Acupuncture & care may help depression; Pneumococcal infection vaccine; A disruptive medical journal

(Press-News.org) Everything published by PLOS Medicine is open access: freely available for anyone to read, download, redistribute and otherwise use, as long as the authorship is properly attributed.

Please mention PLOS Medicine in your report and use the links below to take your readers straight to the online articles:

Acupuncture or counselling plus usual care may improve depression symptoms Vaccine against pneumococcal infections has led to widespread reduction in serious disease The importance of a medical journal being disruptive Improved strategies are needed to assess of postmarket safety and effectiveness of medical devices

For information about PLOS Medicine relevant to journalists, bloggers and press officers, including an outline of our approach to the media, our embargo policy, and how you can re-use PLOS Medicine material, see the Media page on the Speaking of Medicine blog: http://speakingofmedicine.plos.org/media/

Acupuncture or counselling plus usual care may improve depression symptoms Acupuncture or counselling, provided alongside usual care, could benefit patients with depression, according to a study published this week in PLOS Medicine. The results of the study, conducted by Dr Hugh MacPherson and colleagues, from the University of York, UK, found that within a primary care setting, combining acupuncture or counselling with usual care had some benefits after 3 months of treatment to patients with recurring depression. The study was funded by the National Institute for Health Research (NIHR) Programme Grants for Applied Research Programme.

Many patients with depression are interested in receiving non-drug therapies, however, there is limited evidence to support the use of acupuncture or counselling for depression in a primary care setting. In this pragmatic randomised controlled trial conducted in the north of England, the authors randomised patients with depression to receive 12 weekly sessions of acupuncture plus usual care (302 patients), or 12 weekly sessions of counselling plus usual care (302 patients), or usual care alone (151 patients). Compared to usual care alone, there was a significant reduction in average depression scores at 3 months for both the acupuncture and counselling interventions, but there was no significant difference in depression scores between the acupuncture and counselling groups. At 9 months and 12 months, because of improvements in the depression scores in the usual care group, acupuncture and counselling were no longer significantly better than usual care. Although these findings are encouraging, this study does not identify which aspects of acupuncture and counselling are likely to be most beneficial to patients, nor does it provide information about the effectiveness of acupuncture or counselling, compared to usual care, for patients with mild depression.

The authors say: "To our knowledge, our study is the first to rigorously evaluate the clinical and economic impact of acupuncture and counselling for patients in primary care who are representative of those who continue to experience depression in primary care." They continue: "We have provided evidence that acupuncture versus usual care and counselling versus usual care are both associated with a significant reduction in symptoms of depression in the short to medium term, and are not associated with serious adverse events. "

Funding: This article presents independent research funded by the National Institute for Health Research (NIHR) under its Programme Grants for Applied Research Programme (RP-PG-0707-10186). The views expressed are those of the author(s) and not necessarily those of the National Health Service, the NIHR or the Department of Health. The funders, and the University of York in its role as sponsor for the study, had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

Competing Interests: The authors have declared that no competing interests exist.

Citation: MacPherson H, Richmond S, Bland M, Brealey S, Gabe R, et al. (2013) Acupuncture and Counselling for Depression in Primary Care: A Randomised Controlled Trial. PLoS Med 10(9): e1001518. doi:10.1371/journal.pmed.1001518

IN YOUR COVERAGE PLEASE USE THIS URL TO PROVIDE ACCESS TO THE FREELY AVAILABLE PAPER:

http://www.plosmedicine.org/article/info%3Adoi%2F10.1371%2Fjournal.pmed.1001518

Contact:

Dr Hugh MacPherson
Department of Health Sciences
University of York
Tel: +44 (0)1904 321394
https://hsciweb.york.ac.uk/research/public/Staff.aspx?ID=926
http://www.hughmacpherson.com
http://www.stricta.info
E-mail: hugh.macpherson@york.ac.uk

Vaccine against pneumococcal infections has led to widespread reduction in serious disease

Vaccination with the pneumococcal conjugate vaccine-7 [PCV7—a vaccine that covers 7 strains (serotypes) of Streptococcus pneumoniae] is linked to overall decreases in the rate of serious infections caused by this bacterium, such as pneumonia and meningitis, referred to as invasive pneumococcal disease (IPD)], but small increases in IPD caused by serotypes of Streptococcus pneumoniae not covered by the vaccine ( referred to as non-vaccine type IPD), according to a study published in PLOS Medicine this week.

The results of this study, led by Daniel Feikin, Matthew Moore, and their colleagues from Johns Hopkins School of Public Health and the Centers for Disease Control and Prevention, USA, are important as they suggest rapid and sustained reductions in pneumococcal disease after vaccine introduction. The study does show that serotypes causing IPD covered by PCV-7 have been partially replaced by types not covered by PCV-7 (a phenomenon referred to as serotype replacement), which has implications for the surveillance of newer pneumococcal conjugate vaccines, such as PCV10 and PCV13, which cover more serotypes.

The authors combined IPD surveillance information from multiple countries to estimate changes in IPD rates before and after PCV7 introduction. For children aged under 5 years, the authors found that the overall number of observed cases of IPD in the first year after the introduction of PCV7 was about half the expected number; this reduction in the number of IPD cases remained relatively stable over 7 years. Among adults, the authors observed smaller, more variable decreases in overall IPD. Notably, the rate of IPD caused by vaccine serotypes decreased every year, but the rate of IPD caused by non-vaccine serotypes increased annually, which was likely to be the result of serotype replacement.

However, these findings have several limitations: PCV7 is no longer made and so extrapolation of these results to newer PCV10 and PCV13 formulations should be done cautiously. Moreover, because the surveillance data used in this study mainly came from high-income countries, these findings may not be generalizable to low-income countries, in which pneumococcal disease is a major problem.

The authors say: "The most important public health implication of our analysis was that decreases in overall IPD rates in children— the group targeted for PCV7 vaccination— occurred quickly and were sustained after vaccine introduction despite increases in [non-vaccine serotype] rates." They continue: "Optimizing surveillance data that allows for valid interpretations of the vaccine effect on disease is essential for sound policy decisions."

Funding: The study was supported by grant ID# OPP1020720 from the Bill & Melinda Gates Foundation (http://www.gatesfoundation.org/Pages/home.aspx). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

Competing Interests: The manuscript coauthors and members of the Serotype Replacement Study Group have the following conflicts: RD has, in the last five years, received grants/research support from Berna/Crucell, Wyeth/Pfizer, MSD and Protea; he has been a scientific consultant for Berna/Crucell, GlaxoSmithKline, Norvatis, Wyeth/Pfizer, Protea, MSD; he has been a speaker for Berna/Crucell, GlaxoSmithKline, and Wyeth/Pfizer; he is a shareholder of Protea/NASVAX. PDW has received research grants, honoraria, and travel expense reimbursements from vaccine manufacturers including Glaxo SmithKline, Norvatis, Sanofi Pasteur, Merck, and Wyeth, as well as from governmental agencies including the Quebec Ministry of Health and Social Services, Health Canada, and the Public Health Agency of Canada. JE has served as a member of a data safety monitoring board (DSMB) for Novartis meningococcal and typhoid vaccines and participated in an advisory meeting of their pneumococcal protein vaccine in 2009. JE works at the National Institute for Health and Welfare (THL), Helsinki, Finland, which has a research contract with GSK on pneumococcal vaccines. MH is a lead investigator for the Switzerland IPD surveillance program, which is partly funded by an unrestricted grant from Pfizer. JDK and OV are lead investigators of the Calgary Streptococcus pneumoniae Epidemiology Research (CASPER) study which is sponsored in part by an unrestricted grant from Pfizer, Canada. NPK has received research support from Pfizer, GSK, Merck, Sanofi Pasteur, and Norvatis. ML has received consulting fees from Pfizer. KLO has had research grants from Pfizer and GSK in the past 5 years, and has served on expert panels for GSK, Merck, and Aventis. GJT has received research funding from Wyeth and Pfizer, and has also received funding from Wyeth and Pfizer for serving on Advisory boards and as a speaker in relation to pneumococcal disease. EV has received support for travel to meetings from Wyeth/Pfizer and has been a speaker for Pfizer. IV has received funding support from Pfizer. RvK and SW are investigators of the German pneumococcal surveillance project in children/ESPED study, which is sponsored by an unrestricted grant by Pfizer Germany.

Citation: Feikin DR, Kagucia EW, Loo JD, Link-Gelles R, Puhan MA, et al. (2013) Serotype-Specific Changes in Invasive Pneumococcal Disease after Pneumococcal Conjugate Vaccine Introduction: A Pooled Analysis of Multiple Surveillance Sites. PLoS Med 10(9): e1001517.doi:10.1371/journal.pmed.1001517

IN YOUR COVERAGE PLEASE USE THIS URL TO PROVIDE ACCESS TO THE FREELY AVAILABLE PAPER:

http://www.plosmedicine.org/article/info%3Adoi%2F10.1371%2Fjournal.pmed.1001517

Contact:

Dr Daniel Feikin
Johns Hopkins School of Public Health USA
4432872326
Dfeikin@jhsph.edu

The importance of a medical journal being disruptive

This month's editorial, written by Virginia Barbour, who is stepping down this month as PLOS Medicine's Chief Editor but remaining as Medicine Editorial Director for PLOS, reflects on the importance of medical journals being disruptive. She highlights some of the papers published by PLOS Medicine that have contributed to that disruption across a diverse range of topics including lethal injection as a method for execution and the role of "big" industries – pharma, tobacco, alcohol – in health. She notes some key issues for medical journals to address in the future, including open access, and journals' relationship with the pharmaceutical industry. She concludes "Medical publishing, like publishing in general, still has many issues to address, and how these play out over next few years will, I believe, determine the place journals have in the wider dissemination of medical knowledge and, more importantly, its translation into practice and policy."

Funding: VB is paid a salary by the Public Library of Science, and she wrote this editorial during her salaried time.

Competing Interests: VB's competing interests are at http://www.plosmedicine.org/static/editor sInterests.action. PLOS is funded partly through manuscript publication charges, but VB is paid a fixed salary (her salary is not linked to the number of papers published in the journal).

Citation: Barbour V (2013) How to Stir Up Trouble…while Riding a Rollercoaster. PLoS Med 10(9): e1001520.doi:10.1371/journal.pmed.1001520

IN YOUR COVERAGE PLEASE USE THIS URL TO PROVIDE ACCESS TO THE FREELY AVAILABLE PAPER:

http://www.plosmedicine.org/article/info%3Adoi%2F10.1371%2Fjournal.pmed.1001520

Contact: vbarbour@plos.org

FROM THE PLOS Medicine MAGAZINE:

Improved strategies are needed to assess of postmarket safety and effectiveness of medical devices

In this week's PLOS Medicine, Daniel Kramer and colleagues from Harvard Medical School, Boston, US, compare current practices in the EU, the US, China, and Japan for monitoring the safety and effectiveness of medical devices already on the market, to identify strategies that might improve postmarket surveillance of medical devices.

Based on their comparison of current practices in the EU, the US, China, and Japan, the authors call for greater system transparency, regular reexamination of the safety and effectiveness of select devices, and improved balance of central and local control.

The authors say: "Broader use of these strategies could preserve patients' access to new technologies while protecting them as well as possible from devices that later turn out to be unsafe or ineffective."

Funding: This study was supported by funding from the Medical Device Initiative from the Pew Charitable Trusts. DBK is the Lois Green Scholar at the Hebrew Senior Life Institute for Aging Research and is supported in part by a career development award from the Harvard Catalyst Clinical and Translational Research Center. DBK reports serving as a consultant to the US FDA's Circulatory Systems Advisory Panel. ASK is also supported by a career development award from the Agency for Healthcare Research & Quality (K08HS18465-01), and a Robert Wood Johnson Foundation Investigator Award in Health Policy Research. The funders had no role in the decision to publish or preparation of the manuscript.

Competing Interests: ASK is a member of the Editorial Board of PLOS Medicine. DBK and ASK previously were awarded a research contract by the US FDA/CDRH to conduct an independent research project (one piece of which was published in PLOS Medicine). DBK reports serving as a consultant to Circulatory Systems Advisory Panel of the US FDA. DBK and ASK previously published research funded by US FDA on comparative medical device regulation. DBK and ASK are also supported in part by US NIH career development awards. CS is a member for the OECD Advisory Panel of Experts in Health Information Infrastructure, 2013-14, without any payment. YTT has declared that no competing interests exist.

Citation: Kramer DB, Tan YT, Sato C, Kesselheim AS (2013) Postmarket Surveillance of Medical Devices: A Comparison of Strategies in the US, EU, Japan, and China. PLoS Med 10(9): e1001519. doi:10.1371/journal.pmed.1001519

IN YOUR COVERAGE PLEASE USE THIS URL TO PROVIDE ACCESS TO THE FREELY AVAILABLE PAPER:

http://www.plosmedicine.org/article/info%3Adoi%2F10.1371%2Fjournal.pmed.1001519

Contact:

Beth Israel Deaconess Medical Center
UNITED STATES
dkramer@bidmc.harvard.edu