Bad science

Alternative medicine as a placebo

I recently wrote a post about the decision by NICE to no longer recommend acupuncture for lower back pain. This decision was made because, like most alternative medicine, acupuncture hasn’t been shown to work any better than a placebo. However, plenty of people use and get benefit from such treatments. This raises an interesting question: is there a place for complementary and alternative medicine (as a placebo) in the clinic?84109-80065The ethics of prescribing placebos is a complicated topic. People are perfectly entitled to use alternative medicine, and if they get a benefit, that’s obviously good. However, whether a doctor should prescribe alternative medicine is a different matter.As I have previously written, most complementary and alternative medicine works purely on the placebo effect. People argue that alternative medicine should be allowed to be prescribed, because if the placebo effect helps someone, then that justifies its use. Indeed, here in Glasgow we have an NHS funded “homeopathic hospital”, and if it helps people, why should we stop that?Unfortunately it’s not that simple. If a doctor prescribes such a therapy, it has the effect of offering a medical credibility to the therapy that doesn’t work. This may not sound like a big problem, but it is. There are many examples of people eschewing mainstream medicine for “natural” alternatives and herbal remedies.A court in Canada, for example, recently convicted the parents of a child who died from meningitis after they consulted a naturopath rather than a medical professional. The naturopath recommended the parents give ecinachia to their dying child. This isn’t an isolated case; it’s worth visiting the What’s the Harm website to see the toll that belief in pseudoscience can have.The reality is that if a doctor prescribes acupuncture for pain, then a patient is more likely to believe the plethora of false claims that an acupuncturist may make (including it being effective against diabetes, heart attacks, cancer and even ebola). This in turn increases the risk of patients postponing or declining evidence-based conventional treatment when it is needed. It was recently shown that women who were using certain alternative therapies were less likely to start chemo for their breast cancer. Regardless of whether someone benefits from the placebo effect given by an alternative therapy, it is simply not ethical to legitimise it as a practice. Furthermore, it is perfectly possible to give a placebo that does not come with the added nonsense, which brings me on to my next point.In 2008, the American Federal Trade Commission made a ruling on the use of the Q-Ray Ionised Bracelet in medicine. The makers argued that they could claim it was a cure for chronic pain because, like acupuncture and other alternative medicine, it exhibited the placebo effect. In his ruling on the case, the judge said the following:

“Like a sugar pill, it alleviates symptoms even though there is no apparent medical reason. Since the placebo effect can be obtained from sugar pills, charging $200 for a device that is represented as a miracle cure but works no better than a dummy pill is a form of fraud.”

When we can get the same or similar effects from a far cheaper placebo, then a doctor prescribing alternative medicine is ripping off their patient or the NHS. With already stretched resources, it is scandalous that the NHS pays £1.33 million per year to the Glasgow Homeopathic Hospital. People spend a huge amount of money on alternative medicine (it’s a $34 billion industry in the US), a product that doesn’t work, and is also completely unregulated.The unregulated nature of the industry is something that people are generally unaware of. Numerous studies have shown that alternative remedies regularly contain contaminants like toxic metals, pharmaceuticals, insects, rodents, parasites, fungi, pesticides and other fillers. These contaminants have led to serious illness is many cases, and several deaths. Prof. Edzard Ernst (former Chair in Complementary Medicine at the University of Exeter) has written extensively about this topic and is a good place to look for more information.The placebo effect has a significant role to play in health care. It can undoubtedly improve subjective symptoms in a number of contexts. However, while any effect alternative medicine has can be explained by placebo, the industry claims that it does much more than that. Couple this with the unregulated nature of the products and the expense involved, and it is clear that alternative medicine should never be given legitimacy by the mainstream medical community. I’ll leave you with this quote from Tim Minchin: 

"By definition", I begin"Alternative Medicine", I continue"Has either not been proved to work,Or been proved not to work.Do you know what they call "alternative medicine"That's been proved to work?Medicine."

https://www.youtube.com/watch?v=HhGuXCuDb1U

Gluten-free diets

The last few years have brought an increased awareness of the presence of gluten in our diets. In line with this, the Daily Mail recently ran an article headlined “Could going gluten-free boost your brain power? Landmark study reveals diet 'reduces fatigue and increases energy levels'”.breadThe article in question was published on the Mail Online. In it they report on a study that links a gluten-free diet to decreased fatigue, flatulence and bloating. There is so much wrong with the piece it’s difficult to know where to begin, so I’ll start with the most concerning issue: that the study was funded by Genius Gluten Free Foods.That’s right, this “Landmark” study was funded by the very people who will benefit most from its result. This fact alone throws up big red flags, but reading further brings up some other major issues.The study has not been published, neither online or in a peer-reviewed journal. I contacted the University of Aberdeen, The Rowett Institute and authors of the study, to try to get my hands on the data (or the press release the journalist was working from), but to no avail. From the article in the Daily Mail, I can say that the study itself had fewer than 100 people in it, far too small a sample size to say anything concrete unless the study used extremely stringent criteria (which it did not).Furthermore, the article itself points out that the participants ate a healthier diet while on the study, making it entirely possible (and likely) that the effects seen were not as a result of the gluten-free diet, but as a result of eating better in general.I could go on all day, but I’ll leave it at that. The article is clearly rubbish, but it does highlight the recent popularity of gluten-free diets however, and this is a topic about which there is a lot of controversy.Removing gluten from the diet has become big business. According to the BBC, 29% of American adults (70 million people) say they are trying to cut back on gluten. This results in a gluten-free market in the US of almost $9 billion. Here in the UK, sales of gluten-free foods were around £184 million in 2014, which shows just how common it has become.It is safe to say that there are certainly people who do benefit hugely from a gluten-free diet. These are people with coeliac disease, an autoimmune disorder that results a decrease in the ability of the intestine to absorb the nutrients it needs. It is thought that around 1% of the population have some level of coeliac disease, so it is a relatively common disorder. Additionally, most of that 1% are undiagnosed, so it is certain that a gluten-free diet can improve the symptoms of some people.Another group that may benefit from the diet are those with non-coeliac gluten sensitivity, but this is controversial, as it has not yet been shown that gluten sensitivity actually exists. The most definitive study into this (in 2013) showed that gluten was not causing the symptoms of the patients in their study. They laid the blame at the door of a group of carbohydrates known as FODMAPs (which are partially eliminated in a gluten-free diet). Other research has blamed ATIs, plant proteins that are common in grains. Regardless, diet clearly influences the symptoms in these people.With the caveat in mind that going gluten-free will help some people, it must be pointed out that the large majority of people trying to reduce the gluten in their diets have no need to. Studies have shown that at least two-thirds of people who claim they have non-coeliac gluten sensitivity cannot tell if they have been exposed to gluten or not. The design of that study also makes us confident that this is an underestimation. The same study showed that symptoms often got worse if the subjects thought they were eating gluten, suggesting that the nocebo effect plays a large role in their symptoms (I’ve previously written about the nocebo effect here. Put simply, it is an ill effect caused by the suggestion or belief that something is harmful).gluten free“Gluten-free” is a fad diet, albeit an extremely popular one. Gluten is widely perceived to be unhealthy, a contention for which there is little evidence. Celebrities (Gwyneth Paltrow, Miley Cyrus) and sport stars (Novak Djokovic) have further propagated this myth, leading to the boom in sales we have seen recently.The problem is that there are risks attached. It is known that some foods that are free from gluten are actually less healthy than the original variety because they may contain more fat or sugar and thus more calories. In order to attain the same texture and consistancy, starches and binding agents are often added. It has also been shown that avoiding wheat products can lead to deficiencies in nutrients such as folate.The majority of people who are gluten-free do it because they are under the impression that it is better for you. In reality, they are spending more money on products for no real benefit, and feeding an industry that encourages people to unnecessarily buy more expensive foods. Eating more fruit and vegetables is a much wiser investment.As I’ve already pointed out, there are people who benefit from a gluten-free diet. However, that is not the case for the majority. I’ll leave the final word to Dr. Ruth Kava, who is a Senior Nutrition Fellow at the American Council on Science and Health. She commented that “The bottom line is that if you don’t really need to go gluten-free, don’t bother. And to determine if you do, consult a gastroenterologist, not a celebrity diet guru.” Well said.

Have we explained how acupuncture works?

acupuncture1Acupuncture is a topic that divides people. It is seen by some as a little understood branch of medicine, by others simply as pseudoscience. The theory states that inserting needles at specific points can have effects on almost every ailment, from chronic pain and allergies to irritable bowel syndrome and even stroke. At present, however, there is little reliable evidence that acupuncture works any more than placebo, which makes this article from The Guardian quite unexpected:

Rats help scientists get closer to solving the mystery of acupunctureThe Guardian - 21/07/2015

The title is surprising because this was not a report on acupuncture. The scientists applied an electric current through the acupuncture needles. This technique is called transdermal electrical stimulation and is already used in the clinic to treat chronic pain. The authors, however, call it “electroacupuncture“, and equate it to acupuncture. They are not the same thing, and the conclusions are hence not about acupuncture at all.Scientifically there are many other problems with this study. This was a tiny experiment, with only 7 animals being tested with the “electroacupuncture”. It was not blinded, meaning that the experimenters knew what treatment they were giving to each animal. You may not think that this is an important issue, but consider this: studies on acupuncture in the West yield very mixed results, leading us to believe that the effects are either tiny or non-existent. In China, Japan and Taiwan, where there is a culture of belief, almost every single study shows a positive result. The belief of the experimenter can drastically influence the result of an experiment. Blinding is essential in such studies to overcome this.It is also worth drawing attention to the controls used in this study. The experimenters compare “electroacupuncture” to two controls: sham-acupuncture and no acupuncture. Sham-acupuncture is specifically in place to test for the presence of the placebo effect. Depending on the study, sham-acupuncture can be one of a few things, from inserting the needle at a random point in the body to the use of needles that retract into the sheath, so there is no penetration of the skin at all. In this study, the authors used the insertion of their electric needle at a non-acupuncture point as the sham.Tellingly, the authors did not report any difference between sham-acupuncture and acupuncture. The fact that this isn’t reported, and a look at the data presented in the paper, suggests that there is no difference between their “electroacupuncture” and sham. They only report that “electroacupuncture” seems to be slightly better than the no treatment control. So not only their results are unspectacular, but can be entirely explained by placebo effects. It is worth pointing out that the placebo effect can be extremely powerful, and people can see vast improvements when using any therapy that may not be due to the therapy themselves, but down to the placebo effect. This is why we control for it in trials.This control issue with the study is one that is common with other acupuncture research. It is regular these kinds of studies to see no difference between acupuncture and sham-acupuncture, and rather than conclude that acupuncture doesn’t work, they conclude that both acupuncture and sham-acupuncture work, and this is just not true! If a drug had the same level of effect as a sugar pill, we wouldn’t conclude that both are working. Unfortunately, it is rare for studies into pseudoscience to hold themselves to the same standards.Put simply, this is a badly designed study, from which the authors conclude that acupuncture works, seemingly without actually looking at acupuncture at all. At present, we cannot even say that there is a “mystery of acupuncture”, as described in the headline of this article. There is no mechanism in science or medicine through which sticking needles into particular points around the body can have very specific effects on other parts, so to claim acupuncture works would require convincing evidence (extraordinary claims require extraordinary evidence). This is certainly not that.

Can we predict cancer a decade in advance?

Telomere_capsThe Daily Mail, The Telegraph and The Independent are among the many media outlets that reported this week that we could predict cancer a full decade before it appears. Some outlets even went as far as to claim that we could predict it with 100% accuracy 13 years in advance. Unfortunately however, this is media hype of a study that makes claims its data cannot support, helped by a poor press release. There is some interesting science behind this headline, but the simple fact is that we cannot detect cancer that far in advance. If a news story appears too good to be true, then it probably is.The cancer test that these articles are referring to is telomere measurement. Telomeres are protective caps on our DNA. They are found at the end of every chromosome and protect the DNA from degradation. They are often compared to the plastic tips at the end of shoelaces, which protect them from unravelling. They are needed because cells in your body divide at an incredible rate, and every time a cell divides new errors can be introduced to the DNA.To try to get around this problem, every very time a cell divides the telomeres get a little shorter, and when the telomeres get too short, the cell stops dividing. This ensures that no more damage is accumulated, and makes sure that older, damaged cells stop dividing. As a result, telomeres play an important role in ageing (older cells have shorter telomeres than young cells), but also in cancer. Cancer cells, which divide indefinitely, are able to overcome this natural stopping mechanism by building their telomeres back up. Because of this, telomeres have been studied in cancer for decades.This week, a study was published in EBioMedicine which tried to relate changes in telomere size with the odds of developing cancer. To do this, the authors tracked the changes in telomeres in our blood cells over the course of 14 years. They then looked at these changes in patients who developed cancer during the course of the study, as opposed to those who were cancer free. What they report is that patients who are going to develop cancer lose their telomeres at a quicker rate until 3 – 4 years pre-diagnosis, when the trend reverses and the telomeres loss slows down. They suggest that this could be used to predict cancer years before standard diagnosis is possible.The paper has several problems, particularly with the interpretation of the findings. I have included a more technical explanation of some of these problems in “Further Explanations” below, but the authors themselves acknowledge some of these in their discussion.

“Thus, caution should be exercised in interpreting our results as different cancer subtypes have different biological mechanisms, and our low sample size increases the possibility of our findings being due to random chance and/or our measures of association being artificially high.”Hou et al. EBioMedicine 2015

They correctly point out that various cancers act very differently, and crucially that their conclusions may be down to pure chance. This type of correlational study (where measurements are taken and then compared with other things to see if they correlate) is useful as initial data to inform what needs to be studied further, but it is very prone to false positives. It is inevitable that pure chance will cause some correlations in the data. For example, in this study they also reported that less educated people have longer telomeres than their more educated counterparts. Whether this, or the correlation they found with cancer, is true or not can’t be determined without further study.The scientific method is based on the reproducibility of experiments, with the more implausible the finding, the greater the need for repetition. In this case we have an implausible finding using questionable interpretations of the data. While it can’t be ruled out that there is some truth in this finding, it would need to be extensively studied further before any concrete conclusions can be drawn about telomere length in the blood and cancer. But for the time being, we can say that we won't be predicting cancer with this method any time soon.Further ExplanationTelomeres Fig 2The biggest problems I have with this paper are in Figure 2 (above). Firstly, the authors base their conclusion on the fact that there is a statistically significant difference between the groups 3 – 5 years pre-diagnosis (demonstrated in the Figure with “*”). This seems like “cherry picking”, whereby people pick their data to suit their hypothesis. As you can see, any difference between the groups disappears in the 1 – 2 years before diagnosis, a fact that is ignored by the authors. Should their hypothesis be correct (and the cancer is causing decreased telomere degradation), the difference in telomere length should persist.Secondly, the comparison they make in this figure is between the years before people got diagnosed with cancer, versus years before the end of the experiment. As the people who get cancer are inevitably younger than the people who get to the end of the experiment without it, the cancer-free people in this analysis are likely to be significantly older than those diagnosed with the disease. The authors have already shown that telomere length declines with age, so this could be playing a major role in the observed results.