Insomnia medication: Do published studies reflect the complete picture of efficacy and safety?

European Neuropsychopharmacology

Volumn 21, Issue 7, 2011, Pages 500-507

  Mattila, Taina ^a,b   Stoyanova, Violeta ^a   Elferink, André ^a   Gispen de Wied, Christine ^a   de Boer, Anthonius ^b   Wohlfarth, Tamar ^a  

^a MEDICINES EVALUATION BOARD   (Netherlands)

^b UTRECHT UNIVERSITY   (Netherlands)

Author keywords

Clinical trials; Insomnia; Publication bias; Selective publication; Selective reporting

Indexed keywords

ANTIDEPRESSANT AGENT; CENTRAL NERVOUS SYSTEM AGENTS; HERBACEOUS AGENT; HYPNOTIC AGENT; MELATONIN; PLACEBO; RAMELTEON; SEDATIVE AGENT; ZALEPLON;

ARTICLE; COMPARATIVE STUDY; DRUG EFFICACY; DRUG INFORMATION; DRUG RESEARCH; DRUG SAFETY; EFFECT SIZE; HUMAN; INSOMNIA; PRACTICE GUIDELINE; PRIORITY JOURNAL; PUBLICATION; RISK BENEFIT ANALYSIS; SAMPLE SIZE; UNSPECIFIED SIDE EFFECT;

DRUG APPROVAL; EUROPE; EVIDENCE-BASED MEDICINE; HUMANS; HYPNOTICS AND SEDATIVES; PUBLICATION BIAS; PUBLISHING; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RESEARCH DESIGN; SLEEP INITIATION AND MAINTENANCE DISORDERS; TIME FACTORS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 79959281590     PISSN: 0924977X     EISSN: 0924977X     Source Type: Journal    
DOI: 10.1016/j.euroneuro.2010.10.005     Document Type: Article

References (20)

1. Al-Marzouki S., Roberts I., Evans S., Marshall T. Selective reporting in clinical trials: analysis of trial protocols accepted by The Lancet. Lancet 2008, 372:201.
2. Begg C.B., Berlin J.A. Publication bias: a problem in interpreting medical data. J. R. Stat. Soc. A 1988, 151:419-463.
3. Buscemi N., Vandermeer B., Friesen C., Bialy L., Tubman M., Ospina M., Klassen T.P., Witmans M. The efficacy and safety of drug treatments for chronic insomnia in adults: a meta-analysis of RCTs. J. Gen. Intern. Med. 2007, 22:1335-1350.
4. Chan A.W., Hróbjartsson A., Haahr M.T., Gøtzsche P.C., Altman D.G. Empirical evidence for selective reporting of outcomes in randomized trials. JAMA 2004, 291:2457-2465.
5. Chan A.W., Krleža-Jerić K., Scmid I., Altman D.G. Outcome reporting bias in randomized trials funded by the Canadian Institutes of Health Research. CMAJ 2004, 171:735-740.
6. Easterbrook P.J., Berlin J.A., Gopalan R., Matthews D.R. Publication bias in clinical research. Lancet 1991, 337:867-872.
7. Egger M., Davey Smith G., Schneider M., Minder C. Bias in meta-analysis detected by a simple, graphical test. BMJ 1997, 315:629-634.
8. Hemminki E. Study of information submitted by drug companies to licensing authorities. BMJ 1980, 280:833-836.
9. Hopewell S., Clarke M.J., Stewart L., Tierney J. Time to publication for results of clinical trials. Cochrane Database Syst. Rev. 2007, (2).
10. Lee K., Bacchetti P., Sim I. Publication of clinical trials supporting successful new drug applications: a literature analysis. PLoS Med. 2008, 5:e191.
11. Melander H., Ahlqvist-Rastad J., Meijer G., Beermann B. Evidence b(i)ased medicine-selective reporting from studies sponsored by pharmaceutical industry: review of studies in new drug applications. BMJ 2003, 326:1171-1173.
12. Nassir Ghaemi S., Shirzadi A.A., Filkowski M. Publication bias and the pharmaceutical industry: the case of lamotrigine in bipolar disorder. Medscape J. Med. 2008, 10:211.
13. Nowell P.D., Mazumdar S., Buysse D.J., Dew M.A., Reynolds C.F., Kupfer D.J. Benzodiazepines and zolpidem for chronic insomnia: a meta-analysis of treatment efficacy. JAMA 1997, 278:2170-2177.
14. Perlis R.H., Perlis C.S., Wu Y., Hwang C., Joseph M., Nierenberg A.A. Industry sponsorship and financial conflict of interest in the reporting of clinical trials in psychiatry. Am. J. Psychiatry 2005, 162:1957-1960.
15. Rising K., Bacchetti P., Bero L. Reporting bias in drug trials submitted to the Food and Drug Administration: review of publication and presentation. PLoS Med. 2008, 5:e217.
16. Stern J., Simes R.J. Publication bias: evidence of delayed publication in a cohort study of clinical research projects. BMJ 1997, 315:40-45.
17. Turner E.H., Matthews A.M., Linardatos E., Tell R.A., Rosenthal R. Selective publication of antidepressant trials and its influence on apparent efficacy. N Engl J. Med. 2008, 358:252-260.
18. Vitry A., Bertele V., Garattini S. Drug regulation and the need for greater transparency. RAJ Pharma 2009, 1-4. (March).
19. von Elm E., Röllin A., Blümle A., Huwiler K., Witschi M., Egger M. Publication and non-publication of clinical trials: longitudinal study of allocations submitted to a research ethics committee. Swiss Med. Wkly 2008, 138:197-203.
20. Whittington C.J., Kendall T., Finagy P., Cottrell D., Cotgrove A., Boddington E. Selective serotonin reuptake inhibitors in childhood depression: systematic review of published versus unpublished data. Lancet 2004, 363:1341-1345.