MD, PhD, FMedSci, FSB, FRCP, FRCPEd

bias

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WHAT DOCTORS DON’T TELL YOU (WDDTY) is probably the most vile publication I know. It systematically misleads its readers by alarming news about this or that conventional treatment, while relentlessly promoting pseudoscientific non-sense. This article , entitled “MMR can cause skin problems and ulcers if your immune system is compromised” is a good example (one of a multitude):

The MMR vaccine can cause serious adverse reactions, researchers have admitted this week. The rubella (German measles) component of the jab increases the risk of infection from the rubella virus itself, and can cause serious skin inflammation and ulcers in anyone whose immune system is compromised.

The risk is highest among people with primary immunodeficiency diseases (PIDD), chronic genetic disorders that cause the immune system to malfunction.

Although the risk for people with compromised immune systems has been known, and is even included in the package inserts supplied with the vaccine, it was theoretical, say researchers from the Children’s Hospital of Philadelphia, who say they have uncovered “genuine evidence of harm.”

The researchers analysed the health profile of 14 people—four adults and 10 children—who suffered some form of a PIDD. Seven of them still had the rubella virus in their tissues, suggesting that their immune systems were too weak to get rid of the virus in the vaccine. The virus can damage skin cells and cause ulcers, and makes the person more susceptible to the actual rubella virus, the researchers say.

People with a poor immune system already have compromised T-cells—which are responsible for clearing viral infections—and the MMR makes the problem worse.

END OF QUOTE

And what is wrong with this article?

The answer is quite a lot:

  1. The research seems to be about a very specific and rare condition, yet WDDTY seem to want to draw much more general conclusions.
  2. The research itself is not described in a way that it would be possible to evaluate.
  3. The sample size of what seems to have been a case-control study was tiny.
  4. The study is not properly cited for the reader to verify and check; for all we know, it might not even exist.
  5. I was not able to find the publication on Medline, based on the information given.

Collectively, these points render the article not just useless, in my view, but make it a prime example of unethical, unhelpful and irresponsible scaremongering.

 

On 25 and 26 May of this year I wrote two posts about an acupuncture trial that, in my view, was dodgy. To refresh your memory, here is the relevant part of the 2nd post:

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.

…the trial itself raises a number of questions:

  1. Which was the primary outcome measure of this trial?
  2. What was the power of the study, and how was it calculated?
  3. For which outcome measures was the power calculated?
  4. How were the subjective endpoints quantified?
  5. Were validated instruments used for the subjective endpoints?
  6. What type of sham was used?
  7. 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?
  8. What other treatments did each group of patients receive?
  9. Does anyone really think that this trial shows that “acupuncture is a safe, effective and cost-effective treatment for allergic rhinitis”?

In the comments section, the author wrote: “after you have read the full text and answered most of your questions for yourself, it might then be a more appropriate time to engage in any meaningful discussion, if that is in fact your intent”, and I asked him to send me his paper. As he does not seem to have the intention to do so, I will answer the questions myself and encourage everyone to have a close look at the full paper [which I can supply on request].

  1. The myriad of lab tests were defined as primary outcome measures.
  2. Two sentences are offered, but they do not allow me to reconstruct how this was done.
  3. No details are provided.
  4. Most were quantified with a 3 point scale.
  5. Mostly not.
  6. Needle insertion at non-acupoints.
  7. The results are a mixture of inter- and intra-group differences.
  8. Patients were allowed to use conventional treatments and the frequency of this use was reported in patient diaries.
  9. I don’t think so.

So, here is my interpretation of this study:

  • It lacked power for many outcome measures, certainly the clinical ones.
  • There were hardly any differences between the real and the sham acupuncture group.
  • Most of the relevant results were based on intra-group changes, rather than comparing sham with real acupuncture, a fact, which is obfuscated in the abstract.
  • In a controlled trial fluctuations within one group must never be interpreted as caused by the treatment.
  • There were dozens of tests for statistical significance, and there seems to be no correction for multiple testing.
  • Thus the few significant results that emerged when comparing sham with real acupuncture might easily be false positives.
  • Patient-blinding seems questionable.
  • McDonald as the only therapist of the study might be suspected to have influenced his patients through verbal and non-verbal communications.

I am sure there are many more flaws, particularly in the stats, and I leave it to others to identify them. The ones I found are, however, already serious enough, in my view, to call for a withdrawal of this paper. Essentially, the authors seem to have presented a study with largely negative findings as a trial with positive results showing that acupuncture is an effective therapy for allergic rhinitis. Subsequently, McDonald went on social media to inflate his findings even more. One might easily ask: is this scientific misconduct or just poor science?

END OF QUOTE

This and the previous post created lots of discussion and comments. However, the question whether the study in question amounted to scientific misconduct was never satisfactorily resolved. Therefore, I decided to write to the editor of ‘Ann Allergy Asthma Immunol‘ where the trial had been published. He answered by saying I would need to file an official complaint for him to address the issue. On 13 June, I therefore sent him the following email:

Thank you for your letter of 3/6/2016 suggesting I make a formal complaint about the paper entitled ‘EFFECT OF ACUPUNCTURE ON HOUSE DUST MITE…’ [ Ann Allergy Asthma Immunol 2016] by McDonald et al. I herewith wish to file such a complaint.

The article in question reports an RCT of acupuncture for persistent allergic rhinitis. It followed a parallel group design with 3 groups receiving the following interventions:

1.       Acupuncture

2.       Sham-acupuncture

3.       No treatment

There was a plethora of outcome measures and time points on which they were measured. A broad range of parameters was defined as primary endpoints.

The conclusion reached by the authors essentially was that acupuncture affected several outcome measures in a positive sense, thus supporting the notion that acupuncture is efficacious [“Symptoms and quality of life improved significantly and were still continuing to improve 4 weeks after treatment ceased.”] This conclusion, however, is misleading and needs correcting.

The main reasons for this are as follows:

·         Despite the fact that the authors did many dozens of statistical tests for significance, they did not correct for this multiplicity of tests. Consequently, some or most of the significant results are likely to be false positive.

·         Many of the positive results of this paper were not obtained by comparing one group to another but by doing before/after comparisons within one group. This approach defies the principle of a controlled clinical trial. For doing intra-group comparisons, we obviously do not need any control group at all. The findings from intra-group comparisons are prominently reported in the paper, for instance in the abstract, giving the impression that they originate from inter-group comparisons. One has to read the paper very carefully to find that, when inter-group comparisons were conducted, their results did NOT confirm the findings from the reported intra-group comparisons. As this is the case for most of the symptomatic endpoints, the impression given is seriously misleading and needs urgent correction.

On the whole, the article is a masterpiece of obfuscation and misrepresentation of the actual data. I urge you to consider the harm than can be done by such a misleading publication. In my view, the best way to address this problem is to withdraw the article.

I look forward to your decision.

Regards

E Ernst

END OF QUOTE

I had to send several reminders but my most recent one prompted the following response dated 7/11/ 2016:

Dear Professor Ernst,
Thank you for your patience while we worked through the process of considering your complaints levied on the article entitled ‘EFFECT OF ACUPUNCTURE ON HOUSE DUST MITE…’ [ Ann Allergy Asthma Immunol 2016] by McDonald et al. I considered the points that you made in your previous letter, sought input from our editorial team (including our biostatistics editor) , our publisher and the authors themselves. I sent the the  charges ( point by point) anonymously to the authors and allowed them time to respond which they did. I had their responses reviewed by selected editors and , as a result of this process, have decided not to pursue any corrective or punitive action based upon the following :
 
  1. Our editorial team recognizes that this is not the best clinical trial we have published in the Annals of Allergy, Asthma and Immunology. However, neither is is the worst. As in most published research studies, there are always things that could have been done better to make it a stronger paper. Never-the-less, the criticism falls fall short of any sort of remedy that would include withdrawal of the manuscript.
  2. Regarding your accusation that the multiple positive endpoint resulted in the authors making specific therapeutic claims, our assessment is that no specific therapeutic claim was made but rather the authors maintained that the data support the value of acupuncture in improving symptoms and quality of life in patients with AR. We do not believe there was overreach in those statements.
  3. The authors’ stated intent was to show immune changes associated with clinical markers of improvement in the active acupuncture group compared to controls. The authors maintain (and our editors agree) that their data assessments were primarily based upon three statistical tests not “dozens” (as stated in your original letter of complaint).  The power analysis and sample size calculations were presented to us and deemed adequate , making the probability of a type I error quite low.
  4. The authors acknowledge in their paper that there could be limitations to their data interpretation based upon potential disparities between intra- and intergroup comparisons. The editors felt their transparency was adequately disclosed.
In summary, as editor-in-chief of the Annals of Allergy, Asthma and Immunology, I did not find sufficient merit in your charges to initiate any corrective or punitive action for this manuscript. I understand you will strongly disagree with this decision and I regret that. However, in the final analysis, my primary intent is to preserve the objectivity, fairness, and integrity of our journal and its review process. I believe I have accomplished that in this instance.
 
Sincerely
END OF QUOTE
This seems to settle the issue: the study in question does not involve scientific misconduct!
Or does it?
I would be grateful for the view of the readers of this post.

I have published many articles on the risks of various alternative treatments (see for instance here, here, here, here, here and here) – not because I am alarmist but because I have always felt very strongly that, for a researcher into alternative medicine, the most important issue must be to make sure users of these therapies are as safe as possible. Usually I differentiated between direct and indirect risks. The former relate to the risks of the treatment and include, for instance, liver damage caused by a herbal remedy or stroke due to neck manipulation. The latter are mainly due to the poor, often irresponsible advice given by many therapists.

A recent article adopted the same terminology when reviewing the risks of alternative medicine specifically for cancer patients. As the indirect risks are often neglected, I will here quote the relevant section of this paper in full:

…Health care physicians and oncology experts have an ethical responsibility to initiate the communication regarding the use of complementary therapies with cancer patients. However, according to data obtained from this literature review, oncology doctors and physicians will discuss complementary therapies only when a patient him/herself raises this issue within a consultation. This passive attitude was linked to a lack of sufficient scientific evidence for positive outcomes of complementary therapies found in high quality randomized controlled trials (RCTs). Oncology nurses, on the other hand, sometimes actively promote complementary modalities that they find to correspond with their vision of holistic care.

According to the included studies, complementary providers often differ from conventional health care providers in their understanding of treatment concepts, philosophies and diagnostic procedures. This leads to different models of disease causality (cells, blood, nerves vs. energy, vital force, meridians) and treatment philosophy (reductionism vs. holism). As many complementary providers are philosophically oriented towards personal and spiritual growth, patients may feel guilty if the disease continues to advance despite the patients’ best spiritual and mental efforts. According to Broom and colleagues, such philosophies may also give patients false hope of recovery.

Another indirect risk connected to the combination of conventional and complementary treatment in cancer care is the lack of regulation and standardized education in many countries. Currently, there are, for example, no standard training requirements for complementary providers working in cancer care or any other health care setting in the EU. According to Mackareth et al., complementary providers in England need specific training to learn how to practice safely.

Moreover, there is a need for common medical terminology to bridge the communication gap between health care providers working outside the conventional health care system. Common medical terminology may reduce the existing communication gap between conventional and complementary providers about mutual patients. To minimize communication gap between physicians, oncology experts and complementary providers, a medical complementary record should include a treatment plan with conventional and complementary diagnosis, explanation of terminology, possible treatment interactions, description of the complementary treatment plan and goals. If possible, the quality of any complementary supplement given should be reported.

END OF QUOTE

As I said, I find it important to discuss the indirect risks of alternative medicine, and I am therefore pleased that the authors of this article addressed them. At the same time, I find their text remarkably tame.

Why are they not more open and forceful about what, after all, amounts to a serious public health issue? The answer might be simpler than expected: most of them are affiliated with the ‘National Research Center in Complementary and Alternative Medicine (NAFKAM), UiT The Arctic University of Norway, Tromsø, Norway’. Could it be that open warnings about outright quackery is not what suits this unit?

So, what might be an open and frank approach to discussing the indirect risks of alternative medicine? In my view, it should make several points abundantly clear and transparent:

  • Alternative practitioners (APs) are usually not trained to advise patients responsibly, particularly in cases serious disease.
  • The training of APs is often inadequate and sometimes resembles more to brain-washing than to proper education.
  • Consequently, APs often woefully over-estimate what their therapy can achieve.
  • The patients of APs are often desperate and ready to believe even the tallest tales.
  • APs have a huge conflict of interest – in order to make a living they need to treat as many patients as possible and are therefore not motivated to refer them to more suitable care.
  • APs are frequently in denial when it comes to the risks of their treatments.
  • APs are not educated such that they understand the full complexities of serious illness.
  • As a result, APs far too often misguide their patients to make tragically wrong choices thus putting their health at serious risk.
  • In most countries, the regulators turn a blind eye to this huge problem.

These are by no means trivial  points, and they have nothing to do with a ‘turf war’ between conventional and alternative medicine. They relate to our ethical duty to keep our patients as safe as we can. It has been estimated that, in oncology alone, 1 – 5% of deaths are due to patients opting to have alternative instead of conventional treatments. This amounts to an unbearably high absolute number of patients dying prematurely due to the indirect risks of alternative medicine.

It is high time, I think, that we tackle this issue systematically and seriously.

During the last two decades, I have had ample occasion to study the pseudo-arguments of charlatans when trying to defend the indefensible. Here I will try to disclose some of them in the hope that this might help others to identify charlatans more easily and to react accordingly.

Let’s say someone publishes a document showing evidence that homeopathy is a useless therapy. Naturally, this will annoy the many believers in homeopathy, and they will counter by attempting to make a range of points:

  1. THEY WILL STATE THAT THERE IS EVIDENCE TO THE CONTRARY. For instance, proponents of homeopathy can produce studies that seem to ‘prove’ homeopathy’s efficacy. The facts that these are flawed or irreproducible, and that the totality of the evidence is not positive does hardly ever bother them. Charlatans are born cherry-pickers.
  2. THEY WILL SUGGEST THAT THE EXISTING EVIDENCE HAS BEEN MIS-QUOTED. Often they will cite out of context from original studies one or two sentences which seem to indicate that they are correct. Any reminders that these quotes are meaningless fall on deaf ears.
  3. THEY WILL SAY THAT THE PUBLISHED EVIDENCE WAS MISINTERPRETED. Often the evidence is complex and can therefore be open to interpretation. Charlatans use this fact and spin the evidence such that it suits their needs. Charlatans are spin-doctors.
  4. THEY WILL SAY THAT SCIENTIFIC EVIDENCE IS OVER-RULED BY CENTURIES OF EXPERIENCE. The notion that millions of satisfied customers cannot be wrong is used frequently to distract from negative evidence. The fact that such experience can be due to a host of non-specific effects, the natural history of the condition or regression to the mean will not convince the charlatan.
  5. THEY WILL SUGGEST THAT THE AUTHOR IS PAID BY BIG PHARMA TO TRASH HOMEOPATHY. Whenever seemingly reasonable arguments have been exhausted, overtly irrational notions or blatant lies will come into play. The allegation that anyone criticising homeopathy is corrupt is one of the most popular such notion. The truth does not have a high value in charlatanry.
  6. THEY WILL SAY THAT THE CRITIC HAS NO TRAINING IN HOMEOPATHY AND IS THUS NOT COMPETENT. Equally popular is the claim that only trained and experienced homeopaths are able to judge over homeopathy. This pseudo-argument is most handy: experienced homeopaths are invariably believers, and the notion essentially claims that only those who believe in it can judge homeopathy. In other words, criticism of homeopathy is by definition invalid.
  7. THEY WILL SAY THAT THE CRITIC HAS PREVIOUSLY BEEN CRITICISED FOR HIS POOR RESEARCH. Similarly, homeopaths might claim that the critic is someone who is being criticised for being a very bad scientist; therefore, it would be a mistake to trust anything he or she says. Ad hominem is the name of the game!
  8. THEY WILL TRY TO RIDICULE THE CRITIC. Readers of this blog will have noticed how some commentators belittle their opponents by giving them laughable nicknames thus undermining their authority. The obvious aim is to make them look less than credible. Charlatans are like little children.
  9. THEY WILL CLAIM THAT IN OTHER AREAS OF HEALTHCARE THE EVIDENCE IS ALSO NOT CONVINCING. The ‘tu quoque’ fallacy is popular for distracting from the embarrassingly negative evidence in quackery – never mind that problems in the aviation industry are no argument for using flying carpets.
  10. THEY WILL POINT OUT HOW SAFE HOMEOPATHY IS COMPARED TO OTHER DRUGS. This is another form of the ‘tu quoque’ fallacy; it works very well for distracting from the problems with homeopathy and regularly convinces lay people.
  11. THEY WILL SAY THAT MEDICAL RESEARCH IS GENERALLY SO FLAWED THAT IT CANNOT BE TRUSTED. The fact that some medical research is less than rigorous is used here to claim that evidence in general is unreliable. The best solution is therefore to go by experience – a big step into the dark ages, but charlatans don’t seem to mind.
  12. THEY WILL REVERSE THE BURDEN OF PROOF. Homeopathy (or any other alternative therapy) may not have been proven to be effective, they claim, but it has not been proven to be ineffective. Therefore, they say, we must give it the benefit of the doubt. The facts that a) science cannot prove a negative and that b) we therefore should use those treatments that are supported by positive evidence is being ignored by charlatans.

These 12 pseudo-arguments are in my experience the most common defences of charlatanry. I am sure there are others – and I would be delighted if you did elaborate on them in the comments section below. Thanks!

Are you or a family member ill?

No need to call a doctor or other healthcare professional!

Homeopathy DIY is the answer. The website of the NATIONAL CENTER FOR HOMEOPATHY tells you how and gives you concrete advice for specific conditions – at closer inspection, it turns out to be an instruction for killing off your entire family:

START OF QUOTE

It’s easy to get started using homeopathy at home. You don’t need to be an expert in anatomy, physiology, or pharmacology. You only need to be able to observe your and your family’s symptoms and any changes you might see in those symptoms. By using the information on this site you can quickly learn enough about homeopathy to use it at home to care for yourself and your family to address minor illnesses and injuries that don’t necessarily need a doctor’s care.

Asthma Attack

Asthma attacks occur for a variety of reasons. You can help treat asthma attacks with homeopathic remedies based on the type of attack that it is.

  • Arsenicum album: anxiety, restlessness, unable to lie down because of feeling of suffocation shortly after midnight.
  • Carbo vegetabilis: asthma attach occurs after long, spasmodic coughing spell with gagging or vomiting; patient feels worst after eating or talking; worse in the evening.
  • Ipecacuanha: sudden onset of wheezing and feeling of suffocation; coughs constantly, but unable to bring up mucus; feeling of weight on chest.
  • Nux vomica: attack often follows stomach upset with much belching; patient very irritable.

Bleeding

  • Arnica: injury, shock.
  • China: loss of blood.
  • Carbo vegetabilis: steady oozing of dark blood; cold breath, cold limbs; cold, clammy sweat; air hunger.
  • Ipecac: gushes of bright red blood, nausea, cold sweat.
  • Sabina: threatened abortion and uterine hemorrhage.
  • Phosphorus: profuse nosebleed, especially after vigorous blowing, or any hemorrhage; when small wounds bleed profusely.

Chicken Pox

Chicken pox can be uncomfortable and painful (for both the child and the parent) and the only way to deal with it is to wait for it to run its course. However, homeopathy can help speed up the healing process – and quickly calm the itch and irritation of this childhood illness.

Let’s look at the handful of remedies that are often called for in cases of chicken pox:

  • Aconite: Early cases, with restlessness, anxiety and high fever.
  • Antimonium tart: Delayed or receding, blue or pustular eruptions. Drowsy, sweaty and relaxed; nausea. Tardy eruption, to accelerate it. Associated with bronchitis, especially in children.
  • Belladonna: Severe headache: face flushed; hot skin. Drowsiness with inability to sleep.
  • Mercurius: To be used should vesicles discharge pus.
  • Rhus toxicodendron: Intense, annoying itching. Generally the only remedy required; under its action the disease soon disappears.
  • Sulphur: like with Rhus toxicodendron, rash is extremely annoying; very thirsty and hungry but takes more than can eat.

Croup

Croup can be very scary for parents… your child awakens at night coughing and gasping for air. Homeopathy works very well for these young patients.

There are a number of great homeopathic remedies to consider first when you confront this condition late some night:

  • Aconite: This remedy should always be given at the first; it will often prove to be the only one needed, if given right, unless some other remedy is strongly, indicated. Aconite will be called for if there is a high fever, skin dry, much restlessness and distress. Cough and loud breathing during inspiration. Every expiration ends with a hoarse hacking cough.
  • Arsenicum album: For croup with suffocative attacks at night; especially after midnight; croup before or after rashes or hives; patient cannot breath through nose; complaints with much restlessness and thirst, but for less quantity of water; aggravation after drinking.
  • Bromine: Spasms of the larynx, suffocative cough, horse whistling, croupy sound with great effort; rattling breathing; gasping; impeded respiration, heat of the face, much rattling in larynx when coughing.
  • Hepar sulph: If there is a rattling, choking cough, becoming worse particularly in the morning part of the night. Patient tends to be chilly. Cough can be worse from cold drafts or cold room – better warm moist air.
  • Spongia: The cough is dry and silibant; or it sounds like a saw driven through a pine board, each cough corresponding to a thrust of the saw.

Ebola

…The good news is that a small international team of experienced and heroic homeopaths have arrived in West Africa, and are currently on the ground working hard to examine patients, work out the “genus epidemicus,” and initiate clinical trials. This work is being done alongside the current conventional supportive measures and treatments already in place. We applaud and congratulate this team’s dedication and courage in joining the front lines in treating Ebola with homeopathy. The answer to whether homeopathic medicine has an important role in the Ebola epidemic could be forthcoming quite soon.

Flu

The flu can come on suddenly and stop you in your tracks – but there are many homeopathic remedies that can help bring relief and shorten the duration of the flu.

The following are some remedies that can bring relief during the flu:

  • Arsenicum album: great prostration with extreme chilliness and a thirst for frequent sips of warm drinks. The eyes and nose stream with watery, acrid discharges. Feels irritable and anxious.
  • Baptista: gastric flu with vomiting and diarrhea. Comes on suddenly. Feels sore and bruised all over. Profuse perspiration with a high fever and extreme thirst. Feels (and looks) dazed and sluggish.
  • Bryonia: flu comes on slowly. Aching pains in all the joints are worse for the slightest motion. Painful dry cough that makes the head hurt. Extreme thirst at infrequent intervals. Feels intensely irritable and wants to be alone.
  • Eupatorium perfoliatum: the pains are so severe it feels as if the bones are broken. The muscles ache and feel sore and bruised as well. A bursting headache with sore, aching eyeballs. The nose runs with much sneezing, and the chest feels sore and raw. Thirsty for cold water even though it brings on violent chills in the small of the back.
  • Ferrum phosphoricum: a fever develops, a flu is likely but the symptoms aren’t clearly developed yet (and Aconite didn’t help). Take 3 doses every 2-4 hours.
  • Gelsemium: flu comes on slowly especially when the weather changes from cold to warm. The muscles feel weak and achy. There’s a great feeling of heaviness everywhere-the head (which aches dully), limbs, eyelids, etc. No thist at all. Fever alternative with chills and shivers that run up and down the spine. Feels (and looks) apathetic, dull, and drowsy.
  • Mercurius solubilis: fever with copious, extremely offensive perspiration that doesn’t provide any relief (unlike most feverish sweats). The breath smells bad, there’s more salivation than normal and an extreme thirst.
  • Nux vomica: gastric flu with vomiting and diarrhea. The limbs and back ache a great deal. The nose runs during the day and is stopped up at night. Fever with chills and shivering especially after drinking. Very chilly and sensitive to the slightest draught of air or uncovering. Feels extremely impatient and irritable.
  • Pyrogenium: serious flu with severe pains in the back and the limbs and a terrible, bursting headache. Feels beaten and bruised all over. Very restless and feels better on beginning to move. Chills in the back and the limbs with a thumping heart.
  • Rhus toxicodendron: flu in cold, damp weather. Great restlessness: aching and stiffness in the joints is worse for first motion, it eases with continued motion and then they feel weak and have to rest after which they stiffen and have to move again. Pains are better for warmth. Feels anxious and weepy.
At the first sign of a flu Oscillococcinum® can also be taken right at the very beginning of feeling ill but before any symptoms have developed.

Hand, Foot, and Mouth Disease

Hand, foot, and mouth disease (HFM) starts with a fever and shortly after, the spots appear. The spots are more like blisters and can show up on the soles of the feet, palms of the hands, and/or inside the mouth and back of the throat. The blisters in the mouth can be very painful, especially when your little one is trying to swallow or eat.

A child also might:

  • develop fever, muscle aches, or other flu-like symptoms.
  • become irritable or sleep more than usual.
  • begin drooling (due to painful swallowing).
  • gravitate toward cold fluids.

Try the following remedies when HFM makes an appearance in your house.

  • Mercurius solubis: Mouth sores can be very severe, and the person is very sensitive to hot and cold; may have a fever before getting the blisters and may alternate between getting too hot with perspiration and becoming chilled at night; becoming too hot or too cold makes the person worse in general; blisters tend to be more painful at night; one of the characteristic symptoms of Mercurius is the tendency to drool or to have an excess of saliva in the mouth; the breath may be quite offensive with pus visible on the tonsils or elsewhere in the mouth.
  • Antimonium tart: Chill stage of fever: gooseflesh and icy cold skin; heat stage of fever: clings to those around and wants to be carried; does not want to be touched or looked at; thirstless despite the dry parched tongue; wweat stage of fever: profuse, cold, clammy or sticky; dry, cracked, parched tongue with whitish discoloration in the centre; tongue tip and sides clean, moist and red; thrush; may crave apples or apple juice.
  • Borax: Refuses to talk during fever; desire for cold drinks and cold food during fever; great heat and dryness of mouth with white ulcers (aphthae); white fungus-like growth; tender; ulcers bleed on touch and eating; painful red blisters on tongue; sore mouth prevents infants from nursing; fear of downward motion; startle easily; very sensitive to sudden noises.

Measles

While measles is probably best known for its full-body rash, the first symptoms of the infection are usually a hacking cough, runny nose, high fever, and red eyes that can be very sensitive to light. Characteristic markers of measles are Koplik’s spots, small red spots with blue-white centers that appear inside the mouth. The rash first appears on the face and then moves downwards and from the face downward.

  • Euphrasia: Lots of mucus; a mouthful hawked up on cough; clears the throat frequently; cough during the day only and worse in the morning; better lying down; eyes – burning, watery and sensitive to light; eyelids burning, red and swollen; wind and light aggravate; nose – bland, watery unlike the watery discharge of the eyes which burns; throat might be sore with burning pain.
  • Pulsatilla: thirstless; clinging and weepy; warm rooms and becoming warm aggravate; open air ameliorates; low fever and the itchy skin/eruptions are worse for heat; eruptions itching and worse for warmth with white or yellow discharge.
  • Apis: eruptions painful, burning, hot, stinging with swelling where the skin looks shiny/puffy; thirstless; itching better for cold applications and worse for heat, especially heat of bed; if rash is slow to develop or is suppressed; better in general for fresh air, better with cold drinks.
  • Bryonia: Rash/eruptions slow to come out or suppressed; warmth of the bed ameliorates; dryness and dislike of movement; headache has pain behind the eyeballs, bursting and violent, worse for moving; better for cold compresses and pressure; thirsty for large quantities of water all at once; motion aggravates; grumpy bear remedy – want to be left alone; throbbing/pulsating pains; dryness throughout all mucous membranes.

END OF QUOTE

I have only selected conditions that are potentially serious. Originally, I had intended to include all of them in this post, but half way through I gave up: there were just too many.

I am sure that most readers of the above advice would have – like I did – first have giggled a bit and then have felt increasingly angry and eventually slightly depressed: this glimpse into the way homeopaths think is revealing and frightening in equal measure.

I already hear the apologists say: This is unnecessarily alarmist; homeopathic remedies are safe, much safer than conventional medicines. My answer to these two points are as follows:

  1. Homeopathy does not normally harm patients via its remedies but by neglect: it is a non-treatment; and a non-treatment of a serious condition is always life-threatening.
  2. Sure, real medicines have risks, but they also have benefits. Responsible healthcare practitioners use those treatments where the benefits outweigh the risks.

Chiropractors (and other alternative practitioners) tend to treat their patients for unnecessarily long periods of time. This, of course, costs money, and even if the treatment in question ever was indicated (which, according to the best evidence, is more than doubtful), this phenomenon would significantly inflate healthcare expenditure.

This sounds perfectly logical to me, but is there any evidence for it? Yes, there is!

The WSJ recently reported that over 80% of the money that Medicare paid to US chiropractors in 2013 went for medically unnecessary procedures. The federal insurance program for senior citizens spent roughly $359 million on unnecessary chiropractic care that year, a review by the Department of Health and Human Services’ Office of Inspector General (OIG) found.

The OIG report was based on a random sample of Medicare spending for 105 chiropractic services in 2013. It included bills submitted to CMS through June 2014. Medicare audit contractors reviewed medical records for patients to determine whether treatment was medically necessary. The OIG called on the Centers for Medicare and Medicaid Services (CMS) to tighten oversight of the payments, noting its analysis was one of several in recent years to find questionable Medicare spending on chiropractic care. “Unless CMS implements strong controls, it is likely to continue to make improper payments to chiropractors,” the OIG said.

Medicare should determine whether there should be a cut-off in visits, the OIG said. Medicare does not pay for “supportive” care, or maintenance therapy. Patients who received more than a dozen treatments are more likely to get medically unnecessary care, the OIG found, and all chiropractic care after the first 30 treatment sessions was unnecessary, the review found. However, a spokesperson for US chiropractors disagreed: “Every patient is different,” he said. “Some patients may require two visits; some may require more.”

I have repeatedly written about the fact that chiropractic is not nearly as cost-effective as chiropractors want us to believe (see for instance here and here). It seems that this evidence is being systematically ignored by them; in fact, the evidence gets in the way of their aim – which often is not to help patients but to maximise their cash-flow.

Stable angina is a symptom of coronary heart disease which, in turn, is amongst the most frequent causes of death in developed countries. It is an alarm bell to any responsible clinician and requires causal, often life-saving treatments of which we today have several options. The last thing a patient needs in this condition is ACUPUNCTURE, I would say.

Yet acupuncture is precisely the therapy such patients might be tempted to employ.

Why?

Because irresponsible or criminally naïve acupuncturists advertise it!

Take this website, for instance; it informs us that a meta-analysis of eight clinical trials conducted between 2000 and 2014 demonstrates the efficacy of acupuncture for the treatment of stable angina. In all eight clinical trials, patients treated with acupuncture experienced a greater rate of angina relief than those in the control group treated with conventional drug therapies (90.1% vs 75.7%)….

I imagine that this sounds very convincing to patients and I fear that many might opt for acupuncture instead of potentially invasive/unpleasant but life-saving intervention. The original meta-analysis to which the above promotion referred to is equally optimistic. Here is its abstract:

Angina pectoris is a common symptom imperiling patients’ life quality. The aim of this study is to evaluate the efficacy and safety of acupuncture for stable angina pectoris. Clinical randomized-controlled trials (RCTs) comparing the efficacy of acupuncture to conventional drugs in patients with stable angina pectoris were searched using the following database of PubMed, Medline, Wanfang and CNKI. Overall odds ratio (ORs) and weighted mean difference (MD) with their 95% confidence intervals (CI) were calculated by using fixed- or random-effect models depending on the heterogeneity of the included trials. Total 8 RCTs, including 640 angina pectoris cases with 372 patients received acupuncture therapy and 268 patients received conventional drugs, were included. Overall, our result showed that acupuncture significantly increased the clinical curative effects in the relief of angina symptoms (OR=2.89, 95% CI=1.87-4.47, P<0.00001) and improved the electrocardiography (OR=1.83, 95% CI=1.23-2.71, P=0.003), indicating that acupuncture therapy was superior to conventional drugs. Although there was no significant difference in overall effective rate relating reduction of nitroglycerin between two groups (OR=2.13, 95% CI=0.90-5.07, P=0.09), a significant reduction on nitroglycerin consumption in acupuncture group was found (MD=-0.44, 95% CI=-0.64, -0.24, P<0.0001). Furthermore, the time to onset of angina relief was longer for acupuncture therapy than for traditional medicines (MD=2.44, 95% CI=1.64-3.24, P<0.00001, min). No adverse effects associated with acupuncture therapy were found. Acupuncture may be an effective therapy for stable angina pectoris. More clinical trials are needed to systematically assess the role of acupuncture in angina pectoris.

In the discussion section of the full paper, the authors explain that their analysis has several weaknesses:

Several limitations were presented in this meta-analysis. Firstly, conventional drugs in control group were different, this may bring some deviation. Secondly, for outcome of the time to onset of angina relief with acupuncture, only one trial included. Thirdly, the result of some outcomes presented in different expression method such as nitroglycerin consumption. Fourthly, acupuncture combined with traditional medicines or other factors may play a role in angina pectoris.

However, this does not deter them to conclude on a positive note:

In conclusion, we found that acupuncture therapy was superior to the conventional drugs in increasing the clinical curative effects of angina relief, improving the electrocardiography, and reducing the nitroglycerin consumption, indicating that acupuncture therapy may be effective and safe for treating stable angina pectoris. However, further clinical trials are needed to systematically and comprehensively evaluate acupuncture therapy in angina pectoris.

So, why do I find this irresponsibly and dangerously misleading?

Here a just a few reasons why this meta-analysis should not be trusted:

  • There was no systematic attempt to evaluate the methodological rigor of the primary studies; any meta-analysis MUST include such an assessment, or else it is not worth the paper it was printed on.
  • The primary studies all look extremely weak; this means they are likely to be false-positive.
  • They often assessed not acupuncture alone but in combination with other treatments; consequently the findings cannot be attributed to acupuncture.
  • All the primary studies originate from China; we have seen previously (see here and here) that Chinese acupuncture trials deliver nothing but positive results which means that their results cannot be trusted: they are false-positive.

My conclusion: the authors, editors and reviewers responsible for this article should be ashamed; they committed or allowed scientific misconduct, mislead the public and endangered patients’ lives.

A new study tested the efficacy of chiropractic spinal manipulative therapy (CSMT) for migraine. It was designed as a three-armed, single-blinded, placebo -controlled RCT of 17 months duration including 104 migraineurs with at least one migraine attack per month. Active treatment consisted of CSMT (group 1) and the placebo was a sham push manoeuvre of the lateral edge of the scapula and/or the gluteal region (group 2). The control group continued their usual pharmacological management (group 3).

The RCT began with a one-month run-in followed by three months intervention. The outcome measures were quantified at the end of the intervention and at 3, 6 and 12 months of follow-up. The primary end-point was the number of migraine days per month. Secondary end-points were migraine duration, migraine intensity and headache index, and medicine consumption.

The results show that migraine days were significantly reduced within all three groups from baseline to post-treatment (P < 0.001). The effect continued in the CSMT and placebo groups at all follow-up time points (groups 1 and 2), whereas the control group (group 3) returned to baseline. The reduction in migraine days was not significantly different between the groups. Migraine duration and headache index were reduced significantly more in the CSMT than in group 3 towards the end of follow-up. Adverse events were few, mild and transient. Blinding was strongly sustained throughout the RCT.

The authors concluded that it is possible to conduct a manual-therapy RCT with concealed placebo. The effect of CSMT observed in our study is probably due to a placebo response.

Chiropractors often cite clinical trials which suggest that CSMT might be effective. The effects sizes are rarely impressive, and it is tempting to suspect that the outcomes are mostly due to bias. Chiropractors, of course, deny such an explanation. Yet, to me, it seems fairly obvious: trials of CSMT are not blind, and therefore the expectation of the patient is likely to have major influence on the outcome.

Because of this phenomenon (and several others, of course), sceptics are usually unconvinced of the value of chiropractic. Chiropractors often respond by claiming that blind studies of physical intervention such as CSMT are not possible. This, however, is clearly not true; there have been several trials that employed sham treatments which adequately mimic CSMT. As these frequently fail to show what chiropractors had hoped, the methodology is intensely disliked by chiropractors.

The above study is yet another trial that adequately controls for patients’ expectation, and it shows that the apparent efficacy of CSMT disappears when this source of bias is properly accounted for. To me, such findings make a lot of sense, and I suspect that most, if not all the ‘positive’ studies of CSMT would turn out to be false positive, once such residual bias is eliminated.

I have warned you before to be sceptical about Chinese studies. This is what I posted on this blog more than 2 years ago, for instance:

Imagine an area of therapeutics where 100% of all findings of hypothesis-testing research are positive, i.e. come to the conclusion that the treatment in question is effective. Theoretically, this could mean that the therapy is a miracle cure which is useful for every single condition in every single setting. But sadly, there are no miracle cures. Therefore something must be badly and worryingly amiss with the research in an area that generates 100% positive results.

Acupuncture is such an area; we and others have shown that Chinese trials of acupuncture hardly ever produce a negative finding. In other words, one does not need to read the paper, one already knows that it is positive – even more extreme: one does not need to conduct the study, one already knows the result before the research has started. But you might not believe my research nor that of others. We might be chauvinist bastards who want to discredit Chinese science. In this case, you might perhaps believe Chinese researchers.

In this systematic review, all randomized controlled trials (RCTs) of acupuncture published in Chinese journals were identified by a team of Chinese scientists. A total of 840 RCTs were found, including 727 RCTs comparing acupuncture with conventional treatment, 51 RCTs with no treatment controls, and 62 RCTs with sham-acupuncture controls. Among theses 840 RCTs, 838 studies (99.8%) reported positive results from primary outcomes and two trials (0.2%) reported negative results. The percentages of RCTs concealment of the information on withdraws or sample size calculations were 43.7%, 5.9%, 4.9%, 9.9%, and 1.7% respectively.

The authors concluded that publication bias might be major issue in RCTs on acupuncture published in Chinese journals reported, which is related to high risk of bias. We suggest that all trials should be prospectively registered in international trial registry in future.

END OF QUOTE

Now an even more compelling reason emerged for taking evidence from China with a pinch of salt:

A recent survey of clinical trials in China has revealed fraudulent practice on a massive scale. China’s food and drug regulator carried out a one-year review of clinical trials. They concluded that more than 80 percent of clinical data is “fabricated“. The review evaluated data from 1,622 clinical trial programs of new pharmaceutical drugs awaiting regulator approval for mass production. Officials are now warning that further evidence malpractice could still emerge in the scandal.
According to the report, much of the data gathered in clinical trials are incomplete, failed to meet analysis requirements or were untraceable. Some companies were suspected of deliberately hiding or deleting records of adverse effects, and tampering with data that did not meet expectations.

“Clinical data fabrication was an open secret even before the inspection,” the paper quoted an unnamed hospital chief as saying. Contract research organizations seem have become “accomplices in data fabrication due to cutthroat competition and economic motivation.”

A doctor at a top hospital in the northern city of Xian said the problem doesn’t lie with insufficient regulations governing clinical trials data, but with the failure to implement them. “There are national standards for clinical trials in the development of Western pharmaceuticals,” he said. “Clinical trials must be carried out in three phases, and they must be assessed at the very least for safety,” he said. “But I don’t know what happened here.”

Public safety problems in China aren’t limited to the pharmaceutical industry and the figure of 80 percent is unlikely to surprise many in a country where citizens routinely engage in the bulk-buying of overseas-made goods like infant formula powder. Guangdong-based rights activist Mai Ke said there is an all-pervasive culture of fakery across all products made in the country. “It’s not just the medicines,” Mai said. “In China, everything is fake, and if there’s a profit in pharmaceuticals, then someone’s going to fake them too.” He said the problem also extends to traditional Chinese medicines, which are widely used in conjunction with Western pharmaceuticals across the healthcare system.
“It’s just harder to regulate the fakes with traditional medicines than it is with Western pharmaceuticals, which have strict manufacturing guidelines,” he said.

According to Luo, academic ethics is an underdeveloped field in China, leading to an academic culture that is accepting of manipulation of data. “I don’t think that the 80 percent figure is overstated,” Luo said.

And what should we conclude from all this?

I find it very difficult to reach a verdict that does not sound hopelessly chauvinistic but feel that we have little choice but to distrust the evidence that originates from China. At the very minimum, I think, we must scrutinise it thoroughly; whenever it looks too good to be true, we ought to discard it as unreliable and await independent replications.

Over on ‘SPECTATOR HEALTH’, we have an interesting discussion (again) about homeopathy. The comments so far were not short of personal attacks but this one by someone who called himself (courageously) ‘Larry M’ took the biscuit. It is so characteristic of deluded homeopathy apologists that I simply have to share it with you:

Ernst grew up with homeopathy [1], saw how well it worked [2], and chose to become a so-called expert in alternative medicine [3]. To his surprise, he met with professional disapproval [4]. Being the weak ego-driven person that he is [5], he saw an opportunity to still come out on top. He sold his soul in exchange for the notoriety that he now receives for being the crotchety old homeopathy hater that he has become [6]. As with all homeopathy haters, his fundamentalist zeal [7] is evidence of his secret self-loathing [8] and fear that his true beliefs will be found out [9]. It’s no different than the evangelical preacher who rails against gays only to be eventually found out to be a closeted gay [10].

There is not much that makes me speechless these days, but this comment almost did. There is someone who clearly does not even know me and he takes it upon himself to interpret and re-invent my past, my motives and my actions at will. How deluded is that?

After re-reading the comment, I began to see the funny side of it, had a giggle and decided to add a few elements of truth in the form of this blog-post. So I took the liberty to insert some reference numbers into Larry’s text which refer to my brief points below.

  1. This is at least partly true; our family doctor was a prominent homeopath. Whenever one of us was truly ill, he employed conventional treatments.
  2. I was impressed as a young physician working in a homeopathic hospital to see that patients improved on homeopathy – even though, at medical school, I had been told that the remedies were pure placebos. This contradiction fascinated me, and I began to do some own research into the subject.
  3. I did not ‘choose’, I had a genuine interest; and I don’t think that I am a ‘so called’ expert – after 2 decades of research and hundreds of papers, this attribute seems a trifle unfitting.
  4. The disapproval came from the homeopathy fans who were irritated that someone had the audacity to undertake a truly CRITICAL assessment of their treatments and actions.
  5. The amateur psychology here speaks for itself, I think.
  6. Yes, I am no spring chicken! But I am not a ‘hater’ of anything – I try to create progress by convincing people that it is prudent to go for treatments that are evidence-based and avoid those that do not generate more good than harm.
  7. This attitude is not a ‘fundamental zeal’, it is the only responsible way forward.
  8. This made me laugh out loud! Nothing could be further from the truth.
  9. My ‘true belief’ is that patients deserve the best treatments available. I have no fear of being ‘found out’; on the contrary, during my career I stood up to several challenges of influential people who tried to trip me up.
  10. This is hilarious – does Larry not feel how pompously ridiculous and ridiculously pompous he truly is?

This might be all too trivial, if such personal attacks were not an almost daily event. The best I can do with them, I have concluded, is to expose them for what they are and demonstrate how dangerously deluded the advocates of quackery really are. In this way, I can perhaps minimize the harm these people do to public health and medical progress.

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