Sylvia P. Shoffner, M.D.
Clinical Bottom Lines:
1) There was a significant reduction in Hamilton Depression Scale scores in both hypericum extract and imipramine (20.2 to 8.8; and 19.4 to 10.7 respectively) (p< .001).
2) Similar therapeutic effects were also shown using the Depression Scale and similar improvements were noted using the Clinical Global Impressions scale for three criteria: therapeutic effect, alteration in status at the end of treatment and change in severity of illness.
3) in patients with a total Hamilton score of 21 or more, the efficacy of hypericum extract (26 patients) was significantly better than imipramine (25 patients) with regard to Hamilton total score and CGI scale (p< .05).
4) Undesired drug effects occurred in 8 patients (11.9%) on hypericum extract and 11 patients (162%) on imipramine. Of the 11 symptoms mentioned in the hypericum group, 10 were described as mild. 15 of the total 22 symptoms mentioned in the imipramine group were described as mild, 4 were moderate and 3 were severe.
Prospective, multicenter, double-blind, randomized trial involving 135 patients age 18-75 with diagnosis of typical depression with a single or recurrent episodes, neurotic depression or adjustment disorder with depressed mood according to DSM-III-R criteria. 67 patients received hypericum extract (900 mg) and 68 received imipramine (75 mg) for a total of 6 weeks. Endpoints included changes in the Hamilton Depression Scale (HAMD), the von Zerssen Depression Scale (D-S), and the Clinical Global Impressions (CGI).
|decrease in HAMD score||11.4||8.7|
|decrease in D-S||12.4||9.8|
|increase in CGI therapeutic effect||1.8||1.5|
|improvement in CGI severity of illness||81.8%||62.5%|
1) There was no statistical significance in the differences in efficacy between the two drugs in the overall groups.
2) The dose of imipramine used was 75 mg which is in the low to mid range (usual daily dose. for outpatients is 50-150 mg). This could have impacted on efficacy results and side effect profile.
3) The study was only carried out for 6 weeks so no long term outcomes on drug tolerance or efficacy are available.
Reference: Vorbach et al. Effectiveness and Tolerance of the Hypericum Extract LI 160 in Comparison with Imipramine: Randomized double blind study with 135 outpatients. Journ Ger Psych & Neuro: vol 7, suppl 1, October 94., S19-S23.