled trial. SETTING: Secondary care. PARTICIPANTS: 349 patients randomised to surgery (n = 176) or to an intensive rehabilitation programme (n = 173) from 15 centres across the United Kingdom between June 1996 and February 2002. MAIN OUTCOME MEASURES: Costs related to back pain and incurred by the NHS and patients up to 24 months after randomisation. Return to paid employment and total hours worked. Patient utility as estimated by using the EuroQol EQ-5D questionnaire at several time points and used to calculate quality adjusted life years (QALYs). Cost effectiveness was expressed as an incremental cost per QALY. RESULTS: At two years, 38 patients randomised to rehabilitation had received rehabilitation and surgery whereas just seven surgery patients had received both treatments. The mean total cost per patient was estimated to be 7830 pounds sterling (SD 5202 pounds sterling) in the surgery group and 4526 pounds sterling (SD 4155 pounds sterling) in the intensive rehabilitation arm, a significant difference of 3304 pounds sterling (95% confidence interval 2317 pounds sterling to 4291 pounds sterling). Mean QALYs over the trial period were 1.004 (SD 0.405) in the surgery group and 0.936 (SD 0.431) in the intensive rehabilitation group, giving a non-significant difference of 0.068 (-0.020 to 0.156). The incremental cost effectiveness ratio was estimated to be 48,588 pounds sterling per QALY gained (- 279,883 pounds sterling to 372,406 pounds sterling). CONCLUSION: Two year follow-up data show that surgical stabilisation of the spine may not be a cost effective use of scarce healthcare resources. However, sensitivity analyses show that this could change-for example, if the proportion of rehabilitation patients requiring subsequent surgery continues to increase.

Adult↗

Sublingual compared with vaginal misoprostol for labour induction at term: a randomised controlled trial.

OBJECTIVE: To compare the efficacy and safety of 50 microg of sublingual misoprostol with 25 microg of vaginal misoprostol administered for labour induction at term. Design Double-blinded, randomised controlled trial. Setting University Hospital, Kaunas, Lithuania. Sample A total of 140 women at term with indications for labour induction. Methods Women were randomised to receive either 50 microg of sublingual misoprostol with vaginal placebo (n = 70) or sublingual placebo with 25 microg of vaginal misoprostol (n = 70) every 4 hours (maximum six doses). Main outcome measures The number of women delivering vaginally within 24 hours of labour induction. Results Fifty-eight women (83%) in the sublingual misoprostol group and 53 (76%) in the vaginal misoprostol group delivered vaginally within 24 hours [relative risk (RR) 1.1, 95% confidential interval (CI) 0.9-1.3]. However, the induction to vaginal delivery time was significantly shorter in the sublingual group (15.0 +/- 3.7 hours) compared with the vaginal group (16.7 +/- 4.1 hours, P = 0.03). The incidence of tachysystole was more than three-fold higher in the sublingual than in the vaginal group (14 versus 4.3%; RR 3.3, 95% CI 0.9-11.6), but this was not statistically significant. There were no significant differences in the incidence of hypertonus or hyperstimulation syndrome, mode of delivery, interventions for fetal distress or neonatal outcomes between the two groups. Conclusion A 50 microg of sublingual misoprostol 4 hourly for labour induction at term seems to have similar efficacy as 25 microg of vaginal misoprostol. Further studies on safety with larger numbers of women need to be conducted before routine sublingual misoprostol use in this setting.

Administration, Intravaginal↗

Effect of screening on oral cancer mortality in Kerala, India: a cluster-randomised controlled trial.

BACKGROUND: Oral cancer is common in men from developing countries, and is increased by tobacco and alcohol use. We aimed to assess the effect of visual screening on oral cancer mortality in a cluster-randomised controlled trial in India. METHODS: Of the 13 clusters chosen for the study, seven were randomised to three rounds of oral visual inspection by trained health workers at 3-year intervals and six to a control group during 1996-2004, in Trivandrum district, Kerala, India. Healthy participants aged 35 years and older were eligible for the study. Screen-positive people were referred for clinical examination by doctors, biopsy, and treatment. Outcome measures were survival, case fatality, and oral cancer mortality. Oral cancer mortality in the study groups was analysed and compared by use of cluster analysis. Analysis was by intention to treat. FINDINGS: Of the 96,517 eligible participants in the intervention group, 87,655 (91%) were screened at least once, 53,312 (55%) twice, and 29,102 (30%) three times. Of the 5145 individuals who screened positive, 3218 (63%) complied with referral. 95,356 eligible participants in the control group received standard care. 205 oral cancer cases and 77 oral cancer deaths were recorded in the intervention group compared with 158 cases and 87 deaths in the control group (mortality rate ratio 0.79 [95% CI 0.51-1.22]). 70 oral cancer deaths took place in users of tobacco or alcohol, or both, in the intervention group, compared with 85 in controls (0.66 [0.45-0.95]). The mortality rate ratio was 0.57 (0.35-0.93) in male tobacco or alcohol users and 0.78 (0.43-1.42) in female users. INTERPRETATION: : Oral visual screening can reduce mortality in high-risk individuals and has the potential of preventing at least 37,000 oral cancer deaths worldwide.

Adult↗

Patient preference randomised controlled trials in mental health research.

The relationship between psychiatric patients'preferences for different treatments and the outcome of interventions is unclear, as the few relevant trials have tended to be underpowered. Strong patient preferences result in patients refusing to enter a trial. This leads to bias and limits generalisability, and the patient preference randomised controlled trial (RCT) design has been proposed as an alternative. Limitations and advantages of patient preference RCTs are discussed.

Humans↗

Smoking cessation in patients with chronic obstructive pulmonary disease: a double-blind, placebo-controlled, randomised trial.

BACKGROUND: Tobacco smoking is associated with chronic obstructive pulmonary disease (COPD) in more than 80% of cases. Our aim was to investigate the effect of sustained-release bupropion (amfebutamone) (SR) in promoting abstinence from smoking in patients with COPD. METHODS: In a double-blind, randomised, placebo-controlled trial 404 individuals with mild or moderate COPD who smoked 15 or more cigarettes per day, were assigned bupropion SR (150 mg twice daily) or placebo for 12 weeks. All patients received smoking cessation counselling. Study medication was taken for 1 week before patients attempted to stop smoking. The primary efficacy endpoint was the complete and continuous abstinence from smoking from the beginning of week 4 to the end of week 7. Participants were followed up at month 6. Analysis was by intention to treat. FINDINGS: All patients were chronic smokers with a smoking history of about 51 pack-years. Continuous smoking abstinence rates from week 4 to 7 were significantly higher in participants receiving bupropion SR than in those receiving placebo (28% [57/204] vs 16% [32/200], p=0.003). Continuous abstinence rates from weeks 4 to 12 (18% [36/204] vs 10% [20/200]) and weeks 4 to 26 (16% [32/204] vs 9% [18/200]) were also higher in participants receiving bupropion SR than in those taking placebo (p<0.05). Furthermore, symptoms of tobacco craving and withdrawal were attenuated in those receiving bupropion SR. Seven individuals discontinued study medication because of adverse events. INTERPRETATION: Bupropion SRis a well-tolerated and effective aid to smoking cessation in people with mild to moderate COPD.

Adult↗

Bacterial contamination of central venous catheters during insertion: a double blind randomised controlled trial.

Static electricity within sterile packaging may result in bacterial contamination of central venous catheters (CVCs) prior to insertion. To prevent this, some surgeons inject saline into the pack before opening it. This trial was designed to determine the effect of this procedure. A double blind randomised controlled trial of 47 CVCs comparing injection of 2 ml of sterile saline into the pack prior to opening with no injection was performed. Five centimetre lengths cut from the tip of the catheter before and after subcutaneous tunnelling were sent for microbiological culture. Eight catheters (17%) showed evidence of bacterial contamination prior to insertion into the vein. Two (4.2%) were contaminated prior to tunnelling and seven (14.9%) afterwards. One catheter was contaminated before and after tunnelling. All but one of the contaminating bacteria were coagulase negative staphylococci. There was no significant difference in the contamination rate between catheters from packs that had been injected (5/25) and those that had not (3/22), P = 0.56. Just under one-fifth of the catheters were contaminated with bacteria prior to insertion into the vein but this was not influenced by prior injection of saline into the pack. We conclude that there is no evidence to support the practice of injecting the catheter pack prior to opening.

Adolescent↗

Effect of warming adult diphtheria-tetanus vaccine on discomfort after injection: a randomised controlled trial.

OBJECTIVE: To determine whether warming or rubbing adult diphtheria tetanus (ADT) vaccine immediately before administration affects its temperature and reduces the incidence of pain. DESIGN: Double-blind, randomised controlled trial and in-vitro temperature study. SETTING: Emergency department (ED) of a regional hospital between April and December 2001. PATIENTS: Convenience sample of 150 patients aged 16 years or over who presented to the ED requiring ADT booster vaccination. INTERVENTION: Patients were randomised to receive vaccine that was "cold" (no deliberate warming), "rubbed" between the palms for 1 minute, or "warmed" in a 37 degrees C incubator; vaccine was administered as recommended in Australian guidelines. MAIN OUTCOME MEASURES: Incidence of pain and pain score on McGill Present Pain Intensity Questionnaire at 5 minutes, 24 hours and 48 hours after injection; and temperature of vaccine after preparation for simulated administration. RESULTS: The "cold" vaccine had significantly lower temperature (mean, 19.1 degrees C; 95% CI, 17.5-20.7 degrees C) than the "warmed" vaccine (mean, 28.9 degrees C; 95% CI, 28.4-29.4 degrees C) and "rubbed" vaccine (mean, 26.9 degrees C; 95% CI, 24.5-29.3 degrees C). There was no significant difference in incidence of pain between the groups who received vaccine prepared in different ways at any follow-up (5 min: P = 0.62; 24 h: P = 0.58; 48 h: P = 0.61) or overall (P = 0.99). Among those who completed follow-up, incidence of pain at any time was 77/138 (56%); there was no difference in their time-averaged pain scores (P = 0.63) or peak pain scores (P = 0.60). CONCLUSIONS: Warming or rubbing ADT vaccine does not reduce the incidence of pain after administration. Regardless of how ADT vaccine is prepared, its temperature approaches ambient by the time it is injected.

Adolescent↗

[Randomised controlled trials: a reading guide].

This paper, first of a series devoted to evidence-based medicine, describes how to critically read an article on a randomised controlled intervention trial. This guide is applied to the common clinical question, whether or not to prescribe systemic glucocorticoids for patients with exacerbation of chronic obstructive pulmonary disease, through the analysis of two recently published series. It comprises a three-step evaluation: the assessment of the study methods to ensure that the results are valid, the analysis of the results of the larger of the two studies, and the evaluation of whether the results can be applied to a patient whose clinical case illustrates this article. Finally, a few limitations of randomised controlled trials are discussed.

Anti-Inflammatory Agents↗

No effect of birth centre care on either duration or experience of breast feeding, but more complications: findings from a randomised controlled trial.

OBJECTIVE: to study the effect of birth centre care on the duration of breast feeding, breast feeding complications, and women's experiences of breast feeding. DESIGN: randomised controlled trial. SETTING: in-hospital birth centre at South Hospital, Stockholm, and standard obstetric care in the Greater Stockholm area. SUBJECTS: 1230 women with expected date of birth between October 1989 and February 1992, interested in participating in a birth centre trial, and meeting medical low-risk criteria. 617 women were allocated to the experimental group offered birth centre care (EG), and 613 to the control group offered standard obstetric care (CG). MAIN OUTCOME MEASURES: duration of breast feeding, breast feeding complications such as sore nipples, engorgement, milk stasis, and mastitis, and women's experiences of breast feeding. FINDINGS: no difference was found between EG and CG in the duration of breast feeding. Ninety-three per cent in both groups were breast feeding exclusively two months post partum. The average number of months of breast feeding, exclusively or partly, when investigated one year after the birth was 8.6 in EG and 8.5 in CG. No difference was observed in women's experiences of breast feeding, but rather more women in EG than in CG reported sore nipples, 36% and 30% respectively (p = 0.03), and milk stasis, 26% and 19% respectively (p = 0.002). CONCLUSIONS: birth centre care had no effect on the duration of breast feeding, or on women's experiences of breast feeding. Prenatal attitudes were probably more significant predictors of these outcomes than differences in the two modes of maternity care in this population of highly breast feeding-motivated women. The larger proportion of sore nipples and milk stasis in the EG might have been due to earlier discharge, or to midwives less skilled in assisting with breast feeding at the birth centre than in the postpartum wards.

Adult↗

Dietary treatment of rheumatoid cachexia with beta-hydroxy-beta-methylbutyrate, glutamine and arginine: a randomised controlled trial.

BACKGROUND & AIMS: Rheumatoid arthritis (RA) is complicated by cytokine-driven alterations in protein and energy metabolism and consequent muscle wasting (cachexia). The aim of this randomised controlled trial was to investigate the efficacy of a mixture of beta-hydroxy-beta-methylbutyrate, glutamine and arginine (HMB/GLN/ARG) as nutritional treatment for rheumatoid cachexia. METHODS: Forty RA patients supplemented their diet with either HMB/GLN/ARG or a nitrogen (7.19 g/day) and calorie (180 kcal/day) balanced mixture of alanine, glutamic acid, glycine, and serine (placebo) for 12 weeks. Body composition and other outcomes were assessed at baseline and follow-up, and analysed by mixed ANOVA. RESULTS: Dietary supplementation with HMB/GLN/ARG was not superior to placebo in the treatment of rheumatoid cachexia (groupxtime interactions P>0.05 for all outcomes). Both amino acid mixtures significantly increased (main effect of time) fat-free mass (727+/-1186 g, P<0.01), total body protein (719+/-1703 g, P=0.02), arms (112+/-183 g, P<0.01) and legs (283+/-534 g, P<0.01) lean mass, and some measures of physical function. No significant adverse event occurred during the study, but patients in the HMB/GLN/ARG group reported fewer gastrointestinal complaints compared to placebo. CONCLUSIONS: Dietary supplementation with HMB/GLN/ARG is better tolerated but not more effective in reversing cachexia in RA patients compared to the mixture of other non-essential amino acids used as placebo. Further controlled studies are necessary to confirm the beneficial anabolic and functional effects of increased nitrogen intake in this population.

Arginine↗

Review of the radiology in randomised controlled trials in open reduction and internal fixation (ORIF) of displaced intraarticular calcaneal fractures.

The aim of this study was to assess the radiological evaluation of all prospective, randomised, controlled trails of displaced intraarticular calcaneal fractures. A systematic review of the literature, of which only three of 296 references were randomised and controlled, were examined in a blinded fashion. All had preoperative coronal CT for Sander's classification and used a lateral surgical approach or conservative treatment. Thordason (15 patients/11 controls) used interoperative lateral and axial X-rays. Bohler's angle increased on average from 11 to 26 degrees (P<0.001) postoperatively, but decreased (9-8 degrees ) in the conservative group. The posterior facet residual displacement was 1.1 and 4.7 mm, respectively. O'Farrell (12 patients/12 controls) showed 8 out of 12 had Bohler's and Gissane's angle partially or fully restored postoperatively, and not conservatively. Parmar (25 patients/31 controls) used preoperative lateral radiographs, but failed with CT to grade the postoperative reduction, whilst the conservative group was unaltered. There was no systematic, blinded assessment of the change in radiology by the operative intervention. Overall there was weak evidence to support ORIF. In conclusion, there are only three randomised, controlled studies involving small numbers of patients, which showed improved plain radiographic anatomical alignment, in the postoperative but not conservative group. Further prospective randomised, controlled trials with independent and blinded assessment with accurate CT and clinical evaluation will be required before ORIF can be adopted as the best practice.

Calcaneus↗

Cardiotocography only versus cardiotocography plus ST analysis of fetal electrocardiogram for intrapartum fetal monitoring: a Swedish randomised controlled trial.

BACKGROUND: Previous studies indicate that analysis of the ST waveform of the fetal electrocardiogram provides information on the fetal response to hypoxia. We did a multicentre randomised controlled trial to test the hypothesis that intrapartum monitoring with cardiotocography combined with automatic ST-waveform analysis results in an improved perinatal outcome compared with cardiotocography alone. METHODS: At three Swedish labour wards, 4966 women with term fetuses in the cephalic presentation entered the trial during labour after a clinical decision had been made to apply a fetal scalp electrode for internal cardiotocography. They were randomly assigned monitoring with cardiotocography plus ST analysis (CTG+ST group) or cardiotocography only (CTG group). The main outcome measure was rate of umbilical-artery metabolic acidosis (pH <7.05 and base deficit >12 mmol/L). Secondary outcomes included operative delivery for fetal distress. Results were first analysed according to intention to treat, and secondly after exclusion of cases with severe malformations or with inadequate monitoring. FINDINGS: The CTG+ST group showed significantly lower rates of umbilical-artery metabolic acidosis than the cardiotocography group (15 of 2159 [0.7%] vs 31 of 2079 [2%], relative risk 0.47 [95% CI 0.25-0.86], p=0.02) and of operative delivery for fetal distress (193 of 2519 [8%] vs 227 of 2447 [9%], 0.83 [0.69-0.99], p=0.047) when all cases were included according to intention to treat. The differences were more pronounced after exclusion of 291 in the CTG+ST group and 283 in the CTG group with malformations or inadequate recording. INTERPRETATION: Intrapartum monitoring with cardiotocography combined with automatic ST-waveform analysis increases the ability of obstetricians to identify fetal hypoxia and to intervene more appropriately, resulting in an improved perinatal outcome.

Acidosis↗

Arterial embolisation or chemoembolisation versus symptomatic treatment in patients with unresectable hepatocellular carcinoma: a randomised controlled trial.

BACKGROUND: There is no standard treatment for unresectable hepatocellular carcinoma. Arterial embolisation is widely used, but evidence of survival benefits is lacking. METHODS: We did a randomised controlled trial in patients with unresectable hepatocellular carcinoma not suitable for curative treatment, of Child-Pugh class A or B and Okuda stage I or II, to assess the survival benefits of regularly repeated arterial embolisation (gelatin sponge) or chemoembolisation (gelatin sponge plus doxorubicin) compared with conservative treatment. 903 patients were assessed, and 112 (12%) patients were finally included in the study. The primary endpoint was survival. Analyses were by intention to treat. FINDINGS: The trial was stopped when the ninth sequential inspection showed that chemoembolisation had survival benefits compared with conservative treatment (hazard ratio of death 0.47 [95% CI 0.25-0.91], p=0.025). 25 of 37 patients assigned embolisation, 21 of 40 assigned chemoembolisation, and 25 of 35 assigned conservative treatment died. Survival probabilities at 1 year and 2 years were 75% and 50% for embolisation; 82% and 63% for chemoembolisation, and 63% and 27% for control (chemoembolisation vs control p=0.009). Chemoembolisation induced objective responses sustained for at least 6 months in 35% (14)of cases, and was associated with a significantly lower rate of portal-vein invasion than conservative treatment. Treatment allocation was the only variable independently related to survival (odds ratio 0.45 [95% CI 0.25-0.81], p=0.02). INTERPRETATION: Chemoembolisation improved survival of stringently selected patients with unresectable hepatocellular carcinoma.

Aged↗

Pubovaginal sling versus transurethral Macroplastique for stress urinary incontinence and intrinsic sphincter deficiency: a prospective randomised controlled trial.

OBJECTIVE: To compare the pubovaginal sling and transurethral Macroplastique in the treatment of female stress urinary incontinence (SUI) and intrinsic sphincter deficiency (ISD). DESIGN: A prospective randomised controlled trial comparing two surgical treatments for SUI and ISD. SETTING: Tertiary referral urogynaecology unit in Australia. POPULATION: Women with SUI and ISD who were suitable for either surgical technique. METHODS: Forty-five women with SUI and ISD were randomly allocated the pubovaginal sling (n = 22) or transurethral Macroplastique (n = 23). Subjective and objective success rates, patient satisfaction and cost measurements at six months and one year following surgery were the primary outcome measures. A telephone questionnaire survey was performed at a mean follow up period of 62 months (43-71). MAIN OUTCOME MEASURE: Comparison of success rates, complications and costs. RESULTS: The symptomatic and patient satisfaction success rates were similar following the sling and Macroplastique with the objective success rate being significantly greater (P < 0.001) following the sling (81%vs 9%). Macroplastique had significantly lower morbidity but was more expensive than the sling (P < 0.001). Response rate at 62 months follow up was 60% in both groups with the sling group reporting better continence success (69%vs 21%) and satisfaction rates (69%vs 29%, P = 0.057). CONCLUSIONS: The pubovaginal sling was more effective and economical than transurethral Macroplastique for the treatment of SUI and ISD. However, transurethral Macroplastique remains an appropriate treatment in selected cases of SUI and ISD.

Adult↗

Does paracetamol (acetaminophen) reduce the pain of osteoarthritis? A meta-analysis of randomised controlled trials.

OBJECTIVE: To assess the best available evidence for efficacy of paracetamol (acetaminophen) in the treatment of osteoarthritis (OA). DESIGN: Systematic review and meta-analysis of randomised controlled trials (RCTs). DATA SOURCES: Medline, Embase, Scientific Citation Index, CINAHL, Cochrane Library, and conference abstracts in the past 2 years from the British Society for Rheumatology, the European League Against Rheumatism, the American College of Rheumatology, and the Osteoarthritis Research Society International. SUBJECTS: 10 RCTs including 1712 patients with either symptomatic OA of the knee (6 trials) or hip/knee (3 trials) or multiple joints (1 trial). MAIN OUTCOME MEASURES: (a). effect size (ES) for pain, stiffness, and functional scores from baseline to end point; (b). rate ratio (RR) and number needed to treat for clinical response rate and patient preference for treatment. RESULTS: Paracetamol was effective in relieving pain due to OA (ES = 0.21, 95% confidence interval (CI) 0.02 to 0.41). Non-steroidal anti-inflammatory drugs (NSAIDs) were better than paracetamol for pain relief (ES = 0.20, 95% CI 0.10 to 0.30). Clinical response rate was higher with NSAIDs than with paracetamol (RR = 1.24, 95% CI 1.08 to 1.41), and the number of patients who preferred NSAIDs was more than twice the number of those preferring paracetamol (RR = 2.46, 95% CI 1.51 to 4.12). NSAIDs were associated with more frequent gastrointestinal discomfort than paracetamol (RR = 1.35, 95% CI 1.05 to 1.75). CONCLUSION: Paracetamol is an effective agent for pain relief due to OA. Although safer, it is less effective than NSAIDs. For safety reasons paracetamol should be the first line treatment, with NSAIDs reserved for those who do not respond.

Acetaminophen↗