Suppression of Frequently Recurring Herpes

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Suppression of Frequently Recurring Herpes

Summary of A Placebo-Controlled Double Blind Trial of Michael Kelly's Audio Cassette Technology.

Conducted by Donald Soli, M.D.

Abstract

Twenty-six otherwise healthy adults with frequently recurring herpes, both simplex-1 and simplex-2, (ò6 episodes per year), were studied in a double blind trial comparing two audio cassettes provided by Michael Kelly, for the suppression of recurrent herpes infections. The patients were treated five times during 60 days unless herpes recurred. If the patients experienced a recurrent infection they were seen at the clinic within 24-48 hrs, examined, and treated again with their assigned audio cassette. Twenty-three patients completed the testing. Among the 23 evaluable patients, there were significantly fewer recurrences (3 out of 4) in patients using the tape K (real) than in patients using the tape M / placebo tape (8 out of 12).

The duration of therapy (60 days) was the same for all patients.

It was concluded that Michael Kelly's tape K (real tape) suppresses simplex-1 and simplex-2 herpes in patients with frequent recurrences.

Due to the limited duration of testing, it is unknown whether the tape eliminates the latent virus in nerve ganglia i.e. whether the infection recurs after treatment. Despite this limitation, this study suggests that Michael Kelly's audio tape is useful for the suppression of expected herpetic recurrences.

METHODS

Study Population

All patients studied were otherwise healthy patients between 17 and 60 years of age who had reported 6 or more recurrences in the past year, and who agreed to abstain from using any other medications or treatment methods, and agreed to practice effective methods of birth control.

Study Design

Mr. Kelly provided me with a tape "K" and a tape "M". I was further informed that one of the tapes was a placebo while the other contained Mr. Kelly's remedies, but was not informed as to which was which. Both tapes contained the sound of relaxing music and the sound of running water, and were apparently identical in length, appearance, and sound. At the initial visit, informed consent and medical histories were obtained, suspected lesions were examined, and the patients were assigned to the tape "K" or the tape "M". Two coded audio cassettes were used in the medical office with each visit by volunteers. One cassette tape was identified as (M) and one was identified as cassette (K). The first three consecutive days each volunteer was tested and treated and then scheduled to return once per month for two additional visits. During the first visit after a medical history was taken, each person had blood drawn and then they were tested with Voll's Dermatron, a diagnostic device th at measures electrical energy emitted by acupuncture points. After measurements were taken all patients were instructed to listen once to the assigned 20 minute cassette with headphones. Each patient was handed the cassette by the physician's assistant and then listened to the cassette once per day, with each visit when they arrived in the clinic for testing during the first three days of the study. Clinic visits were scheduled once every 4 weeks. Additional visits were arranged as needed to evaluate suspected recurrences within 24 hours after onset. In the absence of a recurrence, the only treatment given every four weeks was listening to the audio tape once every month in the medical office. The entire test period was 60 days. We continue to monitor the patients with monthly phone interviews regarding any changes in the frequency of recurrences. A recurrence was diagnosed clinically when a patient presented with typical symptoms and any number of vesicles, pustules, or ulcers. Each patient was checked with the Voll Dermatron.

On confirmation of a recurrence (clinically), patients immediately were tested with the Dermatron and then treated with their assigned cassette either (K) or (M).

At the conclusion of the study, I opened an envelope that had been provided to me by Mr. Kelly prior to the study. The letter therein identified the "K" tape as the authentic treatment and the "M" tape as the placebo.

Monitoring of Toxicity and Compliance

At all visits, the subjects were questioned regarding signs or symptoms of herpetic disease, as well as any negative reactions to the treatment. There were no complaints about negative side effects from anyone in the (K) group. At each scheduled visit, each patient was tested with the Dermatron and each then listened to their assigned tape.

Virus Isolation

Viral identification was conducted with the Dermatron and blood tests were taken on the first visit and on the last visit. Due to the late date that testing was completed, these tests have not yet been analyzed or reviewed

Results

Twenty-six patients were enrolled in the study. Twenty-three patients completed the treatment. The data from three patients were not included in the analysis of the results of treatment. Two women using the treatment tape (K) withdrew from the study, and one man using the placebo tape (M) withdrew. None of those who withdrew reported any outbreaks of the herpes virus before discontinuing.

Effects of Treatment

Table 2 shows the outcome of treatment of the study. Significantly fewer patients (3 patients in the tape (K) group vs. 8 in the (M) group) experienced recurrences.

Patient Statements

The positive experiences of four patients are noteworthy. The one woman in the (K) group who experienced a recurrence stated "I usually have outbreaks one week after my period. Normally it takes one week to scale over and dry up. It was amazing how it was down, a smaller breakout, clearing and gone in three days." A man who started to have a recurrence on his lower lip stated, "It didn't materialize." Another stated that normally he would have had two additional recurrences by now instead of actually experiencing none.

A third man in the (K) group experienced an outbreak the second day the test began. He healed in two days and stated, "This is the quickest it has ever healed." Since his infection occurred on the second day of the test, within the first three days of the test, it was not counted as a failure of the (K) tape. Another man in the (K) group who did not experience any recurrence stated, "In the past month I would have normally had 2 outbreaks, but nothing!"

Eleven out of 26 patients experienced recurrences. All recurrences were confirmed with clinical visits. Of these 11, 8 patients had used the placebo tape (M), and they had a total of 10 recurrences combined. Two patients from the Tape (K) group had recurrences, 2 outbreaks each.

Moreover, the mean times for healing from the onset of the first recurrence after the start of treatment were significantly shorter in the tape (K) group. Two patients said they healed in 57% less time (3 days instead of 7) and 50% (3 days instead of 6), the third one healed at his normal rate of 6 days.

In the blind study, the (K) tape treatment failed in two of eight men and in one of three women. In the (M) group 5 women and 3 men had recurrences.

The Average Length of Recurrence

Prior to treatment, the patients reported their average duration of outbreaks as follows:

(M) group = 11.58, 139 total days, 12 patients

(K) group = 8.36, 92 total days, 11 patients

During treatment, the patients reported their average duration of outbreaks as follows:

(M) group = 7.75 days, 62 total days, / 8 patients 33.07% improvement

(K) group = 4.66 days, 14 total days, / 3 patients 44.25% improvement

It is believed some improvement in both groups is attributed to the relaxing nature of the music on both tapes as well as heightened expectations.

Additional Sample Data

Prior to test, the number of days most recent recurrence lasted:

Group (M) total 120, average 10

Group (K) total 98, average 8.9

The average age of the male and female participants.

Men's average age = 33.34, low = 17, high = 58, total = 206

Women's average age = 28.8, low = 20, high = 53, total = 173

The number of males 14, and females 12, 3 females dropped out.

Group (M) females 7, males 6, 1 female dropped out.

Group (K) females 5, males 8, 2 females dropped out.

Number of patients experiencing simplex-1 oral, or genital herpes, simplex-2.

Group (M) 8 had simplex-1, 4 had simplex-2

Group (K) 5 had simplex-1, 2 had simplex-2 and 2 patients had both simplex 1 & 2.

None of the patients had more vesicles or reported more severe symptoms during the treatment recurrence than they recalled having had during their more recent pretreatment episodes.

In the (K) group there was two reports of tingling, characteristic of incipient recurrences; however, lesions did not develop. After completing the treatment, all patients received copies of the tape containing the proper sound frequencies.

Compliance

Compliance was verified by visits to the medical office and that is the only time patients had access to use the audio cassette tapes.

Two female patients moved out of state and were unable to complete the test. Another female patient dropped out of the study after being physically abused by her husband.

Adverse Reactions

No problems related to treatment were reported by patients with returning visits of each treatment phase.

I hereby declare that the foregoing is an accurate summary of testing conducted under my control and supervision and that I am a disinterested third party with respect to Michael Kelly's tape.

Townsend Letter for Doctors & Patients.

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By Donald E. Soli

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