Topics Discussed Include the Following…
*PRP for ED
*Variations in PRP
Video/Recording of CMA Journal Club, Pearl Exchange, & Marketing Tips
1. Relevant Research, 2. Transcript, 3. Relevant Links
1. Relevant Research
- Asghar, Aneela, Zahid Tahir, Aisha Ghias, Usma Iftikhar, and Tahir Jameel Ahmad. “Efficacy and Safety of Intralesional Normal Saline in Atrophic Acne Scars.” Annals of King Edward Medical University 25, no. 2 (June 24, 2019). https://doi.org/10.21649/akemu.v25i2.2867.
- El-Amawy, Heba Saed, and Sameh Magdy Sarsik. “Saline in Dermatology: A Literature Review.” Journal of Cosmetic Dermatology 20, no. 7 (2021): 2040–51. https://doi.org/10.1111/jocd.13813.
- Horiuchi, Sakura, Jacob S. Nasser, and Kevin C. Chung. “The Art of a Scientific Presentation: Tips from Steve Jobs.” Plastic & Reconstructive Surgery 149, no. 3 (March 2022): 533–40. https://doi.org/10.1097/PRS.0000000000008849.
- Masterson, Thomas A., Manuel Molina, Braian Ledesma, Isaac Zucker, Russell Saltzman, Emad Ibrahim, Sunwoo Han, Isildinha M. Reis, and Ranjith Ramasamy. “Platelet-Rich Plasma for the Treatment of Erectile Dysfunction: A Prospective, Randomized, Double-Blind, Placebo-Controlled Clinical Trial.” Journal of Urology, April 30, 2023, 10.1097/JU.0000000000003481. https://doi.org/10.1097/JU.0000000000003481.
- ———. “Platelet-Rich Plasma for the Treatment of Erectile Dysfunction: A Prospective, Randomized, Double-Blind, Placebo-Controlled Clinical Trial.” Journal of Urology, April 30, 2023, 10.1097/JU.0000000000003481. https://doi.org/10.1097/JU.0000000000003481.
- Matz, Ethan L, Amy M Pearlman, and Ryan P Terlecki. “Safety and Feasibility of Platelet Rich Fibrin Matrix Injections for Treatment of Common Urologic Conditions.” Investigative and Clinical Urology 59, no. 1 (January 2018): 61–65. https://doi.org/10.4111/icu.2018.59.1.61
- Poulios, Evangelos, Ioannis Mykoniatis, Nikolaos Pyrgidis, Filimon Zilotis, Paraskevi Kapoteli, Dimitrios Kotsiris, Dimitrios Kalyvianakis, and Dimitrios Hatzichristou. “Platelet-Rich Plasma (PRP) Improves Erectile Function: A Double-Blind, Randomized, Placebo-Controlled Clinical Trial.” Journal of Sexual Medicine 18, no. 5 (May 1, 2021): 926–35. https://doi.org/10.1016/j.jsxm.2021.03.008.
- Ruffo, A., M. Franco, E. Illiano, and N. Stanojevic. “Effectiveness and Safety of Platelet Rich Plasma (PrP) Cavernosal Injections plus External Shock Wave Treatment for Penile Erectile Dysfunction: First Results from a Prospective, Randomized, Controlled, Interventional Study.” European Urology Supplements 18, no. 1 (March 2019): e1622–23. https://doi.org/10.1016/S1569-9056(19)31175-3.
- Saltzman, Bryan M., Timothy Leroux, Maximilian A. Meyer, Bryce A. Basques, Jaskarndip Chahal, Bernard R. Bach, Adam B. Yanke, and Brian J. Cole. “The Therapeutic Effect of Intra-Articular Normal Saline Injections for Knee Osteoarthritis: A Meta-Analysis of Evidence Level 1 Studies.” The American Journal of Sports Medicine 45, no. 11 (September 1, 2017): 2647–53. https://doi.org/10.1177/0363546516680607.
- Schirmann, A., E. Boutin, A. Faix, and R. Yiou. “Pilot Study of Intra-Cavernous Injections of Platelet-Rich Plasma (P-Shot®) in the Treatment of Vascular Erectile Dysfunction.” Progrès En Urologie, June 2022, S1166708722001300. https://doi.org/10.1016/j.purol.2022.05.002
- Shaher, Hussein, Abdallah Fathi, Salah Elbashir, Shabieb A. Abdelbaki, and Tarek Soliman. “Is Platelet Rich Plasma Safe And Effective In Treatment Of Erectile Dysfunction? Randomized Controlled Study.” Urology, February 2023, S0090429523000742. https://doi.org/10.1016/j.urology.2023.01.028.
- Sheean, Andrew J., Adam W. Anz, and James P. Bradley. “Platelet-Rich Plasma: Fundamentals and Clinical Applications.” Arthroscopy: The Journal of Arthroscopic & Related Surgery 37, no. 9 (September 2021): 2732–34. https://doi.org/10.1016/j.arthro.2021.07.003.
- Swift, Arthur, Jeremy B. Green, Claudia A. Hernandez, Shino Bay Aguilera, Steven Fagien, Michael H. Gold, Gabriela Casabona, Konstantin Frank, Andreas Nikolis, and Sebastian Cotofana. “Tips and Tricks for Facial Toxin Injections with Illustrated Anatomy.” Plastic & Reconstructive Surgery 149, no. 2 (February 2022): 303e–12. https://doi.org/10.1097/PRS.0000000000008708.
- Toyoda, Toshihisa, Kazushige Isobe, Tetsuhiro Tsujino, Yasuo Koyata, Fumitaka Ohyagi, Taisuke Watanabe, Masayuki Nakamura, et al. “Direct Activation of Platelets by Addition of CaCl2 Leads Coagulation of Platelet-Rich Plasma.” International Journal of Implant Dentistry 4 (August 1, 2018): 23. https://doi.org/10.1186/s40729-018-0134-6.
- Virag, Ronald, Hélène Sussman, Sandrine Lambion, and Valérie de Fourmestraux. “Evaluation of the Benefit of Using a Combination of Autologous Platelet Rich-Plasma and Hyaluronic Acid for the Treatment of Peyronie’s Disease.” Sexual Health Issues 1, no. 1 (2017). https://doi.org/10.15761/SHI.1000102.
2. Transcript
JCPM2023.05.02
Charles Runels, MD:
Good evening and welcome to the Journal Club with Pearls and Marketing. This hit the press today and if you haven’t heard about it yet, you will. I always like to think the best. I think one of the rules of just living is to always assume the best of people until you’re proven otherwise, so I’m going to assume that some things in this paper were erroneous because of just oversight and not malintent. But we should go through it because someone may throw this paper at you as a dart if you were doing the P-shot, and I want you to understand how wrong it actually is.
First of all, I’m actually assuming the best. I’m actually glad they did the study because what they showed is that our protocol works better than the thing they did, which was not a P-shot, but let’s go through it.
All right, so let’s start off with their interpretation, which says that there’s a need for some sort of regenerative therapy for ED, not what we have before we had PRP and shockwave, which is just things that make the disease tissue work harder. That was their premise for doing the double-blind placebo-controlled randomized prospective study. But this one got me because it hints you, in my opinion, of some prejudice.
Here we go. Nonetheless, the study’s objective data contribute to the ongoing research on restorative. We’re going to go through this line at a time, so be patient with me. If you’re not doing the P-shot, then this is probably not a journal club that you’ll want to attend, but it’s also, I think, some lessons in propaganda, maybe unintentional propaganda.
One of my premier teachers as an internal medicine resident back in the ’80s, back when there was still this idea that maybe you could sit with someone for an hour and figure out what they have and then go do testing to see if you’re a right or not in the spirit of Tinsley Harrison.
Anyway, one of my mentors said, “Charles, there was a time when you can read and believe everything in the New England Journal.” He said, “Now half of it’s just bull,” and this was in the ’80s.
Anyway, so let’s see. Let’s go through this without further comment.
Nonetheless, the study’s objective data contribute to the ongoing research on restorative therapies for ED and can be a valuable resource for practicing urologists who are considering restorative therapies and treatment options as well as for the many men’s health clinics that advertise these therapies without any supporting data. That really makes me want to choke because here are some of the supporting data. There are two other double-blind placebo control studies that precede this one. Two. Actually, I take that back, there are three and I’ll show them to you.
That really gets me because this was either extreme oversight or just wrong, and it got published wrong. Anyway, so I’ll quit harping. Let’s go back a step. Let me show you a picture.
Hold on a second. Let’s see if you can recognize this person. Hold on. Here. Not the guy on the left, the guy on the right. Our right. That is Ronald Virag.
He is a legend, and I was extremely honored to share a venue with him in Venice where he spoke at a region PRP company event that was hosted there, actually, twice. I was there with him.
Just so you know who Ronald Virag is, I’m going to show you some of his research, and I want you to realize this is not a hack. All right, so let’s go to something else. Hold on, hang with me.
Propaganda, whatever. It’s the life we live. This is the Wikipedia article about Ronald Rag and what you’ll find, and I’ll throw a link to it in the chat box… I’ve great respect for this man. Because he was the guy that really came up with the idea for Trimix, and he was one of the original people that did the research with Viagra. But yeah, he was the one.
Back in 1981, he was doing a surgical procedure on the penis, and he got this idea that maybe it might work, and it did. Multiple awards, and if you read here, you’ll see that they credit him for basically changing urology forever.
Okay, that’s Ronald Virag. So what? I’m about to show you a study by Ronald Virag.
Before I do that, I want to show you something, remind you of something. This is the paper we are considering, and this is the statement of this paper.
These therapies are without any supporting data. Okay, well, here’s Ronald Virag’s paper which compared PRP with Xiaflex for the treatment of Peyronie’s disease and showed that PRP is superior and has the side effect of improving erectile function.
By the way, I’ve put all these references on a page, and I’ll give you a link to it. Actually, I’ll just give you a link to it right now. Hold on a second. Let’s see, we’ll go ahead and publish this. I’m not quite through with it, but whatever. I’m going to give you the link. Here we go so that you’ll have it. Just click in; that way, it’ll be open when the webinar is over. I don’t know. I just put that in there.
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I always like to think the best of people, but man, surely, if you’re writing for the Journal of Urology, who Ronald Virag is, and surely, you’ve read some of his research about PRP before you try to do a seminal paper regarding it, at least know that there is some supporting data.
By the way, the reason I showed you this picture of me standing with Ronald Virag and honored to do so is so that you know, this man’s in his 80s now, and I bow to his courage and his success, and he says you cannot do a placebo-controlled study with PRP. You can’t do it. That’s why he did his study using Xiaflex as a positive control for Peyronie’s instead of using a placebo.
I think that the sham studies and so does he are a sham when you’re thinking about PRP.
Before we go further into this study that could be weaponized against you if you’re doing platelet-rich plasma, first realize that this statement right here might as well be a flag that says we don’t like it that men’s health clinics are making money doing stuff and we’re going to try to take it down. That’s what that says to me.
Okay, so here is one of the reasons why Ronald Virag says you cannot do a placebo-controlled study with PRP is that saline is not a placebo. I want to show you. Let’s see, where is my list? There. I put these papers on the reference I just gave you. These are papers showing how saline has been used for helping with pain in the knee, and for helping treat scars because saline hydrodissect tissue, it disrupts tissue.
Here’s a literature review of way saline has been used for affecting tissue. Now, if you want, in my opinion, here’s the confusion, and again, I like to think the best of people, the confusion is that if you’re doing a pharmacological study, let’s say IV antibiotic versus placebo or pain medicine versus placebo, and you’re injecting something IV, well, saline is inert. But if you’re hydrodissecting tissue, that is not nothing. I think if you’re wondering if that’s something or not, you can go watch somebody power washing the sidewalk. On a microscopic level, the research bears this out. Not only is it talked about, it’s talked about as a successful way of treating, for example, atrophic acne scars, just saline.
When we’re treating acne with PRP, the undermining we know does something, just fluid does something and so really, the study should be just undermining versus saline versus PRP. There should be three arms to a study looking at that. If you look at the studies of microneedling for acne, they have approached that. You’ve got microneedling with saline versus vitamin C serum versus PRP versus TCA. Even low-dose insulin has some metabolic effects that were looked at. But the saline as a hydrodissection is not nothing.
Really, a placebo should be just injecting the needle or inserting the needle without injecting, which means of course, you can’t do a double-blind placebo. I know that bothers people who think everything has to be a double-blind placebo, but I don’t know of a double-blind placebo-controlled prospective study of birth control pills.
Another example, we now know that all-cause mortality is cut in half for people who are doing around 25 miles a week walking. Well, you can’t do a placebo-control study of that. There are some things done just can’t be done with placebo-controlled studies, but whatever, people feel like they have to do it, so they do it, but I think it’s a sham.
There are placebo-controlled studies of Botox for depression, injecting the glabella region. Really, that’s one of those things where you’re asking me to pretend to be stupid. If you’ve got the placebo versus the real Botox and you have any conscious cerebral function at all, and you’re the patient, it’s not blinded. You know whether you got the placebo or not and yet, we still have strong research and of knowing that Botox helps with depression and migraines, even though you really can’t have placebo control.
You’ll still see it talked about as if the patients can’t tell. And again with PRP, when this is done, if you look at the methods that are done, they have someone draws the blood and we actually did this with a couple of our lichen sclerosus studies and I played the game, but I never really believed this is placebo because unless you can change the viscosity and the color of it, all it takes is a very slight push on the plunger and the injector knows what they have. You can see the color of it, you can feel that it’s thicker, it’s not the same viscosity of saline, it’s a sham. Sham studies with PRP are a sham. Make a poster about it.
All right, now, so first of all, big red flag with this trying to convince us that there is nothing out there supporting it. Okay, actually, before I go any further, let’s look at some of the studies.
Here’s one where they did prospective randomized controlled interventional study looking at… This one was PRP with shockwave but what they found was that when you added the PRP to the shockwave, you got significantly higher scores than just shockwave alone. Well, that’s a reviews article, but we have this one. Let’s read it. Platelet Rich Plasma safe and effective, Randomized controlled study and it showed that it worked.
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Compared to the placebo group, the PRP group demonstrated significant improvement. One in three months follow up. This is urology. I don’t get it yet, and this came out in November of last year.
We covered it here. It was accepted, and we got this out. We talked about it in January, and yet, you have someone telling us that there is no supporting data. It sounds like someone getting ready to go after people that they don’t like.
Intra-cavernous injection platelet-rich plasma. The treatment of vascular erection showed benefits. Platelet-rich plasma improves erectile function. Double-blind, randomized placebo-controlled clinical trial in the Journal of Sexual Medicine. I don’t know what’s this guy reading.
I don’t know, maybe there’s no supporting data if you’re reading Marvel Comics, but if you’re reading the Journal of Sexual Medicine instead about Batman, you know that there is a double-blind randomized placebo-controlled clinical trial and you know that the wizard of urology who changed it, Dr. Ronald Virag actually published a study showing Peyronie’s disease with the side effect of inaudible 00:16:20 erection.
Okay, I’m sorry, I didn’t mean to go clicking off into my baptist preacher mode, but I can’t help being a little upset when people, I’m going to say by carelessness put out… I’m sure no one would intentionally try to sabotage our efforts, so I’m just going to call it carelessness by not noticing that Ronald Virag and three previous placebo-controlled studies show that PRP helped and then, having your opening statement that there’s no supporting data of doing what we do.
But let’s go a little further into this thing. The other thing they did was they did not do a P-shot because if you look at what they did was they drew some blood, they used a decent system to make some good PRP, but they used half the amount of fluid, which means it wouldn’t travel through. They used two and a half CCs per side instead of five. They didn’t put anything in the glands but more importantly, they did not activate with calcium fluoride or anything. They just did it. Now, does that really matter? Anybody that’s been on our website or has been to my workshops know that I think it does.
Now, before we go further, just let’s look at a couple of favorite studies that back that up, so you know I’m not making that up. If you look at the activation of PRP, here’s one of my favorites, the direct by addition of calcium chloride. Basically, what they show here is that when you put the anticoagulant and then you don’t add calcium, well, by definition, you’ve deactivated them. As we all know, when you spin PRP, it can sit for at least four hours a day on your table with no ill effects. But as soon as you add that calcium, things start happening. Anyway, this paper makes the point that really, to get full effect, you need to activate with calcium chloride.
If you want to see it in picture form, let’s see, I love this picture actually because what it does, it shows you in diagram form the answer to one of the biggest criticisms in the meta-analysis of PRP studies. It’s apples to oranges. If one person does a single spin and no activation, you can see the different variables, leukocyte poor versus leukocyte rich. You have platelet concentration variabilities related to baseline, activation methods and the number of white blood cells. Those are all the variables and if you’re going to compare results, you should keep those variables the same.
What these people did along with telling us that there’s no other thing out there they’re aware of in their studies of Marvel comics, what they did was they also failed to recognize, and I’m sure it was not intentional, but we activate when we do the P-shot. That’s part of our protocol. It’s part of what everyone’s learned, it’s part is what everybody agrees to do. We are activating because we know that without it, it’s almost like you undo this centrifuge.
Now, we also know that there’s some discussion and disagreement about how to activate if you should activate, when you should activate. Okay, cool, let’s talk about it. Let’s disagree about it but don’t say that injecting PRP at half the volume without activation approaches what we are doing because it ain’t the same thing.
Ensure they did not do a P-shot, they did something, but they didn’t do a P-shot, and in my opinion, they didn’t have a placebo. They just had a less effective treatment, and if you look at the numbers, that’s exactly what happened. Both groups got better; the PRP group was better than the placebo group, which is exactly what happened when we did or when someone else did a placebo-controlled study using saline hydrodissection as the placebo with lichen sclerosus; the placebo group had a 50% response rate.
So. saline is not, in my opinion, a placebo. They didn’t activate; they used a different volume; they did not do a P-shot; they did something else. What they really showed was not that the P-shot doesn’t work; what they really showed was that their procedure is less effective than a P-shot. It’s less effective than what Ronald Virag does. It’s less effective what these other authors have done and they should probably go and expand their references.
Let me show you something else that will turn your stomach. Even when they start talking about references, free clinical studies also suggest that these growth factors may be beneficial in ED. If you look at their references, they leave out the double plan placebo-controlled studies, and A through Nine only includes some old studies looking at… Look at that, they’re looking at rats. What’s the deal? I’m shocked actually because I’m going to call it oversight because surely they wouldn’t intentionally leave off something that conflicts with their conclusions, so I’m just going to say it’s an oversight. They were too busy reading Superman, and they failed to notice those other three double-blind placebo-controlled studies.
Now, they do mention in here somewhere that this is the first double-blind placebo-controlled study out of the United States, which really should turn your stumble because what the hell. Louis Pastor was from France, and Ronald Virag is from France. The idea is that it doesn’t count unless it comes from the US. I’m sorry, I lost my religion there, but that does make me want to curse because that is the sort of thing that… I don’t know. It’s why people put USA at the top of an alphabetical list, the pride that blinds people to the truth.
Now, it doesn’t mean that we don’t keep doing studies, and I think their conclusion is right, we need more studies. It doesn’t mean that everybody’s going to get well with a P-shot. It does, and yes, more research is needed, but they’ve done far… They have not shown the negative hypothesis at all because they didn’t do a P-shot, but it helped. It showed that if you squirt PRP and it doesn’t do much better than saline, so we need to do a three-arm study.
I think I’m through rambling about that. Let me see if there are any questions, and then I think we will call it a night.
This is important, I think, in the fact that anytime that you are doing something that’s not yet covered by insurance, it makes you out of step with many of your colleagues and out of step sometimes gets shouted at.
I’ll show you the page that I made and I’m going to do a press release about it. I was talking again today with one our premier urologists in our group we have. Actually, I talked with two of them today and we need more studies, so we’re going to get some of those done. This is the link I gave you that has references regarding the P-shot for ED, for Peyronie’s disease reference regarding activation of PRP. I think I need to put this stuff and about saline not being a placebo.
Let’s see if I have questions. Yeah, there are several people here that have smart things to say. I think I’m just going to unmute some people. Let me start with you, Sarah because it looks like you have an oh O-shot question. I’m going to unmute you. Okay, go for it. Are you there? Don’t go away, David; I want to hear what you have to say too. Okay. I guess maybe your mics not working.
The question was, if I add Botox to PRP for the P-shot, do the patients use the pump right away or four hours later? I still think it’s best to use it immediately, but I don’t think it’s necessary. I used to think the P-shot, and when I say I think, I’m just going by what our other providers are doing and telling me and I don’t have the study with doing the pump immediately or later. We do have studies showing the pump helps Peyronie’s disease. The British Journal of Urology help 51% cancel their surgery, and we have a couple of studies showing it helps ED even after you take the pump off by increasing transcutaneous oxygen. But I don’t have one that checks the different timeframes of using post-P-shot. Yeah, I use it immediately afterward.
The question is, I have a patient who had a sling with erosion to the mid-urethra with resection and urethroplasty by urology; since had three welcoming procedures that work temporarily, she’s also had urgent incontinence, would she be a candidate for a PRP? If so, would I do it differently than the O-shot procedure? There are a couple of studies that come to mind where people use PRF and made a gel to patch erosions both in urology and oncology. One patching an erosion between rectal, vaginal fissures. I don’t know if there’s actually an open wound there or not, but as far as using it post-sling, I think the time will come when it’s used along with every sling procedure to improve results.
We now know from Delancy’s study of, excuse me, actually, that was Irwin Goldstein and others studied showing that when you do a sling, it actually passes through the nerves of sexual function right at the G-spot or what’s thought of as the G-spot near the Skene’s glands and you have a 10% instance of interfering with sexual function, so why not make PRP part of the procedure and help with the repair and preservation of nerve function has been shown to be possible in prostate studies.
Absolutely, whether it’s done the day of surgery or sometime afterward, I think it’s worth a try. I think the likelihood of harm is minimal. Lots of studies coupled with Bell’s palsy. Anecdotally, I had a staff member that had jaw surgery for an overbite ten years before she worked for me, and her numbness went away a few months after a Vampire Vacelifts® and multiple studies about PRP growing nerve and repairing tissue, so it’s worth a try.
Sarah. Okay, let me try again. Yeah, I muted you back. Let me try you again. Okay, now try it. I’m sorry, I don’t know why. We’ll send you an unmute request. Okay, now.
Sarah:
Hi.
Charles Runels, MD:
Now, you’re live. Go for it.
Sarah:
Thank you. Thank you so much, Dr. Runels, I appreciate it. I’m Urogyn. I didn’t do the other procedure. She was just a new patient today, and she’s still complaining of stress incontinence and urgent incontinence. I don’t see the point in repeating urethral bulking, which is what she wants, and she’s already had a mesh complication, so that’s why I was thinking PRP. I just was wondering whether I do the same O-Shot® procedure. I wouldn’t add anything differently beneath the urethra.
Charles Runels, MD:
Yeah, I’ve got several urologists and gynecologists on the call. If one of you wants to jump in, punch your little thing, and I’ll put you on the call. I think we don’t have it yet, but… Actually, I think it’s coming soon because I think Red Allen inaudible 00:31:33 is releasing it. If it’s not already FDA-approved, it’s near.
If you’re in Europe, they have an HA that’s activated; excuse me, they have PRP region has a kit that’s activated by a non-cross-linked HA that comes in with the kit. Instead of acting and waiting with calcium chlorides, it’s activated with that. If I had my druthers, I would love to have that option for a little more structure if I were doing something like you’re doing. In the worst case scenario, I think you’re going to have no response or maybe some improvement without a complete resolution. Let me see if anybody else has raised their hand that wants to jump in with that one.
Do you want to answer that one, Alex? I see other surgeons on the call. Well, no one’s jumping in, but that would be my inaudible 00:32:33. If you want to talk to some urologists that might have actually experience with that, text me and I’ll send you some phone numbers because our group loves helping each other and I’m sure they’re-
Sarah:
Okay, thanks. Thanks a bunch.
Charles Runels, MD:
Let me unmute Alex. As you know, my wife’s a gynecologist, I’m going to unmute her and let her see if she’s got… I think she might have something. Hold on a second. You should be able to talk now, Alex.
Alexandra Runnels, MD:
Okay, can you hear?
Charles Runels, MD:
Yep, I can. Did you hear that question? Smart question. Hard patient.
Alexandra Runnels, MD:
I did. I did hear the question. I’ve done a few of these on patients like she’s describing that have had previous slings and have had erosions or some type of complication, and they still have a little bit of incontinence, and I have had the same question that she’s had about do I do something different than just the regular O-shot? I’ve thought hard about it, and when I’ve done the procedures, there really isn’t a whole lot else different to do other than make sure you do everything right. You were talking about activating and using the right kits and all that. But as far as injecting, the only difference is it is sometimes more difficult to inject because of the presence of some of the scar and some of the mesh and that sort of thing, so you have to be a little bit creative sometimes with where you put your needle. But as long as you’re getting the PRP into the same plane as you do with a regular O-shot, I don’t think there’s really anything different to do.
Charles Runels, MD:
Okay. And you’ve had success?
Alexandra Runnels, MD:
I have had success. Yes, I have.
Charles Runels, MD:
Okay. Any other tips before I…
Alexandra Runnels, MD:
I’ve had success with when they still have some residual incontinence, but not when the incontinence is severe and they’ve had a sling; it’s a different story. But if they have some residual and it’s just somewhat mild, then I’ve had great success in these patients.
Charles Runels, MD:
Okay, thanks for jumping in.
Alexandra Runnels, MD:
Perfect. Thank you.
Charles Runels, MD:
Yeah, sure. I’m going to unmute David Harshfield. He still, hopefully, hasn’t gone away. It should go away. There you are.
David, I think, probably knows regenerative therapies more than anybody else I know. And because he’s part of an IRB and his own group, he deals with a lot of research and has a friendly relationship with the FDA. I’m interested in your ideas about what we just talked about, David, with this study about the P-Shot®, and you’re unmuted. Thanks for being here.
David Harshfield, MD:
Charles, the interesting thing is I love the weeds. I’m an interventional radiologist, so I love waiting off any imaging and obscure stuff. But the big picture here, Charles, is that what I think we’re treating in this instance is the interstitial space, interstitial fluid and that’s been promoted to the 80th organ. We have 12 organ systems, and we had 78 organs until a while back; the 79th organ was our mesentery immune system. Okay, we’re getting it, and now’s interstitial. What the heck is that? That’s our interstitial fluid. That’s where we’re injecting this. We do prolotherapy, and when we do the P-shot and the O-shot, we’re injecting growth factors and so forth.
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It’s not nothing to reiterate what you just said. 20% of your memory in your brain; it’s not in the neuron, it’s in the interstitial space of your brain. What? This mineral electricity and so forth and saline is absolutely a treatment, it’s a prolotherapy, and it’s an accelerant, and it’s a particle, and it causes proliferation through an irritation effect, but it’s an accelerant, so it’s kind of painful. Sugar is much better prolotherapy, 5% or 10%, whatever, but it’s an insulator so it doesn’t hurt. What you’re doing when you’re injecting, where you’re injecting beneath the skin is into the interstitium.
In the big picture here, we are changing the memory and so forth of the organ that we’re intervening in and then it gets to do what it wants to and then, whether we use PRP with calcium chloride or not, it’s important.
Now, Charles, what you’re doing, and last week we had the annual conference, 40th annual conference of the American Academy of Orthopedic Medicine, to whom you’ve spoken, Charles several times and these are the first guys to do prolotherapy back in the ’60s and so forth.
Charles Runels, MD:
They were the pioneers.
David Harshfield, MD:
Yeah, and hey were doing stuff that irritated the immune system to wake it up, to fix things, to tighten ligaments and whatnot. Of course, we’ve now into the biologic part where we’re also restoring structure. But there’s something very important to what you do. Sean Mulvaney is a colonel in the Navy SEAL that has done the PTS shot figured this out. Charles, he’s just like you, he questions things and people tell him something, he picks a phone up at a meeting, a guy’s injected the sixth transfers process of C6 where the sympathetic plexus is for treating acne or something, I can’t remember what it was. He said, “Hey, if that turns off sympathetic system,” of course this guy’s a Navy SEAL, “You think it could help with PTS?” The guy on the other of the phone goes, “Maybe this guy is treating post-traumatic stress by injecting in the interstitial fluid around the inaudible 00:38:55 is C6. You got to be careful.
One of the things he’s doing, Charles, and I know you do this when you get close to a patient, we have an energy field around us, and we have to learn that voltage is healing. That’s how we heal. We put electrons in the body no matter what we’re doing, injecting, walking in sunlight, walking on the earth, barefooted, earthing. All the stuff we’re doing is trying to put electrons in the body. Your body has an electronic field. When you share that with another human being, if you ever hug somebody who’s really sick or depressed and you walked away from them a little dizzy-
Charles Runels, MD:
They just walked away feeling tired. That’s why I don’t want to see anybody giving me a massage. If they’re not well, they leave me feeling more tired after their massage.
What’s your thinking though about the… Because I know you have a lot of reading and experience with different ways in the orthopedic world, in the pain world with activating the PRP versus not calcium versus thrombin versus vacuum versus whatever?
David Harshfield, MD:
That’s a good question. This discussion about the PRP here in the placebo being saline is silly. This happened Charles 10 years ago when the orthopedic surgeon. This is existential to those folks. We have to realize that. What we’re talking about is changing. It takes 10 to 20 years to change medicine unless you’re Charles Runels or Sean Mulvaney or people like on this call what we’re doing when we’re injecting a common extensor Tennis elbow. The surgeons go, “Oh darn, they’re doing PRP for Tennis elbow. This is terrible. We’re going to lose this surgical procedure.”
Okay, so let’s do a study, and they did it. It’s in JAMA they use saline as the placebo, but these guys weren’t smart enough. They added a third arm of doing nothing, which of course, did not do well, and the headline of the article was PRP no better than placebo for common extensor tendon tear, but we got the inaudible 00:41:19 from JAMA because I knew the editor compared to nothing, saline was way better, and then PRP was a little bit better than saline but not statistically significantly better, so the headline was not what it should have been. PRP is not significantly different than placebo.
And Charles, it’s just misrepresenting stuff. And you know what we’re talking here, we don’t want to hurt anymore inaudible 00:41:50 but inaudible 00:41:50, I know what I’m doing. If it’s your patient’s erectile dysfunction, you know what you’re doing. Now activation, we jack this stuff in a joint or in a local area; it’s going to stay there. You put this in the cavern also. It’s an IV injection. You know what I’m saying? You probably need to use calcium chloride to make it stay around to hang around.
Charles Runels, MD:
Exactly. I left that part out because I was breezing through it, but one of the things that are mentioned in those activation articles are that without that, even if it’s not IV injection in the tissue, there’s a wash away effect. Somehow, we get away with it when we do scalping hair, but in the beginning, we always added calcium chloride even to that but there’s a wash away effect.
Let me show you this picture. Let’s see, cell fill. Yeah, here we go. Cell fill system, I mean, whatever, it’s commercial, but they have a picture that I think makes a point because they’re the only kit I know of in this country that comes with calcium chloride as part of the kit to activate it. But if you look at their graph of what’s happening, that is what I’m looking thinking about within. Actually, it’s not within minutes, within seconds of just adding PRP to tissue. Some of the growth factors are gone. But when you activate it, as you were saying, there’s a binding and the matrix formation that holds it there with gradual release for hours or days.
Now, I don’t know the biochemistry of this like a bench scientist would, but if you do the simple math on it and if you’re not getting complete activation, depending on which paper you read, you could almost make a case that you’re undoing your centrifuge if you don’t activate because incomplete activation of concentrated platelets winds up putting it back almost like it was in whole blood. Anyway, I didn’t mean to interrupt, but I thought that picture makes the point of what you’re saying right now.
David Harshfield, MD:
Oh, absolutely. Again, I don’t want to inaudible 00:44:04 the conversation here; I’m sorry. I’m honored to be in this conversation.
One last thing. We did the study of several thousand women as interventional radiologists made by the chairman a bunch of money by doing vertebroplasty, injecting these women that had graham cracker crust vertebra with super glue and barium, so you can see it. Within a month, 70% had another fracture because the vertebra next door to the marble I created compressed and I started going, “This is crazy.” I was talking to some people in France and they wrote a paper with several thousand folks and what they found, Charles, is what your patients get from you every day. The placebo effect is not nothing. Psychologists understand this.
There were three key things. 6,000 women got vertebroplasty after the back pain, compression fracture. 6,000 women got care just taking care of it, they didn’t get vertebroplasty. But you know what they all got, they got three things and it was the most powerful thing for the placebo effect. Number one, the doctors, the clinic love the patient up. They’re not just a number, this is not cattle here. We love you, Ms. Smith and you’re going to be in a study and you’re going to either get the actual injection where you going to put a needle in or you won’t, you won’t know. Number two, they love their physician. This guy or girl, “Wow, they like me and I like them.” The third thing is at the end, they had a choice to get a particular plasia or not.
Those three things, the placebo effect is so powerful and Charles, what you do every day with your patients, they know who you are. I’m not blowing smoke up your skirt here, I’m just saying that as physicians, the better the patients feel about us and our energy feels cross and they’re having deficit and they’re taking from us, I’m tired at the end of every day too, just like y’all are. And Sean Mulvaney taking care of these PTSD soldiers, he assist and do eight of these PTSD shots every day, goes home inaudible 00:46:24 has to hold him.
There is a lot more going on than putting needles in the interstitial space. That’s important, Charles, what we’re talking about. What these papers are not including, they got a bunch of kids with a clipboard, I don’t know, they’re not putting that energy into that patient’s energy field. They’re putting a needle into a body part. That’s way more than you wanted to hear. I’m sorry, but I’m just saying I appreciate what you do.
Charles Runels, MD:
I wish we had more time to talk about the electrophysiology of it. Believe it or not, I bought an old book that was published back at the time of the Revolutionary War about the electrical movement through the body using some of the just basic… That’s all they knew about electricity back then was basic.
Anyway, I think we should have a whole meeting just about that and thank you for jumping on. I do want to do a couple of quick miscellaneous questions before we call it a day.
The first one was a man who got a P-shot. If you can see, had a P-shot plus shockwave therapy and things are working well, but now he’s having trouble having an ejaculation. He get an erection, but ejaculations are coming slow. I know there’s pharmacological treatments for this. I have just an old school, when I say old school, I mean a 2000-year-old school from the Tao Te Ching where they talked about a man having a cycle. I think if you’re past about 40, I don’t just think it, it’s also just common sense, if you’re emptying your prostate gland, which is the main reservoir of your ejaculate and you are emptying it more frequently than you make, it’s going to be harder to ejaculate. You can’t urinate when your bladder’s empty, you can’t ejaculate when your prostate is empty.
Now, there’s some talk among our group about increasing volume by using oxytocin, either injection or nasal or sublingual. Doing that daily helps depression and it helps ejaculate volume. I don’t have personal experience with that, but I hear it a lot.
But I have been teaching and experimenting with the cycle. You guys, if you want, if you just Google it, you don’t have to pay for it, you can find it all over the internet, people giving it away, my old book that I did back in 2004 where I summarized that idea about having sex all you want, but spacing out your ejaculations according to the Tao.
Anyway, so that’s what I would tell the guys to have sex all you want, but you’ve got a limit on your ejaculate. If I were going to treat him pharmacologically, it wouldn’t be a P-Shot®; it would be oxytocin, maybe Wellbutrin.
The next one, this is my bad, this has gotten confusing because I confused it, but if you’re doing the wing lift, you really want two-thirds anterior, one-third posterior. If you’re injecting half a Juvederm syringe, which would be a half a CC with two and a half CCs of a PRP, that gives you a total of three. You’d do two of the three CCs in the anterior half of the labia and one CC in the posterior half. It gives a nice contour. The reason I put twice as much upfront is it brings the labia majora up even with the hood, which usually protrudes further than the posterior labium minora. Makes a really beautiful effect. If you want to go up on those volumes, it’s a recipe, just like your chili; you can change it based on what you got in the refrigerator.
In this case, probably not a good analogy, but what you’re looking at an artist, whether it’s a cook or a surgeon, you’re not doing the same thing with everybody because we’re not all the same. But as a general cookbook protocol, that gives you three ccs per side, you’d put two on each side in the anterior half and one posterior and I need to go correct that cause my videos are confusing.
Anyway, thank you for being on the call, David, you always have smart things to say. Thank you, sweet wife, Alex, and thank you for that smart question from Sarah. Y’all have a good night. Hopefully this helps. I’ll be putting out a press release that’s a little toned down version of what I just said, thanking these people for showing a different protocol that doesn’t work as well as PRP-shot. You guys have a good night. Bye-bye.
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