This new RCT was embargoed until today; so, I had to wait until I was able to publish my comments. Here are the essentials of the study:
The Swedish investigators compared the effect of two types of acupuncture versus no acupuncture in infants with colic in public child health centres (CHCs). The study was designed as a multicentre, randomised controlled, single-blind, three-armed trial (ACU-COL) comparing two styles of acupuncture with no acupuncture, as an adjunct to standard care. Among 426 infants whose parents sought help for colic and registered their child’s fussing/crying in a diary, 157 fulfilled the criteria for colic and 147 started the intervention.
Parallel to usual care, study participants visited the study CHC twice a week for 2 weeks. Thus, all infants received usual care plus 4 extra visits to a CHC, during which parents met a nurse for 20–30 min and were able to discuss their infant’s symptoms. Together these were considered to represent gold standard care. The nurse listened, and gave evidence-based advice and calming reassurance. Breastfeeding mothers were encouraged to continue breastfeeding. At each visit, the study nurse carried the infant to a separate treatment room where they were left alone with the acupuncturist for 5 min.
The acupuncturist treated the baby according to group allocation and recorded the treatment procedures and any adverse events. Disposable stainless steel 0.20×13 mm Vinco needles (Helio, Jiangsu Province, China) were used. Infants allocated to group A received standardised MA at LI4. One needle was inserted to a depth of approximately 3 mm unilaterally for 2–5 s and then withdrawn without stimulation. Infants allocated to group B received semi-standardised individualised acupuncture, mimicking clinical TCM practice. Following a manual, the acupuncturists were able to choose one point, or any combination of Sifeng, LI4 and ST36, depending on the infant’s symptoms, as reported in the diary. A maximum of five insertions were allowed per treatment. Needling at Sifeng consisted of 4 insertions, each to a depth of approximately 1 mm for 1 s. At LI4 and ST36, needles were inserted to a depth of approximately 3 mm, uni- or bilaterally. Needles could be retained for 30 seconds. De qi was not sought, therefore stimulation was similarly minimal in groups A and B. Infants in group C spent 5 min alone with the acupuncturist without receiving acupuncture.
The effect of the two types of acupuncture was similar and both were superior to gold standard care alone. Relative to baseline, there was a greater relative reduction in time spent crying and colicky crying by the second intervention week (p=0.050) and follow-up period (p=0.031), respectively, in infants receiving either type of acupuncture. More infants receiving acupuncture cried <3 hours/day, and thereby no longer fulfilled criteria for colic, in the first (p=0.040) and second (p=0.006) intervention weeks. No serious adverse events were reported.
The authors concluded that acupuncture appears to reduce crying in infants with colic safely.
Notice that the investigators are cautious and state in the abstract that “acupuncture appears to reduce crying…” Their conclusions from the actual article are, however, quite different; here they state the following:
Among those initially experiencing excessive infant crying, the majority of parents reported normal values once the infant’s crying had been evaluated in a diary and a diet free of cow’s milk had been introduced. Therefore, objective measurement of crying and exclusion of cow’s milk protein are recommended as first steps, to avoid unnecessary treatment. For those infants that continue to cry >3 hours/day, acupuncture may be an effective treatment option. The two styles of MA tested in ACU-COL had similar effects; both reduced crying in infants with colic and had no serious side effects. However, there is a need for further research to find the optimal needling locations, stimulation and treatment intervals.
Such phraseology is much more assertive and seems to assume acupuncture caused specific therapeutic effects. Yet, I think, this assumption is not warranted.
In fact, I believe, the study shows almost the opposite of what the authors conclude. Both minimal and TCM acupuncture seemed to reduce the symptoms of colic compared to no acupuncture at all. I think, this confirms previous research showing that acupuncture is a ‘theatrical placebo’. The study was designed without an adequate placebo group. It would have been easy to use some form of sham acupuncture in the control group. Why did the authors not do that? Heaven knows, but one might speculate that they were aiming for a positive result – and what better way to ensure it than with a ‘no treatment’ control group?
There are, of course, numerous other flaws. For instance, Prof David Colquhoun FRS, Professor of Pharmacology at University College London, criticised the study because of its lousy statistics:
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“It is truly astonishing that, in the 21st century, the BMJ still publishes a journal devoted to a form of pre-scientific medicine which after more than 3000 trials has still not been able to produce convincing evidence of efficacy1. Like most forms of alternative medicine, acupuncture has been advocated for a vast range of problems, and there is little evidence that it works for any of them. Colic has not been prominent in these claims. What parent would think that sticking needles into their baby would stop it crying? The idea sounds bizarre. It is. This paper certainly doesn’t show that it works.
“The statistical analysis in the paper is incompetent. This should have been detected by the referees, but wasn’t. For a start, the opening statement, ‘A two-sided P value ≤0.05 was considered statistically significant’ is simply unacceptable in the light of all recent work about reproducibility. Still worse, Table 1 uses the description ‘statistical tendency towards significance (p=0.051–0.1)’.
“Worst of all, Table 1 reports 24 different P values, of which three are (just) below 0.05. Yet no correction has been used for multiple comparisons. This is very bad practice. It’s highly unlikely that, if the proper correction had been done, any of the results would have given a type 1 error rate below 5%.
“Even were it not for this, most of the ‘significant’ P values are marginal (only slightly less than 0.05). It is now well known that the type 1 error rate gives an optimistic view. What matters is the false positive rate – the chance that a ‘significant’ result is a false positive. A p-value close to 0.05 implies that there is at least a 30% chance that they are false positives. If one thought, a priori, that the chance of colic being cured by sticking needles into a baby was less than 50%, the false positive rate could easily be greater than 80%2. It is now recognised that this misinterpretation of p-values is a major contributor to the crisis of reproducibility.
“Other problems concern the power calculation. A priori calculations of power are well-known to be overoptimistic, because small trials usually overestimate the effect size. In this case the initial estimated sample size was not attained, and a rather mysterious recalculation of power was used.
“Another small problem: the discussion points out that ‘the majority of infants in this cohort did not have colic’.
“The nature of the control group is not very clear. An appropriate control might have been to cuddle the baby – this was used in a study in which another implausible treatment, chiropractic, was shown not to work. This appears not to have been done.
“Lastly, p-values are reported in the text without mention of effect sizes. This is contrary to all statistical advice.
“In conclusion, the design of the trial is reasonable (apart from the control group) but the statistical analysis is appalling. It’s very likely that there aren’t any real effects of acupuncture at all. This paper serves more to muddy the waters than to add useful information. It’s a model for the sort of mistakes that have led to the crisis in reproducibility. The BMJ should not be publishing this sort of stuff, and the referees seem to have no understanding of statistics.”
END OF QUOTE
Despite these rather obvious – some would say fatal – flaws, the editor of ACUPUNCTURE IN MEDICINE (AIM) thought this trial to be so impressively rigorous that he issued a press-release about it. This, I think, is particularly telling, perhaps even humorous: it shows what kind of a journal AIM is, and also provides an insight into the state of acupuncture research in general.
The long and short of it is that conclusions about specific therapeutic effects of acupuncture are not permissible. We know that colicky babies respond even to minimal attention, and this trial confirms that even a little additional TLC in the form of acupuncture will generate an effect. The observed outcome is most likely unrelated to acupuncture.
The WDDTY is not my favourite journal – far from it. The reason for my dislike is simple: far too many of its articles are utterly misleading and a danger to public health. Take this recent one entitled ‘Paleo-type diet reversing Crohn’s and ulcerative colitis’, for instance:
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Crohn’s disease and ulcerative colitis are being reversed solely by diet—essentially a Paleo diet. The non-drug approach has been successful in 80 per cent of children who’ve been put on the special diet.
The diet—called the specific carbohydrate diet (SCD)—has been pioneered by Dr David Suskind, a gastroenterologist at Seattle Children’s Hospital. The diet excludes grains, dairy, processed foods and sugars, other than honey, and promotes natural, nutrient-rich foods, including vegetables, fruits, meats and nuts.
Children are going into complete remission after just 12 weeks on the diet, a new study has discovered. Ten children with inflammatory bowel disease (IBD)—an umbrella term for Crohn’s and ulcerative colitis—were put on the diet, and eight were completely symptom-free by the end of the study. Suskind started exploring a dietary approach to IBD because he became convinced that the standard medical treatment of steroids or other medication was inadequate. “For decades, medicine has said diet doesn’t matter, that it doesn’t impact disease. Now we know that diet does have an impact, a strong impact. It works, and now there’s evidence,” he said.
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“For decades, medicine has said diet doesn’t matter, that it doesn’t impact disease”.
In this case, I must have studied an entirely different subject all these years ago at university – I had been told it was medicine but perhaps…???…!!!
It took me some time to find the original paper – they cited a wrong reference (2017 instead of 2016). But eventually I located it. Here is its abstract:
To determine the effect of the specific carbohydrate diet (SCD) on active inflammatory bowel disease (IBD).
IBD is a chronic idiopathic inflammatory intestinal disorder associated with fecal dysbiosis. Diet is a potential therapeutic option for IBD based on the hypothesis that changing the fecal dysbiosis could decrease intestinal inflammation.
Pediatric patients with mild to moderate IBD defined by pediatric Crohn’s disease activity index (PCDAI 10-45) or pediatric ulcerative colitis activity index (PUCAI 10-65) were enrolled into a prospective study of the SCD. Patients started SCD with follow-up evaluations at 2, 4, 8, and 12 weeks. PCDAI/PUCAI, laboratory studies were assessed.
Twelve patients, ages 10 to 17 years, were enrolled. Mean PCDAI decreased from 28.1±8.8 to 4.6±10.3 at 12 weeks. Mean PUCAI decreased from 28.3±23.1 to 6.7±11.6 at 12 weeks. Dietary therapy was ineffective for 2 patients while 2 individuals were unable to maintain the diet. Mean C-reactive protein decreased from 24.1±22.3 to 7.1±0.4 mg/L at 12 weeks in Seattle Cohort (nL<8.0 mg/L) and decreased from 20.7±10.9 to 4.8±4.5 mg/L at 12 weeks in Atlanta Cohort (nL<4.9 mg/L). Stool microbiome analysis showed a distinctive dysbiosis for each individual in most prediet microbiomes with significant changes in microbial composition after dietary change.
SCD therapy in IBD is associated with clinical and laboratory improvements as well as concomitant changes in the fecal microbiome. Further prospective studies are required to fully assess the safety and efficacy of dietary therapy in patients with IBD.
What does this mean?
The WDDTY report bears very little resemblance to the journal article (let alone with the title of their article or any other published research by David Suskind).
I cannot be sure, but I would not be surprised to hear that the latter was ‘egged up’ to make the former appear more interesting.
If that is so, WDDTY are (once again) guilty of misleading the public to the point of endangering lives of vulnerable patients.
SHAME ON EVERY OUTLET THAT SELLS WDDTY, I’d say.
Perhaps I have a weak spot for fish oil; more likely, however, I just like positive news – and, in alternative medicine, there is not much of it. That’s why I have written about the potential benefits of fish-oil again and again and again and again.
Reduced intake of fish oil, i.e. n−3 long-chain polyunsaturated fatty acids (LCPUFAs), may be a contributing factor to the increasing prevalence of asthma and other wheezing disorders. Yet the evidence is neither clear nor strong. This study was aimed at shedding more light on the issue; specifically, it tested the effect of supplementation with n−3 LCPUFAs in pregnant women on the risk of persistent wheeze and asthma in their offspring.
The investigators randomly assigned 736 pregnant women at 24 weeks of gestation to receive 2.4 g of n−3 LCPUFA (fish oil) or placebo (olive oil) per day. Their children were followed prospectively with extensive clinical phenotyping. Neither the investigators nor the participants were aware of group assignments during follow-up for the first 3 years of the children’s lives, after which there was a 2-year follow-up period during which only the investigators were unaware of group assignments. The primary end point was persistent wheeze or asthma, and the secondary end points included lower respiratory tract infections, asthma exacerbations, eczema, and allergic sensitization.
A total of 695 children were included in the trial, and 95.5% completed the 3-year, double-blind follow-up period. The risk of persistent wheeze or asthma in the treatment group was 16.9%, versus 23.7% in the control group (hazard ratio, 0.69; 95% confidence interval [CI], 0.49 to 0.97; P=0.035), corresponding to a relative reduction of 30.7%. Prespecified subgroup analyses suggested that the effect was strongest in the children of women whose blood levels of eicosapentaenoic acid and docosahexaenoic acid were in the lowest third of the trial population at randomization: 17.5% versus 34.1% (hazard ratio, 0.46; 95% CI, 0.25 to 0.83; P=0.011). Analyses of secondary end points showed that supplementation with n−3 LCPUFA was associated with a reduced risk of infections of the lower respiratory tract (31.7% vs. 39.1%; hazard ratio, 0.75; 95% CI, 0.58 to 0.98; P=0.033), but there were no statistically significant associations between supplementation and asthma exacerbations, eczema, or allergic sensitization.
The authors concluded that supplementation with n−3 LCPUFA in the third trimester of pregnancy reduced the absolute risk of persistent wheeze or asthma and infections of the lower respiratory tract in offspring by approximately 7 percentage points, or one third.
The authors must be congratulated. This trial is stunning in many ways: it was carefully designed and executed; its results are clear and important; its write-up is excellent. The research was supported by private and public research funds, all of which are listed at www.copsac.com. The Lundbeck Foundation, the Danish Ministry of Health, the Danish Council for Strategic Research, the Danish Council for Independent Research, and the Capital Region Research Foundation provided core support.
It is debatable whether the intake of fish oil falls under the umbrella of alternative medicine. In a way, it reminds me of the famous saying: what do we call alternative medicine that works? We call it medicine. It also holds an important reminder for all who make claims about the benefit of alternative therapies: extraordinary claims require extraordinary evidence.
Can these findings be translated into practical advice to consumers? The NEJM discussed this question in an accompanying article in which the case of a fictional pregnant woman (Ms. Franklin) was considered. Here is what they concluded: …there is benefit and little risk associated with n−3 LCPUFA supplementation. Even though we do not know Ms. Franklin’s EPA and DHA levels, there is likely to be a benefit for her child, at little risk, cost, or inconvenience. She should start taking n−3 LCPUFA supplements.
Despite my soft spot for fish oil, I might add that, while we give advice of this nature, we nevertheless need to insist on independent replications to have certainty.
We had HOMEOPATHS WITHOUT BORDERS and now, I suggest, we acknowledge a similar organisation which could aptly be called CHIROPRACTORS WITHOUT SCRUPLES. This remarkable text from NATURAL NEWS explains it all, I think:
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The following chiropractors are speaking up to inform the public about the dangers of vaccines.
Dr. David Jockers, D.C.
Vaccines are one of medicine’s prized attempts to improve human performance. They use artificial laboratory derived medical technology to produce an immune response within the body in hopes it will lead to a long-term positive antibody response.
The vaccine ideology is based on the belief that people are created with inferior immune systems that are unable to keep up with the demands of the environment and need modern technology in the form of man-made vaccine formulations in order to bolster immunity.
According to the Centers for Disease Control, “The following substances are found in flu vaccines: aluminum, antibiotics, formaldehyde, human aborted fetal apparatus (dead human tissue), monosodium glutamate (MSG), and thimerosal (mercury).” Many of these same ingredients are in childhood vaccines. They are all very toxic for human physiology and have a track record for insulting the body’s immune system.
I would prefer to trust the innate ability of the body to overcome infectious microorganisms and I will fully support my body through healthy diet and lifestyle along with natural supplements and proper spinal alignment. I absolutely reject the idea that injecting a group of toxic, immune insulting chemicals into my bloodstream will improve someone’s long-term immune response.
Nancy Tarlow, D.C.
When you inject chemicals into your body that are toxic, there will be an effect. It may not be obvious at first. A child might have a fever that the doctor says is “normal”, but it isn’t. A fever or screaming could be that the brain is swelling and causing damage. The real problem is that children cannot convey to us how they feel. It’s not like an adult who can tell us that they felt great prior to a vaccination but then started having health problems.
Dr. Haroot Tovanyan, D.C.
I am a doctor of Chiropractic and I primarily work with autistic children.
… Every single parent in my practice that has an autistic child has the same story. Child was born normal; child was developing normal. Child went in for their 12-month, 18-month, normal usually 24 or 36-month shots and regressed. This may be anecdotal, but when you hear it over and over and over again, there’s something to be said. These are children that have severe neurological issues. They’re not verbal; 8-10-year-old children that are still wearing diapers.
I have a quadriplegic niece in my family who received 4 shots, a total of 10 vaccines in 1 day. She was born normal. She developed normal until about a year and a half. At a year and a half she received 4 shots, 1, 2, 3, 4, and she … This was 1990 when they started doing multiple vaccines and they also quadrupled the number of shots that you’re normally receiving. She basically regressed. She’s a vegetable. I mean, she became a quadriplegic. Nowhere in nature would your child go to get exposed to let’s say 6 or 7 or 8 or 9, or in the case of my niece, 10 viruses and bacteria at the same time.
In nature that just doesn’t happen. They don’t co-exist like that. It’s not natural to put a combination of vaccines, combinations of viruses and bacteria that just don’t belong together or don’t co-exist in nature in a vial and inject it into a child and expect them to be healthy. The CDC schedule has never been tested for safety. There have never been double-blind studies. It’s never been tested for synergistic effect. They’ve refused to study un-vaccinated versus vaccinated.
END OF QUOTE
In case you wonder about the origins of this odd and unethical behaviour, you best look into the history of chiropractic. D. D. Palmer, the magnetic healer who ‘invented’ chiropractic some 120 years ago, left no doubt about his profound disgust for immunisation: “It is the very height of absurdity to strive to ‘protect’ any person from smallpox and other malady by inoculating them with a filthy animal poison… No one will ever pollute the blood of any member of my family unless he cares to walk over my dead body… ” (D. D. Palmer, 1910)
D. D. Palmer’s son, B. J. Palmer provided a more detailed explanation for chiropractors’ rejection of immunisation: “Chiropractors have found in every disease that is supposed to be contagious, a cause in the spine. In the spinal column we will find a subluxation that corresponds to every type of disease… If we had one hundred cases of small-pox, I can prove to you, in one, you will find a subluxation and you will find the same condition in the other ninety-nine. I adjust one and return his function to normal… There is no contagious disease… There is no infection…The idea of poisoning healthy people with vaccine virus… is irrational. People make a great ado if exposed to a contagious disease, but they submit to being inoculated with rotten pus, which if it takes, is warranted to give them a disease” (B. J. Palmer, 1909)
We are often told that such opinions have all but died out in today’s chiropractic profession. But is this true? I see precious little evidence to assume this to be true.
Today the anti-vaxx notions of chiropractors are mostly expressed in a less abrupt, more politically correct language: The International Chiropractors Association recognizes that the use of vaccines is not without risk. The ICA supports each individual’s right to select his or her own health care and to be made aware of the possible adverse effects of vaccines upon a human body. In accordance with such principles and based upon the individual’s right to freedom of choice, the ICA is opposed to compulsory programs which infringe upon such rights. The International Chiropractors Association is supportive of a conscience clause or waiver in compulsory vaccination laws, providing an elective course of action for all regarding immunization, thereby allowing patients freedom of choice in matters affecting their bodies and health.
Yes, I do realise that some chiropractors now acknowledge that immunisations have been one of the most successful interventions in the history of medicine. Yet, far too many others still vehemently adhere to the gospel of the Palmers, and statements like the following abound:
Vaccines. What are we taught? That vaccines came on the scene just in time to save civilization from the ravages of infectious diseases. That vaccines are scientifically formulated to confer immunity to certain diseases; that they are safe and effective. That if we stop vaccinating, epidemics will return…And then one day you’ll be shocked to discover that … your “medical” point of view is unscientific, according to many of the world’s top researchers and scientists. That many state and national legislatures all over the world are now passing laws to exclude compulsory vaccines….
Our original blood was good enough. What a thing to say about one of the most sublime substances in the universe. Our original professional philosophy was also good enough. What a thing to say about the most evolved healing concept since we crawled out of the ocean. Perhaps we can arrive at a position of profound gratitude if we could finally appreciate the identity, the oneness, the nobility of an uncontaminated unrestricted nervous system and an inviolate bloodstream. In such a place, is not the chiropractic position on vaccines self-evident, crystal clear, and as plain as the sun in the sky?
So, the opinions by chiropractors cited above seem more the rule than the exception. NATURAL NEWS is not normally one of my favourite publications; on this occasion, however, I am thankful to the editor for alerting us to what I might call CHIROPRACTORS WITHOUT SCRUPLES.
Yes, to a large extend, quacks make a living by advertising lies. A paper just published confirms our worst fears.
This survey was aimed at identifying the frequency and qualitative characteristics of marketing claims made by Canadian chiropractors, naturopaths, homeopaths and acupuncturists relating to the diagnosis and treatment of allergy and asthma.
A total of 392 chiropractic, naturopathic, homeopathic and acupuncture clinic websites were located in 10 of the largest metropolitan areas in Canada. The main outcome measures were: mention of allergy, sensitivity or asthma, claim of ability to diagnose allergy, sensitivity or asthma, claim of ability to treat allergy, sensitivity or asthma, and claim of allergy, sensitivity or asthma treatment efficacy. Tests and treatments promoted were noted as qualitative examples.
The results show that naturopath clinic websites had the highest rates of advertising at least one of diagnosis, treatment or efficacy for allergy or sensitivity (85%) and asthma (64%), followed by acupuncturists (68% and 53%, respectively), homeopaths (60% and 54%) and chiropractors (33% and 38%). Search results from Vancouver were most likely to advertise at least one of diagnosis, treatment or efficacy for allergy or sensitivity (72.5%) and asthma (62.5%), and results from London, Ontario were least likely (50% and 40%, respectively). Of the interventions advertised, few are scientifically supported; the majority lack evidence of efficacy, and some are potentially harmful.
The authors concluded that the majority of alternative healthcare clinics studied advertised interventions for allergy and asthma. Many offerings are unproven. A policy response may be warranted in order to safeguard the public interest.
In the discussion section, the authors state: “These claims raise ethical issues, because evidence in support of many of the tests and treatments identified on the websites studied is lacking. For example, food-specific IgG testing was commonly advertised, despite the fact that the Canadian Society of Allergy and Clinical Immunology has recommended not to use this test due to the absence of a body of research supporting it. Live blood analysis, vega/electrodiagnostic testing, intravenous vitamin C, probiotics, homeopathic allergy remedies and several other tests and treatments offered all lack substantial scientific evidence of efficacy. Some of the proposed treatments are so absurd that they lack even the most basic scientific plausibility, such as ionic foot bath detoxification…
Perhaps most concerning is the fact that several proposed treatments for allergy, sensitivity or asthma are potentially harmful. These include intravenous hydrogen peroxide, spinal manipulation and possibly others. Furthermore, a negative effect of the use of invalid and inaccurate allergy testing is the likelihood that such testing will lead to alterations and exclusions in diets, which can subsequently result in malnutrition and other physiological problems…”
This survey originates from Canada, and one might argue that elsewhere the situation is not quite as bad. However, I would doubt it; on the contrary, I would not be surprised to learn that, in some other countries, it is even worse.
Several national regulators have, at long last, become aware of the dangers of advertising of outright quackery. Consequently, some measures are now beginning to be taken against it. I would nevertheless argue that these actions are far too slow and by no means sufficiently effective.
We easily forget that asthma, for instance, is a potentially life-threatening disease. Advertising of bogus claims is therefore much more than a forgivable exaggeration aimed at maximising the income of alternative practitioners – it is a serious threat to public health.
We must insist that regulators protect us from such quackery and prevent the serious harm it can do.
The common cold is one of the indications for which homeopathy is deemed to be effective… by homeopaths that is! Non-homeopaths are understandably critical about this claim, not least because there is no good evidence for it. But, hold on, there is a new study which might change all this.
This study was recently published in COMPLEMENTARY THERAPIES IN MEDICINE which is supposed to be one of the better journals in this area. According to its authors, it was conducted “to determine if a homeopathic syrup was effective in treating cold symptoms in preschool children.” Children diagnosed with an upper respiratory tract infection were randomized to receive a commercial homeopathic cold syrup containing allium cepa 6X, hepar sulf calc 12X, natrum muriaticum 6X, phosphorous 12X, pulsatilla 6X, sulphur 12X, and hydrastasis 6X or placebo. Parents administered the study medication as needed for 3 days. The primary outcome was change in symptoms one hour after each dose. Parents also assessed the severity of each of the symptoms of runny nose, cough, congestion and sneezing at baseline and twice daily for 3 days, using a 4-point rating scale. A composite cold score was calculated by combining the values for each of the four symptoms. Among 261 eligible participants, data on 957 doses of study medication in 154 children were analyzed. There was no significant difference in improvement one hour after the dose for any symptom between the two groups. Analysis of twice daily data on the severity of cold symptoms compared to baseline values found that improvements in sneezing, cough and the composite cold score were significantly greater at both the first and second assessments among those receiving the cold syrup compared to placebo recipients.
The authors concluded that the homeopathic syrup appeared to be effective in reducing the severity of cold symptoms in the first day after beginning treatment.
Where to start? There are so many problems with this study that I find it difficult to chose the most crucial ones:
- The study had a clearly defined primary endpoint; it was not affected by the homeopathic treatment which doubtlessly makes the study a negative trial. The only correct conclusion therefore is that THE HOMEOPATHIC SYRUP FAILED TO AFFECT THE PRIMARY OUTCOME MEASURE OF THIS STUDY. THEREFORE THE TRIAL DID NOT PRODUCE ANY EVIDENCE TO ASSUME THAT THE EXPERIMENTAL TREATMENT WAS EFFICACIOUS.
- I don’t think that many of the primary or secondary outcome measures are validated or reliable.
- All the positive results reported in the abstract and the article relate to secondary endpoints which are purely explanatory by nature. They should, in my view, not be mentioned in the conclusions at all.
- The fact that some results turned out to be positive can be explained by the fact that the investigators ran dozens of tests for statistical significance which means that, by simple chance, some will turn out to produce a positive result.
- A further explanation for the seemingly positive results might be the fact disclosed in the text of the article that the children in the homeopathy group received more conventional drugs than those in the placebo group.
- Whatever the reason for these positive results, they certainly had nothing to do with the homeopathic syrup.
- The study was funded by the company producing the syrup and for which one of the authors was employed as a consultant. This might be an explanation for the abominably poor science. In other words, this paper is not an exercise in testing a hypothesis but one in marketing.
While I might forgive the company for trying to maximise their sales figures, I do find it harder to forgive the authors, reviewers and editors for publishing such overtly false conclusions. In my view, they are all guilty of scientific misconduct.
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.
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And what is wrong with this article?
The answer is quite a lot:
- The research seems to be about a very specific and rare condition, yet WDDTY seem to want to draw much more general conclusions.
- The research itself is not described in a way that it would be possible to evaluate.
- The sample size of what seems to have been a case-control study was tiny.
- The study is not properly cited for the reader to verify and check; for all we know, it might not even exist.
- 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.
I have been alerted to the fact that my former medical school in Munich at one of Germany’s highest-ranked universities is currently running an elective course in homeopathy. For those who do not read German (the original announcement [apparently posted all over Munich university hospitals] is copied below), it teaches the use of homeopathy in/for:
- INTERNAL MEDICINE
- RECURRENT OTITIS MEDIA
- PALLIATION OF RESPIRATORY PROBLEMS
- PROSTATE CANCER
- POST-TRAUMATIC SYNDROMES
- BIPOLAR DISEASE
- MULTIMORBID PATIENTS WITH UVEITIS
- DISEASES OF THE FEMALE BREAST
- SUPPORTIVE CANCER CARE
- PAEDIATRIC ASTHMA
The course is being organised by Dr. med. Sigrid Kruse, von Haunersches Kinderspital des Klinikums der Universität München in co-operation with the ‘Landesverband Bayern des Deutschen Zentralvereins homöopathischer Ärzte’. The lecturers of this course seem to be mostly homeopaths from practices in and around Munich.
This article provides further explanations:
The project „Homeopathy in pediatrics“ was established in the Dr. von Hauner’s Children’s Hospital University of Munich in 1995 to integrate homeopathy into a university hospital. Selected children (outpatients and in the wards) are treated conventionally and homeopathically. The Karl and Veronica Carstens-Foundation initially financed the project over six years. An association of parents, whose children were treated for cancer, funded the project for one year. Since 2002, for the first time in Germany, the National Health Insurance is providing the financial background for two consultants for Homeopathy at this University hospital.
Who are we?
Dr. Mira Dorcsi-Ulrich, who initiated the project and carries out the supervision. She is a pediatrician in her own practice with 23 years of experience.
Dr. Sigrid Kruse has managed to integrate homeopathy into the clinic, starting at first in 1995 as a resident for pediatrics. Now she fulfills the requests of doctors and parents in the wards demanding concomitant homeopathic treatment.
Dr. Christian Lucae mainly treats the outpatients while focussing on his research project with children showing attention-deficit-hyperactivity-syndrome (ADHS).
Concomitant homeopathic therapy was successful in the following cases: intracerebral bleeding 3rd degree in premature babies, drug withdrawal in neonates addicted mothers, epilepsy, handicapped children, ADHS, migraine, tic, recurrent infections, asthma and atopic eczema, complications in wound healing and other problems. Homeopathic treatment of children parallel to conventional methods is particularly well accepted in the treatment of cancer. The side effects of oncological treatment like vomiting and stomatitis can be relieved, aggressions and anxiety intercepted and life quality improved.
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Which journal with a modicum of self-respect or rigor allows a homeopath to publish anything like the last paragraph without providing a jot of evidence? The answer is the ‘ALLGEMEINE HOMOEOPATHISCHE ZEITUNG’ – no further explanation needed, I think.
Courses like the one above, run at university level, make me first a little speechless and then more than a little angry. Medical schools should have other roles than teaching impressionable students things that fly in the face of science and evidence. They should guide them to become responsible doctors not misguide them to turn into irresponsible quacks. The fact that this comes from the medical school where I, many years ago, studied, graduated, worked and made both my MD and PhD theses renders the whole thing painfully sad for me personally.
But let’s not get depressed… ‘always look on the bright side of life’!!!
Luckily, there are glimpses of a bright side here. For instance, the fact that doctor Quak is one of the lecturers of this course (see below) is not without jollity, I must admit. Also amusing – at least to me – is be the vision of Dr. med. Mira Dorcsi-Ulrich (see below) standing in front of her students explaining the findings of one of the few RCT of individualised homeopathy for paediatric asthma. This study from my team found no evidence that “adjunctive homeopathic remedies, as prescribed by experienced homeopathic practitioners, are superior to placebo in improving the quality of life of children with mild to moderate asthma in addition to conventional treatment in primary care.”
Here is the German original announcement of the course:
RINGVORLESUNG IM WINTERSEMESTER 2016/2017
HOMÖOPATHIE VON DER THEORIE ZUR PRAXIS MIT PRAXISBEISPIELEN UND PATIENTENVORSTELLUNGEN
1. 20.10.2016 … IN DER INNEREN MEDIZIN: MÖGLICHKEITEN UND GRENZEN Dr. med. Ulf Riker
2. 27.10.2016 … IN DER NEONATOLOGIE: IKTERUS, ASPHYXIE UND UNRUHE Dr. med. Monika Grasser
3. 03.11.2016 … BEI PATIENTEN MIT SINUSITIS Dr. med. Michael Schreiner
4. 10.11.2016 … BEI KINDERN MIT REZIDIVIERENDER OTITIS MEDIA Dr. med. Christian Lucae
5. 17.11.2016 … BEI SCHLAFSTÖRUNGEN Dr. med. Brigitte Seul
6. 24.11.2016 … BEI PALLIATIV-PATIENTEN MIT RESPIRATORISCHEN PROBLEMEN Herbert Michalczyk
7. 01.12.2016 … IN DER BEGLEITUNG VON PATIENTEN MIT EINEM PROSTATA-CARCINOM Uwe Kraemer-Hoenes
8. 08.12.2016 … BEI POSTTRAUMATISCHER BELASTUNGS-STÖRUNG Dr. med. Ingrid Pfanzelt
9. 15.12.2016 … BEI EINER PATIENTIN MIT BIPOLARER AFFEKTIVER STÖRUNG Dr. med. Stephan Gerke
10. 12.01.2017 … BEI EINEM MULTIMORBIDEN PATIENTEN MIT UVEITIS Dr. med. Thomas Quak
11. 19.01.2017 … BEI PATIENTEN MIT HUSTEN Dr. med. Renate Grötsch
12. 26.01.2017 … BEI ERKRANKUNGEN DER WEIBLICHEN BRUST Dr. med. Ute Bullemer
13. 02.02.2017 … IN DER BEGLEITUNG VON KREBSPATIENTEN MIT Q-POTENZEN Miclós Takács
15. 09.02.2017… BEI KINDERN MIT ASTHMA BRONCHIALE Dr. med. Mira Dorcsi-Ulrich
Organisation: Dr. med. Sigrid Kruse, Dr. von Haunersches Kinderspital des Klinikums der Universität München
E-Mail: firstname.lastname@example.org in Zusammenarbeit mit dem Landesverband Bayern des Deutschen Zentralvereins homöopathischer Ärzte,
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:
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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 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.
- 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 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 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.
…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.
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.
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.
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.
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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:
- 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.
- Sure, real medicines have risks, but they also have benefits. Responsible healthcare practitioners use those treatments where the benefits outweigh the risks.
This new study is amazing in several respects. It was conducted in Spain by otolaryngologists, and one of its authors is an employee of Boiron, the world’s biggest manufacturer of homeopathic products. It was designed as a double blind, placebo-controlled RCT. Patients aged 2 months to 12 years suffering from otitis media with effusion (OME), as diagnosed by pneumatic otoscopy (PNO) and tympanometry, were randomized into two groups. Both groups received aerosol therapy (mucolytics and corticosteroids). In addition, the experimental group received a homeopathic remedy of Agraphis nutans 5CH, Thuya Occidentalis 5CH, Kalium muriaticum 9CH and Arsenicum iodatum. The placebo group received placebos instead. Both of the treatments were continued for 3 months. Patients were evaluated by PNO examination and tympanometry at baseline, at 45 and 90 days.
A total of 97 patients were enrolled in this study. In the homeopathy group, 61.9% of individuals were cured according to PNO results by the 3rd visit compared with 56.8% of patients treated with placebo. 4.8% of patients in the homeopathy group suffered a recurrence (positive PNO in the 2nd visit changed to negative in the 3rd visit), while 11.4% did in the placebo group. These inter-group differences were not statistically significant. Adverse events were distributed similarly, except in the case of upper respiratory tract infections, which were less frequent in homeopathic group.
The authors of this new RCT concluded that the homeopathic scheme used as adjuvant treatment cannot be claimed to be an effective treatment in children with OME.
No surprises then – we already know that homeopathic remedies are placebos!
Sure, but at least two amazing features need to be pointed out:
- I am delighted that the authors did not try to spin the results such that they appear to be positive. Some investigators might have emphasised the fact that there was a (non-significant) trend in favour of homeopathy, and that, for a secondary outcome measure (upper respiratory infections), it even reached the level of statistical significance.
- Considering that this study was obviously Boiron-sponsored and its list of authors included an employee of this firm, such honesty can’t have been easy to maintain.
- The design of this RCT is also worth a mention: most alt med proponents seem to think that ‘adjunctive’ use of alt med needs to be tested via the infamous ‘A+B vs B’ design which fails to control for placebo effects and therefore invariably produces false positive findings. The authors of this trial did the right thing by randomising their patients into usual care + homeopathy vs usual care + placebo. This is very simple and has the advantage to actually provide a meaningful result.
In view of all this, I raise my hat to the Spanish researchers: very well done!!!
If all trials of homeopathy were conducted and reported in this honourable fashion, the collective evidence would be in a much better state and far less confusing.