Clinical Criteria for review of St. John's Wort as antidepressive therapy

AU - Ernst ESO - Fortschritte der Medizin 1995 Sep 10;113(25):354-5

Study search

A computerized medical search from 1980 through 1994 was made in order to find all randomized clinical trials on the antidepressant effect of hypericum. In addition, all manufacturers of hypericum preparations were asked to contribute published and unpublished material. The references of the studies included were also retrieved in order to not miss anything of importance.

Inclusion criteria

Studies had to score 40 points or more out of 110 possible on a criteria-based evaluation score to be included. The evaluation score was an extended and modified version of the one published by Kleijnen et al. in 1991.

Table 18 gives a brief description of these criteria.

Criterion	points given
required sample size compared to pre-calculated sample size (One point per 10 study participants)	10
Study population adequately described	10
Random procedure described and adequate	10
Double blinding (Placebo and active substance indistinguishable)	10
compliance tested	10
endpoint relevant (tested instrument)	10
results described so that they can be checked	10
information regarding dropouts given	10
information on ADR provided	10
intent to treat analysis performed	10

Fourteen studies comparing hypericum with a placebo were found. Nine of these scored more than 40 points and were thus included in the continuing evaluation.

Four trials were identified where hypericum monopreparations were tested against reference medications. Three of them scored more than 40 points. Thus, twelve studies qualified for further review.