Dietary supplement sales have surpassed $30 billion per year with their use becoming and remaining extremely popular amongst the general public. There are numerous bioactive components, both nutritive and non-nutritiv...Dietary supplement sales have surpassed $30 billion per year with their use becoming and remaining extremely popular amongst the general public. There are numerous bioactive components, both nutritive and non-nutritive, in dietary supplements with considerable efficacy in promoting health. However, there are many ways disallowed ingredients may enter the supplement pipeline with potentially toxic effects. Dietary supplements can be regulated (either pre- or post-market) as a drug, dietary supplement, a nutraceutical, new dietary ingredient (NDI), generally recognized as safe (GRAS) food ingredient, a food additive, or a food. A pharmaceutical drug (medication) is used to treat, cure, prevent, or diagnose a disease and is regulated by the FDA pre-market only and allowed by medical prescription, whereas the other labeling designations are largely regulated post-market. One such molecule with a labeling problem is tianeptine, which has global use as an efficacious, prescribed drug, while at the same time being considered a non-drug and potentially dangerous adulterant often referred to as gas station heroin. In this paper, we critically evaluate the use and labeling of this compound and attempt to clarify the conundrum surrounding its legal or illegal use. Tianeptine is effective and efficacious as an antidepressant in those responding poorly to selective serotonin reuptake inhibitors (SSRIs) and exhibits many medicinal characteristics of tricyclic antidepressants with fewer opioid-like side effects. As a result, sixty-six countries permit use of tianeptine as a prescription drug. At higher doses, tianeptine has recently been shown to exhibit significant potential for abuse and dependency along with toxicity. As such, the US does not recognize tianeptine as an FDA-approved drug or as a dietary supplement, nutraceutical, new dietary ingredient (NDI), GRAS ingredient, or a food. Instead, tianeptine is a synthetic adulterant of a dietary supplement and considered technically an unapproved food additive. In conclusion, 展开更多
文摘Dietary supplement sales have surpassed $30 billion per year with their use becoming and remaining extremely popular amongst the general public. There are numerous bioactive components, both nutritive and non-nutritive, in dietary supplements with considerable efficacy in promoting health. However, there are many ways disallowed ingredients may enter the supplement pipeline with potentially toxic effects. Dietary supplements can be regulated (either pre- or post-market) as a drug, dietary supplement, a nutraceutical, new dietary ingredient (NDI), generally recognized as safe (GRAS) food ingredient, a food additive, or a food. A pharmaceutical drug (medication) is used to treat, cure, prevent, or diagnose a disease and is regulated by the FDA pre-market only and allowed by medical prescription, whereas the other labeling designations are largely regulated post-market. One such molecule with a labeling problem is tianeptine, which has global use as an efficacious, prescribed drug, while at the same time being considered a non-drug and potentially dangerous adulterant often referred to as gas station heroin. In this paper, we critically evaluate the use and labeling of this compound and attempt to clarify the conundrum surrounding its legal or illegal use. Tianeptine is effective and efficacious as an antidepressant in those responding poorly to selective serotonin reuptake inhibitors (SSRIs) and exhibits many medicinal characteristics of tricyclic antidepressants with fewer opioid-like side effects. As a result, sixty-six countries permit use of tianeptine as a prescription drug. At higher doses, tianeptine has recently been shown to exhibit significant potential for abuse and dependency along with toxicity. As such, the US does not recognize tianeptine as an FDA-approved drug or as a dietary supplement, nutraceutical, new dietary ingredient (NDI), GRAS ingredient, or a food. Instead, tianeptine is a synthetic adulterant of a dietary supplement and considered technically an unapproved food additive. In conclusion,
文摘目的系统评价噻奈普汀与阿米替林治疗抑郁症的疗效与安全性。方法检索从建库至2016年3月,中国期刊全文数据库（CNKI）、万方数据库、中文科技期刊全文数据库（VIP）、Cochrane library、Pub Med/Medline等数据库中噻奈普汀与阿米替林治疗抑郁症的随机对照试验（RCTs）,采用Rev Man 5.0软件对各效应指标进行Meta分析。结果共纳入6篇RCTs,714例患者,其中噻奈普汀组（治疗组）359例,阿米替林组（对照组）355例;Meta分析结果显示噻奈普汀组与阿米替林组显效率差异无显著性[OR=1.56,95%CI（0.87~2.79）,P=0.13];两组头晕、口干、恶心呕吐、烦渴、便秘、震颤、排尿困难等不良反应差异有显著性（P〈0.05）,95%CI上下限均小于1,提示噻奈普汀组在上述不良反应发生率方面小于阿米替林组;其他不良反应无显著性差异。结论噻奈普汀与阿米替林治疗抑郁症疗效相当,但噻奈普汀不良反应较轻微;该结论尚需高质量、严格设计的RCTs进一步证实。
