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Table 4 Trials testing St. John's wort

From: Nutritional and herbal supplements for anxiety and anxiety-related disorders: systematic review

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

  1. 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.
  2. 1. Clinician observation [case 1], SCL-90-R [case 2]; self-assessment, HAMA [case 3].
  3. 2. ICD-10: F45.0.
  4. 3. F45.1.
  5. 4. F45.3.
  6. 5. Euvegal Balance tablet; drug-extract-ratio 3-6:1.
  7. 6. Neuroplant tablet; drug-extract-ratio 2.5-5:1.
  8. 7. Euvegal Balance tablet.
  9. 8. Drug/extract ratio of 3-6:1.
  10. 9. Except agitation which was higher with SJW.
  11. 10. Standardized to 990 μg of hypericin, and 1500 μg of flavone glycosides.
  12. 11. Standardized to 50 mg of kavalactones.