Comparing the efficacy of different treatments in psychiatry is difficult for many
reasons, even when they are investigated in `head-to-head' studies. A consensus
meeting was, therefore, held to produce best practice guidelines for such studies.
This article presents the conclusions of this consensus and illustrates it using
published data in the field of antidepressant treatment of generalized anxiety
disorder.
Allgulander, C, Hackett, D, Salinas, E (2001) Venlafaxine extended release (ER) in the
treatment of generalized anxiety disorder. Br J
Psychiatry179: 15-22.
2.
Argyropoulos, SV, Ploubidis, GB, Wright, TS, Palm, ME, Hood, SD, Nash, JR, Taylor, AC, Forshall, SW, Anderson, IM, Nutt, DJ, Potokar, JP (2007) Development and validation of the
Generalized Anxiety Disorder Inventory (GADI). J
Psychopharmacol21: 145- 152.
3.
CHMP Guideline on the Clinical investigation of medicinal products indicated
for Generalised Anxiety Disorder CPMP/EWP/4284/02. Published January
2005 Effective July 2005. Access at http://www.emea.europa.eu/htms/human/humanguidelines/efficacy.htm
4.
CHMP Points to Consider on the Choice of Non-inferiority Margin.
CPMP/EWP/2158/99. Published Jul 2005. Effective Jan 2006.
Access at http://www.emea.europa.eu/htms/human/humanguidelines/efficacy.htm
5.
CHMP Points to Consider on Switching Between Superiority and
Non-inferiority. CPMP/EWP/482/99. Published July 2000. Effective February
2001. Access at http://www.emea.europa.eu/htms/human/humanguidelines/efficacy.htm
6.
Davidson, JRT, Bose, A, Su, G (2002a, b) Escitalopram in the
treatment of generalized anxiety disorder. Poster
presented at the 42nd Annual New Clinical Drug Evaluation (NCDEU)
Meeting. Boca Raton, FL, USA, 10-13 June
2002.
7.
Davidson, JR, Bose, A, Korotzer, A, Zheng, H (2004) Escitalopram in the treatment of
generalized anxiety disorder: a double-blind, placebo-controlled, flexible dose
study. Depress Anxiety19: 234-240.
8.
Davidson, JR, DuPont, RL, Hedges, D, Haskins, JT (1999) Efficacy, safety, and tolerability of
venlafaxine extended release and buspirone in outpatient with GAD.
J Clin Psychiatry60: 528-535.
9.
Gelenberg, AJ, Lydiard, RB, Rudolph, RL, Aguiar, L, Haskins, JT, Salinas, E (2000) Efficacy of venlafaxine extended release
in nondepressed outpatients with generalized anxiety disorder: a 6 month
randomized controlled trial. JAMA283: 3082-3088.
10.
Goodman, WK, Bose, A, Wang, Q (2003) Escitalopram 10 mg/day is
effective in the treatment of generalized anxiety disorder.
Poster presented at: 23rd Annual Conference of the Anxiety Disorders
Association of America ; March 27-30, 2003;
Toronto, Canada.
11.
Gotzsche, PC (2006) Noninferiority and equivalence randomized
trials: lessons and reservations-secondary publication.
Ugeskr Laeger168: 3137-3139.
12.
Hung, HMJ, Wang, SJ, Tsong, Y, Lawrence, J, O'Neil, RT (2003) Some fundamental issues with
non-inferiority testing in active controlled trials.
Statist Med22: 213-225.
13.
ICH Note for Guidance E9 (Statistical Principles for Clinical
Trials). Adopted by CPMP, March 1998, issued as
CPMP/ICH/363/96. Access at http://www.ich.org/cache/compo/475-272-1.html
14.
ICH Note for Guidance E10 (Choice of Control Group). Adopted by
CPMP, July 2000, issued as CPMP/ICH/364/96. Access at http://www.ich.org/cache/compo/475-272-1.html
15.
Lenox-Smith, AJ, Reynolds, A (2003) A double-blind, randomized,
placebo-controlled study of venlafaxine XL in patients with generalized anxiety
disorder in primary care. Br J Gen Pract53: 772- 777.
16.
Pollack, MH, Zaninelli, R, Goddard, A, McCafferty, JP, Bellew, KM, Burnham, DB, Iyengar, MK (2001) Paroxetine in the treatment of generalized
anxiety disorder: results of a placebo-controlled, flexible dosage
trial. J Clin Psychol62: 350-357.
17.
Prescrire International Paroxetine in generalized anxiety: uncertain
efficacy . Prescrire Int2003; 12:
175-177.
18.
Rickels, K, Pollack, MH, Sheehan, DV, Haskins, JT (2000) Efficacy of extended-release venlafaxine
in nondepressed outpatients with GAD. Am J
Psychiatry157: 968-974.
19.
Rickels, K, Zaninelli, R, McCafferty, J, Bellew, K, Iyengar, M, Sheehan, D (2003) Paroxetine treatment of generalized
anxiety disorder: a double-blind, placebo controlled study.
Am J Psychiatry160: 749-756.