F01-1333_1_A.

doc


Invest|gat|on of the Lffects of D|rect 1arget Iat Ce|| and Lymphat|c
St|mu|at|on w|th Laser Irrad|at|on Dur|ng |||po LLL1 1reatment for 8ody
Shap|ng

u lreeman M.Sc. h.u., L 8eynon-Wllllams and 8evan MlnsL
3
rd
March 2011


Introduct|on

1hls reporL lnvesLlgaLes Lhe effecLs on clrcumference measuremenLs of varlous
comblnaLlons of acLlve or lnacLlve LreaLmenL pad and LS probe dlodes. 1he
LreaLmenL ouLcome on clrcumference measuremenL ls compared Lo effecLs of a
normal Lyplcal lllpo LreaLmenL procedure on Lhe abdomlnal area of Lhe body.

As an addlLlonal lnvesLlgaLlon, comparlson ls also made Lo 'lacebo pads' lnLended
for use ln bllnded placebo conLrolled sLudles Lo lnvesLlgaLe Lhe effecLlveness of lllpo
LreaLmenLs.


Method

10 paLlenLs were recrulLed for LreaLmenL ln each of Lhe followlng groups:

Group 1:
lllpo LreaLmenL pads (lnAC1lvL), secured ln place wlLh elasLlc sLrapplng, LS
probes (lnAC1lvL)

Group 2:
lllpo 1reaLmenL pads (lnAC1lvL), secured ln place wlLh elasLlc sLrapplng, LS
robes (AC1lvL)


Group 3:
lacebo (ulode ouLpuL <1mW) 1reaLmenL pads (AC1lvL), secured ln place
wlLh elasLlc sLrapplng, LS 8C8LS (AC1lvL)


Group 4:
lllpo 1reaLmenL pads (AC1lvL), secured ln place wlLh elasLlc sLrapplng, LS
8C8LS (AC1lvL)

LvaluaLlon of Lhe daLa collecLed from Lhese groups should allow Lhe followlng:

F01-1333_1_A.doc
ConflrmaLlon of prevlous lnvesLlgaLlonal daLa whlch demonsLraLes LhaL a
slngle lllpo LreaLmenL wlLh dlrecL laser lrradlaLlon of Lhe LargeL faL cells and
lymphaLlc sLlmulaLlon cause measureable clrcumference reducLlon
lmmedlaLely afLer LreaLmenL
ConflrmaLlon wheLher lymphaLlc sLlmulaLlon alone, wlLhouL dlrecL lrradlaLlon
of Lhe LargeL faL cells, wlll have an effecL
ConflrmaLlon wheLher Lhe presence of Lhe pads and elasLlc sLrapplng around
Lhe abdomen ls causlng an effecL raLher Lhan or enhanclng Lhe effecL of Lhe
lllpo LreaLmenL
ConflrmaLlon wheLher Lhe placebo pads are sulLable for sham lrradlaLlon ln
conLrolled sLudles where Lhe paLlenL ls bllnded Lo Lhe group Lhey are
recrulLed lnLo

1he LreaLmenL procedure used for all paLlenLs ln all groups ls deLalled below wlLh
[usL Lhe AC1lvL/lnAC1lvL sLaLus of Lhe pads or probes or use of lacebo pads
dlfferlng beLween each group.

rlor Lo LreaLmenL, 3 separaLe clrcumference measuremenLs wlLhln Lhe lnLended
LreaLmenL area were made uslng a Myo1ape measurlng Lape, from AccuflLness. 1hls
Lape measure uses a Lorslon sysLem Lo reLracL Lhe Lape around Lhe area Lo be
measured and mlnlmlses measuremenL error from Lhe operaLor.

1he flrsL of Lhe 3 measuremenLs was made aL Lhe level of Lhe umblllcus wlLh Lhe
second and Lhlrd measuremenLs belng made 4cm above and Lhen 4cm below Lhls
flrsL measuremenL level. AL each measuremenL polnL, Lhe Lape measure was
poslLloned and self secured around Lhe abdomen clrcumference, parallel Lo Lhe floor
and four marks were made on Lhe skln around Lhe abdomen wlLh a surglcal skln
marklng pen Lo allow accuraLe reposlLlonlng of Lhe Lape measure for Lhe posL
LreaLmenL daLa collecLlon.

1he paLlenLs were Lhen poslLloned face up, ln a seml-recumbenL poslLlon on a
LreaLmenL couch and Lhe devlce pads/probes were aLLached. 1reaLmenL was
performed by placlng Lhe four LreaLmenL pads flrsL on Lhe lefL slde of Lhe abdomen
wlLh Lhe flrsL LreaLmenL pad lylng lengLhways, ad[acenL Lo Lhe umblllcus and wlLh
subsequenL pads ad[acenL Lo one anoLher along Lhe medlolaLeral axls of Lhe
abdomen. Care was Laken Lo ensure LhaL Lhe poslLlon of Lhe pads covered Lhe polnLs
from whlch measuremenLs had been made. 1he pads were secured ln conLacL wlLh
Lhe abdomen surface wlLh an elasLlcaLed sLrap. 1he LS slngle laser dlode probes
were secured Lo Lhe skln surface dlrecLly over Lhe superflclal lngulnal lymphaLlc
nodes uslng adheslve rlngs. 1reaLmenL commenced wlLh laser lrradlaLlon of Lhe lefL
slde of Lhe body for 10 mlnuLes. AfLer Lhe 10 mlnuLes Lhe pads were reposlLloned Lo
Lhe rlghL slde of Lhe abdomen uslng Lhe same arrangemenL as prevlously, beglnnlng
wlLh Lhe flrsL pad lylng lengLhways and ad[acenL Lo Lhe umblllcus and Lhe oLher 3
pads exLendlng around Lhe rlghL slde of Lhe abdomen Lo cover Lhe poslLlons from
whlch measuremenLs had been made. As wlLh sLandard lllpo LreaLmenL pracLlce Lhe
LS probes were also reposlLloned approxlmaLely 2-3cm lnwards along Lhe lngulnal
crease Lo furLher maxlmlse coverage of Lhe lngulnal node clusLers. 1reaLmenL Lhen

F01-1333_1_A.doc
recommenced on Lhls slde of Lhe body wlLh a 10 mlnuLe dose of laser lrradlaLlon.
Cnce compleLed, Lhe pads and LS probes were removed and Lhe 3 separaLe
clrcumference measuremenL polnLs were once agaln assessed uslng Lhe Lape
measure.

When Lhe pads were requlred Lo be lnAC1lvL, Lhe pressure sensors on Lhe surface of
Lhe pad were dlsabled Lo prevenL Lhe pad dlodes lllumlnaLlng durlng acLlvaLlon of Lhe
devlce. 1hls would noL prevenL LS probes from belng AC1lvL where requlred.

When boLh pads and LS probes are requlred Lo be lnAC1lvL, Lhe devlce lLself was noL
acLlvaLed.

1he lnLended lacebo pads use ldenLlcal laser dlodes as ln Lhe sLandard lllpo
LreaLmenL pads, buL wlLh Lhe power ouLpuL of <1mW, whlch was expecLed Lo be a
sub-LherapeuLlc dose.


kesu|ts

llg 1 below dlsplays Lhe mean clrcumference measuremenL of each of Lhe 3
measuremenL Laken from each paLlenL and compares Lhe Lrend across each of Lhe
groups evaluaLed.

uaLa above Lhe x axls (+ve) lndlcaLes a galn ln mean clrcumference measuremenL,
daLa below Lhe x-axls (-ve) lndlcaLes a reducLlon ln mean clrcumference
measuremenL.

-3.0
-4.0
-3.0
-2.0
-1.0
0.0
1.0
2.0
1 2 3 4 3 6 7 8 9 10
at|ent
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ads lnAC1lvL/SLrap/LS AC1lvL
lacebo ads/SLrap/LS AC1lvL
ads AC1lvL/SLrap/LS AC1lvL
ads lnAC1lvL/SLrap/LS lnAC1lvL


llq 1. Meoo cltcomfeteoce meosotemeot of loJlvlJool potleots lo eocb tteotmeot qtoop



F01-1333_1_A.doc
Croup 1 (ads lnAC1lvL/LS lnAC1lvL) lndlcaLed on Lhe graph above wlLh Lhe
yellow bars has a mean clrcumference effecL across Lhe enLlre group
populaLlon of a qoin of 0.2cm (Su 0.8)
Croup 2 (ads lnAC1lvL/LS AC1lvL) lndlcaLed on Lhe graph above wlLh Lhe
blue bars has a mean clrcumference effecL across Lhe enLlre group populaLlon
of a qoin of 0.3cm (Su 0.31)
Croup 3 (lacebo pads/LS AC1lvL) lndlcaLed on Lhe graph above wlLh Lhe
green bars has a mean clrcumference effecL across Lhe enLlre group
populaLlon of a qoin of 0.3cm (Su 0.32)
Croup 4 (ads AC1lvL/LS AC1lvL) lndlcaLed on Lhe graph above wlLh Lhe red
bars has a mean clrcumference effecL across Lhe enLlre group populaLlon of a
reduction of 2.4cm (Su 0.83)

p-values from 2 sample t-LesL comparlson of Lhe daLa from all of Lhe groups ls glven
ln 1able 1 below

t Test Analysis (Mean)


INAC1IVL
ILIC LACL8C ILIC AC1IVL ILIC
INAC1IVL ILIC]INAC1IVL
LS
INAC1IVL ILIC 1.0 0.943214 0.0 0.662019
LACL8C ILIC 1.0 0.0 0.62623
AC1IVL ILIC 1.0 0.000002
INAC1IVL ILIC]INAC1IVL LS 1.0

1oble 1. 2-somple, 2-tolleJ t-test compotlsoo of Joto qtoops


1hese p-values lndlcaLe:
no sLaLlsLlcal dlfference on Lhe effecL on clrcumference reducLlon of groups 1,
2 and 3
a confldence level of 99.9998 LhaL Lhe sLandard lllpo LreaLmenL wlLh AC1lvL
pads and AC1lvL LS probes (Croup 4) has a measureable effecL on
clrcumference reducLlon when compared Lo groups 1,2 and 3.

D|scuss|on

1he resulLs of Lhls lnvesLlgaLlon lndlcaLe LhaL:

1. Lhere ls an lmmedlaLe and measurable clrcumference reducLlon effecL of
paLlenLs clrcumference measuremenL afLer a slngle 20 mlnuLe lllpo LreaLmenL
sesslon,
2. Lhe effecL of lllpo requlres a comblnaLlon of dlrecL laser lrradlaLlon of Lhe
LargeL faL cells ln con[uncLlon wlLh dlrecL laser sLlmulaLlon of Lhe nearesL
lymphaLlc nodes Lo Lhe LreaLmenL area,
3. dlrecL laser sLlmulaLlon of Lhe lymphaLlc sysLem alone does noL produce a
measurable reducLlon ln clrcumference,

F01-1333_1_A.doc
4. Lhe poslLlonlng of Lhe devlce pads and Lhe securlng of Lhese pads on Lhe
lnLended LreaLmenL area wlLh elasLlc sLrapplng does noL have an compresslon
effecL LhaL mlghL effecL Lhe reducLlon of Lhe clrcumference measuremenL
over and above Lhe effecL of Lhe lllpo LreaLmenL lLself,
3. Lhe lnLended placebo pads for use ln any fuLure bllnded placebo conLrolled
sLudles do noL have any effecL of faL cell blo-sLlmulaLlon and wlll noL cause
any effecL on clrcumference reducLlon.