Journal of Cosmetic and Laser Therapy, 2012; 14: 24–42
`
` REVIEWS OF TREATMENT STUDIES
`
` Electromagnetic fi elds applied to the reduction of abdominal obesity
`
` GHISLAINE BEILIN 1 , PHILIPPE BENECH 2 , RODI COURIE 3 & FLORENCE BENICHOUX 4
`
` 1 Paris, France, 2 Marseille, France, 3 Inserm U939, H ô pital La Piti é Salp ê tri è re, Paris, France, and 4 Toulouse, France
`
` Abstract
` Introduction: According to various researches, abdominal obesity increases the risks of cancers or cardio-vascular diseases.
` Objective: To evaluate the reduction of waistline and the evolution of biological parameters on patients after 12 sessions
`of a new medical device called REDUSTIM ® associating alternate low frequency electromagnetic fi elds and controlled
`micropressure. Methods: Two studies were made: a double-blind randomized study performed on 28 patients with a
`waistline ⬎ 88 cm/35 inches for women and ⬎ 102 cm/40 inches for men for a period of 6 weeks and a functional
`analysis on DNA chips performed on 11 patients showing proven overweight. Results: Following our studies a statistically
`signifi cant reduction of waistline of more than 6 cm after 12 sessions has been observed, and the biological assessments
`performed before and after the treatments showed both a highly signifi cant reduction of transaminases level and the
`device mechanism on the stimulation of insensitive muscle contractions. Conclusions: Facing an alarming increase in
`overweight and obesity and considering the current therapeutic gear offering various results, it seems interesting to
`propose an effi cient technique for the reduction of abdominal obesity. The clinical study demonstrated the safety and
`effi ciency of the device for the reduction of abdominal obesity. Treatment showed itself effi cient with patients who were
`not committed to any weight loss program.
`
`Key Words: electromagnetic fi elds , low frequency , abdominal obesity , lipolysis , DNA chips , waistline , genes activity
`
` Introduction
`
`increasing worldwide.
` Abdominal obesity keeps
`According to a survey of bodyshapes conducted in
`the United Kingdom in 1951, a woman ’ s average
`waistline was 70 cm. A 3-D survey carried out by
`SizeUK in 2004 found the average woman had a
`waist measurement of 86 cm.
` Experts are worried that the increase in waistline
`and obesity will lead to an increased number of
`health problems.
` Abdominal obesity increases the risks of cancers
`or cardio-vascular diseases (1): obesity from the
`lower part of the body (buttocks, thighs) is less dan-
`gerous for health than abdominal obesity (belly),
`which gives evidence of the presence of fat around
`viscera.
` Waistline also reveals the location of visceral fat,
`which plays a key role in cardio-vascular or cancer
`associated pathologies. It is one of the major deter-
`mining factors of the metabolic syndrome (2).
` The basic principles for the reduction of visceral
`fat are: a regular physical activity, a healthier diet, a
`
`reduced consumption of salt, a decreased consumption
`of carbohydrates and a reduction of the waistline.
` The use of alternate low-frequency electromag-
`netic fi elds in order to induce a lipolytic effect (reduc-
`tion of adipose tissue) is a genuine technique that was
`fi rst developed in the 1990s by Comfort Harmony ® ,
`a company specialized in such development.
` This process was patented and enabled the devel-
`opment of equipment called BodySculptor ® , launched
`on the market by Cosmosoft ® in 2002.
` With 9 years of effi ciency, Cosmosoft ® which was
`very concerned about bringing a complementary tool
`for the care of abdominal obesity, decided, thanks to
`a new device, to promote its patented technique in
`the medical fi eld.
`
` Material and methods
`
` A patented technology
`
` The technology is composed of a device and an inte-
`gral suit covering a large part of the body (from the
`feet up to the celiac plexus).
`
` Correspondence : Mrs. Stephanie Audran, COSMOSOFT, 1 rue Pierre Brossolette, Levallois, 92300 France. E-mail: sga@cosmosoft.biz. The other author
`for publication is Dr Ghislaine Beilin, 39 rue de Lisbonne, Paris 75008, France. E-mail: gis.beilin@wanadoo.fr
`
` (Received 26 May 2011 ; accepted 4 November 2011 )
`
`ISSN 1476-4172 print/ISSN 1476-4180 online © 2012 Informa UK, Ltd.
`DOI: 10.3109/14764172.2011.649763
`
`J Cosmet Laser Ther Downloaded from informahealthcare.com by University of Guelph on 12/27/14
`
`For personal use only.
`
`LUMENIS EX1092
`Page 1
`
`

`

` REDUSTIM ® clinical studies 25
`
`action of low-frequency electromagnetic fi elds and
`controlled cutaneous micro-pressure.
`
` Protocol
`
` In October 2009, a double blind randomized study
`(3) was edited by Dr. Rodi Courie (Endocrinology,
`Metabolic Department, H ô pital La Piti é Salp ê tri è re,
`Inserm U939) and performed by Dr. Ghislaine
` Beilin and Dr. Florence Benichoux, and the recruit-
`ment took place with nine doctors from Paris:
`three practitioners specialized in nutrition, one
`phlebologist, one aesthetic physician, four general
`practitioners.
` Twenty-eight volunteers participated in this study
`and were randomized as follows: 15 subjects in the
` ‘ tested equipment ’ group (device associating low fre-
`quency magnetic fi elds and controlled cutaneous
`pressure), and 13 subjects in the ‘ Placebo ’ group
`(device that wasn ’ t generating any waves but with a
`controlled cutaneous pressure lowered to 65% of the
`active value). Both the volunteers and the recruited
`Clinical Research Associate (CRA), performing the
`anthropometric measurements before and after, were
`unable to distinguish the placebo machine from the
`treatment machine during the test.
`
` Results and discussion
`
` Mode of action
`
` First, One main action based on the diffusion of
`alternate low-frequency magnetic fi elds in order to
`stimulate the fatty mass destocking. These waves
`present very particular properties that confer them a
`specifi c role on a lipolytic plan.
` Indeed, several international studies highlighted
`a stimulation of membrane ATPases directly linked
`to calcium regulation, (usually called calcium
`pumps), in the presence of weak alternate magnetic
`fi elds (the low level of magnetic fi elds allows the
`implementation of the device without any risks for
`human body cells or any medical operating con-
`straints), lower than 5 Gauss (corresponding to those
`of the device), and this at low electrical frequencies
`of 40 – 60 Hz (50 Hz for the device).
` Ca 2 ⫹ -ATPases are membrane enzymes located in
`the sarcoplasmic reticulum membrane of muscle cells
`where they represent 90% of membrane proteins.
` Sarcoplasmic reticulum stores Ca 2 ⫹ ions and the
`quick fl ow of these ions from the reticulum towards
`the sarcoplasm (muscle fi bers cytoplasm) results in
`muscle contraction.
` The magnetic stimulation of Ca 2 ⫹ ions results
`in an increased ATPases activity, and therefore
`leads to the stimulation of the lipolytic activity
`towards fat cells stored at the muscular level without
`any additional efforts.
`
` A magnetic fi elds generator transfers the energy
`to inductors located in the integral suit at the level
`of the target zones (abdomen, external parts of the
`thighs, internal parts of the knees, calves) while the
`six cells of the suit induce an upward pressure to
`ensure an effective drainage.
` Considering the purpose of the study, the num-
`bers of magnetic fi elds inductors has been increased
`by 50% on the abdominal part to ensure better
`results on this targeted area.
` The device favours a signifi cant and selective
`reduction of fatty mass thanks to a stimulation of
`lipolytic biological mechanisms with the combined
`
`J Cosmet Laser Ther Downloaded from informahealthcare.com by University of Guelph on 12/27/14
`
`For personal use only.
`
`LUMENIS EX1092
`Page 2
`
`

`

` Evolution of waistline
`
` The main goal of this study was to evaluate the
`ability of the treatment to achieve a waistline reduc-
`tion after 12 sessions on healthy overweight or obese
`volunteers that were not committed to any weight
`loss program.
` Considering the waistline reduction as the main
`assessment criterion, the results were the following
`(full data presented in annex 7):
` The waistline reduction appeared highly signifi -
`cant according to the Student ’ s t-test in matched
`series. The slight weight change shows that the sub-
`jects respected the protocol, which specifi ed that the
`subjects were asked not to modify their diet.
` This study highlighted the specifi c waistline
`reduction, which involves an intra-abdominal fatty
`
`26
`
` G. Beilin et al.
`
`Tested
` equipment
`
`Student
` test
`
`Placebo
` equipment
`
` − 6.07 cm
`
` p ⬍ 0.01
`
` − 1.81 cm
`
` − 0.63 kg
`
`ns
`
` ⫹ 0.35 kg
`
`0 g/l
`
` p ⬍ 0.05
`
` ⫹ 0.11 g/l
`
` − 3.25 UI/l
`
` − 7.08 UI/l
`
`ns
`
`ns
`
` ⫹ 1.50 UI/l
`
` ⫹ 1.60 UI/l
`
`T0 – T12
`
`Average
`waistline
`reduction
`Average
`weight
`change
`Average
`glycaemia
`change
`Average
`ASAT
`change
`Average
`ALAT
`change
`
` The action thus consists in performing part of the
`energy expenditure cycle, but without making
`demands on muscular fi bres, as if a physical activity
`was performed without any muscle fi bre extension.
` Moreover, the excess of ATP produced by this
`stimulation will be eliminated by the body in the
`same way as a sportsman would do it during a recov-
`ery cycle after an effort.
` Second, a secondary draining action of controlled
`cutaneous pressure in order to facilitate the evacua-
`tion of fatty acids through systemic circulation and
`toxins elimination.
`
` Treatment tolerance
`
` Clinical and biological assessments performed before
`the fi rst session and after the last one of the treat-
`ments didn ’ t show any signifi cant change in blood
`pressure SBP and DBP (annex 1), glycaemia
`(annex 2), triglycerides level (annex 3), total choles-
`terol level (annex 4) or LDL (annex 5) and HDL
`cholesterol (annex 6).
` The other blood parameters, as well as blood
`pressure, didn ’ t change statistically both in the ‘ tested
`equipment ’ group and in the ‘ Placebo ’ one. Nor did
`the weight, which varied unevenly between individu-
`als, in the absence of any food rebalancing.
` Furthermore, no signifi cant side effects were
`noticed during this study test.
`
`J Cosmet Laser Ther Downloaded from informahealthcare.com by University of Guelph on 12/27/14
`
`For personal use only.
`
` Figure 1. Pictures before and after treatment.
`
`LUMENIS EX1092
`Page 3
`
`

`

`
`
` REDUSTIM ® clinical studies 27
`
` As a result, at the abdominal level, the magnetic
`fi elds trigger a stimulation of insensitive muscle
` contraction CA 2 ⫹ calcium channels (annex 9 –
` network 1) (annex 10 – network 2) (annex 11 –
` network 3), which increases the production of
`Lipase HSL (annex 12 – network 4), thus resulting
`in the hydrolysis of triglycerides at the intramus-
`cular level.
`
` Biological mode of action of the treatment
`
` Thanks to this new, so-called ‘ DNA chips ’ tech-
`nology, the action mode of the device was explained
`in a consistent manner. The genetic expression
`profi le from 11 patients treated with the device was
`analysed in the conditions of a traditional treat-
`ment of 12 sessions (3 sessions per week during
`1 month).
` The results highlighted a strong to signifi cant
`response on the expression of 89 genes, common to
`all subjects, in 73% of the cases, in parallel to their
`waistline reduction.
` Genes with a positive expression seem to target
`muscle cells, and it is very likely that the sessions
`induce imperceptible muscle contractions similar to
`those resulting from a sustained exercise.
` The induced muscle contraction increases the
`activity of lipase (HSL), which favours the hydrolysis
`of intramuscular triglycerides.
`
`Figure 2. Biological mode of action of the treatment.
`
`mass reduction. Patients who participated in this
`study were selected according to their important
`waistline, but the other four criteria of the metabolic
`syndrome were almost normal.
`it clearly
` Considering the results obtained,
`appears that the medical device, compared to the
` ‘ Placebo ’ one, enables a highly signifi cant ( p ⬍ 0.01)
`waistline reduction: ⫺ 6.1 cm on average versus ⫺ 1.8
`cm for the ‘ Placebo ’ group.
`
` Evolution of ASAT and ALAT Transaminases
`
` Another key-point was highlighted in this study: the
`changes in hepatic transaminases levels (full data
`presented in annex 8).
` Indeed, the hepatic transaminases (ASAT, ALAT)
`were analyzed in order to ensure that the circulating
`fatty acids released by the treatment were not stored
`in the liver (hepatic steatosis).
` The results of the study not only made it possible
`to check that the released fatty acids were not stored
`in the liver, but on the contrary the ALAT levels
`booked a 23% reduction with tested equipment
` versus a reduction of 7% with the ‘ Placebo ’ group,
`and the ASAT levels booked a 13% reduction with
`tested equipment versus a reduction of 8% with the
` ‘ Placebo ’ group.
`
`Comparison of ASAT/ALAT levels ∗
`
`Tested equipment
`
`ASAT
`ALAT
`Placebo
`ASAT
`ALAT
`
`T0: 25.17
`T0: 30.92
`
`T0: 18.80
`T0: 21.80
`
`T12: 21.92
`T12: 23.83
`
`T12: 20.30
`T12: 23.40
`
`∗REDUSTIM: results on 12 individuals / PLACEBO: results on
`10 individuals.
`
` These results are highly signifi cant for the
`ALAT level at risk α ⫽ 0.10 and are generally
`equally signifi cant for the ASAT level at risk
` α ⫽ 0.12. They demonstrate the positive action of
`the device on the liver in the process of discharging
`abdominal fat.
`
` DNA chips study and CA 2 ⫹ channels activation
`
` The results of this double-blind, randomized study
`can be linked to those of the study performed in the
`same conditions, without any food rebalancing, on
` ‘ DNA chips ’ .
`study performed by
` Functional analysis
`Dr Philippe Benech (4) from Prediguard Laborato-
`ries Inc. intended to identify, thanks to DNA chips
`technology, the potential effects of 12 sessions of
`tested equipment, on the activity of genes expressed
`in the peripheral blood of 11 subjects.
`
`J Cosmet Laser Ther Downloaded from informahealthcare.com by University of Guelph on 12/27/14
`
`For personal use only.
`
`LUMENIS EX1092
`Page 4
`
`

`

`28
`
` G. Beilin et al.
`
` The device appears to act on the discharge of
`lipids naturally contained in the hypodermis layer,
`which further substantiates the use of this device for
`aesthetic purposes.
`
` Acknowledgements
`
` This work has been done thanks to the study spon-
`sor, Cosmosoft ® Laboratory, with the loan of the
`equipment called REDUSTIM ® .
`
` Discussion
`
` In this study, several positive effects have been
`observed: the effi ciency in the reduction of waistline
`for people suffering from abdominal obesity; the
`safety of the treatment; the good tolerance of the
`device; and the positive action on the process of dis-
`charging abdominal fat.
` Moreover, we can notice that the treatment allows
`to take out patients of the metabolic syndrome: 5
`volunteers out of 15 saw the waistline criterion,
`according to the defi nition of the metabolic syn-
`drome, going back to a normal level (less than 88 cm
`for women and less than 102 cm for men) or being
`signifi cantly reduced.
` When three out of fi ve criteria exceed the maxi-
`mum tolerated value, there is an acute risk of a short
`or mid-term period of cardio-vascular or cancer asso-
`ciated pathologies.
` Another study is currently processing to evaluate
`the abdominal fat concerned by the reduction, thanks
`to an Echo-Doppler method.
` Finally, looking at the results that have been
`objectivized via the DNA Chips analysis concerning
`the ovogenesis and the spermatogenesis activation
`and noticing the knowledge around the links between
`visceral fats and infertility (5) (annex 13 – network 7),
`we are currently evaluating the action of the device
`on the fertility improvement on patients treated
`by the equipment. This study is currently super-
`vised by Dr Vanessa Gallot (Pr. Ren é FRYDMAN
`Department) at the Antoine B é cl è re Hospital in
` Clamart – France.
`
` Conclusion
`
` The results of this study clearly demonstrated that
`tested equipment treatment had a signifi cant action
`on the waistline reduction and a positive action on
`lipids abnormally accumulated around
`internal
`organs or in muscles (especially on the waistline)
`granting it a positive role in healthcare.
`
` Declaration of interest: The authors report no
` confl icts of interest. The authors alone are respon-
`sible for the content and writing of the paper.
`
` References
`
`1.
`
`2.
`
`3.
`
`4.
`
`5.
`
` Women with an important waistline (greater than 88 cm
`according to the NCEP-ATPIII (A) standards and greater than
`80 cm according to the IDF (B) standards) and men with an
`important waistline (greater than 102 cm according to the
`NCEP-ATPIII standards and greater than 94 cm according to
`the IDF standards) presents acute risks of cardio-vascular
`diseases (C) and cancers (D). Circulation 2005, 112:2735–2752:
`originally published online September 12, 2005; doi: 10.1161/
`CIRCULATIONAHA.105.169404.
` A: NCEP ATP III: National Cholesterol Education Program
`Adult Treatment Panel III
`IDF: International Diabetes Federation
` B:
` C: Rader DJ. Effect of insulin resistance, dyslipidemia, and
`intra-abdominal adiposity on the development of
` cardi ovascular diseases and diabetes mellitus. Am J
`Med. 2007;120(3 Suppl 1):S12–8.
` D: Pischon T. Body size and risk of colon and rectal cancers
`in the European Prospective Investigation Into Cancer
`and Nutrition (EPIC). J Natl Cancer Inst. July 5, 2006;
`98(13).
` According to the NCEP (National Cholesterol Education
` Program), the metabolic syndrome corresponds to the exist-
`ence of at least three of the following criterias:
`i. Waistline greater than 102 cm for men, 88 cm for
`women
` ii. Triglycerides level higher than 1.6 mmol/l
` iii. HDL cholesterol lower than 1.04 mmol/l for men,
`1.29 mmol/l for women
` iv. Blood pressure higher than or equal to 130/85 mmHg
`or anti-hypertensive treatments Glycaemia (Empty
`stomach) greater than or equal to 6.1 mmol/l
` Dr R. Courie, Dr. G. Beilin, Dr. F. Benichoux. Double blind
`randomized study performed from October to December
`2009 – Evaluation of the waistline reduction on 28 subjects
`with a BMI ⬎ 25 and not committed to any weight loss
` program.
` Functional Analysis on DNA Chips – March 2009 –
`Prediguard Laboratories – Expression profi le established
`to characterize the transcription effects induced in total
`blood cells from 11 patients treated with sessions of
` REDUSTIM ® , www.redustim.com.
` Pasquali R. Abdominal obesity, fat distribution and infertility.
`Epub 2006 May 24, www.redustim.com.
`
`J Cosmet Laser Ther Downloaded from informahealthcare.com by University of Guelph on 12/27/14
`
`For personal use only.
`
`LUMENIS EX1092
`Page 5
`
`

`

`
`
` REDUSTIM ® clinical studies 29
`
`Annex 1
`
`J Cosmet Laser Ther Downloaded from informahealthcare.com by University of Guelph on 12/27/14
`
`For personal use only.
`
`LUMENIS EX1092
`Page 6
`
`

`

`30
`
` G. Beilin et al.
`
`J Cosmet Laser Ther Downloaded from informahealthcare.com by University of Guelph on 12/27/14
`
`For personal use only.
`
`LUMENIS EX1092
`Page 7
`
`

`

` REDUSTIM ® clinical studies 31
`
`Annex 2
`
`J Cosmet Laser Ther Downloaded from informahealthcare.com by University of Guelph on 12/27/14
`
`For personal use only.
`
`LUMENIS EX1092
`Page 8
`
`

`

`32
`
` G. Beilin et al.
`
`Annex 3
`
`J Cosmet Laser Ther Downloaded from informahealthcare.com by University of Guelph on 12/27/14
`
`For personal use only.
`
`LUMENIS EX1092
`Page 9
`
`

`

`
`
` REDUSTIM ® clinical studies 33
`
`Annex 4
`
`J Cosmet Laser Ther Downloaded from informahealthcare.com by University of Guelph on 12/27/14
`
`For personal use only.
`
`LUMENIS EX1092
`Page 10
`
`

`

`34
`
` G. Beilin et al.
`
`Annex 5
`
`J Cosmet Laser Ther Downloaded from informahealthcare.com by University of Guelph on 12/27/14
`
`For personal use only.
`
`LUMENIS EX1092
`Page 11
`
`

`

` REDUSTIM ® clinical studies 35
`
`Annex 6
`
`J Cosmet Laser Ther Downloaded from informahealthcare.com by University of Guelph on 12/27/14
`
`For personal use only.
`
`LUMENIS EX1092
`Page 12
`
`

`

`36
`
` G. Beilin et al.
`
`Annex 7
`
`J Cosmet Laser Ther Downloaded from informahealthcare.com by University of Guelph on 12/27/14
`
`For personal use only.
`
`LUMENIS EX1092
`Page 13
`
`

`

`
`
` REDUSTIM ® clinical studies 37
`
`Annex 8
`
`J Cosmet Laser Ther Downloaded from informahealthcare.com by University of Guelph on 12/27/14
`
`For personal use only.
`
`LUMENIS EX1092
`Page 14
`
`

`

`38
`
` G. Beilin et al.
`
`J Cosmet Laser Ther Downloaded from informahealthcare.com by University of Guelph on 12/27/14
`
`For personal use only.
`
`LUMENIS EX1092
`Page 15
`
`

`

`
`
` REDUSTIM ® clinical studies 39
`
`Annex 9
`
`Annex 10
`
`J Cosmet Laser Ther Downloaded from informahealthcare.com by University of Guelph on 12/27/14
`
`For personal use only.
`
`LUMENIS EX1092
`Page 16
`
`

`

`40
`
` G. Beilin et al.
`
`Annex 11
`
`J Cosmet Laser Ther Downloaded from informahealthcare.com by University of Guelph on 12/27/14
`
`For personal use only.
`
`LUMENIS EX1092
`Page 17
`
`

`

` REDUSTIM ® clinical studies 41
`
`Annex 12
`
`J Cosmet Laser Ther Downloaded from informahealthcare.com by University of Guelph on 12/27/14
`
`For personal use only.
`
`LUMENIS EX1092
`Page 18
`
`

`

`42
`
` G. Beilin et al.
`
`Annex 13
`
`J Cosmet Laser Ther Downloaded from informahealthcare.com by University of Guelph on 12/27/14
`
`For personal use only.
`
`LUMENIS EX1092
`Page 19
`
`