Reprinted from the St. Charles
Endometriosis Treatment Program Newsletters Fall 1993

Medical Therapy: Why Use It?
Conclusions Supporting Medical Therapy Based On Assumptions, Not Facts

We frequently receive questions about medical therapy. To answer many of those questions, especially from readers who are relatively new to our publication, we are reprinting (and updating) an article from our Endometriosis Newsletter of June 1990. As always, if you have additional questions please give us a call at 1-800-486-6368 or 541-383-6904.

Dr. Redwine traveled to Calgary, Alberta on May 2nd and 3rd, 1990 to give four talks concerning the treatment of endometriosis. Dr. John Jarrell, chairman of the department of obstetrics and gynecology at the University of Calgary, invited Dr. Redwine to speak at Grand Rounds and at an afternoon Endometriosis Symposium. Karen White-Deroche, Dorothy MacKay and Else Poulsen were instrumental in arranging Dr. Redwine's visit. Dr. David Olive, an infertility and endocrinology expert from San Antonio, Texas, was the other featured speaker at the Symposium.

Dr. Redwine presented information on the study of endometriosis over the years, its visual appearances, surgical management, and treatment results. His primary emphasis was on laparoscopic excision of endometriosis.

...medical treatment does not improve fertility and may decrease it...

In a very honest and courageous talk, Dr. Olive spoke on medical treatment of infertility. The message was loud and clear: medical treatment does not improve fertility and may decrease it for patients with rAFS Stage 1 and 2 endometriosis. Dr. Olive had independently reached conclusions about medical therapy similar to those held by Dr. Redwine. The details are outlined below.

The Flaws Of Medical Therapy

The scientific study of medical therapy for infertility is hampered by several key factors, the most important of which is that endometriosis does not appear to be the potent cause of infertility it was once thought to be.

...endometriosis does not appear to be the potent cause of infertility it was once thought to be.

Although a relationship apparently exists between endometriosis and infertility, previous researchers have concluded-without merit-that it is one of cause and effect. Upon closer examination, it appears however, that endometriosis is merely a marker for the possible presence of something else which may be the true cause of infertility. This assumption of cause has led to pointless efforts to develop drugs that try to improve fertility, and/or recommendations that patients achieve pregnancy to eradicate their disease. Another criticism, particularly with the recent development of Synarel-the GnRH agonist from Syntex-has been the lack of an untreated control group in medical studies. In other words, there weren't any patients in the study who did not receive treatment. There was no group for comparison.

The few danazol studies of endometriosis-associated subfertility which did use a "no treatment" control group provided little support for medical therapy of infertility in patients with Stage 1 and 2 endometriosis. In these studies, untreated endometriosis patients with few or no adhesions conceived at a rate similar to, or better than, a study group given danazol. Danazol did not improve fertility. Interestingly, up to 57% of untreated patients were able to conceive.

Synarel was compared to danazol in test studies, but not to an untreated control group. In these studies it was found equivalent to danazol (in other words, it did nothing for fertility in Stages 1 and 2), but with a different set of side effects.

Another flaw in medical therapy studies is that disease improvement has usually been assessed only on a visual basis at the end of therapy while the ovaries are still suppressed. This leads to the faulty impression that the disease has been eradicated.

We now know, from a few biopsy-controlled studies, that endometriosis persists in a high percentage of patients after medical treatment. Evers has shown that if the ovaries reawaken, disease becomes more visible. And while many patients may experience symptom relief during treatment, several studies have shown that pain relief is only temporary. A final weakness of medical therapy studies (and those of laser vaporization as well) is the lack of long term follow-up. Many medical therapy studies have an end point at the conclusion of six months of therapy or after a year of conception attempts. They have not approached the long term question of what happens to the disease (and the patient) over time.

An unsupported assumption of a causal relationship with infertility, incorrect or misleading disease identification, lack of biopsy-controlled findings, and inadequate follow-up are the essential weaknesses in the search for the true impact of medical therapy on endometriosis.

A Different Approach

By emphasizing pain instead of fertility, broadening the scope of disease identification, confirming findings with biopsy studies, and conducting long term follow-up, the Endometriosis Treatment Program at St. Charles has sought to avoid these scientific pitfalls.

By following our patients beginning at 6-18 months after surgery and continuing on an annual basis, we have been able to document clear support for conservative surgery.

Detailed results of our study were published in the October 1991 issue of Fertility and Sterility. Of 359 patients who had undergone laparoscopic excision by Dr. Redwine, 81 later required re-operation for continuing or recurrent pain. Forty-eight re-operations were done by Dr. Redwine. Only 35 of those re-operated had new endometriosis at re-operation and endometriosis was minimal when it was found. Some patients had only one gland found in the entire pelvis.

These results were achieved in patients having had multiple previous therapies, and only 22 patients received post-operative medical therapy from another physician. The average length of follow-up for the group was 2.02 years. The longest follow-up was 9.82 years.

Our studies show that the risk of finding new endometriosis does not increase with the passage of time since surgery. When disease is found at re-operation, the amount of disease found does not increase with the passage of time since surgery. This clearly contradicts the assumption that endometriosis "grows back."

Other factors were often found to blame for recurrent pain. These additional causes of pelvic pain identified at re-operation included such things as adenomyosis, fibroid tumors, ovarian cysts, and adhesions.

Considering that over 75% of the patients studied had failed one or more previous medical or surgical therapies, and that successful follow-up has been maintained in over 85% of all patients (more than eight years in some cases), these results are encouraging.

Unlike many studies of medical therapies or other treatment approaches, it cannot be said that this study has been hampered by small numbers or inadequate follow-up.

One parting note. After Dr. Olive's presentation, one of Dr. Redwine's former patients asked a very pertinent question: "If everybody knows medical therapy doesn't work, then why do doctors continue to prescribe it?" Good question.


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