SEX

Course Communication and Logistics

• Canvas Inbox Protocol: All course communications to Dr. Gerber must be sent via the Canvas Inbox rather than MWU email.

• Subject Line Requirements: Students are requested to use succinct subject lines for efficient responses. An example of an appropriate heading is: "Questions about risks of valerian in food."

• Response Time: Dr. Gerber aims to respond to Canvas Inbox messages within $48$ hours.

• Office Hours:

  • Schedule: Wednesdays from $12:00\,pm$ to $12:30\,pm$.

  • Platform: Microsoft Teams.

  • Access: A recurring link is provided in the Canvas Announcements.

Learning Objectives for Allopathic Approach to CAM and Sex

By the conclusion of the lecture and study of provided materials, the pharmacy student should be able to:

• Explain the physiological and chemical relationship between yohimbe and tyramine.

• Explain the health risks associated with yohimbe at both high and low dosages.

• Describe the various types of drug and food interactions associated with yohimbe.

• Identify the current FDA regulatory status regarding over-the-counter (OTC) products containing yohimbine marketed for erectile dysfunction (ED).

• Identify the most reliable online resource for pharmacists and patients to investigate safety concerns regarding proprietary dietary supplements.

• Identify the specific prescription medication classes commonly found as undisclosed/hidden ingredients in dietary supplements marketed for sexual dysfunction.

• Describe the appropriate method for assessing the risks versus benefits of the supplement Enzyte©.

• Define the clinical risks and benefits associated with Saw palmetto.

• Describe the professional role of the pharmacist when consulting with patients interested in dietary supplements for sexual health.

• Recite five specific counseling points for patients seeking supplements for sexual dysfunction.

Definitions and Core Resources

• Proprietary: Defined as something used, produced, or marketed under the exclusive legal right of an inventor or maker. In the context of drugs (like patent medicines), it refers to products protected by secrecy, patents, or copyrights against free competition regarding name, composition, or manufacturing processes.

• Proprietary Blends and Labeling: Under the Dietary Supplement Health and Education Act of $1994$ (DSHEA), companies using a "proprietary blend" are only required to list ingredients in descending order of weight and the total weight of the entire blend, rather than the weight of individual constituents.

• Primary Online Resource: The US Food and Drug Administration (FDA) website, fda.gov, is identified as the best resource for both pharmacists and patients to find safety information regarding proprietary supplements.

Dietary Supplements for Sexual Health: Yohimbe

• Botanical Origin: Yohimbe is derived from an evergreen tree.

• Clinical Guidelines: The $2005$ American Urological Association (AUA) guidelines on the management of erectile dysfunction state that yohimbine is not recommended for the treatment of ED.

• Dosing: Regular dosing is noted at $500-750\,mg$ BID (twice daily).

• Respiratory Effects:

  • Low Doses: May stimulate respiration.

  • High Doses: May depress respiration.

• Toxicity and Serious Risks: Toxic doses can lead to psychosis, cardiac failure, severe hypotension, heart conduction disorders, seizures, and death.

• Regulatory Status: It is illegal in the United States to market an OTC product containing yohimbine as a treatment for erectile dysfunction without explicit approval from the FDA.

• International Status: Yohimbe supplements have been restricted or banned in multiple countries due to inaccurate labeling and the potential for severe side effects.

Case Study: Lamar Odom and "Herbal Viagra"

• Incident (October 2015): Former NBA star Lamar Odom was hospitalized after being found unconscious. Reports indicated he had taken up to $10$ tablets of a supplement called "Reload," marketed as "herbal Viagra."

• The Supplement "Reload": The FDA had issued a warning about this product approximately two years prior to the incident because it contained sildenafil.

• Undisclosed Ingredients: Sildenafil is the active prescription ingredient in Viagra. Its presence in "natural" supplements is dangerous because it can severely lower blood pressure.

• High-Risk Populations: Undiscloed sildenafil is particularly hazardous for men with diabetes, high blood pressure, high cholesterol, or heart disease, especially those taking nitrates.

Case Study: Enzyte© (Natural Male Enhancement)

• Marketing: Widely known for its "Smiling Bob" advertisements.

• Formulation Evolution:

  • Pre-2004: Included yohimbe in the original formulation.

  • Post-2004: Yohimbe extract was removed from the product.

  • 2008 Ingredients: Included Swedish flower pollen extract, Tribulus terrestris ($45\%$ saponins), Ginkgo biloba, L-arginine HCl, maca root, saw palmetto berry, Panax ginseng ($80\%$ ginsenosides), Avena sativa, horny goat weed (Epimedium sagittatum with $10\%$ icariin), muira puama, and octacosanol.

  • 2009 Proprietary Blend (541 mg): Contains Korean red ginseng, Ginkgo biloba, pine bark extract, Tribulus terrestris, L-arginine HCl, Avena sativa, horny goat weed, maca root, muira puama, octacosanol, saw palmetto berry, and Swedish flower pollen.

• Nutritional Content (per 2009 label):

  • Niacin: $30\,mg$ ($150\%$ DV)

  • Zinc (as zinc oxide): $30\,mg$ ($200\%$ DV)

  • Copper (as copper oxide): $4\,mg$ ($200\%$ DV)

Dietary Supplements for BPH: Saw Palmetto

• Intended Use: Commonly used to treat symptoms of Benign Prostatic Hyperplasia (BPH) or Lower Urinary Tract Symptoms (LUTS).

• Clinical Evidence:

  • Two NIH-sponsored trials concluded that saw palmetto is not better than placebo for BPH symptoms, even at high doses.

  • A study in JAMA ($2011$) by Barry MJ, et al., found that increasing doses of saw palmetto extract had no impact on urinary symptoms (e.g., incontinence, nighttime urination) or sexual function compared to placebo over $72$ weeks.

• Professional Ratings: The Natural Medicines Comprehensive Database downgraded its rating of saw palmetto to "Possibly Ineffective."

• Pharmacist Advice: Patients should be informed that the benefits are modest at best/no better than placebo. However, it is generally considered safe, and clinicians do not always strongly discourage it if a patient already taking it experiences a perceived benefit (likely via the placebo effect).

The Pharmacist's Role and Patient Counseling

• Addressing Unmet Needs: When a patient is interested in sexual health supplements, the pharmacist should investigate:

  • Is sexual dysfunction a side effect of a current medication?

  • Is sexual dysfunction a symptom of a current disease state?

  • Does the patient know about standard medical treatment options?

  • Is the dose of a current prescription treatment for ED appropriate?

• Encouraging Provider Dialogue: Pharmacists should encourage patients to talk to their healthcare providers about their options.

• FDA Red Flags for Sexual Enhancement Products: Consumers should be warned to avoid products that:

  1. Promise quick results (within $30-40$ minutes).

  2. Are advertised as alternatives to FDA-approved prescription drugs.

  3. Are sold in single servings.

  4. Are advertised through spam or unsolicited emails.

  5. Have labels primarily in a foreign language.

  6. Have directions or warnings that suspiciously mimic FDA-approved products.

• Research Limitations: Students should counsel that research on these herbs is often small, animal-based, or inconclusive, and there is no definite evidence that any herbal product is effective or safe for sexual enhancement.