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HISTORY OF OUR RESEARCH

OVERVIEW OF OUR RESEARCH

Female Infertility

Bowel obstructions

Menstrual and intercourse pain, sexual dysfunction

Adhesions, the common factor

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FEMALE INFERTILITY – GIVING LIFE

Opening blocked fallopian tubes

Clearing hydrosalpinx

Pregnancy rates for women with cleared tubes

Endometriosis: overview and infertility

PCOS related infertility

High FSH – hormone related infertility

Pre-IVF therapy

ADHESIONS AND SMALL BOWEL OBSTRUCTIONS – SAVING LIVES

PELVIC PAIN AND SEXUAL DYSFUNCTION – SAVING RELATIONSHIPS AND MARRIAGES

General population – Pelvic pain and sexual function improvements

Endometriosis pain – overview

Endometriosis patients – Pelvic pain and sexual function improvements

HISTORY OF OUR RESEARCH

Our research efforts began in the early 1990s, when we started seeing some remarkable results decreasing adhesions in patients with chronic pain. We were treating a workers’ compensation patient for a pelvic injury when she told us she was shocked, because she became pregnant.

The patient reported having blocked fallopian tubes for seven years, used no birth control and had the same boyfriend this entire time. The only thing that was different was that we treated her with the therapy we developed to decrease adhesions.

Hearing about that, a physician referred four other women during the next year. Two came with totally blocked fallopian tubes; it was medically impossible for them to conceive naturally. The other two had been infertile for several years, and had given up on medical treatments. Three of the women became pregnant, including the two with totally blocked tubes.

Then the physician referred his wife, who had been infertile for 11 years. She also had significant pain from endometriosis. “If you can just help her pain, that would be great,” the doctor said. His wife was 41 years old at the time.

In truth, we were not trying to open her fallopian tube. She only had one tube and that had been blocked for 11 years. Her gynecologic file was an inch and a half thick, due to all the surgeries she had endured. One day, she came in and said “Belinda, I’m not sure whether to hug you or punch you; before you treated me, I was totally infertile. Now I’m going to be 42 and I’m pregnant!”

Taken together, we felt these were important cases. We knew we needed to share them but we knew nothing about research. About that time, Gerald Wiechmann, PhD, a senior researcher at the National Institutes of Health, heard about our success from his son, a radiologist in our hometown of Gainesville, Florida. The son had apparently viewed several of the pre- and post-therapy dye tests, and mentioned the results to his father – who became fascinated. Together with Dr. Wiechmann, we published a small in-house study in 1997 revealing infertility reversals in a number of women, some with blocked tubes, some without. At this point we began to understand and be guided by the “scientific method.”

Researchers suggest using the “scientific method” when they note unusual results in a single patient. They then attempt the same treatment on other patients with similar conditions, and keep track of the results. If they see positive results in a number of patients, they find or develop an objective test to measure and validate the results. Thankfully, such a test already existed for whether or not we could open blocked fallopian tubes. A simple dye test allowed us to learn which tubes opened after therapy, and which did not. Then, it was a simple mathematics to assess results.

When we shared our results among the gynecologists in our medically oriented town of Gainesville, Florida (home of the University of Florida Medical School) the Chief of Staff of the hospital called us in.

“What’s this about opening blocked fallopian tubes?” he asked. I handed Dr. King half a dozen charts of women whose tubes we had opened. He opened one chart, then another . . . then another. “Good grief” he said you are doing things with your hands I’m not sure I could do surgically – and I am very good surgeon. This is extraordinary.” he said.

He looked me straight in the eye and asked “Are you doing any research on this work?”

“No,” I answered.

“Would you like to?” he asked.

“Yes, I suppose we would, but we know very little about research,” I said.

“I’ll tell you what,” he said. “If you’d like to do some research I will be your research director. I won’t charge you a dime; I believe this is important work. The world needs to know about this.” Thus, our efforts in research began.

Blocked fallopian tubes ended up being a perfect condition to research because we had films taken by an independent radiologist before we treated women showing total blockage. Then we could treat, and have films taken by another radiologist afterwards (unless the woman became pregnant beforehand, which also showed that one or both tubes opened.) If the “after” films showed that a tube opened or the woman became pregnant, we knew were successful in opening her tubes. If the “after” films showed persistent blockage, we knew that we weren’t successful. Thus, we could begin to tabulate results in a scientific manner.

In this vein, we began to publish research in treating blocked fallopian tubes, female infertility, sexual problems, endometriosis pain and small bowel obstructions over the next 25 years. In female infertility, this culminated in a 2015 study of 1,392 infertile women we had treated. The results of that study are shown below, along with results of some of the other studies published on our work to date.

OVERVIEW OF OUR RESEARCH

The purpose of this short book was to give a general overview of adhesions: how they form, their structure and anatomy, the difficulty in diagnosing them, and some of the problems they can cause. We gathered this information over the course of 30 years of treating patients with adhesions. We have worked with scientists, physicians, gifted therapists and patients to investigate the too-often-overlooked phenomenon of adhesions in the body.

This page presents the results of using the therapy we developed, the Clear Passage Approach (CPA) on a variety of conditions caused, or exacerbated by adhesions. We started collecting data in the mid-1990s after we had noticed several positive results that we felt needed to be shared. We began publishing results of our work with an in-house publication in 1997 on decreasing adhesions and improving fertility, in 1997.

Coached by physicians and scientists at the nearby University of Florida medical school, we followed what is called “the scientific method,” which is designed to investigate new phenomena. Using this framework, researchers progress from reporting individual case studies to multiple case studies. If one continues to see good results, we move on to studies which examine larger populations for safety and efficacy. If those studies show the new method is safe and effective with a particular population or condition, the next step is to conduct controlled studies, comparing treated subjects to non-treated groups, or those who are given sham (fake) treatments.

Because our patients were paying for therapy and had limited time to succeed, it was deemed unethical to give them sham treatment, so we compared our results to “no therapy” groups. In some cases, we compared them to published studies of accepted medical treatments, such as “standard of practice” infertility treatments – which already had published results.

Thus, our research expanded from our first in-house study in 1997 through a number of case and pilot studies, to our most recent studies on larger patient populations. Over time, we have found that the results from our pilot studies are valid predictors of results we achieve in larger studies.

In the sections below, we present the most recent studies published on each of a variety of conditions. We did very well with certain conditions, and not with others. Below, we will present all of the results we have at hand, at the time of publication. In all cases, the published data and studies shown below were analyzed and accepted by independent “peer reviewers,” physicians and scientists who examine studies for validity, bias, impartiality, and potential to improve medical knowledge, before being accepted for publication.

Where possible, we will give ‘whole number’ percentage rates for success or failure, followed by the fraction of successes (the numerator, shown as the number above) over the total examined (denominator, below.) For example, 50% (10/20) means we treated 20 patients in this group and 10 had success: thus 50% success rate.

P-value, Odds Ratio (OR), Confidence Interval (CI) and numbers are shown in some cases for readers who understand statistical modeling. In general, the lower the P-value, the greater the validity; anything smaller than P=0.05 was considered scientifically valid in our infertility studies – a commonly used number in medical studies. In some of our bowel studies, we used a more stringent number, P=0.025. OR and CI require a more complex explanation. The scientists affiliated with our studies advised us that our OR and CI numbers are very good.

Infertility: While we began as a clinic treating chronic, debilitating pain, we were surprised when women for whom we were treating pelvic pain reported that we were opening their blocked fallopian tubes. While the only known treatment for this was surgery, it was easy to test whether we were truly helping these women – who were totally infertile due to blocked tubes. It was easy to calculate our results for this; either tubes cleared or they did not, evidenced by a simple dye test (or pregnancy before the test.)

When it became obvious that we were indeed helping open tubes non-surgically, we were encouraged by physicians and patients to branch out into other areas of infertility, and to document areas where we could help. Soon, we began to treat other women with infertility from different causes, such as endometriosis, PCOS, high FSH, etc. When women asked if we could help increase their chances with in vitro fertilization (IVF), we started keeping data on that aspect as well. The more we treated this population, the more we realized that we could offer an effective conservative therapy to women who did not want to undergo a surgery.

Our earliest published studies with infertile women included only small groups of patients. Women in our early studies (natural and pre-IVF) were infertile for an average of 4.5 years (range 1 to 20 years) prior to therapy.

As we progressed over the years, we have reviewed thousands of patient successes and failures in our studies. In a landmark 10-year infertility study published in 2015, we were pleased to find that the results from nearly 1,400 infertile women closely paralleled the results of our earlier pilot studies. Below, we give an overview of our published studies in this area, in an easy to read format.

Bowel obstructions: When people began to read of our success clearing blocked fallopian tubes, several people who suffered recurring small bowel obstructions began contacting us, asking if we could clear their “larger tubes.” We had been wondering this ourselves, but it was a bit daunting to move from ‘life giving’ work returning fertility to infertile women) to ‘live saving’ work – helping people with life-threatening intestinal obstructions.

In looking at the condition, we learned that intestines (bowels) can become partially or totally blocked with adhesions, creating a terrible quality of life for patients. They were often in pain, had great difficulties with food intake, and were often afraid to go to a friend’s or restaurant for dinner, fearful that an obstruction would occur that would send them to the hospital for surgery – or worse, that they would die. They were afraid to travel, to be too far from their hospital. We would commonly hear “when I look in the mirror every morning, I ask myself if this is the day I am going to die?”

Adding to their problem, the main treatment for bowel obstruction was surgery – which is also the primary cause of bowel obstruction. Thus, many found themselves in an ever-revolving circle of adhesions-obstruction-surgery-adhesions, with no end in sight. Naturally, our hearts went out to these people; we wanted to know if we could help them.

Once again, our research in this area started with small single or multiple case pilot studies. As it became obvious that we could help many of these patients, we began publishing larger studies.

As we go to press, we are submitting a relatively large prospective controlled study of over 200 patients examining the therapy’s effectiveness treating people who suffer recurring small bowel obstructions. The results of this study, which compares patients who did and did not receive therapy for recurring bowel obstructions, are remarkably promising. We will be able to share those results in the next edition of this book, once that study has been published.

Menstrual and intercourse pain, sexual dysfunction: We began in 1989 as a small clinic designed to treat unexplained chronic pain. That population of patients remains core to the work we love, and still comprises much of our patient base. While tests exist to test ‘before and after’ results for improving sexual function, the variety of pain problems we treat do not easily allow us to test changes in pain. Thus, while we often see significant turn-arounds, publishing with such a diverse population is problematic, at best. The published data on improvements in sexual function is clear, compelling, and presented below. If you are troubled with chronic pain, we suggest you call for data relative to your needs.

Adhesions, the common factor: In all of these studies, the common factor being studied is the decrease of adhesions via non-surgical manual therapy. Whether we are treating the tiny crosslinks that join individual cells within the uterus or cervix, larger adhesions that squeeze nerves causing pain, or that block organs like the fallopian tubes or intestines, the large rope-like adhesions that bind larger bodily structures together, sometimes pulling the torso forward in people with massive abdominal adhesions – the basic structure of adhesions remains the same. Naturally occurring adhesion formation due to the joining of collagenous crosslinks can create straightjackets within the body, squeezing structures or joining together nearby structures, causing pain and/or dysfunction.

The release of these crosslinks from each other using a natural manual therapy is analogous to pulling apart the run in a three-dimensional sweater, as the adhesions unravel and the body returns to an earlier state of pain-free mobility and function. This deformation of the adhesions is the common factor in all of the studies and conditions in which CPA has improved life for patients.

Millions of people in the world suffer needlessly with adhesions, yet most medical professionals turn their backs on the problem, or simply don’t know a better way to deal with them than surgery. There appears to be no end to this problem that plagues patients and their doctors throughout the world.

Brilliant and gifted physicians are stymied by adhesion formation after performing their best surgical repairs. In fact, healthcare providers and their families represent our largest population base – fully a third of our patients are doctors, physical therapists, nurses, or their parents, children and spouses.

In the following section, you can examine published results that examine the CPA, for many of the conditions covered in this book. Extrapolated from peer-reviewed journals, these results are divided into three sections, based in part on when we developed the work, and in part on importance to us:

  • Female infertility (Giving life)
  • Adhesions and small bowel obstructions (Saving lives)
  • Pelvic pain and sexual dysfunction (Saving relationships and marriages)