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Effects of homeopathy in reducing weight, body fat mass and percent body fat. A randomized, double-blind, placebo controlled clinical trial. Dr. Linda Kim Dr. Pam Swan Dr. Robert Waters Michael Smith Jennifer Orlowski. What is homeopathy?. Like Cures Like Law of Minimums
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Effects of homeopathy in reducing weight, body fat mass and percent body fat. A randomized, double-blind, placebo controlled clinical trial Dr. Linda Kim Dr. Pam Swan Dr. Robert Waters Michael Smith Jennifer Orlowski
What is homeopathy? • Like Cures Like • Law of Minimums • Stimulate body’s own healing process • Ie. Ipecac
Effectiveness of Homeopathy • A meta-analysis of placebo controlled clinical trials demonstrated that homeopathic effects are not due to placebo alone, there was a 2.45 times greater effect than placebo • Meta-analysis of 107 controlled trials showed 76% of those studies were effective
Obesity in Adults • Estimated 97 million adults in US are overweight or obese • Overweight defined as BMI of 25 to 29.9 kg/m² and obesity is a BMI of greater than or equal to 30 kg/m²
Risk of Obesity • Hypertension • Dyslipidemia • Type 2 Diabetes • Coronary heart disease • Stroke • Gallbladder disease • Osteoarthritis • Sleep apnea • Respiratory problems • Endometrial, breast, prostate, or colon cancer
What were the questions we asked? • Does homeopathy promote more weight loss than placebo? • What is the short term efficacy of a homeopathic weight loss product?
What did the treatment address? • Reducing food cravings • Respond to normal satiety • Improving metabolism • Controlling hypoglycemia • Mental/emotional issues • exercise
The product we used in the study • Weight Control ™ manufactured by Dolisos America Inc.
Homeopathics Included • Anacardium orientale • Antimonium crudum • Calcarea carbonica • Graphites • Iodium • Nuv Vomica
Methods • Recruited people from Phoenix metropolitan area • Initial screening was done by phone using inclusion/exclusion criteria • Qualified 35 patient, 30 completed
Methods • Inclusion: • Male/female 21-45 y.o • BMI 30-39 kg/m² • Confirmed menstrual period prior to enrollment • Able to comply with study requirements: informed consent, 2 office visits, follow up monitoring, avoid other diet programs and perform exercise program
Methods • Exclusion: • Pregnant, lactating, or wanting to become pregnant • Obesity of endocrine origin • History of bulimia or anorexia • History of alcohol or drug addiction
Methods • 4 week trial • Take 1 tablet 4 times per day sublingual • Exercise 4 times per week • Wear pedometer daily • Fill out daily questioners • Weekly phone monitoring • Office visit 2 times
Methods: Office visit • Physical exam: • BP, pulse, respiration rate, temperature • Weight, height, body measurements hip and waist • Metabolic testing with a Bod Pod {ADD HERE}
Outcome Parameters • Body weight changes • BMI, lean body mass, fat mass, percent body fat • Body change measurements • Circumference of waist and hip • Hip/waist ratio • Metabolic testing • Respiratory exchange rate • Questionaires • VAS of hunger, satiety, thirst, mood [daily] • Pedometer log • Quality of Life Index SF-36, defecation pattern, satisfaction w/ intervention, compliance [2 times] • Hamilton Depression scale [2 times]
Results • Of the 35 people enrolled 30 completed the study, giving a 14% drop out rate • Screened 126 patients with 230 inquires
Body Measurement changes • These were not significant between the active group and the placebo group. • There weight decreases and body measurement changes in active group from baseline to end of treatment • This suggest a pattern of weight reduction, but not a conclusive difference
Exercise Compliance • There was a significant change (p < .05) noted with exercise compliance between active and placebo • Patients in active group recorded more exercise on average than placebo
Questionaires • These were significant (P < .05) The daily questionaire asking about hunger, satiety, thirst, mood and defecation should overall improvement in active group as compared to placebo • Results from SF –36 confirmed results • Improvements may have been attributed to increase incidence of exercise in active group
Depressive Scale • No conclusive change in scale and patient compliance between placebo and active group
Adverse Effects • None were reported • The only complaint reported by some patient was amount of time required to dissolve pill
Conclusion • It was not conclusively shown that this product promoted weight loss, however the time interval may have been to short to draw a significant conclusion • It was conclusively shown that the active group did notice changes in quality of life issues, suggesting that the product may be effective at a longer interval
Future Studies • We should do a 3 month study to determine if weight loss would be significant at a longer time interval.
Statistical Analysis • Each body measurements were analyzed using a mean, standard deviation, t test and Wilcoxon’s signed rank test. Confidence intervals of 95% were utilized to detect statistical significance