MD, PhD, FMedSci, FRSB, FRCP, FRCPEd

causation

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Reiki has been on my mind repeatedly (see for instance here, here, here and here). It is one of those treatments that are too crazy for words and too implausible to mention. Yet a new paper firmly claims that it is more than a placebo.

This review evaluated clinical studies of Reiki to determine whether there is evidence for Reiki providing more than just a placebo effect. The available English-language literature of Reiki was reviewed, specifically for

  • peer-reviewed clinical studies,
  • studies with more than 20 participants in the Reiki treatment arm,
  • studies controlling for a placebo effect.

Of the 13 suitable studies,

  • 8 demonstrated Reiki being more effective than placebo,
  • 4 found no difference but had questionable statistical resolving power,
  • one provided clear evidence for not providing benefit.

The author concluded that these studies provide reasonably strong support for Reiki being more effective than placebo. From the information currently available, Reiki is a safe and gentle “complementary” therapy that activates the parasympathetic nervous system to heal body and mind. It has potential for broader use in management of chronic health conditions, and possibly in postoperative recovery. Research is needed to optimize the delivery of Reiki.

These are truly fantastic findings! Reiki is more than a placebo – would have thought so? Who would have predicted that something as implausible as Reiki would one day be shown to work?

Now let’s start re-writing the textbooks of physics and therapeutics and research how we can optimize the delivery of Reiki.

Hold on – not so quick! Here are a few reasons why we might be sceptical about the validity of this review:

  • It was published in one of the worst journals of alternative medicine.
  • The author claimed to include just clinical trials but ended up including non-clinical studies and animal studies.
  • Four trials were not double-blind.
  • There was no critical assessment of the studies methodological quality.
  • The many flaws of the primary studies were not mentioned in this review.
  • Papers not published in English were omitted.
  • The author who declared no conflict of interest has this affiliation: “Australasian Usui Reiki Association, Oakleigh, Victoria, Australia”.

I think we can postpone the re-writing of textbooks for a little while yet.

We all know Epsom salt, don’t we? This paper provides an interesting history of it: The purgative effect of the waters of Epsom, in southern England, was first discovered in the early seventeenth century. Epsom subsequently developed as one of the great English spas where high society flocked to take the medicinal waters. The extraction of the Epsom Salts from the spa waters and their chemical analysis, the essential feature of which was magnesium sulphate, were first successfully carried out by Doctor Nehemiah Grew, distinguished as a physician, botanist and an early Fellow of the Royal Society. His attempt to patent the production and sale of the Epsom Salts precipitated a dispute with two unscrupulous apothecaries, the Moult brothers. This controversy must be set against the backcloth of the long-standing struggle over the monopoly of dispensing of medicines between the Royal College of Physicians and the Worshipful Society of Apothecaries of London.

Epsom salt has the reputation of being very safe. But unfortunately, even something as seemingly harmless as Epsom salt can become dangerous in the hand of people who have little understanding of physiology and medicine. Indian doctors have just published a paper in (‘BMJ Case Reports’) with the details of a 38-year-old non-alcoholic, non-diabetic man suffering from gallstones. The patient was prescribed three tablespoons of Epsom salt to be taken with lukewarm water for 15 days for ‘stone dissolution’ by a ‘naturopathy practitioner’. He subsequently developed loss of appetite and darkening of urine from the 12th day of treatment and jaundice from the second day after treatment completion. The patient denied fevers, skin rash, joint pains, myalgia, abdominal pain, abdominal distension and cholestatic symptoms.

Examination revealed a deeply icteric patient oriented to time, place and person without an enlarged liver or stigmata of chronic liver disease. Liver function tests were abnormal, and a  liver biopsy revealed sub-massive necrosis with dense portal-based fibrosis, mixed portal inflammation, extensive peri-venular canalicular and hepatocellular cholestasis with macro-vesicular steatosis and peri-sinusoidal fibrosis (suggestive of steato-hepatitis) without evidence of granulomas, inclusion bodies or vascular changes suggestive of acute drug-induced liver injury.

After discontinuation of Epsom salt and adequate hydration, the patient had an uneventful recovery with normalisation of liver function tests after 38 days.  The Roussel Uclaf Causality Assessment score was strongly suggestive of Epsom salt-induced liver injury.

I was invited to provide a comment and stated that, in my view, this case reminds us:

1) that naturopaths prescribe a lot of nonsense,

2) that not everything which is promoted as natural is safe,

3) that treatments which apparently have ‘stood the test of time’ can still be rubbish, and

4) that even a relatively harmless remedy can become life-threatening, if one takes it at a high dose for a prolonged period of time.

Naturopaths have advocated Epsom salt for gall-bladder problems since centuries, yet there is no good evidence that it works. It is time that alternative practitioners abide by the rules of evidence-based medicine.

A quick Medline search reveals that there is only one further report of a serious adverse effect after Epsom salt intake: a case of fatal hypermagnesemia caused by an Epsom salt enema. A 7-year-old male presented with cardiac arrest and was found to have a serum magnesium level of 41.2 mg/dL (33.9 mEq/L) after having received an Epsom salt enema earlier that day. The medical history of Epsom salt, the common causes and symptoms of hypermagnesemia, and the treatment of hypermagnesemia are reviewed. The easy availability of magnesium, the subtle initial symptoms of hypermagnesemia, and the need for education about the toxicity of magnesium should be of interest to physicians.

… and to alternative practitioners, I hasten to add.

The claims that are being made for the health benefits of Chinese herbal medicine are impressive. I am not sure that there is even a single human disease that is not alleged to be curable with the use of some Chinese herbal mixture. I find this worrying because some patients might actually believe such outrageous nonsense, particularly since Chinese researchers seem to bend over backwards to support them with science… or should I say pseudoscience?

This study was aimed at evaluating the association between mortality rate and early use of Chinese herbal products (CHPs) among patients with lung cancer. The researchers conducted a retrospective cohort study based on the National Health Insurance Research Database, Taiwan Cancer Registry, and Cause of Death Data. Patients with newly diagnosed lung cancer between 2002 and 2010 were classified as either the CHP (n = 422) or the non-CHP group (n = 2828) based on whether they used CHP within 3 months after first diagnosis of lung cancer. A Cox regression model was used to examine the hazard ratio (HR) of death for propensity score (PS) matching samples.

After PS matching, average survival time of the CHP group was significantly longer than that of the non-CHP group. The adjusted HR (0.82; 95% CI: 0.73-0.92) in the CHP group was lower than the non-CHP group. Stratified by clinical cancer stages, CHP group had longer survival time in the stage 3 subgroup. When the exposure period of CHP use was changed from 3 to 6 months, results remained similar.

The authors concluded that results indicated that patients with lung cancer who used CHP within 3 months after first diagnosis had a lower hazard of death than non-CHP users, especially for stage 3 lung cancer. Further experimental studies are needed to examine the causal relationship.

I would argue the direct opposite: further studies along these lines would be a waste of time!

I can name numerous reasons for this, for example:

  • Investigating CHP as though it is one entity is nonsense. There are thousands of different CHPs; some are placebos; some are toxic; and a few might even have some health effects.
  • The observed effect is almost certainly an artefact; the matching of the groups might have been sub-optimal; the CHP group differed systematically from the control group, for instance, by adhering to a healthier life-style; etc, etc.

All of this should be so obvious that it hardly deserves a mention. Why then do the authors not point it out prominently and clearly? Why did they ever embark on such a fatally flawed project? I cannot be sure, of course, … but perhaps one possible answer might be that the lead author is affiliated to a Department of Chinese Medicine?

 

The purpose of the study was to compare utilization of conventional psychotropic drugs among patients seeking care for anxiety and depression disorders (ADDs) from general practitioners (GPs) who

  • strictly prescribe conventional medicines (GP-CM),
  • regularly prescribe homeopathy in a mixed practice (GP-Mx),
  • or are certified homeopathic GPs (GP-Ho).

The investigation was an epidemiological cohort study of general practice in France, which included GPs and their patients consulting for ADDs (scoring 9 or more in the Hospital Anxiety and Depression Scale, HADS). Information on all medication utilization was obtained by a standardised telephone interview at inclusion, 1, 3 and 12 months.

Of 1562 eligible patients consulting for ADDs, 710 (45.5 %) agreed to participate. Adjusted multivariate analyses showed that GP-Ho and GP-Mx patients were less likely to use psychotropic drugs over 12 months, compared to GP-CM patients. The rate of clinical improvement (HADS <9) was marginally superior for the GP-Ho group as compared to the GP-CM group, but not for the GP-Mx group.

The authors concluded that patients with ADD, who chose to consult GPs prescribing homeopathy reported less use of psychotropic drugs, and were marginally more likely to experience clinical improvement, than patients managed with conventional care. Results may reflect differences in physicians’ management and patients’ preferences as well as statistical regression to the mean.

Aren’t we glad they added the last sentence to their conclusion!!!

Without it, one might have thought that the observed differences were due to the homeopathic remedies. In fact, the finding amounts to a self-fulfilling prophecy: Homeopaths tend to be against prescribing conventional drugs. This means that patients consulting homeopaths are bound to use less drugs than patients who consult conventional doctors. In that sense, the study was like monitoring whether consumers who go to the butchers buy more meat than those shopping in a shop for vegetarians.

The only result that requires a more serious consideration is that homeopathically treated patients experienced more clinical improvement than those treated conventionally. But even this difference is not hard to explain: firstly, the difference was merely marginal; secondly, patients with ADD are bound to respond particularly well to the empathetic and long therapeutic encounter most homeopaths offer. In other words, the difference had nothing to do with the alleged effectiveness of the homeopathic remedies.

The goal of this study was to assess clinical outcomes observed among adult patients who received acupuncture treatments at a United States Air Force medical center.

This retrospective chart review was performed at the Nellis Family Medicine Residency in the Mike O’Callaghan Military Medical Center at Nellis Air Force Base in Las Vegas, NV. The charts were from 172 consecutive patients who had at least 4 acupuncture treatments within 1 year. These patients were suffering from a wide range of symptoms, including pain, anxiety and sleep problems. The main outcome measures were prescriptions for opioid medications, muscle relaxants, benzodiazepines, and nonsteroidal anti-inflammatory drugs (NSAIDS) in the 60 days prior to the first acupuncture session and in the corresponding 60 days 1 year later; and Measure Yourself Medical Outcome Profile (MYMOP2) values for symptoms, ability to perform activities, and quality of life.

The most common 10 acupuncture treatments in descending order were: (1) the Auricular Trauma Protocol; (2) Battlefield Auricular Acupuncture; (3) Chinese scalp acupuncture, using the upper one-fifth of the sensory area and the Foot Motor Sensory Area; (4) the Koffman Cocktail; (5) lumbar percutaneous electrical nerve stimulation (PENS); (6) various auricular functional points; (7) Chinese scalp acupuncture, using the frontal triangle pattern; (8) cervical PENS; (9) the Great American Malady treatment; and (10) tendinomuscular meridian treatment with surface release.

The results show that opioid prescriptions decreased by 45%, muscle relaxants by 34%, NSAIDs by 42%, and benzodiazepines by 14%. MYMOP2 values decreased 3.50–3.11 (P < 0.002) for question 1, 4.18–3.46 (P < 0.00001) for question 3, and 2.73–2.43 (P < 0.006) for question 4.

The authors concluded that in this military patient population, the number of opioid prescriptions decreased and patients reported improved symptom control, ability to function, and sense of well-being after receiving courses of acupuncture by their primary care physicians.

The phraseology used by the authors is intriguing; they imply that the clinical outcomes were the result of the acupuncture treatment without actually stating it. This is perhaps most obvious in the title of the paper: Reduction in Pain Medication Prescriptions and Self-Reported Outcomes Associated with Acupuncture in a Military Patient Population. Association is not causation! But the implication of a cause effect relationship is clearly there. Once we realise who is behind this research we understand why: This study was funded by the ACUS Foundation as part of a Cooperative Research and Development Agreement with the 99th Medical Group, at Nellis Air Force Base. 

The mission of Acus Foundation is to educate military physicians in the science and art of medical acupuncture, and to facilitate its integration into conventional military care… we are the most experienced team of physician teachers and practitioners of acupuncture in the United States. If they are so experienced, they surely also know that there are many explanations for the observed outcomes which are totally unrelated to acupuncture, e. g.:

  • the natural history of the conditions that were being treated;
  • the conventional therapies the soldiers received;
  • the regression to the mean;
  • social desirability;
  • placebo effects.

In fact the results could even indicate that acupuncture caused a delay of clinical improvement; without a control group, we cannot know either way. All we can safely assume from this study is that it is yet another example of promotion masquerading as research.

A sizeable proportion of the general population is convinced that certain moon phases and moon signs may impact their health as well as the onset and clinical course of diseases. Those who believe in alternative medicine tend, I guess, to belong to this group. Here is a quote from one of the many websites making such claims: Understanding moon cycles and how they affect the body can be a key to better health. To understand how the moon influences your health the first step is to realize that your human body is made up of over 60% water, and the moon affects all water on the Earth.  The moon controls the ebb and flow of the oceanic tides and it controls your human body in the same way.

There is, of course, no plausible reason for such claims and convictions, but this rarely stops the gullible. And anyway, it could be true – or couldn’t it?

This study investigated the perioperative and long-term outcome of living donor kidney transplantation (LDKT) dependent on moon phases and zodiac signs. Patient data were prospectively collected in a continuously updated kidney transplant database. Two hundred and seventy-eight consecutive patients who underwent LDKT between 1994 and December 2009 were selected for the study and retrospectively assigned to the four moon phases (new-moon, waxing-moon, full-moon, and waning-moon) and the corresponding zodiac sign (moon sign Libra), based on the date of transplantation. Pre-existing comorbidities, perioperative mortality, surgical outcome, and long-term survival data were analysed.

Of all LDKT procedures, 11.9; 39.9; 11.5; and 36.5% were performed during the new, waxing, full, and waning moon, respectively, and 6.2% during the moon sign Libra, which is believed to interfere with renal surgery. Survival rates at 1, 5, and 10 years after transplantation were 98.9, 92, and 88.7% (patient survival) and 97.4, 91.6, and 80.6% (graft survival) without any differences between all groups of lunar phases and moon signs. Overall perioperative complications and early graft loss occurred in 21.2 and 1.4%, without statistical difference (p > 0.05) between groups.

The authors concluded that moon phases and the moon sign Libra had no impact on early and long-term outcome measures following LDKT in our study. Thus, concerns of patients awaiting LDKT regarding the ideal time of surgery can be allayed, and surgery may be scheduled independently of the lunar phases.

The authors also concede that their study has some limitations. First, it is a retrospective analysis of a single transplant centre and the number of patients is not huge. In addition, due to the retrospective design of the study, no randomization of the patients was possible. However, a randomization of the patients would systematically ignore the patients preferences. Realization of such a randomized trial would therefore be challenging. As a consequence, we do not know in how many cases the transplant was scheduled according to the lunar phases on the explicit request of the patient. It would be interesting to know whether a strong desire of the patient and a corresponding fulfilment has any influence on the short- and long-term success of the surgery.

Nonsense, I hear the loonies shout: there are numerous studies confirming that the moon has a definite effect on our health!

How do you explain that?

I think there are at least two possible explanations:

  1. these studies were methodologically flawed and lack independent replications;
  2. it cannot be excluded that patients’ fear of the wrong moon-phase might exert a negative influence on their health, irrespective of any influence of the moon. In this case, the moon-phase itself would be irrelevant, but the fear would mimic a real phenomenon.

I recently came across this article; essentially it claims that, in 1918, chiropractic proved itself to be the method of choice for treating the flu!

Unbelievable?

Here is a short quote from it:

Chiropractors got fantastic results from influenza patients while those under medical care died like flies all around. Statistics reflect a most amazing, almost miraculous state of affairs. The medical profession was practically helpless with the flu victims but chiropractors seemed able to do no wrong.”

“In Davenport, Iowa, 50 medical doctors treated 4,953 cases, with 274 deaths. In the same city, 150 chiropractors including students and faculty of the Palmer School of Chiropractic, treated 1,635 cases with only one death.”

“In the state of Iowa, medical doctors treated 93,590 patients, with 6,116 deaths – a loss of one patient out of every 15. In the same state, excluding Davenport, 4,735 patients were treated by chiropractors with a loss of only 6 cases – a loss of one patient out of every 789.

“National figures show that 1,142 chiropractors treated 46,394 patients for influenza during 1918, with a loss of 54 patients – one out of every 886.”

“Reports show that in New York City, during the influenza epidemic of 1918, out of every 10,000 cases medically treated, 950 died; and in every 10,000 pneumonia cases medically treated 6,400 died. These figures are exact, for in that city these are reportable diseases.”

“In the same epidemic, under drugless methods, only 25 patients died of influenza out of every 10,000 cases; and only 100 patients died of pneumonia out of every 10,000 cases…”

“In the same epidemic reports show that chiropractors in Oklahoma treated 3,490 cases of influenza with only 7 deaths. But the best part of this is, in Oklahoma there is a clear record showing that chiropractors were called in 233 cases where medical doctors had cared for the patients, and finally gave them up as lost. The chiropractors saved all these lost cases but 25.”

END OF QUOTE

So what does that sort of ‘evidence’ really show?

Does it prove that chiropractic is effective against influenza?

No!

Does it even suggest that chiropractic is effective against influenza?

No!

What then?

I think it shows that some chiropractors (like many homeopaths) are deluded to a point where they are unable to differentiate pseudoscience from science, anecdote from evidence, cause from effect, etc.

In the case you need more explanations, let me re-phrase this section from a previous post:

In the typical epidemiological case/control study, one large group of patients [A] is retrospectively compared to another group [B]. By large, I mean with a sample size of thousands of patients. In our case, group A has been treated by chiropractors, while group B received the treatments available at the time. It is true that several of such reports seemed to suggest that chiropractic works. But this does by no means prove anything; the result might have been due to a range of circumstances, for instance:

  • group A might have been less ill than group B,
  • group A might have been richer and therefore better nourished,
  • group A might have benefitted from better hygiene,
  • group A might have received better care, e. g. hydration,
  • group B might have received treatments that made the situation not better but worse.

Because these are RETROSPECTIVE studies, there is no way to account for these and many other factors that might have influenced the outcome. This means that epidemiological studies of this nature can generate interesting results which, in turn, need testing in properly controlled studies where these confounding factors are adequately controlled for. Without such tests, they are next to worthless.

I just came across a new article entitled ” Vaccinated children four times more likely to suffer from ADHD, autism“. It was published in WDDTY, my favourite source of misleading information. Here it is:

Vaccinated children are nearly four times more likely to suffer from learning disabilities, ADHD and autism, a major new study has discovered—and they are six times more likely to suffer from one of these neuro-developmental problems if they were also born prematurely.

The vaccinated child is also more likely to suffer from otitis media, the ear infection, and nearly six times more likely to contract pneumonia.

But the standard childhood vaccines do at least do their job: the vaccinated child is nearly eight times less likely than the unvaccinated to develop chicken pox, and also less likely to suffer from whooping cough (pertussis).

Researchers from Jackson State University are some of the first to look at the long-term effects of vaccination. They monitored the health of 666 children for six years from the time they were six—when the full vaccination programme had been completed—until they were 12. All the children were being home-schooled because it was one of the few communities where researchers could find enough unvaccinated children for comparison; 261 of the children hadn’t been vaccinated and 208 hadn’t had all their vaccinations, while 197 had received the full 48-dose course.

The vaccinated were more likely to suffer from allergic rhinitis, such as hay fever, eczema and atopic dermatitis, learning disability, ADHD (attention-deficit, hyperactive disorder), and autism. The risk was lower among the children who had been partially vaccinated.

Vaccinated children were also more likely to have taken medication, such as an antibiotic, or treatment for allergies or for a fever, than the unvaccinated.

END OF QUOTE

I looked up the original study to check and found several surprises.

The first surprise was that the study was called a ‘pilot’ by its authors, even in the title of the paper: “Pilot comparative study on the health of vaccinated and unvaccinated 6- to 12-year-old U.S. children.”

The second surprise was that even the authors admit to important limitations of their research:

We did not set out to test a specific hypothesis about the association between vaccination and health. The aim of the study was to determine whether the health outcomes of vaccinated children differed from those of unvaccinated homeschool children, given that vaccines have nonspecific effects on morbidity and mortality in addition to protecting against targeted pathogens [11]. Comparisons were based on mothers’ reports of pregnancy-related factors, birth histories, vaccinations, physician-diagnosed illnesses, medications, and the use of health services. We tested the null hypothesis of no difference in outcomes using chi-square tests, and then used Odds Ratios and 96% Confidence Intervals to determine the strength and significance of the association…

What credence can be given to the findings? This study was not intended to be based on a representative sample of homeschool children but on a convenience sample of sufficient size to test for significant differences in outcomes. Homeschoolers were targeted for the study because their vaccination completion rates are lower than those of children in the general population. In this respect our pilot survey was successful, since data were available on 261 unvaccinated children…

Mothers’ reports could not be validated by clinical records because the survey was designed to be anonymous. However, self-reports about significant events provide a valid proxy for official records when medical records and administrative data are unavailable [70]. Had mothers been asked to provide copies of their children’s medical records it would no longer have been an anonymous study and would have resulted in few completed questionnaires. We were advised by homeschool leaders that recruitment efforts would have been unsuccessful had we insisted on obtaining the children’s medical records as a requirement for participating in the study.

A further potential limitation is under-ascertainment of disease in unvaccinated children. Could the unvaccinated have artificially reduced rates of illness because they are seen less often by physicians and would therefore have been less likely to be diagnosed with a disease? The vaccinated were indeed more likely to have seen a doctor for a routine checkup in the past 12 months (57.5% vs. 37.1%, p < 0.001; OR 2.3, 95% CI: 1.7, 3.1). Such visits usually involve vaccinations, which nonvaccinating families would be expected to refuse. However, fewer visits to physicians would not necessarily mean that unvaccinated children are less likely to be seen by a physician if their condition warranted it. In fact, since unvaccinated children were more likely to be diagnosed with chickenpox and whooping cough, which would have involved a visit to the pediatrician, differences in health outcomes are unlikely to be due to under-ascertainment.

The third surprise was that the authors were not at all as certain as WDDTY in their conclusions: “the study findings should be interpreted with caution. First, additional research is needed to replicate the findings in studies with larger samples and stronger research designs. Second, subject to replication, potentially detrimental factors associated with the vaccination schedule should be identified and addressed and underlying mechanisms better understood. Such studies are essential in order to optimize the impact of vaccination of children’s health.”

The fourth surprise was to find the sponsors of this research:

Generation Rescue is, according to Wikipedia, a nonprofit organization that advocates the incorrect view that autism and related disorders are primarily caused by environmental factors, particularly vaccines. These claims are biologically implausible and are disproven by scientific evidence. The organization was established in 2005 by Lisa and J.B. Handley. They have gained attention through use of a media campaign, including full page ads in the New York Times and USA Today. Today, Generation Rescue is known as a platform for Jenny McCarthy‘s autism and anti-vaccine advocacy.

The Children’s Medical Safety Research Institute (CMSRI) was, according to Vaxopedia, created by and is funded by the Dwoskin Family Foundation. It provides grants to folks who will do research on “vaccine induced brain and immune dysfunction” and on what they believe are other “gaps in our knowledge about vaccines and vaccine safety”, including:

While they claim that they are not an anti-vaccine organization, it should be noted that  Claire Dwoskin once said that “Vaccines are a holocaust of poison on our children’s brains and immune systems.”

Did I say SURPRISE?

I take it back!

When it comes to WDDTY, nothing does surprise me.

On this blog, we have often discussed the risks of spinal manipulation. As I see it, the information we have at present suggests that

  • mild to moderate adverse effects are extremely frequent and occur in about half of all patients;
  • serious adverse effects are being reported regularly;
  • the occur usually with chiropractic manipulations of the neck (which are not of proven efficacy for any condition) and often relate to vascular accidents;
  • the consequences can be permanent neurological deficits and even deaths;
  • under-reporting of such cases might be considerable and therefore precise incidence figures are not available;
  • there is no system to accurately monitor the risks;
  • chiropractors are in denial of these problems.

Considering the seriousness of these issues, it is important to do more rigorous research. Therefore, any new paper published on this subject is welcome. A recent article might shed new light on the topic.

The objective of this systematic review was to identify characteristics of 1) patients, 2) practitioners, 3) treatment process and 4) adverse events (AE) occurring after cervical spinal manipulation (CSM) or cervical mobilization. A systematic searches were performed in 6 electronic databases up to December 2014. Of the initial 1043 articles thus located, 144 were included, containing 227 cases. 117 cases described male patients with a mean age of 45 and a mean age of 39 for females. Most patients were treated by chiropractors (66%). Manipulation was reported in 95% of the cases, and neck pain was the most frequent indication for the treatment. Cervical arterial dissection (CAD) was reported in 57%  of the cases and 45.8% had immediate onset symptoms. The overall distribution of gender for CAD was 55% for female. Patient characteristics were described poorly. No clear patient profile, related to the risk of AE after CSM, could be extracted, except that women seemed more at risk for CAD. The authors of this review concluded that there seems to be under-reporting of cases. Further research should focus on a more uniform and complete registration of AE using standardized terminology.

This article provides little new information; but it does confirm what I have been saying since many years: NECK MANIPULATIONS ARE ASSOCIATED WITH SERIOUS RISKS AND SHOULD THEREFORE BE AVOIDED.

This new RCT by researchers from the National Institute of Complementary Medicine in Sydney, Australia was aimed at ‘examining the effect of changing treatment timing and the use of manual, electro acupuncture on the symptoms of primary dysmenorrhea’. It had four arms:

  1. low frequency manual acupuncture (LF-MA),
  2. high frequency manual acupuncture (HF-MA),
  3. low frequency electro acupuncture (LF-EA)
  4. and high frequency electro acupuncture (HF-EA).

A total of 74 women were given 12 treatments over three menstrual cycles, either once per week (LF groups) or three times in the week prior to menses (HF groups). All groups received a treatment in the first 48 hours of menses. The primary outcome was the reduction in peak menstrual pain at 12 months from trial entry.

During the treatment period and 9 month follow-up all groups showed statistically significant reductions in peak and average menstrual pain compared to baseline. However, there were no differences between groups. Health related quality of life increased significantly in 6 domains in groups having high frequency of treatment compared to two domains in low frequency groups. Manual acupuncture groups required less analgesic medication than electro-acupuncture groups. HF-MA was most effective in reducing secondary menstrual symptoms compared to both–EA groups.

The authors concluded that acupuncture treatment reduced menstrual pain intensity and duration after three months of treatment and this was sustained for up to one year after trial entry. The effect of changing mode of stimulation or frequency of treatment on menstrual pain was not significant. This may be due to a lack of power. The role of acupuncture stimulation on menstrual pain needs to be investigated in appropriately powered randomised controlled trials.

If I were not used to reading rubbish research of alternative medicine in general and acupuncture in particular, this RCT would amaze me – not so much because of its design, execution, or write-up, but primarily because of its conclusion (why, oh why, I ask myself, did PLOS ONE publish this paper?). They are, I think, utterly barmy.

Let me explain:

  • acupuncture treatment reduced menstrual pain intensity” – oh no, it didn’t; at least this is not what the study proves; the fact that pain was perceived as less could be due to a host of factors, for instance regression towards the mean, or social desirability; as there was no proper control group, nobody can tell;
  • the lack of difference between treatments “may be due to a lack of power”. Yes, but more likely it is due to the fact that all versions of a placebo therapy generate similar outcomes.
  • acupuncture stimulation on menstrual pain needs to be investigated in appropriately powered randomised controlled trials”. Why? Because the authors have a quasi-religious belief in acupuncture? And if they have, why did they not design their study ‘appropriately’?

The best conclusion I can suggest for this daft trial is this: IN THIS STUDY, THE PRIMARY ENDPOINT SHOWED NO DIFFERENCE BETWEEN THE 4 TREATMENT GROUPS. THE RESULTS ARE THEREFORE FULLY COMPATIBLE WITH THE NOTION THAT ACUPUNCTURE IS A PLACEBO THERAPY.

Something along these lines would, in my view, have been honest and scientific. Sadly, in acupuncture research, we very rarely get such honest science and the ‘National Institute of Complementary Medicine in Sydney, Australia’ has no track record of being the laudable exception to this rule.

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