ASSESSMENT OF THE EFFECTIVENESS OF “AFFINEX FLAT STOMACH “ AFTER 14 DAYS OF TREATMENT
Author(s)
Charles Taieb, MD, Public Health ManagerPierre Fabre, Boulogne, France
Presentation Documents
OBJECTIVES Since it houses the digestive system, the least sign of digestive problems shows up in the stomach. Fermentation, carbonated drinks, air swallowed while eating, constipation… but also stress or strong emotions: it becomes painful and bloated. Evaluate the benefit of using “affinex flat stomach” as part of a weight loss regime. METHODS Prospective pragmatic evaluation under real-life conditions. The pharmacist gave a double questionnaire along with the product to all adult female customers who had started (or were about to start) a weight loss regimen and who asked the pharmacy for help or advice. TOOLS Validated questionnaires were used (SF 12 and BISS (Body Index States Scale)). Moreover, waist measurement and symptoms were assessed and organized in a single score (Pain, Bloating, Belching, Spasm, Transit problems, Flatulence and Nausea). RESULTS A total of 178 female subjects included, age:40.8±12.3 years with an average BMI of 23.5±3.8 kg/m², the score of the symptoms was 146. With regards to QoL scales, the average scores on inclusion for the SF-12 were 52.7 for the physical dimension (PD) and 40.7 for the mental dimension (MD). The average score obtained on the BISS scale is 22.64 and a questionnaire to assess the perceived stress indicates a stress level of 19.01. At 14 days, the decrease in waistline was 1.66cm (p<0.001) and the symptoms score was 91 (p<0.05). With regards to the scales dealing with QoL, average scores at D14 for SF-12 were 53 for PD and 43.4 for MD. Improvement of the mental dimension (p=0.02). Average score obtained on the BISS scale is 26.34 (p<0.01) Perceived stress level was 17.9 (p<0.003) CONCLUSIONS At the end of the 14 days, the reduction in waist circumference is statistically significant. We also noted an improvement in the overall symptoms score; an improvement that has been confirmed by an improvement of all symptoms.
Conference/Value in Health Info
2009-05, ISPOR 2009, Orlando, FL, USA
Value in Health, Vol. 12, No. 3 (May 2009)
Code
PGI21
Topic
Study Approaches
Topic Subcategory
Post Marketing Studies
Disease
Gastrointestinal Disorders, Respiratory-Related Disorders