For the opioids, 10 of the 11 trials used the ITT analysis six utilized the LOCF
approach, but the other trials did not specify any approach.
In Tables 2 to 4, we have applied the repeated significance tests approach to the LOCF
imputed response profiles.
analysis assumes the patient's functional status has not changed.
(Tauchert 2002) or observed cases method (all other trials).
Both methods have statistical limitations, but LOCF
generally is preferred because it accounts for every subject who enrolled in the study.
denotes last observation carried forward; CI, confidence interval.
Moreover, we used the LOCF
methodology in our analysis to ensure that all enrolled patients were represented in the data at all follow-up time points.
Both PP and LOCF
analyses indicated improvements in the 7 dimensions that were interrogated to indicate quality of life.
The analyses were carried out on the basis of "Intention to treat" (ITT) using the LOCF
approach and a modified "Per Protocol" (mPP) with any drop-outs being excluded from subsequent analyses.
Because in the Kava group 5 drop-outs occurred whereas in the Opipramol group not one patient withdrew, the main analysis was performed with the ITT population applying the LOCF
procedure to ensure a more conservative approach avoiding any bias in favour of Kava.