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Research Flaws

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The Scientific Validation of Herbs Part 2

(Read part one)

2) Research Flaws
Flawed research is really an extension of what I was just writing about. It is important to consider research flaws, because if the research used as the basis of an evidence-based practice is flawed, then people are not getting the highest quality of care. Scientifically, there is not a study out there that is flawless. Indeed, researchers get together weekly, review other people’s work, and discuss the limitations (which is an nice way of saying they tear the research apart).

Actually one of the most flawed scientific designs from a practical perspective is what is considered the gold standard of clinical research: the double-blind, randomized, placebo-controlled study. The assumption behind this research design is that substances have inherent power and efficacy and that people’s opinions, attitudes, beliefs, expectations, and intentions also have power. This research is designed to tease apart the inherent power of the drug from the inherent power of the mind. This is a worthy goal, but this research tends to devalue the mind’s power and suggest a substance’s power is more real or valid. Indeed, the placebo effect is often eluded to as an effect that is not really real or worthy of notice.

Personally, I do not understand why, once people recognized the placebo effect, researchers didn’t focus more on optimizing the inherent healing ability of the mind. If the mind is so powerful, why are we even bothering with drugs? I suppose this may have something to do with the economics of selling drugs. In addition, this type of research is just a left-over from the limiting worldview based on Newtonian physics. In Newtonian physics a drug has an action and will always produce a predictable effect. This is a comfortable idea for many people. Quantum physics supports the idea that a wide range of possibilities are possible and that we, as humans, can influence the outcome of a drug’s effect.   Explaining the world as cause and effect will eventually fall by the wayside, along with double-blind, placebo-controlled studies, as our society adopts a worldview more in alignment with quantum physics.

What is the greatest limitation of research that is based on the double-blind, randomized, placebo-controlled study? Well, it is possible that some substances are more active when combined with the mind. This important interaction is neglected in a study designed to take all human connection and intention out of the picture. Further, human variation is amazing. It is possible that people will gravitate to the right treatment for their health problem and the idea of randomly assigning them to a test group limits the broad applicability of the results. A treatment that “doesn’t work” with the population tested, may actually be the perfect cure for certain individuals that might naturally seek out that treatment.

Other common flaws in herbal research are:

Dosing does not reflect clinical practice. I’ve seen this in research on herbs versus the common cold. I, personally, can stop any cold using Berberis. The key things are starting at first onset of cold symptoms and using high and frequent doses as needed to stop symptom progression. If I start when I just feel tired, I just need a squirt or two of tincture every once and awhile. If I start after my throat feels sore, I need a squirt of tincture every half hour until my throat doesn’t feel sore, then I can cut back.

Research was done on a single herb that is usually used in combination. Or vice versa, the research tests a proprietary blend. I was taught that herbs are feeble, but that the target effect of a combination of herbs can have a bigger impact. Still, many herbs are tested using the drug model that ignores the synergistic effects of herbal combinations.

Research was done on a form of the plant not usually used clinically. Often times companies want to validate their product and they fund research on their preparation. It is common to assume that all preparations of the plant will work similarly, but that is just an assumption. It is also assumed that each batch of the plant will work similarly, but because of natural product variability, you cannot even count on that.

Natural products and extraction methods are variable. This is not really a flaw in the research, but does represent a limitation of using research reports about herbs. I used to get menstrual migraines. I was using an alcohol extract of feverfew to reduce the frequency and intensity of those headaches. It seemed to be working. Then some research was released that demonstrated that the powered herb was effective, but not an alcohol extract. I believed it and stopped using the tincture. My headaches got worse. When I resumed taking the extract I once again experience fewer headaches with milder intensity.

Botanical product not characterized. Much of the older herb research doesn’t even report if they confirmed they had the right plant or the correct part of the plant (root vs leaf vs seed, etc). Sorry, scientists make the assumption if they buy something it actually is what they think it is, but herbs are not as straightforward as chemicals. They may also neglect to explain how the plant was extracted. In addition, the chemical analysis of the plant, which is critical to determining if one batch is equivalent to another, is rarely done or reported. Again, there was an assumption that natural products have no variability.

A traditionally used herbs was tested out of context. When herbs are used as part of traditional healing systems other components, such as ritual and/or song, may be necessary to activate the herb. For instance, in Tibetan Buddhism there are mixtures of herbs that allow meditative practitioners to go for long periods of time without food. These herbs have to be activated by special words (mantras) and are used in conjunction with specific practices.

Nettles

Wild Nettles

Test subjects do not match you. The results of using an herb may differ based on the person’s lifestyle, diet, ethnicity, etc. For instance, nettles is a common nutritive herb and food. Indeed, in Britain it is sold as cream of nettles soup. In United States and United Kingdom it is considered to be completely safe to use in any quantity. It really is a food and many women use it during pregnancy because it is rich in minerals. The fresh plant is also a potent anti-histamine and perfect for allergies. I once recommended it to a pregnant friend with hayfever. She was early in her pregnancy and started having uterine cramping/contractions. Thanks to the internet, I was able to find out that nettles does have this effect on Indian women.

Delivery method is not traditional. Some of the research coming out of Europe, where use of herbs is a standard practice in medicine, uses injectable herbal extracts. The results of an injectable form may not reflect what the herb does if taken orally. One example is the treatment of Amarita mushroom poisoning using a milk thistle extract intravenously. In the United States, mushroom poisoning is treated with liver transplants. We don’t have the IV extract they have in Europe and the oral preparations will not protect a liver from Amarita mushroom poisoning. (If you are going to eat poisonous mushrooms, better do it in Europe. Think about the differences in cost and human suffering!)

Placebo used was not really inactive. It is hard to find an inert substance to match a strong tasting herb for a placebo controlled study. I’ve seen research on the common cold that used alfalfa as the placebo. Apparently the researchers didn’t know that alfalfa is an herb that is used in the treatment of the common cold. It’s not a primary defense, but it does support the body’s ability to carry waste out of the body.

Subjects can figure out if they have the placebo or herb. If the researchers pick something that is really just filler, many people can figure out they don’t have the active substance and the study is not longer “blind”. When I was at UC Davis a women enrolled in a long term study involving gingko and the prevention of Alzheimer’s called me. She was worried about developing the disease and did not want to spend years on the placebo. I told her to just open the capsule and taste the contents. It did have flavor, but she wanted to be sure it was gingko so she came over. I tasted it and assured her she was getting gingko. Opps! Study no longer placebo controlled.

Confounding factors matter. Research has shown that the color of the tablet makes a difference in psych medications. The timing of treatment also makes a difference.   Rats undergoing radiation therapy for cancer will either live or die depending on the time of day the treatment was given due to daily fluctuations in cortisol levels. Season and stage of the lunar cycle may also be important in treatment outcome. And, of course, intention and subconscious beliefs can influence treatment results.

3) Incomplete and Inaccurate Research Reports
Read more…

CREDITS:  Urtica dioica by Franz Xaver – Own work. Licensed under CC BY-SA 3.0 via Commons – https://commons.wikimedia.org/wiki/File:Urtica_dioica_1.jpg#/media/File:Urtica_dioica_1.jpg

Placebo

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I’ve been so busy with work and school, it is so good to finally have some time to write.

This week we studied co-occurring disorders.  I was especially interested in the perspective presented on depression.  Mainstream medicine appears to be in denial around the use of anti-depressants.  Research consistently shows that antidepressants do not work any better than placebo.  So why do we still use them?  They get approved as drugs because they do have a statistically significant effect on depression.  However, that effect is not clinically significant.

The difference between clinical significance and statistical significance can be described like this:  Le’ts say that people start the study with depression reported as a 7.0 on a ten point scale with the most severe depression being 10.  And at the end of the study they have improved to a 4.0.  That’s great!  They are feeling better.  However, the placebo controls have also improved and they come in at a 4.1.  For our example the 4.0 is statistically different than the 4.1.  However the difference between placebo and anti-depressant is not clinically different.  People just don’t say, “my depression is down to 4.0 from 4.1 and I feel the difference.”

Different ailments appear to have respond differently to placebo.  Depression is highly responsive to placebo.  Research from 1999 found the effects of placebo on depression to be 75%.  However, these placebo effects on depression have been continuing to grow over the past couple decades, so that now we are finding certain antidepressants no better than placebo.  Menopausal hot flashes also have a nice placebo response.  And at least one third of the results of pain relief can be attributed to placebo effect alone.

Placebo, or context effect as I like to call it, has been extensively studied.  We know some of the things that will increase the likelihood of a treatment being effective.  These range from the color of the pill to patients perception’s of the health care practitioner.   Placebo effect is really not much different than marketing.

The mental health practitioner doesn’t realize that when they listen attentively to their client, label them with a disorder name (e.g. “You have bipolar depression.”) and tell the client that there is a pill that will “stabilize their brain chemistry” they are actually marketing the treatment.  They may also tell the client that the drug’s effects could “kick in” immediately, or they might occur slowly over a period of a couple months.  This gives the client options on how to respond to their “placebo/antidepressant”.  If the client then runs into someone that is on “their” antidepressant and they say it “saved their life”, they have additional context to boost the effectiveness of the treatment.

The word “placebo” has gotten a bad wrap, in the sense that only a fool would respond to placebo effect.  That is one of the reasons I prefer “context effects” over “placebo”.  Context matters and optimizing context to support healing seems like a good strategy, not a unethical strategy.  Certain settings, particular colors, and personal biases make a difference in treatment effectiveness.  Does optimizing context fall under the adage of “first do no harm” or does it harm someone to play into their natural tendencies to put faith in certain people, places and things?

REFERENCES
Kirsch, I., (2008). Challenging Received Wisdom: Antidepressants and the Placebo Effect.  McGill Journal of Medicine, 11(2): 219-222.

Di Blasi, Z. & Kleijnen, J., (2003).  CONTEXT EFFECTS:  Powerful Therapies or Methodological Bias?  Evaluation & The Health Professions, 26(2), 166-179 DOI: 10.1177/0163278703252254.

Cholesterol and Coconut Oil

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High cholesterol, high blood pressure and cardiovascular disease run in my family.  Both my mother and father have had coronary artery bypass operations as did my paternal grandfather.  Being interested in health and knowing my predisposition, I have followed my cardiovascular risk markers with interest.  I believe that improper diet and inadequate exercise play a significant part in the development of heart disease as well as in cancer, type 2 diabetes and many other diseases.

This year, my fiftieth year on the planet, I checked in with blood pressure 110/70, an unremarkable echocardiogram, and total cholesterol at 201 (just a point above the desirable range).  However, a closer look at the cholesterol readings showed that my HDL, the cholesterol that has the beneficial role of acting like a scavenger in the body, was off the chart at 75.  The standard range for HDL is 40 to 59 mg/dl. It was my elevated HDL level that actually put my total cholesterol slightly over range.

My first question was – what does it mean to have HDL way above normal?  Naturally, I did a Google search.  What I found was when HDL is higher than normal it is actually considered protective.  My risk for cardiovascular disease was actually lowered!  (Trumpets sound here!)  All the energy I devote to living a simple, healthy lifestyle paying off.

I then began to wonder – what caused my increase in HDL?  When searching on that question I bumped right into the answer:  Coconut Oil.  Researchers have found that coconut oil consumption is associated with higher levels of total cholesterol and HDL.  (2011)

Every morning for breakfast I have a cup of germinated brown rice with some type of legume dish, typically chili or lentil soup. For years, I adorned the rice with Spike (a salt seasoning blend) and about 1 to 2 teaspoons of flaxseed, hempseed, or other oil high in essential fatty acids.  Then I discovered coconut oil.  It has such a lovely flavor that I started using it on my rice.

Now one of the things about me, the thing that makes my experiment with right diet for a healthy heart so daring, is that I don’t buy into the mainstream ideas.  For instance, when they said eggs were bad for my heart, since they were high in cholesterol, I defied the mainstream ideas and had two or three a day.  When people were switching over to margarine, I was still eating salted butter (I like it plain…).  They think salt raises blood pressure?  Great, I eat as much of it as I can.

Now “they” were saying coconut oil was good for my heart because it increased HDL.  My reaction?  I immediately cut back and started eating more flaxseed oil again.

Yes, I understand that HDL is associated with lower cardiovascular risk, but that is HDL that is naturally high.  My HDL was being artificially elevated by increased intake of coconut oil.  This doesn’t mean that it is beneficial.  It also doesn’t mean it is not beneficial.

This is the mistake people made with eggs.  They thought “eggs have cholesterol,”  then, “Cholesterol is bad” and finally decided “eggs are bad”.  I knew coconut oil raised HDL and I suspected that it has a place in my healthy diet, but I wanted to see some direct evidence about whether it was really beneficial.

To achieve my objective I had to move away from the mainstream news and information websites and into PubMed for primary literature.  I wanted to read, first hand, what scientists had found.

The first thing I discovered was that a 2009 research study reporting on the effects of dietary coconut oil consumption in women with belly fat was being misrepresented by some major health information websites.  The study showed after 12 weeks women that added coconut oil (vs soybean oil) to their diet had a significant reduction in waist circumference.

The first misquote I found said the reduction was after only one week. However, the biggest issue I have was that the reduction was not “real world” significant.  The women using soybean oil (2 Tablespoons (30ml) a day) had a drop of 0.6 centimeter (about a quarter inch) while the women using coconut oil dropped 1.4 cm (just over half an inch).  We are talking about a 1/4 inch difference (technically it would be 5/16ths of an inch) between the two groups. Anybody out their measure their waist lately?  I would say the error in measurements would be greater than a quarter inch!

Next study I looked at was from 2012.  Nice research that investigated what happens to atherosclerotic plaques when people living in Kerala, India switch from the coconut oil they’ve used all their lives to sunflower oil because they have cardiovascular disease.  Well designed study –  but the fact they found 71 people that had used coconut oil all their lives and were undergoing coronary artery bypasses suggests that coconut oil is not a miracle cure nor a miracle prevention for heart disease.

Their results?  The switch to sunflower oil for at least a year didn’t change the composition of the plaques at all.  Here we have a situation where the details of the study are more interesting than the results.  It is interesting to me that the researcher found a population of long term coconut oil users with heart disease. In addition, many of the participants had diabetes and hypertension as well as coronary artery disease.

The last study I looked at was perhaps the most negative regarding coconut oils benefits.  Completed in 2006, it revealed that six hours after a meal (carrot cake and a milkshake made with about two ounces of oil) HDL from people ingesting coconut oil made the cells that line blood vessels more inflammatory than the HDL from safflower eating people.

There were some limitations to the study design and other researcher have published comments suggesting that the differences observed were due to safflower oil having a greater concentration of Vitamin E rather than the fact it is a polyunsaturated oil.  Christopher Masterjohn says,

Compared to coconut oil.. safflower oil contains 77 times the alpha-tocopherol, more than 100 times the gammatocopherol, and 73 times the total tocopherol.

This suggests if you normalize for vitamin E there may have been no difference between coconut oil and safflower oil.  In other words:  their results are inconclusive.

All this said, I’m still looking for evidence regarding the benefits of coconut oil in cardiovascular disease.  In the meantime, it is remains a tasty addition to my morning rice on occasion.

REFERENCES
Asia Pac J Clin Nutr. 2011;20(2):190-5.
Lipids (2009) 44-593-601
J Am Coll Nutr. 2012 Dec;31(6):392-6.
J Am Coll Cardiol. 2006 Aug 15;48(4):715-20. Epub 2006 Jul 24.
J Am Coll Cardiol. 2007 May 1;49(17):1825-6. Epub 2007 Apr 16.