Bogus Studies, Quackery

Quackery Exposed: Balovaptan

There has been many studies with different medications that research doctors conduct to try to find the magical cure for autism. It’s 2022, people would think they would spend this research money to save lives but here we are.

There were two studies. One on and the other on autistic adults.

There is no medical treatment for autism.

What is Balovaptan?

Balovaptan is a highly potent and selective brain penetrant vasopressin receptor antagonist. A vasopressin is a hormone made in the hypothalamus.Vasopressin is similar to oxytocin but that has been tested before.

Its primary function is its ability to affect the kidney’s function to reabsorb water. When it is present, it induces expression of water transport proteins in the late distal tubal and collecting duct to increase water reabsorption.

The hypothalamus is a structure deep in the brain that acts as the body’s smart control coordinating center. Its main function is to keep the body in a stable state called homeostasis. It directly influences the autonomic nervous system which manages hormones.

The side effects are unknown due to it not being approved yet.

Processes the hypothalamus does

  • makes hormones itself that are stored in the posterior pituitary gland
  • send hormones to the pituitary gland. The pituitary releases hormones that directly affect a part of the body or sends another hormone to a different gland in the body that then releases its hormone.

The hypothalamus controls:

  • body temperature
  • blood pressure
  • hunger and thirst
  • sense of fullness when eating
  • mood
  • sex drive
  • sleep

Now why would researchers want to meddle with that in order to make the autistic more social and following neurotypical rules? They want us to be more like them, of course. It does not matter how dangerous it is. This is especially scary since they are testing it on children when long term side effects are unknown.

Bogus Study: Balovaptan Vs. Placebo Social Communication in Childhood Autism Spectrum Disorder

The objective of this study was to evaluate the efficacy and safety of balovaptan compared to a placebo in autistic children and adolescents.

This study was a randomized, double blind 24 week parallels group, placebo controlled phase 2 trial.

This means that the people conducting the study and the people participating would not be aware of who go the actual medication and who got the placebo.

The participants would be taking age adjusted balocaptan equivalent to a 10 mg adult dose and participants from the concurrently randomized placebo group.

This trial is run from 41 different sites in the United States. Participants were aged 5 to 17. The data was gathered from April 8 2019 to November 16, 2020.

The main objective of this study was to change from baseline on the Vineland II two domain campsite score at week 24. They were looking to improve a checklist. Those are extremely unreliable and unscientific.

This randomized trip did not demonstrate efficacy in neurotypical style social communication like the study doctors hoped. It was well tolerated in children 5 years and older but it did not do anything for these children.

The adverse events (76.7% of the test group and 75.3% of the control group):

  • nasopharyngitis (common cold) (24.4% vs 12.3%)
  • headache (16.3% vs 16%)
  • diarrhea (12.8% vs 4.9%)
  • Oropharyngeal pain (10.5% vs 7.4%)
  • One case of suicidal ideation in the balovaptan group
  • 4 events of intentional self injury, aggression, depression dn viral gastroenteritis were observed in the placebo group

Bogus Study: Efficacy and safety of balovaptan for socialisation and communication difficulties in autistic adults in North America and Europe: a phase 3, randomised, placebo-controlled trial

This study is a phase 3, randomized, double blind, placebo controlled study. It was conducted across 46 sites in different countries. Those countries are US, UK, France, Italy, Spain and Canada.

Participants who were eligible for this study were aged 18 or older and had their IQ score 70 or higher and met the criteria for moderate to sever autism (their words, not mine).

Participants were randomly allocated with an independent interactive voice or web based response system to receive balovaptam (10 mg) or placebo for 24 weeks. They accounted for executive dysfunction, so that’s something.

This study did not “improve social communication in autistic adults.”They said that the study did provide insights into challenges facing these autism trials. They did not take into consideration the other therapies the participants were involved in and that alone tainted this study.

This study was discontinued following the analysis after 50% of participants completed the week 24 follow up visit, which found the difference between the placebo group and the test group was very insignificant. When taking the Vineland II score differences were -1.84. This study was a flop.

Not the “Breakthrough” They were Hoping for

A lot of the media coverage labeled the pediatric study as a breakthrough but it failed at both child and adult study.

According to Psychiatry advisor, it “did not show efficacy for improving socialization and communication among children with autism spectrum disorder (ASD), according to the results of a randomized clinical trial published in JAMA Psychiatry.”

sources:

https://jamanetwork.com/journals/jamapsychiatry/fullarticle/2793696

https://www.ncbi.nlm.nih.gov/books/NBK526069/

https://my.clevelandclinic.org/health/articles/22566-hypothalamus

https://www.adooq.com/balovaptan.html

https://pubmed.ncbi.nlm.nih.gov/35151410/

https://www.thelancet.com/journals/lanpsy/article/PIIS2215-0366(21)00504-6/fulltext

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