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## Complete Summary

#### GUIDELINE TITLE

American Association of Clinical Endocrinologists medical guidelines for
the clinical use of dietary supplements and nutraceuticals.

#### BIBLIOGRAPHIC SOURCE(S)

American Association of Clinical Endocrinologists medical guidelines for
the clinical use of dietary supplements and nutraceuticals. Endocr
Pract 2003 Sep-Oct;9(5):417-70. \[550 references\]
[PubMed](http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=14583426)

#### GUIDELINE STATUS

This is the current release of the guideline.

### COMPLETE SUMMARY CONTENT

 SCOPE\
 METHODOLOGY - including Rating Scheme and Cost Analysis\
 RECOMMENDATIONS\
 EVIDENCE SUPPORTING THE RECOMMENDATIONS\
 BENEFITS/HARMS OF IMPLEMENTING THE GUIDELINE RECOMMENDATIONS\
 QUALIFYING STATEMENTS\
 IMPLEMENTATION OF THE GUIDELINE\
 INSTITUTE OF MEDICINE (IOM) NATIONAL HEALTHCARE QUALITY REPORT
CATEGORIES\
 IDENTIFYING INFORMATION AND AVAILABILITY\
 DISCLAIMER

### SCOPE

#### DISEASE/CONDITION(S)

Endocrine and metabolic disorders

#### GUIDELINE CATEGORY

Assessment of Therapeutic Effectiveness

#### CLINICAL SPECIALTY

Endocrinology\
Internal Medicine\
Nutrition

#### INTENDED USERS

Chiropractors\
Dietitians\
Emergency Medical Technicians/Paramedics\
Nurses\
Physician Assistants\
Physicians

#### GUIDELINE OBJECTIVE(S)

-   To provide a definition for dietary supplements and nutraceuticals
    (DS/N)

-   To provide appropriate examples of dietary supplements and
    nutraceuticals that physicians may encounter

-   To suggest strategies for physicians to discuss dietary supplements
    and nutraceuticals with their patients

-   To identify resources for physicians to use to learn more about
    dietary supplements and nutraceuticals

-   To discuss potential interactions between dietary supplements and
    nutraceuticals and drugs, nutrients, and other dietary supplements
    and nutraceuticals

-   To outline the rational use of dietary supplements and
    nutraceuticals in adults, within the framework of traditional
    medicine, based on an established method of grading of the available
    literature

#### TARGET POPULATION

Patients with endocrine or metabolic disorders

#### INTERVENTIONS AND PRACTICES CONSIDERED

The following dietary supplements and nutraceuticals were considered;
some were recommended (see the \"Major Recommendations\" field for
context).

1.  Androstenedione

2.  Carnitine

3.  Choline

4.  Chondroitin

5.  Coenzyme Q10

6.  Creatine

7.  Dehydroepiandrosterone Sulfate (DHEAS)

8.  Glucosamine

9.  Glutamine

10. Melatonin

11. Omega-3 fatty acids

12. Phytosterols

13. Probiotics

14. Saw palmetto

15. Flavonoids

16. Taurine

17. alpha-Lipoic acid

18. Chromium

19. gamma-Linolenic acid

20. *Momordica charantia*

21. Vanadium

22. Vitamin E

#### MAJOR OUTCOMES CONSIDERED

Not stated

### METHODOLOGY

#### METHODS USED TO COLLECT/SELECT EVIDENCE

Hand-searches of Published Literature (Primary Sources)\
Hand-searches of Published Literature (Secondary Sources)\
Searches of Electronic Databases

#### DESCRIPTION OF METHODS USED TO COLLECT/SELECT THE EVIDENCE

Individual dietary supplements and nutraceuticals (DS/N) were selected
by individual task force members on the basis of the relevance to
endocrinologists and physician-nutrition specialists, after topic
assignment by the task force chairman. Only a partial list of dietary
supplements and nutraceuticals were included (see Table 1 in the
original guideline document). Inclusion criteria for use of published
material to grade recommendations were that such sources must clearly
investigate one target agent and not a combination of agents, which
could confound data, and must be classified within one of the four
evidence categories described in Table 2 of the guideline document.
Occasionally, reports that do not adhere to these criteria were
incorporated in the discussion of the dietary supplements and
nutraceuticals because they provide theory.

References were obtained through computerized searching of the
literature, scanning of incoming journals in the medical library, and
review of references in pertinent review articles, major textbooks, and
syllabi from national meetings, on the subjects of clinical nutrition,
natural medicine, alternative medicine, dietary supplements,
nutraceuticals, and phytomedicine.

#### NUMBER OF SOURCE DOCUMENTS

Not stated

#### METHODS USED TO ASSESS THE QUALITY AND STRENGTH OF THE EVIDENCE

Weighting According to a Rating Scheme (Scheme Given)

#### RATING SCHEME FOR THE STRENGTH OF THE EVIDENCE

The evidence categories were adapted from The Evidence Report on Obesity
by the National Institutes of Health and the American Diabetes
Association evidence grading system for clinical practice
recommendations.

**Level 1**

**Prospective, randomized, controlled trials---large**

-   Data derived from a substantial number of trials, with adequate
    power, involving a substantial number of subjects and outcome data

-   Large meta-analyses using raw or pooled data or incorporating
    quality ratings

-   Well-controlled trial at one or more medical centers

-   Consistent pattern of findings in the population for which the
    recommendation is made (generalizable data)

-   Compelling nonexperimental, clinically obvious evidence (for
    example, use of insulin in diabetic ketoacidosis); \"all-or-none\"
    indication

**Level 2**

**Prospective, randomized, controlled trials---limited body of outcome
data**

-   Limited number of trials, small population sizes in trials

-   Well-conducted single prospective cohort study

-   Limited but well-conducted meta-analyses

-   Inconsistent findings or results not representative for the target
    population

-   Well-conducted case-controlled study

**Level 3**

**Other experimental outcome data and nonexperimental data**

-   Nonrandomized, controlled trials

-   Uncontrolled or poorly controlled trials

-   Any randomized clinical trial with one or more major or three or
    more minor methodologic flaws

-   Retrospective or observational data

-   Case reports or case series

-   Conflicting data with weight of evidence unable to support a final
    recommendation

**Level 4**

**Expert opinion**

-   Inadequate data for inclusion in above categories; situation
    necessitates an expert panel\'s synthesis of the literature and a
    consensus

-   Experience-based information

-   Theory-driven conclusions

#### METHODS USED TO ANALYZE THE EVIDENCE

Review of Published Meta-Analyses\
Systematic Review

#### DESCRIPTION OF THE METHODS USED TO ANALYZE THE EVIDENCE

Not stated

#### METHODS USED TO FORMULATE THE RECOMMENDATIONS

Expert Consensus

#### DESCRIPTION OF METHODS USED TO FORMULATE THE RECOMMENDATIONS

Selected dietary supplements and nutraceuticals (DS/N) were reviewed and
clinical evidence graded by the American Association of Clinical
Endocrinologists (AACE) Nutrition Guidelines Task Force members. A
separate panel composed of AACE and non-AACE physicians with expertise
in nutritional medicine then reviewed the compiled report. Final
recommendations for the dietary supplements and nutraceuticals examples
represent a consensus among the task force members. Comments and
recommendations regarding physician-patient communication are based on
expert judgment of task force members.

#### RATING SCHEME FOR THE STRENGTH OF THE RECOMMENDATIONS

**[Grade A]{.underline}\
[\>]{.underline}1 conclusive level 1 publications demonstrating benefit
\>\> risk**\
Recommended for indications reflected by the publications; can be used
with other conventional therapy or as \"first-line\" therapy

**[Grade B]{.underline}\
No conclusive level 1 publication\
[\>]{.underline}1 conclusive level 2 publications demonstrating benefit
\>\> risk**\
Recommended for indications reflected by the publications if the patient
refuses or fails to respond to conventional therapy; must monitor for
adverse effects, if any; can be recommended as \"second-line\" therapy

**[Grade C]{.underline}\
No conclusive level 1 or 2 publication\
[\>]{.underline}1 conclusive level 3 publications demonstrating benefit
\>\> risk\
OR\
No risk at all and no benefit at all**\
Recommended for indications reflected by the publications if the patient
refuses or fails to respond to conventional therapy, provided there are
no significant adverse effects; \"no objection\" to recommending their
use\
OR\
\"no objection\" to continuing their use

**[Grade D]{.underline}\
No conclusive level 1, 2, or 3 publication demonstrating benefit \>\>
risk\
Conclusive level 1, 2, or 3 publications demonstrating risk \>\>
benefit**\
Not recommended\
Patient is advised to discontinue use

#### COST ANALYSIS

A formal cost analysis was not performed and published cost analyses
were not reviewed.

#### METHOD OF GUIDELINE VALIDATION

Peer Review

#### DESCRIPTION OF METHOD OF GUIDELINE VALIDATION

Final recommendations for the dietary supplements and nutraceuticals
were approved by reviewers, the American Association of Clinical
Endocrinologists (AACE) Publications Committee, and the AACE Board of
Directors.

### RECOMMENDATIONS

#### MAJOR RECOMMENDATIONS

Recommendation grades (A-D) and levels of evidence (1-4) are defined at
the end of the \"Major Recommendations\" field. The table below
summarizes the conclusions that follow for specific dietary supplements
and nutraceuticals (DS/N).

**Coenzyme Q10**

Coenzyme Q10 (CoQ10) has beneficial effects for mitochondrial disorders,
congestive heart failure (CHF), and ischemia-reperfusion injury (**Grade
C**). For these indications, physicians may recommend it in situations
in which the patient has not gained sufficient improvement from
conventional therapy, providing there is no reasonable anticipation of
adverse effects. No persuasive data compel this task force to endorse
the use of CoQ10 in a wide variety of other claimed benefits, including
performance enhancement, retardation of the aging process, immune system
enhancement, diabetes mellitus, hypertension, or cancer (**Grade D**).

**Flavonoids, Isoflavones, and Ipriflavone**

Researchers reviewed more than 1,000 articles on phytoestrogens for a
30-year period and found 74 relevant studies to examine in detail. They
concluded that insufficient evidence was available to recommend
phytoestrogens instead of traditional hormone replacement therapy or to
endorse any specific recommendations about particular phytoestrogen
products. The guideline developers agree with this conclusion (**Grade
D**). Nevertheless, it would be prudent to recommend a diet high in
legumes and cereals to women who are at risk for cardiovascular disease
or estrogen-dependent malignant lesions or who are perimenopausal
(**Grade A**). In particular, ample conclusive level 1 and 2 data
support the beneficial effect of soy protein in patients at risk for
cardiovascular disease (**Grade A**). There are also conclusive level 2
and 3 data concerning isoflavones or ipriflavone and osteoporosis
(**Grade B**). Overall, increasing the dietary consumption of fruit,
vegetables, and certain beverages containing flavonoids (tea and red
wine) seems prudent as part of a healthful diet. Currently, however,
specific quantitative recommendations cannot be made for the general
population.

**Phytosterols**

The use of phytosterols has been investigated in patients with
hypercholesterolemia and found to reduce low-density lipoprotein (LDL)
cholesterol levels. Conclusive level 1 data have accrued because of the
numerous prospective, randomized, controlled trials (PRCTs) that have
been conducted. The American Association of Clinical Endocrinologists
(AACE), in agreement with the American Heart Association Nutrition
Committee, recommends the use of phytosterols in patients with
hypercholesterolemia and in patients requiring secondary prevention
after an atherosclerotic event (**Grade A**). All treated patients must
be monitored for sitosterolemia in case they are heterozygotes. Patients
with normal cholesterol levels may also take phytosterols if they and
their physicians are aware of the potential risks of sitosterolemia
(**Grade C**). AACE does not recommend the use of phytosterols for the
treatment or prevention of malignant disease, inasmuch as only
inconclusive level 3 data exist for this indication (**Grade D**).

**Saw Palmetto**

Only two strong studies support the use of saw palmetto extract in
patients with benign prostatic hypertrophy. Clinical toxicities related
to the use of this product seem to be minimal. Therefore, with
conclusive level 2 data available, saw palmetto extract may be
recommended for patients with benign prostatic hypertrophy who refuse
conventional therapy or in whom conventional therapy fails (**Grade
B**). AACE does not support the proactive (first-line) recommendation of
saw palmetto extract in any patient who has prostate cancer or prostate
enlargement or who simply requests prevention of either of these two
conditions by use of this approach rather than conventional therapy.

**Glutamine**

Glutamine is a nontoxic, physiologically important agent that is
beneficial in critical illness (**Grade A**). Glutamine may protect the
gastrointestinal mucosa in the setting of acute stress and surgical
treatment (**Grade B**). This effect is most prominent in
low-birth-weight neonates receiving parenteral nutrition support.
Glutamine also seems to be effective in the treatment of oral mucositis
and stomatitis associated with both localized radiation therapy and
systemic chemotherapy (**Grade C**) and in the decrease of occurrence of
peripheral neuropathy after paclitaxel therapy (**Grade C**). Other
effects attributed to glutamine supplementation are not clearly defined.
Data supporting enhancement of the immune system are weak and
inconclusive at best (**Grade D**). Glutamine seems to have no benefit
as an energy-providing performance-enhancing agent (**Grade D**). Use of
glutamine in patients with liver disease and impaired ureagenesis is
associated with hyperammonemia. Otherwise, published reports have
provided no clear evidence of major toxic effects associated with either
enteral or parenteral supplementation with glutamine.

**Taurine**

A derivative form of taurine, N-acetylhomotaurine, has demonstrated
effectiveness in the treatment of alcohol abuse (**Grade B**). Emerging
clinical data support the addition of taurine to parenteral nutrition
when hepatopathy cannot be explained by any other mechanism (**Grade
C**). No published data clearly support any other beneficial or
therapeutic activity of supplemental taurine in healthy adults or
pathologic states (**Grade D**). In neonates, taurine appears to be an
essential amino acid during stress (\"conditionally essential\")
(**Grade C**).

**Carnitine**

In the rare cases of primary carnitine deficiency, carnitine therapy is
effective (**Grade A**). In secondary carnitine deficiency, carnitine
therapy has limited proven value (**Grade C**). Level 2 and 3 data
regarding carnitine as a performance-enhancing or ergogenic
(energy-providing) agent are available, but not all studies show
conclusive evidence of benefit (**Grade C**). Trials of carnitine used
in the treatment of congestive heart failure are emerging and appear
encouraging (**Grade C**). Similar results have been noted in the
treatment of cardiac and peripheral vascular ischemic disease (**Grade
C**), as well as for the use of carnitine in patients with anemia
associated with chronic renal disease who are receiving hemodialysis
(**Grade C**). Finally, carnitine therapy may be useful in patients
treated with valproic acid for seizure disorders (**Grade C**). No clear
evidence has shown appreciable toxic effects associated with use of
carnitine.

**Creatine**

Contradictory level 1, 2, and 3 evidence of a proenergy effect,
reflected by improved performance, exists for creatine for any type of
exertion, although the weight of evidence favors a beneficial effect
(**Grade C**). Claims for efficacy in the treatment of congestive heart
failure are inconclusive (**Grade D**). Limited data indicate that
careful dosing of creatine may diminish symptoms associated with
McArdle\'s disease (glycogen storage disease type V) (**Grade C**).

**Chondroitin**

Chondroitin sulfate, administered for a long-term period, probably has
some beneficial action in restoring cartilage damaged by osteoarthritis
(**Grade B**). Additional data investigating the combination of
chondroitin sulfate and glucosamine in the management of osteoarthritis
are reviewed in the original guideline document and do not affect this
recommendation.

**Glucosamine**

Glucosamine may be an effective treatment for osteoarthritis. Several
large metareviews have demonstrated such benefit but have failed to meet
level 1 criteria. In addition, several level 2 and 3 studies of
glucosamine demonstrate benefit in the treatment of osteoarthritis
(**Grade B**). Therefore, glucosamine may be recommended for those
patients refusing, or not responding to, conventional therapy for acute
osteoarthritis, administered alone or in combination with chondroitin
sulfate.

**Omega-3 Fatty Acids, Including Fish Oils**

Polyunsaturated fatty acids (PUFAs) and monounsaturated fatty acids
(MUFAs) appear to be useful in the treatment of hypertriglyceridemia and
the prevention of cardiovascular events (**Grade A**). Efficacy in
inflammatory bowel disease is supported by level 3 evidence (**Grade
C**). Adverse effects may be noted at dosages larger than 3 g/day.

**Probiotics**

Probiotics may be used safely in patients with antibiotic-associated
diarrhea and recurrent *Clostridium difficile* colitis. The level 1, 2,
and 3 data are inconclusive, with the weight of evidence favoring
demonstrable benefit (**Grade C**). Chronic pouchitis flare-ups
apparently are prevented by a mixed-organism probiotic, as reported in
recent, conclusive level 2 studies (**Grade B**).

**Dehydroepiandrosterone Sulfate (DHEAS)**

Although many level 3 scientific reports have focused on
dehydroepiandrosterone sulfate (DHEAS), the data are insufficient to
support the use of DHEAS in healthy adults in any circumstance at the
current time (**Grade D**). In 1999, it was argued in an editorial that
DHEAS may be used as part of replacement therapy in women with adrenal
insufficiency; however, as intuitive as this application seems,
confirmation of efficacy with level 1 data is necessary (**Grade D**).

**Androstenedione**

The available data do not support the use of androstenedione or
androstenediol for performance-enhancing effects (**Grade D**). In fact,
deleterious effects on the lipid profile are suggested by the data. The
addition of other herbal compounds with unproven efficacy seems to be a
marketing ploy to entice purchase of these dietary supplements and
nutraceuticals. Any agent that directly or indirectly increases androgen
levels should be avoided in men with prostate cancer until clinical
trials demonstrate its safety.

**Table. Summary of Evidence-based Indications for Dietary Supplements
and Nutraceuticals Reviewed in these Guidelines**

**Androstenedione**

-   **Grade D**: performance; body composition

**Carnitine**

-   **Grade A**: primary deficiency

-   **Grade C**: secondary deficiency; performance; cardiac; renal;
    valproate use

**Choline**

-   **Grade A**: pregnancy; breast feeding

-   **Grade C**: hyperhomocysteinemia; total parenteral nutrition
    (TPN)-induced hepatopathy

-   **Grade D**: memory

**Chondroitin**

-   **Grade B**: osteoarthritis

-   **Grade D**: cognition; cardiovascular; renal stones

**Coenzyme Q10**

-   **Grade C**: mitochondrial disorder; congestive heart failure;
    ischemia-reperfusion injury

-   **Grade D**: performance; antiaging; immunity; diabetes mellitus;
    hypertension; cancer

**Creatine**

-   **Grade C**: ergogenic; McArdle\'s disease

-   **Grade D**: congestive heart failure

**Dehydroepiandrosterone sulfate (DHEAS)**

-   **Grade D**: androgen replacement; performance; antiaging; libido;
    immunity; body composition

**Glucosamine**

-   **Grade B**: osteoarthritis

**Glutamine**

-   **Grade A**: critical illness

-   **Grade C**: stomatitis

-   **Grade D**: Crohn\'s disease; immunity; cancer; performance

**Melatonin**

-   **Grade C**: sleep/jet lag; menopause (mood)

-   **Grade D**: cancer

**Omega-3 fatty acids**

-   **Grade A**: cardiovascular

-   **Grade B**: high triglycerides

-   **Grade C**: inflammatory bowel disease (IBD)

-   **Grade D**: immunity; human immunodeficiency virus (HIV);
    hypertension; behavior; asthma; rheumatoid arthritis; psoriasis;
    chronic fatigue syndrome

**Phytosterols**

-   **Grade A**: high cholesterol; secondary prevention of
    atherosclerosis

-   **Grade D**: normal cholesterol; cancer; chronic disease

**Probiotics**

-   **Grade B**: chronic pouchitis

-   **Grade C**: antibiotic-related diarrhea; *C. difficile* colitis

**Saw palmetto**

-   **Grade B**: benign prostatic hyperplasia (BPH)

**Flavinoids**

-   **Grade A**: coronary artery disease (CAD) risk reduction

-   **Grade B**: osteoporosis

-   **Grade D**: hormone replacement; hot flashes; cognitive therapy;
    antiaging

**Taurine**

-   **Grade B**: chronic alcoholism

-   **Grade C**: total parenteral nutrition-induced hepatopathy

-   **Grade D**: congestive heart failure; diabetes mellitus;
    dyslipidemia

*Antidiabetic indications*

**alpha-Lipoic acid**

-   **Grade B**: neuropathy

**American ginseng**

-   **Grade D**: glycemic control

**Chromium**

-   **Grade A**: chromium deficiency

-   **Grade D**: glycemic control; dyslipidemia; obesity

**gamma-Linolenic acid**

-   **Grade B**: neuropathy

***Ginkgo biloba***

-   **Grade D**: peripheral neuropathy; erectile dysfunction;
    intermittent claudication

***Momordica charantia***

-   **Grade D**: glycemic control

**Vanadium**

-   **Grade D**: glycemic control

**Vitamin E**

-   **Grade D**: cardiovascular risk

**[Definitions]{.underline}**:

**Recommendation Grades**

**[Grade A]{.underline}\
[\>]{.underline}1 conclusive level 1 publications demonstrating benefit
\>\> risk**\
Recommended for indications reflected by the publications; can be used
with other conventional therapy or as \"first-line\" therapy

**[Grade B]{.underline}\
No conclusive level 1 publication\
[\>]{.underline}1 conclusive level 2 publications demonstrating benefit
\>\> risk**\
Recommended for indications reflected by the publications if the patient
refuses or fails to respond to conventional therapy; must monitor for
adverse effects, if any; can be recommended as \"second-line\" therapy

**[Grade C]{.underline}\
No conclusive level 1 or 2 publication\
[\>]{.underline}1 conclusive level 3 publications demonstrating benefit
\>\> risk\
OR\
No risk at all and no benefit at all**\
Recommended for indications reflected by the publications if the patient
refuses or fails to respond to conventional therapy, provided there are
no significant adverse effects; \"no objection\" to recommending their
use\
OR\
\"no objection\" to continuing their use

**[Grade D]{.underline}\
No conclusive level 1, 2, or 3 publication demonstrating benefit \>\>
risk\
Conclusive level 1, 2, or 3 publications demonstrating risk \>\>
benefit**\
Not recommended\
Patient is advised to discontinue use

**Levels of Evidence**

**Level 1**

**Prospective, randomized, controlled trials---large**

-   Data derived from a substantial number of trials, with adequate
    power, involving a substantial number of subjects and outcome data

-   Large meta-analyses using raw or pooled data or incorporating
    quality ratings

-   Well-controlled trial at one or more medical centers

-   Consistent pattern of findings in the population for which the
    recommendation is made (generalizable data)

-   Compelling nonexperimental, clinically obvious evidence (for
    example, use of insulin in diabetic ketoacidosis); \"all-or-none\"
    indication

**Level 2**

**Prospective, randomized, controlled trials---limited body of outcome
data**

-   Limited number of trials, small population sizes in trials

-   Well-conducted single prospective cohort study

-   Limited but well-conducted meta-analyses

-   Inconsistent findings or results not representative for the target
    population

-   Well-conducted case-controlled study

**Level 3**

**Other experimental outcome data and nonexperimental data**

-   Nonrandomized, controlled trials

-   Uncontrolled or poorly controlled trials

-   Any randomized clinical trial with one or more major or three or
    more minor methodologic flaws

-   Retrospective or observational data

-   Case reports or case series

-   Conflicting data with weight of evidence unable to support a final
    recommendation

**Level 4**

**Expert opinion**

-   Inadequate data for inclusion in above categories; situation
    necessitates an expert panel\'s synthesis of the literature and a
    consensus

-   Experience-based information

-   Theory-driven conclusions

#### CLINICAL ALGORITHM(S)

None provided

### EVIDENCE SUPPORTING THE RECOMMENDATIONS

#### TYPE OF EVIDENCE SUPPORTING THE RECOMMENDATIONS

The type of supporting evidence is identified and graded for the
recommendations (see \"Major Recommendations\").

### BENEFITS/HARMS OF IMPLEMENTING THE GUIDELINE RECOMMENDATIONS

#### POTENTIAL BENEFITS

-   This guideline discusses alternative care medicine, introduces
    dietary supplements and nutraceuticals (DS/N) and defines their
    nature, presents a strategy for discussing DS/N with patients,
    provides a list of resources to peruse for further education, and
    reviews specific DS/N in detail based on levels of scientific
    evidence.

-   This guideline focuses on hormonal and metabolic agents and provides
    consensus recommendations formulated by practicing clinical
    endocrinologists.

-   This guideline is intended to serve as a resource for
    endocrinologists and other physicians unfamiliar with the issues
    surrounding the use of DS/N.

-   Refer to Appendix 1 of the original guideline document for a
    detailed discussion of the claimed benefits and controlled clinical
    trial data (where applicable) for select DS/N.

#### POTENTIAL HARMS

See Table 7 in the original guideline document for **potential
interactions** between various dietary supplements and nutraceuticals
(DS/N) and some commonly prescribed medications.

**Adverse Effects of DS/N**

-   *Flavonoids, Isoflavones, and Ipriflavone*: Other than subclinical
    lymphopenia, no serious adverse effects have been associated with
    short-term or long-term use of soy proteins in humans.

-   *Phytosterols*: Adverse effects are generally limited to patients
    homozygous for sitosterolemia, in whom sitosterol is hyperabsorbed
    and hypercholesterolemia and xanthomas may actually develop.
    Erythrocyte membrane fragility and hepatopathy may also be found in
    rare patients. Phytosterols may also have deleterious effects on the
    status of fat-soluble vitamins---alpha- and beta-carotene,
    alpha-tocopherol, and lycopene.

-   *Creatine*: Anecdotal creatine-associated adverse events that have
    been reported to the United States Food and Drug Administration
    (FDA) include rash, dyspnea, vomiting, diarrhea, nervousness,
    anxiety, fatigue, migraine, myopathy, polymyositis, cramping,
    seizure, and atrial fibrillation.

-   *Chondroitin*: Bleeding is a potential adverse effect.

-   *Glucosamine*: Potential concerns with use of glucosamine are
    exacerbation of insulin resistance, through impairment of
    glucosamine-6-phosphate synthase activity and modulation of
    phosphatidylinositol 3-kinase activity, and allergic reactions in
    patients with shellfish allergy.

-   *Omega-3 Fatty Acids, Including Fish Oils*: Use of omega-3 fatty
    acids is associated with three major adverse effects: increased low
    density lipoprotein (LDL) cholesterol levels (\<5 to 10% or up to
    30% in patients with hypertriglyceridemia), excessive bleeding, and
    deterioration of glycemic control in patients with type 2 diabetes
    mellitus. The FDA has concluded that omega-3 fatty acids are
    \"generally recognized as safe\" in dosages of less than 3 g/day, on
    the basis of metareview of more than 2,600 clinical studies.

### QUALIFYING STATEMENTS

#### QUALIFYING STATEMENTS

-   The American Association of Clinical Endocrinologists (AACE) Medical
    Guidelines for Clinical Practice are systematically developed
    statements to assist health-care professionals in medical decision
    making for specific clinical conditions. Most of the content herein
    is based on literature reviews. In areas of uncertainty,
    professional judgment was applied.

-   This report is not intended to be encyclopedic and complete; rather,
    it is intended to serve as a resource for endocrinologists and other
    physicians unfamiliar with the issues surrounding the use of dietary
    supplements and nutraceuticals (DS/N).

### IMPLEMENTATION OF THE GUIDELINE

#### DESCRIPTION OF IMPLEMENTATION STRATEGY

An implementation strategy was not provided.

### INSTITUTE OF MEDICINE (IOM) NATIONAL HEALTHCARE QUALITY REPORT CATEGORIES

#### IOM CARE NEED

Getting Better\
Living with Illness

#### IOM DOMAIN

Effectiveness

### IDENTIFYING INFORMATION AND AVAILABILITY

#### BIBLIOGRAPHIC SOURCE(S)

American Association of Clinical Endocrinologists medical guidelines for
the clinical use of dietary supplements and nutraceuticals. Endocr
Pract 2003 Sep-Oct;9(5):417-70. \[550 references\]
[PubMed](http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=14583426)

#### ADAPTATION

Not applicable: The guideline was not adapted from another source.

#### DATE RELEASED

2003 Sep-Oct

#### GUIDELINE DEVELOPER(S)

American Association of Clinical Endocrinologists - Medical Specialty
Society\
American College of Endocrinology - Medical Specialty Society

#### SOURCE(S) OF FUNDING

American Association of Clinical Endocrinologists (AACE)

#### GUIDELINE COMMITTEE

AACE Nutrition Guidelines Task Force

#### COMPOSITION OF GROUP THAT AUTHORED THE GUIDELINE

*Committee Members*: Jeffrey I. Mechanick, MD, FACP, FACE, FACN
*(Chairman)*; Elise M. Brett, MD, FACE, CNSP; Arthur B. Chausmer, MD,
PhD, FACE, FACN, CNS; Richard A. Dickey, MD, FACP, FACE; Stanley
Wallach, MD, FACP, FACCP, MACN, FACE, CNS

*Reviewers*: Donald A. Bergman, MD, FACP, FACE; Jeffrey R. Garber, MD,
FACE; Carlos R. Hamilton, Jr., MD, FACE; Yehuda Handelsman, MD, FACP,
FACE; Kalman E. Holdy, MD; John S. Kukora, MD, FACS, FACE; Philip Levy,
MD, FACE; Pasquale J. Palumbo, MD, MACE; Steven M. Petak, MD, JD, FACE;
Leonid Poretsky, MD; Philip Rabito, MD, FACE; Herbert I. Rettinger, MD,
FACE, MBA; Helena W. Rodbard, MD, FACE; F. John Service, MD, PhD, FACE,
FACP, FRCPC; Talla P. Shankar, MD, FACE

*Special Reviewer*: Donald D. Hensrud, MD

#### FINANCIAL DISCLOSURES/CONFLICTS OF INTEREST

Not stated

#### GUIDELINE STATUS

This is the current release of the guideline.

#### GUIDELINE AVAILABILITY

Electronic copies: Available in Portable Document Format (PDF) from the
[American Association of Clinical Endocrinologists (AACE) Web
site](http://www.aace.com/pub/pdf/guidelines/Nutraceuticals2003.pdf).

Print copies: Available from the American Association of Clinical
Endocrinologists (AACE), 245 Riverside Avenue, Suite 200, Jacksonville,
FL 32202.

#### AVAILABILITY OF COMPANION DOCUMENTS

The following is available:

-   American Association of Clinical Endocrinologists protocol for
    standardized production of clinical practice guidelines. Endocrine
    Pract 2004 Jul/Aug; 10(4):353-61.

Electronic copies: Available in Portable Document Format (PDF) from the
[American Association of Clinical Endocrinologists (AACE) Web
site](http://www.aace.com/pub/pdf/guidelines/GLStandards.pdf).

Print copies: Available from the American Association of Clinical
Endocrinologists (AACE), 245 Riverside Avenue, Suite 200, Jacksonville,
FL 32202.

#### PATIENT RESOURCES

None available

#### NGC STATUS

This summary was completed by ECRI on February 13, 2004. The information
was verified by the guideline developer on March 8, 2004.

#### COPYRIGHT STATEMENT

All rights reserved. No part of these materials may be reproduced or
retransmitted in any manner without the prior written permission of
American Association of Clinical Endocrinologists (AACE)/American
College of Endocrinology (ACE).

### DISCLAIMER

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Date Modified: 11/10/2008