Summary of the Dr. med Axel Schussmann study

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A prospective, randomised, placebo-controlled, double-blind clinical trial was carried out to obtain clinical data on the effectiveness and safety of Thyreogym.

Thyrogym is a magnetic field therapy device for stimulating the thyroid with the aim of reducing weight. It is manufactured and marketed as a Class IIa medical device by Thyreogym GmbH. In a post-market, clinical follow-up study, performed in accordance with MEDDEV 2.12/2 re2, further clinical data was to be obtained to demonstrate the effectiveness and safety of Thyreogym for the purpose defined above. The primary effectiveness variable was the difference in the study participants’ body weight after an eight-week period of application. In addition, differences in body fat, skeletal muscle mass, BMI and visceral fat region were also used as secondary effectiveness variables. For data collection, a bioelectrical impedance analysis was performed with the InBody 720 using the Lookin’ Body Basic software to determine body composition before the study began, then again after four and after eight weeks.

From October 2012 to January 2013, a prospective, placebo-controlled, randomised, double-blind comparison was performed on 33 overweight patients with a normal thyroid function. The eight-week application of Thyreogym without any change in lifestyle or eating habits during this period led to an average weight reduction of 2.0 kg in overweight patients, while the average weight of the control group increased by 0.9 kg over the same period. The group difference of 2.9 kg is significant (p<0.01). In line with the weight loss observed in the intervention group that received treatment and the increases in the placebo group, significant differences within the groups in terms of reductions or increases could also be observed with the secondary effectiveness variables. The differences in body fat mass was 1.5 kg (p=0.03), 0.9 kg (p=0.011) for skeletal muscle mass, 1.0 kg/m2 (p<0.001) for BMI and 6.1 cm2 (p=0.012) for visceral fat levels. No unexpected events or side effects occurred as a result of using Thyreogym. The effectiveness and safety of Thyreogym was thereby confirmed.

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PROVICELL GMBH

Eisenstrasse 1, D-57482 Wenden
Markus Junge
Email: markus.junge@provicell.com

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