Kobak K, Taylor LvH, Warner G, Futterer R.

Double-Blind Trials of Saint John's Wort vs Placebo in Social Phobia and Obsessive Compulsive Disorder

Dean Foundation, 2711 Allen Blvd, Middleton, WI 53562. Ken.kobak@deancare.com.

METHODS: Two parallel studies with similar protocols and research designs were used. In both studies, patients were randomized to 12 weeks of treatment with SJW (LI 160) or matching placebo. Subjects had a primary diagnosis of OCD (N=60) or social phobia (N= 40) according to DSM-IV criteria. Subjects with comorbid depression (> 16 on the HAMD) were excluded. A flexible-dose schedule was utilized in both studies (600-1800 mg/day). An intent-to-treat analysis was employed.

RESULTS: In the OCD study, the mean change on the Yale-Brown Obsessive Compulsive Scale with SJW (3.43) was not significantly different than the mean change found with placebo (3.60), p = .899. Similarly, in the social phobia study, the mean change on the Liebowitz Social Anxiety Scale with SJW (11.4) was not significantly different than the mean change with placebo (13.2), p = .27. The percent rated "much' or "very much" improved did not significantly differ between SJW and placebo in either study. The percent improvement on placebo was similar to other studies reported in the literature for both disorders, while the drug response was smaller, suggesting a lack of drug response, rather than a larger than average placebo response. Only one patient discontinued SJW due to adverse events (sinus infection in the OCD study). In the social phobia study, larger effect sizes were found with increasing baseline severity, omitting patients with variable scores (+/- 30%) during week 1, and using self-report for depression exclusion, although similar results were not found in the OCD study. A post-study analysis of the hypericin and hyperforin content of the batch used in the trial found levels within the expected range. Although the studies may have been underpowered, there was no signal of any potential efficacy to justify a larger study.

CONCLUSIONS: The results of the study fail to provide support for the efficacy of Saint John's Wort for OCD or social phobia.

 

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