Editor's Note <\/p>\n\n\n\n
June 3, 2024<\/p>\n\n\n\n
Safe and effective treatments for preventing type 2 diabetes in persons at high risk for the disease are needed. In this issue of JAMA Internal Medicine<\/em>, Ji and colleagues1<\/a><\/sup> randomized patients with impaired glucose tolerance and multiple metabolic abnormalities to receive either a traditional Chinese medicine preparation, Jinlida (JLD) granules, 9 g 3 times\/d, or placebo. Participants who received JLD had a 41% lower risk of developing diabetes compared with those receiving placebo over a mean observation period of 2.2 years. Secondary metabolic outcomes also favored JLD crystals, although differences were small. JLD contains 17 different herbal components (listed in the eAppendix in Supplement 11<\/a><\/sup>) provided in a sachet that is taken with warm water.<\/a><\/p>\n\n\n\n Were this a pill, there would be questions about what stage it was at in the US Food and Drug Administration (FDA) approval process. But the path to FDA approval for herbal products, as explained in a commentary by Unger and Clissold,2<\/a><\/sup> is not simple or cheap. Besides proving effectiveness and safety, a company producing any medication has to demonstrate that the product tested in a clinical trial can be consistently manufactured and marketed with equivalent composition and dosage of all active ingredients. This is very difficult for heterogeneous botanical products, which may vary with growing conditions and contain many chemical signatures. Unger and Clissold report that the application fee for requesting a new drug approval from the FDA is approximately $3.2 million.<\/a><\/p>\n\n\n\n As Editors of JAMA Internal Medicine<\/em>, we want to be open to treatments other than pharmaceuticals, yet we recognize that the barriers for herbal treatments may preclude their being approved as medications. Herbal products can be marketed in the US as dietary supplements. Dietary supplements do not require proof of effectiveness or safety. Before marketing a dietary supplement not already part of the food supply, a company would only have to notify the FDA of the basis on which it believed that the supplement would be safe for consumer use.3<\/a><\/sup>The trial of JLD granules demonstrated that they have an excellent safety profile.1<\/a><\/sup> Dietary supplements cannot be marketed to treat, prevent, or cure a specific disease; if claims are made about effectiveness for a specific condition or disease, then they must be determined to be a drug, rather than a dietary supplement, and must be approved as a drug according to FDA guidelines.3<\/a><\/sup><\/a><\/p>\n\n\n\n One final issue: transparency concerning potential conflicts of interest are important to the Editors of JAMA Internal Medicine<\/em>. Although this study was not funded by the makers of JLD granules (Shijiazhuang Yiling Pharmaceutical Co), Zhenhua Jia, MD, the corresponding author, is married to a shareholder and director of the pharmaceutical company, as disclosed by the author.1<\/a><\/sup> The JAMA Internal Medicine<\/em> Editors noted that the company provided only the JLD granules and placebo tablets, as is customary in trials involving pharmaceutical products, and was otherwise uninvolved in any other aspect of the study, which also had an independent data and safety monitoring board.<\/p>\n","protected":false},"excerpt":{"rendered":" Editor’s Note June 3, 2024 Traditional […]<\/p>\n","protected":false},"author":3,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":[],"categories":[24,23],"tags":[],"_links":{"self":[{"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/posts\/26173"}],"collection":[{"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=26173"}],"version-history":[{"count":1,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/posts\/26173\/revisions"}],"predecessor-version":[{"id":26174,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/posts\/26173\/revisions\/26174"}],"wp:attachment":[{"href":"https:\/\/csccm.org.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=26173"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=26173"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=26173"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}