Where Does Evidence from New Trials for Schizophrenia Fit with the Existing Evidence: A Case of the Emperor's New Clothes?

Mahesh Jayaram,Ranganath D Rattehalli,Clive E Adams

doi:10.1155/2012/625738

Abstract

Advent of “atypical” antipsychotics has spawned new trials in the recent years and the number of such trial reports has been increasing exponentially. As clinicians we have been led to believe that “atypicals” are better than “typicals” despite the odd dissenting voice in academic and clinical circles. This has been largely ignored until the publication of two landmark, independent, pragmatic trials, Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) and Cost Utility of the Latest Antipsychotic Drugs in Schizophrenia Study (CUtLASS), which proved that thoughtfully chosen “typical” antipsychotics were as good as the newer “atypicals.” We pooled “leaving the study early data” from Cochrane Reviews that existed before CATIE and CUtLASS and added data from CATIE and CUtLASS to the pool for a “before and after” comparison. Addition of CATIE and CUtLASS data only led to narrowing of the already existing confidence intervals, merely increasing precision, and decreasing the risk of Type II error. Perhaps surprisingly, CATIE and CUtLASS when pooled with the already existing data showed us that we had chosen to turn a blind eye to findings that already existed. This leads clinicians to question as to whether, in future, we need to feel less guilty about crying out early on that the emperor has no clothes on.

Highlights

Once upon a time (60 years ago) there were almost no pharmacological managements for people with schizophrenia
There were other FGAs in CUtLASS, but we did not add them to our comparisons as the numbers in these arms were too small to make any sense of the before-after comparison
What is notable in these results is that, for this particular outcome, data from Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) and CUtLASS only increased precision and decreased the risk of Type II error

Summary

Introduction

Once upon a time (60 years ago) there were almost no pharmacological managements for people with schizophrenia. The advent of chlorpromazine was quickly followed by haloperidol and a whole swathe of other antipsychotics which were often advertised as being clinically effective but with different side effect profiles This seemed to be the case [2, 3], and depot formulations soon followed which represented a further advance in means of administration to a group of people with variable compliance. Two recent landmark independently funded semipragmatic trials, CATIE [15] and CUtLASS [16], addressed issues of antipsychotic discontinuation along with efficacy and adverse effects Since these studies there have been increasing calls that the emperor is less well-clothed than previously thought [14]. With these two important studies, there is an opportunity to investigate if his attire has been immodest or not

Material and Methods

Results and Discussion

Conclusions

Conflict of Interests