ST. JOHN'S WORT - HYPERICUM PERFORATUM - Oral

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This monograph is intended to serve as a guide to industry for the preparation of Product Licence Applications (PLAs) and labels for natural health product market authorization. It is not intended to be a comprehensive review of the medicinal ingredient.

Notes

Date

January 27, 2023

Proper name(s), Common name(s), Source information

Table 1. Proper name(s), Common name(s), Source information
Proper name(s) Common name(s) Source information
Source material(s) Part(s) Preparation
Hypericum perforatum
  • Goatweed
  • Hypericum
  • St. John's wort
  • St. John's-wort
Hypericum perforatum Herb top Dry

References: Proper name: USDA 2018; Common names: Anghelescu et al. 2006,Gastpar et al. 2006, Szegedi et al. 2005, Wichtl 2004, McGuffin et al. 2000; Source information: Bradley 2006; Mills and Bone 2005, Hoffmann 2003, Blumenthal et al. 2000, Felter and Lloyd 1983, Wren 1907.

Route of Administration

Oral

Dosage Form(s)

This monograph excludes foods or food-like dosage forms as indicated in the Compendium of Monographs Guidance Document.

Acceptable dosage forms for oral use are indicated in the dosage form drop-down list of the web-based Product Licence Application form for Compendial applications.

Use(s) or Purpose(s)

  • (Traditionally) used in Herbal Medicine to help relieve restlessness and/or nervousness (calmative) (Mills and Bone 2005; Hoffmann 2003; Blumenthal et al. 2000; Felter and Lloyd 1983; Grieve 1971).
  • (Used in Herbal Medicine to) help(s) promote healthy mood balance (Brattström 2009; Anghelescu et al. 2006; Gastpar et al. 2006; Kasper et al. 2006; Fava et al. 2005; Mills and Bone 2005; Szegedi et al. 2005; Uebelhack et al. 2004; ESCOP 2003; Hoffmann 2003; Lecrubier et al. 2002; Volz et al. 2002; Kalb et al. 2001).
  • (Used in Herbal Medicine to) help(s) relieve sleep disturbances associated with mood imbalance (Randløv et al. 2006; Wichtl 2004; Friede et al. 2001; Wheatley 1999; Schrader et al. 1998).

The following combined use(s) or purpose(s) is/are also acceptable:

(Used in Herbal Medicine to) help(s) promote healthy mood balance and relieve sleep disturbances associated with mood imbalance (Brattström 2009; Anghelescu et al. 2006; Gastpar et al. 2006; Kasper et al. 2006; Randløv et al. 2006; Fava et al. 2005; Mills and Bone 2005; Szegedi et al. 2005; Uebelhack et al. 2004; Wichtl 2004; ESCOP 2003; Hoffmann 2003; Lecrubier et al. 2002; Volz et al. 2002; Friede et al. 2001; Kalb et al. 2001; Wheatley 1999; Schrader et al. 1998).

Note

Claims for traditional use must include the term "Herbal Medicine", "Traditional Chinese Medicine", or "Ayurveda".

Dose(s)

Subpopulation(s)

Adults 18 years and older

Quantity(ies)

Relief of restlessness and/or nervousness

Methods of preparation: Dry, Powder, Non-Standardized Extracts (Dry extract, Tincture, Fluid extract, Decoction, Infusion)

2 - 12.6 grams of dried herb top, per day; Not to exceed 4.2 grams per single dose (Anghelescu et al. 20; Witchtl 2004; ESCOP 2003; Blumenthal et al. 2000).

All uses except the traditional claim for the relief of restlessness and/or nervousness

Methods of preparation: Standardized extracts (Dry extract)

600 - 1800 milligrams of extract, per day, standardized to 3-6% hyperforin and/or 0.12-0.28% hypericin; Not to exceed 600 milligrams of extract per single dose (Anghelescu et al. 2006; Gastpar et al. 2006; Kasper et al. 2006; Fava et al. 2005; Szegedi et al. 2005; Uebelhack et al. 2004; Wichtl 2004; ESCOP 2003; Hoffmann 2003; Lecrubier et al. 2002; Volz et al. 2002; Kalb et al. 2001; Blumenthal et al. 2000; BHP 1983).

Direction(s) for use

No statement required.

Duration(s) of Use

  • Use for at least 1 week to see beneficial effects (Papakostas et al. 2007; Kalb et al. 2001).
  • Consult a health care practitioner/health care provider/health care professional/doctor/physician for use beyond 18 weeks (Anghelescu et al. 2006; Gastpar et al. 2006; Kasper et al. 2006; Fava et al. 2005; Mills and Bone 2005; Szegedi et al. 2005; Uebelhack et al. 2004; ESCOP 2003; Hypericum Depression Trial Study Group 2002; Lecrubier et al. 2002; Vloz et al. 2002; Kalb et al. 2001; BHP 1983).

Risk Information

Caution(s) and warning(s)

All products

  • Avoid prolonged exposure to sunlight, ultraviolet light (UV) or UV therapy (Brinker 2010; Barnes et al. 2007; Mills and Bone 2005; ESCOP 2003; Hoffmann 2003; McGuffin et al. 1997).
  • Consult a health care practitioner/health care provider/health care professional/doctor/physician if symptoms persist or worsen.
  • Consult a health care practitioner/health care provider/health care professional/doctor/physician prior to use if you are pregnant or breastfeeding (Brinker 2010; Barnes et al. 2007; Mills and Bone 2005).
  • Consult a health care practitioner/health care provider/health care professional/doctor/physician prior to use if you are taking antianxiety or seizure medications, antihistamines, bronchodilators, muscle relaxants and/or opiates (Brinker 2010; Barnes et al. 2007; Mills and Bone 2005; Kawaguchi et al. 2004; Morimoto et al. 2004; Eich-Höchli et al. 2003; Dresser et al. 2003; Hoffman 2003; Markowitz et al. 2003; Xie et al. 2003; Dannawi 2002; Gurley et al. 2002; Spinella and Eaton 2002; Wang et al. 2002; Parker et al. 2001; Wang et al. 2001; Burstein et al. 2000; Nebel et al. 1999).

Healthy mood balance

Consult a health care practitioner/health care provider/health care professional/doctor/physician prior to use if you suffer from psychological disorders such as anxiety or depression.

Contraindication(s)

Do not use this product if you are taking anti-cancer, antidepressant [e.g. selective serotonin reuptake inhibitors (SSRI)], cardiovascular, contraceptive medications, blood thinners, anti-HIV agents and/or medications to suppress the immune system (immunosuppressive medications) (Brinker 2010; Barnes et al. 2007; Bradley 2006; Mills and Bone 2005; Murphy et al. 2005; Frye et al. 2004; Hebert et al. 2004; Jiang et al. 2004; Mueller et al. 2004; Smith et al. 2004; Sparreboom et al. 2004; Tannergren et al. 2004; Wichtl 2004; Alscher and Klotz 2003; Bauer et al. 2003; Dresser et al. 2003; ESCOP 2003; Hall et al. 2003; Hoffmann 2003; Pfrunder et al. 2003; Schwarz et al. 2003; Bolley 2002; Gorski et al. 2002; Mathijssen et al. 2002; Ahmed et al. 2001; De Maat et al. 2001; Moschella and Jaber 2001; Roby et al. 2001; Sugimoto et al. 2001; Turton-Weeks 2001; Wang et al. 2001; Barone et al. 2000; Durr et al. 2000; Karliova et al. 2000; Mai et al. 2000; Piscitelli et al. 2000; Ruschitzka et al. 2000; Ernst 1999; Johne et al. 1999; Maurer et al. 1999; Rey and Walter 1998).

Known adverse reaction(s)

  • Stop use if hypersensitivity/allergy occurs (Barnes et al. 2007; ESCOP 2003).
  • Some people may experience mild gastrointestinal disturbances, nausea, restlessness and/or headaches (Barnes et al. 2007; ESCOP 2003).

Non-medicinal ingredients

Must be chosen from the current Natural Health Products Ingredients Database (NHPID) and must meet the limitations outlined in the database.

Storage conditions

Must be established in accordance with the requirements described in the Natural Health Products Regulations (NHPR).

Specifications

  • The finished product specifications must be established in accordance with the requirements described in the Natural and Non-prescription Health Products Directorate (NNHPD) Quality of Natural Health Products Guide.
  • The medicinal ingredient must comply with the requirements outlined in the NHPID.

References Cited

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References reviewed

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