MD, PhD, FMedSci, FRSB, FRCP, FRCPEd

risk/benefit

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Most diabetics need life-long medication. Understandably, this makes many fed-up, and some think that perhaps natural remedies might be a less harmful, less intrusive way to control their condition. They don’t have to look far to find an impressively large choice.

This article in the Canadian Journal of Diabetes was aimed at reviewing CAM, including natural health products (NHP) and others, such as yoga, acupuncture, tai chi and reflexology, that have been studied for the prevention and treatment of diabetes and its complications. It claims that, in adults with type 2 diabetes, the following NHP have been shown to lower glycated hemoglobin (A1C) by at least 0.5% in randomized controlled trials lasting at least 3 months:

Ayurveda polyherbal formulation

Citrullus colocynthis

Coccinia cordifolia

Eicosapentaenoic acid

Ganoderma lucidum

Ginger (Zingiber officinale)

Gynostemma pentaphyllum

Hintonia latiflora

Lichen genus Cladonia BAFS “Yagel-Detox”

Marine collagen peptides

Nettle (Urtica dioica)

Oral aloe vera

Pterocarpus marsupium (vijayasar)

Salacia reticulate

Scoparia dulcis porridge

Silymarin

Soybean-derived pinitol extract

Touchi soybean extract

Traditional Chinese medicine herbs:

Berberine

Fructus Mume

Gegen Qinlian Decoction (GQD)

Jianyutangkang (JYTK) with metformin

Jinlida with metformin

Sancaijiangtang

Shen-Qi-Formula (SQF) with insulin

Tang-Min-Ling-Wan (TM81)

Xiaoke (contains glyburide)

Zishentongluo (ZSTL)

Trigonella foenum-graecum (fenugreek)

Even though the authors caution that these remedies should not be recommended for routine use, I fear that such lists do motivate diabetics to give them a try. If they do, the outcome could be that:

  • Nothing at all happens other than the patient wasting some money on useless remedies. The clinical trials on which the above list is based are usually so flimsy that their findings are next to meaningless and quite possibly false-positive.
  • The patient might, if the remedy does affect blood sugar levels, develop hypoglycaemia. If severe, this could be life-threatening.
  • The patient might trust in a natural remedy and thus discontinue the prescribed anti-diabetic medication. In this case, she could develop hyperglycaemia. If severe, this could be life-threatening.

It seems obvious that none of the possible outcomes are in the patients’ interest. I fear that it is dangerous to tempt diabetics with the possibility that a natural remedy. Even if such treatments did work, they are not well-researched, unreliable and do not have sufficiently large effects (a 0.5% decrease of glycated haemoglobin is hardly impressive) to represent realistic options.

I have written about the use of homeopathy in France before (as I now live half of my time in France, this is a subject of considerable interest to me). After decades of deafening silence and uncritical acceptance by the French public, it seems that finally some change to the better might be on its way. Recently, a sizable number of prominent doctors protested publicly against the fact that, despite its implausibility and the lack of proof of efficacy, homeopathy continues to be reimbursed in France and scarce funds are being wasted on it. This action seems to have put pressure on officials to respond.

Yesterday (just in time for the ‘HOMEOPATHIC AWARENESS WEEK’) the French minister of health was quoted making a statement on homeopathy. Here is my translation of what Agnès Buzyn was quoted saying:

“There is a continuous evaluation of the medicines we call complementary. A working group* at the head office of my department checks that all these practices are not dangerous. If a therapy continues to be beneficial without being harmful, it continues to be reimbursed… The French are very attached [to homeopathy]; it’s probably a placebo effect. If it can prevent the use of toxic medicine, I think that we all win. I does not hurt.”

Agnès Buzyn

  • I would like to know who they are, how they can be contacted, and whether they would consider recruiting my assistance in evaluating alternative therapies.

So, if I understand her correctly, Agnès Buzyn believes that:

  1. the French people are fond of homeopathy;
  2. homeopathy is a placebo-therapy;
  3. homeopathy does no harm;
  4. homeopathy can even prevent harm from conventional medicine;
  5. on balance, therefore, homeopathy should continue to be reimbursed in France.

My views of this type of reasoning have been expressed repeatedly. Nevertheless, I will briefly state them again:

  1. true but not relevant; healthcare is not a popularity contest; and the current popularity is essentially the result of decades of systematic misinformation of consumers;
  2. correct;
  3. wrong: we have, on this blog, discussed ad nauseam how homeopathy can cause serious harm; for instance, whenever it replaces effective treatments, it can cause serious harm and might even kill patients;
  4. if doctors harm patients by needlessly prescribing harmful treatments, we need to re-train them and stop this abuse; using homeopathy is not the solution to bad medicine;
  5. wrong: the reimbursement of homeopathy is a waste of money and undermines evidence-based medicine.

So, what’s the conclusion?

Politicians are usually not good at understanding science or scientific evidence. They (have to?) think in time spans from one election to the next. And they are, of course, keenly aware that, in order to stay in power, they rely on the vote of the people. Therefore, the popularity of homeopathy (even though it is scientifically irrelevant) is a very real factor for them. This means that, on a political level, homeopathy is sadly much more secure than it should be. In turn, this means we need to:

  • use different arguments when arguing with politicians (for instance, the economic impact of wasting money on placebo-therapies, or the fact that systematically misinforming the public is highly unethical and counter-productive),
  • and make politicians understand science better than they do at present, perhaps even insist that ministers are experts in their respective areas (i. e. a minister of health fully understands the fundamental issues of healthcare).

Does that mean the new developments in the realm of French homeopathy are all doomed to failure?

No, I don’t think so – at least (and at last) we have a vocal group of doctors protesting against wasteful nonsense, and a fairly sound and accurate statement from a French minister of health:

HOMEOPATHY, IT’S PROBABLY A PLACEBO EFFECT!

 

This week, I find it hard to decide where to focus; with all the fuzz about ‘Homeopathy Awareness Week’ it is easy to forget that our friends, the chiros are celebrating  Chiropractic Awareness Week (9-15 April). On this occasion, the British Chiropractic Association (BCA), for instance, want people to keep moving to make a positive impact on managing and preventing back and neck pain.

Good advice! In a recent post, I even have concluded that people should “walk (slowly and cautiously) to the office of their preferred therapist, have a little rest there (say hello to the staff perhaps) and then walk straight back home.” The reason for my advice is based on the fact that there is precious little evidence that the spinal manipulations of chiropractors make much difference plus some worrying indications that they may cause serious damage.

It seems to me that, by focussing their PR away from spinal manipulations and towards the many other things chiropractors sometimes do – they often call this ‘adjunctive therapies’ – there is a tacit admission here that the hallmark intervention of chiros (spinal manipulation) is of dubious value.

A recent article entitled ‘Spinal Manipulative Therapy and Other Conservative Treatments for Low Back Pain: A Guideline From the Canadian Chiropractic Guideline Initiative’ seems to confirm this impression. Its objective was to develop a clinical practice guideline on the management of acute and chronic low back pain (LBP) in adults. The specific aim was to develop a guideline to provide best practice recommendations on the initial assessment and monitoring of people with low back pain and address the use of spinal manipulation therapy (SMT) compared with other commonly used conservative treatments.

The topic areas were chosen based on an Agency for Healthcare Research and Quality comparative effectiveness review, specific to spinal manipulation as a non-pharmacological intervention. The panel updated the search strategies in Medline and assessed admissible systematic reviews and randomized controlled trials. Evidence profiles were used to summarize judgments of the evidence quality and link recommendations to the supporting evidence. Using the Evidence to Decision Framework, the guideline panel determined the certainty of evidence and strength of the recommendations. Consensus was achieved using a modified Delphi technique. The guideline was peer reviewed by an 8-member multidisciplinary external committee.

For patients with acute (0-3 months) back pain, we suggest offering advice (posture, staying active), reassurance, education and self-management strategies in addition to SMT, usual medical care when deemed beneficial, or a combination of SMT and usual medical care to improve pain and disability. For patients with chronic (>3 months) back pain, we suggest offering advice and education, SMT or SMT as part of a multimodal therapy (exercise, myofascial therapy or usual medical care when deemed beneficial). For patients with chronic back-related leg pain, we suggest offering advice and education along with SMT and home exercise (positioning and stabilization exercises).

The authors concluded that a multimodal approach including SMT, other commonly used active interventions, self-management advice, and exercise is an effective treatment strategy for acute and chronic back pain, with or without leg pain.

I find this paper most interesting and revealing. Considering that it originates from the ‘Canadian Chiropractic Guideline Initiative’, it is remarkably shy about recommending SMT – after all their vision is “To enhance the health of Canadians by fostering excellence in chiropractic care.” They are thus not likely to be overly critical of the treatment chiropractors use most, i. e. SMT.

Perhaps this is also the reason why, in their conclusion, they seem to have rather a large blind spot, namely the risks of SMT. I have commented on this issue more often than I care to remember. Most recently, I posted this:

The reason why my stance, as expressed on this blog and elsewhere, is often critical about certain alternative therapies is thus obvious and transparent. For none of them (except for massage) is the risk/benefit balance positive. And for spinal manipulation, it even turns out to be negative. It goes almost without saying that responsible advice must be to avoid treatments for which the benefits do not demonstrably outweigh the risks.

 

HAPPY CHIROPRACTIC AWARENESS WEEK EVERYONE!

The media have (rightly) paid much attention to the three Lancet-articles on low back pain (LBP) which were published this week. LBP is such a common condition that its prevalence alone renders it an important subject for us all. One of the three papers covers the treatment and prevention of LBP. Specifically, it lists various therapies according to their effectiveness for both acute and persistent LBP. The authors of the article base their judgements mainly on published guidelines from Denmark, UK and the US; as these guidelines differ, they attempt a synthesis of the three.

Several alternative therapist organisations and individuals have consequently jumped on the LBP  bandwagon and seem to feel encouraged by the attention given to the Lancet-papers to promote their treatments. Others have claimed that my often critical verdicts of alternative therapies for LBP are out of line with this evidence and asked ‘who should we believe the international team of experts writing in one of the best medical journals, or Edzard Ernst writing on his blog?’ They are trying to create a division where none exists,

The thing is that I am broadly in agreement with the evidence presented in Lancet-paper! But I also know that things are a bit more complex.

Below, I have copied the non-pharmacological, non-operative treatments listed in the Lancet-paper together with the authors’ verdicts regarding their effectiveness for both acute and persistent LBP. I find no glaring contradictions with what I regard as the best current evidence and with my posts on the subject. But I feel compelled to point out that the Lancet-paper merely lists the effectiveness of several therapeutic options, and that the value of a treatment is not only determined by its effectiveness. Crucial further elements are a therapy’s cost and its risks, the latter of which also determines the most important criterion: the risk/benefit balance. In my version of the Lancet table, I have therefore added these three variables for non-pharmacological and non-surgical options:

EFFECTIVENESS ACUTE LBP EFFECTIVENESS PERSISTENT LBP RISKS COSTS RISK/BENEFIT BALANCE
Advice to stay active +, routine +, routine None Low Positive
Education +, routine +, routine None Low Positive
Superficial heat +/- Ie Very minor Low to medium Positive (aLBP)
Exercise Limited +/-, routine Very minor Low Positive (pLBP)
CBT Limited +/-, routine None Low to medium Positive (pLBP)
Spinal manipulation +/- +/- vfbmae
sae
High Negative
Massage +/- +/- Very minor High Positive
Acupuncture +/- +/- sae High Questionable
Yoga Ie +/- Minor Medium Questionable
Mindfulness Ie +/- Minor Medium Questionable
Rehab Ie +/- Minor Medium to high Questionable

Routine = consider for routine use

+/- = second line or adjunctive treatment

Ie = insufficient evidence

Limited = limited use in selected patients

vfbmae = very frequent, minor adverse effects

sae = serious adverse effects, including deaths, are on record

aLBP = acute low back pain

The reason why my stance, as expressed on this blog and elsewhere, is often critical about certain alternative therapies is thus obvious and transparent. For none of them (except for massage) is the risk/benefit balance positive. And for spinal manipulation, it even turns out to be negative. It goes almost without saying that responsible advice must be to avoid treatments for which the benefits do not demonstrably outweigh the risks.

I imagine that chiropractors, osteopaths and acupuncturists will strongly disagree with my interpretation of the evidence (they might even feel that their cash-flow is endangered) – and I am looking forward to the discussions around their objections.

Today, the BMJ published our ‘head to head‘ article on the above question. Dr Mike Cummings argues the pro-part, while Prof Asbjorn Horbjardsson and I argue against the notion.

The pro arguments essentially are the well-rehearsed points acupuncture-fans like to advance:

  • Some guidelines do recommend acupuncture.
  • Sham acupuncture is not a valid comparator.
  • The largest meta-analysis shows a small effect.
  • Acupuncture is not implausible.
  • It improves quality of life.

Cummings concludes as follows: In summary, the pragmatic view sees acupuncture as a relatively safe and moderately effective intervention for a wide range of common chronic pain conditions. It has a plausible set of neurophysiological mechanisms supported by basic science.12 For those patients who choose it and who respond well, it considerably improves health related quality of life, and it has much lower long term risk for them than non-steroidal anti-inflammatory drugs. It may be especially useful for chronic musculoskeletal pain and osteoarthritis in elderly patients, who are at particularly high risk from adverse drug reactions.

Our arguments are also not new; essentially, we stress that:

  • The effects of acupuncture are too small to be clinically relevant.
  • They are probably not even caused by acupuncture, but the result of residual bias.
  • Pragmatic trials are of little value in defining efficacy.
  • Acupuncture is not free of risks.
  • Regular acupuncture treatments are expensive.
  • There is no generally accepted, plausible mechanism.

We concluded that after decades of research and hundreds of acupuncture pain trials, including thousands of patients, we still have no clear mechanism of action, insufficient evidence for clinically worthwhile benefit, and possible harms. Therefore, doctors should not recommend acupuncture for pain.

Neither Asbjorn nor I have any conflicts of interests to declare.

Dr Cummings, by contrast, states that he is the salaried medical director of the British Medical Acupuncture Society, which is a membership organisation and charity established to stimulate and promote the use and scientific understanding of acupuncture as part of the practice of medicine for the public benefit. He is an associate editor for Acupuncture in Medicine, published by BMJ. He has a modest private income from lecturing outside the UK, royalties from textbooks, and a partnership teaching veterinary surgeons in Western veterinary acupuncture. He has participated in a NICE guideline development group as an expert adviser discussing acupuncture. He has used Western medical acupuncture in clinical practice following a chance observation as a medical officer in the Royal Air Force in 1989.

My question to you is this: WHICH OF THE TWO POSITION IS THE MORE REASONABLE ONE?

Please, do let us know by posting a comment here, or directly at the BMJ article (better), or both (best).

The ‘best homeopathy doctor in Delhi‘  is so ‘marvellous’ that he and his colleagues offer homeopathic treatment for HIV/AIDS:

START OF QUOTE

Antiretroviral Therapy (ART) is recommended for each and every case of AIDS where CD4 count goes less than 350.  Aura Homeopathy does not offer cure for AIDS. However, several research and clinical studies done by various Research centre including few from CCRH (Central Council for Research in Homeopathy, Govt. of India), have prove the supportive role of homeopathic medicines. Homeopathy medicine only relief symptoms but also reduced frequency of opportunistic infections, increase appetite, weight, and sense of well being, etc. At Aura Homeopathy, we apply classical homeopathy protocols on HIV/AIDS patients, as a part of our Clinical trial and Research projects. The results were very encouraging.

At Aura Homeopathy, we have seen an increase in the CD4 count in number of patients, after using Aura homeopathy medicines. Dr.Abhishek recommend’s Homeopathy as supporting line of therapy for all HIV patients.

END OF QUOTE

When I read this I wanted to be sick; but instead I did something a little more sensible: I conducted a quick Medline search for ‘homeopathy, AIDS’.

It returned 30 articles. Of these, there were just 4 that presented anything remotely resembling data. Here are their abstracts:

1st paper

Allopathic practitioners in India are outnumbered by practitioners of traditional Indian medicine and homeopathy (TIMH), which is used by up to two-thirds of its population to help meet primary health care needs, particularly in rural areas. India has an estimated 2.5 million HIV infected persons. However, little is known about TIMH use, safety or efficacy in HIV/AIDS management in India, which has one of the largest indigenous medical systems in the world. The purpose of this review was to assess the quality of peer-reviewed, published literature on TIMH for HIV/AIDS care and treatment.

Of 206 original articles reviewed, 21 laboratory studies, 17 clinical studies, and 6 previous reviews of the literature were identified that covered at least one system of TIMH, which includes Ayurveda, Unani medicine, Siddha medicine, homeopathy, yoga and naturopathy. Most studies examined either Ayurvedic or homeopathic treatments. Only 4 of these studies were randomized controlled trials, and only 10 were published in MEDLINE-indexed journals. Overall, the studies reported positive effects and even “cure” and reversal of HIV infection, but frequent methodological flaws call into question their internal and external validity. Common reasons for poor quality included small sample sizes, high drop-out rates, design flaws such as selection of inappropriate or weak outcome measures, flaws in statistical analysis, and reporting flaws such as lack of details on products and their standardization, poor or no description of randomization, and incomplete reporting of study results.

This review exposes a broad gap between the widespread use of TIMH therapies for HIV/AIDS, and the dearth of high-quality data supporting their effectiveness and safety. In light of the suboptimal effectiveness of vaccines, barrier methods and behavior change strategies for prevention of HIV infection and the cost and side effects of antiretroviral therapy (ART) for its treatment, it is both important and urgent to develop and implement a rigorous research agenda to investigate the potential risks and benefits of TIMH and to identify its role in the management of HIV/AIDS and associated illnesses in India.

2nd paper (I am a co-author of this one)

The use of complementary and alternative medicine (CAM) is widespread. Yet, little is known about the evidence supporting its use in HIV/AIDS. We conducted a systematic review of randomized clinical trials assessing the effectiveness of complementary therapies for HIV and HIV-related symptoms. Comprehensive literature searches were performed of seven electronic databases. Data were abstracted independently by two reviewers. Thirty trials met our predefined inclusion/exclusion criteria: 18 trials were of stress management; five of Natural Health Products; four of massage/therapeutic touch; one of acupuncture; two of homeopathy. The trials were published between 1989 and 2003. Most trials were small and of limited methodological rigour. The results suggest that stress management may prove to be an effective way to increase the quality of life. For all other treatments, data are insufficient for demonstrating effectiveness. Despite the widespread use of CAM by people living with HIV/AIDS, the effectiveness of these therapies has not been established. Vis à vis CAM’s popularity, the paucity of clinical trials and their low methodological quality are concerning.

3rd paper (author is our old friend Dana Ullman!)

Homeopathic medicine developed significant popularity in the nineteenth century in the United States and Europe as a result of its successes treating the infectious disease epidemics during that era. Homeopathic medicine is a medical system that is specifically oriented to using nanopharmacologic and ultramolecular doses of medicines to strengthen a person’s immune and defense system rather than directly attacking the microbial agents.

To review the literature referenced in MEDLINE and in nonindexed homeopathic journals for placebo-controlled clinical trials using homeopathic medicines to treat people with AIDS or who are human immunodeficiency virus (HIV)-positive and to consider a different theoretical and methodological approach to treating people with the viral infection.

A total of five controlled clinical trials were identified. A double-blinded, placebo-controlled study was conducted on 50 asymptomatic HIV-positive subjects (stage II) and 50 subjects with persistent generalized lymphadenopathy (stage III) in whom individualized single-remedy homeopathic treatment was provided. A separate body of preliminary research was conducted using homeopathic doses of growth factors. Two randomized double-blinded, placebo-controlled studies were conducted with a total of 77 people with AIDS who used only natural therapies over a 8-16-week period. Two other studies were conducted over a 2.5-year period with 27 subjects in an open-label format.

The first study was conducted by the Regional Research Institute for Homeopathy in Mumbai, India, under the Central Council for Research in Homeopathy, with the approval of the Ministry of Health and Family Welfare, Government of India. The second body of studies was conducted in clinic settings in California, Oregon, Arizona, Hawaii, New York, and Washington.

The first study found no statistically significant improvement in CD4 T-lymphocytes, but did find statistically significant pretest and post-test results in subjects with stage III AIDS, in CD4 (p = 0.008) and in CD8 (p = 0.04) counts. The second group of studies found specific physical, immunologic, neurologic, metabolic, and quality-of-life benefits, including improvements in lymphocyte counts and functions and reductions in HIV viral loads.

As a result of the growing number of people with drug-resistant HIV infection taking structured treatment interruptions, homeopathic medicine may play a useful role as an adjunctive and/or alternative therapy.

4th paper

In 1996, [name removed] was convicted on charges of conspiracy and introducing an unapproved drug into interstate commerce and the 2nd U.S. Circuit Court of Appeals upheld the conviction. [Name removed]’s company, Writers and Researchers Inc. sold a drug called 714X to individuals and physicians, promoting it as a nontoxic therapy for AIDS, cancer, and other chronic diseases. The Food and Drug Administration (FDA) warned [name removed] that his marketing was illegal because the product had not been proven safe and effective for use in treating disease. [Name removed] argued that the product was a homeopathic drug, revealed by FDA tests to contain 94 percent water, and a mixture of nitrate, ammonium, camphor, chloride, ethanol, and sodium. The courts found that 714X was subject to FDA scrutiny because it was touted as a cure for cancer and AIDS.

————————————————————————————————————————————

So, what does this collective evidence tell us?

I think it makes it abundantly clear that there is no good reason to suggest that HIV/AIDS patients can be helped in any way by homeopathy. On the contrary, homeopathy might distract them from essential conventional care and it would needlessly harm their bank balance. It follows that claims to the contrary are bogus, unethical, reckless, and possibly even criminal.

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).

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!?!

This is a question most clinicians must have asked themselves. The interest of patients in this area is enormous, and many do seek advice from their doctor, nurse, pharmacist, midwife etc. In a typical scenario, a patient might plug up her courage (yes, for many it does take courage) and ask:

What about therapy xy for my condition? My friend suffers from the same problem, and she says the treatment works very well.

The way I see it, there are essentially 4 options for formulating a reply:

1.       Uncompromisingly negative

2.       Evidence-based

3.       Open-minded

4.       Uncritically promotional

Let me explain and address these 4 options in turn.

1.       Uncompromisingly negative

I know that it can be tempting to be wholly dismissive and simply state that all alternative medicine is rubbish; if it were any good, it would have been adopted by conventional medicine. Therefore, alternative medicine is never an alternative; it is by definition implausible, ineffective and often dangerous.

Even if all of this were true, the uncompromisingly negative approach is not helpful, in my experience. Patients need and deserve some empathy and understanding of their position. If we brusque them, they feel insulted and go elsewhere. Not only would we then lose a patient, but we would run a high risk of exposing her to a practitioner who promotes quackery. The disservice seems obvious.

2.       Evidence-based

Clinicians might consider their patient’s question and reply to it by explaining what the current best available evidence tells us about the therapy in question. This can be done with empathy and compassion. For instance (if that is true), the clinician can explain that the treatment in question lacks a scientific basis, that it has nevertheless been tested in clinical trials which sadly do not show that it works. Crucially, the clinician should subsequently explain what effective treatments do exist and discuss a viable treatment plan with the patient.

The problem with this approach is that many, if not most conventional clinicians are fairly clueless about the evidence as it relates to the plethora of alternative therapies. Therefore, an honest discussion around the current best evidence is often difficult or impossible.

3.       Open-minded

This is the approach many clinicians today use as a default position. They basically tell their patient that there is not a lot of evidence for the treatment in question. However, it seems harmless, and therefore – if the patient is really keen on going down this route – why not? This type of response is, I fear, given regardless of the therapy in question and it largely ignores the evidence – some alternative treatments do work, some don’t, some are fairly safe, some aren’t.

Condoning alternative medicine in this way gives the impression of being ‘open-minded’ and ‘patient-centred’. It has the considerable advantage that it does not require any hard work, such as informing oneself about the current best evidence. It’s disadvantage is that it neither correct nor ethical.

4.       Uncritically promotional

Many clinicians go even one decisive step further. Under the banner of ‘integrative medicine’, they openly recommend using ‘the best of both worlds’ as being ‘holistic’, ’empathetic’, ‘patient-centred’, etc. By this, they usually mean employing as many unproven or disproven treatments as alternative medicine has to offer.

This approach gives the impression of being ‘modern’ and in tune with the wishes of patients. Its disadvantages are, however, obvious. Introducing bogus treatments into clinical routine can only render it less effective, more expensive, and less safe. Integrative medicine is therefore not in the best interest of patients and arguably unethical.

Conclusion

So, how should we advise patients on alternative medicine? I know what I would say and probably most of my readers can guess. But I do not want to prejudge the issue; I prefer to hear your views, please.

Traditional Chinese Medicine (TCM) is popular, not least because it is heavily marketed and thus often perceived as natural and safe. But is this assumption true?

This study analysed  liver tests before and following treatment with herbal Traditional Chinese Medicine (TCM) in order to evaluate the risk of liver injury. Patients with normal values of alanine aminotransferase (ALT) as a diagnostic marker for ruling out pre-existing liver disease were enrolled in a prospective study of a safety program carried out at the First German Hospital of TCM from 1994 to 2015. All patients received herbal products, and their ALT values were reassessed 1-3 d prior to discharge. To evaluate causality for suspected TCM herbs, the Roussel Uclaf Causality Assessment Method (RUCAM) was used.

The report presents data of 21470 patients. ALT ranged from 1 × to < 5 × upper limit normal (ULN) in 844 patients (3.93%) and suggested mild or moderate liver adaptive abnormalities. A total of 26 patients (0.12%) experienced higher ALT values of ≥ 5 × ULN (300.0 ± 172.9 U/L, mean ± SD). Causality for TCM herbs was estimated to be probable in 8/26 patients, possible in 16/26, and excluded in 2/26 cases.

Compared with the large TCM study cohort, patients in the liver injury study cohort were older and contained a higher percentage of women, whereas the duration of the hospital stay was similar in both cohorts. The TCM herbs were rarely applied mostly as mixtures consisting of several herbs adding up to 35 different drugs during the patients’ four-week stay. The daily dosage was 95 ± 30 g and thus slightly higher than in the TCM study cohort. Among the many herbal TCM used by the 26 patients in the liver injury cohort, Bupleuri radix and Scuterllariae radix were the two TCM herbs most frequently implicated in liver injury, with variable RUCAM-based causality gradings. Most of the patients received one to six TCM drugs that were associated with potential liver injury as evidenced from the scientific literature, e.g., one patient (case 8) received six potentially hepatotoxic herbal TCM drugs during their hospital stay.

The authors concluded that in 26 (0.12%) of 21470 patients treated with herbal TCM, liver injury with ALT values of ≥ 5 × ULN was found, which normalized shortly following treatment cessation, also substantiating causality.

In the discussion section of the paper, the authors comment that the use of TCM is widely considered less risky as compared with synthetic drugs, although data on direct comparisons are not available in support of this view. Populations using herbal TCM, drugs, either alone, or combined experience more drug-induced liver injury (DILI) than herb-induced liver injury (HILI), possibly due to a higher use of drugs. Valid data of incidence and prevalence of HILI caused by TCM herbs are lacking, and respective data cannot be derived from the present study.

This study is most valuable, in my view. Its strength is clearly the huge sample size. Top marks for the authors for publishing it!

Having said that, we need to take the incidence figures with a pinch of salt, I think. In reality they could be much higher because:

  • other settings will not be as tightly supervised as the unusual hospital setting;
  • in most other situations the quality of the Chinese herbs might be less controlled;
  • there could be adulteration;
  • there could be contamination.

The ‘elephant in the room’ obviously is the inevitable question about benefit. Like any other treatment, TCM cannot be judged on the basis of its risk but must be evaluated according to its risk/benefit balance. I realise that this was not the subject of the present study, but it is nevertheless crucial: do the benefits of TCM outweigh its risks?

I am not aware that this is the case (but more than willing to consider any sound evidence readers might supply). More importantly, I am not aware of good evidence to show that, for any condition, TCM would be superior in terms of risk/benefit balance than conventional options. This is not a trivial issue: clinicians have the ethical obligation to apply the best (the one with the most positive risk/benefit balance) treatment to their patients.

If I am right, then TCM should not be used in therapeutic routine in or outside hospitals.

If I am right, the ‘First German Hospital of TCM‘ should close asap; it would be violating fundamental ethical principles.

If I am right, the debate about the risks of TCM is almost irrelevant because we simply should not use it.

Or did I misunderstand something here?

What do you think?

 

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