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.
The boom of alternative medicine in the US – and consequently in the rest of the developed world – is intimately connected with a NHI centre now called NCCIH (National Center for Complementary and Integrative Health). It was founded in the early 1990s because some politicians were bent on promoting quackery. Initially the institution had modest funding but, after more political interference, it had ample cash to pursue all sorts of activities, including sponsoring research into alternative therapies at US universities. A most interesting video summarising the history of the NCCIH can be seen here.
No other institution in the world had more funds for research into alternative medicine than the NCCIH, and it soon became the envy of alt med researchers globally. I have been invited by the NCCHI on several occasions and invariably was impressed by their apparent affluence. While we Europeans usually had to do our research on a shoe-string, our American colleagues seemed to be ‘rolling in it’.
I was often far less impressed with the research they sponsored. Not only it was invariably eye-wateringly expensive, but also its quality seemed often dismal. Sometimes, I even got the impression that research was used as a means of mainstreaming quackery for the unsuspecting American – and consequently world-wide – public.
An example of this mainstreaming is an article in JAMA published yesterday. Here is a short but telling excerpt:
Researchers led by Richard L. Nahin, PhD, MPH, lead epidemiologist at the NIH’s National Center for Complementary and Integrative Health (NCCIH), examined efficacy and safety evidence in 105 randomized controlled trials (RCTs) conducted between January 1966 and March 2016. The review—geared toward primary care physicians as part of the journal’s Symposium on Pain Medicine—focused on popular complementary approaches to common pain conditions.
Unlike a typical systematic review that assigns quality values to the studies, the investigators conducted a narrative review, in which they simply looked at the number of positive and negative trials. “If there were more positives than negatives then we generally felt the approach had some value,” Nahin explained. “If there were more negatives, we generally felt the approach had less value.” Trials that were conducted outside of the United States were excluded from the review.
Based on a “preponderance” of positive vs negative trials, complementary approaches that may offer pain relief include acupuncture and yoga for back pain; acupuncture and tai chi for osteoarthritis of the knee; massage therapy for neck pain; and relaxation techniques for severe headaches and migraine. Several other techniques had weaker evidence, according to the qualitative assessments, for specific pain conditions (see “Selected Complementary Health Approaches for Pain”). The treatments were generally safe, with no serious adverse events reported.
To me, this looks that NCCIH has now managed to persuade even the editors of JAMA to white-wash their dodgy science. The review referred to here is a paper we discussed some time ago on this blog. I then stated about it the following:
Reading the article carefully, it is impossible not to get troubled. Here are a few points that concern me most:
- the safety of a therapy cannot be evaluated on the basis of data from RCTs (particularly as it has been shown repeatedly that trials of alternative therapies often fail to report adverse effects); much larger samples are needed for that; any statements about safety in the aims of the paper are therefore misplaced;
- the authors talk about efficacy but seem to mean effectiveness;
- the authors only included RCTs from the US which must result in a skewed and incomplete picture;
- the article is from the National Center for Complementary and Integrative Health which is part of the NIH but which has been criticised repeatedly for being biased in favour of alternative medicine;
- not all of the authors seem to be NIH staff, and I cannot find a declaration of conflicts of interest;
- the discussion of the paper totally lacks any critical thinking;
- there is no assessment of the quality of the trials included in this review.
My last point is by far the most important. A summary of this nature that fails to take into account the numerous limitations of the primary data is, I think, as good as worthless. As I know most of the RCTs included in the analyses, I predict that the overall picture generated by this review would have changed substantially, if the risks of bias in the primary studies had been accounted for.
I find it puzzling that the ‘lead epidemiologist at the NIH’s National Center for Complementary and Integrative Health’ would publish such dubious research. Why does he do it? If you have watched the video mentioned above, you are inclined to think that it might be because of political interference.
However, I suggest another, in a way much more damming reason or contributing factor: the NCCIH has so long indulged in such poor science that even its top people have forgotten what good science looks like. I know this is a bold hypothesis; so, let me try to support it with some data.
Several years ago, my team together with several other researches have looked at the NCCIH-sponsored research systematically according to 4 different subject areas. Here are the conclusions of our articles reporting the findings:
Seven RCTs had a low risk of bias. Numerous methodological shortcomings were identified. Many NCCAM-funded RCTs of acupuncture have important limitations. These findings might improve future studies of acupuncture and could be considered in the ongoing debate regarding NCCAM-funding. [Focus on Alternative and Complementary Therapies Volume 17(1) March 2012 15–21]
This independent assessment revealed a plethora of serious concerns related to NCCAM studies of herbal medicine. [Perfusion 2011; 24: 89-102]
In conclusion, the NCCAM-funded RCTs of energy medicine are prime examples of misguided investments into research. In our opinion, NCCAM should not be funding poor-quality studies of implausible practices. The impact of any future studies of energy medicine would be negligible or even detrimental. [Focus on Alternative and Complementary Therapies Volume 16(2) June 2011 106–109 ]
In conclusion, our review demonstrates that several RCTs of chiropractic have been funded by the NCCAM. It raises numerous concerns in relation to these studies; in particular, it suggests that many of these studies are seriously flawed. [https://www.ncbi.nlm.nih.gov/pubmed/21207089]
I think I can rest my case and urge you to watch the video mentioned above.
This randomized, double-blind study evaluated the efficacy of a homeopathic treatment in preventing excessive weight gain during pregnancy in overweight or obese women who were suspected of having a common mental disorder. For the homeopathic group (n=62), 9 homeopathic remedies were pre-selected: (1) Pulsatilla nigricans, (2) Sepia succus, (3) Lycopodium clavatum, (4) sulphur, (5) Lachesis trigonocephalus, (6) Nux vomica, (7) Calcarea carbonica, (8) phosphorus; and (9) Conium maculatum. From those 9 drugs, one was prioritized for administration for each participant. After the first appointment, a re-selection or selection of a new, more appropriate drug occurred, using the list of preselected drugs. The dosage was 6 drops orally 2 ×/day, in the morning and at night, on 4 consecutive days each week, with an interval of 3 d between doses, up until the next appointment medical appointment. The control group (n=72) took placebos. Both groups also received a diet orientation.
Weight change during pregnancy was defined as the difference between the body mass index (BMI) at the initial evaluation and that recorded at the final evaluation, adjusted for 40 weeks of gestation. In addition, the APGAR index in the newborn (a measure of the health of the baby) was evaluated. The mean variation between baseline BMI and BMI at week 40 of gestation was +4.95 kg/m2 in the control group and +5.05 kg/m2 in the homeopathy group. The difference between the two groups was not significant. APGAR 10 at 5 min (59.6% in the homeopathy group and 36.4% in the control group) was statistically significant (P = .016).
The authors concluded that homeopathy does not appear to prevent excessive body mass gain in pregnant women who are overweight or obese and suspected of having a common mental disorder. Homeopathy did not change the APGAR score to modified clinical attention at delivery room. However, the evidence observed at APGAR 10 at minute 5 suggests that homeopathy had a modulating effect on the vitality of newborns, warranting further studies designed to investigate it.
I have seen many odd studies in my time, but this must be one of the oddest?
- What is the rationale for assuming that homeopathy might affect body weight?
- Why take pregnant women with a weight problem who were suspected of having a common mental disorder?
- Why try to turn a clearly negative result into a finding that is (at least partly) positive?
The last point seems the most important one to me. The primary outcome measure of this study (weight gain) was clearly defined and was not affected by the therapy. Yet the authors feel it justified to add to their conclusions that homeopathy had a modulating effect on the vitality of newborns (almost certainly nothing but a chance finding).
Are they for real?
I suppose they are: they are real pseudo-scientific promoters of quackery!
You probably remember: the US Federal Trade Commission’s (FTC) has issued a statement announcing that unsupported claims for homeopathic remedies will be no longer allowed. Specifically, they said that, in future, homeopathic remedies have to be held to the same standard as other medicinal products. In other words, American companies must now have reliable scientific evidence for health-related claims that their products can treat specific conditions and illnesses.
Now the AMERICAN INSTITUTE OF HOMEOPATHY (AIH) has published a rebuttal. It is hilarious and embarrassing in equal measure. Here it is in full (I have only omitted their references – they can be seen in the linked original – and added footnotes in bold square brackets with my very short comments):
START OF QUOTE
November 30, 2016
The American Institute of Homeopathy applauds the Federal Trade Commission’s (FTC) goal of protecting the American public from false advertising claims, but in a recent circumstance we believe the FTC has overstepped its jurisdictional bounds and promulgated false information in what appears to be a bid to restrict health care choices  available to the American public.
In Response to the recent Enforcement Policy Statement1 and a Consumer Information Blog,2 both issued by the FTC on November 15, 2016, the American Institute of Homeopathy registers our strong concern regarding the content of the following inaccurate statements:
- “Homeopathy… is based on the view that disease symptoms can be treated by minute doses of substances that produce similar symptoms…”
Homeopathy is not based on a “view” or an opinion. It is based on reliable, reproducible, clinically acquired, empiric evidence  gathered through two centuries of corroborated data, assisted by thousands of practitioners worldwide , demonstrating the actions of different medicinal substances in living systems, aka: the science of homeopathy. In fact, the homeopathic scientific community were pioneers of the modern scientific method including the widespread adoption of blinded and placebo controlled studies in 1885 , decades before conventional medicine.3
Homeopathy is not based on a theory or on conjecture, but on principles that have been confirmed by long-studied clinical data, meticulously gathered and analyzed over many years .
- “Many homeopathic products are diluted to such an extent that they no longer contain detectable levels of the initial substance.”
While the dilution and succussion process of formulating homeopathic medicines does reduce the concentration (and the toxicity) of the original substances, detectable amounts of these materials remain quantifiable in the form of nanoparticles  dispersed throughout.4 Multiple independent laboratories, worldwide have confirmed that these nanoparticles persist,5 and that they are biologically active.6 Many other homeopathic products (particularly those sold OTC and described as “low potency”) have dilute amounts of the original substance  that remain chemically detectable by straightforward titration.
- “…homeopathic product claims are not based on modern scientific methods…”
This statement is false and misleading. The active ingredients within most OTC homeopathic products have hundreds or thousands of case reports from physicians who have used these medicines . These reports of direct clinical experiences establish a collective, real-world dataset that demonstrates which conditions have been observed to respond to treatment. Such historical data is similar to the types of information used to demonstrate effectiveness for many conventional OTC medicines on the market today .
The Homeopathic Pharmacopeia Convention of the United States (HPCUS) maintains a formulary describing the appropriate manufacturing standards for homeopathic medicines . Every homeopathic manufacturer member of the American Association of Homeopathic Pharmacists in good ethical standing complies with both manufacturing and labeling standards set by the HPCUS. Consumers should be cautious when using any products that are not distinguished by conformance with “HPUS” on the label.
- “…the case for efficacy is based solely on traditional homeopathic theories…”
This statement is false. Neither homeopathy nor homeopathic efficacy is based on any theories. Efficacy for various homeopathic medicines has been established by scientifically reproducible clinical empiric research evidence  and cured patient cases followed over many years . Homeopathy is an evidence-based medical subspecialty rooted in patient care.
- “…there are no valid studies using current scientific methods showing the product’s efficacy.”
While this statement may have limited accuracy with respect to some OTC products, it is false and misleading with respect to most homeopathic medicines listed in the Homeopathic Pharmacopeia of the United States. Hundreds of state-of-the-art double-blinded, randomized, placebo-controlled studies, many in peer-reviewed journals, demonstrate the superior efficacy of homeopathic medicines in a wide range of conditions, including asthma,7 depression and anxiety,8 chronic illness,9 allergic rhinitis,10 hypertension,11 headaches/migraines,12 sepsis,13 mild traumatic brain injury,14 otitis media,15 cancer,16 and many other conditions . The American Institute of Homeopathy maintains and continually updates an extensive database, available free to the public, with over 6,000 research articles .17
Multiple meta-analyses published in peer reviewed medical journals that conclude that homeopathic medicine effects are superior to placebo  and that additional study of this therapeutic system is warranted.18,19,20,21,22,23 To that end, we encourage the National Institutes of Health to reverse their current position of blocking funding for homeopathic trials.24
- “…marketing claims that such homeopathic products have a therapeutic effect lack a reasonable basis and are likely misleading…”
The conclusion of whether a product has a “reasonable basis” is entirely irrelevant if that product has demonstrable clinical effectiveness. The important question, when it comes to homeopathy, is whether it is effective in clinical settings, not whether it has a “reasonable basis” for how it works. The mechanism by which homeopathy works differs from conventional medicines , but this fact does not make these products “misleading”.
Several recent class-action lawsuits brought against homeopathic manufacturers confirm that marketing practices were neither deceptive nor misleading .25
The FTC’s inability to formulate a reasonable basis for why homeopathic medicines work should not enter into any governmental enforcement policy statement. The FTC is not a medical organization, lacks expertise in interpreting scientific research , and is not qualified to make any comment on the validity of any field of medicine. To be less misleading, the FTC should exclude opinions from its policy statements.
- “Homeopathy: Not backed by modern science”
Homeopathy, as a system of medicine, does not fall under the purview of the FTC. Therefore, the FTC has been reckless in expressing an opinion of this magnitude. In this situation, the FTC’s comments can only be construed as being prejudicially biased and intentionally discriminatory against homeopathy. Such statements cause unwarranted harm to public trust and damage to a respected traditional system of medicine in the United States .
The American Institute of Homeopathy strongly objects to the FTC’s characterization of the entire field of homeopathic medicine as being without scientific evidence of efficacy. These comments are unqualified and wholly lacking in merit. The release of this Enforcement Policy Statement serves only to align the FTC with several recently released scientifically fraudulent  reports by a variety of pseudoscientists  and lowers the credibility of this valued consumer protection agency.
This type of misinformation should be embarrassing to a government organization striving to be nonpartisan and objective. The FTC owes an apology to the American Institute of Homeopathy as well as the many consumer groups that look toward this agency for fair and accurate information.
END OF QUOTE
1 In healthcare, choice must be restricted to treatments which demonstrably generate more good than harm.
2 The AIH seems to be unaware of the difference between the nature of evidence, anecdote and experience.
3 Fallacy – appeal to popularity.
4 The first randomized, placebo-controlled study of homeopathy was, in fact, published in 1835 – its results were negative.
5 Fallacy – appeal to tradition.
6 The nano-particle explanation of homeopathy is but a theory (at best).
7 Fallacy – appeal to tradition.
8 Fallacy – appeal to authority.
9 Really? Which ones? Examples would help, but I doubt they exist.
10 The proper manufacturing of nonsense must still result in nonsense.
11 See footnote number 2
12 Fallacy – appeal to tradition.
13 For all of these conditions, the totality of the reliable evidence fails to demonstrate efficacy.
14 In this context, only clinical trials are relevant, and their number is nowhere near 6,000.
15 Most of the independent systematic reviews fail to be positive.
16 The mechanism is well-known and is called ‘placebo-effect’.
17 Many class actions also went against the manufacturers of homeopathic preparations.
18 I assume they ‘bought in’ the necessary expertise.
19 Surely, the damage is only to the cash-flow of firms selling bogus products.
20 Really? Name the report you libel here or be quiet!
21 Name the individuals you attack in this way or be quiet!
I must say, I had fun reading this. In fact, I cannot remember having seen a document by an organisation of healthcare professionals which was so embarrassingly nonsensical that it becomes comedy gold. If one of my PhD students, for instance, had submitted such drivel, I would have had no choice but to fail him or her.
Having said that, I need to stress to the AIH:
FULL MARKS FOR AMUSEMENT!!!
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:
- 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.
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:
- Which was the primary outcome measure of this trial?
- What was the power of the study, and how was it calculated?
- For which outcome measures was the power calculated?
- How were the subjective endpoints quantified?
- Were validated instruments used for the subjective endpoints?
- What type of sham was used?
- Are the reported results the findings of comparisons between verum and sham, or verum and no acupuncture, or intra-group changes in the verum group?
- What other treatments did each group of patients receive?
- Does anyone really think that this trial shows that “acupuncture is a safe, effective and cost-effective treatment for allergic rhinitis”?
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].
- The myriad of lab tests were defined as primary outcome measures.
- Two sentences are offered, but they do not allow me to reconstruct how this was done.
- No details are provided.
- Most were quantified with a 3 point scale.
- Mostly not.
- Needle insertion at non-acupoints.
- The results are a mixture of inter- and intra-group differences.
- Patients were allowed to use conventional treatments and the frequency of this use was reported in patient diaries.
- 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:
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.
END OF QUOTE
I had to send several reminders but my most recent one prompted the following response dated 7/11/ 2016:
- 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.
- 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.
- 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.
- 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.
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:
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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!
- 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.
- 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.
- 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.
- 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.
- 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:
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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.
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.