By Dr. Emilia A. Ripoll, M.D.
For the last couple of years, I have conducted a small clinical study using ozone bladder instillation to treat women who suffer from recalcitrant interstitial cystitis (IC)/chronic pelvic pain (CPP) — pain that did not respond to traditional treatments. The results of this study are quite encouraging, and I would like to share them with my readers, just as I have with my colleagues at the International Pelvic Pain Society annual meeting in Orlando, Florida.
The idea of using ozone to treat IC/CPP came to me after reading about European doctors successfully using this treatment modality for patients with radiation cystitis. In the United States, Dr. Frank Shallenberger has also been using ozone for over a decade to treat Interstitial cystitis — with good success and minimal side effects. Dr. Shallenberger is a co-investigator in the ongoing study I presented in Orlando.
Before we launch into the results of this study, I would like to provide you with a little background on ozone — especially its effects on the human body.
Ozone is a pale blue gas that gives the sky its color. An ozone molecule consists of three oxygen atoms bonded together (O3). Ozone is much less stable than it’s molecular cousin, O2, which is the oxygen we breathe. In nature, ozone is formed when oxygen is exposed to ultraviolet light or electrical discharges like lightning. It also has a distinct metallic odor.
Ozone is considered “highly oxidizing,” because this molecule quickly gives off an oxygen free radical (one of its three oxygen atoms) as it reverts to the more stable form of oxygen (02). This process happens in our bodies under a variety of conditions including when white blood cells attack unwanted microbes. The presence of this oxygen free radical disrupts the cell walls and membranes of microbes. More importantly, it also creates microscopic areas of inflammation, which triggers a healing response within the body.
According to a study done by Velio Bocci, ozone administered at concentrations between 30-55 μg/cc causes an increase in the production of interferon, tumor necrosis factor, and interleukin-2. An additional study by Bocci found that ozone stimulates the production of ATP in the mitochondria, which provides additional energy for cellular metabolism and healing. Also, ozone therapy causes an increase in the red blood cell glycolysis rate, which increases the amount of oxygen released to the tissues.
Historically, ozone has been used widely for disinfection and medicinal purposes since Nicola Tesla first started manufacturing ozone generators back in the late 19th century. In the early part of the 20th century, doctors in Europe and the United States began treating patients who were afflicted with conditions ranging from anemia to whooping cough with ozone bubbled through water (marketed under the trade names “Oxygenium” and “Hydrozone”) or various types of oil (trade names “glycozone” and “Ozol”) or injected directly into the body.
Ozone was used in WWI as an antimicrobial agent in treating wounds, trench foot, gangrene, and the effects of poison gas.
Ozone gained additional attention after Nobel Prize for Medicine winner, Dr. Otto Warburg, revealed that cancer cells are created by a deficiency of oxygen.
In the 1926 paper The Metabolism of Tumors in the Body, which Warburg co-authored with Franz Wind and Edwin Negelein, states: “Deprive a cell of 35% of its oxygen for 48 hours and it may become cancerous.”
Furthermore, cancer tumors create their own acidic, anaerobic micro-environments by replacing oxygen respiration with the fermentation of sugar. In 1966, the Nobel Prize winner, Warburg wrote, “Cancer, above all other diseases, has countless secondary causes. But, even for cancer, there is only one prime cause. Summarized in a few words, the prime cause of cancer is the replacement of the respiration of oxygen in normal body cells by a fermentation of sugar.”
Warburg’s research opened the door to further study of “bio-oxidative therapies” and the value of creating an oxygen-rich and pH neutral internal landscape. Warburg’s work also sparked additional interest in the healing properties of ozone.
Although the success of ozone therapy in combating pain and treating diseases such as cancer, Alzheimer’s, Multiple Sclerosis, arthritic joints, and herniated discs has been well documented in Europe, it continues to receive opposition from the more conservative voices within the U.S. medical community.
These voices have well-founded concerns about ozone toxicity, especially regarding the negative effects to lung tissue caused by chronic exposure to higher ozone concentrations. Although these concerns are valid, ozone bladder instillations do not expose patients’ lungs to ozone.
A cohort of 12 women were selected for ozone bladder instillations because their IC/CPP symptoms stubbornly refused to heal using standard forms of treatment. Every woman in our study group failed virtually all of the traditional approaches to healing IC/CPP.
They all had a long history of IC, followed an IC diet, and took several oral medications to treat their bladder pain/discomfort: Elmiron (a prescription medication for bladder pain/discomfort), antihistamines, analgesics, antispasmodics, and/or antidepressants. Most of these patients had also received physical therapy for IC. In addition, all of these patients had received traditional bladder instillations for at least six months and continued to have symptoms.
In other words, the pain and irritation from IC/CPP dramatically diminished the quality of life for these 12 women to the point where normal activities like dancing, hiking, traveling, yoga, or even sex had become difficult, or in some cases, unbearable.
What is a Bladder Instillation?
For those of you who have never heard of a bladder instillation, the following summary is adapted from the IC Network Web site.
During a bladder instillation, the bladder is filled with a therapeutic solution via a catheter. The instillation is held for varying periods of time (known as the “dwell time”), which range from a few seconds to 20 minutes or more. After the dwell time is over, the fluid is drained or voided.
Different instillations are used for different purposes. Some solutions are thought to coat and protect the bladder, while others suppress inflammation or numb the pain. Ingredients traditionally used in bladder instillations include dimethyl sulfoxide (DMSO), heparin, hyaluronic acid, silver nitrate, various antibiotics, and other medicated solutions. Many physicians instill combinations of ingredients, called “cocktails,” which they believe work better than a single agent.
Ozone Bladder Instillations
Ozone bladder instillations differ from regular BIs in that gaseous ozone is used in addition to a normal cocktail of ingredients. With these 12 patients, an initial bladder instillation solution was given that consisted of 20 ml of 0.5% Marcaine, 40 mg triamcinolone, 40 mL sodium bicarbonate 48 mmol, and 10,000 IU heparin. This solution was inserted into the bladder via a catheter, held for 20 minutes, and then drained.
Then ozone was inserted directly into the bladder via catheter at an initial concentration of 10 cc at 10 Gamma. If the patients tolerated the gaseous ozone well in the initial bladder instillations, the concentration of ozone in subsequent BIs was increased to a final level of 30 cc at 30 Gamma.
Treating Interstitial Cystitis with Ozone Bladder Instillations
Initially, we began treatment for each of these 12 women with an ozone bladder instillation every two to three days for the first two to three weeks. Depending upon the severity of the patient’s symptoms, we slowly began to expand the time between treatments to one week, and eventually to one month. We followed these patients for six to 12 months after treatment.
The results were impressive — especially considering that all 12 of these patients had failed all other traditional treatments and were in chronic daily pain from their IC/CPP symptoms.
Of the 12 women, eight received long-term benefits, which included improved voiding symptoms and a resolution of their pain. The majority of these eight women were able to stop all pain medications and analgesics.
Two of the 12 women saw marked improvement in their symptoms and pain levels but continued to require ongoing ozone BIs.
So 10 out of the 12 women who received ozone bladder instillations felt better and saw a reduction in their symptoms. In terms of treatment effectiveness, this 83 percent of patients seeing improvement is very encouraging, especially for a new treatment technique.
Only two of the 12 women showed no significant improvement in their symptoms or pain levels; however, the women with the most frequent urinary tract infections (UTIs) showed a dramatic decrease in the recurrence of their UTIs.
In addition, the side effects of ozone bladder instillations were no more or less prevalent than those observed by patients who have traditional bladder instillations. The only unusual side effect reported by a few patients was bubbles in their urine immediately after an ozone bladder instillation.
If you or someone you know suffers from recurrent interstitial cystitis and/or chronic pelvic pain, and would like to become part of this ongoing clinical study, please contact the Choices in Health office at 303-444-0840 or email us at [email protected].