Study, Mar/19: Discontinuing Psychotropic Drugs from Participants in RCTs

Journal: Psychotherapy and Psychosomatics (impact factor 13.1)

 

Full title: "Discontinuing Psychotropic Drugs from Participants in Randomized Controlled Trials: A Systematic Review."

 

Abstract

BACKGROUND AND OBJECTIVE:

Methods and justifications for discontinuing psychotropic drugs in randomized controlled trials (RCTs), and RCTs' acknowledgement of possible withdrawal symptoms following discontinuation, have not been examined systematically, which this review aims to do. Study Eligibility, Data Extraction, and Synthesis: Publications in MEDLINE, EMBASE, and PsycINFO (2000-2017) randomly assigning participants diagnosed with mental disorders to discontinue antipsychotic, antidepressant, anticonvulsant, antimanic, mood-stabilizing, benzodiazepine, or stimulant drugs. Authors independently extracted data, devised a typology of trials, and assessed trials' recognition of withdrawal symptoms.

 

RESULTS:

Eighty RCTs (70% with industry participation) discontinued drugs from 5,757 participants to investigate relapse prevention (44%), successful dis-continuation (26%), architecture of withdrawal (14%), and practicality of discontinuation (10%). RCTs of stimulants, antidepressants, and antipsychotics mostly aimed to reach conclusions about relapse prevention by testing abrupt or rapid discontinuations; RCTs of benzodiazepines mostly aimed to reduce drug use by testing longer-lasting, supportive discontinuations. In 67% of RCTs, no justification was given for the specific discontinuation strategy, which lasted under 2 weeks in 60% of RCTs. Possible withdrawal confounding of trial outcomes was addressed in 14% of eligible RCTs.

 

LIMITATIONS:

Only the published literature was searched.

 

CONCLUSIONS AND IMPLICATIONS:

RCTs use drug discontinuation to study several key issues in psychopharmacology but infrequently justify how they implement it or acknowledge that possible withdrawal symptoms may threaten internal validity. Reappraising the use of drug discontinuation and the recognition of withdrawal symptoms in RCTs is required.

 

https://www.ncbi.nlm.nih.gov/pubmed/30923288

Here's the full study: https://sci-hub.tw/https://www.ncbi.nlm.nih.gov/pubmed/30923288

 

Supplementary material can be accessed here: https://karger.figshare.com/articles/Supplementary_Material_for_Discontinuing_Psychotropic_Drugs_from_Participants_in_Randomized_Controlled_Trials_A_Systematic_Review/7907267

 

Lots of important information in this article.  Here are some quotes from the discussion and conclusion sections:

 

"Abrupt discontinuation is useful only to provoke reactions expected to contrast on average with those of participants not discontinued, thus putting the tested drug in a positive light – but potentially harming participants."

 

"...drugs are discontinued from participants to test relapse prevention, help people reduce drug use, and chart withdrawal symptoms. This usefulness, however, contrasts with the lack of justifications in over two thirds of trials for how discontinuation is actually employed. Especially in relapse prevention RCTs, drugs are rapidly or abruptly discontinued in order to compare drugged patients to nondrugged patients, and trials deliberately ignore cautions from the literature that such a method may subvert the logic of the comparison and potentially harm participants by inducing symptoms resembling those the drugs are meant to treat."

 

The authors disclose the following:

"D.C. and A.R. have clinical experience with individuals considering drug discontinuation or in assessing suspected withdrawal syndromes. D.C. has served as a consultant to the Withdrawal Project."

And it looks like the lesson should be..."Don't participate in such drug trials."

 

Yikes!

 

Scary as hell.

Yes, scary as hell is right!!

 

Knowing what I know now, I would NOT EVER want to participate in one of those RCTs. I know so much more about my body's responses to drug reactions, and I'm afraid a lot of people in those RCTs do not realize what's coming.

 

Would they be able to sue (or are they barred from suing due to volunteering for an RCT) if their withdrawals lasted for a long time?

Don't they have to sign various wavers in order to participate? I assume people do that in order to get paid, and perhaps they're willing to take all sorts of risks. Personally, I would never do so, but you never know if people are desperate for money or something.