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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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Dr linda kim dr pam swan dr robert waters michael smith jennifer orlowski

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
What is homeopathy? percent body fat. A randomized, double-blind, placebo controlled clinical trial

  • Like Cures Like

  • Law of Minimums

  • Stimulate body’s own healing process

    • Ie. Ipecac


Effectiveness of homeopathy
Effectiveness of Homeopathy percent body fat. A randomized, double-blind, placebo controlled clinical trial

  • 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
Obesity in Adults percent body fat. A randomized, double-blind, placebo controlled clinical trial

  • 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
Risk of Obesity percent body fat. A randomized, double-blind, placebo controlled clinical trial

  • 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
What were the questions we asked? percent body fat. A randomized, double-blind, placebo controlled clinical trial

  • 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
What did the treatment address? percent body fat. A randomized, double-blind, placebo controlled clinical trial

  • Reducing food cravings

  • Respond to normal satiety

  • Improving metabolism

  • Controlling hypoglycemia

  • Mental/emotional issues

  • exercise


The product we used in the study
The product we used in the study percent body fat. A randomized, double-blind, placebo controlled clinical trial

  • Weight Control ™ manufactured by Dolisos America Inc.


Homeopathics included
Homeopathics Included percent body fat. A randomized, double-blind, placebo controlled clinical trial

  • Anacardium orientale

  • Antimonium crudum

  • Calcarea carbonica

  • Graphites

  • Iodium

  • Nuv Vomica


Remedies and their roles in weight loss
Remedies and their roles in weight loss percent body fat. A randomized, double-blind, placebo controlled clinical trial


Methods
Methods percent body fat. A randomized, double-blind, placebo controlled clinical trial

  • Recruited people from Phoenix metropolitan area

  • Initial screening was done by phone using inclusion/exclusion criteria

  • Qualified 35 patient, 30 completed


Methods1
Methods percent body fat. A randomized, double-blind, placebo controlled clinical trial

  • 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


Methods2
Methods percent body fat. A randomized, double-blind, placebo controlled clinical trial

  • Exclusion:

    • Pregnant, lactating, or wanting to become pregnant

    • Obesity of endocrine origin

    • History of bulimia or anorexia

    • History of alcohol or drug addiction


Methods3
Methods percent body fat. A randomized, double-blind, placebo controlled clinical trial

  • 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
Methods: Office visit percent body fat. A randomized, double-blind, placebo controlled clinical trial

  • Physical exam:

    • BP, pulse, respiration rate, temperature

    • Weight, height, body measurements hip and waist

    • Metabolic testing with a Bod Pod {ADD HERE}


Outcome parameters
Outcome Parameters percent body fat. A randomized, double-blind, placebo controlled clinical trial

  • 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
Results percent body fat. A randomized, double-blind, placebo controlled clinical trial

  • Of the 35 people enrolled 30 completed the study, giving a 14% drop out rate

  • Screened 126 patients with 230 inquires


Body measurement changes
Body Measurement changes percent body fat. A randomized, double-blind, placebo controlled clinical trial

  • 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
Exercise Compliance percent body fat. A randomized, double-blind, placebo controlled clinical trial

  • 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
Questionaires percent body fat. A randomized, double-blind, placebo controlled clinical trial

  • 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
Depressive Scale percent body fat. A randomized, double-blind, placebo controlled clinical trial

  • No conclusive change in scale and patient compliance between placebo and active group


Adverse effects
Adverse Effects percent body fat. A randomized, double-blind, placebo controlled clinical trial

  • None were reported

  • The only complaint reported by some patient was amount of time required to dissolve pill


Conclusion
Conclusion percent body fat. A randomized, double-blind, placebo controlled clinical trial

  • 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
Future Studies percent body fat. A randomized, double-blind, placebo controlled clinical trial

  • We should do a 3 month study to determine if weight loss would be significant at a longer time interval.


Statistical analysis
Statistical Analysis percent body fat. A randomized, double-blind, placebo controlled clinical trial

  • 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


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