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From: jaks on 22 Aug 2005 07:00
Immunotherapy with transfer factor of recurrent herpes simplex type I.
Arch Med Res 1995;26 Spec No:S87-92 (ISSN: 0188-4409) .... This
clinical trial of Transfer Factor, an immunomodulator, in the treatment
of herpes simplex type I, proved this agent to be more effective as
regards duration of acute phase recurrences as well as the frequency of
the reappearance of relapses of this disease. The evaluation was made
in 20 patients whose disease had been treated before with other
therapeutic agents (including acyclovir) which permitted them to be
their own controls for the comparative data obtained and submitted to
statistical analysis of the two parameters mentioned, duration of the
acute phase and frequency of relapses. Patients with compromised
cellular immunity or with any additional disease were excluded from the
study. Transfer factor, one unit, was administered subcutaneously daily
for 3 to 4 days during the acute phase of the disease, and subsequently
at 15-day intervals for the first 6 months; followed by a continuation
of monthly injections until the termination of the study period. In six
of the 20 patients there was a recurrence of the disease while
receiving maintenance dosages of TF. These patients were again given
the full initial dosage schedule and reinstated again with the
maintenance dosage. In the initial eight patients, an immune status
profile was obtained, and all results were found to be in the normal
range. This was considered sufficient evidence that the criteria for
the selection of patients excluded any with detectable variations in
the profile of the immune status, and it was decided to eliminate this
as a prerequisite for participating in the study. The results showed an
important improvement in the response to transfer factor immune
modulation therapy. A statistically significant reduction in the
frequency of recurrences within a one month period, the Student t test
gave a p = 0.0001 in TF treated patients. The average duration in days
of the acute phase also showed an important difference in favor of the
TF treatment. The U Mann-Whitney test gave a p = 0.0005. These results
suggest that, at present, TF may be considered the therapeutic agent of
choice in the treatment of herpes simplex type 1 disease.

More info at www.healthandhabitat.com

From: Jim on 31 Aug 2005 17:47
Again the treatment patients are used as their own controls. In a
condition that tends to decrease in frequency and severity over time, the
only way to make such a study valid is to have two groups of patients: one
to serve as controls first, then take the treatment, the other to take the
treatment first and then to act as controls. This is the _only_ way to
factor out the effect of decreasing frequency/severity over time when using
treatment patients as their own controls. Because that was not done, IMHO
the study shows nothing


"In six of the 20 patients there was a recurrence of the disease while
receiving maintenance dosages of TF. These patients were again given the
full initial dosage schedule and reinstated again with the maintenance
dosage"
Just exactly what does that mean, anyway?! Does it mean that at the
"reinstatement" the time prior to "reinstatement" will be the new control
time? If so, showing "an effect" would be inevitable: just keep
reinstating them (and resetting the "controll" time) until their recurrances
have died down that the new treatment time will show an effect as compared
to the new control time. Sure as heck couldn't prove any efficacy before
the FDA with _that_ kind of approach!

"In the initial eight patients, an immune status profile was obtained, and
all results were found to be in the normal range. This was considered
sufficient evidence that the criteria for the selection of patients excluded
any with detectable variations in the profile of the immune status, and it
was decided to eliminate this as a prerequisite for participating in the
study."
Reeks of cherry picking, IMHO

Please note that if a study was poorly designed, that doesn't mean that the
treatment in question does or doesn't work. It merely indicates that the
question of whether or not it actually does or doesn't hasn't been
adequately addressed.

Jim
..
<jaks(a)jansons.id.au> wrote in message
news:1124708446.529020.244020(a)g47g2000cwa.googlegroups.com...
> Immunotherapy with transfer factor of recurrent herpes simplex type I.
> Arch Med Res 1995;26 Spec No:S87-92 (ISSN: 0188-4409) .... This
> clinical trial of Transfer Factor, an immunomodulator, in the treatment
> of herpes simplex type I, proved this agent to be more effective as
> regards duration of acute phase recurrences as well as the frequency of
> the reappearance of relapses of this disease. The evaluation was made
> in 20 patients whose disease had been treated before with other
> therapeutic agents (including acyclovir) which permitted them to be
> their own controls for the comparative data obtained and submitted to
> statistical analysis of the two parameters mentioned, duration of the
> acute phase and frequency of relapses. Patients with compromised
> cellular immunity or with any additional disease were excluded from the
> study. Transfer factor, one unit, was administered subcutaneously daily
> for 3 to 4 days during the acute phase of the disease, and subsequently
> at 15-day intervals for the first 6 months; followed by a continuation
> of monthly injections until the termination of the study period. In six
> of the 20 patients there was a recurrence of the disease while
> receiving maintenance dosages of TF. These patients were again given
> the full initial dosage schedule and reinstated again with the
> maintenance dosage. In the initial eight patients, an immune status
> profile was obtained, and all results were found to be in the normal
> range. This was considered sufficient evidence that the criteria for
> the selection of patients excluded any with detectable variations in
> the profile of the immune status, and it was decided to eliminate this
> as a prerequisite for participating in the study. The results showed an
> important improvement in the response to transfer factor immune
> modulation therapy. A statistically significant reduction in the
> frequency of recurrences within a one month period, the Student t test
> gave a p = 0.0001 in TF treated patients. The average duration in days
> of the acute phase also showed an important difference in favor of the
> TF treatment. The U Mann-Whitney test gave a p = 0.0005. These results
> suggest that, at present, TF may be considered the therapeutic agent of
> choice in the treatment of herpes simplex type 1 disease.
>
> More info at www.healthandhabitat.com
>


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