0
Get Alert
Please Wait... Processing your request... Please Wait.
You must sign in to sign-up for alerts.

Please confirm that your email address is correct, so you can successfully receive this alert.

1
Letters to the Editor   |    
Maintenance Treatment for Patients With Bipolar Disorder
BETTAHALASOOR S. SOMASHEKAR; ASHOK KUMAR JAINER; WAJID SHAFI
Am J Psychiatry 2009;166:1185-1185. doi:10.1176/appi.ajp.2009.09050700

To the Editor: We read the study by Dr. Suppes et al. (1) with a great deal of interest and wish to raise concerns about the methodology. The authors evaluated the efficacy and safety of the combination of quetiapine with lithium or divalproex relative to monotherapy with lithium or semisodium valproate in maintenance treatment for patients with bipolar I disorder.

Randomized controlled trials are usually cited as the gold standard for detecting the efficacy of results. However, they often can be flawed in design and are not immune to bias.

First, in this study, 1,953 patients received open-label quetiapine. However, only 628 patients were randomly allocated for maintenance treatment. This indicates that only one-third of the patients were selected for maintenance therapy, which raises the possibility of selection bias. In this regard, Healy (2) stated that company sponsored clinical trials invariably recruit samples of convenience, which by definition do not actually sustain extrapolation to normal clinical practice.

Second, the authors used a wide range of exclusion and restricted inclusion criteria, which minimized the generalizability of the results.

Finally, although both arms received active treatment, the authors failed to perform power calculation, and they did not justify the sample size, which is also a requirement of the Consolidated Standards of Reporting Trials guidelines (3).

We would appreciate clarification of these issues raised.

1. Suppes T, Vieta E, Liu S, Brecher M, Paulsson B: Maintenance treatment for patients with bipolar I disorder: results from a North American study of quetiapine in combination with lithium or divalproex (trial 127). Am J Psychiatry 2009; 166:476–488
 
2. Healy D: Evidence biased psychiatry? Psychiatr Bull 2001; 25:290–291
 
3. Begg C, Cho M, Eastwood S: Improving the quality of reporting of randomized controlled trials: the CONSORT statement. JAMA 1996; 276:637–639
 
+

References

+The authors report no competing interests.

+This letter (doi: 10.1176/appi.ajp.2009.09050700) was accepted for publication in July 2009.

+

References

1. Suppes T, Vieta E, Liu S, Brecher M, Paulsson B: Maintenance treatment for patients with bipolar I disorder: results from a North American study of quetiapine in combination with lithium or divalproex (trial 127). Am J Psychiatry 2009; 166:476–488
 
2. Healy D: Evidence biased psychiatry? Psychiatr Bull 2001; 25:290–291
 
3. Begg C, Cho M, Eastwood S: Improving the quality of reporting of randomized controlled trials: the CONSORT statement. JAMA 1996; 276:637–639
 
+
+

CME Activity

There is currently no quiz available for this resource. Please click here to go to the CME page to find another.
Submit a Comments
Please read the other comments before you post yours. Contributors must reveal any conflict of interest.
Comments are moderated and will appear on the site at the discertion of APA editorial staff.

* = Required Field
(if multiple authors, separate names by comma)
Example: John Doe



Related Content
Books
Manual of Clinical Psychopharmacology, 7th Edition > Chapter 1.  >
Manual of Clinical Psychopharmacology, 7th Edition > Chapter 2.  >
Manual of Clinical Psychopharmacology, 7th Edition > Chapter 2.  >
Manual of Clinical Psychopharmacology, 7th Edition > Chapter 5.  >
Manual of Clinical Psychopharmacology, 7th Edition > Chapter 5.  >
Topic Collections
Psychiatric News
Read more at Psychiatric News >>
APA Guidelines
PubMed Articles