As you requested, here is the very preliminary Raw data on the first 11 study participants: we had 9 of 11 fissures heal. Nitroglycerin did not appear to enhance the healing rate but the small numbers we have analyzed and completed to date will not reach statistical significance. Subjects 12-16 are currently in the treatment phases and were not included in the analysis. Three patients were not included in the study for exclusion criteria.
I would add the caveat again, That this is very preliminary early raw data and one should be careful in applying it to all situations. Once the study data is completed then statiscal methods will be applied to dtermine the actual benefits.
The study is still accrueing patients and will not be completed unitl August 2000. See the Clinical Watch posting: Study Posting (1069) -- Trial #19040, Anal Fissures, New York City, NY for information on participating in the study.
David m. Feldman, M.D.
Saint Vincents Hospital Medical Center
New York City
The response to your posting of my study for Botox (R) for anal fissures has been overwhelming. I have responded to a large number of queries from throughout the United States, Canada and Europe. Also, several anal fissure sufferers from the Midwest and Southeast have come to us in New York City for entry into the study. I am also very pleased by the early preliminary results of this study.
To encourage dissemination of Botox(R) information and for future participants in this important study, I ask that you update interested sufferers of anal fissures with this information. And encourage people to enter controlled study trials, so that we can determine how best to treat the sufferers of disorder.
Here is some information about Botox(R):
I hope this information is useful to you.
David Feldman, MD
Investigator, Botox Study
Saint Vincent's Hospital Medical Center of New York
Clinical Instructor, New York Medical College
Really great and valuable information resource you have assembled on the web.I am quite impressed with the plethora of valuable information.
I am a New York City Gastroenterologist interested in treating diseases of the Anus, including Anal Fissures. Most of the time Anal Fissures are treated by Surgeons who have a tendency to perform surgery. I do not perform surgery and therefore, I am involved in attempting to cure without surgery. My current research project, for which I have a grant, is to study treatment of fissures with Botulinum toxin (BOTOX). I am currently putting together a presentation for my research project On Botox for Treatment of Chronic Anal Fissures. Which is how I came across your web site.
As you probably have come to realize the anal area has often been ignored by the medical doctors and many patients suffer in embarassement. The pharmaceutical companies on the other hand have recognized this as a very large market. And this accounts for the many over the counter remedies. Albeit with unproven efficacy. The unfortunate and timely demise of Proctology as a bonafide specialty has further led to the decline in interest in the medical community.
I believe there exists a renewed interest in this important, although not lifethreatening condition. As evidenced by the lead article in the New England Journal of Medicine- July 8, 1999 A comparasion of Nitroglycerin and Botulinum to treat anal fissures. This study was from Italy.
If anyone is in interested in participating in my US study using Botox and nitroglycerin, I am still recruiting patients. They can contact me at Gastrowebmd.com or 888-391-9532
David Feldman MD
Principal Investigator Botulinum Toxin for Anal Fissures
Section of Gastroenterology