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Journal Cover   The Lancet
  [SJR: 11.563]   [H-I: 514]   [1270 followers]  Follow
    
   Full-text available via subscription Subscription journal
   ISSN (Print) 0140-6736 - ISSN (Online) 1474-547X
   Published by Elsevier Homepage  [2812 journals]
  • Effectiveness and cost-effectiveness of mindfulness-based cognitive
           therapy compared with maintenance antidepressant treatment in the
           prevention of depressive relapse or recurrence (PREVENT): a randomised
           controlled trial
    • Abstract: Publication date: 4–10 July 2015
      Source:The Lancet, Volume 386, Issue 9988
      Author(s): Willem Kuyken , Rachel Hayes , Barbara Barrett , Richard Byng , Tim Dalgleish , David Kessler , Glyn Lewis , Edward Watkins , Claire Brejcha , Jessica Cardy , Aaron Causley , Suzanne Cowderoy , Alison Evans , Felix Gradinger , Surinder Kaur , Paul Lanham , Nicola Morant , Jonathan Richards , Pooja Shah , Harry Sutton , Rachael Vicary , Alice Weaver , Jenny Wilks , Matthew Williams , Rod S Taylor , Sarah Byford
      Background Individuals with a history of recurrent depression have a high risk of repeated depressive relapse or recurrence. Maintenance antidepressants for at least 2 years is the current recommended treatment, but many individuals are interested in alternatives to medication. Mindfulness-based cognitive therapy (MBCT) has been shown to reduce risk of relapse or recurrence compared with usual care, but has not yet been compared with maintenance antidepressant treatment in a definitive trial. We aimed to see whether MBCT with support to taper or discontinue antidepressant treatment (MBCT-TS) was superior to maintenance antidepressants for prevention of depressive relapse or recurrence over 24 months. Methods In this single-blind, parallel, group randomised controlled trial (PREVENT), we recruited adult patients with three or more previous major depressive episodes and on a therapeutic dose of maintenance antidepressants, from primary care general practices in urban and rural settings in the UK. Participants were randomly assigned to either MBCT-TS or maintenance antidepressants (in a 1:1 ratio) with a computer-generated random number sequence with stratification by centre and symptomatic status. Participants were aware of treatment allocation and research assessors were masked to treatment allocation. The primary outcome was time to relapse or recurrence of depression, with patients followed up at five separate intervals during the 24-month study period. The primary analysis was based on the principle of intention to treat. The trial is registered with Current Controlled Trials, ISRCTN26666654. Findings Between March 23, 2010, and Oct 21, 2011, we assessed 2188 participants for eligibility and recruited 424 patients from 95 general practices. 212 patients were randomly assigned to MBCT-TS and 212 to maintenance antidepressants. The time to relapse or recurrence of depression did not differ between MBCT-TS and maintenance antidepressants over 24 months (hazard ratio 0·89, 95% CI 0·67–1·18; p=0·43), nor did the number of serious adverse events. Five adverse events were reported, including two deaths, in each of the MBCT-TS and maintenance antidepressants groups. No adverse events were attributable to the interventions or the trial. Interpretation We found no evidence that MBCT-TS is superior to maintenance antidepressant treatment for the prevention of depressive relapse in individuals at risk for depressive relapse or recurrence. Both treatments were associated with enduring positive outcomes in terms of relapse or recurrence, residual depressive symptoms, and quality of life. Funding National Institute for Health Research (NIHR) Health Technology Assessment (HTA) programme, and NIHR Collaboration for Leadership in Applied Health Research and Care South West Peninsula.


      PubDate: 2015-07-05T07:10:24Z
       
  • At last, vaccine-induced protection against Helicobacter pylori
    • Abstract: Publication date: Available online 30 June 2015
      Source:The Lancet
      Author(s): Philip Sutton



      PubDate: 2015-07-05T07:10:24Z
       
  • Efficacy, safety, and immunogenicity of an oral recombinant Helicobacter
           pylori vaccine in children in China: a randomised, double-blind,
           placebo-controlled, phase 3 trial
    • Abstract: Publication date: Available online 30 June 2015
      Source:The Lancet
      Author(s): Ming Zeng , Xu-Hu Mao , Jing-Xin Li , Wen-De Tong , Bin Wang , Yi-Ju Zhang , Gang Guo , Zhi-Jing Zhao , Liang Li , De-Lin Wu , Dong-Shui Lu , Zhong-Ming Tan , Hao-Yu Liang , Chao Wu , Da-Han Li , Ping Luo , Hao Zeng , Wei-Jun Zhang , Jin-Yu Zhang , Bo-Tao Guo , Feng-Cai Zhu , Quan-Ming Zou
      Background Helicobacter pylori is one of the most common gastric pathogens, affecting at least half the world's population, and is strongly associated with gastritis, peptic ulcer, gastric adenocarcinoma, and lymphoma. We aimed to assess the efficacy, safety, and immunogenicity of a three-dose oral recombinant H pylori vaccine in children in China. Methods We did this randomised, double-blind, placebo-controlled, phase 3 trial at one centre in Ganyu County, Jiangsu Province, China. Healthy children aged 6–15 years without past or present H pylori infection were randomly assigned (1:1), via computer-generated randomisation codes in blocks of ten, to receive the H pylori vaccine or placebo. Participants, their guardians, and study investigators were masked to treatment allocation. The primary efficacy endpoint was the occurrence of H pylori infection within 1 year after vaccination. We did analysis in the per-protocol population. This trial is registered with ClinicalTrials.gov, number NCT02302170. Findings Between Dec 2, 2004, and March 19, 2005, we randomly assigned 4464 participants to either the vaccine group (n=2232) or the placebo group (n=2232), of whom 4403 (99%) participants completed the three-dose vaccination schedule and were included in the per-protocol efficacy analysis. We extended follow-up to 3 years. We recorded 64 events of H pylori infection within the first year (14 events in 2074·3 person-years at risk in the vaccine group vs 50 events in 2089·6 person-years at risk in the placebo group), resulting in a vaccine efficacy of 71·8% (95% CI 48·2–85·6). 157 (7%) participants in the vaccine group and 161 (7%) participants in the placebo group reported at least one adverse reaction. Serious adverse events were reported in five (<1%) participants in the vaccine group and seven (<1%) participants in the placebo group, but none was considered to be vaccination related. Interpretation The oral recombinant H pylori vaccine was effective, safe, and immunogenic in H pylori-naive children. This vaccine could substantially reduce the incidence of H pylori infection; however, follow up over a longer period is needed to confirm the protection of the vaccine against H pylori-associated diseases. Funding Chongqing Kangwei Biological Technology.


      PubDate: 2015-07-05T07:10:24Z
       
  • Department of Error
    • Abstract: Publication date: Available online 2 July 2015
      Source:The Lancet




      PubDate: 2015-07-05T07:10:24Z
       
  • Putting raised intraocular pressure in context
    • Abstract: Publication date: 4–10 July 2015
      Source:The Lancet, Volume 386, Issue 9988
      Author(s): Fion D Bremner



      PubDate: 2015-07-05T07:10:24Z
       
  • More DATA to guide sequential osteoporosis therapy
    • Abstract: Publication date: Available online 2 July 2015
      Source:The Lancet
      Author(s): Lorenz C Hofbauer , Tilman D Rachner



      PubDate: 2015-07-05T07:10:24Z
       
  • Denosumab and teriparatide transitions in postmenopausal osteoporosis (the
           DATA-Switch study): extension of a randomised controlled trial
    • Abstract: Publication date: Available online 2 July 2015
      Source:The Lancet
      Author(s): Benjamin Z Leder , Joy N Tsai , Alexander V Uihlein , Paul M Wallace , Hang Lee , Robert M Neer , Sherri-Ann M Burnett-Bowie
      Background Unlike most chronic diseases, osteoporosis treatments are generally limited to a single drug at a fixed dose and frequency. Nonetheless, no approved therapy is able to restore skeletal integrity in most osteoporotic patients and the long-term use of osteoporosis drugs is controversial. Thus, many patients are treated with the sequential use of two or more therapies. The DATA study showed that combined teriparatide and denosumab increased bone mineral density more than either drug alone. Discontinuing teriparatide and denosumab, however, results in rapidly declining bone mineral density. In this DATA-Switch study, we aimed to assess the changes in bone mineral density in postmenopausal osteoporotic women who transitioned between treatments. Methods This randomised controlled trial (DATA-Switch) is a preplanned extension of the denosumab and teriparatide administration study (DATA), in which 94 postmenopausal osteoporotic women were randomly assigned to receive 24 months of teriparatide (20 mg daily), denosumab (60 mg every 6 months), or both drugs. In DATA-Switch, women originally assigned to teriparatide received denosumab (teriparatide to denosumab group), those originally assigned to denosumab received teriparatide (denosumab to teriparatide group), and those originally assigned to both received an additional 24 months of denosumab alone (combination to denosumab group). Bone mineral density at the spine, hip, and wrist were measured 6 months, 12 months, 18 months, and 24 months after the drug transitions as were biochemical markers of bone turnover. The primary endpoint was the percent change in posterior-anterior spine bone mineral density over 4 years. Between-group changes were assessed by one-way analysis of variance in our modified intention-to-treat population. This study is registered with ClinicalTrials.gov, number NCT00926380. Findings Between Sept 27, 2011, and Jan 28, 2013, eligible women from the DATA study were enrolled into DATA-Switch. Of 83 potential enrollees from the DATA study, 77 completed at least one post-baseline visit. After 48 months, the primary outcome of mean spine bone mineral density increased by 18·3% (95% CI 14·9–21·8) in 27 women in the teriparatide to denosumab group, 14·0% (10·9–17·2) in 27 women the denosumab to teriparatide group, and 16·0% (14·0–18·0) in 23 women in the combination to denosumab group, although this increase did not differ significantly between groups (for between-group comparisons, p=0·13 for the teriparatide to denosumab group vs the denosumab to teriparatide group, p=0·30 for the teriparatide to denosumab group vs the combination to denosumab group, and p=0·41 for the denosumab to teriparatide group vs the combination to denosumab group). For the bone mineral density secondary outcomes, total hip bone mineral density increased more in the teriparatide to denosumab group (6·6% [95% CI 5·3–7·9]) than in the denosumab to teriparatide group (2·8% [1·3–4·2], p=0·0002), but had the greatest increase in the combination to denosumab group (8·6% [7·1–10·0]; p=0·0446 vs the teriparatide to denosumab group, p<0·0001 vs the denosumab to teriparatide group). Similarly, femoral neck bone mineral density increased more in the teriparatide to denosumab group (8·3% [95% CI 6·1–10·5]) and the combination to denosumab group (9·1% [6·1–12·0]) than in the denosumab to teriparatide group (4·9% [2·2–7·5]; p=0·0447 for teriparatide to denosumab vs denosumab to teriparatide, p=0·0336 for combination to denosumab vs denosumab to teriparatide). Differences between the combination to denosumab group and the teriparatide to denosumab group did not differ significantly (p=0·67). After 48 months, radius bone mineral density was unchanged in the teriparatide to denosumab group (0·0% [95% CI −1·3 to 1·4]), whereas it decreased by −1·8% (−5·0 to 1·3) in the denosumab to teriparatide group, and increased by 2·8% (1·2–4·4) in the combination to denosumab group (p=0·0075 for the teriparatide to denosumab group vs the combination to denosumab group; p=0·0099 for th...
      PubDate: 2015-07-05T07:10:24Z
       
  • Acute pancreatitis
    • Abstract: Publication date: 4–10 July 2015
      Source:The Lancet, Volume 386, Issue 9988
      Author(s): Paul Georg Lankisch , Minoti Apte , Peter A Banks
      Acute pancreatitis, an inflammatory disorder of the pancreas, is the leading cause of admission to hospital for gastrointestinal disorders in the USA and many other countries. Gallstones and alcohol misuse are long-established risk factors, but several new causes have emerged that, together with new aspects of pathophysiology, improve understanding of the disorder. As incidence (and admission rates) of acute pancreatitis increase, so does the demand for effective management. We review how to manage patients with acute pancreatitis, paying attention to diagnosis, differential diagnosis, complications, prognostic factors, treatment, and prevention of second attacks, and the possible transition from acute to chronic pancreatitis.


      PubDate: 2015-07-05T07:10:24Z
       
  • Can mass media interventions reduce child mortality'
    • Abstract: Publication date: 4–10 July 2015
      Source:The Lancet, Volume 386, Issue 9988
      Author(s): Roy Head , Joanna Murray , Sophie Sarrassat , Will Snell , Nicolas Meda , Moctar Ouedraogo , Laurent Deboise , Simon Cousens
      Many people recognise that mass media is important in promoting public health but there have been few attempts to measure how important. An ongoing trial in Burkina Faso (ClinicalTrials.gov, NCT01517230) is an attempt to bring together the very different worlds of mass media and epidemiology: to measure rigorously, using a cluster-randomised design, how many lives mass media can save in a low-income country, and at what cost. Application of the Lives Saved Tool predicts that saturation-based media campaigns could reduce child mortality by 10–20%, at a cost per disability-adjusted life-year that is as low as any existing health intervention. In this Viewpoint we explain the scientific reasoning behind the trial, while stressing the importance of the media methodology used.


      PubDate: 2015-07-05T07:10:24Z
       
  • Sight-threatening intraocular pressure due to an upper arm dialysis
           fistula
    • Abstract: Publication date: 4–10 July 2015
      Source:The Lancet, Volume 386, Issue 9988
      Author(s): Miles Kiernan , Maninder Bhogal , Ken Wong , Rajesh Sivaprakasam , Neil Ashman , Nadeem Ali



      PubDate: 2015-07-05T07:10:24Z
       
  • Vitiligo
    • Abstract: Publication date: 4–10 July 2015
      Source:The Lancet, Volume 386, Issue 9988
      Author(s): Khaled Ezzedine , Viktoria Eleftheriadou , Maxine Whitton , Nanja van Geel
      Vitiligo, an acquired pigmentary disorder of unknown origin, is the most frequent cause of depigmentation worldwide, with an estimated prevalence of 1%. The disorder can be psychologically devastating and stigmatising, especially in dark skinned individuals. Vitiligo is clinically characterised by the development of white macules due to the loss of functioning melanocytes in the skin or hair, or both. Two forms of the disease are well recognised: segmental and non-segmental vitiligo (the commonest form). To distinguish between these two forms is of prime importance because therapeutic options and prognosis are quite different. The importance of early treatment and understanding of the profound psychosocial effect of vitiligo will be emphasised throughout this Seminar.


      PubDate: 2015-07-05T07:10:24Z
       
  • Breakdown of simple female genital fistula repair after 7 day versus 14
           day postoperative bladder catheterisation: a randomised, controlled,
           open-label, non-inferiority trial
    • Abstract: Publication date: 4–10 July 2015
      Source:The Lancet, Volume 386, Issue 9988
      Author(s): Mark A Barone , Mariana Widmer , Steven Arrowsmith , Joseph Ruminjo , Armando Seuc , Evelyn Landry , Thierno Hamidou Barry , Dantani Danladi , Lucien Djangnikpo , Tagie Gbawuru-Mansaray , Issoufa Harou , Alyona Lewis , Mulu Muleta , Dolorès Nembunzu , Robert Olupot , Ileogben Sunday-Adeoye , Weston Khisa Wakasiaka , Sihem Landoulsi , Alexandre Delamou , Lilian Were , Vera Frajzyngier , Karen Beattie , A Metin Gülmezoglu
      Background Duration of bladder catheterisation after female genital fistula repair varies widely. We aimed to establish whether 7 day bladder catheterisation was non-inferior to 14 days in terms of incidence of fistula repair breakdown in women with simple fistula. Methods In this randomised, controlled, open-label, non-inferiority trial, we enrolled patients at eight hospitals in the Democratic Republic of the Congo, Ethiopia, Guinea, Kenya, Niger, Nigeria, Sierra Leone, and Uganda. Consenting patients were eligible if they had a simple fistula that was closed after surgery and remained closed 7 days after surgery, understood study procedures and requirements, and agreed to return for follow-up 3 months after surgery. We excluded women if their fistula was not simple or was radiation-induced, associated with cancer, or due to lymphogranuloma venereum; if they were pregnant; or if they had multiple fistula. A research assistant at each site randomly allocated participants 1:1 (randomly varying block sizes of 4–6; stratified by country) to 7 day or 14 day bladder catheterisation (via a random allocation sequence computer generated centrally by WHO). Outcome assessors were not masked to treatment assignment. The primary outcome was fistula repair breakdown, on the basis of dye test results, any time between 8 days after catheter removal and 3 months after surgery. The non-inferiority margin was 10%, assessed in the per-protocol population. This trial is registered with ClinicalTrials.gov, number NCT01428830. Findings We randomly allocated 524 participants between March 7, 2012, and May 6, 2013; 261 in the 7 day group and 263 in the 14 day group. In the per-protocol analysis, ten (4%) of 250 patients had repair breakdown in the 7 day group (95% CI 2–8) compared with eight (3%) of 251 (2–6) in the 14 day group (risk difference 0·8% [95% CI −2·8 to 4·5]), meeting the criteria for non-inferiority. Interpretation 7 day bladder catheterisation after repair of simple fistula is non-inferior to 14 day catheterisation and could be used for management of women after repair of simple fistula with no evidence of a significantly increased risk of repair breakdown, urinary retention, or residual incontinence up to 3 months after surgery. Funding US Agency for International Development.


      PubDate: 2015-07-05T07:10:24Z
       
  • Human resources for health: a new narrative
    • Abstract: Publication date: 4–10 July 2015
      Source:The Lancet, Volume 386, Issue 9988
      Author(s): Judith Shamian , Gail Tomblin Murphy , Annette Elliott Rose , Lianne Jeffs



      PubDate: 2015-07-05T07:10:24Z
       
  • Mechanical chest compression in the PARAMEDIC trial
    • Abstract: Publication date: 4–10 July 2015
      Source:The Lancet, Volume 386, Issue 9988
      Author(s): Pierre-Nicolas Carron , Rémy Pantet , Mathieu Pasquier , Olivier Hugli



      PubDate: 2015-07-05T07:10:24Z
       
  • Ralph Lainson
    • Abstract: Publication date: 4–10 July 2015
      Source:The Lancet, Volume 386, Issue 9988
      Author(s): Geoff Watts



      PubDate: 2015-07-05T07:10:24Z
       
  • Asylum seekers' access to health care in Israel
    • Abstract: Publication date: 4–10 July 2015
      Source:The Lancet, Volume 386, Issue 9988
      Author(s): Nora Gottlieb , Habtom Ghebrezghiabher , Tsega Gebreyesus



      PubDate: 2015-07-05T07:10:24Z
       
  • “Let us go forward together”
    • Abstract: Publication date: 4–10 July 2015
      Source:The Lancet, Volume 386, Issue 9988
      Author(s): Natalie Harrison



      PubDate: 2015-07-05T07:10:24Z
       
  • All creatures great and small
    • Abstract: Publication date: 4–10 July 2015
      Source:The Lancet, Volume 386, Issue 9988
      Author(s): Danielle R Spencer



      PubDate: 2015-07-05T07:10:24Z
       
  • Why do we forget' DouweDraaismaForgetting: Myths, Perils and
           Compensations2015Yale University Press9780300207286288£18·99
    • Abstract: Publication date: 4–10 July 2015
      Source:The Lancet, Volume 386, Issue 9988
      Author(s): Steven Rose



      PubDate: 2015-07-05T07:10:24Z
       
  • Making sex add up DavidSpiegelhalterSex by Numbers: What Statistics Can
           Tell Us About Sexual Behaviour2015Wellcome Collection and Profile
           Books9781781253298368£7·99
    • Abstract: Publication date: 4–10 July 2015
      Source:The Lancet, Volume 386, Issue 9988
      Author(s): Emily Dubberley



      PubDate: 2015-07-05T07:10:24Z
       
  • Too many unknowns stymie response to MERS
    • Abstract: Publication date: 4–10 July 2015
      Source:The Lancet, Volume 386, Issue 9988
      Author(s): John Maurice



      PubDate: 2015-07-05T07:10:24Z
       
  • US Supreme Court upholds ACA subsidies
    • Abstract: Publication date: 4–10 July 2015
      Source:The Lancet, Volume 386, Issue 9988
      Author(s): Susan Jaffe



      PubDate: 2015-07-05T07:10:24Z
       
  • Ethiopia sets impressive carbon reduction target
    • Abstract: Publication date: 4–10 July 2015
      Source:The Lancet, Volume 386, Issue 9988
      Author(s): Sharmila Devi



      PubDate: 2015-07-05T07:10:24Z
       
  • Diabetes, obesity, and the metabolic syndrome: a call for papers for EASD
           and the World Diabetes Congress
    • Abstract: Publication date: 4–10 July 2015
      Source:The Lancet, Volume 386, Issue 9988
      Author(s): Philippa Berman , Justine Davies , Richard Horton



      PubDate: 2015-07-05T07:10:24Z
       
  • Offline: From Bedford Square to London Wall
    • Abstract: Publication date: 4–10 July 2015
      Source:The Lancet, Volume 386, Issue 9988
      Author(s): Richard Horton



      PubDate: 2015-07-05T07:10:24Z
       
  • Depression relapse: importance of a long-term perspective
    • Abstract: Publication date: 4–10 July 2015
      Source:The Lancet, Volume 386, Issue 9988
      Author(s): Roger Mulder



      PubDate: 2015-07-05T07:10:24Z
       
  • The Wakley Prize, 2015: what do you know'
    • Abstract: Publication date: 4–10 July 2015
      Source:The Lancet, Volume 386, Issue 9988
      Author(s): Joanna Palmer , Philippa Berman , Priya Venkatesan



      PubDate: 2015-07-05T07:10:24Z
       
  • AVERT: a major milestone in stroke research
    • Abstract: Publication date: 4–10 July 2015
      Source:The Lancet, Volume 386, Issue 9988
      Author(s): Peter M Rothwell



      PubDate: 2015-07-05T07:10:24Z
       
  • Bladder catheterisation after female genital fistula repair
    • Abstract: Publication date: 4–10 July 2015
      Source:The Lancet, Volume 386, Issue 9988
      Author(s): Anyetei Tonyeli Lassey



      PubDate: 2015-07-05T07:10:24Z
       
  • Efficacy and safety of very early mobilisation within 24 h of stroke onset
           (AVERT): a randomised controlled trial
    • Abstract: Publication date: 4–10 July 2015
      Source:The Lancet, Volume 386, Issue 9988

      Background Early mobilisation after stroke is thought to contribute to the effects of stroke-unit care; however, the intervention is poorly defined and not underpinned by strong evidence. We aimed to compare the effectiveness of frequent, higher dose, very early mobilisation with usual care after stroke. Methods We did this parallel-group, single-blind, randomised controlled trial at 56 acute stroke units in five countries. Patients (aged ≥18 years) with ischaemic or haemorrhagic stroke, first or recurrent, who met physiological criteria were randomly assigned (1:1), via a web-based computer generated block randomisation procedure (block size of six), to receive usual stroke-unit care alone or very early mobilisation in addition to usual care. Treatment with recombinant tissue plasminogen activator was allowed. Randomisation was stratified by study site and stroke severity. Patients, outcome assessors, and investigators involved in trial and data management were masked to treatment allocation. The primary outcome was a favourable outcome 3 months after stroke, defined as a modified Rankin Scale score of 0–2. We did analysis on an intention-to-treat basis. The trial is registered with the Australian New Zealand Clinical Trials Registry, number ACTRN12606000185561. Findings Between July 18, 2006, and Oct 16, 2014, we randomly assigned 2104 patients to receive either very early mobilisation (n=1054) or usual care (n=1050); 2083 (99%) patients were included in the 3 month follow-up assessment. 965 (92%) patients were mobilised within 24 h in the very early mobilisation group compared with 623 (59%) patients in the usual care group. Fewer patients in the very early mobilisation group had a favourable outcome than those in the usual care group (n=480 [46%] vs n=525 [50%]; adjusted odds ratio [OR] 0·73, 95% CI 0·59–0·90; p=0·004). 88 (8%) patients died in the very early mobilisation group compared with 72 (7%) patients in the usual care group (OR 1·34, 95% CI 0·93–1·93, p=0·113). 201 (19%) patients in the very early mobilisation group and 208 (20%) of those in the usual care group had a non-fatal serious adverse event, with no reduction in immobility-related complications with very early mobilisation. Interpretation First mobilisation took place within 24 h for most patients in this trial. The higher dose, very early mobilisation protocol was associated with a reduction in the odds of a favourable outcome at 3 months. Early mobilisation after stroke is recommended in many clinical practice guidelines worldwide, and our findings should affect clinical practice by refining present guidelines; however, clinical recommendations should be informed by future analyses of dose–response associations. Funding National Health and Medical Research Council, Singapore Health, Chest Heart and Stroke Scotland, Northern Ireland Chest Heart and Stroke, UK Stroke Association, National Institute of Health Research.


      PubDate: 2015-07-05T07:10:24Z
       
  • Stem cells in age-related macular degeneration and Stargardt's macular
           dystrophy – Authors' reply
    • Abstract: Publication date: 4–10 July 2015
      Source:The Lancet, Volume 386, Issue 9988
      Author(s): Steven D Schwartz , Eddy Anglade , Robert Lanza



      PubDate: 2015-07-05T07:10:24Z
       
  • Department of Error
    • Abstract: Publication date: 4–10 July 2015
      Source:The Lancet, Volume 386, Issue 9988




      PubDate: 2015-07-05T07:10:24Z
       
  • Department of Error
    • Abstract: Publication date: 4–10 July 2015
      Source:The Lancet, Volume 386, Issue 9988




      PubDate: 2015-07-05T07:10:24Z
       
  • Efficacy and safety of RTS,S/AS01 malaria vaccine with or without a
           booster dose in infants and children in Africa: final results of a phase
           3, individually randomised, controlled trial
    • Abstract: Publication date: 4–10 July 2015
      Source:The Lancet, Volume 386, Issue 9988

      Background The efficacy and safety of the RTS,S/AS01 candidate malaria vaccine during 18 months of follow-up have been published previously. Herein, we report the final results from the same trial, including the efficacy of a booster dose. Methods From March 27, 2009, until Jan 31, 2011, children (age 5–17 months) and young infants (age 6–12 weeks) were enrolled at 11 centres in seven countries in sub-Saharan Africa. Participants were randomly assigned (1:1:1) at first vaccination by block randomisation with minimisation by centre to receive three doses of RTS,S/AS01 at months 0, 1, and 2 and a booster dose at month 20 (R3R group); three doses of RTS,S/AS01 and a dose of comparator vaccine at month 20 (R3C group); or a comparator vaccine at months 0, 1, 2, and 20 (C3C [control group]). Participants were followed up until Jan 31, 2014. Cases of clinical and severe malaria were captured through passive case detection. Serious adverse events (SAEs) were recorded. Analyses were by modified intention to treat and per protocol. The coprimary endpoints were the occurrence of malaria over 12 months after dose 3 in each age category. In this final analysis, we present data for the efficacy of the booster on the occurrence of malaria. Vaccine efficacy (VE) against clinical malaria was analysed by negative binomial regression and against severe malaria by relative risk reduction. This trial is registered with ClinicalTrials.gov, number NCT00866619. Findings 8922 children and 6537 young infants were included in the modified intention-to-treat analyses. Children were followed up for a median of 48 months (IQR 39–50) and young infants for 38 months (34–41) after dose 1. From month 0 until study end, compared with 9585 episodes of clinical malaria that met the primary case definition in children in the C3C group, 6616 episodes occurred in the R3R group (VE 36·3%, 95% CI 31·8–40·5) and 7396 occurred in the R3C group (28·3%, 23·3–32·9); compared with 171 children who experienced at least one episode of severe malaria in the C3C group, 116 children experienced at least one episode of severe malaria in the R3R group (32·2%, 13·7 to 46·9) and 169 in the R3C group (1·1%, −23·0 to 20·5). In young infants, compared with 6170 episodes of clinical malaria that met the primary case definition in the C3C group, 4993 episodes occurred in the R3R group (VE 25·9%, 95% CI 19·9–31·5) and 5444 occurred in the R3C group (18·3%, 11·7–24·4); and compared with 116 infants who experienced at least one episode of severe malaria in the C3C group, 96 infants experienced at least one episode of severe malaria in the R3R group (17·3%, 95% CI −9·4 to 37·5) and 104 in the R3C group (10·3%, −17·9 to 31·8). In children, 1774 cases of clinical malaria were averted per 1000 children (95% CI 1387–2186) in the R3R group and 1363 per 1000 children (995–1797) in the R3C group. The numbers of cases averted per 1000 young infants were 983 (95% CI 592–1337) in the R3R group and 558 (158–926) in the R3C group. The frequency of SAEs overall was balanced between groups. However, meningitis was reported as a SAE in 22 children: 11 in the R3R group, ten in the R3C group, and one in the C3C group. The incidence of generalised convulsive seizures within 7 days of RTS,S/AS01 booster was 2·2 per 1000 doses in young infants and 2·5 per 1000 doses in children. Interpretation RTS,S/AS01 prevented a substantial number of cases of clinical malaria over a 3–4 year period in young infants and children when administered with or without a booster dose. Efficacy was enhanced by the administration of a booster dose in both age categories. Thus, the vaccine has the potential to make a substantial contribution to malaria control when used in combination with other effective control measures, especially in areas of high transmission.
      PubDate: 2015-07-05T07:10:24Z
       
  • Trials of obeticholic acid for non-alcoholic steatohepatitis –
           Authors' reply
    • Abstract: Publication date: 4–10 July 2015
      Source:The Lancet, Volume 386, Issue 9988
      Author(s): Brent A Neuschwander-Tetri , Mark L Van Natta , James Tonascia , Elizabeth M Brunt , David E Kleiner



      PubDate: 2015-07-05T07:10:24Z
       
  • Stem cells in age-related macular degeneration and Stargardt's macular
           dystrophy
    • Abstract: Publication date: 4–10 July 2015
      Source:The Lancet, Volume 386, Issue 9988
      Author(s): Janet S Sunness



      PubDate: 2015-07-05T07:10:24Z
       
  • Stem cells in age-related macular degeneration and Stargardt's macular
           dystrophy
    • Abstract: Publication date: 4–10 July 2015
      Source:The Lancet, Volume 386, Issue 9988
      Author(s): Guo-You Zhang , Tian Liao , Xiao-Bing Fu , Qing-Feng Li



      PubDate: 2015-07-05T07:10:24Z
       
  • Mechanical chest compression in the PARAMEDIC trial – Authors' reply
    • Abstract: Publication date: 4–10 July 2015
      Source:The Lancet, Volume 386, Issue 9988
      Author(s): Gavin D Perkins , Tom Quinn , Charles D Deakin , Ranjit Lall , Simon Gates



      PubDate: 2015-07-05T07:10:24Z
       
  • Trials of obeticholic acid for non-alcoholic steatohepatitis
    • Abstract: Publication date: 4–10 July 2015
      Source:The Lancet, Volume 386, Issue 9988
      Author(s): Giovanni Musso , Maurizio Cassader , Roberto Gambino



      PubDate: 2015-07-05T07:10:24Z
       
  • Trials of obeticholic acid for non-alcoholic steatohepatitis
    • Abstract: Publication date: 4–10 July 2015
      Source:The Lancet, Volume 386, Issue 9988
      Author(s): Matthew J Armstrong , Philip N Newsome



      PubDate: 2015-07-05T07:10:24Z
       
  • A new approach for cancer primary care in England
    • Abstract: Publication date: 4–10 July 2015
      Source:The Lancet, Volume 386, Issue 9988
      Author(s): The Lancet



      PubDate: 2015-07-05T07:10:24Z
       
  • US Supreme Court decides in favour of the Affordable Care Act
    • Abstract: Publication date: 4–10 July 2015
      Source:The Lancet, Volume 386, Issue 9988
      Author(s): The Lancet



      PubDate: 2015-07-05T07:10:24Z
       
  • STIs climbing in men who have sex with men in England
    • Abstract: Publication date: 4–10 July 2015
      Source:The Lancet, Volume 386, Issue 9988
      Author(s): The Lancet



      PubDate: 2015-07-05T07:10:24Z
       
  • Keeping score: fostering accountability for children's lives
    • Abstract: Publication date: 4–10 July 2015
      Source:The Lancet, Volume 386, Issue 9988
      Author(s): Christopher Murray , Ray Chambers



      PubDate: 2015-07-05T07:10:24Z
       
  • Final results from a pivotal phase 3 malaria vaccine trial
    • Abstract: Publication date: 4–10 July 2015
      Source:The Lancet, Volume 386, Issue 9988
      Author(s): Vasee S Moorthy , Jean-Marie Okwo-Bele



      PubDate: 2015-07-05T07:10:24Z
       
  • Public health, universal health coverage, and Sustainable Development
           Goals: can they coexist?
    • Abstract: Publication date: Available online 29 June 2015
      Source:The Lancet
      Author(s): Harald Schmidt , Lawrence O Gostin , Ezekiel J Emanuel



      PubDate: 2015-06-30T07:07:54Z
       
  • The UK's strong contribution to health globally
    • Abstract: Publication date: Available online 28 June 2015
      Source:The Lancet
      Author(s): Nadeem Hasan , Sarah Curran , Arnoupe Jhass , Shoba Poduval , Helena Legido-Quigley , Nigel Crisp



      PubDate: 2015-06-30T07:07:54Z
       
  • Periprosthetic joint infection
    • Abstract: Publication date: Available online 28 June 2015
      Source:The Lancet
      Author(s): Bhaveen H Kapadia , Richard A Berg , Jacqueline A Daley , Jan Fritz , Anil Bhave , Michael A Mont
      Periprosthetic joint infections are a devastating complication after arthroplasty and are associated with substantial patient morbidity. More than 25% of revisions are attributed to these infections, which are expected to increase. The increased prevalence of obesity, diabetes, and other comorbidities are some of the reasons for this increase. Recognition of the challenge of surgical site infections in general, and periprosthetic joint infections particularly, has prompted implementation of enhanced prevention measures preoperatively (glycaemic control, skin decontamination, decolonisation, etc), intraoperatively (ultraclean operative environment, blood conservation, etc), and postoperatively (refined anticoagulation, improved wound dressings, etc). Additionally, indications for surgical management have been refined. In this Review, we assess risk factors, preventive measures, diagnoses, clinical features, and treatment options for prosthetic joint infection. An international consensus meeting about such infections identified the best practices and further research needs. Orthopaedics could benefit from enhanced preventive, diagnostic, and treatment methods.


      PubDate: 2015-06-30T07:07:54Z
       
  • Oral versus intravenous high-dose methylprednisolone for treatment of
           relapses in patients with multiple sclerosis (COPOUSEP): a randomised,
           controlled, double-blind, non-inferiority trial
    • Abstract: Publication date: Available online 28 June 2015
      Source:The Lancet
      Author(s): Emmanuelle Le Page , David Veillard , David A Laplaud , Stéphanie Hamonic , Rasha Wardi , Christine Lebrun , Fabien Zagnoli , Sandrine Wiertlewski , Véronique Deburghgraeve , Marc Coustans , Gilles Edan
      Background High doses of intravenous methylprednisolone are recommended to treat relapses in patients with multiple sclerosis, but can be inconvenient and expensive. We aimed to assess whether oral administration of high-dose methylprednisolone was non-inferior to intravenous administration. Methods We did this multicentre, double-blind, randomised, controlled, non-inferiority trial at 13 centres for multiple sclerosis in France. We enrolled patients aged 18–55 years with relapsing-remitting multiple sclerosis who reported a relapse within the previous 15 days that caused an increase of at least one point in one or more scores on the Kurtzke Functional System Scale. With use of a computer-generated randomisation list and in blocks of four, we randomly assigned (1:1) patients to either oral or intravenous methylprednisolone, 1000 mg, once a day for 3 days. Patients, treating physicians and nurses, and data and outcome assessors were all masked to treatment allocation, which was achieved with the use of saline solution and placebo capsules. The primary endpoint was the proportion of patients who had improved by day 28 (decrease of at least one point in most affected score on Kurtzke Functional System Scale), without need for retreatment with corticosteroids, in the per-protocol population. The trial was powered to assess non-inferiority of oral compared with intravenous methylprednisolone with a predetermined non-inferiority margin of 15%. This trial is registered with ClinicalTrials.gov, number NCT00984984. Findings Between Jan 29, 2008, and June 14, 2013, we screened 200 patients and enrolled 199. We randomly assigned 100 patients to oral methylprednisolone and 99 patients to intravenous methylprednisolone with a mean time from relapse onset to treatment of 7·0 days (SD 3·6) and 7·4 days (3·9), respectively. In the per-protocol population, 66 (81%) of 82 patients in the oral group and 72 (80%) of 90 patients in the intravenous group achieved the primary endpoint (absolute treatment difference 0·5%, 90% CI −9·5 to 10·4). Rates of adverse events were similar, but insomnia was more frequently reported in the oral group (77 [77%]) than in the intravenous group (63 [64%]). Interpretation Oral administration of high-dose methylprednisolone for 3 days was not inferior to intravenous administration for improvement of disability scores 1 month after treatment and had a similar safety profile. This finding could have implications for access to treatment, patient comfort, and cost, but indication should always be properly considered by clinicians. Funding French Health Ministry, Ligue Française contre la SEP, Teva.


      PubDate: 2015-06-30T07:07:54Z
       
  • Secukinumab, a human anti-interleukin-17A monoclonal antibody, in patients
           with psoriatic arthritis (FUTURE 2): a randomised, double-blind,
           placebo-controlled, phase 3 trial
    • Abstract: Publication date: Available online 28 June 2015
      Source:The Lancet
      Author(s): Iain B McInnes , Philip J Mease , Bruce Kirkham , Arthur Kavanaugh , Christopher T Ritchlin , Proton Rahman , Désirée van der Heijde , Robert Landewé , Philip G Conaghan , Alice B Gottlieb , Hanno Richards , Luminita Pricop , Gregory Ligozio , Manmath Patekar , Shephard Mpofu
      Background Interleukin 17A is a proinflammatory cytokine that is implicated in the pathogenesis of psoriatic arthritis. We assessed the efficacy and safety of subcutaneous secukinumab, a human anti-interleukin-17A monoclonal antibody, in patients with psoriatic arthritis. Methods In this phase 3, double-blind, placebo-controlled study undertaken at 76 centres in Asia, Australia, Canada, Europe, and the USA, adults (aged ≥18 years old) with active psoriatic arthritis were randomly allocated in a 1:1:1:1 ratio with computer-generated blocks to receive subcutaneous placebo or secukinumab 300 mg, 150 mg, or 75 mg once a week from baseline and then every 4 weeks from week 4. Patients and investigators were masked to treatment assignment. The primary endpoint was the proportion of patients achieving at least 20% improvement in the American College of Rheumatology response criteria (ACR20) at week 24. Analysis was by intention to treat. This study is registered with ClinicalTrials.gov, number NCT01752634. Findings Between April 14, and Nov 25, 2013, 397 patients were randomly assigned to receive secukinumab 300 mg (n=100), 150 mg (n=100), 75 mg (n=99), or placebo (n=98). A significantly higher proportion of patients achieved an ACR20 at week 24 with secukinumab 300 mg (54 [54%] patients; odds ratio versus placebo 6·81, 95% CI 3·42–13·56; p<0·0001), 150 mg (51 [51%] patients; 6·52, 3·25–13·08; p<0·0001), and 75 mg (29 [29%] patients; 2·32, 1·14–4·73; p=0·0399) versus placebo (15 [15%] patients). Up to week 16, the most common adverse events were upper respiratory tract infections (four [4%], eight [8%], ten [10%], and seven [7%] with secukinumab 300 mg, 150 mg, 75 mg, and placebo, respectively) and nasopharyngitis (six [6%], four [4%], six [6%], and eight [8%], respectively). Serious adverse events were reported by five (5%), one (1%), and four (4%) patients in the secukinumab 300 mg, 150 mg, and 75 mg groups, respectively, compared with two (2%) in the placebo group. No deaths were reported. Interpretation Subcutaneous secukinumab 300 mg and 150 mg improved the signs and symptoms of psoriatic arthritis, suggesting that secukinumab is a potential future treatment option for patients with this disorder. Funding Novartis.


      PubDate: 2015-06-30T07:07:54Z
       
 
 
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