Saturday, August 22, 2015

Fraudlent Claims made by Dr. Oz and Marketers of Garcinia Cambogia Supplements: An Exercise in the Scientific Method

Plenty of people admire Dr.Oz. He’s charismatic, entertaining, and a damn good transplant surgeon at a very respectable hospital. His face graces magazine covers and millions of people watch him on TV every day. What most people don’t know is that he’s actually very greedy and unethical. He uses his prestige to sell under researched products for weight loss. What’s worse is that he makes false medical claims regarding the efficacy of these products.

Many of us are unhappy with our body composition, and the idea of taking a pill to become thin is extremely alluring. We are bombarded with ads for supplements that are regarded as miracle plants. We are duped in to thinking that these supplements will make us thin without any work on our part. We mistakenly believe that these products are safe because they are natural. Indeed, the FDA classifies supplements as foods. But, this does not guarantee safety or efficacy. In fact, these compounds are not considered drugs because there has much research in to whether or not they will kill us. Drugs are rigorously tested for safety and efficacy. This process is extremely expensive for companies, so supplement distributors forgo applying to be designated as a drug. Furthermore, drugs must be prescription for a period of time. This is a safety net for compounds that don’t have much research. Doctors can monitor how their patient’s bodies respond to the compound and provide intervention before too much damage occurs. Doctors may also chose not to prescribe a drug to a patient if their case does not warrant the use. Distributors of these shady supplements would prefer to directly market and sell products to the public.

I am not saying the supplements are inherently evil. I take calcium, folate, and melatonin on a regular basis. Some supplements are not drugs because they cannot be patented, so no companies want to invest the money and time in to research and development. Most supplements are harmless, and may actually do some really great things. I’m also not saying that drug companies are benevolent gods. They do awful things as well (eg. direct marketing, falsifying of data, and price gouging). And the compounds classified as drugs have done far more damage than most supplements. I’m just attempting to point out that certain supplement companies are acting unethically in order to get your hard earned money.

I did a little research on GC after seeing a slew of Facebook pages designed to sell this supplement. These pages had normal sounding titles like “I love Yoga” or “Fitness Club”, however they were run by the supplement company. They were designed to trick consumers in to believing that other consumers were writing positive reviews of a specific GC product. In reality, a marketing professional employed by the company was generating fake countless fake Facebook accounts and writing all of the reviews. I researched the claims found in these pages and on the company’s website. Here are my findings: 

Citing Claims/ Fraudenlent Claims:
The author claimed to have "poured through mountains research", but did not care to share any of her sources. I actually did a little meta-analysis on the current data. Here is a link to an article in The Journal of the American Medical association: http://goo.gl/M08b8. The conclusion section in the abstract is one line long and reads: "Garcinia cambogia failed to produce significant weight loss and fat mass loss beyond that observed with placebo (Hemysfeild et al.,1998)."

Of course that was just one study. Another study found in the journal "Phytotherapy Research" found that GC demonstrates lipid lowering activity in lab rats (Koshy et al.,2001). http://goo.gl/kjcmu

A more recent study from 2011, can be cited as saying, "To date, there is little clinical evidence to support [weight loss supplement, including GC] use. More data is necessary to determine the efficacy and safety of these supplements. Healthcare providers should assist patients in weighing the risks and benefits of dietary supplement use for weight loss(Egras et al., 2011)." http://goo.gl/o0OKa

I did find a 2011 study that substantiates GC claims using a biochemical approach. This study is cited as saying, "
Clerodendron glandulosum.Coleb extract prevents adipocyte differentiation and visceral adiposity by down regulation of PPARĪ³-2 related genes and Lep expression thus validating its traditional therapeutic use in controlling obesity(Jadja et al., 2011)"

I found two articles in Lipids in Health and Disease, the journal cited by the manufacturer as claiming "
subjects taking Miracle Garcinia Cambogia lost an average of 19.3 pounds in 28 days without diet or exercise(Prima Lite Nutrition).  
The first study addressed the role high fat diets with relation to brain oxidative stress and metabolic disturbances. CG was investigated as an antiobesity agent. This study, which utilized lab rats, found that CG was effective in lowering blood cholesterol, and in weight management (Amin et al., 2011). Though it made no mention of a 19.83 pound fat loss in 28 days. The authors describe this data as novel, meaning far more data is needed to fully substantiate claims.http://goo.gl/Mkf4H
The second study addressed renal oxidative stress from high fat, high sugar diets. The study's findings concurred with the previous study. Again, this data is described as novel and took place on lab rats(Amin et al., 2011). Still no mention of 19.3 pounds in 28 days. http://goo.gl/CUWMv

Finally, I found a study that evaluated the safety of GC. This study can be cited as saying, "[Clinical studies on GC] 
support its safety demonstrating a wide margin of safety for human consumption. Recent animal and clinical toxicology studies have shown that G. cambogia/HCA is generally safe and is classified as NOAEL up to 1240 mg/kg/day(Chaun et al.,2011)" However, the study was short-term random trials. The authors have identified a need for studies addressing the long term effects of the supplement. http://goo.gl/uh8x6
Conclusion:
Based on the data gathered in this meta-analysis, I suspect that the manufacturer is making fraudulent claims to sell a supplement. However, with more research, CG may be a very effective antiobesity agent. There is some biochemical basis for the use of CG in oxidation prevention and weight management. There has to be human trials before an respectable claims about the effectiveness in humans can be made. 






A Very Scientifc Explaination Possibly Describing Why Neurodiverse Children are Often Picky Eaters

I am a huge fan of the neurodiversity movement. This movement empowers people with autism and other differences in behavior that are thought to be related to how the brain works. The movement asks neurotypicals (such as myself) to view people with autism or pervasive development disorder as human beings who simply do things a little differently. These people are not victims, and the current act of glorifying people who do "nice" things for the "poor helpless special kid at school" (see the quarterback who takes the down syndrome girl to the prom because he's like soooo nice) actually have a negative emotional impact on them.

But, I digress. As mentioned before, the brains of the neurodiverse do things a little differently than those of neurotypicals, and we should ALL (neurodiverse included) have an understanding of these differences. Perhaps you have stumbled upon this post because you are neurodiverse and were doing research on why you perceive certain things in certain ways. Maybe you are looking for information on how to deal with sensory overstimulation in order to live more comfortably.  Maybe you’re the parent of a neurodiverse kid who is at their wits end about why their child is so bothered by seemingly insignificant things. Or perhaps, you just really like science and have an interest in learning about the latest data out there, regardless of what category you fall in to.

I wrote this piece using data gathered via metanalysis for a poster session I did in grad school. The topic is a fascinating look in to the human mind. If you are a parent of a neurodiverse kid who is an incredibly picky eater, this topic is very important for you. It is imperative for your child’s health and wellbeing that you understand what is at the root of this “annoying behavior”. The sensory stimuli differences that cause your child to be a picky eater are actually extremely uncomfortable. This behavior is markedly different than a neurotypical child who refuses to eat certain foods because they are “yucky”. You can convince a child who does not have sensory processing child to eat, and eventually enjoy, broccoli. A child with sensory processing disorder who experiences extreme physical discomfort (eg. nausea, physical pain, ect) from eating broccoli cannot be coaxed out of this. Furthermore, to force them to eat broccoli is cruel. It is your job to take all the necessary steps to ensure that your child will not become malnourished. There are plenty of things that you can do to help them eat a balanced diet.

If you an older neurodiverse person who is interested in using therapies to be able to eat a more diverse diet (perhaps because you would like to try new foods, or because you have developed a health ailment related to your diet), I urge you to talk to your doctor and find therapists who are educated in this area. It would be most beneficial to find a doctor or therapist who also has sensory processing disorder, as their personal experience with the condition is worth more than most textbook education on the topic.

Though I am neurotypical, I have sensory processing disorder. That’s why I am so interested in the topic.

DISCLAIMER: I am not a prescribing provider, occupational therapist, or registered dietitian. This information is provided by a graduate student who is not yet allowed to practice. This information is in no way medical advice, and is not intended to diagnose or treat any condition. It is merely for entertainment. If you would like more information on this topic, please seek medical advice from a doctor or midlevel practitioner who can provide you with a diagnosis. 

Introduction
Sensory processing disorder (SPD), formerly sensory integration disorder, is a neurological disorder affecting the perception of sensory stimuli perception.1 SPD patients may experience overstimulation in certain sensory receptors, as well as under stimulation in other sensory receptors. Furthermore, SPD patients may exhibit crossed sensory paths, such as the nausea and vomiting from hearing certain sounds that should not be expected to cause vomiting. SPD commonly co-occurs with autism spectrum disorder (ASD) and other pervasive development disorders (PDD).2
Thesis
Children diagnosed with SPD are at an increased risk of malnourishment due to malfunctioning sensory input. All children with an ASD or PDD diagnosis should be monitored for SPD signs. Furthermore, all children with an SPD diagnosis should be monitored for signs of poor nutritional status.
Pervasive Development Disorder, Specifically Autism
PDD is a broad diagnosis that includes autism, Asperger’s, Rett’s syndrome, childhood disintegrative disorder, and PDD-not otherwise specified.3 PDD is generally characterized in developmental delay, failure, or regression.
One in sixty-eight US children fall somewhere on the autism spectrum.4 ASD is characterized by a regression of normal development between ages 1-3 years old. ASD toddlers may suddenly stop making eye contact or speaking after a period of normal development. The spectrum ranges from “high autism-low functioning” to “low autism-high functioning”. Patients on the “high autism-low functioning” area of the range are generally unable to walk, speak, feed, or clothe themselves. High functioning autistics have relatively few developmental disabilities, and can lead fairly average lives. The hallmark signs of autism are obsessive fixation on a particular topic, avoidance of eye contact, inability to read social cues, and unusual interaction with peers. Young children with autism may prefer to organize toys, rather than act out in an imaginative fashion.5 ASD can occur with or without a deficit in intelligence quotient.
The cause of ASD is currently unknown, however, there is thought to be a genetic component.6 ASD occurs commonly in siblings, particularly identical twins. An environmental activation of genes is the leading theory on the development of the condition.
Sensory Processing Disorder
SPD is a malfunction of the sensory system. This condition affects both ascending and descending neurological pathways.5 SPD is not currently recognized as occurring as a standalone condition, however emerging research is suggesting that SPD can occur in the absence of PDD. 90% of ASD patients experience SPD, and 5-16% of the general population experience SPD.
According to adult self-report data and observational data of children, the overstimulation that results from SPD is extremely uncomfortable.7 Simple everyday experiences, such as television viewing or teeth brushing, can be unbearable for SPD patients. As a result, patients will actively avoid stimuli that they know to be unpleasant. Avoidance of unpleasant stimuli is perfectly normal, but becomes a problem when the unpleasant stimuli is hard to avoid.
SPD also involves some degree of understimulation.8 In cases of understimulation, it is unclear whether the ascending path way, the cortex, or the descending pathway are responsible for the inappropriate stimuli response. It is also unclear why some stimuli causes overstimulation, while other stimuli goes almost unnoticed.
Sensory Processing Disorder’s Effect on Feeding
SPDs can interfere greatly with mealtimes, as mealtimes are generally filled with stimuli.2 There is a wide range of smells and colors in foods. This provides olfactory and optical stimuli. Eating is generally a social activity, this provides auditory stimuli. The texture of foods ranges from soft and mushy to hard and crunchy. Utensils can be cold, metallic, and sharp or they can be plastic and flimsy. This provides both oral tactile stimulation and digital tactile stimulation. Finally, there is a wide array of food flavor combinations. This provides gustatory stimulation.
Patients with ASD may gag or vomit when they attempt to eat certain foods, as a result of inappropriate signaling from the brain that the food should be expelled via emesis. They may feel physical pain from the sound of a fork scraping against a plate. They may feel an indescribable discomfort from having a grape explode in their mouth.
Sensory Processing Disorder, Food Selectivity, and Malnourishment
SPD patients actively seek to avoid eating foods that cause them discomfort. Older children and adults may flat out refuse to eat certain foods and food groups, while younger children throw tantrums and dodge the feeding spoon7. Children with ASD are more likely to refuse foods, and have a smaller bank of acceptable foods relative to their non-ASD peers.9
Omission of foods and refusal to eat put SPD patients at risk for malnourishment.10 The majority of studied SPD patients consume adequate kilocalories, but favor carbohydrates over lipids and proteins. SPD patients generally demonstrate normal anthropometric values due to acceptable kcal intake. However, they tend to favor refined carbohydrates as their primary source of kcals. A lack of lipid, fat, and plant based carbohydrate intake results in micronutrient deficiencies. Most SPD patients do not consume the recommended daily intake (RDI) levels of vitamins A,D, and K. Their intake also lacks calcium, choline, fiber, magnesium, phosphorous, and potassium. Furthermore, excess consumption of specific foods results in intakes above the upper limit (UL) of copper, retinol (despite low intakes of vitamin A overall),folic acid, zinc, and manganese. Most B vitamin and iron levels are adequate.
Interventions for Sensory Processing Disorder Related Malnourishment
Anthropometric values and blood values for micronutrients should be measured by a prescribing provider during annual checkups.10 Additionally, the patient should be monitored for signs and symptoms of nutrient deficiencies. Access to a dietitian should be recommended at the first sign of malnourishment. Occupational therapists (OTs) should be utilized from the beginning of the SPD diagnosis. OTs can help the patient learn to effectively cope with overstimulation. They can also provide insight on how to limit stimuli that is not absolutely essential to feeding. Stimulation is compounded by all of the stimuli in the environment, therefore, it is beneficial to limit stimuli during feeding. Dimming lights, reducing noises, and using utensils that the patient does not have a strong reaction to can help them adequately cope with food specific overstimulation. Foods that cause overstimulation can be hidden in foods that the patient does not have difficulty with. This practice can help provide needed nutrients without causing a reaction in the patient. Finally, supplementation via nutritional formulas can be beneficial to the patient. In the rare case that kcal requirements can not being met through interventions, total parenteral nutrition (TPN) and enteral nutrition (EN) can be used.
Conclusion

SPD is a condition that often co-occurs with PDD. SPD is over or under stimulation resulting from environmental stimulation. The condition becomes a problem when it interferes with the life of the patient in a profoundly negative way. SPD affects nutritional status due to the stimuli filled nature of feeding. A multi-disciplinary therapeutic approach can provide relief of SPD symptoms for patients. This team should include prescribing providers, dietitians, and occupational therapists. SPD patients should be monitored for malnutrition and below average anthropometric values.