Table 4

Trials testing St. John's wort

Reference

Study Design

Sample Population

Intervention

Control

Length of Treatment

Outcomes

Direction of Evidence

Reported Adverse Events


Taylor (2000) [63]

Open-label; Uncontrolled; Observational

13 subjects with a primary DSM-IV diagnosis of OCD of at least 12 month duration

Fixed dose of 900 mg/day of 0.3% hypericin (a psychoactive compound in Hypericum)

N/A

12 weeks

Significant improvement in Y-BOCS scores in SJW group (comparable to those seen in clinical trials with SSRIs).

+

Diarrhea

Restless sleep


Volz (2002) [61]

Randomized; Double-blind; Parallel Group

149 outpatients diagnosed with somatization

Disorder2, undifferentiated somatoformDisorder3, or somatoform autonomic

Dysfunctions4

Hypericum extract LI 160

(600 mg/day)

Placebo

6 weeks

Significant reduction in anxiety (HAMA-SOM, CGI, HAMA-T, HAMA-PSY, HDS, SCL-90-R, SCL-90-R-ANX) in favour of SJW treatment.

+

Verywell tolerated.

Mild/moderate:

Abdominal pain

Arthritis

Arrythmia

Bronchitis

Cystitis

Headache

Neuralgia


Muller (2003) [62]

Open-label; uncontrolled observational

500 patients diagnosed with depression comorbid with anxiety

(1) 500 mg valerian extract5 and 600 mg/day St John's Wort6(2) 1,000 mg valerian extract7 and 600 mg/day St John's wort6

N/A

6 weeks

Significant reduction in anxiety disorder symptoms (HAMA) in both treatment groups.

Higher dosage results in greater improvements.

+

Allergy

Bad dreams

Sleep disorders

Dysphoria


Kobak (2005) [60]

Randomized; Double-blind;Parallel Group

40 subjects with GAD

St John's wort8; flexible dose (600-1800 mg/day), mean dose at week 12 was 1676 mg/day

Placebo

12 weeks

No significant difference to placebo (LSAS)

-

Similar to placebo.

Mild/moderate:

Gastrointestinal upset

Dizziness

Insomnia

Fatigue


Kobak (2005) [59]

Randomized;

Double-blind;

Parallel Group

60 outpatients with primary diagnosis of OCD

St John's wort LI 1608; flexible dose (600-1800 mg/day), mean dose at week 12 was 1663 mg/day

Placebo

12 weeks

No significant difference to placebo (Y-BOCS)

-

Similar to placebo9.

Mild/moderate:

Headache

Gastrointestinal symptoms

Fatigue

Agitation

Sleep disturbance


Sarris (2009) [51]

Randomized; Double-blind; Crossover

28 adults with MDD and co-occurring anxiety

Hypericum perforatum10

(1 × 1.8 g tablet, three times/day); Kava rhizome aqueous extract11(1 × 2.66 g tablet, 3 times/day)

Placebo

4 weeks

Combination treatment had no significant effects on anxiety (BDI-II).

-

No serious adverse events.

Mild gastrointestinal upset.

No liver toxicity


DSM-IV: Diagnostic and Statistical Manual of Mental Disorders, fourth edition; Y-BOCS: Yale-Brown Obsessive-Compulsive Scale; OCD: obsessive-compulsive disorder; GAD: generalized anxiety disorder; SJW: St John's wort; SCL-90-R-ANX: Self-Report Symptom Inventory-90 Items revised, subscore somatic anxiety; HAMA: Hamilton Anxiety Scale; ICD-10; International Classification of Diseases; LSAS: Liebowitz Social Anxiety Scale; HAMA-SOM: Hamilton Anxiety Scale, subscore somatic anxiety; CGI: Clinical Global Impressions; HAMA-PSY: Hamilton Anxiety Scale, subscore psychic anxiety; HAMA-T: Hamilton Anxiety Scale, total score; HDS: Hamilton Depression Scale; SCL-90-R: Self-Report Symptom Inventory-90 Items revised; PGI-I: Patient Global Impressions of Improvement; CGI-I: Clinical Global Impressions of Improvement; CGI-S: Clinical Global Impressions of Severity.

1. Clinician observation [case 1], SCL-90-R [case 2]; self-assessment, HAMA [case 3].

2. ICD-10: F45.0.

3. F45.1.

4. F45.3.

5. Euvegal Balance tablet; drug-extract-ratio 3-6:1.

6. Neuroplant tablet; drug-extract-ratio 2.5-5:1.

7. Euvegal Balance tablet.

8. Drug/extract ratio of 3-6:1.

9. Except agitation which was higher with SJW.

10. Standardized to 990 μg of hypericin, and 1500 μg of flavone glycosides.

11. Standardized to 50 mg of kavalactones.

Lakhan and Vieira Nutrition Journal 2010 9:42   doi:10.1186/1475-2891-9-42

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