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Clinical Trials- The importance of them; Ensayos clínicos

A lot of people sometimes base their claims on scientific studies, but the funny thing is they don´t even know how to understand that scientific study and, just because a scientific study comes out, it doesn´t really prove anything, especially if the scientific trial is not done correctly. So, I just want to highlight some interesting points that most people should know. Below I have also translated it into spanish.

The scientific study should be RANDOMIZED: This means that when we do a study, we should assign patients to each group ¨alternatively¨ and ¨indiscriminately¨. Let´s use an example: I´m testing this new pill for a headache. I have 2 groups, the group that is receiving a pill and the group that is not receiving anything. Imagine in one group I put young people, who exercise, eat properly and have no history of headaches, and in the other group I put obese people, who don´t do any sports and have a history of migraines. This would affect my results. But if the patients are randomly assigned to groups, then it can be assumed that both groups will be broadly similar in terms of any factor, such as age, income, gender.

The number: The more patients in a study, the better.

Sometimes it is not possibile to do a randomized scientific study so they do a ¨prospective cohort study¨ or an ¨observational study¨. This is a step down from a randomized trial but, if done properly, you can still come to decent conclusions. This studies are usually done for long term health issues. For example they did this kind of test in the 50´s to see if smoking was bad. What they did in this study was:

  1. The participants had to be established smokers or really Non-smokers, meaning they had never smoked in their life.
  2. The participants had to be reliable and dedicated.
  3. In order to control for other factors, it would help if all the participants were similar in terms of their backgrounds, income, working conditions.

So they got DOCTORS, over 30,000 doctors, and they observed them during 5-10 years. That is how they proved that smoking is horrible to our health.

Ok, so now that we know that there are at least 2 types of scientific studies.  And we  also know that a randomized trial is  usually better but it should follow certain rules:

  1. We have to test for PLACEBO. A genuine medicine offers a benefit that is largely due to the medicine itself and partly due to the placebo effect, whereas a fake medicine offers a benefit that is entirely due to the placebo effect. So for example, in the example I used about the headaches, I would also need a group that is taking a ¨fake pill¨ which would be my control group. In other words, I would have one group who takes the real medicine, another group that takes nothing, and a third group who takes a fake pill. If this is done then it´s called a RANDOMIZED, PLACEBO CONTROLLED TRIAL
  2. Blinding- meaning the patients don´t know what they are getting, the real or fake treatment. This is really important and can affect the outcome of the study!! But, it is also CRUCIAL that both the control group and the treatment group are treated in similar ways, because any variation can potentially affect the recovery of patients and bias the result. If this is done then it´s called a RANDOMIZED; PLACEBO CONTROLLED, BLIND CLINICAL TRIAL
  3. Double blinding-  Meaning whoever is administering the treatment or placebo should also be ¨blind¨. This is because a doctor´s demeanour, enthusiasm and tone of voice can all be affected by knowing that he or she is administering a placebo, which means that the doctor might unconsciously give hints to the patients that the medicine is merely a placebo. If this is done then it´s called a RANDOMIZED, PLACEBO CONTROLLED; DOUBLE-BLIND CLINICAL TEST and this is the GOLD STANDARD of clinical trials!!

So next time you see a study, lets try to look for these things to see how serious the study really is.

 

Este va a ser uno de mis post más importantes y por eso he decidido traducirlo al castellano. Muchas veces nos basamos nuestras conclusiones en diferentes estudios que hemos visto o leido, pero lo gracioso es que muchas veces verdaderamente no entendemos esos estudios. Y solo porque veamos un estudio que llegue a una conclusión, no signifique que la conclusión sea verdadera, ya que el estudio puede haber tenido varios fallos. Entonces, ¿en que cosas nos tenemos que fijar para saber si un estudio es válido?
1) Que el estudio se ALEATORIO: Esto quiere decir que cuando se hace un estudio los pacientes de este estudio tienen que haber sido elegidos ¨alternativamente ¨ e ¨ indiscriminadamente. Por ejemplo: Imaginaros que estoy haciendo un ensayo clinico sobre una pastilla que supuestamente quita el dolor de cabeza. Tengo 2 grupos y en uno de esos 2 grupos pongo a gente que es deportista, come bien, poco estres, y joven. Y en el otro grupo pongo a gente mayor, obesa, depresiva, y no hace deporte. Lo más seguro que esto afectaria los resultados de mi estudio. En cambio, si los pacientes son asignados al azar a los diferentes grupos, se puede suponer que ambos grupos serán muy similares en términos de cualquier factor, como la edad, el ingreso, el género y salud.
2) El número: Fijaros en el número de pacientes que tiene ese estudio. Si ese estudio se ha hecho en una persona o en pocas personas los resultados no se pueden extrapolar. En cambio, si el estudio tiene a 500 pacientes pues las conclusiones seran más validas e fiables. Entonces, cuantas más gente en un estudio mejor.

*A veces no se puede hacer un estudio científico aleatorizado así que se hacen otros estudios, cono un estudio de ¨cohorte prospectivo ¨ o ¨un estudio de observación ¨. Estos estudios no son tan fiables como los ensayo aleatorios, pero si se hace correctamente se puede todavía llegar a unas conclusiones dignas. Estos estudios se realizan cuando el estudio va a durar mucho años. Por ejemplo , un estudio muy famoso de este tipo fue el que se hizo en los años 50 para ver si tabaco era perjudicial para la salud. Lo que hicieron en este estudio fue:
•Los participantes tenian que ser fumadores ¨establecidos¨o no fumadores, es decir que NUNCA habian fumado
•Los participantes tenian que ser gente en la que se pueda confiar y dedicados
•Y para controlar otros variables, intentarón elegir a participantes con el mismo estilo de vida en lo que se refiere a, educación, dinero, condiciones de trabajo.

Pues para cumplir estos requisitos eligierón a MEDICOS. En total unos 30.000 médicos. El estudio tenia que durar 30 años pero al cabo de 5 años lo pararon porque ya tenian suficiente información para concluir que el tabaco era perjudicial para la salud humana.
Ok, así, que ahora sabemos que hay por lo menos 2 tipos de estudios científicos.También sabemos que un ensaño aleatorio suele ser mejor, pero para que esto sea cierto el estudio tiene que cumplir ciertas reglas .
1.
Tenemos que contralar contra el efecto placebo. Un medicamento real ofrece un beneficio que es en gran parte debido a la propia medicina y en otra parte debido al efecto placebo, mientras que un medicamento falso ofrece un beneficio que es enteramente debido al efecto placebo. Así que por ejemplo, si estoy probando si un medicamento es efectivo contra el dolor de cabeza,tendre que tener un grupo ¨controlado¨. Es decir, un grupo que toma la medicación falsa sin que ellos sepan que el medicamento es falso. Si en el estudio se ha controlado contra el efecto placebo, al estudio se le llama ESTUDIO ALEATORIO, AL AZAR, Y PLACEBO CONTROLADO

2.
E lciego- los pacientes no saben si están recibiendo el tratamiento real o falso. Esto es muy importante y puede influir en el resultado del estudio! Pero, también es fundamental que tanto el grupo control y el grupo de tratamiento son tratados de manera similar, ya que cualquier variación puede afectar potencialmente la recuperación de los pacientes y el sesgo de los resultados. Si esto se hace el estudia se le llama ESTUDIO ALEATORIO, CIEGO Y CONTROLADO CON PLACEBO .

3.
El doble ciego-que significa que el que está administrando el tratamiento en el estudio no sabe si esta dando la pastilla verdadera o el placebo. Esto se debe a que la conducta de un médico puede influir en el resultado de un estudio. Inconscientemente puede dar pistas ( el entusiasmo, tono de voz) a los pacientes que el medicamento es un mero placebo o que es verdaderamente el real. Si se hace esto, entonces el estudio se le llama ESTUDIO ALEATORIO, DOBLE CIEGO Y CONTROLADO CON PLACEBO y este es el estándar de oro de los ensayos clínicos!

Normalmente los estudios de calidad han demostrado que la ¨medicina alternativa¨no tiene ningún efecto más que el placebo.

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Alternative medicine part 3

My last post has created some controversy and some people were not happy with what I had written. I even got a couple of e-mails asking why I was so harsh with ¨alternative medicine¨. The senders said that, in their case, they had tried ¨alternative therapy¨ and it had worked for them, whereas ¨real medicine¨ had failed. And if their problem was one that had to do with pain or some other disease that is ¨subjective¨, I believe them. Yes, that´s right I believe them, but not for the reasons they think that the alternative therapy worked. I´ll use the example of pain and I will try to explain it.

In my last post (click here) I gave an example of an experiment which demonstrated that, subjectively, everything works. There wasn´t really any difference between any of the treatments, right? Well, pain is a very subjective feeling. We can´t measure pain. Some people have a small injury and lots of pain, while other people can have a huge injury and no pain. Pain is influenced by stress, anxiety, your beliefs, attitude, and a thousand other things. That is why pain is very complex, after all, pain is in the brain (click here). Your belief in a therapy can even influence pain, so if you belief something is going to help you with your pain then it probably will! And that may be the reason why sometimes alternative therapy helps these patients.
Now, when you have a disease that can be measured, for example diabetes, asthma, high blood pressure, etc. alternative therapy simply doesn´t work.  Because different trials have shown that  alternative  therapy is no better than placebo. A pill is horrible and I wish doctors would stop prescribing so many of them. But a pill is only released onto the market when it has been proven that is has a BETTER effect than placebo, while with alternative therapy that doesn´t happen. 
But not only this, if we look at the logic behind these alternative therapies we realize that there is no logic. For example, acupuncture bases itself on the principles that a ¨life force called qi flows through bodies along 12 channels or ¨meridians¨, and that illness and pain occur when qi cannot flow freely. Science cannot do a lot of things but it can measure energy, and ¨QI¨has never been found.
Homeopathy dilutes one drop of the original substance  in a hundred, thirty times over, meaning  that less than one part per million of the original solution is in the final product, but this doen´t matter because homoeopathist believe that ¨water has memory¨.
I will say, though, that most alternative therapists usually listen better to their clients, they create a greater bond than a doctor does with his client. If you are lucky the doctor will maybe give you 5 minutes and prescribes you something. I think this is horrible and something that should change. The best thing would be to combine both treatments, things that have been demonstrated to work in clinical studies, with the care and effort that alternative therapists treat their patients.
So in conclusion: I believe those patients 100% when they say that the alternative therapy worked for them… but it´s not for the reasons why they think it worked.
References
  1. Singh S, Ernst E. Trick or Treatment? Alternative medicine on trial. Transworld Publishers.2009
  2. Shang A, Huwiler-Müntener K, Nartey L, Jüni P, Dörig S, Sterne JA, Pewsner D, Egger M. Are the clinical effect of homeopathy placebo effects? Comparative study of placebo-controlled trials of homoepathy and allopathy. Lancet.2005
  3. Ernst E. Homeopathy: what does the ¨best¨evidence tell us? Med J Aust. 2010 Apr 19;192(8):458-60.
  4. Ernst E, Lee MS, Choi TY. Acupuncture: does it alleviate pain and are there serious risks? A review of reviews. Pain. 2011:152:755-64.
  5. Shang A, Huwiler-Müntener K, Nartey L, Jüni P, Dörig S, Sterne JA, Pewsner D, Egger M. Are the clinical effect of homeopathy placebo effects? Comparative study of placebo-controlled trials of homoeopathy and allopathy. Lancet.2005
  6. David Colquhoun (UCL) and Steven Novella (Yale). acupuncture is a theatrical placebo. Anesthesia & Analgesia, June 2013 116:1360-63
  7. Asbjørn Hróbjartsson, M.D., and Peter C. Gøtzsche, M.D. Is the Placebo Powerless?-An analysis of clinical trials comparing Placebo with no Treatment.N Engl J Med 2001; 344:1594-1602.

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Alternative medicine part 2: subjectively – objectively

Anyone who has followed me knows that I am not a big fan of alternative medicine. Not because I have anything against it, it is just because it doesn´t really work. Study after study has found that alternative medicine is just NO good (1-4), and when they have found that something really works, well, it stopped being called alternative medicine and started being called MEDICINE.

The thing is, sometimes when you visit one of these ¨alternative therapists¨, you may come out feeling better and thinking ¨his medicine or therapy is working¨. Now, a couple of factors may come into play why ¨his therapy may be working¨,  like the ones I mentioned  in one of my previous blogs (click here). But, people sometimes don´t understand this quite well so I want to explain it with an example.

Three years ago they did a study on asthma (5). Now, I first want to mention that we know how to treat asthma. If you have asthma and take your medication you probably won´t have any problems and can live a normal life. However, if asthma is not treated properly it can lead to complications and even death. annually 250,000 people worldwide die due to asthma (6).

Ok, so the experiment went like this: There were 4 groups of people with asthma. Each group was treated with a different technique. One group was given the real medicine (albuterol), another group was given fake medicine (fake albuterol or fake inhaler), another group received sham acupuncture (there is really no difference between sham acupuncture and real acupuncture (7-12)), and the last group received nothing, they were only controlled.

SUBJECTIVELY all 4 groups improved a lot. A visual analogue scale was used to measure this (with 0 indicating no improvement and 10 indicating complete improvement). The results went as follows:

  1. ALBUTEROL- 50% improvement
  2. FAKE ALBUTEROL- 45% improvement
  3. SHAM ACUPUNCTURE- 46% improvement
  4. NO INTERVENTION CONTROL- 21% improvement

This is so important because there was really no difference between the fake treatments and the real treatments. After the experiment the patients felt quite good.

Now, OBJECTIVELY, meaning they can measure it (they measured the percent change in Maximum Forced Expiratory Volume in 1 Second), they all improved!! And here are the results:

  1. ALBUTEROL- 20.1% improvement
  2. FAKE ALBUTEROL- 7.5% improvement
  3. SHAM ACUPUNCTURE- 7.1% improvement
  4. No-INTERVENTION CONTROL- 7.1% improvement

The real medicine worked 3 TIMES BETTER than all the fake medicines, even though subjectively there was barely any difference. This is important because, like I said before, if asthma is not treated properly it can lead to a lot of complications and even death!!  Subjectively you may go to an ALTERNATIVE THERAPIST and feel great, but objectively it probably isn´t helping you too much. Because alternative medicine is no better than Placebo (1-4).

Another thing to take into account from this study, is the power of the brain. Because even though the 3 ¨fake groups¨ are inefficient in treating asthma, they (objectively) improved the outcome of each patient. Even the group that was only being observed!!! This phenomenon is called Hawthorne effect and it means: Clinical improvement in a group of patients in a clinical trial that is attributable to the fact of being under study!!

Hoped you liked it

References

  1. Ernst E, Lee MS, Choi TY. Acupuncture: does it alleviate pain and are there serious risks? A review of reviews. Pain. 2011:152:755-64.
  2. Shang A, Huwiler-Müntener K, Nartey L, Jüni P, Dörig S, Sterne JA, Pewsner D, Egger M. Are the clinical effect of homeopathy placebo effects? Comparative study of placebo-controlled trials of homoeopathy and allopathy. Lancet.2005
  3. David Colquhoun (UCL) and Steven Novella (Yale). acupuncture is a theatrical placebo. Anesthesia & Analgesia, June 2013 116:1360-63
  4. Asbjørn Hróbjartsson, M.D., and Peter C. Gøtzsche, M.D. Is the Placebo Powerless?-An analysis of clinical trials comparing Placebo with no Treatment.N Engl J Med 2001; 344:1594-1602.
  5. Michael E. Wechsler, M.D., John M. Kelley, Ph.D., Ingrid O.E. Boyd, M.P.H., Stefanie Dutile, B.S., Gautham Marigowda, M.B., Irving Kirsch, Ph.D., Elliot Israel, M.D., and Ted J. Kaptchuk. Active Albuterol or Placebo, Sham Acupuncture, or No Intervention in Asthma.N Engl J Med 2011; 365:119-126
  6. http://www.aaaai.org/about-the-aaaai/newsroom/asthma-statistics.aspx
  7. Linde K, Streng A, Jürgens S, Hoppe A, Brinkhaus B, Witt C, Wagenpfeil S, Pfaffenrath V, Hammes MG, Weidenhammer W, Willich SN, Melchart D. Acupuncture for patients with migraine: a randomized controlled trial. JAMA. 2005;293:2118–25
  8. Melchart D, Streng A, Hoppe A, Brinkhaus B, Witt C, Wagenpfeil S, Pfaffenrath V, Hammes M, Hummelsberger J, Irnich D, Weidenhammer W, Willich SN, Linde K. Acupuncture in patients with tension-type headache: randomised controlled trial. BMJ. 2005;331:376–82
  9. Haake M, Müller HH, Schade-Brittinger C, Basler HD, Schäfer H, Maier C, Endres HG, Trampisch HJ, Molsberger A. German Acupuncture Trials (GERAC) for chronic low back pain: randomized, multicenter, blinded, parallel-group trial with 3 groups. Arch Intern Med. 2007;167:1892–8
  10. Witt C, Brinkhaus B, Jena S, Linde K, Streng A, Wagenpfeil S, Hummelsberger J, Walther HU, Melchart D, Willich SN. Acupuncture in patients with osteoarthritis of the knee: a randomised trial. Lancet. 2005;366:136–43
  11. Cherkin DC, Sherman KJ, Avins AL, Erro JH, Ichikawa L, Barlow WE, Delaney K, Hawkes R, Hamilton L, Pressman A, Khalsa PS, Deyo RA. A randomized trial comparing acupuncture, simulated acupuncture, and usual care for chronic low back pain. Arch Intern Med. 2009;169:858–66
  12. Madsen MV, Gøtzsche PC, Hróbjartsson A. Acupuncture treatment for pain: systematic review of randomised clinical trials with acupuncture, placebo acupuncture, and no acupuncture groups. BMJ. 2009;338:a3115

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Why do ¨alternative¨ therapies seem to work?

Whenever we feel sick, or have pain, we tend to go to the doctor or to a therapist of some kind. The thing is that most of us usually don´t  like going to the doctor or therapist and we wait a long time before we finally decide to go. And then when we finally decided to go, the symptoms usually improve. This makes us think that the doctor we decided to go to or the therapy we decided to do worked. I mean it´s quite simple, A leads to B, or doesn´t it? Let´s take a closer look at that.

When we think that just because two things happen together,  then one must have been the cause of the other is called a LOGICAL FALLACY and this is something we do a lot.

Let me give you an example: When the rooster crows, the sun rises.  Therefore, the rooster causes the sun to rise.

We do this more than we can imagine, and especially in my field (physical therapy) I see it a lot, I have also done it. Patients would come to me, I would treat them and they would get better, so I would naturally think ¨I´m the best¨ and ¨he got better because of me and my new wonderful technique that I applied on him¨ . We tend to base clinical convictions on personal experience and this, my friends, is a mistake. We have to base our treatments on randomized, placebo-controlled trials.  Any treatment that doesn´t base itself on that is ¨bogus¨. This is the foundation of modern healthcare.

And which treatments usually don´t base themselves on that……¨alternative medicine¨(https://sports-diet-pain.com/?s=acupuncture). But sometimes ¨alternative medicine¨ works, why is that? Well, here are just a couple of reasons why sometimes it ¨works¨.

  1. The natural history of a disease- Many diseases are self-limiting. If the condition is not chronic or fatal, the body´s own recuperative processes usually restores the sufferer to health.
  2. Regression to the mean- Many diseases are cyclical, meaning they get worse or better temporarily, but always move back to an average severity(1). Back pain, arthritis, allergies, and multiple sclerosis are cyclical, meaning sometimes they get worse and sometimes they get better. Usually, we go to the therapist or doctor when we have the most pain, so it´s bound to get better no matter what the therapist does to you.
  3. Placebo effect – ineffective treatment that can nevertheless be consoling. But the placebo effect is not restricted only to fake treatments, it also plays a role in the impact of real medicine. For example, although a patient will derive benefit from taking aspirin largely due to the pill´s biochemical effects, there can also be an added bonus as a result of the patient´s confidence in the aspirin itself or in the doctor who prescribes it (2). That is why sometimes the doctor´s reputation, the cost of the treatment, its novelty, a gentle touch, a nurse´s smile, a diploma-covered wall, could all increase the placebo effect(3-5). https://sports-diet-pain.com/2013/10/18/placebo/
  4. Confirmation bias- We desire treatment success because illness is unpleasant. Recently there was a study (6 ) that measured objectively and subjectively the effectiveness of active albuterol against placebo (the patients were given a fake active albuterol), sham acupuncture or no intervention.  Active albuterol is used for those who have asthma, it’s a bronchodilator. Subjectively ALL experienced an improvement (they used a visual analog from 0 to 10, in which 0 means no improvement and 10 means complete resolution). With albuterol the subjective improvement was of  50%,  with placebo it was 45%, sham acupuncture 46% and the no-intervention control group getting a 21%. So, all improved subjectively but there was a big difference between placebo-sham acupuncture and the no intervention group, even though all 3 were INEFFECTIVE for the disease, crazy right?! Well, objectively (which means we can measure it), they made each of the 4 groups blow to measure lung function. And not surprisingly, the albuterol group improved the best, in fact, the real albuterol did 3 times better than all the other three groups. But, what was amazing is that all 3 ¨fake¨ groups improved a little, even thought NOTHING was being done to them. And also, objectively there was a HUGE difference between the real treatment and the fake treatment although subjectively there was barely any difference!!!! I hope you all understood the importance of this.

Alternative medicine is called alternative because it really doesn´t work. If it worked it would be called MEDICINE. Physical therapists out there reading this, let´s try to base our treatments on randomized, placebo-controlled trials and not on our own clinical or personal experience.

Here is a nice video that talks about alternative medicine. It´s 45 minutes but very interesting.

http://www.youtube.com/watch?v=2M7x9wuKswI

References

  1. Streiner DL. Regression toward the mean: Its etiology, diagnosis, and treatment. Can J Psychiatry. 2001;46:72–76
  2. Ernst E, Simon S. Trick or Treatment ? Alternative medicine on trial. Transworld Publishers.London,UK.2008
  3. Benedetti F, Mayberg HS, Wager TD, Stohler CS, Zubieta JK. Neurobiological mechanisms of the placebo effect. J Neurosci. 2005;25:10390–10402.
  4. Ernst E, Resch KL. Concept of true and perceived placebo effects. BMJ . 1995;311:551–553.
  5. Evans D.  Placebo: Mind over matter in modern medicine. Oxford University Press; 2004
  6. Michael E. Wechsler, John M. Kelley, Ingrid O.E. Boyd, Stefanie Dutile, Gautham Marigowda, Irving Kirsch, Elliot Israel, Ted J. Kaptchuk. Active Albuterol or Placebo, Sham Acupuncture, or No Intervention in AsthmaN Engl J Med. Author manuscript; available in PMC 2012 January 14.Published in final edited form as: N Engl J Med. 2011 July 14; 365(2): 119–126
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Acupuncture

A quick side note before I start talking about acupuncture. I want to say that I did a Postgraduate degree on acupuncture 8 years ago, after finishing my Physical Therapist studies. I never got the hang of it, and I never really understood it, so I never used it with my clients, but during the time of my studies, I inserted needles and people inserted needles onto me.

OK, let´s begin by saying what acupuncture is: Acupuncture is a collection of procedures involving penetration of the skin with needles to stimulate certain points on the body. It is based on the notion that health and well-being relate to the flow of a life force through pathways (meridians) in the human body (1). In its classical form it is a characteristic component of traditional Chinese medicine. There are various schools of acupuncture but the majority support the notion of 12 meridians (there are 12 main rivers in China). Meridians supposedly are associated or connected to one of the mayor organs and there are hundreds of possible acupuncture points along the meridians. Before deciding on the acupuncture points, the acupuncturist must first diagnose the patient by inspection, auscultation, olfaction, palpation and inquiring. (1)

The thing that I always find funny is the way people defend acupuncture. They always say to me ¨it has existed for thousand of years so it has to be true¨, and this makes me believe they don´t know what they just said because right there, in that sentence, is part of the answer of why acupuncture doesn´t really work. First, I´ll start by saying that over 2000 years ago (the first mention of acupuncture was 2,600 BC), we didn´t really know how the human body worked, even now, with all the technology we still can´t explain certain things. So you think 2,000 thousand years ago in a culture that performed no DISSECTIONS, they knew what they were doing or where they were sticking their needles (1,2)? If you believe that, then you have to believe on the principles that a ¨life force¨ called qi flows through bodies along 12 channels or ¨meridians¨, and that illness and pain occur when qi cannot flow freely……….and if that´s the case then acupuncture is the right treatment for you.

Let´s just imagine that qi doen´t really exist, since it has never been proven by science (3), this doesn´t mean acupuncture doesn´t work. Maybe acupuncture works through a theory called ¨gate control theory of pain¨. The theory is based on the idea that the spinal cord contains a neural ¨gate¨ that can open and close to reduce or enhance pain messages passing to the brain. This theory seems more logical and maybe that´s why acupuncture does seem to work, or maybe it´s just all a placebo effect.

So to see if acunpuncture is a real treatment or a ¨trick¨, the scientific community has been doing trials, and a lot of trials have been done.

At the beginning these trials compared acupuncture with no treatment. These studies suffered from bias because as I mentioned in my last post (https://sports-diet-pain.com/2013/10/18/placebo/): patients having any procedure tend to feel better than those who have none. So a lot of positive clinical trials came out in the 1970s, 80s and even 90s. Also a lot of positive clinical trials were coming in from China. But if you compared the clinical trials coming from China from the ones coming in from other countries, the Chinese trials were always positive!! (Most people don´t know that during the Daoguang Emperor (1782-1850) acupuncture was in decline and that it only experienced a revival in 1949 as a direct result of Mao Zedong, who promoted Chines traditional medicine during the Cultural Revolution as a way to boost national identity and deliver cheap healthcare (1,2) .

So in 2003 the World Health Organization did a review and analysis of reports on controlled clinical trials and they said that the benefits of acupuncture were either proven or had been shown in the treatment of 91 conditions!!!! (4). But… they had included all those clinical trials that I have mentioned before that were badly conducted and the ones coming in from China.

Cochrane Collaboration is a global network of experts coordinated via its headquarters in Oxford. They adhere to the principles of evidence-based medicine and what they do, is examine clinical trials and other medical research in order to offer clear conclusions about which treatments are genuinely effective for which conditions. It´s basically the  ¨gold standard¨ inside the scientific community. They disregard any clinical trial that is not reliable and only look at those in which their quality is reliable. They published their conclusions and said that there is no significant evidence that acupuncture is an effective treatment for the following conditions:  Smoking addiction, cocaine dependence, induction of labour, Bell´s palsy, chronic asthma, stroke rehabilitation, breech presentation, depression, epilepsy, carpal tunnel syndrome, irritable bowel syndrome, schizophrenia, rheumatoid, arthritis, insomnia, non-specific back pain, lateral elbow pain, shoulder pain, soft tissue shoulder injury, morning sickness, eggcollection, glaucoma,vascular dementia, period pain, whiplash injury and acute stroke (5). They did however say that it ¨could¨ help in the cases of pelvic and back pain during pregnancy, low back pain, headaches, post-operative nausea and vomiting, neck disorders and bed wetting – the important word here is ´could´.

The problem with clinical trials with acupuncture is how do you create a ¨sham¨ group or control group? With pills it´s easy, one group takes the real pill and the ¨control group¨ takes the fake pill, the patients don´t know what they are taking. After that, you just compare results between one group and the other, to see if the real pill does really have an effect or if it´s just a placebo effect. With acupuncture is quite hard because you HAVE to use needles, if not the patient is going to know the difference. So a doctor by name of Edzar Ernst and Jongbae Park created a telescopic needle- that is, an acupuncture needle that looks as if it penetrates the skin, but which instead retracts into the upper handle part (1). The needle offers some resistance as it is retracted into the upper handle. This meant that it would cause some minor sensation during its apparent insertion, so patients would think they were getting real acupuncture but were actually not.

After this new invention came out, new trials started to be conducted and the results of these trial were not that good for acupuncture (6). It showed that acupuncture is just as good as ¨sham acupuncture¨, meaning its benefits are only derived from its placebo effect. A lot of people will say who cares if it´s a placebo effect or something else, if the patient is deriving benefit from the treatment, why not just go ahead with it. I have my opinion regarding to this, which I stated in my last post. Some agree with it, some disagree with it and that´s perfectly fine, as long as you know the real reason why you are doing acupuncture or getting acupuncture.

My next post will be about pain. Do we really know what pain is?  How come people who have arthritis in their knee have no pain and some do have pain? How come people with herniation have pain in their back, and some don´t? Is pain really in the knee, back, arm……… or is it all in the head? If so, then maybe we have to start changing the way we deal with injuries or treat our patients. Until next time enjoy the weekend!

P.S. I have added a video to my last post. I would highly recommend that you take a look at it. Sometimes videos express things more clearly than I do. So far I have posted 2 videos. One in the ¨placebo¨ article and the other one in ¨the myth about fast and slow metabolism¨. Really interesting both of them.

Bibliography

1.Ernst E, Simon S. Trick or Treatment ? Alternative medicine on trial. Transworld Publishers.London,UK.2008.

2. Derbyshire D. Why acupuncture is giving sceptics the needle. The observer 2013.

3. Gorski D. A Trilogy of (Acupuncture) Terror. Science Based medicine 2013.

4.http://www.who.int/en/ . Word Health Organization.2003.

5.http://www.thecochranelibrary.com/view/0/AboutCochraneSystematicReviews.html

6. Ingraham P. Does acupuncture work for pain? http://saveyourself.ca/articles/acupuncture-for-pain.php 2009.

7. Moffet HH. Sham acupuncture may be as efficacious as true acupuncture: a systematic review of clinical trials. J Altern Complement Med. 2009 Mar;15(3):213-6.

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