Dutch tapering study under fire

[Fromthenetherlands]

A large-scale Dutch study of the AmsterdamUMC and Radboudumc into safe weaning of antidepressants is under fire from a patient association. According to the Association for “Finishing Medication”, the study is 'redundant' and it is also unethical to let subjects wean the ssri”s off according to the common weaning method.

https://www.volkskrant.nl/nieuws-achtergrond/kritiek-op-studie-naar-afbouw-antidepressiva-onethisch-en-overbodig~b762ac465/

 

 

 

Edited August 25, 2021 by Altostrata
removed coding

[Altostrata]

@Fromthenetherlands could you translate the article for us? (Please post unformatted text, if you use a translator.)

 

What is the "the common weaning method"?

 

Is the Association for Finishing Medication the same as the International Institute for Psychiatric Drug Withdrawal (IIPDW)?

[Fromthenetherlands]

Hi @Altostrata,

 

The common method is the method presrcibed often by psychiatrist. The fast way of weaning they mean in the article. I will translate it as soon as I will have the time for it. 

[Fromthenetherlands]

@Altostrata

The association named in the article is a dutch patient association named Vereniging Afbouwmedicatie. 

[DutchMaddy]

Thank you!

[Paquita]

I can also help translate

[Nomansland]

Here is a quick translation of the article by DeepL-Translator with a few corrections:

 

"Criticism of study on tapering antidepressants: 'unethical' and 'unnecessary'

 

A large-scale Dutch study about tapering of antidepressants is under fire from a patients' association. The "Vereniging Afbouwmedicatie" calls the study by AmsterdamUMC and Radboudumc 'unnecessary' and 'unethical'.

This study, known as TAPER-AD, will investigate with 200 test subjects the best way to get off antidepressants: the standard procedure or a slow phasing out process with increasingly smaller doses - also known as tapering.

The study will look at the withdrawal symptoms, the patient's well-being and whether the method of stopping affects the risk of a new depression.

 

A superfluous study, thinks professor of psychiatry Jim van Os of UMC Utrecht, who regularly assists the Association for Reduction of Medication with scientific advice. It has long been known that the standard way of phasing out drugs can often cause severe withdrawal symptoms. He therefore finds it 'unethical' that half of the test subjects in the TAPER-AD study will be phased out in this way. 'It's irresponsible to do that to patients.'

According to the researchers, there is nothing unethical about it. The knowledge about tapering is insufficient. This includes the number of people who actually experience withdrawal symptoms. And we too want tapering out of antidepressants for patients who need them,' says Eric Ruhé, psychiatrist, epidemiologist and researcher at the Radboudumc, who alongside Christiaan Vinkers (AmsterdamUMC) is the principal investigator of TAPER-AD. 'It is not without reason that various professional associations, scientists, insurers and other patient groups support our research.'

 

In the Netherlands, more than a million people are prescribed antidepressants every year. Not everyone needs to take that medication long-term, and some don't want to. But stopping can produce a wide range of physical and psychological symptoms. The TAPER-AD study focuses on the two drugs that are the most difficult to taper off: paroxetine and venlafaxine. The researchers will not only look at whether slow tapering leads to fewer withdrawal symptoms, but also which tapering strategy reduces the likelihood of the depression returning and also what the best cost option is. The researchers see the study as a "world first" because it has not been studied scientifically before. 'There are also people who stop in one go without too many problems,' Ruhé emphasizes. 'We want to know how large the group with discontinuation problems is and whether you can recognize them, so that you know in advance which discontinuation method is most suitable for whom.'

 

In 2018, psychiatrists, pharmacists, general practitioners and patient associations wrote a guideline on antidepressant discontinuation. That guideline advises physicians to tailor the tapering process to the type of antidepressant and the patient's characteristics and, if necessary, to slow down the tapering process using tapering medications (including tapering strips) that contain very small doses. It is explicitly not an official guideline because a guideline must always be based on scientific evidence - and there isn't any yet. With TAPER-AD, that evidence should be forthcoming. There have been studies of patient experiences with discontinuation. But these were selected groups of patients whose previous discontinuation attempts had failed because of withdrawal symptoms. That is not the highest standard of scientific evidence. The TAPER-AD will 'provide that high level of evidence', says Ruhé, 'because it compares the effects of two ways of phasing out in a double-blind fashion'. Double-blind means that neither the patient nor the treatment provider knows who will receive which method of phasing out.

 

ZonMW is providing 1.5 million euros for the study. An assessment by a medical ethics committee will follow. The results will probably be known early next year. For years, tapering strips have been the subject of a battle between the insurers and the Association for the Reduction of Medication, a patient association whose front man is a former general practitioner and epidemiologist d*ck Bijl, who is a member of the Medical Council. Most insurers do not reimburse these strips because they, too, feel that there is insufficient scientific evidence that they facilitate tapering."

 

Greetings

[Nomansland]

Informations about the study in english can be found here (click on "Samenvatting").

 

"STUDY DESIGN: Multicenter double-blind randomized (1:1) controlled trial of 200 patients with remitted depression using PAR (20-50mg) or VLX (75-375mg).

 

TAPER-AD has three consecutive phases (52 wks):

Phase I: Non-contrasting double-blind phase for dosages higher than the minimal effective dose (MED; PAR, 20mg; VLX, 75mg): dose reduction in steps of 10/75mg per 2 weeks until MED (max. 8 wks).

Phase II: Contrasting double-blind phase; i) conventional dose reduction (using available dosing-units) vs. ii) gradual dose reduction from the MED (max. 10 wks).

Phase III: Follow up without medication (max. 38 wks)"

 

So in general, only tapering Paroxetine and Venlafaxine will be studied. In the first step patients on higher doses above the so called "minimal effective dose" ( = 20 mg for paroxetine and 75mg for venlafaxine)

will taper in 10mg/75mg steps per 2 weeks for a maximum length of 8 weeks until they are at this "minimal effective dose".

 

Then they want group 1 patients to taper by "conventional dose reduction (using available dosing-units)" and group 2 by "gradual dose reduction from the minimal effective dose" (i guess with tapering strips) with a maximum taper time of 10 weeks. After tapering they will monitor the patients for up to 38 weeks.

 

Why 10 weeks (or 18 weeks if you add phase 1) and not longer like the UK Royal College of Psychiatrists suggests with 10 % steps? Noone knows. Guess its too costly (1.5 million euro already with such a short taper time) to make a real tapering study which goes much longer. How to acknowledge withdrawal symptoms? By reinstating? When this doesnt work to stabilise or take much longer than expected, will it be diagnosed as "relapse"?

 

Also the minimal effective/therapeutic dose was created by the pharma companies when they were marketing/starting these drugs (tapering from higher doses does not always mean lesser withdrawal symptoms). Seeing the scientific data of the receptor occupancy, these drugs could be described in much, much lesser dose with the same "effect". Phase I, where the patients have to taper to the "minimal effective dose" in 8 weeks, can also bring up severe withdrawal symptoms.

 

10 weeks is very often not enough time to taper safely from these medications. In the end, they may misinterprete it and say "tapering slowly will not prevent patients from having withdrawal symptoms". Well, we will see.

 

 

Greetings

[Fromthenetherlands]

@Altostrata

[Altostrata]

Thanks for the translation. I know Jim van Os and Peter Groot.

[Machi]

https://www.madinamerica.com/2021/08/jim-van-os-peter-groot-assessing-antidepressant-withdrawal-methods-rcts-fall-short/?fbclid=IwAR2a8kz6OwiQJpbvLiT86vdZ2v9LdiKSRVmlJBRazs-Afw8wWWmDb6Ck4hA

SA and Alto are also mentioned in this article. Maybe someone has already posted this....