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Group interpersonal psychotherapy for depression in rural Uganda: 6-month outcomes: randomised controlled trial.

BACKGROUND: A randomised controlled trial comparing group interpersonal psychotherapy with treatment as usual among rural Ugandans meeting symptom and functional impairment criteria for DSM-IV major depressive disorder or sub-threshold disorder showed evidence of effectiveness immediately following the intervention. AIMS: To assess the long-term effectiveness of this therapy over a subsequent 6-month period. METHOD: A follow-up study of trial participants was conducted in which the primary outcomes were depression diagnosis, depressive symptoms and functional impairment. RESULTS: At 6 months, participants receiving the group interpersonal psychotherapy had mean depression symptom and functional impairment scores respectively 14.0 points (95% CI 12.2-15.8; P<0.0001) and 5.0 points (95% CI 3.6-6.4; P<0.0001) lower than the control group. Similarly, the rate of major depression among those in the treatment arm (11.7%) was significantly lower than that in the control arm (54.9%) (P<0.0001). CONCLUSIONS: Participation in a 16-week group interpersonal psychotherapy intervention continued to confer a substantial mental health benefit 6 months after conclusion of the formal intervention.

Adult↗

[A national prospective trial register for randomised controlled trials: ethical and practical necessity].

The decision to treat a patient is often based on the results of randomised controlled trials (RCTs). These important investigations inform physicians and patients with regard to the chance of favourable results of treatment and the risks of adverse reactions. However, research has shown that especially the smaller RCTs in which no or even an adverse effect of new interventions is found run a relatively high risk of remaining unpublished, which leads to publication bias and an overestimate of the efficacy of an intervention. This is undesirable. The best way to identify possible publication bias and reduce its negative effects is to register RCTs from their starting date onwards in a prospective and publicly accessible register. Other motives for such a register are the prevention of duplication of research work and its financial support, and informing patients. Currently, a prospective Dutch national trial register is being developed by the Dutch Cochrane Centre. This is not only of importance to researchers and patients, but also to grant-providing bodies and the editors of medical scientific journals.

Humans↗

Foot exercise plus education versus brief advice for the treatment of plantar heel pain (FEET Trial): a feasibility randomised controlled trial.

BACKGROUND: Despite foot muscle strengthening being a target of exercise interventions for plantar heel pain (PHP) no study has measured foot muscle outcomes, and existing research is limited by a lack of control (no treatment) comparisons. OBJECTIVES: To determine the feasibility of conducting a randomised controlled trial and investigate the acceptability and credibility of comprehensive progressive foot exercise and education compared to brief advice for PHP. DESIGN: Randomised parallel group feasibility trial. METHOD: People with PHP were randomised (1:1 concealed allocation) to receive either foot exercise plus education or brief advice for twelve weeks. Primary outcomes included willingness to enrol, recruitment rate, adherence, logbook completion, dropout rate, early withdrawal reasons, adverse events, additional treatments sought, and credibility/expectancy. RESULTS: Twenty people with PHP (16 women; age 50&#x202f;&#xb1;&#x202f;9 years; body mass index&#x202f;=&#x202f;30.7&#x202f;&#xb1;&#x202f;4.6&#x202f;kg/m2) were recruited over 15 weeks (1.3 participants per week). Primary outcomes were willingness to enrol (80%), adherence (physiotherapy sessions attended: foot exercise plus education 85%, brief advice 100%; home exercise program: 62% daily sessions completed, 72% thrice weekly sessions completed), logbook completion (foot exercise plus education 75%, brief advice 90%), dropout rate (15%), and additional treatments sought (69%). There were no intervention-related adverse events, and credibility scores were higher for foot exercise plus education. CONCLUSIONS: This study confirms feasibility and acceptability of a protocol comparing foot exercise plus education with brief advice in individuals with PHP, generating key insights to inform future trial design.

Humans↗

Low-dose dopamine in patients with early renal dysfunction: a placebo-controlled randomised trial. Australian and New Zealand Intensive Care Society (ANZICS) Clinical Trials Group.

BACKGROUND: Low-dose dopamine is commonly administered to critically ill patients in the belief that it reduces the risk of renal failure by increasing renal blood flow. However, these effects have not been established in a large randomised controlled trial, and use of dopamine remains controversial. We have done a multicentre, randomised, double-blind, placebo-controlled study of low-dose dopamine in patients with at least two criteria for the systemic inflammatory response syndrome and clinical evidence of early renal dysfunction (oliguria or increase in serum creatinine concentration). METHODS: 328 patients admitted to 23 participating intensive-care units (ICUs) were randomly assigned a continuous intravenous infusion of low-dose dopamine (2 microg kg(-1) min(-1)) or placebo administered through a central venous catheter while in the ICU. The primary endpoint was the peak serum creatinine concentration during the infusion. Analyses excluded four patients with major protocol violations. FINDINGS: The groups assigned dopamine (n=161) and placebo (n=163) were similar in terms of baseline characteristics, renal function, and duration of trial infusion. There was no difference between the dopamine and placebo groups in peak serum creatinine concentration during treatment (245 [SD 144] vs 249 [147] micromol/L; p=0.93), in the increase from baseline to highest value during treatment (62 [107] vs 66 [108] micromol/L; p=0.82), or in the numbers of patients whose serum creatinine concentration exceeded 300 micromol/L (56 vs 56; p=0.92) or who required renal replacement therapy (35 vs 40; p=0.55). Durations of ICU stay (13 [14] vs 14 [15] days; p=0.67) and of hospital stay (29 [27] vs 33 [39] days; p=0.29) were also similar. There were 69 deaths in the dopamine group and 66 in the placebo group. INTERPRETATION: Administration of low-dose dopamine by continuous intravenous infusion to critically ill patients at risk of renal failure does not confer clinically significant protection from renal dysfunction.

Analysis of Variance↗

Design of the BiRmingham Early Detection In untREated psyChosis Trial (REDIRECT): cluster randomised controlled trial of general practitioner education in detection of first episode psychosis [ISRCTN87898421].

BACKGROUND: Treatment delay in first episode psychosis is common. As general practitioners are the first point of contact for many individuals with first episode psychosis, they are well placed to detect the early symptoms and make urgent referrals to specialist secondary care services. However, early psychosis is often difficult to detect. The primary objective of the Redirect trial is to estimate whether an educational intervention targeted at general practitioners increases the general practitioner referral rate of young people with first episode psychosis to Early Intervention Services. METHODS/DESIGN: This paper describes the design of a stratified-cluster randomised controlled trial of an educational intervention on first episode psychosis in primary care. The primary outcome is the number of general practitioner referrals of young people with first episode psychosis to Early Intervention Services. Secondary outcomes are duration of untreated psychosis, time to recovery, use of the Mental Health Act, and general practitioner consultation rate. Young people with first episode psychosis referred to Early Intervention Services will be recruited over a two-year period from 1 March 2004. Seventy-eight out of 89 eligible general practices were recruited. The educational intervention has been implemented and evaluated by general practitioners. The education was well received and considered relevant to clinical practice by the general practitioners. DISCUSSION: The results suggest that the recruitment strategy and implementation of the educational intervention are feasible and acceptable in a primary care setting. The Redirect trial will provide robust information about the efficacy of an evidence-based complex educational intervention targeted at general practitioners on referral rates of young people with first episode psychosis to Early Intervention Services.

Adolescent↗

Treatment of acute mountain sickness by simulated descent: a randomised controlled trial.

OBJECTIVE: To evaluate the therapeutic efficacy of a portable hyperbaric chamber for treatment of acute mountain sickness. DESIGN: Controlled randomised trial over two mountaineering seasons. SETTING: High altitude research laboratory at 4559 m above sea level. SUBJECTS: 64 climbers with acute mountain sickness randomly allocated to different treatments. INTERVENTIONS: One hour of treatment in the hyperbaric chamber at a pressure of 193 mbar or 20 mbar as control or bed rest. MAIN OUTCOME MEASURES: Symptoms of acute mountain sickness before, immediately after, and 12 hours after treatment. Permitted intake of analgesic and antiemetic drugs in the follow up period. RESULTS: Treatment with 193 mbar caused greater relief of symptoms than did control treatment or bed rest. During the 12 hour follow up period intake of analgesics was similar (58-80% of subjects in each group). Symptom scores had improved in all subjects after 12 hours with no significant differences between groups. CONCLUSIONS: One hour of treatment with 193 mbar in a portable hyperbaric chamber, corresponding to a descent of 2250 m, leads to a short term improvement in symptoms of acute mountain sickness but has no beneficial long term effects attributable to pressurisation.

Acute Disease↗

Randomised controlled trials of homeopathy in hyperactive children: treatment procedure leads to an unconventional study design. Experience with open-label homeopathic treatment preceding the Swiss ADHD placebo controlled, randomised, double-blind, cross-over trial.

BACKGROUND: Treatment of patients with attention deficit hyperactivity disorder (ADHD) with homeopathy is difficult. The Swiss randomised, placebo controlled, cross-over trial in ADHD patients (Swiss ADHD trial) was designed with an open-label screening phase prior to the randomised controlled phase. During the screening phase, the response of each child to successive homeopathic medications was observed until the optimal medication was identified. Only children who reached a predefined level of improvement participated in the randomised, cross-over phase. Although the randomised phase revealed a significant beneficial effect of homeopathy, the cross-over caused a strong carryover effect diminishing the apparent difference between placebo and verum treatment. METHODS: This retrospective analysis explores the screening phase data with respect to the risk of failure to demonstrate a specific effect of a randomised controlled trial (RCT) with randomisation at the start of the treatment. RESULTS: During the screening phase, 84% (70/83) of the children responded to treatment and reached eligibility for the randomised trial after a median time of 5 months (range 1-18), with a median of 3 different medications (range 1-9). Thirteen children (16%) did not reach eligibility. Five months after treatment start, the difference in Conners Global Index (CGI) rating between responders and non-responders became highly significant (p = 0.0006). Improvement in CGI was much greater following the identification of the optimal medication than in the preceding suboptimal treatment period (p < 0.0001). CONCLUSIONS: Because of the necessity of identifying an optimal medication before response to treatment can be expected, randomisation at the start of treatment in an RCT of homeopathy in ADHD children has a high risk of failure to demonstrate a specific treatment effect, if the observation time is shorter than 12 months.

Adolescent↗

Bezafibrate in men with lower extremity arterial disease: randomised controlled trial.

OBJECTIVE: To assess the effect of bezafibrate on the risk of coronary heart disease and stroke in men with lower extremity arterial disease. DESIGN: Double blind placebo controlled randomised trial. SETTING: 85 general practices and nine hospital vascular clinics. PARTICIPANTS: 1568 men, mean age 68.2 years (range 35 to 92) at recruitment. INTERVENTIONS: Bezafibrate 400 mg daily (783 men) or placebo (785 men). MAIN OUTCOME MEASURES: Combination of coronary heart disease and of stroke. All coronary events, fatal and non-fatal coronary events separately, and strokes alone (secondary end points). RESULTS: Bezafibrate did not reduce the incidence of coronary heart disease and stroke. There were 150 and 160 events in the active and placebo groups respectively (relative risk 0.96, 95% confidence interval 0.76 to 1.21). There were 90 and 111 major coronary events in the active and placebo groups respectively (0.81, 0.60 to 1.08), of which 64 and 65 were fatal (0.95, 0.66 to 1.37) and 26 and 46 non-fatal (0.60, 0.36 to 0.99). Beneficial effects on non-fatal events were greatest in men aged <65 years at entry, in whom benefit was also seen for all coronary events (0.38, 0.20 to 0.72). There were no significant effects in older men. There were 60 strokes in those on active treatment and 49 in those on placebo (1.34, 0.80 to 2.01). There were 204 and 195 deaths from all causes in the two groups respectively (1.03, 0.83 to 1.26). Bezafibrate reduced the severity of intermittent claudication for up to three years. CONCLUSIONS: Bezafibrate has no effect on the incidence of coronary heart disease and of stroke combined but may reduce the incidence of non-fatal coronary events, particularly in those aged <65 years at entry, in whom all coronary events may also be reduced.

Adult↗

Sesame oil use in ameliorating cough in children: a randomised controlled trial.

OBJECTIVES: To examine the role of sesame oil (SO) in reducing the frequency and severity of acute cough in children 2-12 years of age. DESIGN: Double blind, placebo controlled randomised trial. SETTING: Seven primary health care centres/clinics in Lebanon. A total of 107 children between the age of 2 and 12 years with cough secondary to common cold were enrolled. INTERVENTION: Five milliliters of SO or placebo by mouth at bed time. OUTCOME MEASURES: Cough strength and frequency as judged by parents on a four points Likert scale after giving three syrup doses over three consecutive nights. Analysis was performed on an intention to treat basis. RESULTS: At day 1, the effect size for cough frequency and cough strength were +0.26 (95%CI -0.64,+0.12) and +0.15 (95%CI -0.53, +0.23), respectively. SO decreased cough symptoms more than placebo but these were not statistically significant. The effect size decreased from days 1 to 3. Cough symptoms improved over the 3 days both in SO and placebo group. No evidence of undesirable effects were noted to SO. CONCLUSION: Like other over the counter antitussives, SO did not result in marked improvement in cough symptoms.

Child↗

Venlafaxine in management of hot flashes in survivors of breast cancer: a randomised controlled trial.

BACKGROUND: Hot flashes can be troublesome, especially when hormonal therapy is contraindicated. Preliminary data have suggested that newer antidepressants, such as venlafaxine, can diminish hot flashes. We undertook a double-blind, placebo-controlled, randomised trial to assess the efficacy of venlafaxine in women with a history of breast cancer or reluctance to take hormonal treatment because of fear of breast cancer. METHODS: Participants were assigned placebo (n=56) or venlafaxine 37.5 mg daily (n=56), 75 mg daily (n=55), or 150 mg daily (n=54). After a baseline assessment week, patients took the study medication for 4 weeks. All venlafaxine treatment started at 37.5 mg daily and gradually increased in the 75 mg and 150 mg groups. Patients completed daily hot-flash questionnaire diaries. The primary endpoint was average daily hot-flash activity (number of flashes and a score combining number and severity). Analyses were based on the women who provided data throughout the baseline and study weeks. FINDINGS: 191 patients had evaluable data for the whole study period (50 placebo, 49 venlafaxine 37.5 mg, 43 venlafaxine 75 mg, 49 venlafaxine 150 mg). After week 4 of treatment, median hot flash scores were reduced from baseline by 27% (95% CI 11-34), 37% (26-54), 61% (50-68), and 61% (48-75) in the four groups. Frequencies of some side-effects (mouth dryness, decreased appetite, nausea, and constipation) were significantly higher in the venlafaxine 75 mg and 150 mg groups than in the placebo group. INTERPRETATION: Venlafaxine is an effective non-hormonal treatment for hot flashes, though the efficacy must be balanced against the drug's side-effects. Confirmation of the results of this 4-week study awaits the completion of three ongoing randomised studies to assess the effects of other related antidepressants for the treatment of hot flashes.

Antidepressive Agents, Second-Generation↗

Routine oxytocin in the third stage of labour: a placebo controlled randomised trial.

OBJECTIVE: To compare intravenous oxytocin administration (Partocon 10 IU) with saline solution in the management of postpartum haemorrhage in the third stage of labour. DESIGN: A double-blind, randomised controlled trial involving 1000 parturients with singleton fetuses in cephalic presentation and undergoing vaginal delivery, randomly allocated to treatment with oxytocin (n = 513) or 0.9% saline solution (n = 487). SETTING: Labour ward at a central county hospital. MAIN OUTCOME MEASURES: Mean blood loss (total, and before and after placenta delivery); frequencies of blood loss > 800 mL, need of additional oxytocic treatment, postpartum haemoglobin < 10 g/dL; and duration of postpartum hospitalisation. RESULTS: As compared with saline solution, oxytocin administration was associated with significant reduction in mean total blood loss (407 versus 527 mL), and in frequencies of postpartum haemorrhage > 800 mL (8.8% versus 5.2%), additional treatment with metylergometrine (7.8% versus 13.8%), and postpartum Hb < 10 g/dL (9.7% versus 15.2%), and a nonsignificant increase in the frequency of manual placenta removal (3.5% versus 2.3%). There was no group difference in the mean duration of postpartum hospitalisation (4.6 versus 4.5 days, respectively). CONCLUSIONS: Administration of intravenous oxytocin in the third stage of labour is associated with an approximately 22% reduction in mean blood loss, and approximately 40% reductions in frequencies of postpartum haemorrhage (> 500 mL or > 800 mL) and of postpartum haemoglobin < 10 g/dL. Identification of risk groups for oxytocin treatment does not seem worthwhile. Oxytocin is a cheap atoxic drug and should be given routinely after vaginal delivery.

Adult↗

Endocrinology trial design: adverse event reporting in randomised controlled trials of recombinant human GH in GH-deficient adults.

We have evaluated the reporting of withdrawals due to adverse effects and specific adverse effects in randomised controlled trials of recombinant human GH in adults. A systematic review was carried out of randomised controlled trials of the clinical effectiveness of recombinant human GH in adults with GH deficiency in relation to impact on quality of life. Trials were identified from searching electronic databases, bibliographies of related articles and consulting experts. There was reporting of withdrawals due to adverse effects and specific adverse effects. Rates of oedema and arthralgia were reported in included trials. Seventeen randomised controlled trials, published between 1990 and 1999, met the inclusion criteria for the review. Nine trials reported data on the effectiveness of GH on quality of life in adults. Only five trials (29%) reported both withdrawals from the study because of adverse events and specific adverse events with numbers per study arm and per type. Six further trials (35%) reported either withdrawal details or specific adverse event details or partial data on specific adverse events. Six trials (35%), however, did not report information on either withdrawals or specific adverse events. Ten of the 17 studies (59%) reported the number of patients who withdrew from the study due to adverse events per study arm and type of adverse event per study arm. Seven of the 17 trials (41%) reported the number of specific adverse events per study arm and six (35%) reported the type per study arm. The reporting of adverse events in randomised controlled trials of GH is variable and not consistent across trials. It is not possible to assess the impact that adverse events may have had on unblinding patients, and therefore the extent to which the effects of GH may have been overestimated. Therefore those conducting endocrinology trials in the future need to pay attention to the reporting of withdrawals due to adverse events and specific adverse events.

Adult↗

Randomised controlled trial of L-carnitine as a nutritional supplement in preterm infants.

AIMS: To evaluate the effect of L-carnitine supplementation (25 mg/kg/d) on the growth and incidence of hypoglycaemia in preterm infants. METHODS: A double blind, placebo controlled randomised trial, stratified for gestational age, was conducted of 86 preterm infants between 28 and 34 gestational weeks. The median gestational ages in the carnitine group and placebo groups were 30.7 weeks (range 28.0 to 33.6) and 31.4 weeks (range 28.0 to 33.9), respectively. The median birthweights were 1.557 kg (range 0.944 to 2.275) and 1.645 kg (range 0.885 to 2.545), respectively. RESULTS: Mean plasma free carnitine concentrations were below values for normal term infants in both groups on day 1 (carnitine group 44.8 mumol/l, placebo group 25.5 mumol/l) in the placebo group on day 7 (50.7 mumol/l), but in neither group on days 14 and 28. Total, free, and acylcarnitine concentrations were significantly increased in both urine and blood in the L-carnitine group. There was no significant difference between the placebo and carnitine supplemented groups in growth rate, as assessed by weight, length, skinfold thickness and head circumference measurements, or in the incidence of episodes of hypoglycaemia. CONCLUSION: The addition of carnitine as a nutritional supplement at a dose of 25 mg/kg/day did not improve growth in our group of preterm infants nor protect them from episodes of hypoglycaemia.

Carnitine↗

Who should provide routine antenatal care for low-risk women, and how often? A systematic review of randomised controlled trials. WHO Antenatal Care Trial Research Group.

Many activities, the timing and the frequency of visits of conventional antenatal care provided to low-risk pregnant women have most often been introduced without proper scientific evaluation. Few trials, to date, have been conducted to evaluate the effectiveness of antenatal care programmes for low-risk women with varied number of antenatal visits and type of care providers. We have performed a systematic review of these randomised controlled trials. Five randomised controlled trials were identified in which the effectiveness of a schedule of reduced number of antenatal visits (n = 12,883) was compared with the existing practice (n = 9438). Four of these trials were carried out in developed countries. The difference in the number of visits between intervention and control arms of the trials was moderate. Only one trial achieved a reduction in the median number of visits, from six in the standard care to four in the intervention group, that could be considered to be of health-care relevance for the study population. No significant differences were observed in the two arms of the trials when low birthweight, small-for-gestational-age, Caesarean section, induction of labour, antepartum haemorrhage and postpartum haemorrhage were considered as outcome measures. However, there was a tendency towards an increased rate of preterm delivery in the intervention group in three of the trials. Conversely, the largest trial in Harare, Zimbabwe, demonstrated a statistically significant reduction in preterm delivery in the intervention group (relative risk [RR] 0.88; 95% confidence interval [CI] 0.80, 0.96). Neither the individual studies nor the review had the statistical power to evaluate mortality outcome variables. When perception of care was assessed, women participating in two trials expressed less satisfaction with frequency of visits in the experimental group. In the London, UK, trial, some women in the reduced number of visits group felt that their expectations were not completely fulfilled. However, an opposite trend was reflected when women were asked for their preference of the type of care for any future pregnancy. We also identified three trials that compared midwife/general practitioner-managed care vs. obstetrician/gynaecologist-led shared care. The results were indicative of similar clinical efficacy of the two groups. However, women's response regarding the continuity of care favoured midwife-led care. From the health economics perspective, there is evidence of cost reduction if antenatal care was provided by staff other than the obstetrician/gynaecologist. The available data demonstrate no significant differences in selected perinatal outcomes for low-risk women receiving care according to a reduced frequency (approximately two visits fewer) of prenatal visits vs. those following the existing practice. However, there are differences in satisfaction with the prenatal care provider and the prenatal care system. There is evidence that a midwife's clinic for provision of antenatal care for low-risk pregnancies is feasible and therapy reduction in costs achievable.

Appointments and Schedules↗

Effect of community based management in failure to thrive: randomised controlled trial.

OBJECTIVE: To evaluate the effectiveness of a health visitor led intervention for failure to thrive in children under 2 years old. DESIGN: Controlled trial, randomised by primary care practice. SETTING: Newcastle upon Tyne health district. INTERVENTION: Structured health visitor management, with dietetic, paediatric, and social work input as required. SUBJECTS: 229 children (120 in intervention practices and 109 in control practices) were identified as failing to thrive by population screening during the first 2 years of life. Follow up was by home visit of a research nurse and review of the childrens' records at age 3 years. MAIN OUTCOME MEASURES: Follow up weight and height and number of routinely collected weights. RESULTS: 95 of the 97 families offered intervention completed at least the initial assessment. At follow up, 187 (82%) records were reviewed, and these suggested that 15 (16%) controls were lost to follow up immediately after the screening weight was taken compared with only one child in the intervention group. In the 134 (58%) families who consented to home visits, children in the intervention group were significantly heavier and taller and were reported to have better appetites than childen in the control group, although both groups were equally satisfied by the services they had received. When the children were last weighed, 91 (76%) in the intervention group had recovered from their failure to thrive compared with 60 (55%) in the control group (P<0.001). CONCLUSION: In failure to thrive, health visitor intervention, with limited specialist support, can significantly improve growth compared with conventional management.

Body Height↗

Effects of single-injection vs. continuous brachial plexus blocks for shoulder surgeries on patient-reported outcomes: a systematic review and meta-analysis with trial sequential analysis of randomised controlled trials.

INTRODUCTION: Single-injection and continuous brachial plexus block techniques are used widely for postoperative analgesia in patients undergoing shoulder surgery. Although patient-reported outcomes are described in individual studies, their effects have not been synthesised comprehensively using a patient-centred framework. We sought to compare the effects of single-injection vs. continuous brachial plexus block techniques on patient-reported outcomes in adult patients following elective shoulder surgery. METHODS: Databases were searched from inception to October 2025 and randomised controlled trials reporting patient-reported outcomes were included. Co-primary outcomes were postoperative patient-reported pain intensity at rest and during movement at 12&#x2009;h, 24&#x2009;h and 48&#x2009;h post-surgery. Secondary outcomes included nausea and vomiting; sleep quality; patient satisfaction; opioid requests; and functional scores. Random-effects meta-analysis and trial sequential analysis were performed, with risk of bias and quality of patient-reported outcome reporting assessed. RESULTS: Twenty randomised controlled trials that included 1198 patients were analysed. Continuous brachial plexus blocks were associated with lower pain at rest at 12&#x2009;h, 24&#x2009;h and 48&#x2009;h, with mean differences (MD) of -1.96 (95%CI -2.81 to -1.11, p&#x2009;<&#x2009;0.001), -1.66 (95%CI -2.27 to -1.05, p&#x2009;<&#x2009;0.001) and&#x2009;-&#x2009;1.18 (95%CI -1.84 to -0.53, p&#x2009;<&#x2009;0.001), respectively. Pain on movement could only be pooled at 24&#x2009;h and 48&#x2009;h and showed MD -2.04 (95%CI -4.26-0.19, p&#x2009;=&#x2009;0.07) and&#x2009;-&#x2009;1.30 (95%CI -3.67-1.07, p&#x2009;=&#x2009;0.28) respectively. The co-primary outcomes approached or exceeded the predefined minimal clinically important difference for pain scores after shoulder surgery, in favour of continuous techniques. DISCUSSION: Continuous brachial plexus blocks are associated with better pain at rest and other patient-centred outcomes following shoulder surgery, while effects on dynamic pain and long-term functional recovery remain uncertain.

Humans↗

Treatment of warfarin-associated coagulopathy with oral vitamin K: a randomised controlled trial.

BACKGROUND: Warfarin-associated coagulopathy is a frequent clinical complication. We aimed to assess whether treatment with vitamin K is safe and more effective than placebo in rapidly lowering the international normalised ratio (INR) into the therapeutic range in over anticoagulated patients receiving warfarin. METHODS: We did a multicentre, double-blind, placebo-controlled, randomised trial in five tertiary care hospitals. In this study, patients receiving warfarin who had an INR value between 4.5 and 10.0, and who did not have an indication for the immediate normalisation of their INR, had their warfarin withheld, and were randomly allocated to receive either 1 mg of vitamin K or placebo orally. The primary outcome measure was the INR value on the day after treatment. Secondary outcome measures included INR values on subsequent days, and the risk of haemorrhage and recurrent thrombosis over a 3 month follow-up period. FINDINGS: Patients given vitamin K had a more rapid decrease in the INR than those given placebo (25 of 45 (56%] vs nine of 44 [20%] patients with INR values of 1.8-3.2 on the day after treatment, respectively, p=0.001; odds ratio [OR] 0.21, 95% CI 0.07-0.57). Fewer patients given vitamin K had bleeding episodes during the follow-up period than those given placebo (two [4%] vs eight [17%] patients, respectively, p=0.050; OR 0.87, 95% CI 0.019-0.999). INTERPRETATION: Low dose oral vitamin K is more effective than placebo for the rapid lowering of raised INR values in patients taking warfarin.

Administration, Oral↗