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Sage - Salvia Officinalis - 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
  • Text in parentheses is additional optional information which can be included on the PLA and product label at the applicant's discretion.
  • The solidus (/) indicates that the terms and/or the statements are synonymous. Either term or statement may be selected by the applicant.

Date

February 28, 2013

Proper name(s)

Salvia officinalis L. (Lamiaceae) (USDA 2001; McGuffin et al. 2000)

Common name(s)

  • Sage (USDA 2001; McGuffin et al. 2000)
  • Common sage (McGuffin et al. 2000)
  • Dalmation sage (McGuffin et al. 2000)
  • Garden sage (McGuffin et al. 2000)

Source material(s)

Leaf (Blumenthal et al. 2000; BHP 1983; Cook 1869)

Route(s) of administration

Oral

Dosage form(s)

  • The acceptable pharmaceutical dosage forms include, but are not limited to capsules, chewables (e.g. gummies, tablets), liquids, powders, strips or tablets.
  • This monograph is not intended to include foods or food-like dosage forms such as bars, chewing gums or beverages.

Use(s) or Purpose(s)

Statement(s) to the effect of

  • Provides antioxidants (BHC 2006; Lima et al. 2005)
  • (Traditionally) used in Herbal Medicine as a carminative/ to help provide relief of upset stomach and flatulence (flatulent dyspepsia) (Godfrey et al. 2010; EMEA 2009; BHC 2006; Mills and Bone 2005; BHP 1983; Culbreth 1927; Felter 1922).
  • Traditionally used in Herbal Medicine as a diaphoretic/ to increase perspiration/sweating (PDR 2007; Culbreth 1927; Felter 1922; Cook 1869).
  • Traditionally used in Herbal Medicine to reduce hyperhidrosis/ excessive sweating or perspiration (antihidrotic) (EMEA 2009; BHC 2006; Mills and Bone 2005; BHP 1983; Culbreth 1927; Felter 1922).
  • Used in Herbal Medicine to help reduce hot flushes/flashes and/or night sweat associated with menopause (Romm 2010; BHC 2006; Mills and Bone 2000).
  • (Traditionally) used in Herbal Medicine to stop the production of breast milk (antigalactagogue) (Godfrey and Saunders 2010; Wichtl 2004; Yarnell et al. 2003; Felter and Lloyd 1983; Culbreth 1927; Cook 1869).

Note
A claim for a traditional use must include either the term "Herbal Medicine".

Dose(s)

Statement(s) to the effect of

Subpopulation(s)

Adults (≥ 19 years)

Quantity(ies)

All products

Fluidextract:
1-6 ml per day (1:1, 45% ethanol) (BHC 2006; BHP 1983)

Tincture:
0.3-1.5 g dried leaf, per day (1:4-10, 50-70% ethanol) (EMEA 2009; ESCOP 2003) 0.3-2.25 g dried leaf, per day (1:2-5, 31.5% ethanol) (EMEA 2009; Mills and Bone 2005)

Antioxidants

Infusion:
up to 6 g dried leaf, per day (BHC 2006).

Carminatives, Diaphoretics, Antihidrotics, and Antigalactagogues

Infusion:
1-12 g dried leaf, per day (Mills and Bone 2005; Blumenthal 2000; BHP 1983; Culbreth 1927)

Directions for use

Antihidrotic

Infusion:
Pour hot boiled water on dried herb and steep. Let infusion cool before drinking (BHC 2006; Mills and Bone 2005; BHP 1983; Culbreth 1927; Felter 1922).

Diaphoretic

Infusion:
Pour hot boiled water on dried herb and steep. Drink infusion while still warm (PDR 2007; Culbreth 1927; Felter 1922; Cook 1869).

Night sweat

Take one hour before bedtime (EMEA 2009).

Note
Refer to Appendix 1 for examples of dosage preparations and directions for use, according to cited references. The purpose of Appendix 1 is to provide guidance to industry.

Duration of use

Statement(s) to the effect of

Infusion:
For use beyond 4 weeks, consult a health care practitioner (Wichtl 2004; McGuffin et al. 1997: ESCOP 2003).

Other preparations:
For use beyond 2 weeks, consult a health care practitioner (EMEA 2009; Wichtl 2004; McGuffin et al. 1997).

Risk information

Statement(s) to the effect of

Caution(s) and warning(s)

Carminatives, Diaporetics, Antihidrotics and Antigalactagogues:
If symptoms persist of worsen, consult a health care practitioner.

Contraindication(s)

All products:
  • If you are pregnant or breastfeeding, do not use this product (BHC 2006; Mills and Bone 2005; McGuffin et al. 1997).
  • If you have a seizure disorder (e.g. epilepsy), do not use this product (BHC 2006; Mills and Bone 2005).

Known adverse reaction(s)

No statement required.

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

Statement(s) to the effect of
All products, except those encapsulated:
Store protected from light and moisture (Martindale 2010; Wichtl 2004)

Specifications

References cited

  • BHC 2006: Bradley PR, editor. British Herbal Compendium Volume 2: A Handbook of Scientific Information on Widely Used Plant Drugs-Companion to the British Herbal Pharmacopoeia. Bournemouth (GB): British Herbal Medicine Association; 2006.
  • BHP 1983: British Herbal Medicine Association's Scientific Committee. British Herbal Pharmacopoeia. Bournemouth (GB): The British Herbal Medicine Association; 1983.
  • Blumenthal M, Goldberg A, Brinckmann J. Herbal Medicine: Expanded Commission E Monographs. Boston (MA): American Botanical Council. 2000.
  • BP 2012: British Pharmacopoeia 2012. Volume I. London (GB): The Stationary Office on behalf of the Medicines and Healthcare products Regulatory Agency (MHRA); 2012.
  • Cook WMH.Next link will take you to another Web site The Physio-Medical Dispensatory: A Treatise on Therapeutics, Materia Medica, and Pharmacy, in Accordance with the Principles of Physiological Medication. [Internet] Cincinnati (OH): WM.H. Cook; 1869. Reprint version by Medical Herbalism and medherb.com, Boulder (CO). [Accessed 2012 April 27].
  • Culbreth DMR.Next link will take you to another Web site A Manual of Materia Medica and Pharmacology [Internet] 7th ed. Philadelphia (PA): Lea & Febiger; 1927. Abridged and alphabetized by Michael Moore, director. The Southwest School of Botanical Medicine, Bisbee (AZ). [Accessed 2012 April 27].
  • EMEA 2009:Next link will take you to another Web site EMA/HMPC/331653/2008 Community herbal monograph on Salvia officinalis L., folium. Final. 12 November 2009. London (GB): European Medicines Agency: Committee on Herbal Medicinal Products (HMPC). [Accessed 2013 February 06].
  • ESCOP 2003:E/S/C/O/P Monographs: The Scientific Foundation for Herbal Medicinal Products. Second edition. Completely revised and Expanded. Exeter (GB): ESCOP, the European Scientific Cooperative on Phytotheraphy in collaboration with Georg ThiemeVerlag and Thieme; 2003.
  • Felter HW.Next link will take you to another Web site The Eclectic Materia Medica, Pharmacology and Therapeutics [Internet]. Cincinnati (OH): John K. Scudder; 1922. Reprint version by Michael Moore, The Southwest School of Botanical Medicine, Bisbee (AZ). [Accessed 2012 April 27].
  • Felter HW, Lloyd JU. King’s American Dispensatory. Volume 2, 18th edition. Sandy (OR): Eclectic Medical Publications; 1983 [Reprint of 1898 original].
  • Godfrey A, Saunders PR, Barlow K, Gilbert C, Gowan M, Smith F. Principles and Practices of Naturopathic Botanical Medicine. Volume 1: Botanical Medicine Monographs. Toronto (ON): CCNM Press; 2010.
  • Lima CF, Andrade PB, Seabra RM, Fernandes-Ferreira M, Pereira-Wilson C. The drinking of a Salvia officinalis infusion improves liver antioxidant status in mice and rats. J Ethnopharmacol 2005; 97(2): 383-9
  • Martindale 2010: Sweetman SC, editor.Next link will take you to another Web site Martindale: The Complete Drug Reference 37th edition [Internet]. London (GB): Pharmaceutical Press; 2012. [Sage: Salvia officinalis, Date of monograph revision 20101127; Accessed 2012 August 1].
  • McGuffin M, Hobbs C, Upton R, Goldberg A, editors. American Herbal Products Association's Botanical Safety Handbook. Boca Raton (FL): CRC Press LLC; 1997
  • McGuffin M, Kartesz JT, Leung AY, Tucker AO, editors. Herbs of Commerce. 2nd edition. Silver Spring (MD): American Herbal Products Association; 2000.
  • Mills S, Bone K. The Essential Guide to Herbal Safety. St. Louis (MO): Elsevier Churchill Livingstone; 2005.
  • Mills S, Bone K. Principles and Practice of Phytotherapy. Toronto (ON): Churchill Livingstone; 2000.
  • PDR 2007: Gruenwald J, Brendler T, Jaenicke C, editors. PDR for Herbal Medicines. 4th ed. Montvale (NJ): Thomson Healthcare Inc; 2007.
  • Ph.Eur. 2013: European Pharmacopoeia. 7th edition. Strasbourg (FR): Directorate for the Quality of Medicines and HealthCare of the Council of Europe (EDQM); 2012.
  • Romm A. Botanical Medicine for Women’s Health. St. Louis (MO): Churchill Livingstone; 2010.
  • USDA 2001:Next link will take you to another Web site United States Department of Agriculture, Agricultural Research Service, National Genetic Resources Program. Germplasm Resources Information Network (GRIN). [Internet]. National Germplasm Resources Laboratory, Beltsville (MD). [Salvia officinalis L. Last updated: 31-Dec-2001; Accessed 2012 August 1].
  • Wichtl M, editor. Herbal Drugs and Phytopharmaceuticals: A Handbook for Practice on a Scientific Basis. 3rd edition. Stuttgart (DE): Medpharm Scientific Publishers; 2004.
  • Yarnell E, Abascal JD, Hooper CG. Clinical Botanical Medicine. Larchmont (NY): Mary Ann Leibert Inc.; 2003.

References reviewed

  • ASHP 2005: American Society of Health-System Pharmacists. American Hospital Formulary Service (AHFS) Drug Information. Philadelphia (PA): Lippincott Williams and Wilkins; 2005.
  • AU TGA 1999: Australian Therapeutic Goods AdministrationNext link will take you to another Web site TGA Approved Terminology for Medicines, Section 3 - Herbal Substances. July 1999. [Internet]. Symonston (AU): Australian Government Department of Health and Ageing, Therapeutic Goods Administration. [Accessed 2012 Apr 27].
  • Azevedo MF, Lima CF, Fernandes-Ferreira M, Almeida MJ, Wilson JM, Pereira-Wilson C. Rosmarinic acid, major phenolic constituent of Greek sage herbal tea, modulates rat intestinal SGLT1 levels with effects on blood glucose. Molecular Nutrition & Food Research 2011;55(S1): S15-S25.
  • Barnes J, Anderson LA, Philipson JD. Herbal Medicines.3rd edition. London (GB): The Pharmaceutical Press; 2007.
  • Bartram T. Bartram's Encyclopaedia of Herbal Medicine: The definitive guide to the herbal treatment of diseases. New York: Marlowe & Company; 1998.
  • Blumenthal M, Brusse WR, Goldberg A, Gruenwald J, Hall T, Riggins CW, Rister RS. The Complete German Commission E Monographs: Therapeutic Guide to Herbal Medicines. Austin (TX): American Botanical Council in Cooperation with Integrative Medicine Communications; 1998
  • Bommer S, Klein P, Suter A. First time proof of sage's tolerability and efficacy in menopausal women with hot flushes. Advances in Therapy 2011;28(6):490-500.
  • Brinker F. Herbal Contraindications and Drug Interactions: Plus Herbal Adjuncts With Medicines, expanded 4th Edition. Sandy (OR): Eclectic Medical Publications; 2010.
  • Brinker, F.Next link will take you to another Web site Final updates and Additions for Herb Contraindications and Drug Interactions, 3rd ed including extensive Appendices addressing common problematic conditions, medications and nutritional supplements, and influences on Phase I, II & III metabolism with new appendix on botanicals and complementary adjuncts with drugs. [Internet] Sandy (OR): Eclectic Medical Publications. [Updated July 13, 2010; Accessed 2012 April 27].
  • Next link will take you to another Web site Canadian Nutrient File (CNF), 2012 [Internet]. Ottawa (ON): Food and Nutrition, Health Canada. [Date Modified 2012-02-10; Accessed 2012 Apr 27].
  • Next link will take you to another Web site Canada Vigilance Adverse Reaction Online Database. Ottawa (ON): Marketed Health Products Directorate, Health Canada; 2011. [Accessed 2012 April 27].
  • Christensen KB, Jorgensen M, Kotowska D, Petersen RK, Kristiansen K, Christensen LP. Activation of the nuclear receptor PPAR? by metabolities isolated from sage (Salvia officinalis L.). Journal of Ethnopharmacology 2010;132(1):127-133.
  • derMarderosian A, Beutler JA, editors. The Review of Natural Products. "Sage: Date of Issue February 2010" St Louis (MO): Facts and Comparisons, Wolters Kluwer Health; Printed in 2008 and Updated to May 2012.
  • Dos Santos-Neto LL, de Vilhena Toledo MA, Medeiros-Souza P, de Souza GA. The Use of Herbal Medicine in Alzheimer’s Disease – A Systematic Review. Evidence-Based Complementary and Alternative Medicine 2006;3(4):441-445.
  • Duke JA, Bogenschutz-Godwin MJ, duCellier J, Duke P-AK. Handbook of Medicinal Herbs. 2nd ed. Boca Raton (FL): CRC Press LLC; 2002.
  • European Medicines Agency.Next link will take you to another Web site Community Herbal Monograph on Salvia officinalis L., Folium. London (GB): EMEA Committee on Herbal Medicinal Products (HMPC); 03 February 2010. [Accessed 2012 April 27]
  • European Medicines Agency.Next link will take you to another Web site Public statement on Salvia officinalis L., aetheroleum London (GB): EMEA Committee on Herbal Medicinal Products (HMPC); 19 October 2010. [Accessed 2012 April 27]
  • European Scientific Cooperative of Phytotherapy. Monographs on the Medicinal Uses of Plant Drugs. Exeter (GB): European Scientific Cooperative on Phytotheraphy; 1996.
  • Facciola S. Cornucopia II: A source book of edible plants. Vista (CA): Kampong Publications; 1998.
  • Felter HW, Lloyd JU.Next link will take you to another Web site Kings American Dispensatory [Internet]. 18th ed, 3rd revision. Cincinnati (OH): Ohio Valley Co.; 1898. Scanned version by Henriette Kress 1999-2011. [Accessed 2012 April 27].
  • Grieve, M. A Modern Herbal, Volume 1-2. New York (NY): Dover Publications, 1971 [Reprint of 1931 Harcourt, Brace & Company publication].
  • Halicioglu O, Astarcioglu G, Yaprak I, Aydinlioglu H. Toxicity of Salvia officinalis in a newborn and a child: an alarming report. Pediatr Neurol 2011; 45(4): 259-60
  • Kennedy DO, Scholey AB. The psychopharmacology of European herbs with cognition-enhancing properties. Current Pharmaceutical Design 2006;12(35):4613-4623.
  • Kennedy DO, Pace S, Haskell C, Okello EJ, Milne A, Scholey AB. 2006. Effects of Cholinesterase Inhibiting Sage (Salvia officinalis) on Mood, Anxiety and Performance on a Psychological Stressor Battery. Neuropsychopharmacology 2006;31:845-852.
  • Kennedy DO, Dodd FL, Robertson BC, Okello EJ, Reay JL, Scholey AB, Haskell CF. Monoterpenoid extract of sage (Salvia lavandulaefolia) with cholinesterase inhibiting properties improves cognitive performance and mood in healthy adults. Journal of Psychopharmacology 2011;25(8):1088-1100.
  • Lachenmeier DW, Uebelacker M. Risk assessment of thujone in foods and medicines containing sage and wormwood – Evidence for a need of regulatory changes? Regulatory Toxicology and Pharmacology 2010;58:437-443.
  • Lima CF, Azevedo MF, Araujo R, Fernandes-Ferreira M, Pereira-Wilson C. Metform-like effect of Salvia officinalis (common sage): is it useful in diabetes prevention? British Journal of Nutrition 2006; 92(2):326-333.
  • Newall CA, Anderson LA, Phillipson JD. Herbal Medicines: A Guide for Health-care Professionals. London (GB): Pharmaceutical Press; 1996
  • Next link will take you to another Web site National Nutrient Database for Standard Reference. Spices, sage, ground. United States Department of Agriculture, Agricultural Research Service; 2011 [Accessed 2012 April 27].
  • Next link will take you to another Web site Natural Standard. Sage (Salvia officinalis, Salvia lavandulaefolia, Salvia lavandulifolia) Copyright 2012 [Internet]. [Accessed 2012 April 27].
  • Perry NS, Bollen C, Perry EK, Ballard C. Salvia for dementia therapy: review of pharmacological activity and pilot tolerability clinical trial. Pharmacology, Biochemistry, and Behaviour 2003;75(3):651-659.
  • Remington JP, Woods HC, editors. 1918.Next link will take you to another Web site The Dispensatory of the United States of America [Internet] 20th edition. Abridged; botanicals only. Scanned by Michael Moore, director, The Southwest School of Botanical Medicine, Bisbee (AZ). [Accessed 2011 April 27].
  • Sá CM, Ramos AA, Azevedo MF, Lima CF, Fernandes-Derreira M, Pereira-Wilson C. Sage tea drinking improves lipid profile and antioxidant defences in humans. International Journal of Molecular Sciences 2009;10(9):3937-3950.
  • Swanston-Flatt SK, Day C, Flatt PR, Gould BJ, Bailey CJ. Diabetes Res. 1989; 10(2): 69-73
  • Tildesley NTJ, Kennedy DO, Perry EK, Ballard CG, Savelev S, Wesnes KA, Scholey AB. Salvia lavandulaefolia (Spanish Sage) enhances memory in healthy young volunteers. Pharmacology, Biochemistry and Behavior 2003;75:669-674.
  • Tildesley NTJ, Kennedy DO, Perry EK, Ballard CG, Wesnes KA, Scholey AB. Positive modulation of mood and cognitive performance following administration of acute doses of Salvia lavandulaefolia essential oil to healthy young volunteers. Physiology & Behavior 2005;83:699-709.
  • Umezu T. Evaluation of the effects of plant-derived essential oils on central nervous system function using discrete shuttle-type conditioned avoidance response in mice. Phytotherapy Research 2012;26(6):884-891.
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  • Walch SG, Kuballa T, Stühlinger W, Lachenmeier DW. Determination of the biologically active flavour substances thujone and camphor in foods and medicines containing sage (Salvia officinalis L.). Chemistry Central Journal 2011;5:44.
  • Weiss RF. Fintelmann VF. Herbal Medicine. Second edition, revised and expanded. Stuggart (NY): Thieme; 2000.
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Appendix 1

Examples of dosage preparations and directions for use

EMEA 2009

Tincture:
0.2-0.3 g dried leaf, three times per day (1:10, 70% ethanol, 2-3 ml)
0.4-0.5 g dried leaf, three times per day (1:4-5, 50% ethanol, 2 ml)
0.1-0.23 g dried leaf, three times per day (1:3.5-5, 31.5% ethanol, 0.4-0.8 ml)
0.24-0.34 g dried leaf, per day (1:3.5-5, 31.5% ethanol, 1.2 ml)

Mills and Bone 2005

Infusion: 3 to 12g/day of dried leaf
Tincture: 2 to 4.5 ml/day or a 1:2 liquid extract or equivalent in tablet or capsule form.

Blumenthal et al. 2000

Unless otherwise prescribed: 4-6 g per day of cut leaf for infusions.
Internal: Infusion: 1-3 g in 150 ml water, three times daily.

BHC 2006

Internal daily dose:
3-6g of dried leaf, usually as an infusion;
liquid extract 1:1 in 45% ethanol, 2-6 ml

BHP 1983

(thrice daily):
Dried herb. Dose 1-4g or by infusion.

Culbreth 1927

1-4 g per day as an infusion