Bogus Studies, Quackery

Bogus Study: Drug Repurposing Candidates To Treat Core Symptoms in Autism Spectrum Disorder

In this study, the people conducting the study were testing Loperamide or branded Imodium in the United States to “treat autism.” They were trying to treat “social communication deficits” instead of accepting that the autistic community has its own set of norms and rules for social communication.

Rationale of Study

There are no medications currently approved for the treatment of social communication differences. Most adults and children who are autistic are treated with antipsychotic medications to reduced “non core symptoms” such as irritability, hyper activity and self injury.

The clinical and genetic heterogeneity of autism complicates the development of pharmacological treatments. This necessitates the use of new approaches to identify novel treatment options for autism.

With all this, they believe that using a drug that targets a specific receptor or enzyme encoded by a gene in which genetic variants associate with the target “disease” have a higher success rate in the drug development pipeline.

In other words, since loperamide targets opoid receptors, this is a better study, in their opinion.

They believe that using this drug will change the gene expression of the autistic individual.

A major problem with this study is that the medications that they selected come with severe side effects. Some of them are not meant to be taken long term. If someone takes them long term, it can cause serious health problems. These people are more worried about making us more like them than the health and quality of life of the individual.

Methods

Two different sources were used to define autism genes. There is a problem with that, there is no definitive autism gene. They have genetic links but they aren’t concrete.

One was the large scale GWAS on Autism that included 18, 381 autistic people and 27, 969 control individuals.

The Stable 10 is the second source. 25 genes from MAGMA gene based association were included. This resulted in 54 GWAS identified autism gene, according to GWAS.

Both of these genetic databases identified 102 genes as possible “autism genes.” There are no specific autism genes.

In a study conducted in 2020, multiple studies literature was reviewed and it was determined that there are no specific autism genes, just genes linked to the brain. According to this study, there was insufficient evidence to establish autism specific genes based on a large effect rare variant data.

A side note, the controls may not be controls. There are many individuals who are autistic and do not have a diagnosis because it is not accessible. This control group may not be accurate. There is no way to know if the data of the control group were from non autistic people.

This was not a clinical trial. There is no way to know if this was effective if they did not give an autistic this medication to try. Its a good thing too. These medications come with serious side effects.

Results

They identified existing drugs that could potentially be used for repurposing to mask signs of autism. They identified and Autism Network via network based methods. They studied genes in this network in relation to interaction with approved drugs.

They identified four drugs showing opposite gene expression in the drug vs autistic expression in the gene in the autism network. They are loperamide, bromocriptine, drospirenone and progesterone.

Drospirenone is a birth control pill that contains progesterone. Both drugs are incredibly similar.

Explanation of the Drugs in Question:

What is Loperamide?

Loperamide is a common over the counter medication to treat diarrhea or to reduce the amount of stool in people who have an ileostomy(when a surgeon reroutes the bowel to a small opening in the torso).

It works by acting on mu-opoid receptors in the gut to slow down the movement. This causes the contractions in the intestines to slow down. This allows for more time for fluids and nutrients to be absorbed into the body. This process makes the stool less watery and decreases the number toilet trips.

Contraindications

  • ulcerative colitis
  • bloody or tarry stools
  • diarrhea with a high fever
  • diarrhea caused by an antibiotic
  • stomach pains without diarrhea
  • diarrhea that is caused by a bacterial infection
  • breast or chest feeding

Warnings:

Do not take more than indicated on the packing. Taking more can cause serious heart problems or death.

Serious heart problems can happen if there is an interaction with another medication. Ask a doctor or pharmacist before taking loperamide.

NEVER GIVE TO A CHILD YOUNGER THAN 2.

Stop taking loperamide and call your doctor if you have :

  • diarrhea that is watery or bloody
  • ongoing or worsening diarrhea
  • fast or pounding heartbeats, fluttering in the chest, shortness of breath and sudden dizziness

Common Side Effects:

  • constipation
  • dizziness or drowsiness
  • nausea
  • stomach cramps
  • bloating
  • loss of appetite
  • vomitting
  • acid or sour stomach
  • belching
  • dry mouth
  • excess air or gas in stomach or bowels
  • heartburn
  • indigestion
  • upset stomch
  • passing gas

What is bromocriptine?

Bromocriptine is a medication that is used to treat hormone impedance when there is too much prolactin in the blood. High levels of prolactin may cause sexual problems, hot flashes, menstrual problems or infertility in AFAB, muscle loss in AMAB, breast enlargement and lack of sexual development in adolescents. It is also used to treat these disorders they are caused by a. non cancerous tumor of the pituitary gland that can over produce prolactin.

It is sometimes used together with surgery or radiation in treating acromegaly, a condition caused by a pituitary gland tumor that produces too much growth hormone.

It’s also used to treat Parkinson’s disease. It treats stiffness, tremors, muscle spasms and poor muscle control.

Warnings

You should not take bromocriptine if:

  • you are breast/chest feeding
  • you have uncontrolled high blood pressure
  • you have hypertension caused by pregnancy or
  • you recently had a baby and you have a history of coronary artery disease or severe heart disease

Bromocriptine contains lactose. Tell your doctor if you are lactose intolerant.

Side Effects:

  • numbness, pain and paleness or discoloration of the fingers or toes, especially in cold weather
  • vision problems, constant runny nose
  • chest pain, pain when you breathe, fast heart rate, rapid breathing feeling short of breath (especially when lying down)
  • back pain, swelling in the ankles or feet, urinating less than usual or not at all
  • confusion, hallucinations, feeling like you are going to pass out
  • involuntary muscle movements, loss of balance or coordination
  • bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds

What is Drospirenone?

Drospirenone is a progestin only birth control pill that is used to prevent pregnancy. It might be used for other reasons not listed here such as polycystic ovaries.

Don’t take prospirenone if you have:

  • an adrenal gland disorder
  • kidney disease
  • unusual vaginal bleeding that has not been checked by a doctor
  • liver disease or live cancer
  • history of hormone related cancer, or breast cancer, uterus/cervix or vagina

This is not approved for anyone who has not yet had a menstrual cycle

Side Effects

  • vaginal bleeding, menstrual cramps
  • breast pain or tenderness
  • headache
  • nausea
  • acne
  • weight gain
  • decreased sex drive

What is Progesterone?

Progesterone is a naturally occurring hormone that is important for the regulation of ovulation and menstruation. Progesterone is produced in high amounts in the ovaries. It is also produced in smaller amounts by the adrenal glands.

It is used to cause menstrual cycles in people who have them and who have not went through menopause yet.It is also used to prevent overgrowth of the uterine lining in post menopausal people who are using estrogen hormone replacement therapy.

Warnings:

Do not use progesterone without telling a doctor if you are pregnant. It can cause harm to the fetus.

Do not take progesterone if you have:

  • abnormal vaginal bleeding that a doctor that has no tchecked
  • a history of breast cancer
  • liver disease
  • a peanut allergy
  • if you are pregnant
  • if you have had stroke, heart attack, or blood clot in the past year
  • if you recently had an incomplete miscarriage or a missed abortion

Progesterone can increase the risk of blood clots stroke, heart attack or breast cancer.

Side effect

  • unusal vaginal bleeding
  • pain or burning when urinating
  • breast lump
  • sudden vision problems, sever headache or pain behind the eyes
  • symptoms of depression
  • severe dizziness or drowsiness, spinning sensation, confusion, shortness or breath
  • heart attack symptoms- chest pain or pressure, pain spreading to the jaw or shoulder, nausea or sweating
  • liver problems- nausea, upper stomach pain, itching tired feeling, loss of appetite, dark urine, clay colored stool, jaundice
  • signs of stroke- sudden numbness or weakness, sudden headache, slurred speech, problems with speech or balance
  • sign of a blood clot in the lung- chest pain, sudden cough, wheezing rapid breathing, coughing up blood
  • sign of a blood clot in your leg- pain, swelling, warmth, or redness in one or both legs.

Sources:

https://www.drugs.com/loperamide.html

https://www.drugs.com/mtm/bromocriptine.html

https://www.frontiersin.org/articles/10.3389/fphar.2022.995439/full

https://www.drugs.com/mtm/drospirenone.html

https://www.drugs.com/progesterone.html

https://pubmed.ncbi.nlm.nih.gov/32359473/

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