Critique of a Slenderiix paper

The paper can be found here.

This paper has been given by people peddling Ariix products as evidence that it works. Here are the products mentionned in the paper.

Screenshot 2016-05-11 10.18.55

Screenshot 2016-05-11 10.19.21

Screenshot 2016-05-11 10.19.46

Screenshot 2016-05-11 10.19.56

Screenshot 2016-05-11 10.21.04

Screenshot 2016-05-11 10.21.13

So that is what is claimed by Ariix. They also claim this-

Screenshot 2016-05-11 10.25.11.png

Let’s not just take their word for it, let’s have a look at the actual paper and evaluate it properly. I would like to point out that I have been trained in how to analyse a research paper and even worked in clinical research for a year.

Context of the study

  • The publication that the study appeared in. This paper was given to me as a pdf and no journal is mentioned on it. Where did this paper appear? Was it peer reviewed? Normally a paper is submitted to a journal and it then goes through a vigorous process of reading and checking by experts in the field. Only if the experts agree that the study is a good one, will it be published. Different journals have different levels of credibility and expertise. It would be useful to know which journal it appeared in (If any).

If it has not been in a peer-reviewed journal, this immediately casts doubt onto its                credibility.

Who did the study?

It is useful to know the background of the researchers. Do they have the proper expertise? What papers have they published in the past? Are they credible? What institution do they work for? It is common practice to research the authors of papers as this is all relevant.

There is no mention of who carried out the research or where. This is extremely unusual in a research paper. In fact, when research is quoted, you start with the names of the authors. There is a mention of someone called Dr Hurt who interviewed the participants. I initially googled ‘Dr Hurt’ and found this-

Screenshot 2016-05-11 19.56.50.png

He is a character from Batman. I assumed it wasn’t him that wrote the paper. He’s a psychiatrist.

 

Googling ‘Dr Hurt ariix’ reveals this-

Screenshot 2016-05-11 14.51.29.png

Dr Hurt worked for Ariix. She seemed to have a part in designing the products. She is not the best person to be testing these products. She will not be non-biased at all. In fact, normally research papers have a section where authors declare interests that might conflict with the study. There is no such section here.

Dr Hurt’s qualifications

It is normal practice to examine the qualifications of authors of papers. It is standard practice for CVs to be submitted to Journals when papers are being submitted to a journal. It is normal for critical readers to examine the available evidence of an author’s qualifications and job role. I am not getting personal or nasty here, I am just doing what is expected in a thorough review.

Dr Hurt is the only name mentioned in the paper so I can only look at her information. Here is her LinkedIn profile-

Screenshot 2016-05-13 10.21.33

Ah, it says this on her profile-

Screenshot 2016-05-13 10.22.56

So she was the only person involved in the study. OK, let’s look at her qualifications.

Screenshot 2016-05-13 10.23.34

What is a ‘Fellow, functional Endocrinology’? A quick goole tells me a ‘fellowship’ is obtained in the US by a physician or dentist undertaking about a year of additional medical training. More details can be found here about the qualification. It is open to people with a phd and is an online course.

Dr Hart’s phd was gained in Kingdom College of Natural Health. Is this an acredited college? No. This is from their own website.

Screenshot 2016-05-13 10.42.00

The KCNH just do distance and online courses. It is possible to get a degree there in 30 days if you already think you know the subject! You can just take the test and skip the course.Screenshot 2016-05-13 10.59.40.png

Screenshot 2016-05-13 10.56.17.png

I do not know if Marlisa got her doctorate this way or if she studied hard for years. Either way, it isn’t recognised by the US Education Department.

What about Liberty University where she got her Bachelor’s degree? This is a very Christian University where their programs are ‘Christ-centred’. Her degree is in Human ecology which is the study of humans in their environment.

Is someone with a ‘Christ-centred’ degree in human ecology and a non-accredited phd the best person to be conducting a clinical trial?

 

When was the article written/ published?

Normally, papers have the date mentioned somewhere on it. It is important to know the date so the research can be put in context. Also, studies are normally referred to by author and year published as a way of identifying it. This is how a research paper should be referenced-

Screenshot 2016-05-13 09.33.52

Note that the information contains the names of the authors, date, title, journal it was in. Every single piece of this information is missing from the Slenderiix study.

Note also that the above example was taken from the reference list of the Slenderiix paper. It was one of the few that was correctly referenced. Most of the other references were of a very poor standard, well below that expected of an A-Level student (for our non-UK readers, A-Levels are undertaken by 16-18 year olds).

 

What is being studied?

  • Normally I would look at the title of the paper next to see what it was examining. There is no title. This is very unusual for a proper scientific paper.

 

  • This is mentioned in the abstract- “Exploring the relationship of an exclusive homeopathic weight loss tincture combined with therapeutic nutrition in relation to reversal of visceral adipose fat tissue stores and serum inflammatory markers, which indicate risk factors for leading causes of death, including congestive heart disease and hormone-related cancers.”

The dependent variable here (the thing that you are trying to effect) is amount of visceral adipose fat tissue stores and serum inflammatory markers.

The independent variable here (the thing you have control over and are tweaking) is the homeopathic weight loss tincture and therapeutic nutrition.

Right, so we’ve managed to work out what they are testing. Let’s see how they went about it.

Design of the study

  • In the Abstract the phrase “A Randomized, Blind, Placebo-Controlled Cross-Over Study:” is used. This is good news. This is nearly the gold standard for research studies.
  • Randomised means that people are allocated to groups randomly, not chosen by a researcher which might bias the results.
  • Blind means that the participants don’t know if they are in the experimental or control group. This is supposed to weed out any placebo effect. This is not a double-blind study, where the researchers don’t know who is in what group. When it is not double-blinded, there is the possibility of researchers interpreting information in a biased way.
  • Placebo-controlled means that there was a group of participants who had exactly the same treatment as the experimental group except they were given products without active ingredients. The participants themselves wouldn’t know if they were having the active ingredients or an inactive substance. It is important that the products taken look and feel the same. They would be treated the same by the researchers as well if it was a double-blind trial but this isn’t one of those.
  • Cross-over means that the same people were put through being in the placebo group and experimental group.  They essentially act as their own control. This would factor out any differences found being down to individual differences in the participants. For example, if you have a young person and an old person in the group, their age wouldn’t affect anything because they would be in the control group and experimental group. Old control vs olds experimental and young control vs young experimental. Their age would become irrelevant.

 

Is the study Placebo controlled?

  • If the study is placebo controlled, then there should be an experimental group where they try the product/method and a placebo group where the participants have exactly the same as the experimental group except their products do not contain any of the active ingredients. Because it is a cross-over study, each person should be in each group over a period of time.  This should mean we can see if it is these specific products that have made the difference, rather than just being involved in a study and having the help and support of the researchers.

Having a look at the paper  though, they describe their groups like this-

Screenshot 2016-05-11 11.42.19

There is no mention at all of a placebo group. There is mention that the people in group C have a placebo instead of Slenderiix. But they are still having the other two elements of the program so this is not a placebo group. Each group appears to just be doing different components of the weight loss program. These groups might be useful when trying to determine which element is having any effect, but it would be an entirely different study to the one that is presumably being done.

Later the groups are referred to like this

Screenshot 2016-05-11 11.58.50

Group C seems to be labelled as a placebo group now. This is not a placebo group at all. This is quite deceptive in my opinion.

Then these two pieces of information appear-

Screenshot 2016-05-11 12.03.04.png

This sounds like a control group where the participants had no diet. Where did this group come from? How many people were in it?

Screenshot 2016-05-11 12.02.06.png

Now there is a diet only group as well. Where has this come from? Note Group C is still being referred to as a placebo group. Where are the people who had no diet?

From the information given, it is very unclear exactly who is in what group. There doesn’t appear to be a proper placebo group.

 

Is the study a cross-over study?

The study does not appear to be a proper cross-over study where all the participants serve in all the groups so they are their own control. The paper has this to say about it-

Screenshot 2016-05-11 13.34.09.png

This means that for the first 4 weeks there were groups A,B,C and D (plus the mysterious diet only and no diet groups) and for the remaining 8 weeks, A,B and C joined D. On the charts the people stayed in their labelled groups even though they had changed regimes. All very confusing.

This is not a cross-over study.

 

What do we know about the particpants?

The paper has this to say-

Screenshot 2016-05-11 12.12.55.png

Only 19 of the participants completed the experiment. This is an extremely small group and is not representative of the population. The men:women ratio is very uneven, why not just choose one sex to study? Or do half and half?

Because the study is a crossover study it should not need as many participants because each person will be used in each group. However, as this is not a true cross-over study that is irrelevant.

19 participants is an extremely low number to use. There is no reason to use such a small number of people in this study. It just undermines any results found.

 

 

Results

What did they find in relation to the initial research question? I.e. visceral fat stores and inflammatory markers?

  • visceral fat stores.

The most accurate way to measure visceral fat stores in with CT imaging. I would expect a proper clinical trial testing a product to use this most accurate method. There other, less accurate ways to measure it according to this health website.

Screenshot 2016-05-11 14.05.31.png

So there’s a few ways to measure it- each becoming less accurate. They are- CT, Bioelectrical impedence machines, waist to hip ratio.

Which method did this study use to measure visceral fat?

They talk about weight loss amounts and produce charts and graphs but this is irrelevant to the question being asked. We want to know about visceral fat, the dangerous type that can increase your chances of having health problems. Normal weight loss is not a good indicator of this.

In the write up of results there is mention of some measurements taken. There are no figures, no statistical analysis. There is some anecdotal information thrown in too.

Screenshot 2016-05-11 14.21.49.png

There does not seem to be any attempt to measure waist-hip ratios which would have given some idea of visceral fat loss. (The third best way to measure this fat.) I am suspicious as to why the researchers have not done a thorough analysis and made their results properly known, seeing as this is what they initially set out to test.

 

  • serum inflammatory markers.

The best way to measure these according to Patient is to measure three things-

Screenshot 2016-05-11 14.16.37.png

The study reports that over half of the participants did not have their blood tests repeated after the 12 weeks. This is a major concern and seriously puts any results into jeopardy. There were only 19 participants anyway, to lose half of them at this stage is catastrophic! They blame the participants’ own doctors because they were supposed to be doing the tests. Why are the researchers not doing the blood tests? This all sounds a bit odd!

Anyway, what blood tests were done on the remaining 10 participants?

These are the tests that were done on the people in the non-placebo groups.

Screen Shot 2016-05-11 at 14.35.16

ESR and PV are not tested for. CRP is though. The CRP levels have been shown to reduce in the non placebo people and this is statistically significant.

What about in comparison to the placebo group then? Which is the comparison we are here to make. They don’t mention the placebo group on their own, but lump all the post-study blood together here and say they all improved.Screenshot 2016-05-11 14.40.17

Serum inflammatory markers have not been tested for adequately or compared between the groups at all. In fact, only one of the markers was tested, and then not properly compared.

Analysis of the paper’s conclusions

The conclusion does not mention at all the results of what hey set out to test. This is the bit where the original question is revisited, the results related back to this and meaningful conclusions drawn as to what the results might mean. Instead there is a rambling essay of things that were discovered along the way but this is meaningless if it was not studied properly.

 

Other observations

Many statements are included in the paper that are not backed up with research. This is very poor for a scientific study. If you are going to state something as a fact in a paper, you need to back it up. It is not enough to just include a list of references at the end. You need to annotate points as they arise. Sometimes this is done, mostly it is not.

There are many pages of irrelevant details that serve as descriptions of Ariix products. This is totally unnecessary.

The aim of the paper. Why was it written? This is offered in the introduction-

Screenshot 2016-05-13 10.05.07

I would have to conclude, after examining the evidence, that this is not a proper study at all, it is a very poor attempt at one. The inclusion of statements such as this one

Screenshot 2016-05-13 10.08.44.png

ring alarm bells at the assumptions being made. It is my considered opinion that this paper is psuedoscientific.

 

Conclusions

This is not in a peer-reviewed journal which means it has not been checked by experts. (As happens with normal research)

It is written by someone working for the company and she may also have been involved in making the product. Her professional qualifications are doubtful.

It is not placebo controlled as claimed in the paper.

It is not a cross-over study as claimed in the paper.

They set out to test visceral fat stores and inflammatory markers. They didn’t test visceral fat stores. Only half the people had inflammatory markers tested.

Only 23 people started the study, 19 completed it, 10 had blood tests done.

There are many pages of irrelevant information about the products.

The study is rambling, and disjointed. Groups of participants appear and disappear with no explanation. It is not properly referenced and follows very few basic scientific paper standards.

This study cannot be trusted in any way. No meaningful conclusions can be made from it. IT DOES NOT SHOW THAT SLENDERIIX IS EFFECTIVE.

 

 

 

 

 

 

 

 

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Critique of a Slenderiix paper

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