Non Invasive Treatment Studies for Peyronie's

  Non Surgical Peyronie's Studies

I will start this article about Medical studies with Drugs and Supplements that have been studied and the results, and also cover some other products that have not been tested.  If you wish to take the time to go through these studies, you will see the reasoning behind the 3 step program that I developed and used to successfully treat my Peyronie’s disease.
Colchicine:
Colchicine is a drug that is mainly used to treat Gout due to its’ anti-inflammatory qualities.  It is also known to reduce the production of collagen and increase the activity of collagenase. (the enzyme that breaks down collagen)  Colchicine is extracted from the “Meadow Saffron” plant.  It is a toxic drug and its’ toxic qualities are amplified or multiplied when combined with cholesterol lowering drugs. (statins)
Adverse Reactions to Colchicine include nerve damage that causes numbness and tingling in the hands and feet, in advanced cases this effect can be permanent along with an increased risk of dementia.  Large doses can result in respiratory failure and death.  Colchicine is not FDA approved for treating Peyronie’s Disease and the toxic side effects really are not worth the risk, since study results have been mixed.
An uncontrolled group study of 24 men took Colchicine in 1994.  The results of the study were, 26% of the men reported a marked decrease in curvature, 11% reported a slight decrease, 63% were unchanged, and 50% of the men reported plaque size reduction.  I do not have the duration or dosage taken in this study.
The next study in 2004, involved 78 men broken into two groups.  One group took .5mg-2.5mg. colchicine per day for 4 months.  The other group took a placebo.  There was no difference in curvature reduction reported between both groups.  There was another study undertaken using 84 men with the same protocol above.  All of the men were screened to make sure they had similar duration of disease – 15 months.  The results were no difference between Colchicine group and placebo group.
Pentoxifylline:
Pentoxifiylline works by changing the shape of red blood cells in the body, thus reducing the viscosity (thickness) of the blood.  This allows blood to circulate more freely, especially to the bodies extremities.  Pentoxifylline acts as a mild stimulant and is in the same family as caffeine.  Men that are allergic to caffeine should not take Pentoxifyllline without medical observation.  Brand names are Pentoxil and Trental.
A study by the University of California at San Francisco treated 71 men with Peyronie’s Disease.  62 men took Pentoxiffyline for a year and 9 men received no treatment.  The calcifications stabilized or improved in 57 of the 62 men who took Pentoxiffyline compared to 4 of the 9 men in the no treatment group.  I found no reports of curvature improvement in the study, so that part is unknown.
Another larger study with 228 men participating was don at Ahahid Beheshti University in Tehran, Iran.  114 men took 400 mg. Pentoxifylline twice daily.  The other 114 men took a similar regimen of placebo.
Results: 35.9% of the men in the PTX group reported a positive response with only 4.5% in the placebo group.  Improvement in measured curvature on average was between 11.4 – 11.7% in the PTX group.  In the placebo group curvature improvement was .2 to neg.4.2%
11% of the PTX group still have disease progression compared to 42% in the placebo group.
Tamoxifen:
In a study using Tamoxifen VS. Placebo there was no significant improvement VS. the placebo group so this study is a non-story.
Tamoxifen VS. Acetyl-L-Carnitine:
Results: Acetyl-L-Carnitine was significantly more effected and safer to use in the treatment of early acute Peyronie’s Disease.  Tamoxifen induced significant undesirable side effects.
L-Carnitine:
The body produces carnitine in the liver and kidnesy and then stores it in the heart, brain, sperm and muscles.  It acts as an anti-oxidant and helps restore cells damaged by inflammation.  Only one study has been done on L-Carnitine for treatment in Peyronie’s Disease.  Acetyl-L-Carnitine significantly reduced penile curvature and plaque size. (Biagiotti, 2001, Turin, Italy)
The suggested dosage of carnitine for Peyronie’s Disease is 1 gram (1000 mg.) twice daily for three months.
L-Arginine:
L-Arginine is a popular supplement for Peyronie’s but studies are very limited.  In 2003 a study found arginine given to rats in mixed in their water.  L-Arginine was effective in reducing plaque building components. L- Arginine was also used in an another study, but it was combined with other drugs, so the reports would be mixed and not statistically significant.  There are other studies with L-Arginine in treatment of erectile dysfunction and the results are significant.  I will be posting a separate article on L-Arginine soon.
L-Arginine should not be taken with sildenafil (Viagra), or with blood pressure lowering medications.
PABA: Para-Aminobenzoic Acid
PABA (Para-Aminobenzoic Acid) is a popular Peyronies remedy. It is best known as a sunscreen in topical lotions, since it blocks UV light.  The reviews are mixed on how effective PABA is for treating Peyronie’s. A typical safe dose of PABA for therapeutic use is 400 mg. daily. Most of the studies using PABA are very old, dating back to the early 1940′s.
There is only one double blind placebo study that I could find, that used a control group of over 100 men with Peyronies. The trial enrolled 103 men and for one year they ingested 3 grams, 4 times daily. The progression of their Peyronie’s was significantly slowed, but it did not reduce any pre-existing plaque. Doctor’s consider 400 mg. a day a safe dose, but the men in this study were ingesting 12,000mg. or 12 grams daily. This is far beyond the safety threshold, and should not be done except under strict medical supervision.
In 1959 a study was undertaken with 21 patients and another study in 1997 included 32 patients, but since they were not double blind placebo studies there was not a control group to compare the results with. These studies used from 12 grams daily to a maximum of 20 grams daily. Because it takes such high doses of PABA to get a positive response, and it causes significant gastrointestinal side effects, PABA for Peyronie’s Disease often is not recommended as a treatment. Other more uncommon side effects include nausea, reduced appetite, fever, and rash. PABA can also interact with some medications, including sulfa antibiotics.
Vitamin E
Vitamin E as an oral supplement has been extensively studied, and shown to have no impact on Peyronie’s Disease.  Vitamin E may be effective in combination with other supplements and treatment combinations.  One possible medical regimen is 100 mg of vitamin E taken three times a day for a minimum of four months. Theoretically, this antioxidant will prevent further development of plaque, although studies have suggested that it is no more effective than placebo.
Gotu Kola 
Use of Gotu Kola, which is also called Centella asiatica, Indian pennywort, and other less known names is believed to contain certain chemicals that seem to decrease inflammation and also decrease blood pressure in veins.  Gotu Kola is used to treat various conditions in which fibrous scar tissue causes problems, and for that reason it has been advocated for Peyronie’s disease. However,  there are no studies with evidence to show that it is effective.  http://www.med.nyu.edu/content?ChunkIID=35551
Some of the comments about Gotu Kola at the Peyronies’ forum can be read  here: http://www.peyroniesforum.net/index.php?topic=2940.0
The verdict is out on Gotu Kola’s effectiveness in treating Peyronie’s, but it does seem to have many other health benefits, and is generally accepted as safe.
Omega 3 Oils
The data from a study of 224 patients with chronic Peyronie’s Disease was divided into two groups.  The results of the study did not show any data that would support Omega 3 supplements to be beneficial in treating chronic Peyronie’s Disease.
One of the problems with this study in my opinion, was the low dosage of Omega3 that was given to patients, and the questionable quality of the products administered.  There are all types of Omega3 oils, and many brands are so processed, that their effectiveness is in doubt, and questionable at best.

Proteolytic Enzymes
Serrapeptase is a potent proteolytic enzyme that contains 470 amino acids and a zinc atom, which is essential for proteolytic activity.  Medical studies have not been done for treatment on Peyronie’s Disease specifically, but other medical studies have proven this enzyme to be more effective in anti-inflammatory activity on collagen than the other proteolytic enzymes that were used in the study.  It was also shown to have a synergistic effect with aspirin.  (2008 Dept. of Pharmacology, J.N. Medical College, India)
A study conducted in Jordan in 2008,  found Serrapeptase to offer significant reduction in swelling and pain, with oral surgery, and no negative side effects.  It has been used in numerous studies from Breast engorgement to acute inflammation in chronic ear, nose and throat disorders, with significant symptom reduction.  These double blind placebo studies found that Serrapeptase was well tolerated and its’ anti-inflammatory, anti-oedemic and fribrinolytic activity, acts rapidly on localized inflammation.
Serrapeptase/Nattokinase blends have been found to be very effective in the reduction of Fibroid tumors, and Endomitriosis in women.  Serrapeptase also has the ability to digest non-living tissue that is a by-product of the healing response without harming living tissue. Serrapeptase is used to dissolve non-living tissues to include: scar tissue, fibrosis, blood clots, cysts and arterial plaque. It is also used as an anti-inflammatory agent against Sinusitis, and as a thinner for mucous secretion.
Bromelain is a powerful proteolytic enzyme that has anti-inflammatory effects and is known to increase fibrinolytic activity in the blood.  Bromelain is derived from pineapples. Bromelain is a popular enzyme used in the treatment of Peyronie’s Disease.  It is a candidate for studies, because of its’ link to promoting the enzyme collagenase, which digests collagen.  Bromelain has many of the qualities of Serrapeptase but it is not as well tolerated.  Common side effects include diarrhea, increased heart rate, nausea, stomach pain and vomiting.  Avoid Bromelain if you are allergic to bee venom, carrots, celery, papaya, pineapple, rye, wheat and pollen.
Bromelain by itself is effective as a blood thinner.  When taken with blood thinners it can raise the risk of bleeding.  Bromelain for health maintenance is generally deemed safe at 50 mg. a day with little risk of side effects.  The recommended dose for treating Peyronie’s is 500 mg. a day.  This high of a dose should not be maintained on a long term basis.
Topical Gel Applications
DMSO with Serrapeptase was studied in use for a transdermal topical gel to treat subcutaneous inflammation.  It was found that DMSO concentrations had to be  unacceptably high in order to transfer the enzyme beneath the skin, due to Serrapeptase having a large molecule weight, it would not readily permeate the skin.  Indian J Pharm Sci. 2010 Jan-Feb
DMSO with iodine was found to reduce infections and increase the effectiveness of iodine alone in hospitals where Staphylococcus epidermidis was causing increased infection, mortality, and health care cost. (J Clin Microbiol. 2012 May)
An article by Dr. Jonathan Wright of the Tahoma Medical Clinic discusses the use of Iodine and DMSO  http://tahomaclinicblog.com/iodide/
DMSO may be an important stimulator of the tumor suppressor protein HLJ1 through AP-1 activation in highly invasive lung adenocarcinoma cells. Targeted induction of HLJ1 represents a promising approach for cancer therapy, which also implied that DMSO may serve as a potential lead compound or coordinated ligand for the development of novel anticancer drugs. (Published online 2012 April 17)
DMSO in the treatment of Scleroderma.  Scleroderma is a baffling disease in which the body begins manufacturing collagen, where it begins collecting in the extremities.  Scleroderma often will go into remission, but can be fatal if it continues its’ progression, unabated.  Dr. Jacobs is well known for treating Scleroderma with DMSO.  The following is the conclusion of this study.
The relief of pain, stiffness and, to a lesser extent, weakness in these patients who have been treated with DMSO is impressive, and most of the patients are continuing maintenance treatment. It appears that DMSO, as administered at present, has no effect on the internal manifestations of scleroderma. Of 26 patients who had good to excellent improvement, 16 had minimal, and eight had moderate disease, according to our criteria for classification of the severity.
It should be emphasized, however, that the results seen in treating patients with scleroderma with DMSO have never been observed with any other method of therapy. It is the first time we have observed evidence, both clinical and histological, that the collagen is undergoing definite change.
Verapamil GEL has been falling from favor as a viable treatment option of Peyronie’s.  A survey of 236 practicing urologists in 2008 found that only 10% selected Verapamil gel as their first treatment choice.  In 2002 Loyola University Medical center came to the conclusion in their study that the use of transdermal verapamil has no scientific basis.  Transdermal Verapamil does not infiltrate into the Tunica Albuginea.  Wish I had known this before spending $1,000.00 on Verapamil.
 Intralesional Injection and Iontophorisis
Verapamil VS. Saline – Iontophorisis, electromotive drug administration.  This placebo study has 23 men in the Verapamil group and 19 men in the saline placebo group.  Results:  The Verapamil group achieved greater decrease in curvature, but the results were not statistically significant.  The results concluded this option was effective in patients complaining of pain and with mild curvature.
Verapamil Intralesional injection, (Long term study 1994-1996 Dept. of Urology, Montefiore Medical Center, Bronx, NY)  Conclusions:  The study suggests that intralesional injection may be a reasonable approach in some selected patients with non calcified plaques and penile angulation of less than 30 degrees.
A placebo controlled study involving 80 patients in Iran, actually showed more curvature decrease in the saline control group, than in the Verapamil group.
Corticosteriod injections VS. Saline Placebo:  Placebo was more effective in curvature correction than the cortisol group . . . enough said?
Another reason that steroid injection has become less popular is that we know that steroids can result in tissue atrophy, and thereby may cause thinning and weakening of the penile tissues. Therefore, with rare exceptions the use of intralesional steroids have been completely abandoned.   http://www.peyroniesassociation.org/forums/topic/intralesional-injection-therapy-dr-laurence-levine/

Interferon Alpha 2B injections VS. Saline Placebo: A study of 39 men at Tulane University, New Orleans, LA,  injected Interferon Alpha 2B directly into the plaque of 19 men.  20 men received saline placebo injections.  Same protocol for each group, injections were given once a week for 12 weeks.  6 months later they received a follow up visit and evaluation.  The Interferon group showed significant improvement over the placebo group in curvature, plaque size and density, and pain with erection.
30 men in Ankara Turkey were studied using a similar protocol as the test above for management of early stage Peyronie’s.  The conclusion was that Interferon Alpha 2B was not clinically effective in treatment and management of early stage disease.
Interferon Alpha 2 B frequent side effects are fever, and mild to moderate flu like symptoms,of short duration.  Further study is currently ongoing to determine precise quantities and frequency of application to be most effective.
Xiaflex by Auxilium Pharmaceuticals  clinical studies for FDA approval have shown impressive results with intralesional injections of Xiaflex.  Phase III studies showed 67% of patients showed significant improvement.  Significant improvement was counted as a 25% improvement or better from the original measured angle. http://www.auxilium.com/productpipeline/PeyroniesDisease.aspx

Combination Therapy:

Source

Larson/Levine
Department of Urology, Rush University Medical Center, Chicago, IL 60612, USA.

Abstract

Non-surgical treatment of Peyronie’s disease (PD) has come a long way since it was first described in 1743. A myriad of treatment options are currently available, including oral, intralesional and external energy therapies. The purpose of this article is to review the contemporary literature on non-surgical therapies for PD, and where possible, focus on randomized, placebo-controlled trials, as well as review the latest guidelines for the management of PD from the International Committee on Sexual Medicine, which conveyed its findings in July 2009.  At this time, it appears that a combination of oral agents and/or intralesional injection with traction therapy may provide a synergy between the chemical effects of the drugs and the mechanical effects of traction. Until a reliable treatment emerges, it does appear that some of the non-surgical treatments discussed can be used to stabilize the scarring process and may result in some reduction of deformity with improved sexual function.

1 comment:

  1. This is a great page to read. Full of facts. Perfect and thank you.

    Cheers,
    Jim

    ReplyDelete