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. 2020 May 19;31(2):53–65. doi: 10.3233/JRS-191023

Table 3.

Predefined criteria

Criteria Standards for scientific evidence
1 Effect Effect estimated in meta-analyses of placebo-controlled trials should be correctly conveyed [1214].
2 Relapse of depression Withdrawal symptoms may be mistaken for relapse [15,16]; no good evidence for advising long-term treatment [1719]; depression usually remits spontaneously [20].
3 Chemical imbalance No evidence for a chemical imbalance as a cause of depression, or for drugs fixing or correcting an imbalance of chemicals in the brain [19,2123].
4 Functioning/Quality of life No evidence that drugs help people return to work, reduce sick leave and improve their social relationships [19].
5 Sexual function The drugs cause sexual dysfunction in many people, e.g. lack of libido and impotence [24].
6 Emotional numbing The drugs may blunt people’s emotions [25].
7 Suicidality The drugs may increase the risk of suicidality, with no age limit [19,2629].
8 Addiction Objectively and subjectively, the drugs are addictive [3032].
9 Withdrawal effects The drugs may cause withdrawal effects, which may make it difficult for the patients to come off them [15,16,19,32].
10 Foetal harms The drugs may cause neonatal abstinence syndrome [33]; it is less clear whether they may cause foetal malformations [34,35].
11 Duration of treatment Randomised trials have only tested the drugs in the short term [19]. There is no evidence for their benefit in the long term [17,18].
12 Tapering People must not stop the drugs suddenly [15]; a tapering is needed, often for a duration of many months [16,32,36].
13 Psychotherapy Psychotherapy is effective [37,38] and may reduce the risk of suicide [39].
14 Off-label prescribing The drugs are generally not approved for young people [40].