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FDA clearance for medical devices is a much lower bar than medications since it primarily evaluates safety. Allure reached out to the FDA and AAD for comment about the use of medical devices that are not cleared by the FDA: The FDA did not respond to our requests
FC: Formal Analysis, Validation, Writing original draft, Project administration
In a randomized controlled trial in 48 breast cancer patients without anemia who were undergoing hormonal therapy, treatment with 3000 mg of Ganoderma lucidum (reishi) spore powder daily for four weeks resulted in significant improvements in fatigue and physical well-being, as well as in anxiety, depression, and overall quality of life (Zhao 2012)
Missed Contraindications A patient with a history suggestive of pancreatic vulnerability may not be identified without an appropriate screening context
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