Subject numbers and placebo outcome variability in clinical trials of new CNS medications

Drug Information Journal

Volumn 41, Issue 6, 2007, Pages 701-708

  Ridgway, Derry ^a   Khan, Arif ^b,c   Ridgway, Gavin ^d   Cierpial, Mark A ^a   Lineberry, Charles G ^a  

^a Constella Group ^*  (United States)

^b Northwest Clinical Research Center   (United States)

^c DUKE UNIVERSITY MEDICAL CENTER   (United States)

^d NONE

Author keywords

Funnel plot; Outcome variability; Placebo

Indexed keywords

ALMOTRIPTAN; ANALGESIC AGENT; ANTIDEPRESSANT AGENT; BROMFENAC; CELECOXIB; CITALOPRAM; ELETRIPTAN; ENTACAPONE; ESCITALOPRAM; FLUOXETINE; FROVATRIPTAN; HYDROCODONE BITARTRATE PLUS IBUPROFEN; KETOROLAC; NARATRIPTAN; NEUROLEPTIC AGENT; OLANZAPINE; PARACETAMOL PLUS TRAMADOL; PAROXETINE; PLACEBO; PRAMIPEXOLE; RISPERIDONE; RIZATRIPTAN; ROFECOXIB; ROPINIROLE; SERTRALINE; SUMATRIPTAN; TOLCAPONE; TRAMADOL; UNINDEXED DRUG; VENLAFAXINE;

CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DEPRESSION; DOUBLE BLIND PROCEDURE; DRUG APPROVAL; FOOD AND DRUG ADMINISTRATION; HEADACHE; HUMAN; MAJOR CLINICAL STUDY; MIGRAINE; OUTCOME VARIABLE; PARKINSON DISEASE; POSTOPERATIVE PAIN; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; REVIEW; RISK ASSESSMENT; SCHIZOPHRENIA;

EID: 36248937244     PISSN: 00928615     EISSN: None     Source Type: Journal    
DOI: 10.1177/009286150704100602     Document Type: Review

References (20)

1. Ernst E, Resch KL. Concept of true and perceived placebo effect. Br Med J. 1995;311:551-553.
2. Silverman G. Placebo effect and changes in response set with re-testing: a further source of bias. Neuropharmacology. 1979;18(12):1019-1021.
3. Levine JD, Gordon NC, Fields HL. The mechanism of placebo analgesia. Lancet. 1978;2:654-657.
4. Turner JA, Deyo RA, Loeser JD, Von Korff M, Fordyce WE. The importance of placebo effects in pain treatment and research. JAMA. 1994;271(20):1609-1614.
5. Fava M, Evins AE, Dorer DJ, Schoenfeld DA. The problem of the placebo response in clinical trials for psychiatric disorders: culprits, possible remedies, and a novel study design approach. Psychother Psychosom. 2003;72(3):115-127.
6. Jellinek EM. Clinical tests on comparative effectiveness of analgesic drugs. Biometrics Bull. 1946;2(5):87-91.
7. Beecher HK. The powerful placebo. JAMA. 1955;159(17):1602-1606.
8. Hrobjartsson A, Gotzsche PC. Is the placebo powerless? Update of a systematic review with 52 new randomized trials comparing placebo with no treatment. J Mem Med. 2004;256:91-100.
9. Hrobjartsson A, Gotzsche PC. Is the placebo powerless? An analysis of clinical trials comparing placebo with no treatment. N Engl J Med. 2001;344:1594-1602.
10. Khan A, Kolts RL, Rapaport MH, Krishman KRR, Brodhead AE, Brown WA. Magnitude of placebo response and drug-placebo differences across psychiatric disorders. Psychol Med. 2005;135:743-749.
11. Khan A, Leventhal RM, Khan SR, Brown WA. Severity of depression and response to antidepressants and placebo: an analysis of the Food and Drug Administration database. J Clin Psychopharmacol. 2002;22(1):40-45.
12. Khan A, Kolts RL, Thase ME, Krishman KRR, Brown W. Research design features and patient characteristics associated with the outcome of antidepressant clinical trials. Am J Psychiatry. 2004;161(11):2045-2049.
13. Ridgway D. Analgesics for acute pain: meeting the United States Food and Drug Administration's requirements for proof of efficacy. Clin J Pain. 2004;20(3):123-132.
14. Egger M, Smith GD, Schneider M, Minder C. Bias in meta-analysis detected by a simple, graphical test. Br Med J. 1997;315:629-634.
15. Robinson DS, Rickels K. Concerns about clinical drug trials. J Clin Psychopharmacol. 2000;20(6):593-596.
16. Loder E, Goldstein R, Biondi D. Placebo effects in oral triptan trials; the scientific and ethical rationale for continued use of placebo controls. Cephalgia. 2005;25:124-131.
17. Bendtsen L, Mattsson P, Zwart JA, Lipton RB. Placebo response in clinical randomized trials of analgesics in migraine. Cephalgia. 2003;23:487-490.
18. Shetty N, Friedman JH, Kieburtz K, Marshall FJ, Oakes D. The placebo response in Parkinson's disease: the Parkinson's disease study group. Clinical Neuropharmacol. 1999;22(4):207-212.
19. De la Fuente-Fernandez R, Ruth TJ, Sossi V, Schulzer M, Calne DB, Stoessl AJ. Expectation and dopamine release: mechanism of the placebo effect in Parkinson's disease. Science. 2001;293(5532):1164-1166.
20. Walsh BT, Seidman SN, Sysko R, Gould M. Placebo response in studies of major depression. Variable, substantial, and growing. JAMA. 2002;287(14):1840-1847.