Danborg P B, Valdersdorf M, Gøtzsche P C
Nordic Cochrane Centre, Rigshospitalet, Copenhagen, Denmark.
Int J Risk Saf Med. 2019;30(2):59-71. doi: 10.3233/JRS-180046.
Millions of people are treated with antidepressants like selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs). This clinical practice is based on short-term trials that have exaggerated the benefits and underestimated the harms. We also know too little about long-term harms.
To assess harms of SSRIs and SNRIs that persist after end of drug intake.
Systematic review of placebo-controlled randomised trials of any length in patients with a psychiatric diagnosis and a follow-up of at least six months. Our primary outcomes were mortality, functional outcomes, quality of life and core psychiatric events. We searched PubMed, Embase, and the Cochrane Central Register of Controlled Trials and checked the references for eligible articles. One researcher extracted data and another checked the data extraction.
Our searches returned 9,153 unique records. We included 22 papers for 12 trials on SSRIs. Median intervention and follow-up periods were 15 and 52 weeks, respectively. Median number of randomised participants was 51; only two trials had a drop-out rate below 20%.Outcome reporting was less thorough during follow-up than for the intervention period and only two trials maintained the blind during follow-up. All authors concluded that the drugs were not beneficial in the long term.All trials reported harms outcomes selectively or did not report any. Only two trials reported on any of our primary outcomes (school attendance and number of heavy drinking days).
The randomised trials currently available cannot be used to investigate persistent harms of antidepressants.
数以百万计的人正在使用选择性5-羟色胺再摄取抑制剂(SSRIs)或5-羟色胺-去甲肾上腺素再摄取抑制剂(SNRIs)等抗抑郁药进行治疗。这种临床实践是基于一些短期试验,这些试验夸大了益处而低估了危害。而且我们对长期危害了解甚少。
评估停止用药后仍持续存在的SSRIs和SNRIs的危害。
对有精神疾病诊断且随访至少6个月的患者进行的任何时长的安慰剂对照随机试验进行系统评价。我们的主要结局指标是死亡率、功能结局、生活质量和核心精神事件。我们检索了PubMed、Embase和Cochrane对照试验中央注册库,并检查了符合条件文章的参考文献。一名研究人员提取数据,另一名研究人员检查数据提取情况。
我们的检索返回了9153条独特记录。我们纳入了关于SSRIs的12项试验的22篇论文。干预和随访期的中位数分别为15周和52周。随机分组参与者的中位数为51名;只有两项试验的脱落率低于20%。随访期间的结局报告不如干预期间全面,并且只有两项试验在随访期间保持了盲法。所有作者均得出结论,这些药物从长期来看并无益处。所有试验均选择性地报告了危害结局或未报告任何危害结局。只有两项试验报告了我们的任何一项主要结局指标(上学出勤率和重度饮酒天数)。
目前可用的随机试验不能用于研究抗抑郁药的持续危害。