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Posts tagged ‘placebo effect’

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

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.

Placebo

So now we are going to change topic and start talking about pain. I´m a physical therapist and I treat a lot of patients and I am always surprised by how pain can be so different from one person to the other, even though they may have the same ¨injury¨. Pain is a complex thing and something I will talk more deeply about in one of my next post, but now I want to talk about how to treat pain and the placebo effect.

It´s funny how sometimes using the same technique in 2 different people, I would have different results. In some of my patients the pain would disappear and in other, the pain would just stay there. I know each patient is different and you have to treat every single one individually, but still, wouldn´t you expect to get more or less the same result? I especially remember one time when this patient came by to my clinic. He arrived 30 minutes late, so I didn´t have that much time to treat him, since my next client was already waiting. So I treated him with this new ultrasound that had just arrived to the clinic. I told him how good this ultrasound was and since I didn´t have that much time, I just gave him 5 minutes of ultrasound. After the 5 minutes of ultrasound, the patient felt great, his pain was gone, he had more movement in his shoulder than before he came in!! I couldn´t believe it, especially since the ultrasound was so new that I didn´t even know how to use it properly. I had mistakenly pressed the wrong button, and the 5 minutes that I had thought I had given him ultrasound, I had actually done nothing!!!… but the patient felt better than before, how is that possible?? Well it´s because of the effect of PLACEBO.

Placebo can be defined as an ineffective treatment that can nevertheless be consoling, but placebo effect is not restricted only to fake treatments, it also has 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 confidence in the doctor who prescribes it (1). That is why sometimes the doctor´s reputation, the cost of the treatment and its novelty could all increase the placebo effect. Some known cases of placebo:

  1. In the Second World War, there was a lack of morphine at the hospitals so doctors would instead inject saline into the patient saying ¨that it was a powerful painkiller¨. The soldiers would relax immediately and show no signs of pain.(1)
  2. In the 1950´s a new technique came out that could help patients with angina. A cardiologist was not sure about this treatment, so he did a trial. Some of the patients received the new surgery with the new technique, while the other patients did not, the doctor just opened them up so the arteries were exposed, but he performed no further surgery. None of the patients knew what was happening to them, they all thought they were getting the same process. Afterwards, roughly three-quarters of the patients in both groups reported significantly benefits.(1)
  3. 117 patients with chronic low pain, divided into 4 groups. The first group received electrotherapy after limited, five minute interaction with the physical therapist, who avoided eye contact and did not openly engage the patient.The second group received the same electrotherapy with enhanced interaction, meaning the physical therapist talked to him for 30 minutes and was open and nice. The third group limited interaction while hooked to electrotherapy but the device was not connected (patients did not know this). The fourth group enhanced interaction, while hooked to electrotherapy but the device was not connected. The patients who experienced the greatest benefits were the second and fourth group!!(2)

So, as you can see, placebo can be influenced by a lot of things. In example three, just by talking to the patients and being nice and friendly, the patients experienced a better result than when the doctor gave them the real treatment but did not even look at them. It is also know for example, that a drug administered by injection has a bigger placebo effect than the same drug taken in pill form, and that taking two pills provokes a greater placebo response than taking just one. Also, green pills have the strongest placebo effect on relieving anxiety, whereas yellow pills work best for depression.

So now that you know the influence of placebo and how it can influence pain, perception and a thousand other things, do you want to know when the treatment you are receiving is placebo (fake treatment)? I mean does it really matter, as long as you, the patient, is experiencing the real benefit? I have had clients come up to me and say ¨I don´t care what you do to me, just take the pain away¨, and guess what, placebo can do that, but placebo can also be dangerous, as it could hide a serious disease.

I think it´s better to find the true therapy, something that has no doubt, something that has been scientifically proven, but however with the placebo, even test can show up to be false. So how do they really know if something works? Well, the scientifically community does trials to see if the new medicine-treatment works and this is what they do:

  1. They first do a comparison between a control group and a group receiving the treatment being tested (treatment group).
  2. There has to be a sufficiently large number of patients in each group.
  3. Random assignment of patients to each group.
  4. They administer placebo to the control group.
  5. The control group and the treatment group must have identical conditions.
  6. Blinding patients (meaning patients know as little as possible) so that they are unaware to which group they belong.
  7. Blinding doctors so that they are unaware whether they are giving a real or a placebo treatment to each patient.

This is called a randomized placebo controlled, double-blind clinical trial and it is considered to be the highest possible standard of medical testing.

OK, now that we know what placebo is and how it can affect a treatment, we must also be aware that the opposite also exist and this is called Nocebo effect. Nocebo effect is a negative reaction to harmless stimulus, the opposite of placebo. I´ll give a quick example of a nocebo effect: It has been shown that if they did an MRI (magnetic resonance imaging) on us, that about 81% (3) of us could have a disc herniation and be asymptomatic, meaning no pain. But most people think that a disc herniation is a horrible thing. Now, imagine we have back pain and we decide to go to the doctor and the doctor prescribes an MRI. In that MRI the doctor says you have a herniation (which may be producing your pain or may not be producing the pain), this information will most likely cause a very NEGATIVE effect on you and cause you to experience more pain. Instead, if the doctor explains to you that 85-95% of the people that experience back pain is non-specific (meaning they don´t know where it comes from) and that only less than 10% experiences back pain because of a herniation (4-5). And if he also says that most low back conditions have a favorable natural history, that only 5% of the patients with lower back pain will go on to have chronic lower back pain (6), and that the best thing is to try to continue with your daily activity, just maybe that would have a better effect on you.

Here is a nice video that talks about Placebo. http://crpsuk.com/2013/08/19/is-there-scientific-proof-that-we-can-heal-ourselves-lissa-rankin-talks/

So in my next post I will be talking about acupuncture. A treatment that has existed for thousand of years, there is the Yin and the Yang, it cures morning sickness, strokes, abdominal pain, whooping cough, deafness, chronic asthma, carpal tunnel, rheumatoid arthritis, insomnia, non-specific back pain, shoulder pain, period pains, whiplash……..and the list goes on. Something that can cure so much and has existed for so many years must be true, right …………or is it placebo?? Well, in my next post we will see what the scientific community has to say about that. By the way, if you get treated by acupuncture and get better every time someone sticks a needle on you, you may not want to read my next post. Until then.

Bibliography

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

2. Medical Xpress: Physiotherapy patient interaction a key ingredient to pain reduction. University Alberta. Profesour Jorge Fuentes.

3. Kim S, Lee T, Lim Soo. Prevalence of Disc Degeneration in Asymptomatic Korean Subjects. Part 1: Lumbar Spine: Journal of Korean Neurosurgical society.2013 January; 53(1):31-38.

4.Agency for Health Care Policy and Research (AHCPR). Acute low back problems in adults. Clinical Practice Guideline Number 14. Wahington DC, US Government Printing, 1994.

5.Danish Health Technology Assessment (DIHTA). Manniche C, et al. Low back pain: Frequency Management and Prevention from an HAD Perspective, 1999.

6. Wiesel SE, Tsourmans N, Fefter HL, et al. A study of computer assisted tomography. The incidence of positive CAT scans in an asymptomatic group of patients. Spine 1984; 9: 549.

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