Borchert Jill S, Wang Bo, Ramzanali Muzaina, Stein Amy B, Malaiyandi Latha M, Dineley Kirk E
Chicago College of Pharmacy, Midwestern University, Downers Grove, IL, United States.
Chicago College of Osteopathic Medicine, Midwestern University, Downers Grove, IL, United States.
J Med Internet Res. 2019 Nov 8;21(11):e13371. doi: 10.2196/13371.
Patient online drug reviews are a resource for other patients seeking information about the practical benefits and drawbacks of drug therapies. Patient reviews may also serve as a source of postmarketing safety data that are more user-friendly than regulatory databases. However, the reliability of online reviews has been questioned, because they do not undergo professional review and lack means of verification.
We evaluated online reviews of hypnotic medications, because they are commonly used and their therapeutic efficacy is particularly amenable to patient self-evaluation. Our primary objective was to compare the types and frequencies of adverse events reported to the Food and Drug Administration Adverse Event Reporting System (FAERS) with analogous information in patient reviews on the consumer health website Drugs.com. The secondary objectives were to describe patient reports of efficacy and adverse events and assess the influence of medication cost, effectiveness, and adverse events on user ratings of hypnotic medications.
Patient ratings and narratives were retrieved from 1407 reviews on Drugs.com between February 2007 and March 2018 for eszopiclone, ramelteon, suvorexant, zaleplon, and zolpidem. Reviews were coded to preferred terms in the Medical Dictionary for Regulatory Activities. These reviews were compared to 5916 cases in the FAERS database from January 2015 to September 2017.
Similar adverse events were reported to both Drugs.com and FAERS. Both resources identified a lack of efficacy as a common complaint for all five drugs. Both resources revealed that amnesia commonly occurs with eszopiclone, zaleplon, and zolpidem, while nightmares commonly occur with suvorexant. Compared to FAERS, online reviews of zolpidem reported a much higher frequency of amnesia and partial sleep activities. User ratings were highest for zolpidem and lowest for suvorexant. Statistical analyses showed that patient ratings are influenced by considerations of efficacy and adverse events, while drug cost is unimportant.
For hypnotic medications, online patient reviews and FAERS emphasized similar adverse events. Online reviewers rated drugs based on perception of efficacy and adverse events. We conclude that online patient reviews of hypnotics are a valid source that can supplement traditional adverse event reporting systems.
患者在线药物评价是其他患者获取药物治疗实际利弊信息的资源。患者评价也可作为上市后安全性数据的来源，这些数据比监管数据库更便于用户使用。然而，在线评价的可靠性受到质疑，因为它们未经专业审核且缺乏验证手段。
我们评估了催眠药物的在线评价，因为它们常用且其治疗效果特别适合患者自我评估。我们的主要目的是将向美国食品药品监督管理局不良事件报告系统（FAERS）报告的不良事件类型和频率与消费者健康网站Drugs.com上患者评价中的类似信息进行比较。次要目的是描述患者对疗效和不良事件的报告，并评估药物成本、有效性和不良事件对催眠药物用户评分的影响。
从2007年2月至2018年3月Drugs.com上关于艾司佐匹克隆、雷美替胺、苏沃雷生、扎来普隆和唑吡坦的1407条评价中检索患者评分和叙述。评价被编码为《监管活动医学词典》中的首选术语。将这些评价与2015年1月至2017年9月FAERS数据库中的5916例病例进行比较。
Drugs.com和FAERS报告了类似的不良事件。两种资源都指出缺乏疗效是所有五种药物的常见抱怨。两种资源都显示，失忆在艾司佐匹克隆、扎来普隆和唑吡坦中常见，而噩梦在苏沃雷生中常见。与FAERS相比，唑吡坦的在线评价报告失忆和部分睡眠活动的频率要高得多。用户评分唑吡坦最高，苏沃雷生最低。统计分析表明，患者评分受疗效和不良事件考虑因素的影响，而药物成本不重要。
对于催眠药物，在线患者评价和FAERS强调了类似的不良事件。在线评价者根据疗效和不良事件的感知对药物进行评分。我们得出结论，催眠药物的在线患者评价是可以补充传统不良事件报告系统的有效来源。
