A 46-year-old woman comes to the physician for a routine follow-up visit. She has a history of depression treated with fluoxetine but has had only partial improvement. She continues to struggle with mild sadness and weight gain. Her medical history is significant for obesity and hypertension. The patient has a 30-pack-year smoking history and consumes 2 alcoholic drinks daily. Examination shows no abnormalities. She gives the physician a printout of a study posted on the internet about a new herbal preparation said to be very effective for depression. According to the open-label, uncontrolled study, 15 patients took the herb for 6 weeks and 11 were full responders. No dangerous side effects were reported. The patient has purchased the product but wants to consult the physician before taking it. Which of the following is the most appropriate response to the patient's inquiry?

Question

A 46-year-old woman comes to the physician for a routine follow-up visit.  She has a history of depression treated with fluoxetine but has had only partial improvement.  She continues to struggle with mild sadness and weight gain.  Her medical history is significant for obesity and hypertension.  The patient has a 30-pack-year smoking history and consumes 2 alcoholic drinks daily.  Examination shows no abnormalities.  She gives the physician a printout of a study posted on the internet about a new herbal preparation said to be very effective for depression.  According to the open-label, uncontrolled study, 15 patients took the herb for 6 weeks and 11 were full responders.  No dangerous side effects were reported.  The patient has purchased the product but wants to consult the physician before taking it.  Which of the following is the most appropriate response to the patient's inquiry?

Quizplus · Accepted Answer

Explanation: Herbal preparations are widely available and physicians are commonly consulted about their use. Although some herbal medications have established safety and efficacy, others may contain unknown toxic ingredients and cause dangerous drug interactions. The U.S. Food and Drug Administration (FDA) regulates dietary supplements, but the regulations are less strict than those for prescription and over-the-counter medications. This patient is referencing a single study with multiple methodological limitations (eg, small number of subjects, unblinded, no placebo control). The best approach is to explain that the product cannot be recommended based on this limited evidence. The physician should remain open to recommending the herbal preparation if additional information regarding its safety, efficacy, and quality can be obtained. (The FDA website's "Dietary Supplement Alerts and Safety Information" section and the National Center for Complementary and Alternative Medicine website's "Alerts and Advisories" section can provide up-to-date information). "Dietary Supplement Alerts and Safety Information" "Alerts and Advisories" (Choice A) Patients increasingly obtain health information on the internet, and physicians should avoid a paternalistic and dismissive response to their inquiries. Many online health resources provide reliable information, including the results of research studies, while others may present information that is inaccurate, outdated, or geared to promoting sales. Patients should be encouraged to discuss internet-based information with their physicians prior to making health care decisions. (Choice B) This statement is an inaccurate generalization (some herbal products have established efficacy and safety) and fails to educate the patient about the need to obtain further information. (Choices D and E) This uncontrolled, unblinded study on a relatively small number of subjects provides insufficient evidence to draw conclusions about the efficacy or safety of the herbal product. Educational objective: Physicians must be cautious when asked about new therapies that have not been adequately tested. They should defer recommending alternate therapies until obtaining adequate information from well-designed research studies that substantiate the efficacy, safety, and quality of these products. References: The growing use of herbal medicines: issues relating to adverse reactions and challenges in monitoring safety. (http://www.ncbi.nlm.nih.gov/pubmed/24454289)

A 46-Year-Old Woman Comes to the Physician for a Routine