Herbal Supplements and Anabolic Steroids Notes

Herbal Supplements and Anabolic Steroids

Herbal Drugs

• Herbal drugs are derived from plant matter.

• An herb, also called a botanical, is a plant or part of a plant used for its scent, flavor, and/or therapeutic properties.

• Herbal drugs are sometimes called supplements.

• The herbal drugs discussed are mainly sold over-the-counter as natural products to treat health conditions.

• They are generally described as safe because they are “natural” but they can cause health problems.

Natural ≠ Better

• A product labeled “natural” does not necessarily equal “SAFE” or without effects.

• It can cause medical problems if used incorrectly.

• Some people will experience negative effects even when taken correctly.

• Many powerful drugs are extracted from plants, such as cocaine, opium, and tobacco.

Herbal Drug Regulation

• The FDA (Food and Drug Administration) regulates dietary supplements under a different set of regulations than those covering "conventional" foods and drug products.

• The Human Foods Program’s Office of Food Chemical Safety, Dietary Supplements, and Innovation coordinates the FDA's dietary supplement oversight.

• Herbal drugs are not part of the DEA’s (Drug Enforcement Administration) drug schedules.

Dietary Supplement Health & Education Act (DSHEA)

• The FDA does not have the authority to approve dietary supplements before they are marketed.

• Dietary supplements with “established ingredients” (ingredients sold in the US before 1994) may be marketed without any evidence of efficacy or safety.

• For new ingredients, manufacturers must provide evidence supporting a “reasonable expectation of safety”. However, this has not been strictly enforced.

• Since DSHEA became law in 1994, the number of supplements has increased from an estimated 4,000 to more than 55,000.

• It is not known how many new supplements include novel (post-1994) ingredients.

• The FDA has received adequate notification for only 170 new supplement agreements since 1994.

• New guidelines were proposed in 2019, but are still not implemented, for assessing new ingredients to improve safety.

• These guidelines would require in vitro, animal, and tolerability testing for consumption at doses greater than those historically ingested.

• Safety of supplements is evaluated based on:

  • Documented history of use

  • Formulation

  • Proposed daily dose

  • Recommended use duration

• Any ingredient prepared/formulated in a novel manner is considered a “new ingredient”.

• The aim is to create a database of evidence for making informed decisions about the use of supplements.

Mixing Supplements and Prescription Meds

• Extensive review of medical literature found many cases where herbal supplements altered conventional medication effectiveness and/or created harmful side effects.

• Harmful herbal-drug interactions occurred in patients with:

  • Cardiovascular disease (31%)

  • Cancer (22%)

  • Kidney transplant (16%)

  • Other conditions: epilepsy, depression, anxiety, schizophrenia

• Fatal results have been reported in some cases.

Interactions

Herbal supplements can interfere with:

• Blood-thinners

• Cholesterol-lowering statins

• Chemotherapy (anti-cancer drugs)

• Antidepressants

• Immunosuppressant drugs (often taken by transplant patients)

• Antiretroviral drugs (taken for HIV)

Supplement Use in the U.S.

• More than half of American adults report taking dietary and herbal supplements.

• 1 in 4 adults in the U.S. report taking supplements and prescription meds at the same time.

• Very few people tell their physician/clinician about supplements they are taking, even when asked.

The Supplement Paradox

• The number of U.S. adults using supplements in 2018 was approximately equal to the number in 1999.

• This is despite research showing that dietary supplements offer no benefit to most healthy people and can be harmful.

• A major reason for this paradox is that the law allows manufacturers significant leeway to advertise supplements for a broad spectrum of conditions, even after studies show no meaningful clinical differences between supplements and placebos.

Study of Drug Contaminants in Supplements

• A study examined FDA reports on supplements found to contain potentially harmful substances, including prescription drugs.

• Most ads for these products promised:

  • Help with weight loss

  • Muscle building

  • Viagra-like male sexual enhancement

• These categories of supplements have been found to be responsible for a disproportionate number of the estimated 23,000 ER visits attributed each year to supplements in the U.S.

• Between 2007 and 2016, the FDA identified 746 brands of supplements with pharmaceutical agents, including:

  • Prescription medications

  • Medications withdrawn from U.S. markets

  • Unapproved drugs (including designer steroids)

• 20% contained $≥2$ undeclared drugs.

St. John’s Wort

• Used historically to treat:

  • Mental health disorders

  • Nerve pain

  • Malaria

  • As a sedative

  • As a balm for wounds, burns, and insect bites

• Used today as a traditional remedy for:

  • Depression

  • Anxiety

  • Sleep disorders

• Some studies have reported benefits for depression, while others have not.

  • A large study found St. John’s Wort was no more effective than placebo in treating major depression of moderate severity.

• Another study found St. John’s Wort did not relieve symptoms of minor depression better than placebo. It also found that standard antidepressant medication was no better than placebo for minor depression.

St. John’s Wort: Side Effects & Cautions

• May interact with many medications, including:

  • Antidepressants

  • Birth control pills

  • Cyclosporine (prevents the body from rejecting transplanted organs)

  • Seizure control drugs (phenytoin and phenobarbital)

  • Digoxin (heart medication)

  • Indinavir (& possibly other drugs used to control HIV)

  • Irinotecan (& possibly other drugs used to treat cancer)

• May cause:

  • Increased sensitivity to sunlight

  • Anxiety

  • Dry Mouth

  • Dizziness

  • GI symptoms

  • Fatigue

  • Headache

  • Sexual Dysfunction

• Taking with certain antidepressants may lead to potentially serious increased serotonin-related side effects.

• NOT a proven therapy for depression.

Melatonin

• A hormone found naturally in the body.

• Regulates night/day cycles.

• Darkness causes the body to produce more melatonin, signaling the body to prepare for sleeping.

• Light decreases production, signaling the body to prepare for waking.

• Some people with trouble sleeping have low levels.

• Melatonin used as a supplement is usually made synthetically in a laboratory.

• Most commonly available in pill form.

• Also available in forms that can be placed in the cheek or under the tongue.

Uses:

• Adjusting the body’s internal clock

• Jetlag

• Adjusting sleep-wake cycles in people with shift changes

Melatonin: Other Uses

Some people use for:

• Alzheimer's

• Ringing in ears

• Depression

• Chronic Fatigue Syndrome

• Fibromyalgia

• Migraines/other headaches

• Irritable Bowel Syndrome

• Bone loss (osteoporosis)

• Movement disorder (aka, tardive dyskinesia)

• Epilepsy

• Anti-aging agent

• Menopause

• Birth control

Melatonin: Interactions

• Should not be taken with sedative medications (CNS depressants), as it might cause sleepiness/drowsiness.

• Birth control pills may increase melatonin; taking with birth control pills may cause excessive melatonin in the body.

• Caffeine may decrease melatonin; taking with caffeine may decrease the effectiveness of melatonin supplements.

Kratom

• A tropical tree (Mitragyna speciosa) native to Southeast Asia.

• Leaves of the tree contain compounds that can have psychotropic effects.

• Taken as a pill, capsule, or extract; leaves can be chewed; brewed for tea; can also be smoked or used in food.

• Stimulant in low doses.

• Sedative in large doses.

• Purported to help with chronic pain; some people use it to ease opioid withdrawal.

• Can cause addiction; has many possible side effects; deaths have been reported.

• The DEA attempted to make it a Schedule I drug in 2016.

• Kratom is not currently controlled under the Controlled Substances Act.

• The FDA got involved in 2017; the commissioner warns against its use for opioid addiction.

• Not approved for medical use.

• Banned in several states, cities, and counties in the U.S.

• Banned in numerous countries.

• Listed by the DEA as a Drug and Chemical of Concern.

Anabolic Steroids

• A group of natural & synthetic drugs chemically similar to cholesterol and related to testosterone.

• Anabolic refers to the ability to promote muscle growth.

• Can be legally prescribed to treat conditions resulting from steroid hormone deficiency.

• Some athletes, bodybuilders, & others misuse them in an attempt to enhance performance and/or improve physical appearance.

Athletes & Drug Misuse

• Drug misuse has been reported since the ancient Greek Olympics.

• 1950s-1960s: Eastern European countries started giving anabolic steroids to athletes during training for international competition to improve performance.

• Early 1970s: about 75% of athletes in middle- or short-distance running or in field events admitted to using steroids.

• 1976: the use of anabolic steroids was banned in Olympic competition, and testing began.

• 1989: the NFL started testing athletes for anabolic steroids.

• 1991: MLB banned anabolic steroids (started testing athletes in 2003).

• New designer drugs constantly become available that can escape detection.

Reasons for Use

• Improve athletic performance

• Increase muscle size or reduce body fat

• Might prevent muscle breakdown

• It is possible that just the sense of energy that anabolic steroids can give, or even the psychological boost of taking a performance-enhancing drug, can have a real impact on performance in sports.

Doping

• Doping: Deliberate/inadvertent use by an athlete of a substance or method banned by the International Olympic Committee.

• The International Federation of Sports Medicine supports the prohibition of doping to protect athletes from:

  • Unfair advantage

  • Possible harmful side effects

Steroid Use

• Taken orally or injected into the muscles

• Sometimes applied topically

• Doses taken by misusers may be 10-100 times higher

• Typically taken intermittently

• Continuous use can decrease the body’s responsiveness as well as cause the body to stop producing its own testosterone.

• Breaks in steroid use are believed to address these issues.

Patterns of Use by Athletes

• Cycling: Use of multiple doses of a steroid over a specific period of time, stopping for a while, and starting again.

• Stacking: Use of several types of steroids at the same time.

• Plateauing: Developing tolerance to a particular steroid.

• Pyramiding: Beginning steroid use with low doses moving to higher doses, then reducing the dosage at the end of the cycle.

• Array: Use of other drugs while taking anabolic steroids to avoid possible side effects, such as taking diuretics, anti-acne, and anti-estrogens.

Athletes and Drug Misuse

• Athletes are not more likely than non-athletes to use drugs like cannabis, alcohol, barbiturates, and hallucinogens.

• However, athletes are much more likely than other groups to take drugs to enhance performance. This includes stimulants (e.g., amphetamines, cocaine) and an array of drugs with presumed ergogenic (i.e., performance-enhancing) effects, such as anabolic steroids.

Misuse of Anabolic Steroids by Athletes

• Estimated 1 million Americans have used or are using these drugs to achieve a “competitive edge”.

• Males are much more likely to use them than females.

• 1.3% of 8th graders and 10th graders, and 2.2% of 12th graders used steroids during their lifetime.

• Among seniors in high school, 3.2% of males and 1.1% of females used steroids, while 1.5% of college-aged men used them.

Anabolic Steroids Differ From Other Drugs

Anabolic steroids work very differently from other drugs of misuse:

• Do not have the same acute effects on the brain.

• The most important difference is that steroids do not trigger rapid increases in the neurotransmitter dopamine.

However,

• Long-term steroid use can affect some of the same brain pathways and chemicals—including dopamine, serotonin, and opioid systems—affected by other drugs.

• May have a significant impact on mood and behavior.

• Abuse of anabolic steroids may lead to aggression.

Anabolic Steroid Effects

• Withdrawal symptoms: craving, fatigue, depression, restlessness, loss of appetite, insomnia, diminished sex drive, headaches

• Alterations in reproductive systems and sex hormones

  • Breast enlargement in males; breast reduction and hair growth in females

  • Infertility

  • Atrophy (shrinkage of the penis and testicles in males and enlargement of external genitalia in females)

• Stunted growth in adolescents

• Deepening of voice in females

• Water retention

• Change in skin and hair (severe acne, male pattern baldness, and increased body hair)

• Persistent unpleasant breath odor

• Swelling of feet and limbs

Misuse Concerns

• Individuals who misuse steroids can experience withdrawal symptoms when they stop—including mood swings, fatigue, restlessness, loss of appetite, reduced sex drive, and steroid cravings.

• All of these can contribute to continued misuse.

• Some steroid misusers turn to other drugs such as opioids to counteract the negative effects of steroids.

• Steroid misuse may lead to serious, even irreversible, health problems:

  • Kidney impairment/failure

  • Damage to liver

  • Cardiovascular problems: Increased risk of stroke and heart attack