conflict of interest
While looking up an acupuncturist who has recently commented on this blog trying to teach me how to do science and understand research methodology, I was impressed that he, Dr John McDonald, PhD, has just published a clinical trial. Not many acupuncturists do that, you know, and I very much applaud this action, which even seems to have earned him his PhD! McDonald is understandably proud of his achievement – all the more because the study arrived at positive conclusions. This is what he wrote about it:
…So, in a nutshell, acupuncture is a safe, effective and cost-effective treatment for allergic rhinitis which produces lasting changes in the immune system and hence improvements in symptoms and quality of life. Dr John McDonald
Fascinating! I quickly looked up the paper. Here it is:
This new study was designed as a randomized, sham-controlled trial of acupuncture for persistent allergic rhinitis in adults investigated possible modulation of mucosal immune responses. A total of 151 individuals were randomized into real and sham acupuncture groups (who received twice-weekly treatments for 8 weeks) and a no acupuncture group. Various cytokines, neurotrophins, proinflammatory neuropeptides, and immunoglobulins were measured in saliva or plasma from baseline to 4-week follow-up.
Statistically significant reduction in allergen specific IgE for house dust mite was seen only in the real acupuncture group. A mean (SE) statistically significant down-regulation was also seen in pro-inflammatory neuropeptide substance P (SP) 18 to 24 hours after the first treatment. No significant changes were seen in the other neuropeptides, neurotrophins, or cytokines tested. Nasal obstruction, nasal itch, sneezing, runny nose, eye itch, and unrefreshed sleep improved significantly in the real acupuncture group (post-nasal drip and sinus pain did not) and continued to improve up to 4-week follow-up.
The authors concluded that acupuncture modulated mucosal immune response in the upper airway in adults with persistent allergic rhinitis. This modulation appears to be associated with down-regulation of allergen specific IgE for house dust mite, which this study is the first to report. Improvements in nasal itch, eye itch, and sneezing after acupuncture are suggestive of down-regulation of transient receptor potential vanilloid 1.
These conclusions seem to be based on the data of the study. But they are oddly out of line with the above statement made by McDonald about his trial. What could be the reason for this discrepancy? Could it be that he behaves ‘scientifically’ correct when under the watchful eye of numerous co-authors from the School of Medicine, Menzies Health Institute, Griffith University, Queensland, Australia, the School of Medicine, Menzies Health Institute, Griffith University, Queensland, Australia, the National Institute of Complementary Medicine, Western Sydney University, Sydney, Australia, the Health Innovations Research Institute and School of Health Sciences, RMIT University, Melbourne, Victoria, Australia, and the Stanford University, Palo Alto, California? And could it be that he is a little more ‘liberal’ when on his own? A mere speculation, of course, but it would be nice to know.
Anyway, the trial itself raises a number of questions – unfortunately I have no access to the full paper – which I will post here in the hope that my acupuncture friend, who are clearly impressed by this paper, might provide the answers in the comments section below:
- Which was the primary outcome measure of this trial?
- What was the power of the study, and how was it calculated?
- For which outcome measures was the power calculated?
- How were the subjective endpoints quantified?
- Were validated instruments used for the subjective endpoints?
- What type of sham was used?
- Are the reported results the findings of comparisons between verum and sham, or verum and no acupuncture, or intra-group changes in the verum group?
- Was the success of patient-blinding checked, quantified and successful?
- What other treatments did each group of patients receive?
- Does anyone really think that this trial shows that “acupuncture is a safe, effective and cost-effective treatment for allergic rhinitis”?
“Conflicts of interest should always be disclosed.”
This is what I wrote in the ‘RULES’ of this blog when I first started it almost 4 years ago. Sadly, very few people writing comments observe this rule. Perhaps, I just thought, I did not observe it either? So, here are my conflicts of interest: none.
Not true!!! I hear some people say. But it is!
I have no financial interest in any ‘Big Pharma’ or ‘TINY CAM’, and I get not a penny for writing this blog.
How do I pay for my living? Mind your own business… well, on second thought, even that must not be a secret: I get a small pension and have some savings.
Still not convinced?
Perhaps it’s time to define what ‘conflicts of interests’ are. According to Wikipedia, they can be defined as situations in which a person or organization is involved in multiple interests, financial interest, or otherwise, one of which could possibly corrupt the motivation of the individual or organization.
So, not having financial benefits from my current work does not necessarily mean that I have no conflicts of interest. The above definitions vaguely mentions ‘or otherwise’ – and that could be important. What could this mean in the context of this blog?
Well, I might have very strong beliefs, for instance (for instance, very strong beliefs that acupuncture is by definition nonsense [see below]). We all know that strong beliefs can corrupt motivation (and a lot more). And if I ask myself, do you have strong beliefs?, I have to say: Yes, absolutely!
I believe that:
- good evidence is a prerequisite for progress in healthcare,
- good evidence must be established by rigorous research,
- we should not tolerate double standards in healthcare,
- patients deserve to be treated with the best available treatments,
- making therapeutic claims that are not supported by sound evidence is wrong.
These strong beliefs might make me biased in the eyes of many who comment on this blog. In Particular, we recently had a bunch of acupuncturists who went on the rampage attacking me personally the best they could. However, a rational analysis of my beliefs can hardly produce evidence for bias against anything other than the promotion of unproven therapies to the unsuspecting public.
The above mentioned acupuncturists seem to think that I have always been against acupuncture for the sake of being against acupuncture. However, this is not true. The proof for this statement is very simple: I have published quite a bit of articles that concluded positively – even (WOULD YOU BELIEVE IT?) about acupuncture for back pain! A prominently published meta-analysis of 2005 (with me as senior author) concluded: “Acupuncture effectively relieves chronic low back pain.” (This of course was 11 years ago when the evidence was, in fact, positive; today, this seems to have changed – just like the NICE guidelines [probably not a coincidence!])
Conflicts of interest? No, not on my side, I think.
But what about the ‘other side’?
The unruly horde of acupuncturists (no, this is not an ad hominem attack, it’s a fact) who recently made dozens of ad hominem attacks against me, what about them?
- They earn their money with acupuncture.
- They have invested in acupuncture training often for long periods of time.
- They have invested in practice equipment etc.
- Some of them sell books on acupuncture.
- Others run courses.
- And all of them very clearly and demonstrably have strong beliefs about acupuncture.
I think the latter point constitutes by far the most important conflict of interest in this context.
And this is where the somewhat trivial story has an unexpected twist and gets truly bizarre:
I have just leant that the same group of conflicted acupuncturists are now planning to publicly attack the panel of experts responsible for drafting the NICE guidelines. The reason? They feel that this panel had significant conflicts of interest that led them to come out against acupuncture.
Perhaps I should mention that I was not a member of this group, but I suspect that some of its members might have links to the pharmaceutical industry. It is almost impossible to find top experts in any area of medicine who do not have such links. You either gather experts with potential conflicts of interest, or you get non-experts without them. Would that bias them against acupuncture or any other alternative therapy? I very much doubt it.
What I do not doubt for a minute is that conflicts of interest are of major importance in these discussions. And by that I mean the more than obvious (but nevertheless undeclared) conflicts of interest of the acupuncturists. It seems that those with the strongest conflicts of interest shout the loudest about the non-existent or irrelevant conflict of interest of those who do not happen to share their quasi-religious belief in acupuncture.
The ‘ALT MED HALL OF FAME’ is filling up very nicely. Remember: so far, I have honoured the following individuals for (almost) never publishing anything else but positive results (in brackets are the main alternative therapies of each researcher and the countries where they are currently based):
Peter Fisher (homeopathy, UK)
Simon Mills (herbal medicine, UK)
Gustav Dobos (various, Germany)
Claudia Witt (homeopathy, Germany and Switzerland)
George Lewith (acupuncture, UK)
John Licciardone (osteopathy, US)
Today, I am about to admit another female to our club of alt med elite (the group was in danger of getting a bit too male-dominated) : Prof Nicola Robinson from the School of Health and Social Care, London South Bank University, UK. She may not be known to many of my readers; therefore I better provide some extra information. Her own institution wrote her up as follows:
Professor Nicola Robinson joined London South Bank University in March 2011 as Professor of Traditional Chinese Medicine and Integrated Health. Previously she was Professor of Complementary Medicine, University of West London. Professor Robinson’s former posts include; Consultant Epidemiologist Brent and Harrow Health Authority, Senior lecturer in Primary Healthcare University College London, Lecturer at Charing Cross and Westminster Hospital Medical School and Research Fellow at the London School of Hygiene and Tropical Medicine.
She graduated from Leicester University with a BSc (Hons) in Biological Sciences, and her PhD from Manchester University was in Immunology. She has been a registered acupuncturist since 1982. In 1985 Nicola was awarded an RD Lawrence Fellowship by Diabetes UK and in 1993 she was given an Honorary Membership of the Faculty of Public Health Medicine for her contribution to epidemiology and health services research.
In 2004, Nicola was awarded a Winston Churchill Traveling Fellowship to visit China, to explore educational and research initiatives in Traditional Chinese Medicine at various universities and hospitals. Nicola has a keen interest in complementary medicine and its assimilation and integration into mainstream health care and has been involved in various research initiatives with professional groups.
Nicola has written over 200 scientific articles in peer reviewed journals, prepared scientific reports and presented research at local, national and international conferences. She is the Editor in Chief of the European Journal of Integrative Medicine (Elsevier) as well as being on the editorial boards of other scientific journals. She has had considerable research experience in various aspects of public health that has covered a wide range of subject arenas including: complementary medicine, cancer, patient public engagement, mental health, diabetes, coronary heart disease, HIV, cystic fibrosis and psychosocial aspects of disease. She has various research links in China and has had successfully supervised both Chinese and UK PhD students.
As always, I conducted a Medline search for ‘Robinson N, alternative medicine’, which generated 50 articles. I excluded those articles that were not on alternative medicine (probably from someone by the same name) and those that had no abstract with conclusions about the value of alternative medicine. Of the rest, I included the most recent 10 papers. Below I show these articles with the appropriate links and the conclusion (in bold).
Hu XY, Chen NN, Chai QY, Yang GY, Trevelyan E, Lorenc A, Liu JP, Robinson N.
Chin J Integr Med. 2015 Oct 26. [Epub ahead of print]
Integrative treatment that combines CAM with conventional therapies appeared to have beneficial effects on pain and function. However, evidence is limited due to heterogeneity, the relatively small numbers available for subgroup analyses and the low methodological quality of the included trials. Identification of studies of true IM was not possible due to lack of reporting of the intervention details.
Lorenc A, Banarsee R, Robinson N.
Complement Ther Clin Pract. 2014 Feb;20(1):65-9. doi: 10.1016/j.ctcp.2013.10.003. Epub 2013 Oct 15
Complementary Ttherapies may provide important support and treatment options for HIV disease, but cost effectiveness requires further evaluation.
Lorenc A, Robinson N.
AIDS Patient Care STDS. 2013 Sep;27(9):503-10. doi: 10.1089/apc.2013.0175. Review
Clinicians, particularly nurses, should consider discussing CAM with patients as part of patient-centered care, to encourage valuable self-management and ensure patient safety.
Lorenc AB, Wang Y, Madge SL, Hu X, Mian AM, Robinson N.
Respir Care. 2014 Mar;59(3):427-40. doi: 10.4187/respcare.02570. Epub 2013 Jul 23. Review
The available evidence does not support meditative movement for patients with CF, and there is very limited evidence for respiratory function in healthy populations. The available studies had heterogeneous populations and provided inadequate sampling information, so clinically relevant conclusions cannot be drawn. Well powered, randomized studies of meditative movement are needed.
Huang W, Taylor A, Howie J, Robinson N.
J Altern Complement Med. 2012 Mar;18(3):242-50. doi: 10.1089/acm.2010.0325. Epub 2012 Mar 2.
This pilot study suggests that TCA could reduce stress and increase the morning rise of the cortisol profile; however, this was not distinguishable from the effect of attention only.
Robinson N, Lorenc A, Liao X.
BMC Complement Altern Med. 2011 Oct 7;11:88. doi: 10.1186/1472-6882-11-88. Review.
Evidence is improving in quantity, quality and reporting, but more research is needed, particularly for Shiatsu, where evidence is poor. Acupressure may be beneficial for pain, nausea and vomiting and sleep.
Bowden A, Lorenc A, Robinson N.
Prim Health Care Res Dev. 2012 Apr;13(2):175-85. doi: 10.1017/S1463423611000181. Epub 2011 Jul 26
This study suggests that AT may improve sleep patterns for patients with various health conditions and reduce anxiety and depression, both of which may result from and cause insomnia. Improvements in sleep patterns occurred despite, or possibly due to, not focusing on sleep during training. AT may provide an approach to insomnia that could be incorporated into primary care.
Robinson N, Lorenc A.
Nurs Stand. 2011 May 25-31;25(38):39-47.
Health visitors had greater knowledge and understanding of TCA than practice nurses or nurse practitioners, often informed by patients and personal experience. Health visitors reported that they discussed TCA with families using a culturally competent and family-centred approach to explain the advantages and disadvantages of TCA. This is probably made possible by their ongoing, close relationship with parents in the home environment and their focus on child health. Other primary care nurses were reluctant to engage with patients on TCA because of concerns about liability, lack of information and practice and policy constraints. Practice nurses and nurse practitioners may be able to improve their holistic and patient-centred practice by learning from health visitors’ experience, particularly cultural differences and safety issues. Nurses and their professional bodies may need to explore how this can be achieved given the time-limited and focused nature of practice-based consultations.
Ronan P, Robinson N, Harbinson D, Macinnes D.
Zhong Xi Yi Jie He Xue Bao. 2011 May;9(5):503-14
The study indicates that patients diagnosed with schizophrenia would benefit from acupuncture treatment alongside conventional treatment.
Huang W, Howie J, Taylor A, Robinson N.
Complement Ther Clin Pract. 2011 Feb;17(1):16-21. doi: 10.1016/j.ctcp.2010.05.013. Epub 2010 Jun 19
This pilot study suggests that TCA may be successful in treating the symptoms of stress, through a combination of specific and non-specific effects; but may not relate directly to how a person perceives their stress.
I think we have here a very clear case: Prof Robinson has investigated a range of very different alternative therapies for vastly different conditions. She drew 9 positive and one negative conclusions. This renders her ‘Trustworthiness Index’ truly remarkable. I am therefore confident that we all can agree to admit her to the ALT MED HALL OF FAME.
On this blog, I have repeatedly tried to explain why integrative (or integrated) medicine is such a deceptive nonsense; see for instance here, here and here. Today, I have reason to make another attempt: The International Congress on Integrative Medicine & Health.
In 2012, I published an analysis of the ‘3rd European Congress of Integrated Medicine’ which had taken place in December 2010 in Berlin (in Europe they call it ‘integrated’ and in the US ‘integrative’ medicine). For this purpose, I simply read all the 222 abstracts and labelled them according to their contents. The results showed that the vast majority were on unproven alternative therapies and none on conventional treatments.
The abstracts from the International Congress on Integrative Medicine & Health (ICIMH, Green Valley Ranch Resort, Las Vegas, Nevada, USA, May 17–20, 2016) which were just published provide me with the opportunity to check whether this situation has changed. There were around 400 abstracts, and I did essentially the same type of analysis (attributing one subject area to each abstract). And what a tedious task this was! I spotted just two articles of interest, and will report about them shortly.
This time I also assessed whether the conclusions of each paper were positive (expressing something favourable about the subject at hand), negative (expressing something negative about the subject at hand) or neither of the two (surveys, for instance, rarely show positive or negative results).
Here are the results: mind-body therapies were the top subject with 49 papers, followed by acupuncture (44), herbal medicine (37), integrative medicine (36), chiropractic and other manual therapies (26), TCM (19), methodological issues (16), animal and other pre-clinical investigations (15) and Tai Chi (5). The rest of the abstracts were on a diverse array of other subjects. There was not a single paper on a conventional therapy and only 4 focussed on risk assessments.
The 36 articles on integrative medicine deserve perhaps a special mention. The majority of these papers were about using alternative therapies as an add-on to conventional care. They focussed on the alternative therapies used and usually concluded that this ‘integration’ was followed by good results. None of these papers discussed integrative medicine and its assumptions critically, and none of these investigations cast any doubt about the assumption that integrative medicine is a positive thing.
I should also mention that my attributions of the subject areas were not always straight forward. I allowed myself only one subject per paper, but there were, of course, many that could be categorised in more than one subject area ( for instance, a paper on an herbal medicine might be in that category, or in TCM or in pre-clinical). So I tried to attribute the subject that seemed to dominate the abstract in question.
My analysis according to the direction of the conclusions was equally revealing: I categorised 260 papers as positive, 5 as negative and 116 as neither of the two. That means for every negative result there were 52 positive ones. I find this most remarkable.
Essentially, my two analyses of conference abstracts published 6 years apart show the same phenomenon: on the ‘scientific level’, integrative medicine is not about the ‘best of both worlds’ (i. e. the best alternative medicine has to offer integrated with the best conventional medicine offers) – the slogan by which advocates of integrative medicine usually try to ‘sell’ their dubious approach to us. It is almost exclusively about alternative therapies which advocates of integrative medicine aim to smuggle into mainstream healthcare. Critical analysis seems to be unwelcome in this area, and – perhaps worse of all – in the last 6 years, there does not seem to have been any improvement.
And that’s just on the ‘scientific level’, as I said. If you wonder what is happening on the ‘practical level’, you will find that, in the realm of integrative medicine, every quackery under the sun is being promoted at often exorbitant prices to the often gullible and always unsuspecting public. If you don’t believe me, search for ‘integrative medicine clinic’ on the Internet; I promise, you will be surprised!
Personally, I am sometimes amused by the sheer idiocy of all this, but more often I am enraged and ask myself:
- Why are we allowing quackery to make such a spectacular come-back?
- Why is hardly anyone voicing strong objections?
- Is it not our ethical duty to do something about it and try to prevent the worse?
Yes, I think he does deserve to join this fast-expanding club which, so far, consists of the following people:
They have been admitted mostly because they have demonstrated that they exclusively or mostly publish positive results about alternative medicine. Therefore, their ‘TRUSTWORTHYNESS INDEX’ is remarkable.
With Peter Fisher, things are a little different, and in a way much more convincing. He also has a remarkable publication record, of course. As the Queen’s homeopath, he is a stark defender of homeopathy. He has just under 100 Medline-listed articles in this area, and, if I am not mistaken, only one of them cast any doubt on the effectiveness of homeopathy.
Peter is also the long-term editor of the journal HOMEOPATHY, and he used this position to fire me from its editorial board. Furthermore, he has been shown to have an unusual attitude towards telling the truth. But the decider for his admission to THE ALT MED HALL OF FAME was the following recent interview for NATURALLYSAVVY where he shows himself as a fierce defender of science, evidence-based medicine and critical thinking:
Andrea Donsky: I understand you arrived yesterday from England. I’m curious what you take for jetlag?
Peter Fisher: We have a traditional combination that we use for jetlag, which is arnica montana, and cocculus indicus. So arnica is something that is traditionally used for bruises, and cocculus is used for sleep problems. So arnica and cocculus combined, 6CH every hour or two, helps with jetlag.
Andrea Donsky: I read about the incredible work you do as an Integrative Medicine Doctor so I thought we would start today’s interview with having you explain what that means.
Peter Fisher: Simply put, it means the best of both worlds: the best of conventional, and the best of complementary medicine. There is also a much longer and more complicated definition, but essentially it’s integrating complementary medicine in care packages to avoid some of the worst excesses of conventional medicines, like over-drugging, and excess use of medication.
Andrea Donsky: I know you don’t see patients with the common cold or flu, but if you did, what would be your protocol?
Peter Fisher: I’ve done quite a lot of research on the flu. It’s quite clear that conventional treatments don’t work all that well, and may even prolong the flu. Most of the conventional treatments push the symptoms down [suppress them] and actually prolong the illness.
Andrea Donsky: So something like Oscillococcinum would be a perfect thing to recommend to people.
Peter Fisher: Yes, and other homeopathic combinations that can speed up the resolution, relieve the symptoms, and make the flu go away quicker.
Andrea Donsky: Tell me a little bit about the European way of practicing medicine. I remember hearing that in Europe doctors prescribe homeopathy alongside medication. Is this true?
Peter Fisher: It varies widely between countries. In France, Germany, and increasingly in Spain, it is the case, but not so much in the UK. A lot of doctors do incorporate it in their practice and they integrate homeopathy when it seems appropriate, but they also use antibiotics and other drugs when they feel it is appropriate.
Andrea Donsky: Do you often approach these skeptics and say: “Listen, you are wrong because there is research behind it!”
Peter Fisher: I will debate with anybody, anytime. The trouble is, skeptics don’t like that because they always lose. I’ve been involved in a series of debates with “so called” skeptics. But many well-known skeptics avoid me because they lose the debate. What they prefer to do is to blog, or tweet, so they can make nasty sneering public remarks and you can’t come back at them. If it’s a proper debate, I say my piece, you say your piece, there’s somebody there to make sure that it’s fair play, and that could be in a journal, it could be in a lower court, I don’t care. There was a big court case in the U.S. that was resolved in September where that happened. An allegation was made that false claims were being made for homeopathic medicines and they lost the case…homeopathy won!
Andrea Donsky: Tell us how you came to be a physician to Her Majesty the Queen.
Peter Fisher: There’s a long tradition of the Royal Family having a homeopathic physician. It actually goes back 150 years to Queen Victoria and her beloved Prince Albert. The founder of our hospital was Prince Albert’s father’s doctor. There has been an official homeopathic physician treating the Royal Family since the 1930s. It’s been me since 2001.
Andrea Donsky: It is nice to hear that the Royal Family is open to integrative medicine. Do you just treat the Queen, or the whole family? I read that Prince Charles eats organic and has an organic garden so I am assuming he is quite open to it as well.
Peter Fisher: I treat the entire family. I think Kate and Will are too young and healthy so they don’t need medicine. But the Prince of Wales, Prince Charles, is very friendly, and he is more than willing to stick his neck out to actually say things. He has spoken at the World Health Assembly, which is the AGN of the World Health Organization. So he’s really quite fond of integrative medicine.
Andrea Donsky: I think that’s incredible. As a conventionally trained physician, how did you become interested in homeopathy?
Peter Fisher: At the end of the Cultural Revolution I went to visit China. I was a medical student at the time, and I remember the moment when it became clear to me. I was in the operating room of a small Chinese provincial town and there was a woman lying on the operating table with her entire abdomen open, fully conscious talking to the anesthetist with three needles in her left ear.
Andrea Donsky: Acupuncture needles?
Peter Fisher: Yes.
Andrea Donsky: That’s amazing.
Peter Fisher: The needles were connected to a little electrical box. I thought, “That doesn’t happen. They didn’t tell us about this at Cambridge.” I went to the best medical school, Cambridge, a very elite medical school, and I just thought, “This can’t happen. This doesn’t happen.” That experience is what made me think that there was more to medicine than what we were taught in medical school. Then a few years later, I became ill myself. I was still a medical student so I went to see a very distinguished professor at my medical school who made a precise diagnosis and said, “Tough, nothing can be done.” So my friends suggested I try homeopathy, and I did, and it helped. So it snowballed from there.
Andrea Donsky: Oftentimes we need to see things for ourselves and/or experience it to believe it.
Peter Fisher: Yes. I got almost obsessed by it, you know. In many ways as a scientific thing it shouldn’t work. I mean I do understand to that extent where the skeptics are coming from. There does appear to be a good reason why it can’t possibly work, and yet it does.
Andrea Donsky: Can you define what homeopathy is and how it works?
Peter Fisher: Homeopathy is based on the idea of like curing like. So you give a very small dose of something that could cause a similar illness if given an enlarged dose. Some people say it’s like holding a mirror up to nature. You’re saying to the body, “OK, this is what your problem is, this is what the disease is.” The idea is that the body has very strong self-healing capabilities; it is strong, but sometimes it can be stupid like when it comes to autoimmune diseases. In that case it is actually the body’s defensive mechanism being misdirected.
Andrea Donsky: Can you explain the difference between a single remedy and a combination?
Peter Fisher: A single remedy is one remedy and a combination is multiple. Broadly speaking, there are two kinds of homeopathy. One is the so-called “keynote prescribing way,” where you prescribe for one or two keynote symptoms like a cold, sore throat, or runny nose.Then there is “constitutional medicine” where you are not so much treating the disease, but rather the person. So for example, if someone has insomnia, muscular aches and pains or even a cold and/or flu, they can take a combination of two, three, four, or even five different homeopathic medicines, which will likely cover the symptoms. This is more for self-treatment, rather than doctor prescribed.
Andrea Donsky: That makes sense. I like that there is a role in homeopathy for both self (like for the common cold) and expert prescribing.
Peter Fisher: Yes. It is one thing if someone has a short-term health issue, but it is another thing if they have a chronic complicated, multi-faceted issue. I mean one of the interesting things about homeopathy is the idea of treating the person, and not the disease
I AM CONFIDENT THAT THE MAJORITY OF MY READERS AGREE TO ADMIT DR FISHER TO THE ALT MED HALL OF FAME.
Polycystic ovarian syndrome (PCOS) is a common condition characterised by oligo-amenorrhoea, infertility and hirsutism. Conventional treatment of PCOS includes a range of oral pharmacological agents, lifestyle changes and surgical modalities. Some studies have suggested that acupuncture might be helpful but the evidence is often flawed and the results are mixed. What is needed in such a situation is, of course, a systematic review.
The aim of this new Cochrane review was to assess the effectiveness and safety of acupuncture treatment of oligo/anovulatory women with polycystic ovarian syndrome (PCOS). The authors identified relevant studies from databases including the Cochrane Central Register of Controlled Trials (CENTRAL), Ovid MEDLINE, EMBASE, PsycINFO, CNKI and trial registries. The data are current to 19 October 2015.
They included randomised controlled trials (RCTs) that studied the efficacy of acupuncture treatment for oligo/anovulatory women with PCOS. We excluded quasi- or pseudo-RCTs. Primary outcomes were live birth and ovulation (primary outcomes), and secondary outcomes were clinical pregnancy, restoration of menstruation, multiple pregnancy, miscarriage and adverse events. We assessed the quality of the evidence using GRADE methods.
Two review authors independently selected the studies, extracted data and assessed risk of bias. They calculated Mantel-Haenszel odds ratios (ORs) and mean difference (MD) and 95% confidence intervals (CIs).
Five RCTs with 413 women were included. They compared true acupuncture versus sham acupuncture (two RCTs), true acupuncture versus relaxation (one RCT), true acupuncture versus clomiphene (one RCT) and electroacupuncture versus physical exercise (one RCT). Four of the studies were at high risk of bias in at least one domain. No study reported live birth rate. Two studies reported clinical pregnancy and found no evidence of a difference between true acupuncture and sham acupuncture (OR 2.72, 95% CI 0.69 to 10.77, two RCTs, 191 women, very low quality evidence). Three studies reported ovulation. One RCT reported number of women who had three ovulations during three months of treatment but not ovulation rate. One RCT found no evidence of a difference in mean ovulation rate between true and sham acupuncture (MD -0.03, 95% CI -0.14 to 0.08, one RCT, 84 women, very low quality evidence). However, one other RCT reported very low quality evidence to suggest that true acupuncture might be associated with higher ovulation frequency than relaxation (MD 0.35, 95% CI 0.14 to 0.56, one RCT, 28 women). Two studies reported menstrual frequency. One RCT reported true acupuncture reduced days between menstruation more than sham acupuncture (MD 220.35, 95% CI 252.85 to 187.85, 146 women). One RCT reported electroacupuncture increased menstrual frequency more than no intervention (0.37, 95% CI 0.21 to 0.53, 31 women). There was no evidence of a difference between the groups in adverse events. Evidence was very low quality with very wide CIs and very low event rates. Overall evidence was low or very low quality. The main limitations were failure to report important clinical outcomes and very serious imprecision.
The authors concluded that, thus far, only a limited number of RCTs have been reported. At present, there is insufficient evidence to support the use of acupuncture for treatment of ovulation disorders in women with PCOS.
This is, in my view, a rigorous assessment of the evidence leading to a clear conclusion. Foremost, I applaud the authors from the Faculty of Science, University of Technology Sydney for using such clear language. Such clarity seems to be getting a rare event in reviews of alternative medicine. To demonstrated this point, here are the most recent 5 systematic reviews which came up on my screen when I searched today Medline for ‘complementary alternative medicine, systematic review’.
The combination of TGP and LEF in treatment of RA presented the characteristics of notably decreasing the levels of laboratory indexes and higher safety in terms of liver function. However, this conclusion should be further investigated based on a larger sample size.
CHM as an adjunctive therapy is associated with a decreased risk of in-hospital mortality compared with WT in patients with AKI. Further studies with high quality and large sample size are needed to verify our conclusions.
As an important supplementary treatment, TCM may provide benefits in repair of injured spinal cord. With a general consensus that future clinical approaches will be diversified and a combination of multiple strategies, TCM is likely to attract greater attention in SCI treatment.
I think the phenomenon is fairly obvious: authors of such papers are far too often not able or willing to express the bottom line of their work openly. As systematic reviews are supposed to be the ultimate type of evidence, this trend is very worrying, I think. In my view, such conclusions merely display the bias of the authors. If the evidence is not convincingly positive (which it very rarely is), authors have an ethical obligation to clearly say so.
If they don’t do it, journal editors have the duty to correct the error. If neither of these actions happen, funding agencies should make sure that such teams get no further research money until they can demonstrate that they have learnt the lesson.
This may sound a bit drastic but I think such steps would be both necessary and urgent. The problem is now extremely common, and if we do not quickly implement some effective preventative measures, our scientific literature will become contaminated to the point of becoming useless. This surely would be a disaster that affects us all.
There can, of course, be several reasons for the evidence being not positive:
- there can be a paucity of data
- the results might be contradictory
- the trials might be open to bias
- some of the primary data might look suspicious
In all of these cases, the evidence would be not convincingly positive, and it would be wrong and unhelpful not to be frank about it. Beating about the bush, like so many authors nowadays do, is misleading, unhelpful, unethical and borderline fraudulent. Therefore it constitutes a disservice to everyone concerned.
In a previous post, I asked this important question: how can research into alternative medicine ever save a single life?
The answer I suggested was as follows:
Since about 20 years, I am regularly pointing out that the most important research questions in my field relate to the risks of alternative medicine. I have continually published articles about these issues in the medical literature and, more recently, I have also made a conscious effort to step out of the ivory towers of academia and started writing for a much wider lay-audience (hence also this blog). Important landmarks on this journey include:
Alternative medicine is cleverly, heavily and incessantly promoted as being natural and hence harmless. Several of my previous posts and the ensuing discussions on this blog strongly suggest that some chiropractors deny that their neck manipulations can cause a stroke. Similarly, some homeopaths are convinced that they can do no harm; some acupuncturists insist that their needles are entirely safe; some herbalists think that their medicines are risk-free, etc. All of them tend to agree that the risks are non-existent or so small that they are dwarfed by those of conventional medicine, thus ignoring that the potential risks of any treatment must be seen in relation to their proven benefit.
For 20 years, I have tried my best to dispel these dangerous myths and fallacies. In doing so, I had to fight many tough battles (sometimes even with the people who should have protected me, e.g. my peers at Exeter university), and I have the scars to prove it. If, however, I did save just one life by conducting my research into the risks of alternative medicine and by writing about it, the effort was well worth it.
END OF QUOTE FROM MY PREVIOUS POST
Just now, I received an email from someone who clearly and vehemently disagrees with any of the above. As this blog is a forum where all sorts of opinions can and should be voiced, I thought I share this communication with you. Here it is:
Having been out of chiropractic practice for a while, I was thrilled to hear that you have been forced into early retirement on today’s Radio 4 programme. You have caused so many good people anguish and pain and your tunnel-visioned arrogance is staggering and detrimental to humanity. You REALLY think modern science has all the answers? Wow.
The question I ask myself is who is correct, the (ex-)chiropractor or I?
- Have I caused anguish and pain to many?
- Do I suffer from tunnel-vision?
- Am I arrogant?
- Is my work detrimental to humanity?
- Do I believe that modern science has all the answers?
Here is what I think about these specific questions:
- I have probably caused anguish (but no pain, as far as I am aware). This sadly is unavoidable if one seeks the truth in an area as alternative medicine.
- I am not the best person to judge this.
- Possibly; again I cannot judge.
- I truly don’t see this at all.
- No, not for one second.
In case you wonder what programme the author of the above email had been listening to, you can find it here.
Is there a bottom line? I am not sure. Perhaps this: whenever strong believes clash with scientific facts, some people are going to be unhappy. If we want to make progress, this seems to be almost unavoidable; all we can try to do is to minimize the anguish by being humble and by showing human decency.
I am pleased to report that my ‘ALTERNATIVE MEDICINE HALL OF FAME’ is growing steadily. So far, this elite club includes:
Time, I think, to elect another member. I was fascinated to read what the COLLEGE OF MEDICINE (I have published about this organisation before, for instance, here) writes about a former co-worker of mine, Simon Mills (those who have read my memoir will know more about him and about my struggle to disassociate me and my work from him and his activities):
Simon Mills is a member of the College of Medicine Council. He is a Cambridge graduate in medical sciences who has since 1977 been a herbal practitioner and natural therapist in Exeter. In that time he has led the main organizations for herbal medicine in the UK (the British Herbal Medicine Association, the College of Practitioners of Phytotherapy, and National Institute of Medical Herbalists) and served on Government and House of Lords committees. Since 1997 he has been Secretary of ESCOP, the lead herbal scientific network in Europe, that produces defining monographs on herbal medicines for the European Medicines Agency. He has also written award-winning seminal herbal medicine textbooks, notably with Kerry Bone the two editions of Principles and Practice of Phytotherapy and the Essential Book of Herbal Safety. He has long been involved in academic work having co-founded the world’s first University centre for complementary health in Exeter (1987), the first integrated health course at a UK medical school at the Peninsula Medical School in Exeter (2000) and the first masters degree programme in herbal medicine in the USA (2001). He has published in many peer-reviewed scientific journals including full clinical trials with herbal medicines, and has supervised 10 successful doctorate theses. Simon is currently building a new role for healthcare practitioners as ‘health guides. With health workbooks, training programmes, community projects and websites.
It was new to me that he has ‘published in many peer-reviewed scientific journals’, so I did a Medline search and found a total of 14 articles. Most of these were comments, letters etc. I decided to identify the first 10 papers that drew some sort of conclusions about the value of alternative therapies. This is what I found (as usual, I have copied the conclusions in bold):
Pengelly A, Snow J, Mills SY, Scholey A, Wesnes K, Butler LR.
J Med Food. 2012 Jan;15(1):10-7. doi: 10.1089/jmf.2011.0005. Epub 2011 Aug 30.
The positive effect of the dose nearest normal culinary consumption points to the value of further work on effects of low doses over the longer term.
Dent HE, Dewhurst NG, Mills SY, Willoughby M.
Complement Ther Med. 2003 Jun;11(2):72-7.
Continuous 24-h PC6 acupressure therapy as an adjunct to standard antiemetic medication for post-MI nausea and vomiting is feasible and is well accepted and tolerated by patients. In view of its benefits, further studies are worthwhile using earlier onset of treatment.
Mills SY, Jacoby RK, Chacksfield M, Willoughby M.
Br J Rheumatol. 1996 Sep;35(9):874-8.
It is concluded that Reumalex has a mild analgesic effect in chronic arthritis at a level appropriate to self-medication.
Yes, there were just three such papers; perhaps the College of Medicine’s description is just a trifle misleading? As all of these arrived at positive conclusions, I think Mr Mills nevertheless deserves a place in my ALTERNATIVE MEDICINE’S HALL OF FAME.
A recent comment to a blog-post about alternative treatments for cancer inspired me to ponder a bit. I think it is noteworthy because it exemplifies so many of the comments I hear in the realm of alternative medicine on an almost daily basis. Here is the comment in question:
“Yes…it appears that the medical establishment have known for years that chemotherapy a lot of the time kills patients faster than if they were untreated…what’s more, it worsens a person’s quality of life in which many die directly of the severe effects on the endocrine, immune system and more…cancers often return in more aggressive forms metastasising with an increased risk of apoptosis. In other words it makes things worse whereas there are many natural remedies which not only do no harm but accumulating evidence points to their capacity to fight cancer…some of it is bullshit whilst some holds some truth!! So turning away from toxic treatments that kill towards natural approaches that are showing more hope with the backing of trials kinda reverses the whole argument of this article.”
The comment first annoyed me a bit, of course, but later it made me think and consider the differences between conspiracy theories, assumptions, opinions, evidence and scientific facts. Let’s tackle each of these in turn.
A conspiracy theory is an explanatory or speculative theory suggesting that two or more persons, or an organization, have conspired to cause or cover up, through secret planning and deliberate action, an event or situation typically regarded as illegal or harmful.
Part of the above comment bears some of the hallmarks of a conspiracy theory: “…the medical establishment have known for years that chemotherapy a lot of the time kills patients faster than if they were untreated…” The assumption here is that the conventional healthcare practitioners are evil enough to knowingly do harm to their patients. Such conspiracy theories abound in the realm of alternative medicine; they include the notions that
- BIG PHARMA is out to kill us all in order to maximize their profits,
- the ‘establishment’ is suppressing any information about the benefits of alternative treatments,
- vaccinations are known to be harmful but nevertheless being forced on to our children,
- drug regulators are in the pocket of the pharmaceutical industry,
- doctors accept bribes for prescribing dangerous drugs
- etc. etc.
In a previous blog-post, I have discussed the fact that the current popularity of alternative medicine is at least partly driven by the conviction that there is a sinister plot by ‘the establishment’ that prevents people from benefitting from the wonders of alternative treatments. It is therefore hardly surprising that conspiracy theories like the above are voiced regularly on this blog and elsewhere.
An assumption is something taken for granted or accepted as true without proof.
The above comment continues stating that “…[chemotherapy] makes things worse whereas there are many natural remedies which not only do no harm but accumulating evidence points to their capacity to fight cancer…” There is not proof for these assertions, yet the author takes them for granted. If one were to look for the known facts, one would find the assumptions to be erroneous: chemotherapy has saved countless lives and there simply are no natural remedies that will cure any form of cancer. In the realm of alternative medicine, this seems to worry few, and assumptions of this or similar nature are being made every day. Sadly the plethora of assumptions or bogus claims eventually endanger public health.
The above comment continues with the opinion that “…turning away from toxic treatments that kill towards natural approaches that are showing more hope with the backing of trials kinda reverses the whole argument of this article.” In general, alternative medicine is based on opinions of this sort. On this blog, we have plenty of examples for that in the comments section. This is perhaps understandable; evidence is usually in short supply, and therefore it often is swiftly replaced with often emotionally loaded opinions. It is even fair to say that much of alternative medicine is, in truth, opinion-based healthcare.
One remarkable feature of the above comment is that it is bar of any evidence. In a previous post, I have tried to explain the nature of evidence regarding the efficacy of medical interventions:
The multifactorial nature of any clinical response requires controlling for all the factors that might determine the outcome other than the treatment per se. Ideally, we would need to create a situation or an experiment where two groups of patients are exposed to the full range of factors (e. g. placebo effects, natural history of the condition, regression towards the mean), and the only difference is that one group does receive the treatment, while the other one does not. And this is precisely the model of a controlled clinical trial.
Such studies are designed to minimise all possible sources of bias and confounding. By definition, they have a control group which means that we can, at the end of the treatment period, compare the effects of the treatment in question with those of another intervention, a placebo or no treatment at all.
Many different variations of the controlled trial exist so that the exact design can be adapted to the requirements of the particular treatment and the specific research question at hand. The over-riding principle is, however, always the same: we want to make sure that we can reliably determine whether or not the treatment was the cause of the clinical outcome.
Causality is the key in all of this; and here lies the crucial difference between clinical experience and scientific evidence. What clinician witness in their routine practice can have a myriad of causes; what scientists observe in a well-designed efficacy trial is, in all likelihood, caused by the treatment. The latter is evidence, while the former is not.
Don’t get me wrong; clinical trials are not perfect. They can have many flaws and have rightly been criticised for a myriad of inherent limitations. But it is important to realise that, despite all their short-comings, they are far superior than any other method for determining the efficacy of medical interventions.
There are lots of reasons why a trial can generate an incorrect, i.e. a false positive or a false negative result. We therefore should avoid relying on the findings of a single study. Independent replications are usually required before we can be reasonably sure.
Unfortunately, the findings of these replications do not always confirm the results of the previous study. Whenever we are faced with conflicting results, it is tempting to cherry-pick those studies which seem to confirm our prior belief – tempting but very wrong. In order to arrive at the most reliable conclusion about the efficacy of any treatment, we need to consider the totality of the reliable evidence. This goal is best achieved by conducting a systematic review.
In a systematic review, we assess the quality and quantity of the available evidence, try to synthesise the findings and arrive at an overall verdict about the efficacy of the treatment in question. Technically speaking, this process minimises selection and random biases. Systematic reviews and meta-analyses [these are systematic reviews that pool the data of individual studies] therefore constitute, according to a consensus of most experts, the best available evidence for or against the efficacy of any treatment.
Some facts related to the subject of alternative medicine have already been mentioned:
- chemotherapy prolongs survival of many cancer patients;
- no alternative therapy has achieved anything remotely similar.
The comment above that motivated me to write this somewhat long-winded post is devoid of facts. This is just one more feature that makes it so typical of the comments by proponents of alternative medicine we see with such embarrassing regularity.
My last post was about a researcher who manages to produce nothing but positive findings with the least promising alternative therapy, homeopathy. Some might think that this is an isolated case or an anomaly – but they would be wrong. I have previously published about researchers who have done very similar things with homeopathy or other unlikely therapies. Examples include:
But there are many more, and I will carry on highlighting their remarkable work. For example, the research of a German group headed by Prof Gustav Dobos, one of the most prolific investigator in alternative medicine at present.
For my evaluation, I conducted a Medline search of the last 10 of Dobos’ published articles and excluded those not assessing the effectiveness of alternative therapies such as surveys, comments, etc. Here they are with their respective conclusions and publication dates:
RCTs with different yoga styles do not differ in their odds of reaching positive conclusions. Given that most RCTs were positive, the choice of an individual yoga style can be based on personal preferences and availability.
Despite methodological drawbacks, yoga can be preliminarily considered a safe and effective intervention to reduce body mass index in overweight or obese individuals.
REVIEW OF INTEGRATIVE MEDICINE IN GYNAECOLOGICAL ONCOLOGY (2016)
…there is published, positive level I evidence for a number of CAM treatment forms.
Mindfulness- and acceptance-based interventions can be recommended as an additional treatment for patients with psychosis.
Cabbage leaf wraps are more effective for knee osteoarthritis than usual care, but not compared with diclofenac gel. Therefore, they might be recommended for patients with osteoarthritis of the knee.
This review found strong evidence for A. paniculata and ivy/primrose/thyme-based preparations and moderate evidence for P. sidoides being significantly superior to placebo in alleviating the frequency and severity of patients’ cough symptoms. Additional research, including other herbal treatments, is needed in this area.
Dietary approaches should mainly be tried to reduce macronutrients and enrich functional food components such as vitamins, flavonoids, and unsaturated fatty acids. People with Metabolic Syndrome will benefit most by combining weight loss and anti-inflammatory nutrients.
In patients with CHD, MBM programs can lessen the occurrence of cardiac events, reduce atherosclerosis, and lower systolic blood pressure, but they do not reduce mortality. They can be used as a complement to conventional rehabilitation programs.
CST was both specifically effective and safe in reducing neck pain intensity and may improve functional disability and the quality of life up to 3 months after intervention.
Study data have shown that therapy- and disease-related side effects can be reduced using the methods of integrative medicine. Reported benefits include improving patients’ wellbeing and quality of life, reducing stress, and improving patients’ mood, sleeping patterns and capacity to cope with disease.
Dobos seems to be an ‘all-rounder’ whose research tackles a wide range of alternative treatments. That is perhaps unremarkable – but what I do find remarkable is the impression that, whatever he researches, the results turn out to be pretty positive. This might imply one of two things, in my view:
- all alternative therapies are effective,
- the ‘Trustworthiness Index’ of Prof Dobos is unusual.
I let my readers chose which possibility they deem to be more likely.