Imulux President
Guest
|
Oct-09-06, 06:00 PM (CDST) |
|
|
1. "RE: Questions for Imulux President..."
In response to message #0
| |
Dear Rajah,
I forwarded your questions to Dr. Martin and he returned the following answers:
Dear Jon,
You may wish to provide the following answers to Rajah.
Q1. The paper says nothing about number of patients enrolled in each group.
Answer. The Table in the paper indicates that 25 patients with HSV were enrolled in the study. The specific dye was applied to 15 of the patients and a control colored substance used in the remaining 10 patients. All lesions were then exposed to a source of ultraviolet-A light. The patients were unaware at the time of therapy as to whether they were assigned to the test or to the control group. The investigators could not be blinded from the study since lesions exposed to the specific dye invariably became fluorescent.
Q2. Who was the IRB
Answer. Center for Complex Infectious Diseases IRB #1 Registered with the Office for Human Research Protections, Department of Health and Human Services. Registration Number IRB00003897
Q3. Were measures such as time to healing compared between the two groups or were all patients eventually treated with his method? This of course does not allow for end point measurement at all between the two groups which is what studies are all about.
Answer. A positive response was defined as marked reduction in pain and irritation accompanied by definite signs of healing well beyond that anticipated by the patient based on prior experience. A lack of response was indicated by persisting symptoms and essentially no change in the anticipated course of the lesion(s). The assessments were made 24 hours. All 15 patients treated with the specific dye reported a positive response that was confirmed by the investigator. None of the 10 control patients reported a positive response and again this finding was confirmed by the investigator. As stipulated in the protocol, the placebo treated patients were offered therapy with the specific dye. All 10 reported a positive response when examined the following day.
Q4. 4) Is Imulux planning a standard clinical trial following the two groups until the end?
Answer. An IND that addresses a specific research topic has been approved by the FDA. If the proposed modifications are ineffective, FDA is allowing use of the procedure that was previously shown to be effective. If the modifications are effective, they will be incorporated into future studies.
Q5. Where in the study does it talk about people not recurring again?
Answer. This was not part of the published study. Issues of patients’ privacy need to be addressed by an IRB before a comprehensive survey of previously treated patients can be conducted.
Q6. What study describes 6% of people getting a second strain of HSV 2?
Answer. The study did not involve typing of HSV viruses. I understand from Dr. Stoneburner that only occasional patients request further therapy.
W. John Martin, M.D., Ph.D.
Institute of Progressive Medicine
I wish to add that my staff was successful in following up with 56 patients that underwent the Imulux protocol in an unpublished study conducted in Henderson Nevada by East Park Research under the direction of Dr. Tamara Stevens. In the follow up patients were asked if they had experienced any outbreaks since undergoing the Imulux protocol in 2001. The 7% reoccurence rate was arrived at from this followup. |
|
|
Alert | IP |
Printer-friendly page | Edit |
Reply |
Reply With Quote | Top |
|
|
Printer-friendly copy
Email this topic to a friend
