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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
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What is homeopathy? Like Cures Like Law of Minimums Stimulate bodys own healing process Ie. Ipecac
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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
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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
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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
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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?
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What did the treatment address? Reducing food cravings Respond to normal satiety Improving metabolism Controlling hypoglycemia Mental/emotional issues exercise
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The product we used in the study Weight Control manufactured by Dolisos America Inc.
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Homeopathics Included Anacardium orientale Antimonium crudum Calcarea carbonica Graphites Iodium Nuv Vomica
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Remedies and their roles in weight loss Sx Anacar dium Antimoni um CalceraGraphite s IodiumNux vomica Curbing Hunger XXXXXX Improving metabolis m XXX Hypo - glycemia XX Over - eating XX mood XX Craving sugar X Craving Fat XX
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Methods Recruited people from Phoenix metropolitan area Initial screening was done by phone using inclusion/exclusion criteria Qualified 35 patient, 30 completed
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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
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Methods Exclusion: Pregnant, lactating, or wanting to become pregnant Obesity of endocrine origin History of bulimia or anorexia History of alcohol or drug addiction
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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
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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}
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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]
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Results Of the 35 people enrolled 30 completed the study, giving a 14% drop out rate Screened 126 patients with 230 inquires
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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
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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
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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
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Depressive Scale No conclusive change in scale and patient compliance between placebo and active group
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Adverse Effects None were reported The only complaint reported by some patient was amount of time required to dissolve pill
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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
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Future Studies We should do a 3 month study to determine if weight loss would be significant at a longer time interval.
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Statistical Analysis Each body measurements were analyzed using a mean, standard deviation, t test and Wilcoxons signed rank test. Confidence intervals of 95% were utilized to detect statistical significance
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