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The benefits of an active control arm

Published online by Cambridge University Press:  02 January 2018

Andy R. Shepherd*
Affiliation:
Greater Manchester West Mental Health Trust. Email: [email protected]
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Abstract

Type
Columns
Copyright
Copyright © Royal College of Psychiatrists, 2011 

Lesem et al Reference Lesem, Tran-Johnson, Riesenberg, Feifel, Allen and Fishman1 highlight the importance of rapid and safe treatment of agitation, indicating the delayed onset of action associated with intramuscular injection. They make no reference to the time from oral medication administration to onset of effect. However, the combination of oral atypical antipsychotics, with or without benzodiazepines, is well described. Reference Yildiz, Sachs and Turgay2 Small trials have compared the efficacy of oral atypical antipsychotics with that of intramuscular typicals and produced mean changes in rating scale scores similar to those in Lesem et al's paper, on similar timescales. Reference Lim, Kim, Pae, Lee, Lee and Paik3

When alternative treatments exist, placebo-controlled trials are appropriate if the target condition is characterised by a high placebo-response rate or a high relapse, remission or spontaneous resolution rate, or if existing therapies are partially effective or have high side-effect rates. Reference Emanuel and Miller4 Inclusion of an active control arm to the trial would have added to the number of patients required in each arm, but would have provided valuable information on the tolerability and efficacy of the inhaled or oral medication.

Footnotes

Edited by Kiriakos Xenitidis and Colin Campbell

References

1 Lesem, MD, Tran-Johnson, TK, Riesenberg, RA, Feifel, D, Allen, MH, Fishman, R, et al. Rapid acute treatment of agitation in individuals with schizophrenia: multicentre, randomised, placebo-controlled study of inhaled loxapine. Br J Psychiatry 2011; 198: 51–8.Google Scholar
2 Yildiz, A, Sachs, G, Turgay, A. Pharmacological management of agitation in emergency settings. Emerg Med J 2003; 20: 339–46.Google Scholar
3 Lim, HK, Kim, JJ, Pae, CU, Lee, CU, Lee, C, Paik, IH. Comparison of risperidone orodispersible tablet and intramuscular haloperidol in the treatment of acute psychotic agitation: a randomized open, prospective study. Neuropsychobiology 2010; 62: 81–6.CrossRefGoogle ScholarPubMed
4 Emanuel, EJ, Miller, FG. The ethics of placebo controlled trials – a middle ground. N Engl J Med 2001; 345: 915–9.CrossRefGoogle ScholarPubMed
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