20 Apart from these areas of agreement, the joint report also identifies areas of disagreement. Professor De Domenico and Dr Wilson consider that the term "muscle tone" can be defined as the amount of tension in a muscle. They refer to the Oxford Dictionary of Sports Science and Medicine (1994) where "tone" is defined as:
A state of tension, such as that caused by a sustained, partial muscle contraction.
21 This implies that tone describes the state of a contracted, or partially contracted muscle. Dr Coombes agrees "in principle" but asserts that in lay usage, the term "muscle tone" is synonymous with muscle definition, and is generally used by lay people to refer to muscles in a resting state rather than in contraction. Professor De Domenico and Dr Wilson consider that muscle tone is most accurately quantified by the strength of the muscle, with a stronger muscle capable of exerting greater tension when contracted, and therefore exhibiting more tone. Dr Coombes considers that, in lay terms, that view is incorrect because the term "muscle tone" describes muscle in a resting state.
22 Professor De Domenico and Dr Wilson agree that continued use of the AbTronic is likely to increase abdominal muscle strength and size. Dr Coombes disagrees. Professor De Domenico and Dr Wilson summarize their reasons for so concluding as follows:
… the human body is an adaptive organism and will tend to adapt to the level of stress imposed upon it. This is known as the 'training principle of overload', and is one of the fundamental training principles that exercise science is based upon. The Abtronic will cause the muscles to repeatedly contract at a level of intensity, and for a period of time, that is greater than that usually experienced by the individual, particularly untrained individuals, and over time this will force the body to adapt to the training stimulus causing the stimulated muscles to increase in strength.
23 Dr Coombes gives the following reasons for his contrary view:
Firstly, the Abtronic does not cause muscles to contract against a substantial resistance. Therefore the muscles are doing little or no work. For muscles to improve in strength they need to contract against resistance so they can adapt and become stronger. With no resistance there will be little or no adaptation.
Secondly, the Abtronic is not capable of causing substantial muscle contraction. It will cause muscles near the surface of the body to contract but will not have the power (or people will not be able to tolerate the pain involved) in trying to cause a significant amount of the muscle to contract. Furthermore many individuals with large amounts of fat around the abdomen will not be able to get the abdominal muscles to contract as the electrical power will be dissipated in the fat.
24 Professor de Domenico and Dr Wilson refer to various studies in support of their views. Dr Coombes considers many of these studies to be inappropriate. It is fair to say that his view has changed over time. In particular, he originally excluded the possibility that the use of EMS on healthy muscle could ever contribute to improvement in muscle tone or definition. He now accepts that there is evidence suggesting that EMS may, in some circumstances, make such a contribution. He does not agree with that view and, in particular, asserts that the AbTronic cannot do so.
25 The overall conclusions reached by Professor De Domenico and Dr Wilson are as follows:
In many areas of science there is considerable debate and discussion about different points of view, and often many instances of different experimental findings on various issues. The area of EMS is similar in that there exists scientific evidence supportive of, and dismissive of, the effectiveness of this modality. However, in overall balance and on the basis of reasonable probabilities, (Professor de Domenico and Dr Wilson) … find that:
Ÿ There is a reasonable amount of scientific support for the majority of representations made by Danoz Direct in relation to the Abtronic device. These representations are:
(a) it generates pulses that activate a person's underlying motor nerves, causing a person's muscles to contract and relax, just like normal exercise;
(b) it is a brilliant training and toning tool;
(d) it firms, tones and tightens the upper abs, lower abs, and/or a person's love handles with no sweat; (provided the reference to love handles is deleted)
(e) it will tone and firm muscles;
(f) it can provide a vigorous workout for the abdominal region, the love handles, arms, buttocks, thighs; (provided the reference to love handles is deleted)
(h) it can work out and tone different muscle groups;
While there exists strong support for the majority of representations made by Danoz Direct, there are some claims that (Professor de Domenico and Dr Wilson) … do not believe can be supported at the present time and thus should be withdrawn. These representations are:
(c) 10 minutes of it is equivalent of up to 600 sit-ups without any effort;
(g) it has a fat and cellulite blaster setting that is designed to work on fat cells, not on muscles;
(i) it will flatten your stomach once and for all.
26 As I have said the respondents accept that these "unsupported statements" were misleading. The rather curious references to "love handles" flow from a previous disagreement concerning the meaning of the term, which disagreement has been resolved.
27 Dr Coombes concludes that:
The scientific evidence supplied by (Professor De Domenico and Dr Wilson) …is inappropriate when looking at the representations made by Danoz Direct in regards to the Abtronic. There are hundreds of published research studies using EMS however these should not be simply applied to the Abtronic. Overall there is insufficient scientific evidence to support any of the representations listed in this document. Furthermore, my own testing of the device (as outlined in previous affidavit, in September 2002) showed no benefits of using the Abtronic.
28 I turn now to consider the individual expert reports provided by these three witnesses.
29 Professor De Domenico considers that:
There is no doubt that properly administered, electrical stimulation can be a powerful tool in strengthening human muscles. In fact, the evidence reviewed in the studies cited above, shows that as few as 15 to 30 strong but well tolerated contractions, performed 3 to 5 times a week for as little as 3 to 5 weeks, can be effective. The strength gains seen with these short-term stimulation protocols are said to be 'neural' in nature, rather than morphologic. This means that the increases in strength are due to an increased ability of the subject to make the muscle in question contract (activate the appropriate motor nerves), rather than by the muscle becoming larger in size. Morphologic changes require much longer stimulation protocols, in the order of 10 to 12 weeks or longer. … These concepts have now been incorporated into standard texts on electrotherapy … .
30 At p 3 of his report he observes:
When a muscle contracts, whether by voluntary effort or under electrical stimulation, the same neural and metabolic pathways are activated and, given an appropriate regime of exercise, there is every reason to expect similar training effects. I have personally been involved in several studies that have investigated this question under carefully controlled circumstances. Two of these studies … are relevant to the question of how much contraction force is needed in order to gain significant strength gains under electrical stimulation. Lai, De Domenico and Strauss (1987) used a carefully graduated training protocol of EMS to the anterior thigh muscle (Quadriceps Femoris), stimulating five times a week for three weeks. One group (Low Intensity) of subjects used EMS to produce a training contraction force equal to 25% of his or her maximal voluntary isometric contraction (MVIC) force. A second group (High Intensity) used 50% of MVIC training contraction level. A third group acted as controls for the study and received no training.
The entire protocol was repeated by Szeto, Lai and Strauss, in a follow-up study using voluntary exercise, instead of EMS … . The results from both studies were almost identical. In both cases, training at either 25% or 50% of MVIC produced significant strength gains. There were no differences between the EMS and the voluntary groups. These two studies indicate that significant strength gains can be achieved with relatively low contraction levels of EMS (25% Of MVIC). However, as expected, the largest and most significant improvements in strength were seen at the higher training levels. Similar results have been reported by other investigators … .
Another important issue concerning EMS relates to the type of stimulation used and whether one form is more effective than another. … (A) commonly addressed question concerned the issue of how much force could be produced in a muscle during electrical stimulation and whether there were significant differences between stimulators. I have personally been involved in another carefully controlled and comprehensive study …, reported by Strauss and De Domenico in 1986. In this study, seven different types of stimulator were compared. Some of the stimulators were large and 'powerful' units, while others were very small, battery powered, portable devices. Results showed no significant differences in muscle torque produced by each of the seven types of stimulator. The small, portable, battery powered units were just as powerful as the much larger clinic models.
Under the right conditions, electrically stimulated muscle contractions can be an effective method of conditioning and strengthening human muscles. While most of the studies on EMS have involved the quadriceps muscle, there is no reason to believe that other muscles in the body (including the abdominal muscles) will produce different results. In fact, a number of well controlled studies have investigated the direct effects of exercise … and EMS on the abdominal and other trunk muscles of healthy subjects. In general, these studies also report significant improvements in strength and/or endurance … of the abdominal muscles.
31 Professor De Domenico refers to various studies and then concludes at p 4 of his report:
Taken together, these studies provide persuasive evidence that statistically significant increases in the strength of the abdominal muscles, can result from the use of electrical stimulation delivered over a relatively short period of time (3 to 4 weeks). The results also suggest that daily stimulation is likely to result in greater strength improvement. Most importantly, these increases in strength were produced using contraction forces ranging from the minimally perceived level, to the maximally tolerated. This strongly suggests that any level of contraction force produced by electrical stimulation can induce strength changes in the abdominal muscles. Lower force levels however, may need a stimulation protocol lasting several hours each day. Since this type of protocol does not require strong contractions, it seems particularly suitable for a small stimulator worn in direct contact, under everyday clothing and used throughout the day. Both high and low levels of muscle contraction can be produced by the Abtronic stimulator and for this reason I believe it is well suited to take advantage of such protocols.
32 Professor De Domenico then refers to a number of the specific representations made by the first respondent. I will deal with these matters at a later stage.
33 In his oral evidence, Professor De Domenico was asked to comment upon an article by Dr Alon and others concerning the effects of electrode size in EMS. The paper is ex 8. Professor De Domenico said that the paper demonstrated that the size of the electrode used to stimulate a muscle should reflect the size of the muscle. Merely to use a larger, rather than a smaller electrode provides no extra benefit. The important factor in determining the size of the electrode is the size ratio appropriate to the individual muscle to be stimulated. Professor De Domenico said that the positioning of the electrodes in ex 7 (part of an earlier report by Alon and others which is ex 12) could be effectively replicated using the AbTronic. He also said that gel, which is applied between the electrode pads and the skin in using the AbTronic, would tend to extend the area over which the electrical stimulation was provided, creating the effect of a larger electrode. Professor De Domenico stated that the instructions given on pg 11 of the AbTronic instruction manual (ex 11) as to location of the electrodes were appropriate to achieve the relevant purpose.
34 Professor De Domenico asserts in his report that numerous studies have demonstrated that normal and atrophied muscles can gain significant increases in strength from a suitable EMS regime. In cross-examination, it was suggested to him that one of the four articles cited in support of that proposition, (by Kramer and Mendryk), does not support it. Apparently the authors of that review article conclude that "…insufficient scientific evidence currently exists to warrant either the acceptance or rejection of electrical stimulation as a strength improvement technique." Professor De Domenico said that review articles assemble information from various sources. Some of those sources may support a proposition while others do not. He included the article for the sake of completeness. Professor De Domenico agreed that in order to induce strength changes in abdominal muscles, it might be necessary to apply the AbTronic for several hours each day, possibly in two different locations.
35 In the course of cross-examination he demonstrated a phenomenon to which he refers in his report, namely the capacity of a human being to use abdominal muscles to hold in intestinal content, thus creating a "slimmer" appearance. He offered the view that electrical stimulation is helpful in facilitating improved control over the muscles to enable production of this effect. Professor De Domenico said that fat deposits are not themselves significant obstacles to the penetration of electrical stimulation. He said that the greatest barrier to penetration is the skin. Fat deposits might make it difficult to position the electrodes accurately but would not significantly impair the flow of current. However he later seemed to concede that fat layers might pose problems by increasing the distance over which the current must pass to reach the target muscle.
36 Dr Wilson considers that there has been an enormous amount of scientific research into the area of EMS, particularly over the last thirty years. He considers that "… the overwhelming majority of research in this area has demonstrated positive effects on the human body from the use of EMS". EMS can be used effectively to increase the size, strength and function of muscle. It is effective because the human body is an adaptive organism which adapts to the stresses imposed upon it. The various EMS devices cause muscles to contract repeatedly at a level of intensity, and for a period of time that is greater than that usually experienced by the person in question, particularly a sedentary person. The body adapts to the increased workload, resulting in muscular adaptation, including increased muscular strength, size, tone, function and expenditure of energy. Dr Wilson conducted tests using a number of people as subjects, including himself. He says that the AbTronic is capable of repeatedly producing strong contractions of underlying muscle. He asserts that EMS, plus diet and voluntary exercise, can aid in a number of ways including:
Ÿ Strengthening, shaping and toning muscle;
Ÿ Improving posture;
Ÿ Reducing incidence of low back pain and injury;
Ÿ Reducing muscular aches and pains in a variety of bodily regions;
Ÿ Improving diet;
Ÿ Increasing the amount of voluntary exercise;
Ÿ Losing body weight and body fat;
Ÿ Reducing blood pressure, total cholesterol and blood sugar levels; and
Ÿ Improving overall health and self esteem.
37 I am not sure how EMS can improve diet. In any event, many of these assertions are beyond the ambit of the current proceedings, given the respondents' concessions as to weight loss, fat reduction and exercise equivalence.
38 In the course of Dr Wilson's cross-examination he said that in lay terms, muscle tone is affected by strength and "feeling" of the muscle (its firmness or hardness), appearance, size of the muscle and degree of contraction at the relevant time. If one muscle is flexed and another not, the flexed muscle may well exhibit more tone. Stronger muscle is capable of exerting greater tension. It therefore exhibits more tone. Dr Wilson appears to accept that in lay usage, the word "tone" is somewhat imprecise. He also says that current thinking suggests that although early changes as a result of EMS may be neural, morphological changes may also occur within four weeks. As previously mentioned Professor De Domenico has a different view.
39 Dr Coombes considers that the AbTronic will not achieve the primary goals of changing body shape or improving muscle firmness and tone. To change body shape requires a loss of fat or an increase in muscle size. Tests carried out by Dr Coombes demonstrated that the AbTronic does not significantly affect the metabolic rate and therefore will not result in the additional energy expenditure necessary to decrease body fat. This is conceded. He considers that the AbTronic, used in accordance with the instruction manual, will not result in an increase in muscle size. The applicant does not plead inadequacy of such instructions in its pleadings, although counsel raised the matter on a number of occasions in cross-examination and in addresses. I do not understand the case to have been conducted on that basis. If the applicant wishes to seek further findings in this respect, it may apply after the publication of these reasons.
40 As Dr Coombes considers that the term "muscle tone", in common usage, describes the ability to visualize muscles through the skin, he also considers that improvement in muscle tone depends primarily upon a decrease in body fat. AbTronic will not facilitate this. In clinical usage, the term "muscle tone" denotes the activity of the alpha motor neurons. It is "plausible" that the AbTronic may affect the activity of the alpha motor neurons while the device is being used and for about half a second afterwards. This will not result in any change to body shape or to the appearance of the muscles through the skin.
41 Dr Coombes considers that for muscle fibre to become thicker (hypertrophy), there must be an increase in the amount of protein within the cell. In his first report, he asserts that there is no evidence that the use of EMS devices such as the AbTronic will result in such increase. For hypertrophy to occur, the load against which the muscle is working must be large enough to elicit a response in order to produce additional muscle protein. When using an EMS device, the muscles contract against little or no resistance. It is therefore unlikely that any such stimulus will result in increased muscle size. He refers to a report (Porcari and others, 2002) in which the authors report that subjects who underwent EMS training over a particular period had no change in body weight, body fat, girth, isometric or isokinetic strength or appearance, and that "… claims relative to the effectiveness of EMS for apparently healthy individual are not supported by the findings of the study".
42 In his first report Dr Coombes concludes (at pp 42 and 43) that:
There is very little evidence that EMS using a device such as the Abtronic will significantly increase muscle size in normally active individuals. It is important not to be confused with the effects of EMS on musculoskeletal rehabilitation patients. There is much scientific evidence that EMS will decrease muscle loss (atrophy) in immobilised or injured muscle. This may be described as causing muscle hypertrophy (increasing muscle size) and although this definition is technically correct, the term muscle hypertrophy is much more commonly used in describing the increase in muscle mass from a resting level due to a resistance training program. A resistance training program, by definition, requires muscles to contract against resistance. The resistance is usually provided either by the persons (sic) body weight (e.g. abdominal sit-up) or equipment (e.g. gym equipment or free weights). When a device such as the Abtronic stimulates muscle to contract it is not causing the muscle to generate sufficient force such that an adaptation, such as hypertrophy, would occur. To summarise, an EMS device such as the Abtronic, may increase the size of a muscle that has wasted away but there is no evidence that muscle size can be increased in active healthy muscle.
43 Dr Coombes also observes that EMS will not cause any increased hardness in resting muscle. He considers that there is no significant increase in energy expenditure associated with the use of EMS. Representations to the effect that using such devices is equivalent to performing conventional exercise are incorrect.
44 In his second report, Dr Coombes deals with some of the reported studies relied upon by Professor De Domenico and Dr Wilson. He asserts that such studies are generally inapplicable to the AbTronic regime. It is important, in considering Dr Coombes' evidence, to keep in mind the distinction between the two issues which I have previously identified, namely: