The O shot is untested with a sketchy past

That isn't stopping doctors from doing it

I am often tagged in posts on Instagram about the O shot®, and so it feels time to update everyone on this sexual health scam. Because that is what a completely unstudied procedure that costs $1500-$2,500 and that takes advantage of people who are experiencing sexual difficulties is…a scam. 

If you don’t know, the “O shot®” is an injection of platelet rich plasma (PRP) into the vagina and clitoris that claims to improve orgasms, desire, and even incontinence. However, when a procedure hasn’t been studied it is easy to make bold claims. So let’s take a deep dive into the O Shot®, and when we’re done I suspect you will be as enraged as I am. 

Platelet rich plasma is plasma, the liquid part of blood, and platelets, cells that help blood clotting and have a function in wound healing. It is obtained by drawing a patient’s own blood and passing that blood through a machine that separates the plasma and platelets from the other components. It is then injected back into the body and is supposed to help with healing.  

There is no biological reason that platelet rich plasma would help with orgasm as there is no diseased or damaged tissue to heal. In addition, platelet rich plasma is supposed to mimic the healing substances released in response to injury, and yet we don’t see improvement in orgasms or sexual function after surgery around the clitoris or in the vagina. Meaning, in real life when we stimulate the growth factors and cytokines during surgery, exactly what the platelet rich plasma claims to stimulate, there is no resulting improvement in orgasm.

This lack of support from basic biology is a huge red flag, but sometimes treatments work and we don’t always know why. That being said, when there is no sound biological basis for a procedure there better be some damn good supporting data published in quality journals. And we most certainly do not have that with the O-shot®.

There is currently no data to show that platelet rich plasma is effective for any condition that affects the vagina or vulva. It has been studied for lichen sclerosus (a skin condition) and found to be ineffective. Albeit small, this was a well-done study

The only study for sexual dysfunction was authored by the inventor of the O-shot®, Dr. Charles Runels (we’ll get to him in a minute). This study is published by what we in medicine call a predatory publisher, OMICS. Meaning the publisher has journals that look legitimate, but anyone can pay and get essentially anything published. Predatory journals are a huge concern, as the general public often doesn’t know such a thing exists. People see a study in a “medical” journal, and assume that means it is both safe and well tested. For example, look at this screenshot from a plastic surgery practice offering the O-shot®. The link to the “biopsy studies”  hyperlinks to the predatory study I mentioned above. The study also doesn’t involve biopsies.

Runels' study on PRP and sexual health is abysmal. It is a case series of 11 patients and lumps together several different medical conditions in one study when really they should be evaluated separately. Oh, and one of the medical conditions being “evaluated” in the paper, dyspareunia, is misspelled. I know this sounds as if I am being an Internet grammar hound, but this is offered up as a supposedly serious research paper. The key condition that you as a researcher are studying shouldn’t be misspelled because spelling it should be second nature to you. In addition, it should have been proofread by your coauthors and/or caught in the editorial process (although keep in mind there is no editorial process with a predatory publisher). 

This study tells you nothing. It’s fit for lining a hamster cage, and that’s about it.

Dr. Charles Runels, according to this study, operates out of a place called Medical School in Alabama. Is that to make people think this has been studied at a real medical school? Who calls their office Medical School?

So who is this Dr. Runels who injects untested platelet rich plasma into the clitoris and anterior vaginal wall of women out of an office he calls Medical School?

Dr. Runnels lists his medical specialty as internal medicine, so he is no expert in vaginal health. He told The Guardian that he got his start with platelet rich plasma by injecting his own penis and his sex partner wanted him to inject hers. So he did. This is how the story appears on Runels’ own website:

“On the evening of April first, 2011, I drove through Fairhope, Alabama to pick up my girlfriend from her house to take her to dinner for her birthday. As we were preparing to leave her house to go to dinner, she said, ‘I want PRP injected into my vagina!’ For the past year, Laura had watched me inject people and rejuvenate the face and the breasts. She actually had the procedure done more than once and saw her face improve in color, texture, and shape with a procedure I invented, the Vampire Facelift®. She had delivered 3 children and wanted to see if PRP would make her vagina feel tighter.”

This may sound totally sketchy to you…and it should. Doctors are not supposed to do gynecological procedures on intimate partners as once you do a procedure that person becomes your patient. Doctors should especially not perform experimental vaginal procedures on their sexual partners. 

Dr. Runels has other interesting experiences in his past. In 2009 the Food and Drug Administration disqualified him as a clinical investigator because of concerns with studies in which he was involved. Runels apparently recruited homeless people for a study that was not approved to recruit vulnerable populations. He also failed to promptly inform the IRB of serious adverse events and other concerns. You can read the FDA letter to Runels here and below is a screenshot from the FDA showing his disqualified status. 

Getting disqualified by the FDA means a clinical investigator has “repeatedly or deliberately failed to comply with applicable regulatory requirements or the clinical investigator has repeatedly or deliberately submitted false information to the sponsor or, if applicable, to FDA, in any required report.” A disqualified clinical investigator is not “eligible to conduct any clinical investigation that supports an application for a research or marketing permit for products regulated by FDA (including drugs, biologics, devices, new animal drugs, foods, including dietary supplements, that bear a nutrient content claim or a health claim, infant formulas, food and color additives, and tobacco products).” 

Dr. Runels has also been in trouble with the Alabama State Board of Medical Examiners for his practices surrounding hormones, among other things. 

I have heard from several women who had the procedure and had complications. In one heartbreaking moment in 2019 when I was on tour for The Vagina Bible a woman stood up during the question and answer period to detail her complication with the O-Shot®. She explained how she felt she had really researched the procedure and yet here she was suffering. What is tragic to me is I am sure she did research the procedure. When you Google it there are pages of doctors’ sites promoting it and puff pieces in women’s magazines. Because what Dr. Runels is actually great at is something called search engine optimization, which is the art of driving traffic to a particular website or websites. He has done an amazing job of publishing articles himself as have the physicians who are trained on this procedure resulting in page after page of gushing positive commentary. The result? It is next to impossible to find any negative reviews of the O-shot. Think about it, when have you ever seen any procedure that had literally no negative review? You haven’t. 

The average person—even most doctors—don’t know about predatory journals. The odds are stacked against consumers wanting unbiased, quality information about the O-shot®.

Runels even has a book promoting the O shot® and the glowing Amazon Reviews are stacked with providers who charge for the O-shot®, although there is a comment from the late Betty Dodson (a well-known sexologist). I checked all the other reviews from this account, and I don’t see how it could be any one else but Betty Dodson.

Share

So let’s sum up the O-shot® and sexual dysfunction.

It is completely untested for sexual dysfunction. A predatory publisher counts as being untested.

There is no biological basis to support the O Shot®.

The inventor first injected his sex partner, is disqualified as an investigator by the FDA, listed his address as “Medical School” in a study, and has been in trouble with his own medical board. 

And yet, doctors are willing to be trained in this procedure and offer it to their patients. It’s awful, but it’s allowed to happen. The doctors who do this procedure make $1500 and up, but what does Runels get by licensing his trademarked procedure? Likely a lot of money. It’s $997 to get trained and then the fee, or rather “membership,” to keep offering the O Shot® is $97 a month (see the screenshot from his site). If 100 doctors have active memberships, Runnels gets about $10k a month.

Women have suffered through the years from under tested medical procedures and they deserve better. 

Given the number of doctors who are offering this procedure and their grand claims of success, it should be easy to do a legitimate study that would truly prove the efficacy of the O Shot®. What are they all afraid of? Prove me wrong with a high quality study.... I’m waiting.