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'''Megavitamin therapy''' is the use of large amounts of [[vitamin]]s, often many times greater than the [[recommended dietary allowance]] (RDA) in the attempt to prevent or treat many types of [[disease]]s.
'''Megavitamin therapy''' is the use of large amounts of [[vitamin]]s, often many times greater than the [[recommended dietary allowance]] (RDA) in the attempt to prevent or treat many types of [[disease]]s.


Frequently used in [[complementary and alternative medicine]] and [[orthomolecular medicine]], megavitamin therapists also may employ nutrients{{Fact|date=May 2008}} such as [[dietary minerals]], [[enzymes]], [[amino acids]], [[essential fatty acids]], natural [[antioxidants]], [[glyconutrients|fermentable]] [[prebiotics|dietary]] [[dietary fiber|fiber]] or short chain [[fatty acids]].
Frequently used in [[complementary and alternative medicine]] and [[orthomolecular medicine]], megavitamin therapists also may employ nutrients{{Fact|date=May 2008}} such as [[dietary minerals]], [[enzymes]], [[amino acids]], [[essential fatty acids]], natural [[antioxidants]], [[glyconutrients|fermentable]] [[prebiotics|dietary]] [[dietary fiber|fiber]] or short chain [[fatty acids]].


The use of large doses of vitamins is medically supported for several dozen specific medical conditions.<ref name="Menolascino">Menolascino FJ, et al. "Orthomolecular Therapy: Its History and Applicability to Psychiatric Disorders", ''Child Psychiatry and Human Development'', Vol.18(3), Spring 1988, pp 140-1 </ref><ref name=toxicity_of_vitimins>http://www.pubmedcentral.nih.gov/picrender.fcgi?artid=1339500&blobtype=pdf</ref><ref> Canadian Paediatric Society (CPS), [http://www.cps.ca/english/statements/II/FNIM07-01.htm "Vitamin D supplementation: Recommendations for Canadian mothers and infants"], ''Paediatrics & Child Health'' 2007;12(7): 583-589</ref><ref>Barker BM, Bender DA (1980, 1982) ''The Vitamins in Medicine'', 4th ed, Vols 1 & 2, William Heinemann Medical Books, London.</ref> Historically, some megadose treatments with non-orthomolecular vitamin forms used in conventional medicine have been known to cause harm. The broad claims of effectiveness of many other treatments made by advocates of alternative medicine are considered inadequately substantiated by mainstream medicine.<ref name="Menolascino"/><ref name=AMA>[http://www.ama-assn.org/ama/pub/category/13638.html Report 12 of the Council on Scientific Affairs: Alternative medicine] ''American Medical Association'' June 1997, Accessed 21 March 2008</ref>
Nutrients may be useful in preventing and treating some illnesses,<ref name = ACS>{{cite web | url = http://www.cancer.org/docroot/ETO/content/ETO_5_3X_Orthomolecular_Medicine.asp?sitearea=ETO | title = ACS : Orthomolecular Medicine | accessdate = 2008-04-04 | format = | work = | publisher = [[American Cancer Society]] | date = 2007-06-19}}</ref> but the conclusions of medical research are that the broad claims of disease treatment by advocates of orthomolecular medicine or megavitamin therapy are unsubstantiated by the available evidence.<ref name="isbn1-55009-213-8">{{cite book |author=Aaronson S ''et al.'' |title=Cancer medicine 6 (Frei, Emil; Kufe, Donald W.; Holland, James F., eds)|publisher=BC Decker |location=Hamilton, Ont |year=2003 |pages= |isbn=1-55009-213-8 |chapter= Cancer medicine|pages=76 |accessdate=}}</ref><ref name=References1990>{{cite journal | author = Nutrition Committee, Canadian Paediatric Society | year = 1990 | title = Megavitamin and megamineral therapy in childhood | journal = CMAJ | volume = 143 | issue = 10 | pages = 1009–1013 | url = http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=1452516 | accessdate = 2008-04-04 | pmid = 1699646}}</ref><ref name=ACS/> Critics have described some aspects of orthomolecular medicine as [[food faddism]] or even [[quackery]].<ref name="autogenerated3">{{cite journal |author=Jarvis WT |title=Food faddism, cultism, and quackery |journal=Annu. Rev. Nutr. |volume=3 |pages=35–52 |year=1983 |pmid=6315036 |doi=10.1146/annurev.nu.03.070183.000343}}</ref><ref name=Jukes1990>{{cite journal | author = Jukes, T.H. | year = 1990 | title = Nutrition Science from Vitamins to Molecular Biology | journal = Annual Review of Nutrition | volume = 10 | issue = 1 | pages = 1–20 | doi = 10.1146/annurev.nu.10.070190.000245}} A short summary is in [http://arjournals.annualreviews.org/doi/full/10.1146/annurev.nu.10.072106.100001 the journal's preface].</ref><ref name="autogenerated2">{{cite journal | author = Braganza, S.F. | coauthors = Ozuah, P.O. | year = 2005 | title = Fad Therapies | journal = Pediatrics in Review | volume = 26 | issue = 10 | pages = 371–376 | doi = 10.1542/pir.26-10-371 | pmid = 16199591}}</ref> Research on nutrient supplementation in general suggests that some nutritional supplements might be beneficial, and that others might be harmful;<ref>{{cite journal |title=NIH State-of-the-Science Conference Statement on Multivitamin/Mineral Supplements and Chronic Disease Prevention |journal=NIH Consens State Sci Statements |volume=23 |issue=2 |pages=1–30 |year=2006 |pmid=17332802 |url=http://consensus.nih.gov/2006/2006MultivitaminMineralSOS028main.htm}}</ref><ref>{{cite journal |author=Huang HY, Caballero B, Chang S, ''et al'' |title=The efficacy and safety of multivitamin and mineral supplement use to prevent cancer and chronic disease in adults: a systematic review for a National Institutes of Health state-of-the-science conference |journal=Ann. Intern. Med. |volume=145 |issue=5 |pages=372–85 |year=2006 |month=September |pmid=16880453 |url=http://www.annals.org/cgi/pmidlookup?view=reprint&pmid=16880453 |doi=10.1001/archinte.145.2.372}}</ref><ref name="Cochrane2008">{{cite journal |author=Bjelakovic G, Nikolova D, Gluud LL, Simonetti RG, Gluud C |title=Antioxidant supplements for prevention of mortality in healthy participants and patients with various diseases |journal=Cochrane Database of Systematic Reviews |issue=2 |pages=CD007176 |year=2008 |doi=10.1002/14651858.CD007176}}</ref> several specific nutritional therapies are associated with an increased likelihood of the condition they are meant to prevent.<ref name="AmJEpidem2009">{{cite journal | authors = Satia JA, Littman A, Slatore CG, Galanko JA, White E | year = 2009 | title = Long-term Use of {beta}-Carotene, Retinol, Lycopene, and Lutein Supplements and Lung Cancer Risk: Results From the VITamins And Lifestyle (VITAL) Study | journal = American Journal of Epidemiology | volume = | issue = | pages = | doi = 10.1093/aje/kwn409 | pmid = }}</ref> A recent study analyzing over 161,000 individuals (post-menopausal women) provided, in the words of the authors, "convincing evidence that multivitamin use has little or no influence on the risk of common cancers, cardiovascular disease, or total mortality in postmenopausal women".<ref name="WHI">{{cite journal |author=Neuhouser ML, Wassertheil-Smoller S, Thomson C, ''et al'' |title=Multivitamin use and risk of cancer and cardiovascular disease in the Women's Health Initiative cohorts |journal=Arch. Intern. Med. |volume=169 |issue=3 |pages=294–304 |year=2009 |month=February |pmid=19204221 |doi=10.1001/archinternmed.2008.540 |url=}}</ref>
==Background==
⚫
In the 1930s and 1940s, some scientific and clinical evidence suggested that there might be beneficial uses of vitamins [[Vitamin C|C]], [[Vitamin E|E]] and [[Vitamin B3|B-3]] in large doses. Beginning in the 1930s, the Shutes in Canada developed a megadose vitamin E therapy for cardiovascular and circulatory complaints, naming it the "Shute protocol" <SUP>[http://www.doctoryourself.com/shute_protocol.html]</SUP>. Tentative experiments in the 1930s<SUP>[http://www.seanet.com/~alexs/ascorbate/193x/][http://www.jem.org/cgi/content/abstract/65/1/127]</SUP> with larger doses of vitamin C were superseded by [[Fred R. Klenner]]'s development of [[Vitamin C megadosage|megadose]] intravenous vitamin C treatments in the 1940s<SUP>[http://www.orthomed.com/klenner.htm]</SUP>. William Kaufman, MD, PhD, published two books in the 1940s that detailed his treatment of arthritis with frequent, high doses of niacinamide<SUP>[http://www.doctoryourself.com/JOM1.html][http://www.doctoryourself.com/kaufman3.html][http://www.doctoryourself.com//kaufman10.html]</SUP>.


In 1954, Professor [[R. Altschul]] and [[Abram Hoffer]], MD, PhD, applied large doses of the immediate release form of [[niacin]] (Vitamin B-3) to treat [[hypercholesterolemia]] (high cholesterol). High dose niacin was shown to be more effective than conventional treatments in the Canner study of the [[Coronary Drug Project]], a large scale, prospective, randomized, controlled trial to reduce long term total mortality, showed 11% reduction in mortality at 15 years follow up with only 6 years of niacin treatment. The other conventional approaches (two estrogen regimens, dextrothyroxine and clofibrate) —treatments that are no longer standard of care—were ineffective.<ref name="niacin27g">Fifteen year mortality in Coronary Drug Project patients: long-term benefit with niacin. Canner PL, Berge KG, Wenger NK, Stamler J, Friedman L, Prineas RJ, Friedewald W in ''J Am Coll Cardiol 1986 Dec;8(6):1245-55 '' PMID: 3782631 “With a mean follow-up of 15 years, nearly 9 years after termination of the trial, mortality from all causes in each of the drug groups, except for niacin, was similar to that in the placebo group. Mortality in the niacin group was 11% lower than in the placebo group (52.0 versus 58.2%; p = 0.0004).” Dose used = 2g – 3g/day for 6 years. The drop in mortality was only evident after 6-8 years.</ref>. Niacin is used to treat hypercholesterolemia because of its low cost and its unique ability to broadly improve lipid profiles for ApoB<SUP>[http://atvb.ahajournals.org/cgi/content/abstract/19/4/1051]</SUP>, LDL, small dense LDL, HDL, HDL<SUB>2b</SUB> (extremely good cholesterol), Lp(a), fibrinogen and trigycerides<SUP>[http://www.bhlinc.com/CIRM.shtml]</SUP>.
==History==
⚫
In the 1930s and 1940s, some scientific and clinical evidence suggested that there might be beneficial uses of vitamins [[Vitamin C|C]], [[Vitamin E|E]] and [[Vitamin B3|B-3]] in large doses. Beginning in the 1930s, the Shutes in Canada developed a megadose vitamin E therapy for cardiovascular and circulatory complaints, naming it the "Shute protocol".<ref name="pmid18911314">{{cite journal |author=VOGELSANG A, SHUTE E, SHUTE W |title=Some medical uses of vitamin E |journal=Med World (New York) |volume=161 |issue=2 |pages=83–9 |year=1948 |month=February |pmid=18911314 |doi= |url=}}</ref> Tentative experiments in the 1930s<ref>{{cite journal|last=Jungeblut|first=CW|date=1937|title=VITAMIN C THERAPY AND PROPHYLAXIS IN EXPERIMENTAL POLIOMYELITIS |journal=The Journal of Experimental Medicine|volume=65|pages=127-146|url=http://jem.rupress.org/cgi/content/abstract/65/1/127}}</ref> with larger doses of vitamin C were superseded by [[Fred R. Klenner]]'s development of [[Vitamin C megadosage|megadose]] intravenous vitamin C treatments in the 1940s.<ref name="pmid18147027">{{cite journal |author=KLENNER FR |title=The treatment of poliomyelitis and other virus diseases with vitamin C |journal=South Med Surg |volume=111 |issue=7 |pages=209–14 |year=1949 |month=July |pmid=18147027 |doi= |url=}}</ref> William Kaufman, MD, PhD, published articles in the 1940s that detailed his treatment of arthritis with frequent, high doses of niacinamide.<ref name="pmid13060032">{{cite journal |author=KAUFMAN W |title=Niacinamide therapy for joint mobility; therapeutic reversal of a common clinical manifestation of the normal aging process |journal=Conn State Med J |volume=17 |issue=7 |pages=584–9 |year=1953 |month=July |pmid=13060032 |doi= |url=}}</ref>


In 1954, Professor [[R. Altschul]] and [[Abram Hoffer]], MD, PhD, applied large doses of the immediate release form of [[niacin]] (Vitamin B-3) to treat [[hypercholesterolemia]] (high cholesterol).<ref name="pmid13792994">{{cite journal |author=ALTSCHUL R, HOFFER A |title=The effect of nicotinic acid on hypercholesterolaemia |journal=Can Med Assoc J |volume=82 |issue= |pages=783–5 |year=1960 |month=April |pmid=13792994 |pmc=1938010 |doi= |url=}}</ref> The 1956 publication of [[Roger J. Williams]] <i>Biochemical Individuality<i> introduced concepts for individualized megavitamins and nutrients.<ref name="isbn0-87983-893-0">{{cite book |author=Williams, Roger Lawrence |title=Biochemical Individuality |publisher=McGraw-Hill |location=New York |year=1998 |pages= |isbn=0-87983-893-0 |oclc= |doi= |accessdate=}}</ref> In the 1960s, biochemist [[Irwin Stone]], author of ''The Healing Factor'', observed that vitamin C's utility in the megadose treatments of human disease parallels the amounts of [[vitamin C]] physiologically produced in most animals and postulated humans' evolutionary loss of this capability. Megavitamin therapies were also publicly advocated by [[Linus Pauling]] in the late 1960s.<ref name="isbn0-399-50764-7">{{cite book |author=Stone, Irwin |title=The healing factor: "vitamin C" against disease |publisher=Perigee Books |location=New York |year=1982 |pages= |isbn=0-399-50764-7 |oclc= |doi= |accessdate=}}</ref>
The 1956 publication of [[Roger J. Williams]] <i>Biochemical Individuality<i> introduced concepts for individualized megavitamins and nutrients. In the 1960s, biochemist [[Irwin Stone]], author of ''The Healing Factor'', observed that vitamin C's utility in the megadose treatments of human disease parallels the amounts of [[vitamin C]] physiologically produced in most animals and postulated humans' evolutionary loss of this capability. Megavitamin therapies were also publicly advocated by [[Linus Pauling]] in the late 1960s.


Several orthomolecular megavitamin protocols have been publicized.<ref name="urlCancer Survival - Cancer Help">{{cite web |url=http://www.cancersurvival.com/help_pauling.html |title=Cancer Survival - Cancer Help |format= |work= |accessdate=2009-02-18}}</ref> While formal medical recognition of niacin therapy for hypercholesterolemia followed confirmation by William Parsons of the Mayo Clinic (1956) and the Canner study (1986), the success of several popular books since the 1980s has made the public more aware of niacin's role in combination with other medications, for [[dyslipidemia]]s (abnormal [[lipid]] levels in the blood).<ref name="pmid18973399">{{cite journal |author=Sanford M, Curran MP |title=Niacin extended-release/simvastatin |journal=Drugs |volume=68 |issue=16 |pages=2373–86 |year=2008 |pmid=18973399 |doi= |url=}}</ref> Pauling's advocacy of megadoses of vitamin C for colds, beginning in the 1960s, and later for cancer, made millions aware of the concept of megavitamin treatment in disease. Pauling's vitamin C recommendations are lower than some modern recommendations.<ref name="pmid5107925">{{cite journal |author=Pauling L |title=Vitamin C and common cold |journal=JAMA |volume=216 |issue=2 |pages=332 |year=1971 |month=April |pmid=5107925 |doi= |url=}}</ref>
Several orthomolecular megavitamin protocols have been publicized.<ref>[http://www.cancersurvival.com/help_pauling.html Cancer Survival - Cancer Help<!-- Bot generated title -->]</ref> While formal medical recognition of niacin therapy for hypercholesterolemia followed confirmation by William Parsons of the Mayo Clinic (1956) and the Canner study (1986), the success of several popular books since the 1980s has made the public more aware of niacin's effective megavitamin therapy for [[dyslipidemia]]s (abnormal [[lipid]] levels in the blood). Pauling's advocacy of megadoses of vitamin C for colds, beginning in the 1960s, and later for cancer, made millions aware of the concept of megavitamin treatment in disease. Pauling's vitamin C recommendations are lower than some modern recommendations.


Other treatments include orthomolecular oral dosing schedules for an early treatment of colds,<ref name="urlThe Vitamin C Foundation - Cold Cure">{{cite web |url=http://www.vitamincfoundation.org/surefire.htm |title=The Vitamin C Foundation - Cold Cure |format= |work= |accessdate=2009-02-18}}</ref> and for bowel tolerance for more established colds.<ref name="pmid7321921">{{cite journal |author=Cathcart RF |title=Vitamin C, titrating to bowel tolerance, anascorbemia, and acute induced scurvy |journal=Med. Hypotheses |volume=7 |issue=11 |pages=1359–76 |year=1981 |month=November |pmid=7321921 |doi= |url=http://linkinghub.elsevier.com/retrieve/pii/0306-9877(81)90126-2}}</ref>
Other treatments include orthomolecular oral dosing schedules for an early, [http://www.vitamincfoundation.org/surefire.htm "abortive" treatment of a cold at onset,] and for bowel tolerance for more established colds,<REF>[http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=7321921&dopt=Abstract |RF Cathcart, Vitamin C, Titrating to Bowel Tolerance, Anascorbemia, and Acute Induced Scurvy, Medical Hypotheses, 7:1359-1376, 1981]</REF> typically using 40 to 100<SUP>+</SUP> grams per day in hourly doses as recommended as effective by orthomolecular practitioners.


==Usage of therapy==
==Usage of therapy==
An American [[cottage industry]] in the late 20th century, the evolving megavitamin therapy are integrated with orthomolecular and [[naturopathic medicine]]. Although megavitamin therapy still largely remains outside of the structure of [[evidence-based medicine]], they are increasingly used by patients, with or without the approval of their treating physicians.<ref name="pmid10893280">{{cite journal |author=Richardson MA, Sanders T, Palmer JL, Greisinger A, Singletary SE |title=Complementary/alternative medicine use in a comprehensive cancer center and the implications for oncology |journal=J. Clin. Oncol. |volume=18 |issue=13 |pages=2505–14 |year=2000 |month=July |pmid=10893280 |doi= |url=http://jco.ascopubs.org/cgi/content/full/18/13/2505}}</ref> In the 21st century, proposed megavitamin therapies with vitamin C are being evaluated for their possible use in cancer, but clinical results have shown no effect on treating or reducing the risk of cancer.<ref name="pmid19116389">{{cite journal |author=Lin J, Cook NR, Albert C, ''et al'' |title=Vitamins C and E and beta carotene supplementation and cancer risk: a randomized controlled trial |journal=J. Natl. Cancer Inst. |volume=101 |issue=1 |pages=14–23 |year=2009 |month=January |pmid=19116389 |doi=10.1093/jnci/djn438 |url=}}</ref>
An American [[cottage industry]] in the late 20th century, the evolving megavitamin therapy are integrated with orthomolecular and [[naturopathic medicine]]. Although megavitamin therapy still largely remains outside of the structure of [[conventional medicine]] and the [[pharmaceutical industry]], they are increasingly used by patients, with or without the approval of their treating physicians.<SUP>[http://www.jco.org/cgi/content/full/18/13/2505]</SUP> In the 21st century, proposed megavitamin therapies with vitamin C are being evaluated for their possible use in cancer.<SUP>[http://www.pnas.org/cgi/content/abstract/102/38/13604]</SUP>


==Criticism ==
==Criticism and side effects ==
The effectiveness of various megavitamin therapies has been disputed by many conventional medical personnel,<ref> Robert Landwehr, [http://www.seanet.com/~alexs/ascorbate/199x/landwehr-r-j_orthomol_med-1991-v6-n2-p99.htm The Origin of the 42-Year Stonewall of Vitamin C] J Orthomolecular Medicine, Vol 6, No. 2, 1991, pp. 99-103</ref> including about safety, definition and validation of efficacy. For example, some critics claim that there is no evidence that ingesting once a day supplements of 1 to 3 grams of Vitamin C is significant in treating the common cold for ordinary people. Reviews and re-examinations by Colchrane Collection author, Harri Hemilä, have meticulously documented that many previous "expert" statements on vitamin C have suffered from serious mathematical errors, selection bias, and misinterpretation,<ref name="Hemilä">Hemilä H. [http://ethesis.helsinki.fi/julkaisut/laa/kansa/vk/hemila/"Do vitamins C and E affect respiratory infections?"] Univ. of Helsinki, Dissertation, Faculty of Medicine, Dept. of Public Health. 2006.</ref> and that even these infrequent, intermediate "megadoses", although much lower than the dosages recommended by vitamin C megavitamin advocates,<ref>[http://www.vitamincfoundation.org/surefire.htm Surefire Cures for the Common Cold or the Flu!], [http://www.vitamincfoundation.org/tech.html Vitamin C Foundation], accessed online 27 Feb 2008.</ref> do show statistically significant benefit. There has been more general agreement that such intermediate dosages may help some stressed or compromised subpopulations.<ref name="Hemilä"/> The orthomolecular advocates publish, and use, much higher, more frequent oral dose recommendations for vitamin C, in the 40 to 100+ grams per day range for treating [[Common cold#Vitamin C|colds]] and around 150 grams per day for flu.<ref> Cathcart RF, [http://www.doctoryourself.com/titration.html Vitamin C, Titrating to Bowel Tolerance, Anascorbemia, and Acute Induced Scurvy], ''Medical Hypotheses'', 7:1359-1376, 1981.</ref>
The efficacy of various megavitamin therapies has been contradicted by results of numerous clinical trials.<ref name="WHI"/><ref name="pmid19116389"/><ref name="pmid14563626">{{cite journal |author=Johnson LJ, Meacham SL, Kruskall LJ |title=The antioxidants--vitamin C,vitamin E, selenium, and carotenoids |journal=J Agromedicine |volume=9 |issue=1 |pages=65–82 |year=2003 |pmid=14563626 |doi= |url=}}</ref> For example, a thorough review of clinical trials in the treatment of colds with small and large doses of Vitamin C have established that there is no evidence for its efficacy.<ref name="pmid17636648">{{cite journal |author=Douglas RM, Hemilä H, Chalker E, Treacy B |title=Vitamin C for preventing and treating the common cold |journal=Cochrane Database Syst Rev |volume= |issue=3 |pages=CD000980 |year=2007 |pmid=17636648 |doi=10.1002/14651858.CD000980.pub3 |url=}}</ref>


The term "megavitamin therapy" itself was criticized by opponents of [[orthomolecular psychiatry]] in the early 1970s as misleading, because they believed the term falsely implied therapeutic benefit, because of still unresolved disputes over scientific rigor and efficacy for the early 1950s treatment of a carefully specified type of acute schizophrenia.<ref>[http://www.quackwatch.org/01QuackeryRelatedTopics/ortho.html Orthomolecular Therapy<!-- Bot generated title -->]</ref><ref>Lipton M and others. Task Force Report on Megavitamin and Orthomolecular Therapy in Psychiatry. Washington D.C., 1973, American Psychiatric Association.</ref><ref>[http://www.us.oup.com/pdf/0195140710_01.pdf '''Megavitamin Therapy'''] In Reply To Task Force Report on Megavitamin and Orthomolecular Therapy in Psychiatry. Canadian Schizophrenia Foundation. August 1976</ref>
Toxic effects of high doses of Vitamin A,<ref name="pmid1463588">{{cite journal |author=Snodgrass SR |title=Vitamin neurotoxicity |journal=Mol. Neurobiol. |volume=6 |issue=1 |pages=41–73 |year=1992 |pmid=1463588 |doi= |url=}}</ref>, Vitamin D,<ref name="pmid1463588"/> and Vitamin B12<ref name="pmid3818116">{{cite journal |author=Mangiarotti G, Canavese C, Salomone M, ''et al'' |title=Hypervitaminosis B12 in maintenance hemodialysis patients receiving massive supplementation of vitamin B12 |journal=Int J Artif Organs |volume=9 |issue=6 |pages=417–20 |year=1986 |month=November |pmid=3818116 |doi= |url=}}</ref> are well established. The [[United States Department of Agriculture]] establishes a maximum intake level for most vitamins, at which no adverse effects should occur including many infrequent or minor effects. These are part of the [[Dietary Reference Intake| Tolerable upper intake level]] (UL) recommendations.

Some megadose vitamin uses, often older pharmaceutical ones such as neonatal use of synthetic [[menadione]], "a synthetic lipid soluble product which was once called vitamin K<SUB>3</SUB>",<ref>[http://www.fda.gov/cvm/FOI/VKAS_EA.pdf] FDA, Environmental Assessment: Vitamin K Active Substances, Section 2.4.3.2. Animal Toxicity,
"Phylloquinone[K<sub>1</sub>] and menaquinone [K<sub>2</sub>] are nontoxic to animals even when given in large doses. For example, mice receiving a single oral dose of 15-25 g phylloquinone/kg BW showed no adverse effects (Molitor and Robinson, 1940).</REF><REF>[http://redpoll.pharmacy.ualberta.ca/drugbank/cgi-bin/getCard.cgi?CARD=NUTR00062.txt] DrugBank, ''Vitamin K3'', University of Alberta</REF>
<REF>[http://www.innvista.com/health/nutrition/vitamins/k.htm Vitamin K], Innvista </ref> can cause toxicity. In the specific case of synthetic K<sub>3</sub>, large doses may cause [[hemolytic anemia]], which occurs when the red blood cells die more quickly than the body can reproduce. In addition, K<sub>3</sub> speeds liver damage, producing jaundice, deafness, and severe neurological problems, including retardation in infants. There is no record that the other two, natural series of Vitamin K, have produced toxic levels.<REF> FDA, [http://www.fda.gov/cvm/FOI/VKAS_EA.pdf Environmental Assessment: Vitamin K Active Substances] </REF><REF>CA Burtis, ER Ashwood, DE Bruns (2005) ''Tietz Textbook of Clinical Chemistry and Molecular Diagnostics'', p. 1089, Elsevier-Saunders; 4th ed. ISBN 0721601898 "The use of high doses of naturally occurring vitamin K (K<sub>1</sub> and K<sub>2</sub>) appears to have no untoward effect; however, menadione (K<sub>3</sub>) treatment can lead to the formation of erythrocyte cytoplasmic inclusions known as Heinz bodies and hemolytic anemia....As no adverse effects associated with vitamin K consumption from food or supplements have been reported in humans or animals, the U.S. Institute of Medicine has reported that a quantitative risk assessment cannot be performed, and thus a UL cannot be derived for vitamin K"</REF> The pharmaceutical synthetic, K<sub>3</sub>, is now banned in most countries for neonatal or general human use. These were previously conventional medical therapeutics, not orthomolecular type megavitamin treatments.

The [[United States Department of Agriculture]] establishes a maximum intake level for most vitamins, at which no adverse effects should occur including many infrequent or minor effects. These are part of the [[Dietary Reference Intake| Tolerable upper intake level]] (UL) recommendations. Extremely high dose vitamin A for previous conventional pediatrics and dermatology practices,<REF>[http://www.amazon.com/dp/0071422803 Goodman & Gilman's The Pharmacological Basis of Therapeutics, 9th ed, Ch 63.]</REF> beyond orthomolecular therapy ranges, have been deprecated by some medical organizations of minor political units as ineffective and potentially toxic.<ref name="bccancer">[http://www.bccancer.bc.ca/PPI/UnconventionalTherapies/VitaminTherapyMegadoseOrthomolecularTherapy.htm "Vitamin Therapy, Megadose / Orthomolecular Therapy" British Columbia Provincial Health Services Authority 2000]</ref> Administration of very large doses of [[vitamin A]],<ref> Penniston KL, Tanumihardjo SA (2006) The acute and chronic toxic effects of vitamin A. ''Am J Clin Nutr.'' 83:191-201. PMID: 16469975</ref> [[vitamin C]], [[vitamin D]], and [[pyridoxine]] ([[Vitamin B6]]) may have [[Adverse effect (medicine)|adverse side effect]]s [http://www.pubmedcentral.nih.gov/picrender.fcgi?artid=1339500&blobtype=pdf].


==See also==
==See also==
Line 35: Line 44:
==Footnotes==
==Footnotes==
{{reflist}}
{{reflist}}

==References==
* Abram Hoffer (1998) Putting It All Together: The New Orthomolecular Nutrition, McGraw-Hill, ISBN 0-87983-633-4
* Pauling, Linus (1986) How to Live Longer and Feel Better, W. H. Freeman and Company, ISBN 0-380-70289-4
* Roger J. Williams, Dwight K. Kalita (1979) Physician's Handbook on Orthomolecular Medicine, Keats Publishing, ISBN 0-87983-199-5
* Roger J Williams (1998) Biochemical Individuality: The Basis for the Genetotrophic Concept. 2nd ed. Keats Publishing. ISBN 0-87983-893-0
* Canner, P.L., Berge, K.G., Wenger, N.K., ''et al.'' Fifteen year mortality in Coronary Drug Project patients: long-term benefit with niacin. J Am Coll Cardiol, 1986, 8: 1245-1255.
* Meyers, et al, Varying Cost and Free Nicotinic Acid Content in Over-the-Counter Niacin Preparations for Dyslipidemia, Annals of Internal Med. 2003 Dec 16;139(12):996-1002 [http://www.annals.org/cgi/reprint/139/12/996.pdf]
* Guyton, J. R., Blazing, M.A., Hagar, J., ''et al.'' Extended-release niacin vs Gemfibrozil for the treatment of low levels of high density lipoprotein cholesterol. Arch Intern Med, 2000, 160: 1177-1184.
* Kamanna, V.S., Kashyap, M.L., Mechanism of Action of Niacin on Lipoprotein Metabolism, Current Atherosclerosis Reports 2000, 2:36-46
* Heady JA, Morris JN, Oliver MF. WHO clofibrate/cholesterol trial: clarifications. Lancet 1992; 340: 1405-1406.
* Frick MH, Elo O, Haapa K, ''et al.'' Helsinki Heart Study: primary prevention trial with gemfibrozil in middle-aged men with dyslipidemia. Safety of treatment, changes in risk factors, and incidence of coronary heart disease. N Engl J Med 1987; 317: 1237-1245.
* Irwin Stone (1972) The Healing Factor: Vitamin C Against Disease, GD/Perigee Books (Putnam Pub) ISBN 0-399-50764-7 [http://vitamincfoundation.org/stone/]


==External links==
==External links==

Revision as of 17:36, 18 February 2009

Megavitamin therapy is the use of large amounts of vitamins, often many times greater than the recommended dietary allowance (RDA) in the attempt to prevent or treat many types of diseases.

Frequently used in complementary and alternative medicine and orthomolecular medicine, megavitamin therapists also may employ nutrients[citation needed] such as dietary minerals, enzymes, amino acids, essential fatty acids, natural antioxidants, fermentable dietary fiber or short chain fatty acids.

The use of large doses of vitamins is medically supported for several dozen specific medical conditions.[1][2][3][4] Historically, some megadose treatments with non-orthomolecular vitamin forms used in conventional medicine have been known to cause harm. The broad claims of effectiveness of many other treatments made by advocates of alternative medicine are considered inadequately substantiated by mainstream medicine.[1][5]

Background

In the 1930s and 1940s, some scientific and clinical evidence suggested that there might be beneficial uses of vitamins C, E and B-3 in large doses. Beginning in the 1930s, the Shutes in Canada developed a megadose vitamin E therapy for cardiovascular and circulatory complaints, naming it the "Shute protocol" [3]. Tentative experiments in the 1930s[4][5] with larger doses of vitamin C were superseded by Fred R. Klenner's development of megadose intravenous vitamin C treatments in the 1940s[6]. William Kaufman, MD, PhD, published two books in the 1940s that detailed his treatment of arthritis with frequent, high doses of niacinamide[7][8][9].

In 1954, Professor R. Altschul and Abram Hoffer, MD, PhD, applied large doses of the immediate release form of niacin (Vitamin B-3) to treat hypercholesterolemia (high cholesterol). High dose niacin was shown to be more effective than conventional treatments in the Canner study of the Coronary Drug Project, a large scale, prospective, randomized, controlled trial to reduce long term total mortality, showed 11% reduction in mortality at 15 years follow up with only 6 years of niacin treatment. The other conventional approaches (two estrogen regimens, dextrothyroxine and clofibrate) —treatments that are no longer standard of care—were ineffective.[6]. Niacin is used to treat hypercholesterolemia because of its low cost and its unique ability to broadly improve lipid profiles for ApoB[10], LDL, small dense LDL, HDL, HDL2b (extremely good cholesterol), Lp(a), fibrinogen and trigycerides[11].

The 1956 publication of Roger J. Williams Biochemical Individuality introduced concepts for individualized megavitamins and nutrients. In the 1960s, biochemist Irwin Stone, author of The Healing Factor, observed that vitamin C's utility in the megadose treatments of human disease parallels the amounts of vitamin C physiologically produced in most animals and postulated humans' evolutionary loss of this capability. Megavitamin therapies were also publicly advocated by Linus Pauling in the late 1960s.

Several orthomolecular megavitamin protocols have been publicized.[7] While formal medical recognition of niacin therapy for hypercholesterolemia followed confirmation by William Parsons of the Mayo Clinic (1956) and the Canner study (1986), the success of several popular books since the 1980s has made the public more aware of niacin's effective megavitamin therapy for dyslipidemias (abnormal lipid levels in the blood). Pauling's advocacy of megadoses of vitamin C for colds, beginning in the 1960s, and later for cancer, made millions aware of the concept of megavitamin treatment in disease. Pauling's vitamin C recommendations are lower than some modern recommendations.

Other treatments include orthomolecular oral dosing schedules for an early, "abortive" treatment of a cold at onset, and for bowel tolerance for more established colds,[8] typically using 40 to 100+ grams per day in hourly doses as recommended as effective by orthomolecular practitioners.

Usage of therapy

An American cottage industry in the late 20th century, the evolving megavitamin therapy are integrated with orthomolecular and naturopathic medicine. Although megavitamin therapy still largely remains outside of the structure of conventional medicine and the pharmaceutical industry, they are increasingly used by patients, with or without the approval of their treating physicians.[12] In the 21st century, proposed megavitamin therapies with vitamin C are being evaluated for their possible use in cancer.[13]

Criticism and side effects

The effectiveness of various megavitamin therapies has been disputed by many conventional medical personnel,[9] including about safety, definition and validation of efficacy. For example, some critics claim that there is no evidence that ingesting once a day supplements of 1 to 3 grams of Vitamin C is significant in treating the common cold for ordinary people. Reviews and re-examinations by Colchrane Collection author, Harri Hemilä, have meticulously documented that many previous "expert" statements on vitamin C have suffered from serious mathematical errors, selection bias, and misinterpretation,[10] and that even these infrequent, intermediate "megadoses", although much lower than the dosages recommended by vitamin C megavitamin advocates,[11] do show statistically significant benefit. There has been more general agreement that such intermediate dosages may help some stressed or compromised subpopulations.[10] The orthomolecular advocates publish, and use, much higher, more frequent oral dose recommendations for vitamin C, in the 40 to 100+ grams per day range for treating colds and around 150 grams per day for flu.[12]

The term "megavitamin therapy" itself was criticized by opponents of orthomolecular psychiatry in the early 1970s as misleading, because they believed the term falsely implied therapeutic benefit, because of still unresolved disputes over scientific rigor and efficacy for the early 1950s treatment of a carefully specified type of acute schizophrenia.[13][14][15]

Some megadose vitamin uses, often older pharmaceutical ones such as neonatal use of synthetic menadione, "a synthetic lipid soluble product which was once called vitamin K3",[16][17] [18] can cause toxicity. In the specific case of synthetic K3, large doses may cause hemolytic anemia, which occurs when the red blood cells die more quickly than the body can reproduce. In addition, K3 speeds liver damage, producing jaundice, deafness, and severe neurological problems, including retardation in infants. There is no record that the other two, natural series of Vitamin K, have produced toxic levels.[19][20] The pharmaceutical synthetic, K3, is now banned in most countries for neonatal or general human use. These were previously conventional medical therapeutics, not orthomolecular type megavitamin treatments.

The United States Department of Agriculture establishes a maximum intake level for most vitamins, at which no adverse effects should occur including many infrequent or minor effects. These are part of the Tolerable upper intake level (UL) recommendations. Extremely high dose vitamin A for previous conventional pediatrics and dermatology practices,[21] beyond orthomolecular therapy ranges, have been deprecated by some medical organizations of minor political units as ineffective and potentially toxic.[22] Administration of very large doses of vitamin A,[23] vitamin C, vitamin D, and pyridoxine (Vitamin B6) may have adverse side effects [14].

See also

Footnotes

  1. ^ a b Menolascino FJ, et al. "Orthomolecular Therapy: Its History and Applicability to Psychiatric Disorders", Child Psychiatry and Human Development, Vol.18(3), Spring 1988, pp 140-1
  2. ^ http://www.pubmedcentral.nih.gov/picrender.fcgi?artid=1339500&blobtype=pdf
  3. ^ Canadian Paediatric Society (CPS), "Vitamin D supplementation: Recommendations for Canadian mothers and infants", Paediatrics & Child Health 2007;12(7): 583-589
  4. ^ Barker BM, Bender DA (1980, 1982) The Vitamins in Medicine, 4th ed, Vols 1 & 2, William Heinemann Medical Books, London.
  5. ^ Report 12 of the Council on Scientific Affairs: Alternative medicine American Medical Association June 1997, Accessed 21 March 2008
  6. ^ Fifteen year mortality in Coronary Drug Project patients: long-term benefit with niacin. Canner PL, Berge KG, Wenger NK, Stamler J, Friedman L, Prineas RJ, Friedewald W in J Am Coll Cardiol 1986 Dec;8(6):1245-55 PMID: 3782631 “With a mean follow-up of 15 years, nearly 9 years after termination of the trial, mortality from all causes in each of the drug groups, except for niacin, was similar to that in the placebo group. Mortality in the niacin group was 11% lower than in the placebo group (52.0 versus 58.2%; p = 0.0004).” Dose used = 2g – 3g/day for 6 years. The drop in mortality was only evident after 6-8 years.
  7. ^ Cancer Survival - Cancer Help
  8. ^ |RF Cathcart, Vitamin C, Titrating to Bowel Tolerance, Anascorbemia, and Acute Induced Scurvy, Medical Hypotheses, 7:1359-1376, 1981
  9. ^ Robert Landwehr, The Origin of the 42-Year Stonewall of Vitamin C J Orthomolecular Medicine, Vol 6, No. 2, 1991, pp. 99-103
  10. ^ a b Hemilä H. "Do vitamins C and E affect respiratory infections?" Univ. of Helsinki, Dissertation, Faculty of Medicine, Dept. of Public Health. 2006.
  11. ^ Surefire Cures for the Common Cold or the Flu!, Vitamin C Foundation, accessed online 27 Feb 2008.
  12. ^ Cathcart RF, Vitamin C, Titrating to Bowel Tolerance, Anascorbemia, and Acute Induced Scurvy, Medical Hypotheses, 7:1359-1376, 1981.
  13. ^ Orthomolecular Therapy
  14. ^ Lipton M and others. Task Force Report on Megavitamin and Orthomolecular Therapy in Psychiatry. Washington D.C., 1973, American Psychiatric Association.
  15. ^ Megavitamin Therapy In Reply To Task Force Report on Megavitamin and Orthomolecular Therapy in Psychiatry. Canadian Schizophrenia Foundation. August 1976
  16. ^ [1] FDA, Environmental Assessment: Vitamin K Active Substances, Section 2.4.3.2. Animal Toxicity, "Phylloquinone[K1] and menaquinone [K2] are nontoxic to animals even when given in large doses. For example, mice receiving a single oral dose of 15-25 g phylloquinone/kg BW showed no adverse effects (Molitor and Robinson, 1940).
  17. ^ [2] DrugBank, Vitamin K3, University of Alberta
  18. ^ Vitamin K, Innvista
  19. ^ FDA, Environmental Assessment: Vitamin K Active Substances
  20. ^ CA Burtis, ER Ashwood, DE Bruns (2005) Tietz Textbook of Clinical Chemistry and Molecular Diagnostics, p. 1089, Elsevier-Saunders; 4th ed. ISBN 0721601898 "The use of high doses of naturally occurring vitamin K (K1 and K2) appears to have no untoward effect; however, menadione (K3) treatment can lead to the formation of erythrocyte cytoplasmic inclusions known as Heinz bodies and hemolytic anemia....As no adverse effects associated with vitamin K consumption from food or supplements have been reported in humans or animals, the U.S. Institute of Medicine has reported that a quantitative risk assessment cannot be performed, and thus a UL cannot be derived for vitamin K"
  21. ^ Goodman & Gilman's The Pharmacological Basis of Therapeutics, 9th ed, Ch 63.
  22. ^ "Vitamin Therapy, Megadose / Orthomolecular Therapy" British Columbia Provincial Health Services Authority 2000
  23. ^ Penniston KL, Tanumihardjo SA (2006) The acute and chronic toxic effects of vitamin A. Am J Clin Nutr. 83:191-201. PMID: 16469975

References

  • Abram Hoffer (1998) Putting It All Together: The New Orthomolecular Nutrition, McGraw-Hill, ISBN 0-87983-633-4
  • Pauling, Linus (1986) How to Live Longer and Feel Better, W. H. Freeman and Company, ISBN 0-380-70289-4
  • Roger J. Williams, Dwight K. Kalita (1979) Physician's Handbook on Orthomolecular Medicine, Keats Publishing, ISBN 0-87983-199-5
  • Roger J Williams (1998) Biochemical Individuality: The Basis for the Genetotrophic Concept. 2nd ed. Keats Publishing. ISBN 0-87983-893-0
  • Canner, P.L., Berge, K.G., Wenger, N.K., et al. Fifteen year mortality in Coronary Drug Project patients: long-term benefit with niacin. J Am Coll Cardiol, 1986, 8: 1245-1255.
  • Meyers, et al, Varying Cost and Free Nicotinic Acid Content in Over-the-Counter Niacin Preparations for Dyslipidemia, Annals of Internal Med. 2003 Dec 16;139(12):996-1002 [15]
  • Guyton, J. R., Blazing, M.A., Hagar, J., et al. Extended-release niacin vs Gemfibrozil for the treatment of low levels of high density lipoprotein cholesterol. Arch Intern Med, 2000, 160: 1177-1184.
  • Kamanna, V.S., Kashyap, M.L., Mechanism of Action of Niacin on Lipoprotein Metabolism, Current Atherosclerosis Reports 2000, 2:36-46
  • Heady JA, Morris JN, Oliver MF. WHO clofibrate/cholesterol trial: clarifications. Lancet 1992; 340: 1405-1406.
  • Frick MH, Elo O, Haapa K, et al. Helsinki Heart Study: primary prevention trial with gemfibrozil in middle-aged men with dyslipidemia. Safety of treatment, changes in risk factors, and incidence of coronary heart disease. N Engl J Med 1987; 317: 1237-1245.
  • Irwin Stone (1972) The Healing Factor: Vitamin C Against Disease, GD/Perigee Books (Putnam Pub) ISBN 0-399-50764-7 [16]
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