CLINICAL EXPERIENCE

Clinical observations than a decade on a sample of over 1,500 overweight and obese patients, supplemented with a detailed literature review work, have enabled us to develop a theoretical and operational model for the application of Acupuncture Headset in the obese patient therapy. The method defined "DIMANAT® - Lose Weight Naturally" provides for the integration of:

- Stimulation HEADSET

- The FOOD EDUCATION PROGRAM

- Of ACTIVITY 'PHYSICAL PROGRAM

The method is aimed initially to weight loss and subsequently to the maintenance of the same during the control phase. The action of the Stimulation Headset acts primarily on feeding behavior of the obese patient and only secondarily on metabolism and energy consumption. (Fig 1) From our experience shows that the headset therapy can be applied on the overweight and obese patient with different purposes depending on the type or of the phases of the dieto-therapeutic program in place and the presence or absence of DCA

A) In the first period of treatment (1-3 months). Objective: improve the adhesion to the caloric restriction. This phase is reserved for those patients who have already tried to lose weight but he failed and / or obese patients with a diagnosis of BED in combination with appropriate psycho-educational intervention and cognitive behavioral psychotherapy (CBT).

B) In the second phase (3 to 6-12 months). It corresponds to the slowdown of slimming, per share of homeostatic mechanisms that active body in an attempt to bring the body weight to the values prior to weight loss. Objective: To maintain adherence to dietary restriction in place, reducing the phenomenon of relapse.

C) At the end of the weight loss period, however obtained. Goal: to prevent the recovery of short-term weight lost, (12-24 months), as established in 1995 by '' Institute of Medicine of the National Academy of Sciences "(weight decrease by at least 5% and maintained for at least 1 year.) (from the grave R, 2004) D) in association with very low calorie diets (Very Low calorie diets - VLCD) in patients with severe obesity (grade II), BMI between 35 to 39.9 and severe obesity ( III), BMI equal to or greater than 40.

(Armellini F et al., 1998)

Objective: improve the adhesion to the dietary restriction, support the maintenance of the lost weight.

CLINICAL EXPERIENCE

a) In the first period of treatment (1-3 months) Objective: To improve adhesion to the caloric restriction. This phase is reserved for patients who have already tried unsuccessfully to weight loss and / or obese patients with a diagnosis of BED in combination with appropriate psycho-educational intervention and cognitive behavioral psychotherapy (CBT). b) Second Phase (3 to 6-12 months) This corresponds to slowing of weight loss, per share of homeostatic mechanisms that active body in an attempt to bring the body weight to the values prior to weight loss. Objective: To maintain adherence to dietary restriction in place, reducing the phenomenon of relapse. c) Third Step (12 - 24 months) At the end of the weight loss period, however obtained. Goal: to prevent the recovery of short-term weight lost, as established in 1995 by '' Institute of Medicine of the National Academy of Sciences "(weight decrease by at least 5% and maintained for at least one year.) D) Fourth Stage in association with very low calorie diets (Very Low calorie diets - VLCD) in patients with severe obesity (grade II), BMI between 35 to 39.9 and severe obesity (grade III), BMI greater than or equal to 40. Objective : improve adherence to dietary restriction and support the maintenance of the lost weight.

METHOD

The method provides stimulation continues in time of 6/7 acupoints earphones identified in the framework of a group of 13. (Fig 2) The acupoints are grouped together to form "therapeutic sets" primary and secondary, capable of acting on the various aspects eating behavior. Acupoints earphones are then stimulated with small metal spheres, Vaccaria seeds, needles semipermanenza left in place for a period of 7 to 28 days, as determined by the therapist in relation to the different phases of the program that the patient is taking, and the results obtained. At first (1993-1998) have been used needles to semipermanenza (ASP Sedatelec-France), subsequently magnetic beads from 100 Gauss (1998-2001) and in the last magnetic beads to 800 Gauss. In subjects allergic to the metal have been applied Vaccaria seeds. Currently particularly used are the microneedles type Pyonex (0.3 - 0.6 - 0.9 mm in length) of the Japanese company Seirin. The protocol begins with the administration set Therapeutic Primary applied according to the dominant laterality of the patient. The 2nd session takes place after seven days stimulating the contralateral pavilion. In some patients it is possible to practice therapy indifferently on both pavilions, alternating the side of stimulation. In contrast, in other proves responsive only the pavilion of one side. The therapy continues with sessions at regular intervals of 21- 30 days. At first (1993-1998) have been used needles to semipermanenza (ASP Sedatelec-France), subsequently magnetic beads from 100 Gauss (1998-2001) and in the last magnetic beads to 800 Gauss. In subjects allergic to the metal have been applied Vaccaria seeds. Currently particularly used are the microneedles of Pyonex type (0.3 - 0.6

- 0.9 mm in length) of the Japanese company Seirin. The protocol begins with the administration set Therapeutic Primary applied according to the dominant laterality of the patient. The 2nd seat is made after seven days stimulating the contralateral pavilion. In some patients it is possible to practice therapy indifferently on both pavilions, alternating the side of stimulation. In contrast, in other proves responsive only the pavilion of one side. The therapy continues with sessions at intervals of 21- 30 days. In the remainder of the therapy, the maintenance phase can be practiced using a magnetopressione headset system (Zeroplus), in this case is the same patient who applies on well defined areas of the pavilion the presser magnete-, according to a precise temporal pattern defined by the therapist (Cronostimolazione headset). The choice of points is driven by an algorithm based on the information provided to the therapist from the same patient that compiles several self-assessment tools in eating behavior and psycho-emotional state. And 'it is validated a dedicated software that can help the therapist and the patient in the application of the method. The DIMANAT ® evaluation board includes two parts, the first (A board) integrates the classic food diary with that of physical activity. The second (card B) includes different tools for assessment of the patient's eating behavior. To assess the subjective feeling of satiety at different times of the day we used a unipolar scale without subdivision (VAS Visual Analogue Scale). With regard to the phenomenon of "Food Craving", waiting for validation in Italian language of "Food Craving Inventory," we have used, also in this case, an SEA, applied to one of the 4 categories, indicated by the same patient, in which They have classified the different types of object of craving food. The card itself provides information about the patient's psycho-emotional state (Anxiety, Mood, Hostility / Aggression / Anger). Feeding behavior Binge Eating is instead evaluated by administration dellaBinge Eating Scale (BES), in the Italian version. This scale can be used for screening of uncontrolled eating disorder, but can also be useful in the assessment of response to treatment. (G Bazzoni, 2009)