MD, PhD, FMedSci, FSB, FRCP, FRCPEd

alternative medicine

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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 One needle was inserted to a depth of approximately 3 mm unilaterally for 2–5 s and then withdrawn without stimulation.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:

START OF QUOTE

“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.

Originally, I had meant this blog to discuss all types of alternative therapies – well, perhaps not all (there are simply too many of them), but at least the most popular ones. And so far, I have omitted one that seems certainly quite wide-spread: CRYSTAL HEALING.

What the Dickens is crystal healing, you ask? It is the attempt to bring about healing with the power of crystals, of course. And how is it supposed to work? This is where things get quite nebulous; this website, for instance tells us that the repeating chemical structure of crystals is said to invest them with a kind of memory. This means that crystals have the power to hold energies. You may hold a quartz crystal with the intention of filling it with your love. This is what is meant by programming a crystal. You do not need any wires or a special connection with God – all you need is intention and focus. The crystal will remember your love, which will then permeate any environment in which the crystal is placed. Crystals can remember negative as well as positive energies and so will sometimes need to be cleansed. For instance, an amethyst will actually help to cleanse a room of negative energies (eg. anger) but this means that the amethyst, which will retain an element of that negative energy, will itself occasionally require cleansing.

Most crystal healers make fairly specific claims about the healing power of specific crystals. This website explains it in some detail. The following text is an extract of several key (only marginally altered) passages from much longer instructions about the use of different crystals for healing purposes:

Crystal healing specialists generally agree that garnet promotes rapid general healing and regeneration in users. Garnet also has a positive effect on disorders such as acid reflux, blood-related illnesses, and physical strength.

Rose quartz is considered, by practitioners of alternative medicine, to be the stone of love—in this case, love of the self, in the form of self-esteem and self-worth. Rose quartz is simply brimming with happiness, and is a very positive stone that can help bring out forgiveness, compassion, and tolerance in users.

Fluorite is of mental order and clarity, and can be used to help alleviate instability, paving the way for a more balanced view of life. Feeling tossed about on a sea of restless emotions? Try carrying fluorite with you throughout the day—it helps cleanse and detoxify the centers of emotion. Fluorite is also the stone of learning, and can improve concentration and focus, while simultaneously reducing the anxiety that can sometimes make retaining information difficult. If you’re a student, learning a new instrument, or facing a complex new job, fluorite may be the stone you’ll want to keep on your person.

Lapis lazuli is beneficial to the throat, vocal cords, and larynx, and can help to regulate endocrine and thyroid issues. This is one of the most effective stones to meditate with, as lapis lazuli is the stone of higher awareness, able to bring information to the mind in images rather than words. This is an especially great boon to those who have creative jobs, as their next big inspiration can come from this.

If you suffer from anxiety, hematite is for you. A heavy, calming stone, hematite is very grounding—it leaves the user feeling comfortable and “in the moment,” rather than being lost in memory or worry. This disconnection from the present—which many of us suffer from—is the cause of much discomfort. But by practicing mindfulness through meditation with hematite, you can reconnect with what’s currently going on in your life.

Alternative medicine practitioners consider jade to be the stone of the heart, and as such, affects this organ in a positive way, promoting heart health. Not only does jade promote physical heart health, but heals emotionally, as well. Focusing energies on the emotional heart, jade helps regulate what we embrace and what we resist, giving us better self-control, as well as a better picture of our own wants and needs.

Turquoise is powerful, giving peace to the spirit and well-being to the body. This stone induces a sense of serenity, keeping physically harmful stress and inflammation at bay. Holding turquoise can bring back focus and restore vitality. Turquoise is also a stabilizer, and can calm the nerves when working on a difficult problem, or when performing or speaking in public. It is known for its effectiveness in alleviating the fear of flying.

Obsidian is a protective stone, able to remove and guard against negativity. If you are trying to release issues from your past, including emotions such as anger, resentment, and fear, handling obsidian can help by allowing you to see them for what they are so that they can be dealt with. Physically, obsidian is said to benefit good health in muscle tissue and the digestive system, and can help rid the body of infection. It helps to reduce the pain of arthritis, joint problems, and cramps.

Citrine holds the power of granting energy and stamina and supporting proper metabolism. Especially beneficial for those suffering from chronic fatigue syndrome, this stone can bring back some much-needed vitality, and can even alleviate nausea and vomiting for those suffering from morning sickness. This gem also aids in keeping the nails, skin, and hair healthy, and is effective in relieving skin irritation of any kind. Emotionally, citrine is the gem of joy, helping the subconscious mind to accept happiness in life, releasing anger and negativity. This is the most effective gem for those suffering from depression—combined with the skills of a trained counselor, meditation with citrine can help channel happiness through you, imbuing you with real joy.

Whether you believe in the healing power of crystals or not, they are worth trying alongside your normal health regimen. At best, you’ll find a spiritual support for your physical and mental health goals. And at worst? You’ll be in possession of a few beautiful stones that make great meditative focal points. So do a little research and go try out a few of your favorite stones!

END OF QUOTES

Recently, I promised to be more respectful in my criticism of quackery, but when it comes to things like crystal healing this is a difficult task indeed. It goes almost without saying that there is not a jot of evidence for any of the therapeutic claims made in the above quotes or other promotional texts on crystal healing.

Who publishes this sort of nonsense? The above excerpts come from ‘BELIEFNET‘, the “leading lifestyle site dedicated to faith and inspiration. Beliefnet helps people find and walk a spiritual path that instills comfort, hope, strength and happiness. It is through this discovery that our readers are empowered to live a more meaningful life.”

Say no more!

You probably guessed: this is the headline of a new WDDTY articleWDDTY tell us that they provide “information on complimentary therapies and alternative medicines” (I don’t want to sound snobbish, but I have my doubts about people who don’t even know how to spell their subject area). As the actual article in question (on vitamin C for cancer, a subject we have discussed on this blog before here and here) is quite short, I might as well show you its full beauty:

START OF QUOTE

High-dose vitamin C does kill cancer—but only when it’s given intravenously. It’s now just a few steps away from being approved as a safe and effective cancer treatment alongside chemotherapy and radiation.

Although researchers have tested the vitamin as a cancer therapy many times, they almost always concluded that it was ineffective—but they were guaranteeing failure by giving it orally to patients.

When it’s given intravenously, it bypasses the gut and goes directly into the bloodstream—where concentrations of the vitamin are up to 500 times higher than when it’s taken orally—and targets cancer cells, say researchers at the University of Iowa.

The therapy is now going through the approval process, and could soon be available as an alternative to chemotherapy or radiation, the two conventional cancer treatments.

It’s been proved to be effective in animal studies, and phase 1 trials have demonstrated that it’s safe and well-tolerated.

Now doctors at the university are starting to use it on patients with pancreatic cancer and lung cancer, and are measuring their progress against other patients who will continue to be given chemotherapy or radiation.

Biologist Garry Buettner, who works at the university, has worked out just why vitamin C is so effective: the vitamin breaks down quickly in the body, and generates hydrogen peroxide that kills cancer cells. “Cancer cells are much less efficient in removing hydrogen peroxide than normal cells, so cancer cells are much more prone to damage and death from a high amount of hydrogen peroxide”, he explained. “This explains how very, very high levels of vitamin C do not affect normal tissue, but can be damaging to tumour tissue.”

END OF QUOTE

According to the author, these amazing claims are based on one single source: a Medline-listed article with the following abstract:

Ascorbate (AscH) functions as a versatile reducing agent. At pharmacological doses (P-AscH; [plasma AscH] ≥≈20mM), achievable through intravenous delivery, oxidation of P-AscH can produce a high flux of H2O2 in tumors. Catalase is the major enzyme for detoxifying high concentrations of H2O2. We hypothesize that sensitivity of tumor cells to P-AscH compared to normal cells is due to their lower capacity to metabolize H2O2. Rate constants for removal of H2O2 (kcell) and catalase activities were determined for 15 tumor and 10 normal cell lines of various tissue types. A differential in the capacity of cells to remove H2O2 was revealed, with the average kcell for normal cells being twice that of tumor cells. The ED50 (50% clonogenic survival) of P-AscH correlated directly with kcell and catalase activity. Catalase activity could present a promising indicator of which tumors may respond to P-AscH.

The author of the WDDTY article is Bryan Hubbard. I did not know this man but soon learnt that he is actually the co-founder of WDDTY. He may not know how to spell ‘complementary medicine’ but he certainly has a lot of fantasy! His latest drivel on vitamin C for cancer seems to prove it. He seems to have the ability to extrapolate from the truth to a point where it becomes unrecognisable. The claims he makes in his article in question certainly are in no way supported by the evidence he provided as his source.

This could be trivial; yet sadly, it isn’t: WDDTY is read by many members of the unsuspecting public. Some of them might have cancer or know someone who has cancer. These desperate patients are likely to believe what is published in WDDTY and might be tempted to act upon it. In other words, the totally misleading articles by Hubbard put lives at risk – and that I cannot find trivial!

What doctors don’t tell you is not what WDDTY suggest; doctors don’t tell you that vitamin C reverses cancer because it is not true. In view of this and other evidence, perhaps the acronym WDDTY is not the best for this publication? Could I perhaps suggest to ‘Hubbard and Co’ another abbreviation? How about MIFUC (MisInformation From Unethical Columnists)?

[yes, I know, I was tempted to chose another noun for the ‘C’, but I resisted!]

Homeopaths have, since about 200 years, insisted that their remedies are efficacious treatments for infectious diseases. As evidence for this notion, they often produce epidemiological data showing that a group of infected patients treated homeopathically had better results than another group treated conventionally. While potentially interesting, such findings never constitute proof, because the two groups might not have been comparable and many other factors could have determined the observed outcome. In fact, these stories are prime examples for the need of rigorously controlled trials when testing the efficacy of medical treatments.

Homeopaths are invariably unable to provide more compelling evidence for their claims. Instead, they repeat, since 200 years, their assumptions over and over again. Are they not aware, I ask myself, that the repetition of a lie does not create a truth?

What their repetition of lies sometimes does create, unfortunately, is some impact on a political level. This website explains it fairly well:

The Public Health Ministry (of Thailand) is thinking of implementing alternative therapy homeopathy in all districts of Sing Buri this year, after a report that it could boost the human’s body immunity to fight dengue fever, an inspector-general at the ministry said.

Homeopathic medicines had been given to Sing Buri volunteer students from kindergarten to lower-secondary level in a 2012-13 trial and it yielded satisfactory results, said Dr Jakkriss Bhumisawasdi, director of the Inspector-General Region for Bureau of Inspection and Evaluation.

The number of dengue fever cases in Sing Buri have gone down, taking its rankings from No 67 in the country (with one death) in 2011 to No 76 in 2012. As there was a nationwide dengue fever outbreak in 2013, Sing Buri reported the country’s lowest prevalence at 44.95 per 100,000 population.

Jakkriss said “homeopathy” was safe and low-cost and had been used in various countries including the United Kingdom, France, Italy, Switzerland, Belgium, the United States, Australia, India and Malaysia.

Pilot project

Next, the system of medicine would be implemented in Region 4 Bureau’s seven other provinces: Nakhon Nayok, Nonthaburi, Pathum Thani, Ayutthaya, Lop Buri, Sara Buri and Ang Thong. If this one district per province pilot project went well, they would consider implementing it across the country, he said.

Sing Buri Hospital paediatrician Dr Wali Suwatthika said the preparation involved dissolving Eupatorium herbal pills in drinking water. Each child would be given 3cc of this tasteless water every three months. The trial, which began in July 2012, covered 4,250 children in Muang district and only four of them developed mild dengue fever in one year, while seven out of the district’s 2,856 remaining kids who didn’t get the medicine had dengue fever, in a more severe condition.

Thailand reported 150,934 dengue fever patients last year, double the previous year’s number, and 133 deaths. As there is no vaccine for dengue fever, the Public Health Ministry used a combination of several measures, including the eradication of mosquito larva incubation grounds and a campaign for people to install mosquito nets.

END OF QUOTE

So, where is the evidence that homeopathy does anything at all for Dengue patients? The 2012-13 trial referred to above has, as far as I can see, not been published. This probably means that it was not a publishable study at all. The only study available on Medline is this one:

A double-blind, placebo-controlled randomized trial of a homeopathic combination medication for dengue fever was carried out in municipal health clinics in Honduras. Sixty patients who met the case definition of dengue (fever plus two ancillary symptoms) were randomized to receive the homeopathic medication or placebo for 1 week, along with standard conventional analgesic treatment for dengue. The results showed no difference in outcomes between the two groups, including the number of days of fever and pain as well as analgesic use and complication rates. Only three subjects had laboratory confirmed dengue. An interesting sinusoidal curve in reported pain scores was seen in the verum group that might suggest a homeopathic aggravation or a proving. The small sample size makes conclusions difficult, but the results of this study do not suggest that this combination homeopathic remedy is effective for the symptoms that are characteristic of dengue fever.

END OF QUOTE

The bottom line is simple and depressing: the totality of the best available evidence fails to show that homeopathy is efficacious for Dengue fever (or any other infectious disease). It is irresponsible to claim otherwise.

Trump says he never mocked a disabled journalist.

YET THE WHOLE WORLD SAW HIM DO IT!

UK Brexit politicians such as Boris Johnson claim they never promised £ 350 million per week of EU funds for the NHS.

BUT WE ALL SAW THE PICTURES OF THE CAMPAIGN BUS!

These are just two of the numerous, obvious and highly significant lies that we have been told in recent months. In fact, we have heard so many lies recently that some of us seem to be getting used to them. We even have a new term for the phenomenon: the ‘post-truth society’.

Personally I don’t like the word at all: it seems to reflect a tacit acceptance of lies and their legitimisation.

I find it dangerous to put up with falsehoods in that way. And I think the truth is far too valuable to abandon it without a fight. I will therefore continue to call a lie a lie!

And, by Jove, in alternative medicine, we have no shortage of them:

  • Homeopaths claiming to be able to treat any condition with their ‘high potency remedies’.
  • Chiropractors who claim that spinal manipulation improves health.
  • Healers who state that their paranormal healing affects symptoms.
  • Alternative practitioners who claim that they treat the root cause of diseases.
  • Naturopaths who pretend they can treat childhood conditions.
  • Acupuncturists who say that rebalancing yin and yang affects health.
  • Alternative practitioners who insist they can detox our bodies.
  • Politicians who claim that TCM save lives.
  • Slapping therapists who say they can cure diabetes.
  • Journalists who publish that Paleo-diet can cure inflammatory bowel diseases.
  • Entrepreneurs who promote their unproven products as diabetes cures.
  • Academics who teach homeopathy to medical students.
  • Homeopaths who claim that their remedies are effective alternatives for vaccinations.

Do I need to go on?

These are not ‘post-truths’ – these are just lies, pure and simple.

We must not be lulled into complacency or false tolerance. Lies are lies, and they are wrong and unethical. In many instances they can even kill. To ignore or accept a steady stream of lies is not a solution; on the contrary, it can easily become part of the problem.

So, let’s continue to call them by their proper name – no matter whether they originate from the dizzy heights of world politics or the low lands of quackery.

If you want to scientifically investigate this question, it might be a good idea NOT to start with the following sentence: “Auricular acupuncture (AA) is effective in the treatment of preoperative anxiety”. Yet, this is exactly what the authors did in their recent publication.

The aim of this new study was to investigate whether AA can reduce exam anxiety as compared to placebo and no intervention. Forty-four medical students were randomized to receive AA, placebo, or no intervention in a crossover manner. Subsequently they completed three comparable oral anatomy exams with an interval of one month between the exams/interventions.

A licensed acupuncturist with more than five years of experience with this technique applied AA at the acupuncture points MA-IC1 (Lung), MA-TF1 (ear Shenmen), MA-SC (Kidney), MA-AT1 (Subcortex) and MA-TG (Adrenal gland) bilaterally. Indwelling fixed ‘New Pyonex’ needles embedded in a skin-coloured adhesive tape were used for AA. The participants were instructed by the acupuncturist to stimulate the auricular needles for 3–5 minutes, if they felt anxious. For the placebo procedure, ‘New Pyonex’ placebo needles were attached to five sites on the helix of the auricle bilaterally. ‘New Pyonex’ placebo needles have the same appearance as AA needles but consist of self-adhesive tape only. In order to avoid potential physiologic effects of acupressure, the participants were not instructed to stimulate the attached ‘New Pyonex’ placebo needles. AA and placebo needles were left in situ until the next day and were removed out of sight of the participants after the exam by the investigator, who was not involved in acupuncture procedure

Levels of anxiety were measured using a visual analogue scale before and after each intervention as well as before each exam. Additional measures included the State-Trait-Anxiety Inventory, duration of sleep at night, blood pressure, heart rate and the extent of participant blinding.

All included participants finished the study. Anxiety levels were reduced after AA and placebo intervention compared to baseline and the no intervention condition (p < 0.003). Moreover, AA was also better at reducing anxiety than placebo in the evening before the exam (p = 0.018). Participants were able to distinguish between AA and placebo intervention.

The authors concluded that both auricular acupuncture and placebo procedure were shown to be effective in reducing levels of exam anxiety in medical students. The superiority of verum AA over placebo AA and no intervention is considered to be due to stimulation of cranial nerves, but may have been increased in effect by insufficient participant blinding.

Here are just three of the major concerns I have about this study:

  • The trial design seems odd: a crossover study can only work well, if there is a stable baseline. This may not be the case with three consecutive exams; the anxiety experienced by students is bound to get less as time goes by. I think anyone who has passed a series of exams will confirm that there is a large degree of habituation.
  • It seems inadequate to employ just one acupuncturist; it means that the trial might end up testing not acupuncture per se but the skills of the therapist.
  • The placebo used for this study cannot possibly have fooled anyone into believing that it was real AA; volunteers were not even instructed to ‘stimulate’ the placebo devices. The difference to the ‘real thing’ must have been very clear to all involved. This means that the control for placebo-effects was woefully incomplete. In turn, this means that the observed outcomes are most likely due to residual bias.

In view of these concerns, allow me to re-phrase the authors’ conclusions:

THE RESULTS OF THIS POORLY-DESIGNED STUDY ARE DIFFICULT TO INTERPRET. MOST LIKELY THEY SHOW THAT ACUPUNCTURE IS NOT EFFECTIVE BUT MERELY WORKS THROUGH A PLACEBO-RESPONSE.

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:

START OF QUOTE
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.

END OF QUOTE

“For decades, medicine has said diet doesn’t matter, that it doesn’t impact disease”.

Really?

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:

GOAL:

To determine the effect of the specific carbohydrate diet (SCD) on active inflammatory bowel disease (IBD).

BACKGROUND:

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.

STUDY:

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.

RESULTS:

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.

CONCLUSIONS:

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).

How come?

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.

The ACUPUNCTURE NOW FOUNDATION (ANF) has featured on this blog before. Today I want to re-introduce them because I just came across one of their articles which I found remarkable. In it, they define what many of us have often wondered about: the most important myth about acupuncture.

Is it acupuncture’s current popularity, its long history, its mode of action, its efficacy, its safety?

No, here is the answer directly from the ANF:

The most important myth that needs to be put to rest is the idea promoted by a small group of vocal critics that acupuncture is nothing more than a placebo. Many cite the fact that studies showing acupuncture to be highly effective were of low quality and that several higher quality studies show that, while acupuncture was clinically effective, it usually does not outperform “sham” acupuncture. But those studies are dominated by the first quality issue cited above; studies with higher methodological rigor where the “real” acupuncture was so poorly done as to not be a legitimate comparison. Yet despite the tendency toward poor quality acupuncture in studies with higher methodological standards, a benchmark study was done that showed “real” acupuncture clearly outperforming “sham” acupuncture in four different chronic pain conditions.3 When you add this study together with the fact veterinary acupuncture is used successfully in many different animals, the idea of acupuncture only being placebo must now be considered finally disproven. This is further supported by studies which show that the underlying physiological pathways activated by acupuncture sometimes overlap, but can be clearly differentiated from, those activated by placebo responses.

Disappointed?

Yes, I was too.

The myth, according to the ANF, essentially is that sceptics do not understand the scientific evidence. And these blinkered sceptics even go as far as ignoring the findings from what the ANF consider to be a ‘benchmark study’! Ghosh, that’s nasty of them!!!

But, no – the benchmark study (actually, it was not a ‘study’ but a meta-analysis of studies) has been discussed fully on this blog (and in many other places too). Here is what I wrote in 2012 when it was first published:

An international team of acupuncture trialists published a meta-analysed of individual patient data to determine the analgesic effect of acupuncture compared to sham or non-acupuncture control for the following 4 chronic pain conditions: back and neck pain, osteoarthritis, headache, and shoulder pain. Data from 29 RCTs, with an impressive total of 17 922 patients, were included.

The results of this new evaluation suggest that acupuncture is superior to both sham and no-acupuncture controls for each of these conditions. Patients receiving acupuncture had less pain, with scores that were 0.23 (95% CI, 0.13-0.33), 0.16 (95% CI, 0.07-0.25), and 0.15 (95% CI, 0.07-0.24) SDs lower than those of sham controls for back and neck pain, osteoarthritis, and chronic headache, respectively; the effect sizes in comparison to no-acupuncture controls were 0.55 (95% CI, 0.51-0.58), 0.57 (95% CI, 0.50-0.64), and 0.42 (95% CI, 0.37-0.46) SDs.

Based on these findings, the authors reached the conclusion that “acupuncture is effective for the treatment of chronic pain and is therefore a reasonable referral option. Significant differences between true and sham acupuncture indicate that acupuncture is more than a placebo. However, these differences are relatively modest, suggesting that factors in addition to the specific effects of needling are important contributors to the therapeutic effects of acupuncture”.

… even the enthusiastic authors of this article admit that, when compared to sham, the effect size of real acupuncture is too small to be clinically relevant. Therefore one might argue that this meta-analysis confirms what critics have suggested all along: acupuncture is not a useful treatment for clinical routine.

Unsurprisingly, the authors of the meta-analysis do their very best to play down this aspect. They reason that, for clinical routine, the comparison between acupuncture and non-acupuncture controls is more relevant than the one between acupuncture and sham. But this comparison, of course, includes placebo- and other non-specific effects masquerading as effects of acupuncture – and with this little trick (which, by the way is very popular in alternative medicine), we can, of course, show that even sugar pills are effective.

I do not doubt that context effects are important in patient care; yet I do doubt that we need a placebo treatment for generating such benefit in our patients. If we administer treatments which are effective beyond placebo with kindness, time, compassion and empathy, our patients will benefit from both specific and non-specific effects. In other words, purely generating non-specific effects with acupuncture is far from optimal and certainly not in the interest of our patients. In my view, it cannot be regarded as not good medicine, and the authors’ conclusion referring to a “reasonable referral option” is more than a little surprising in my view.

Acupuncture-fans might argue that, at the very minimum, the new meta-analysis does demonstrate acupuncture to be statistically significantly better than a placebo. Yet I am not convinced that this notion holds water: the small residual effect-size in the comparison of acupuncture with sham might not be the result of a specific effect of acupuncture; it could be (and most likely is) due to residual bias in the analysed studies.

The meta-analysis is strongly driven by the large German trials which, for good reasons, were heavily and frequently criticised when first published. One of the most important potential drawbacks was that many participating patients were almost certainly de-blinded through the significant media coverage of the study while it was being conducted. Moreover, in none of these trials was the therapist blinded (the often-voiced notion that therapist-blinding is impossible is demonstrably false). Thus it is likely that patient-unblinding and the absence of therapist-blinding importantly influenced the clinical outcome of these trials thus generating false positive findings. As the German studies constitute by far the largest volume of patients in the meta-analysis, any of their flaws would strongly impact on the overall result of the meta-analysis.

So, has this new meta-analysis finally solved the decades-old question about the effectiveness of acupuncture? It might not have solved it, but we have certainly moved closer to a solution, particularly if we employ our faculties of critical thinking. In my view, this meta-analysis is the most compelling evidence yet to demonstrate the ineffectiveness of acupuncture for chronic pain.

END OF QUOTE

The ANF-text then goes from bad to worse. First they cite the evidence from veterinary acupuncture as further proof of the efficacy of their therapy. Well, the only systematic review in this are is, I think, by my team; and it concluded that there is no compelling evidence to recommend or reject acupuncture for any condition in domestic animals. Some encouraging data do exist that warrant further investigation in independent rigorous trials.

Lastly, the ANF mentions acupuncture’s mode of action which they seem to understand clearly and fully. Congratulations ANF! In this case, you are much better than the many experts in basic science or neurology who almost unanimously view these ‘explanations’ of how acupuncture might work as highly adventurous hypotheses or speculations.

So, what IS the most important myth about acupuncture? I am not sure and – unlike the ANF – I do not feel that I can speak for the rest of the world, but one of the biggest myths FOR ME is how acupuncture fans constantly manage to mislead the public.

Can intercessory prayer improve the symptoms of sick people?

Why should it? It’s utterly implausible!

Because the clinical evidence says so?

No, the current Cochrane review concluded that [the] findings are equivocal and, although some of the results of individual studies suggest a positive effect of intercessory prayer, the majority do not and the evidence does not support a recommendation either in favour or against the use of intercessory prayer. We are not convinced that further trials of this intervention should be undertaken and would prefer to see any resources available for such a trial used to investigate other questions in health care.

Yet, not all seem to agree with this; and some even continue to investigate prayer as a medical therpy.

For this new study (published in EBCAM), the Iranian investigators randomly assigned 92 patients in 2 groups to receive either 40 mg of propranolol twice a day for 2 month (group “A”) or 40 mg of propranolol twice a day for 2 months with prayer (group “B”). At the beginning of study and 3 months after intervention, patients’ pain was measured using the visual analogue scale.

All patients who participate in present study were Muslim. At the beginning of study and before intervention, the mean score of pain in patients in groups A and B were 5.7 ± 1.6 and 6.5 ± 1.9, respectively. According to results of independent t test, mean score of pain intensity at the beginning of study were similar between patients in 2 groups (P > .05). Three month after intervention, mean score of pain intensity decreased in patients in both groups. At this time, the mean scores of pain intensity were 5.4 ± 1.1 and 4.2 ± 2.3 in patients in groups A and B, respectively. This difference between groups was statistically significant (P < .001).

figure

The above figure shows the pain score in patients before and after the intervention.

The authors concluded that the present study revealed that prayer can be used as a nonpharmacologic pain coping strategy in addition to pharmacologic intervention for this group of patients.

Extraordinary claims require extraordinary proof. This study is, in fact, extraordinary – but only in the sense of being extraordinarily poor, or at least it is extraordinary in its quality of reporting. For instance, all we learn in the full text article about the two treatments applied to the patient groups is this: “The prayer group participated in an 8-week, weekly, intercessory prayer program with each session lasting 45 minutes. Pain reduction was measured at baseline and after 3 months, by registered nurses who were specialist in pain management and did not know which patients were in which groups (control or intervention), using a visual analogue scale.”

Intercessory prayer is the act of praying on behalf of others. This mans that the patients receiving prayer might have been unaware of being ‘treated’. In this case, the patients could have been adequately blinded. But this is not made clear in the article.

More importantly perhaps, the authors fail to provide any numeric results. All that we are given is the above figure. It is not possible therefore to run any type of check on the data. We are simply asked to believe what the authors have written. I for one have great difficulties in doing so. All I do believe in relation to this article is that

  • the journal EBCAM is utter trash,
  • constantly publishing rubbish is unethical and a disservice to everyone,
  • prayer does not need further research of this nature,
  • and poor studies often generate false-positive findings.

Is acupuncture a pseudoscience? An interesting question! It was used as the title of a recent article. Knowing who authored it, the question unfortunately promised to be rhetorical. Dr Mike Cummings is (or was?) the ‘Medical Director at British Medical Acupuncture Society’ – hardly a source of critical or sceptical thinking about acupuncture, I’d say. The vast majority of his recent publications are in ‘ACUPUNCTURE IN MEDICINE’ and his blog post too is for that journal. Nevertheless, his thoughts might be worth considering, and therefore I present the essence of his post below [the footnotes refer to my comments following Cummings’ article]:

…Wikipedia has branded acupuncture as pseudoscience and its benefits as placebo [1]. ‘Acupuncture’ is clearly is not pseudoscience; however, the way in which it is used or portrayed by some may on occasion meet that definition. Acupuncture is a technique that predates the development of the scientific method [2] … so it is hardly fair to classify this ancient medical technique within that framework [3]. It would be better to use a less pejorative classification within the bracket of history when referring to acupuncture and other ancient East Asian medical techniques [4]. The contemporary use of acupuncture within modern healthcare is another matter entirely, and the fact that it can be associated with pre-scientific medicine does not make it a pseudoscience.

The Wikipedia acupuncture page is extensive and currently runs to 302 references. But how do we judge the quality or reliability of a text or its references? … I would generally look down on blogs, such as this, because they lack … hurdles prior to publication [5]. Open peer review was introduced relatively recently associated with immediate publication. But all this involves researchers and senior academics publishing and reviewing within their own fields of expertise. Wikipedia has a slightly different model built on five pillars. The second of those pillars reads:


Wikipedia is written from a neutral point of view: We strive for articles that document and explain major points of view, giving due weight with respect to their prominence in an impartial tone. We avoid advocacy and we characterize information and issues rather than debate them. In some areas there may be just one well-recognized point of view; in others, we describe multiple points of view, presenting each accurately and in context rather than as “the truth” or “the best view”. All articles must strive for verifiable accuracy, citing reliable, authoritative sources, especially when the topic is controversial or is on living persons. Editors’ personal experiences, interpretations, or opinions do not belong.


Experts within a field may be seen to have a certain POV (point of view), and are discouraged from editing pages directly because they cannot have the desired NPOV (neutral POV). This is a rather unique publication model in my experience, although the editing and comments are all visible and traceable, so there is no hiding… apart from the fact that editors are allowed to be entirely anonymous. Have a look at the talk page behind the main acupuncture page on Wikipedia. You may be shocked by the tone of much of the commentary. It certainly does not seem to comply with the fourth of the five pillars, which urges respect and civility, and in my opinion results primarily from the security of anonymity. I object to the latter, but there is always a balance to be found between freedom of expression (enhanced for some by the safety of anonymity) and cyber bullying (almost certainly fuelled in part by anonymity). That balance requires good moderation, and whilst there was some evidence of moderation on the talk page, it was inadequate to my mind… I might move to drop anonymity from Wikipedia if moderation is wanting.

Anyway my impression, for what it’s worth, is that the acupuncture page on Wikipedia is not written from an NPOV, but rather it appears to be controlled by semi professional anti-CAM pseudosceptics [6]. I have come across these characters [6] regularly since I was introduced to the value of needling in military general practice. I have a stereotypical mental image: plain or scary looking bespectacled geeks and science nuts [6], the worst are often particle physicists … Interacting with them is at first intense, but rapidly becomes tedious as they know little of the subject detail [6], fall back on the same rather simplistic arguments [6] and ultimately appear to be motivated by eristic discourse rather than the truth [6].

I am not surprised that they prefer to close the comments, because I imagine that some people might object rather strongly to many of the statements made in this text.

Here are my short comments:

[1] I should perhaps stress that I am not the author of nor a contributor to this Wiki (or any other) page.

[2] Is this an attempt to employ the ‘appeal to tradition’ fallacy?

[3] The Wiki page does by no means classify the ancient history of acupuncture as pseudoscience.

[4] I have always felt that classification of science or medicine according to geography is nonsensical; they should not be classified as Western or Asian but as sound or not, effective or not, etc.

[5] As we have often seen on this blog, the ‘hurdles’ (peer-review) are often laughable, particularly in the realm of alternative medicine.

[6] This article is essentially trying to show that the Wiki page is biased. Yet it ends with a bonanza of insults which essentially reveal the profound bias of the author.

IS ACUPUNCTURE PSEUDOSCIENCE? Cummings’ article promised to address this question. Sadly it did nothing of the sort. It  turned out to be an incompetent rant about a Wiki page. If anything, Cummings contributed to the neutral reader of his text getting convinced that, indeed, acupuncture IS a pseudoscience! At least Wiki used facts, arguments, evidence etc. and it went a lot further in finding a rational answer to this intriguing question.

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