Bogus Study:Probiotic and Oxytocin Combination Therapy in Patients with Autism Spectrum Disorder: A Randomized, Double Blind, Placebo Controlled Pilot Trial

This study is led on the belief that the gut biome has anything to do with autism. This study was ran by Bened Biomedical Co, LTD. If anything has the word "biomedical" when it comes to autism, it's more than likely quackery. This study was published in the Journal "Nutrients" which is a well known journal in the biomedical community. Quackery. 

One of the researchers Dr. Wenn Liu said,"Because wide ranging autism symptoms seem to develop though multiple pathways, it makes sense that a combination of treatments like this could prove effective."  He is a gut researcher at the National Yang-Ming University in Taiwan. These biomedical researchers are really obsessed with autistic fecal matter. 


What is Oxytocin?

Oxytocin is a neuropeptide that is produced by the hypothalamus, the part of the brain that is well known for its ability to regulate emotions and social communication, bonding and reward related behaviors. It is often called the love hormone. Oxytocin have been show to increase sociability in mice so therefore they believe it will do the same in autistic humans. 

Oxytocin is indicated for:

  • bring on labor 
  • speed up labor
  • help clear debris in the uterus
  • bring on post operative contraction after a c section
  • control a uterine hemorrhage
Side Effects:

  • slow heart rate
  • fast heart rate
  • premature ventricular (heart chamber) complexes and other irregular heartbeats (arrhythmias)
  • Permanent central nervous system  or brain damage and death secondary to suffocation
  • neonatal yellowing of skin or eyes (jaundice)
  • fetal death
  • low Apgar score (rating scale for newborns)
  • uteroplacental hyoperfusion and low fetal heart rate
  • low fetal oxygen levels (hypoxia)
  • perinatal hepatic necrosis (liver damage)
  • fetal hypercapnia (increased carbon dioxide in the blood)
  • severe degreases in maternal blood pressure
  • increased maternal heart rate
  • increased systemic venous return and cardiac output and arrhythmia 
  • Risk of severe water intoxication on prolonged administration 
  • IM (intramuscular injection) not recommended for labor induction
Drugs that interact with oxytocin:
  • mefloquine
Contraindications (people who have these should not take this medication):
  • significant cephalopelvic disproportion (when a baby is too large to fit through the birth canal)
  • when a baby is breech
  • emergencies that effect the fetus
  • when the fetus is in distress
  • hypersensitivity

What is Lactobacilus Plantarum PS128 Probiotic

Lactobacilus is a type of baterica. There are many different species of it, lactobacillus plantarum being one of them. These are often found in our digestive, urinary and genital systems without causes any illness. It can also be found in fermented foods like yogurt and in dietary supplements. 

It is mostly used for diarrhea, including infectious diarrhea and for diarrhea caused by antibiotics. 

Used for:
  • stomach pain
  • hay fever
  • diarrhea
  • eczema
  • allergies
  • overgrowth of vaginal bacteria
  • diarrhea caused by cancer treatment
  • excessive crying in infants
  • constipation
  • type 2 diabetes
  • digestive tract infection
  • high cholesterol
  • swelling and sores inside the mouth
  • complications after surgery for ulcerative colitis
  • infection of airway
  • rheumatoid arthritis
  • inflammatory bowel disease
Side effects:
  • intestinal gas
  • bloating
Warnings:
  • don't give if person has weaken immune system
  • don't give if they have short bowel syndrome
  • don't give if the person has ulcerative colitis
  • don't have if they have damage heart valves
Drug interactions
  • antibiotics since it is a bacteria. 
  • immunosuppressants

Study Design

In this study, the hypothesis was that a combination of oxytocin (a natural occurring hormone that induces happiness and labor in pregnant people) and probiotics will make someone seem less autistic. This is not the first time this has been studied. There has been mixed results in the past but, like anything else, these researchers are convinced it works, even if it doesn't. 

This was touted as a double blind, randomized, placebo controlled, two stage pilot trial to test their hypothesis. The participants were randomly placed into two groups with a 1:1 ratio into this two stage study. It was only half correct. 

stage 1:

Probiotics group received oral probiotics while the placebo pups recieved an oral placebo for 16 weeks

stage 2

Both groups continued their respective administration and added intranasal oxytocin spray. 

The treatment proceeded for a total of 28 weeks with 3 visits for outcome measurement at 0, 16 weeks and 28 weeks. 

If this was a true double blind study, there would have been an oxytocin placebo. There was not one in this study. This was not a true double blind, placebo controlled study. 

Method of Data Collection

As per any other biomedical study, they relied heavily on parent checklists. They can be biased and are a very unscientific way to obtain data. The checklists used were the Social Responsiveness Scale and the Aberrant Behavior Checklist. 

They also used blood collection to measure biomarkers. Participants made visits on week 0, 16 and 28 for blood draws. Serum (liquid left over after clotting) was measured for oxytocin levels, myelin basic protein, glial fibrillary acidic protein, calcium binding protein and interleukin using ELSIA tests. 

GI symptoms were assessed by the GI severity index. Constipation, diarrhea, flatualance, stool consistency, abdominal pain, unexpected daytime irritability, night time awakening and abdominal tenderness were evaluated. The stool status was scored using the Bristol Stool Chart. 

Stool samples were also taken. Stool samples were collected at home using a provided kit with the supervision of trained parents and stored at room temperature. Microbial DNA was extracted and DNA samples were quantified. 

Results

There were no adverse events and the treatments were well tolerated. The study doctors did notice an "improvement" in behavior according to the parent checklists in both groups. The participants did not discontinue the other therapy they were currently participating in, so there was no way to determine if this actually worked, which it did not. In this study they correlated gut microbiome with social behavior. 

Limitations

  • participation enrĂ´lement and retainment was difficult. There was a small sample size, so nothing was proven at all.
  • There was no statistical difference between the clinical indices between the probiotics and the placebo groups at the baseline, a wide age range  was used in the study. They use this as an excuse on why the study didn't prove anything. 
  • This limitation is racist and I'm sorry, its not my words "Due to considerable Asian and other minority patients with some cultural and language barriers, in addition multiple influencing factors and behavioral variabilities, the parent rating of social behavior scales maybe somewhat biased." News flash, parent rating scales are ALWAY BIASED. 
  • Sequential comparisons were not made that the same time point for having four groups The prolonged treatment was influenced by occurring factors. 
In this study they know its bad science and tried to use racist reasons on why their study did not work. I am an autistic mother who had oxytocin with each live birth. I had 3 of them. I am still autistic. They need to stop wasting time in trying to cure us and actually research the services we need. We want to be accepted and accommodated. This is not a hard thing to do. 

Sources:

https://www.mdpi.com/2072-6643/13/5/1552/htm

https://www.prnewswire.com/news-releases/combined-oxytocin-and-psychobiotic-therapy-improves-autism-symptoms-in-novel-clinical-study-301312611.html

https://www.rxlist.com/stages_of_pregnancy_slideshow/article.htm

https://www.webmd.com/vitamins/ai/ingredientmono-790/lactobacillus

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