Crossconnect.hu2

Peter H Andersen
Department of Dermatology
Marselisborg Hospital
P.P Orumsgade 11
DK-8000 Ärhus C.
Title:
Treatment of recurrent herpes labialis (cold sores) using trans-cutaneous electrical nerve
stimulation
Purpose:
To investigate if recurrent attacks of herpes labialis may be prevented or the severity
diminished using trans-cutanneous electrical nerve stimulation (TCNS).
Panellist:
29 otherwise healthy volunteers with more than 7 recurrent attacks pr year of cold sores and
positive HSV cultivation, were included.
Materials & Methods:
The investigation was planned as a randomised double blind cross-over study. After one
observation attack where no TCNS was offered subjects were randomised. The following
episode of cold sores were TCNS treated (active / placebo). After the first treatment period
panellists initially receiving placebo were given active treatment or vice versa. However, it
was soon clear that this set-up was impossible, since most of the panellist immediately knew
if the pen was active. Therefore, most included patients were initially given placebo. To
record symptoms panellists were supplied with a diary card and as soon as a cold sore
episode was suspected time was noted and prodomal symptoms graded: itch, stinging and
pain. This was done as soon as the first symptoms develop and routinely three times daily.
When a clear blister had developed the subjects were allowed to initiate standard systemic
aciclovir treatment (200 mg x 5, for 5 days). After the initial attack patients are supplied
with equipment to perform TCNS (placebo / active) and a new diary card. At the next two
HSV episodes TCNS were started as soon as prodomal symptoms developed and diary cards
were filled out.

Effect parameters:
Due to the limited numbers going through all 3 observations period the statistical
calculations were modified and performed "semi-quantitative". It was not possible to select
any single primary efficacy Parameter. Therefore a overall estimation was performed in
each case diving the panellists in 3 groups. No difference between active versus placebo.
Active > placebo or placebo > active. In the cases were panellists failed to complete the
entire study active was compared to run in periods.
Results:
A total of 29 panellists were included. Three newer reported back after the initial
enrolment. 18 panellist were observed during the first observation outbreak and one
treatment period (active/placebo) and 8 complete totally. Of the 18 patients 3 were given
active treatment. In this group all had better results in active period than in observation
period. Of the 8 completing all 3 periods 7 were better in active period and in one panellist
there were no difference between periods (p<0.01).
Discussion:
A disappointingly low number completed the study, which overall reduced the statistical
strength of our conclusion. However, even though we only managed to complete a small
group of patients, it seem as if electrical stimulation of a Herpes Labialis episode may
diminish symptoms; both in terms of symptom severity and disease duration, but blisters
always developed after the prodomal period.
A total of 15 episodes of pen-dysfunction developed and we therefore had to redo the active
period in these cases. This lead to high numbers of drop-outs in this period. Today it is
clear, that it was not a sound decision to change from a random order of active versus
placebo to a predetermined form. However, there was no way the study could have been
completed double blind, since the patients immediately knew it the pen was active.
The patients included all had very active Herpes Labialis, and it is a known fact from
pharmaceutical studies that this group often needs more active treatment. Therefore, when
we can show effect it this group of patients, it is likely that people with less severe disease
activity may gain even more. In the present experiment no visible damage was noted in the
skin after treatment, and besides a tingling effect when stimulation was performed on the
lips no side effects were observed. However it is important to realise that this experiment
can not stand alone. Further tests may document safety profile, possible side effects and
effect verification.

Project location and responsible:
The investigation is performed at Marselisborg hospital, department of dermatology, Ärhus,
Denmark. Peter H. Andersen, MD will be project responsible. Furthermore Sanne K.
Hansen MD will perform some of the clinical controls.
References:
1.
Omura Y. Treatment of acute or chronic severe, intractable pain and other intractable medical problems associated with unrecognised viral or bacterial infection: Part I. Acupunct Electrother Res. 1990;15:51-69. Morcos R, Seidah NG, Lazure C, Chretien M. [Endorphins 1989: neuroendocrine aspects]. Rev Neurol Paris. 1989;145:747-63. 3. Rawat B, Genz A, Fache JS, Ong M, Coldman Aj, Burhenne HJ. Effectiveness of transcutaneous electrical nerve stimulation (TENS) for analgesia during biliary lithotripsy. Invest Radiol. 1991;26:866-9.

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