Monograph: Aloe - Oral

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This monograph is intended to serve as a guide to industry for the preparation of Product Licence Applications (PLA) and labels for natural health product market authorization. It is not intended to be a comprehensive review of the medicinal ingredient. It is a referenced document to be used as a labelling standard. Notes: Text in parentheses is additional optional information which can be included on the PLA and product labels at the applicant's discretion. The solidus (/) indicates that the terms are synonyms or that the statements are synonymous. Either term or statement may be selected by the applicant. Claims for traditional use must include the term "Herbal Medicine"

Date: 2018-07-31

NHPID name

Aloe vera ( Germplasm Resources Information Network Taxonomy )

Proper name(s)

Aloe vera ( USDA 2018 )

Common name(s)

Aloe ( USDA 2018 , McGuffin et al. 2000 )
Aloe vera ( Unavailable )
Barbados aloe ( Unavailable )
Curaçao aloe ( USDA 2018 , McGuffin et al. 2000 )
True aloe ( Unavailable )
West Indian aloe ( USDA 2018 , McGuffin et al. 2000 )

Source material

Latex ( Barnes et al. 2007 , Williamson 2003 )

Route Of administration

Oral

Dosage form(s)

Those suited to the allowable route(s) of administration. This monograph is not intended to include food-like dosage forms such as bars, chewing gums or beverages.

Use(s) or purpose(s)

Statement(s) to the effect of:

(Traditionally used in Herbal Medicine as a) stimulant laxative. (Williamson 2003, Bradley 1992, Felter and Lloyd 1983[1898], Grieve 1971[1931])
(Used in Herbal Medicine for the) short-term relief of occasional constipation. (EMEA 2006)
(Used in Herbal Medicine to) promote(s) bowel movement (by direct action on the large intestine). (Sweetman 2007, EMEA 2006, WHO 1999)

Dose(s)

Adults and adolescents 12 and over:

Preparation:

All Standardized Extracts

Dose(s):

10-30 Milligrams Hydroxyanthracene derivatives as barbaloin/aloin per day

(Barnes et al. 2007, EMEA 2006, Blumenthal et al. 1998)

Directions for use:

Allow at least 6-12 hours for laxative effect to occur. ( EMEA 2006 )
Take a single dose at bedtime, a few hours before or after taking other medications or health products, two to three times per week. Frequency of use may be increased up to once daily if results are not observed. ( Bradley 1992 )

Preparation:

Dry, Powder, Decoction & Infusion + All Non-Standardised Extracts

Dose(s):

50 - 300 Milligrams per day, dried leaf latex

(Williamson 2003, Bradley 1992)

Directions for use:

Allow at least 6-12 hours for laxative effect to occur. ( EMEA 2006 )
Take a single dose at bedtime, a few hours before or after taking other medications or health products, two to three times per week. Frequency of use may be increased up to once daily if results are not observed. ( Bradley 1992 )

For products which provide a dosage range, the following directions for use is considered optional: The correct individual dose is the smallest one required to produce a comfortable, soft-formed stool (EMEA 2006)
See Appendix 1 for examples of appropriate dosage preparations and frequencies of use, according to cited references. The purpose of Appendix 1 is to provide guidance to industry.

Duration of use

Consult a health care practitioner/health care provider/health care professional/doctor/physician for use beyond 7 days. (EMEA 2006, Brinker 2001)

Risk information

Statement(s) to the effect of:

Caution(s) and Warning(s):

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 taking thiazide diuretics, corticosteroids, licorice root, or other medications or health products that may aggravate electrolyte imbalance. (EMEA 2006, Brinker 2001, McGuffin et al. 1997)
Consult a health care practitioner/health care provider/health care professional/doctor/physician prior to use if you have a kidney disorder, or are taking cardiac medications (e.g. cardiac glycosides or antiarrhythmic medications). (EMEA 2006, Brinker 2001, McGuffin et al. 1997)
Consult a health care practitioner/health care provider /health care professional/ doctor/ physician prior to use if you have faecal impaction or symptoms such as abdominal pain, nausea, vomiting or fever. (EMEA 2006, Brinker 2001, McGuffin et al. 1997)
Reduce dose or stop use if you experience abdominal pain, cramps, spasms and/or diarrhoea. (EMEA 2006, Brinker 2001)

Contraindication(s):

Do not use this product if you are pregnant or breastfeeding. (Brinker 2001, McGuffin et al. 1997)
Do not use this product if you have abnormal constrictions of the gastrointestinal tract, potential or existing intestinal blockage, atonic bowel, appendicitis, inflammatory colon disease (e.g. Crohn's disease or ulcerative colitis), abdominal pain of unknown origin, undiagnosed rectal bleeding, severe dehydration with depleted water or electrolytes, hemorrhoids or diarrhoea. (Brinker 2010, EMEA 2006, Brinker 2001, McGuffin et al. 1997)

Known Adverse Reaction(s): Stop use if hypersensitivity/allergy occurs.

Non-medicinal ingredients

Must be chosen from the current Natural health products ingredients database and must meet the limitations outlined in the database.

Specifications

The finished product specifications must be established in accordance with the requirements described in the NHPD Quality of natural health products guide.
The medicinal ingredient must comply with the requirements outlined in the Natural health products ingredient database (NHPID).
The medicinal ingredient may comply with the specifications outlined in one of the following pharmacopoeial monographs: 'Barbados Aloes' or 'Standardised Aloes Dry Extract' monograph in British Pharmacopoeia, 'Aloes, Barbados' or 'Aloes Dry Extract, Standardised' monograph in European Pharmacopoeia, and 'Aloe' monograph in US Pharamcopoeia.

References cited

Barnes J, Anderson LA, Philipson JD. 2007. Herbal Medicines, 3rd edition. London (GB): Pharmaceutical Press.
Berardi RR, DeSimone EM, Newton GD, Oszko MA, Popovich NG, Rollins CJ, Shimp LA, Tietze KJ, editors. Handbook of Nonprescription Drugs: An Interactive Approach to Self-Care, 13th edition. Washington (DC): American Pharmaceutical Association; 2002.
Blumenthal M, Busse W, Goldberg A, Gruenwald J, Hall T, Riggins C, Rister R, editors. The Complete German Commission E Monographs: Therapeutic Guide to Herbal Medicines. Austin (TX): American Botanical Council; 1998.
Boon H, Smith MJ. 2004. The Complete Natural Medicine Guide to the 50 Most Common Medicinal Herbs, 2nd edition. Toronto (ON): Robert Rose Inc.
Bove M. 2001. An Encyclopedia of Natural Healing for Children and Infants, 2nd edition. Toronto (ON): McGraw-Hill.
Bradley PR, editor. 1992. British Herbal Compendium: A Handbook of Scientific Information on Widely Used Plant Drugs, Volume 1. Bournemouth (GB): British Herbal Medicine Association.
Brinker F. 2001. Herb Contraindications and Drug Interactions, 3rd edition. Sandy (OR): Eclectic Medical Publications.
Brinker F. 2010. Online Updates and Additions to Herb Contraindications and Drug Interactions, 3rd edition. Sandy (OR): Eclectic Medical Publications. [Updated 2010 July 13; Accessed 2013 January 30]. Available from: http://www.eclecticherb.com/emp/updatesHCDI.html
EMEA 2006. European Medicines Agency. Community Herbal Monograph on Aloe Barbadensis Miller and on Aloe (Various Species, Mainly Aloe Ferox Miller And Its Hybrids). London (UK): EMEA Committee on Herbal Medicinal Products (HMPC), 26 October 2006. Available from: http://www.emea.europa.eu/pdfs/human/hmpc/aloe/7631006en.pdf [Accessed 08 August 2008].
Felter HW, Lloyd JU. King's American Dispensatory, Volume 1, 18th edition. Sandy (OR): Eclectic Medical Publications; 1983 [Reprint of 1898 original].
Fulton JE. 1990. The stimulation of post dermabrasion wound healing with stabilized Aloe vera gel-polyethylene oxide dressing. Journal of Dermatologic Surgery and Oncology 16(5):460-467.
Grieve M. 1971. A Modern Herbal, Volume 1. New York (NY): Dover Publications [Reprint of 1931 Harcourt, Brace & Company publication].
McGuffin M, Hobbs C, Upton R, Goldberg A, editors. 1997. American Herbal Products Association's Botanical Safety Handbook. Boca Raton (FL): CRC Press.
McGuffin M, Kartesz JT, Leung AY, Tucker AO, editors. 2000. Herbs of Commerce, 2nd edition. Austin(TX): American Herbal Products Association.
McIntyre A. Herbal Treatment of Children - Western and Ayurvedic Perspectives. Toronto (ON): Elsevier Limited; 2005.
Sweetman SC , editor. Martindale: The Complete Drug Reference, 35th edition. London (UK): Pharmaceutical Press; 2007.
USDA 2008: ARS, National Genetic Resources Program. Germplasm Resources Information Network (GRIN). National Germplasm Resources Laboratory, Beltsville (MD). [Accessed 2008-01-21]. Available at http://www.ars-grin.gov/cgi-bin/npgs/html/tax_search.pl
WHO 1999: World Health Organization. WHO Monographs on Selected Medicinal Plants, Volume 1. Geneva (CH): World Health Organization; 1999.
Williamson EM. Potter's Herbal Cyclopaedia: The Authoritative Reference work on Plants with a Known Medical Use. Saffron Walden (UK): The C.W. Daniel Company Limited; 2003.

References reviewed

Felter HW. The Eclectic Materia Medica, Pharmacology and Therapeutics. Sandy (OR): Eclectic Medical Publications; 1983 [Reprint of 1922 original].
Gallagher J, Gray M. 2003. Is aloe vera effective for healing chronic wounds? Journal of Wound, Ostomy and Continence Nursing 30(2):68-71.
Gerard J. The Herbal or General History of Plants. The Complete 1633 Edition as Revised and Enlarged by Thomas Johnson. NY (NY): Dover Publications; 1975.
HC 1997. Health Canada. TPD/NHPD Category IV Labelling Standard, Stimulating Laxatives [online]. Ottawa (ON): Therapeutic Products Directorate, Health Canada. Available from: http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/label-etiquet-pharm/laxstimu-eng.php [Accessed 08 October 2008].
Hoffmann D. 2003. Medical Herbalism: The Science and Practice of Herbal Medicine. Rochester (VT): Healing Arts Press.
MacKay D, Miller AL. Nutritional support for wound healing. Alternative Medicine Review 2003;8(4):359-377.
Maenthaisong R, Chaiyakunapruk N, Niruntraporn S, Kongkaew C. 2007. The efficacy of aloe vera used for burn wound healing: a systematic review. Burns 33(6):713-718.
Mills S, Bone K. 2000. Principles and Practice of Phytotherapy. Toronto (ON): Churchill Livingstone.
Mills S, Bone K. 2005. The Essential Guide to Herbal Safety. St. Louis (MO): Elsevier Churchill Livingstone.
Mills S. The Dictionary of Modern Herbalsim. Wellingborough (UK): Thorsons Publishers Ltd; 1985.
Schilcher H. Phytotherapy in Paediatrics: Handbook for Physicians and Pharmacists. Stuttgart (D): Medpharm Scientific Publishers; 1997.
Vogler BK, Ernst E. 1999. Aloe vera: a systematic review of its clinical effectiveness. British Journal of General Practice 49(447):823-828.
Williamson EM, Evans FJ, Wren RC. Potter's New Cyclopaedia of Botanical Drugs and Preparations. Saffron Walden (GB): C.W. Daniel Company Limited; 1988.

Appendix 1: Examples of appropriate dosage preparations, frequencies of use and directions for use

Oral:

Dried leaf latex:

100-300 mg per day (Williamson 2003)
50-200 mg per day (Bradley 1992)

Tincture:

50-200 mg dried equivalent, per day
(1:40, 45% ethanol, 2-8 ml)(Bradley 1992)

Preparations providing the following quantities of hydroxyanthracene derivatives:

10-30 mg hydroxyanthracene derivatives (calculated as barbaloin/aloin), per day (Barnes et al. 2007; EMEA 2006)
20-30 mg hydroxyanthracene derivatives (calculated as anhydrous aloin), per day (Blumenthal et al. 1998)