conflict of interest
Yesterday, a press-release about our new book has been distributed by our publisher. As I hope than many regular readers of my blog might want to read this book – if you don’t want to buy it, please get it via your library – I decided to re-publish the press-release here:
Governments must legislate to regulate and restrict the sale of complementary and alternative therapies, conclude authors of new book More Harm Than Good.
Heidelberg, 20 February 2018
Commercial organisations selling lethal weapons or addictive substances clearly exploit customers, damage third parties and undermine genuine autonomy. Purveyors of complementary and alternative medicine (CAM) do too, argue authors Edzard Ernst and Kevin Smith.
The only downside to regulating such a controversial industry is that regulation could confer upon it an undeserved stamp of respectability and approval. At best, it can ensure the competent delivery of therapies that are inherently incompetent.
This is just one of the ethical dilemmas at the heart of the book. In all areas of healthcare, consumers are entitled to expect essential elements of medical ethics to be upheld. These include access to competent, appropriately-trained practitioners who base treatment decisions on evidence from robust scientific research. Such requirements are frequently neglected, ignored or wilfully violated in CAM.
“We would argue that a competent healthcare professional should be defined as one who practices or recommends plausible therapies that are supported by robust evidence,” says bioethicist Kevin Smith.
“Regrettably, the reality is that many CAM proponents allow themselves to be deluded as to the efficacy or safety of their chosen therapy, thus putting at risk the health of those who heed their advice or receive their treatment,” he says.
Therapies covered include homeopathy, acupuncture, chiropractic, iridology, Reiki, crystal healing, naturopathy, intercessory prayer, wet cupping, Bach flower therapy, Ukrain and craniosacral therapy. Their inappropriate use can not only raises false hope and inflicts financial hardship on consumers, but can also be dangerous; either through direct harm or because patients fail to receive more effective treatment. For example, advice given by homeopaths to diabetic patients has the potential to kill them; and when anthroposophic doctors advise against vaccination, they can be held responsible for measles outbreaks.
There are even ethical concerns to subjecting such therapies to clinical research. In mainstream medical research, a convincing database from pre-clinical research is accumulated before patients are experimented upon. However, this is mostly not possible with CAM. Pre-scientific forms of medicine have been used since time immemorial, but their persistence alone does not make them credible or effective. Some are based on notions so deeply implausible that accepting them is tantamount to believing in magic.
“Dogma and ideology, not rationality and evidence, are the drivers of CAM practice,” says Professor Edzard Ernst.
Edzard Ernst, Kevin Smith
More Harm than Good?
1st ed. 2018, XXV, 223 p.
Softcover $22.99, €19,99, £15.99 ISBN 978-3-319-69940-0
Also available as an eBook ISBN 978-3-319-69941-7
END OF PRESS RELEASE
As I already stated above, I hope you will read our new book. It offers something that has, I think, not been attempted before: it critically evaluates many aspects of alternative medicine by holding them to the ethical standards of medicine. Previously, we have often been asking WHERE IS THE EVIDENCE FOR THIS OR THAT CLAIM? In our book, we ask different questions: IS THIS OR THAT ASPECT OF ALTERNATIVE MEDICINE ETHICAL? Of course, the evidence question does come into this too, but our approach in this book is much broader.
The conclusions we draw are often surprising, sometimes even provocative.
Well, you will see for yourself (I hope).
Some say that Chinese herbal medicine offers a solution.
This Chinese multi-centre RCT included 588 mothers considering breastfeeding. The intervention group received the Chinese herbal mixture Zengru Gao, while the control group received no therapy. The primary outcomes were the percentages of fully and partially breastfeeding mothers, and a secondary outcome was baby’s daily formula intake.
At day 3 and 7 after delivery, significant differences were found in favour of Zengru Gao group on the percentage of full/ partial breastfeeding. At day 7, the percentage of full/ partial breastfeeding of the active group increased to 71.48%/20.70% versus 58.67%/30.26% in the control group, the differences remained significant. No statistically significant differences were detected on primary measures at day. While intake of formula differed between groups at day 1 and 3, this difference did not achieve statistical significance, but this difference was apparent by day 7.
The authors concluded that the Chinese Herbal medicine Zengru Gao enhanced breastfeeding success during one week postpartum. The approach is acceptable to participants and merits further evaluation.
To the naïve observer, this study might look rigorous, but it is a seriously flawed RCT. Here are just some of its most obvious limitations:
- All we get in the methods section is this explanation: Participants were randomly allocated to the blank control group or the intervention group: Zengru Gao, orally, 30 g a time and 3 times a day. This seems to indicate that the control group got no treatment at all which means there was no blinding nor placebo control. The authors even comment on this point in the discussion section of their paper stating that because we included new mothers who received no treatment as a control group, we were able to prove that the improvement in breastfeeding was not due to the placebo effect. However, this is a totally nonsensical argument.
- The experimental treatment is not reproducible. The authors state: Zengru Gao, a Chinese herbal formula, which is composed of 8 herbs: Semen Vaccariae, Medulla Tetrapanacis, Radix Rehmanniae Praeparata, Radix Angelicae Sinensis, Radix Paeoniae Alba,Rhizoma Chuanxiong, Herba Leonuri, Radix Trichosanthis. This is not enough information to replicate the study outside China where the mixture is not commercially available.
- The primary outcome was the percentage of fully, and partially breastfeeding mothers. Breastfeeding was defined as mother’s milk given by direct breast feeding. Full breastfeeding meant that no other types of milk or solids were given. Partially breastfeeding meant that sustained latch with deep rhythmic sucking through the length of the feed, with some pause, on either/ or both breasts. We are not being told how the endpoint was quantified. Presumably women kept diaries. We cannot guess how accurate this process was.
- As far as I can see, there was no correction for multiple testing for statistical significance. This means that some or all of the significant results might be false-positive.
- There is insufficient data to show that the herbal mixture is safe for the mothers and the babies. At the very minimum, the researchers should have measured essential safety parameters. This omission is a gross violation of research ethics.
- Towards the end of the paper, we find the following statement: The authors would like to thank the Research and Development Department of Zhangzhou Pien Tze Huang Pharmaceutical co., Ltd. … The authors declare that they have no competing interests. And the 1st and 3rd authors are “affiliated with” Guangzhou Hipower Pharmaceutical Technology Co., Ltd, Guangzhou, China, i. e. work for the manufacturer of the mixture. This does clearly not make any sense whatsoever.
I have seen too many flawed studies of alternative medicine to be shocked or even surprised by this level of incompetence and nonsense. Yet, I still find it lamentable. But, in my view, the worst is that supposedly peer-reviewed journals such as ‘BMC Complement Altern Med’ publish such overt rubbish.
It would be easy to shrug one’s shoulder and bin the paper. But the effect of such fatally flawed research is too serious for that. In our recent book MORE HARM THAN GOOD? THE MORAL MAZE OF COMPLEMENTARY AND ALTERNATIVE MEDICINE, we discuss that such flawed science amounts to a violation of medical ethics: CAM journals allocate peer review tasks to a narrow range of CAM enthusiasts who often have been chosen by the authors of the article in question. The raison d’être of CAM journals and CAM researchers is inextricably tied to a belief in CAM, resulting in a self-referential situation which is permissive to the acceptance of weak or ﬂawed reports of clinical effectiveness… Defective research—whether at the design, execution, analysis, or reporting stage—corrupts the repository of reliable medical knowledge. Ultimately, this leads to suboptimal and erroneous treatment decisions…
The authors of this systematic review aimed to summarize the evidence of clinical trials on cupping for athletes. Randomized controlled trials on cupping therapy with no restriction regarding the technique, or co-interventions, were included, if they measured the effects of cupping compared with any other intervention on health and performance outcomes in professionals, semi-professionals, and leisure athletes. Data extraction and risk of bias assessment using the Cochrane Risk of Bias Tool were conducted independently by two pairs of reviewers.
Eleven trials with n = 498 participants from China, the United States, Greece, Iran, and the United Arab Emirates were included, reporting effects on different populations, including soccer, football, and handball players, swimmers, gymnasts, and track and field athletes of both amateur and professional nature. Cupping was applied between 1 and 20 times, in daily or weekly intervals, alone or in combination with, for example, acupuncture. Outcomes varied greatly from symptom intensity, recovery measures, functional measures, serum markers, and experimental outcomes. Cupping was reported as beneficial for perceptions of pain and disability, increased range of motion, and reductions in creatine kinase when compared to mostly untreated control groups. The majority of trials had an unclear or high risk of bias. None of the studies reported safety.
The authors concluded that no explicit recommendation for or against the use of cupping for athletes can be made. More studies are necessary for conclusive judgment on the efficacy and safety of cupping in athletes.
Considering the authors’ stated aim, this conclusion seems odd. Surely, they should have concluded that THERE IS NO CONVINCING EVIDENCE FOR THE USE OF CUPPING IN ATHLETES. But this sounds rather negative, and the JCAM does not seem to tolerate negative conclusions, as discussed repeatedly on this blog.
The discussion section of this paper is bar of any noticeable critical input (for those who don’t know: the aim of any systematic review must be to CRITICALLY EVALUATE THE PRIMARY DATA). The authors even go as far as stating that the trials reported in this systematic review found beneficial effects of cupping in athletes when compared to no intervention. I find this surprising and bordering on scientific misconduct. The RCTs were mostly not on cupping but on cupping in combination with some other treatments. More importantly, they were of such deplorable quality that they allow no conclusions about effectiveness. Lastly, they mostly failed to report on adverse effects which, as I have often stated, is a violation of research ethics.
In essence, all this paper proves is that, if you have rubbish trials, you can produce a rubbish review and publish it in a rubbish journal.
The Australian Acupuncture and Chinese Medicine Association Ltd (AACMA) is the “peak professional body of qualified acupuncture and Chinese herbal medicine practitioners in Australia. AACMA has represented the profession since 1973 and values high standards in ethical and professional practice.”
High standards in ethical and professional practice?
Somehow, I doubt it!
Because they recently wrote to ‘Friends of Science in Medicine‘ categorically stating that I have “undeclared links to the pharmaceutical industry”.
To set the record straight (yet again), I here provide a complete list of all my links to the pharmaceutical industry, plus all my sponsorships and inducements from BIG PHARMA and elsewhere :
END OF LIST
As erring is human but lying is unethical, I herewith want to give the The Australian Acupuncture and Chinese Medicine Association an opportunity to withdraw their statement and post an apology. To make sure they know about this invitation, I have sent them this blog via an email. Failing an apology I might take appropriate action and I will certainly declare the association to be neither professional nor ethical.
I am waiting – shall we say until one week from today?
Yesterday, I received a ‘LETTER FROM DR JONAS’ (the capital lettering was his) – actually, it was an email, and not a very personal one at that. Therefore I feel it might be permissible to share some of it here (you do remember Jonas, don’t you? I did mention him in a recent post: “Considering the prominence and experience of Wayne Jonas, the 1st author of this paper, such obvious transgression is more than a little disappointing – I would argue that is amounts to overt scientific misconduct.”)
Here we go:
As part of my book tour, I spent last month visiting hospitals and medical schools, talking to the doctors, nurses and students. I tell them to think of a chronically ill patient, and I ask:
“What matters most for this patient? What is the person’s lifestyle like – their nutrition, movement and sleep? How does that patient manage their stress? Does that patient have a good support system at home? What supplements does that patient take? Has your patient seen any CAM practitioners to cope with their condition? Why do they want to get well?”
Most can’t answer these questions. Providers may know the diagnosis and treatments a patient gets, but few know their primary determinants of health. They know ‘what’s the matter’, but not ‘what matters.’ …
END OF QUOTE
Let’s have a closer look at those items of which Jonas thinks they matter:
- What is the person’s lifestyle like – their nutrition, movement and sleep? Depending on the condition of the patient, these issues might indeed matter. And if they do, any good doctor will consider them. There is nothing new about this; it is stuff I learnt in medical school all those years ago.
- How does that patient manage their stress? The question supposes that all patients suffer from stress. I know it is fashionable to ‘have stress’, but not every patient suffers from it. If the patient does suffer, it goes without saying that a good doctor would consider it.
- Does that patient have a good support system at home? Elementary, my dear Watson! If a doctor does not know about this, (s)he has slept through medical school (where did you go to medical school Wayne, and what did you do during these 6 years?).
- What supplements does that patient take? That’s a good one. I suppose Jonas would ask it to see what further nonsense he might recommend. Most rational doctors would ask this question to see what (s)he must advise the patient to discontinue.
- Has your patient seen any CAM practitioners to cope with their condition? As above.
- Why do they want to get well? Most patients would assume we are pulling their leg, if we really asked this. Instead of a response, they might return a question: Why do you ask, do you think being ill is fun?
So, doctor Jonas’ questions might do well during lectures to a self-selected audience, but in reality they turn out to be a mixture of embarrassing re-discoveries from conventional medicine, platitudes and outright nonsense. “My goal is for integrative healthcare to become the standard of care…” says Jonas towards the end of his ‘LETTER’. I suppose, this explains it!
Thus Jonas’ ‘LETTER’ turns out to be yet another indication to suggest that the reality of ‘integrative medicine’ consists of little more than re-discoveries from conventional medicine, platitudes and outright nonsense.
The authors of this review aimed to present an overview of the literature on physicochemical research performed on homeopathic preparations with respect to publication quality and methods used. They searched major scientiﬁc databases to ﬁnd relevant publications from its origin to the end of 2015. Publications were assessed using a scoring scheme, the Manuscript Information Score (MIS). Information regarding country of origin of the research and experimental techniques used was extracted.
The authors identiﬁed 183 publications. The rate of publication in the ﬁeld was 2 per year from the 1970s until 2000. Afterward, it increased to over 5.5 publications per year. The quality of publications was seen to increase sharply from 2000 onward: before 2000, only 12 (13%) publications were rated as ‘‘high quality’’ (MIS ‡7.5); 44 (48%) publications were rated as ‘‘high quality’’ after 2000.
Countries with most publications were Germany (n=42, 23%), France (n=29, 16%), India (n=27, 15%), and Italy (n=26, 14%). Techniques most frequently used were electrical impedance (26%), analytical methods (20%), spectroscopy (20%), and nuclear magnetic resonance (19%).
The authors concluded that physicochemical research into homeopathic preparations is increasing both in terms of quantity and quality of the publications.
They also announce that there will be a further paper on the subject: In part 2, we aim to identify the most interesting experimental techniques. With this, we aim to be in a position to generate meaningful hypotheses regarding a possible mode of action of homeopathic preparations.
- Institute of Complementary Medicine, University of Bern, Switzerland.
- Scientiﬁc & Regulatory Affairs, Hevert-Arzneimittel GmbH & Co. KG, Germany.
- Society for Cancer Research, Arlesheim, Switzerland.
- Institute of Integrative Medicine, University of Witten/Herdecke, Germany.
- Homeopathy Research Institute (HRI), London, United Kingdom.
In other words, they are without exception proponents of homeopathy, some burdened with considerable conflicts of interest in the subject. Personally, I think it unlikely that anything meaningful will ever come of this research. But unsurprisingly, the enthusiasts beg to differ: on facebook, the HRI claimed that this new systematic review is a major step towards developing clear and testable hypotheses regarding the mode of action of homeopathy.
In a previous blog-post I have tried to explain my reservations in some detail; please allow me to repeat them here:
… homeopaths have been keen to find more rational support for their theories. Thus they have developed several ‘sciency’ concepts to explain the mode of action of their highly diluted homeopathic remedies. For instance they postulated that water can form secondary structures that hold some information of the original substance (stock), even if it has long been diluted out of the remedy. Alternatively, they claimed that the shaking of the remedy generates nano-particles or silicone-particles which, in turn, are the cause of the clinical effects.
Today, I want to assume for a minute, that one of these theories is correct – they cannot all be right, of course. Homeopaths regularly show us investigations that seem to support them, even though it only needs a real expert in the particular field of science to cast serious doubt on them. I will nevertheless assume that, after potentisation, the diluent retains information via nano-particles or some other phenomenon. For the purpose of this mind-experiment, I grant homeopaths that, in this respect, they are correct. In other words, let’s for a moment assume that the ‘memory of water’ theory is correct.
As I have been more than generous, I want homeopaths to return the favour and consider what this would really mean: information has been transferred from the stock to the diluent. Does that prove anything? Does it show that homeopathy is valid?
Could the homeopaths who make this assumption be equally generous and answer the following questions, please?
- How does a nano-particle of coffee, for instance, affect the sleep centre in the brain to make the patient sleep? Or how does a nano-particle of the Berlin Wall or a duck liver affect anything at all in the human body? The claim that information has been retained by the diluent is no where near to an explanation of a rational mode of action, isn’t it?
- Most homeopathic remedies are consumed not as liquids but as ‘globuli’, i. e. tiny little pills made of lactose. They are prepared by dropping the liquid remedy on to them. The liquid subsequently evaporates. How is it that the information retained in the liquid does not evaporate with the diluent?
- The diluent usually is a water-alcohol mixture which inevitably contains impurities. In fact, a liquid C12 remedy most certainly contains dimensions more impurities than stock. These impurities have, of course, also been vigorously shaken, i. e. potentised. How can we explain that their ‘potency’ has not been beefed up at each dilution step? Would this not necessitate a process where only some molecules in the diluent are agitated, while all the rest remain absolutely still? How can we explain this fantastic concept?
- Some stock used in homeopathy is insoluble (for instance Berlin Wall). Such stock is not diluted but its concentration in the remedy is initially lowered by a process called ‘trituration’, a process which consists in grinding the source material in another solid material, usually lactose. I have granted you that potentisation works in the way you think. But how is information transferred from one solid material to another?
- Everything we drink is based on water containing molecules that have been inadvertently potentised in nature a million times and therefore should have hugely powerful effects on our bodies. How is it that we experience none of these effects each time we drink?
Now, homeopaths, let me propose a deal.
If you can answer these questions satisfactorily, I will no longer doubt your memory of water theory. If you cannot do this, I think you ought to admit that all your ‘sciency’ theories about the mode of action of highly diluted homeopathic remedies are really quite silly – more silly even than Hahnemann’s idea of a ‘spirit-like’ effect.
HELLO HOMEOPATHS OF THIS WORLD…
SO FAR NOBODY HAS TAKEN UP MY OFFER.
BUT IT STILL STANDS!
HOW ABOUT IT?
You might remember: I have been badly misquoted in an article in THE DAILY TELEGRAPH. Based on a newly published scientific paper, the Telegraph article was about herbal medicines and their potential to interact with synthetic drugs. Towards its end, it cited me stating this:
Emeritus Professor Edzard Ernst, Britain’s first professor of complementary medicine at Exeter University said that doctors should make it clear to patients that they could not be taking herbal remedies alongside drugs.
Prof Ernst said there was no good evidence that they work and that doctors were ‘contributing to disinformation’ by turning a blind eye to the practice.
Not only did this not make any sense (I felt, it made me look like an idiot), but crucially I had never stated this nor had I even commented to a Telegraph journalist about this scientific paper. This was (27/1) when I wrote my blog-post about it.
Several friends persuaded me to file an official complaint – which I somewhat reluctantly did. Subsequently, I received an email from the paper’s ‘editorial compliance executive’ asking me to supply more details about my grievances. I complied with the request by pointing out that:
The following things are wrong with this passage:
1) I never said this.
2) I have not even been interviewed by your journalist and do not know where this quote is supposed to come from.
3) As far as I am aware, I also never stated anything like this anywhere else.
4) It is not and never has been my view that there is no good evidence that herbal remedies can never be combined with drugs.
5) It is not and never has been my opinion that there is no good evidence to suggest that herbal remedies work.
6) It is not and never has been my view that doctors were contributing to disinformation by turning a blind eye to the use of herbal remedies.
The response came swiftly:
The quoted words were recorded at a briefing at the SMC to launch your new book, More Harm than Good? The Moral Maze of Complementary and Alternative Medicine on 17th January 2018.
We are aware that you have had correspondence with our Science Editor, Sarah Knapton who has since amended the online article to make this clear.
We do however accept that one sentence was mistakenly attributed to you. We have therefore amended the online article and added a footnote to explain what has been updated.
This was most bizarre, I thought, because I did NOT have a correspondence with Sarah Knapton, the author of the Telegraph article. On the plus-side, the Telegraph had indeed changed the passage in question; it now read (and did so until yesterday):
Emeritus Professor Edzard Ernst, Britain’s first professor of complementary medicine at Exeter University said there was a ‘potential for harm’.
“It’s a lazy way out of the problem,” he said at a briefing to launch his new book More Harm than Good? The Moral Maze of Complementary and Alternative Medicine. “In medicine you give treatment for a reason and if there is no reason for the homeopathic remedy why should you support it for the placebo treatment.
“As a good doctor you should be able to transmit a placebo effect any case. I just don’t see a reason, I see the potential for harm.”
The research was published in the British Journal of Clinical Pharmacology.
CORRECTION: This article originally stated that Professor Edzard Ernst said there was no good evidence that herbal remedies work and that doctors were ‘contributing to disinformation’ by turning a blind eye to their usage. In fact, this was not said by Professor Ernst. The article has been amended.
I felt that this was a correction of one mistake by another mistake and pointed out that the briefing had been about homeopathy and NOT about herbal medicine or herb/drug interactions. Therefore I replied to the ‘editorial compliance executive’ insisting on further corrections and pointing out that such an utterly nonsensical comment might harm my reputation as an expert. I also posted a comment under the Telegraph article explainig that homeopathy is not herbal medicine.
Sadly, nothing happened.
So, a few days later, I sent a reminder to the ‘editorial compliance executive’.
And again nothing happened.
… until yesterday.
I had almost given up and was contemplating what to do next, when I received an email. It was not from the ‘editorial compliance executive’, but from THE TELEGRAPH’s ‘Head of Editorial Compliance’. He wrote that he had listened to the tapes of the original briefing and realised that my comments were indeed made in a different context. Therefore, they had now erased all of the nonsensical stuff and replaced it with this text:
CORRECTION: This article originally stated that Professor Edzard Ernst, professor of complementary medicine at Exeter University, had said there was ‘potential for harm’ in herbal remedies and that doctors were ‘contributing to disinformation’ by turning a blind eye to this. These comments did not in fact relate to interactions between herbal remedies and prescribed medication, and they have been removed. We apologise to the Professor for the error.
I am pleased!
And I gratefully accept the apology.
This might be a long, convoluted and somewhat boring story, but I think it has at least two important elements to it:
- It may seem petty to complain, and complain, and send reminders when the complaint seems to be getting ignored (I certainly did not feel sure that I was doing the right thing). But occasionally, it is worth the effort – not because of the personal satisfaction (nice but not essential), but because the truth has a high value which should be respected.
- Wondering how all this mess came about, I am asking myself: Does the author of the Telegraph article perhaps genuinely not know the difference between herbal and homeopathic remedies? Obviously, I don’t know the answer to this question, but it would explain the mess she got herself (and me) into. And it would also suggest that it might be necessary to educate journalists about alternative medicine in general and homeopathy in particular (In case there is any interest, I offer to give a few informative lectures with opportunities to ask questions to London-based health writers and science journalists).
Many hard-nosed sceptics might claim that there is no herbal treatment for upper respiratory infections that makes the slightest difference difference. But is this assumption really correct?
According to my own research of 2004, it is not. Here is the abstract of our systematic review:
Acute respiratory infections represent a significant cause of over-prescription of antibiotics and are one of the major reasons for absence from work. The leaves of Andrographis paniculata (Burm. f.) Wall ex Nees (Acanthaceae) are used as a medicinal herb in the treatment of infectious diseases. Systematic literature searches were conducted in six computerised databases and the reference lists of all papers located were checked for further relevant publications. Information was also requested from manufacturers, the spontaneous reporting schemes of the World Health Organisation and national drug safety bodies. No language restrictions were imposed. Seven double-blind, controlled trials (n = 896) met the inclusion criteria for evaluation of efficacy. All trials scored at least three, out of a maximum of five, for methodological quality on the Jadad scale. Collectively, the data suggest that A. paniculata is superior to placebo in alleviating the subjective symptoms of uncomplicated upper respiratory tract infection. There is also preliminary evidence of a preventative effect. Adverse events reported following administration of A. paniculata were generally mild and infrequent. There were few spontaneous reports of adverse events. A. paniculata may be a safe and efficacious treatment for the relief of symptoms of uncomplicated upper respiratory tract infection; more research is warranted.
A. Paniculata (Burm.f.) Wall ex Nees (Acanthaceae family), also known as nemone chinensi, Chuān Xīn Lián, has traditionally been used in Indian and Chinese herbal medicine mostly as an antipyretic for relieving and reducing the severity and duration of symptoms of common colds and alleviating fever, cough and sore throats, or as a tonic to aid convalescence after uncomplicated respiratory tract infections. The active constituents of A. paniculata include the diterpene, lactones commonly known as the andrographolides which have shown anti-inflammatory, antiviral, anti-allergic, and immune-stimulatory activities. A. Paniculata has also been shown, in vitro, to be effective against avian influenza A (H9N2 and H5N1) and human influenza A H1N1 viruses, possibly through blocking the binding of viral hemagglutinin to cells, or by inhibiting H1N1 virus-induced cell death.
But our systematic review was published 14 years ago!
We need more up-to-date information!
And I am pleased to report that a recent paper provided exactly that.
This systematic review included published and unpublished RCTs. Quasi-RCTs, crossover trials, controlled before and after studies, interrupted time series (ITS) studies, and non-experimental studies were not included due to their potential high risk of bias.
Thirty-three trials involving 7175 patients with ARTIs were included. Their methodological quality was restricted as randomisation was not well documented; 73% of the trials included were not blinded; where ITT analysis were performed, loss to follow-up data were counted as no effect; and most trials were published without a protocol available.
Findings suggested limited but consistent evidence that A. Paniculata improved cough and sore throat when compared with placebo. A. Paniculata (alone or plus usual care) had a statistically significant effect in improving overall symptoms of ARTIs when compared to placebo, usual care, and other herbal therapies. A. Paniculata in pillule tended to be more effective in improving overall symptoms over A. Paniculata in tablet. Evidence also suggested that A. Paniculata (alone or plus usual care) shortens the duration of cough, sore throat and sick leave/time to resolution when compared versus usual care. Reduction in antibiotic usage was seldom evaluated in the included trials.
The authors concluded that A. Paniculata appears beneficial and safe for relieving ARTI symptoms and shortening time to symptom resolution. However, these findings should be interpreted cautiously owing to poor study quality and heterogeneity. Well-designed trials evaluating the effectiveness and potential to reduce antibiotic use of A. Paniculata are warranted.
In case you wonder about conflicts of interest: there were none with my 2004 paper, and the authors of the new review state that this paper presents independent research funded by the National Institute for Health Research School for Primary Care Research (NIHR SPCR). The views expressed are those of the author(s) and not necessarily those of the NIHR, the NHS or the Department of Health.
Yes, the RCTs are not all of top quality.
And yes, the effect size is not huge.
But maybe – just maybe – we do have here an alternative therapy that does help against a condition for which conventional drugs are fairly useless!?!
The aim of this three-armed, parallel, randomized exploratory study was to determine, if two types of acupuncture (auricular acupuncture [AA] and traditional Chinese acupuncture [TCA]) were feasible and more effective than usual care (UC) alone for TBI–related headache. The subjects were previously deployed Service members (18–69 years old) with mild-to-moderate TBI and headaches. The interventions explored were UC alone or with the addition of AA or TCA. The primary outcome was the Headache Impact Test (HIT). Secondary outcomes were the Numerical Rating Scale (NRS), Pittsburgh Sleep Quality Index, Post-Traumatic Stress Checklist, Symptom Checklist-90-R, Medical Outcome Study Quality of Life (QoL), Beck Depression Inventory, State-Trait Anxiety Inventory, the Automated Neuropsychological Assessment Metrics, and expectancy of outcome and acupuncture efficacy.
Mean HIT scores decreased in the AA and TCA groups but increased slightly in the UC-only group from baseline to week 6 [AA, −10.2% (−6.4 points); TCA, −4.6% (−2.9 points); UC, +0.8% (+0.6 points)]. Both acupuncture groups had sizable decreases in NRS (Pain Best), compared to UC (TCA versus UC: P = 0.0008, d = 1.70; AA versus UC: P = 0.0127, d = 1.6). No statistically significant results were found for any other secondary outcome measures.
The authors concluded that both AA and TCA improved headache-related QoL more than UC did in Service members with TBI.
The stated aim of this study (to determine whether AA or TCA both with UC are more effective than UC alone) does not make sense and should therefore never have passed ethics review, in my view. The RCT followed a design which essentially is the much-lamented ‘A+B versus B’ protocol (except that a further groups ‘C+B’ was added). The nature of such designs is that there is no control for placebo effects, the extra time and attention, etc. Therefore, such studies cannot fail but generate positive results, even if the tested intervention is a placebo. In such trials, it is impossible to attribute any outcome to the experimental treatment. This means that the positive results are known before the first patient has been enrolled; hence they are an unethical waste of resources which can only serve one purpose: to mislead us. It also means that the conclusions drawn above are not correct.
An alternative and in my view more accurate conclusion would be this one: both AA and TCA had probably no effect; the improved headache-related QoL was due to the additional attention and expectation in the two experimental groups and is unrelated to the interventions tested in this study.
In our new book, MORE HARM THAN GOOD, we discuss that such trials are deceptive to the point of being unethical. Considering the prominence and experience of Wayne Jonas, the 1st author of this paper, such obvious transgression is more than a little disappointing – I would argue that is amounts to overt scientific misconduct.
An article in the medical magazine ‘GP’ caught my eye. In it, a GP from Southampton argues that it is counter-productive for the NHS to ban ineffective treatments. Here are a few excerpts (my comments are inserted in brackets and are in bold print):
START OF QUOTES
NHS England’s recent decision requiring GPs stop prescribing a list of 18 medicines will reinforce the fears of many doctors that healthcare rationing is being introduced by the back door (all finite NHS resources need to be and always have been rationed). I would also argue that it is an illogical and ill-informed decision that will not achieve the professed aim of saving NHS resources (perhaps the decision is not purely based on the need to save money but also on a matter of principle and an attempt to make the NHS evidence-based?).
The decision to impose a blanket ban on these items will disproportionately affect those patients who currently receive free prescriptions: the young, the poor and the elderly (where is the evidence for this statement?). The conditions these patients are suffering from will persist (treating them with ineffective medications would also make them persist).
If in future these vulnerable patients want to continue with their medicines, they will be forced to pay for them. While wealthier patients will have the option to pay for their medications, those unable to do so will return to their GP for an alternative medication or procedure that has not been prohibited by NHS England’s recommendations. GPs will then find themselves prescribing other more costly medications. How this is helping NHS England to reduce prescribing costs is difficult to see (really? I don’t find it difficult to see that spending money on effective treatments is a better investment than wasting it on ineffective stuff)…
… ‘evidence-informed practice’… not only includes scientific research, but also evidence from clinical practice acquired over many years and endorsed by numerous clinicians. Yet this type of evidence, from the front line of medicine, is being dismissed as ‘unscientific’ or ‘anecdotal’ (no, it has never been considered to be evidence; remember: the plural of anecdote is anecdotes, not evidence)…
We all want the NHS to operate cost effectively… (as long as the NHS continues to pay for homeopathy?). Of course, treatments that have no good evidence of benefit to patients should be questioned (as long as the NHS continues to pay for homeopathy?)…
NHS England needs to conduct a review of how it evaluates treatments and take far more notice of the experiences of doctors and patients. Then perhaps we will see a more financially efficient health service, healthier patients and an end to the injustice of healthcare rationing (the author forgot to tell her readers that she is a homeopath – in fact, she did not even once use the word ‘homeopathy’ in her diatribe. Because of her extreme views, she has featured on this blog before. [“homeopathy can be helpful for pretty much any condition”] Dr Day also forgot to declare conflicts of interest in her most recent vituperation [easy mistake to make; I know I am being petty).
If I were a fan of homeopathy and a believer in the magical healing power of shaken water, I would be very worried. While homeopaths put forward such embarrassingly daft arguments, the future of homeopathy looks bleak indeed.