A new acupuncture study puzzles me a great deal. It is a “randomized, double-blind, placebo-controlled pilot trial” evaluating acupuncture for cancer-related fatigue (CRF) in lung cancer patients. Twenty-eight patients presenting with CRF were randomly assigned to active acupuncture or placebo acupuncture groups to receive acupoint stimulation at LI-4, Ren-6, St-36, KI-3, and Sp-6 twice weekly for 4 weeks, followed by 2 weeks of follow-up. The primary outcome measure was the change in intensity of CFR based on the Chinese version of the Brief Fatigue Inventory (BFI-C). The secondary endpoint was the Functional Assessment of Cancer Therapy-Lung Cancer Subscale (FACT-LCS). Adverse events were monitored throughout the trial.
A significant reduction in the BFI-C score was observed at 2 weeks in the 14 participants who received active acupuncture compared with those receiving the placebo. At week 6, symptoms further improved. There were no significant differences in the incidence of adverse events of the two group.
The authors, researchers from Shanghai, concluded that fatigue is a common symptom experienced by lung cancer patients. Acupuncture may be a safe and feasible optional method for adjunctive treatment in cancer palliative care, and appropriately powered trials are warranted to evaluate the effects of acupuncture.
And why would this be puzzling?
There are several minor oddities here, I think:
- The first sentence of the conclusion is not based on the data presented.
- The notion that acupuncture ‘may be safe’ is not warranted from the study of 14 patients.
- The authors call their trial a ‘pilot study’ in the abstract, but refer to it as an ‘efficacy study’ in the text of the article.
But let’s not be nit-picking; these are minor concerns compared to the fact that, even in the title of the paper, the authors call their trial ‘double-blind’.
How can an acupuncture-trial be double-blind?
The authors used the non-penetrating Park needle, developed by my team, as a placebo. We have shown that, indeed, patients can be properly blinded, i. e. they don’t know whether they receive real or placebo acupuncture. But the acupuncturist clearly cannot be blinded. So, the study is clearly NOT double-blind!
As though this were not puzzling enough, there is something even more odd here. In the methods section of the paper the authors explain that they used our placebo-needle (without referencing our research on the needle development) which is depicted below.
Then they state that “the device is placed on the skin. The needle is then gently tapped to insert approximately 5 mm, and the guide tube is then removed to allow sufficient exposure of the handle for needle manipulation.” No further explanations are offered thereafter as to the procedure used.
Removing the guide tube while using our device is only possible in the real acupuncture arm. In the placebo arm, the needle telescopes thus giving the impression it has penetrated the skin; but in fact it does not penetrate at all. If one would remove the guide tube, the non-penetrating placebo needle would simply fall off. This means that, by removing the guide tube for ease of manipulation, the researchers disclose to their patients that they are in the real acupuncture group. And this, in turn, means that the trial was not even single-blind. Patients would have seen whether they received real or placebo acupuncture.
It follows that all the outcomes noted in this trial are most likely due to patient and therapist expectations, i. e. they were caused by a placebo effect.
Now that we have solved this question, here is the next one: IS THIS A MISUNDERSTANDING, CLUMSINESS, STUPIDITY, SCIENTIFIC MISCONDUCT OR FRAUD?
This is a fascinating new review of upper neck manipulation. It raises many concerns that we, on this blog, have been struggling with for years. I take the liberty of quoting a few passages which I feel are important and encourage everyone to study the report in full:
The Minister of Health, Seniors and Active Living gave direction to the Health Professions Advisory Council (“the Council”) to undertake a review related to high neck manipulation.
Specifically, the Minister directed the Council to undertake:
1) A review of the status of the reserved act in other Canadian jurisdictions,
2) A literature review related to the benefits to patients and risks to patient safety associated with the procedure, and
3) A jurisprudence review or a review into the legal issues that have arisen in Canada with respect to the performance of the procedure that touch upon the risk of harm to a patient.
In addition, the Minister requested the Council to seek written input on the issue from:
- Manitoba Chiropractic Stroke Survivors
- Manitoba Chiropractic Association
- College of Physiotherapists of Manitoba
- Manitoba Naturopathic Association
- College of Physicians and Surgeons of Manitoba
- other relevant interested parties as determined by the Council
… The review indicated that further research is required to:
- strengthen evidence for the efficacy of cervical spinal manipulations (CSM) as a treatment for neck pain and headache, “as well as for other indications where evidence currently does not exist (i.e., upper back and should/arm pain, high blood pressure, etc.)”
- establish safety and efficacy of CSM in infants and children
- assess the risk versus benefit in consideration of using HVLA cervical spine manipulation, which also involve cost-benefit analyses that compare CSM to other standard treatments.
… the performance of “high neck manipulation” or cervical spine manipulation does present a risk of harm to patients. This risk of harm must be understood by both the patient and the practitioner.
Both the jurisprudence review and the research literature review point to the need for the following actions to mitigate the risk of harm associated with the performance of cervical spine manipulation:
- Action One: Ensure that the patient provides written informed consent prior to initiating treatment which includes a discussion about the risk associated with cervical spine manipulation.
- Action Two: Provide patients with information to assist in the early recognition of a serious adverse event.
Some doctors use homeopathy, and for proponents of homeopathy this has always been a strong argument for its effectiveness. They claim that someone who has studied medicine would not employ a therapy that does not work. I have long felt that this view is erroneous.
This article goes some way in finding out who is right. It was aimed at describing the use of homeopathy by physicians working in outpatient care, factors associated with prescribing homeopathy, and the therapeutic intentions and attitudes involved.
All physicians working in outpatient care in the Swiss Canton of Zurich in the year 2015 (n = 4072) were approached. Outcomes of the survey were:
- association of prescribing homeopathy with medical specialties;
- intentions behind prescriptions;
- level of agreement with specific attitudes;
- views towards homeopathy including explanatory models,
- rating of homeopathy’s evidence base,
- the endorsement of indications,
- reimbursement of homeopathic treatment by statutory health insurance providers.
The participation rate was 38%, mean age 54 years, 61% male, and 40% specialised in general internal medicine. Homeopathy was prescribed at least once a year by 23% of the respondents. Medical specialisations associated with prescribing homeopathy were: no medical specialisation (OR 3.9; 95% CI 1.7-9.0), specialisation in paediatrics (OR 3.8 95% CI 1.8-8.0) and gynaecology/obstetrics (OR 3.1 95% CI 1.5-6.7).
Among prescribers, only 50% clearly intended to induce specific homeopathic effects, only 27% strongly adhered to homeopathic prescription doctrines, and only 23% thought there was scientific evidence to prove homeopathy’s effectiveness. Seeing homeopathy as a way to induce placebo effects had the strongest endorsement among prescribers and non-prescribers of homeopathy (63% and 74% endorsement respectively). Reimbursement of homeopathic remedies by statutory health insurance was rejected by 61% of all respondents
The authors concluded that medical specialties use homeopathy with significantly varying frequency and only half of the prescribers clearly intend to achieve specific effects. Moreover, the majority of prescribers acknowledge that effectiveness is unproven and give little importance to traditional principles behind homeopathy. Medical specialties and associated patient demands but also physicians’ openness towards placebo interventions may play a role in homeopathy prescriptions. Education should therefore address not only the evidence base of homeopathy, but also ethical dilemmas with placebo interventions.
These data suggest than many doctors use homeopathy as a placebo. And this is what I had always suspected. Certainly I did often employ it in this way when I still worked as a clinician. The logic of doing so is quite simple: there are many patients where, after running all necessary tests, you conclude that there is nothing wrong with them. You try your best to get the message across but it is not accepted by the patient who clearly wants to have a prescription for something. In the end, due to time pressure etc., you give up and prescribe a homeopathic remedy hoping that the placebo effect, regression towards the mean and the natural history of the condition will do the trick.
And often they do!
I do know that this is hardly good medicine and arguably even not entirely ethical, but it is the reality. If I found myself in the same situation again, I am not sure that I would not do something similar.
This randomized controlled trial was aimed to investigate the effect of aromatherapy massage on anxiety, depression, and physiologic parameters in older patients with acute coronary syndrome. It was conducted on 90 older women with acute coronary syndrome. The participants were randomly assigned into the intervention and control groups. The intervention group received reflexology with lavender essential oil plus routine care and the control group only received routine care. Physiologic parameters, the levels of anxiety and depression in the hospital were evaluated using a checklist and the Hospital’s Anxiety and Depression Scale, respectively, before and immediately after the intervention.
Significant differences in the levels of anxiety and depression were reported between the groups after the intervention. The analysis of physiological parameters revealed a statistically significant reduction in systolic blood pressure, diastolic blood pressure, mean arterial pressure, and heart rate. However, no significant difference was observed in the respiratory rate.
The authors concluded that aromatherapy massage can be considered by clinical nurses an efficient therapy for alleviating psychological and physiological responses among older women suffering from acute coronary syndrome.
This trial does not show remotely what the authors think. It demonstrates that A+B is always more than B. We have discussed this phenomenon so often that I hesitate to mention it again. Any study with the ‘A+B versus B’ design can only produce a positive result. The danger that this result is false-positive is so high that it is best to forget about such investigations altogether.
Ethics committees should not accept such protocols.
Researchers should stop running such studies.
Reviewers should not pass them for publication.
Editors should not publish such trials.
THEY MISLEAD ALL OF US AND GIVE CLINICAL RESEARCH A BAD NAME.
During Voltaire’s time, this famous quote was largely correct. But today, things are very different, and I often think this ‘bon mot’ ought to be re-phrased into ‘The art of alternative medicine consists in amusing the patient, while medics cure the disease’.
To illustrate this point, I shall schematically outline the story of a patient seeking care from a range of clinicians. The story is invented but nevertheless based on many real experiences of a similar nature.
Tom is in his mid 50s, happily married, mildly over-weight and under plenty of stress. In addition to holding a demanding job, he has recently moved home and, as a consequence of lots of heavy lifting, his whole body aches. He had previous episodes of back trouble and re-starts the exercises a physio once taught him. A few days later, the back-pain has improved and most other pains have subsided as well. Yet a dull and nagging pain around his left shoulder and arm persists.
He is tempted to see his GP, but his wife is fiercely alternative. She was also the one who dissuaded Tom from taking Statins for his high cholesterol and put him on Garlic pills instead. Now she gives Tom a bottle of her Rescue Remedy, but after a week of taking it Tom’s condition is unchanged. His wife therefore persuades him to consult alternative practitioners for his ‘shoulder problem’. Thus he sees a succession of her favourite clinicians.
THE CHIROPRACTOR examines Tom’s spine and diagnoses subluxations to be the root cause of his problem. Tom thus receives a series of spinal manipulations and feels a little improved each time. But he is disappointed that the pain in the left shoulder and arm returns. His wife therefore makes another appointment for him.
THE ENERGY HEALER diagnoses a problem with Tom’s vital energy as the root cause of his persistent pain. Tom thus receives a series of healing sessions and feels a little improved each time. But he is disappointed that the pain in the left shoulder and arm returns. His wife therefore makes another appointment for him.
THE REFLEXOLOGIST examines Tom’s foot and diagnoses knots on the sole of his foot to cause energy blockages which are the root cause of his problem. Tom thus receives a series of most agreeable foot massages and feels a little improved each time. But he is disappointed that the pain in the left shoulder and arm returns. His wife therefore makes another appointment for him.
THE ACUPUNCTURIST examines Tom’s pulse and tongue and diagnoses a chi deficiency to be the root cause of his problem. Tom thus receives a series of acupuncture treatments and feels a little improved each time. But he is disappointed that the pain in the left shoulder and arm returns. His wife therefore makes another appointment for him.
THE NATUROPATH examines Tom and diagnoses some form of auto-intoxication as the root cause of his problem. Tom thus receives a full program of detox and feels a little improved each time. But he is disappointed that the pain in the left shoulder and arm returns. His wife therefore makes another appointment for him.
THE HOMEOPATH takes a long and detailed history and diagnoses a problem with Tom’s vital force to be the root cause of his pain. Tom thus receives a homeopathic remedy tailor-made for his needs and feels a little improved after taking it for a few days. But he is disappointed that the pain in the left shoulder and arm returns. His wife therefore tries to make another appointment for him.
But this time, Tom had enough. His pain has not really improved and he is increasingly feeling unwell.
At the risk of a marital dispute, he consults his GP. The doctor looks up Tom’s history, asks a few questions, conducts a brief physical examination, and arranges for Tom to see a specialist. A cardiologist diagnoses Tom to suffer from coronary heart disease due to a stenosis in one of his coronary arteries. She explains that Tom’s dull pain in the left shoulder and arm is a rather typical symptom of this condition.
Tom has to have a stent put into the affected coronary artery, receives several medications to lower his cholesterol and blood pressure, and is told to take up regular exercise, lose weight and make several other changes to his stressful life-style. Tom’s wife is told in no uncertain terms to stop dissuading her husband from taking his prescribed medicines, and the couple are both sent to see a dietician who offers advice and recommends a course on healthy cooking. Nobody leaves any doubt that not following this complex (holistic!) package of treatments and advice would be a serious risk to Tom’s life.
It has taken a while, but finally Tom is pain-free. More importantly, his prognosis has dramatically improved. The team who now look after him have no doubt that a major heart attack had been imminent, and Tom could easily have died had he continued to listen to the advice of multiple non-medically trained clinicians.
The root cause of his condition was misdiagnosed by all of them. In fact, the root cause was the atherosclerotic degeneration in his arteries. This may not be fully reversible, but even if the atherosclerotic process cannot be halted completely, it can be significantly slowed down such that he can live a full life.
My advice based on this invented and many real stories of a very similar nature is this:
- alternative practitioners are often good at pampering their patients;
- this may contribute to some perceived clinical improvements;
- in turn, this perceived benefit can motivate patients to continue their treatment despite residual symptoms;
- alternative practitioner’s claims about ‘root causes’ and holistic care are usually pure nonsense;
- their pampering may be agreeable, but it can undoubtedly cost lives.
George Vithoulkas * (GV) is one of today’s most influential lay-homeopaths, a real ‘super guru’. He has many bizarre ideas; one of the most peculiar one was recently outlined in his article entitled ‘An innovative proposal for scientific alternative medical journals’. Here are a few excerpts from it:
…the only evidence that homeopathy can present to the scientific world at this moment are these thousands of cured cases. It is a waste of time, money, and energy to attempt to demonstrate the effectiveness of homeopathy through double blind trials.
… the international “scientific” community, which has neither direct perception nor personal experience of the beneficial effects of homeopathy, is forced to repeat the same old mantra: “Where is the evidence? Show us the evidence!” … the successes of homeopathy have remained hidden in the offices of hardworking homeopaths – and thus go largely ignored by the world’s medical authorities, governments, and the whole international scientific community…
… simple questions that are usually asked by the “gnorant”, for example, “Can homeopathy cure cancer, multiple sclerosis, ulcerative colitis, etc.?” are invalid and cannot elicit a direct answer because the reality is that many such cases can be ameliorated significantly, and a number can be cured…
A journal could invite a selected number of good prescribers from all over the world as a start to this project and let them contribute to their honest experience and results, as well as their failures. The possibilities and limitations would soon be revealed…
I admit that an argument against accepting cases is that it is possible that false or unreliable information could be provided. This risk could be minimized by preselecting a well-known group of good prescribers, who could be asked to submit their cases, at least in the first phase of such a radical change in the policy of the journals…
This way, instead of rejecting important homeopathic case studies, in the name of a dry intellectualism and conservatism, homeopathy journals (including alternative and complementary journals) could become lively and interesting: initiating debates and discussions on real issues of therapeutics in medicine…
Our own “Evidence Based Medicine” lies in the multitude of chronic cases treated with homeopathy that we can present to the world and on the better quality of life that such cures offer.
END OF QUOTES
So, GV wants homeopathy to thrive by means of publishing lots of case reports of patients who benefitted from homeopathy. And he believes that this suggestion is ‘innovative’? It is not! Case reports were all the rage 150 years ago before medicine started to become a little more scientific. And today, there are several journals specialising in the publication of case-reports, hundreds of journals that like accepting them, as well as dozens of websites that do little else but publishing case reports of homeopathy.
But case reports essentially are anecdotes. Medicine finally managed to progress from its dark ages when we realised how unreliable case reports truly are. To state it yet again (especially for GV who seems to be a bit slow on the uptake): THE PLURAL OF ANECDOTE IS ANECDOTES, NOT EVIDENCE!
In the above article, GV claims that ‘it is a waste of time, money, and energy to attempt to demonstrate the effectiveness of homeopathy through double blind trials.’ That is most puzzling because, only a few years ago, he did publish this:
Alternative therapies in general, and homeopathy in particular, lack clear scientific evaluation of efficacy. Controlled clinical trials are urgently needed, especially for conditions that are not helped by conventional methods. The objective of this work was to assess the efficacy of homeopathic treatment in relieving symptoms associated with premenstrual syndrome (PMS). It was a randomised controlled double-blind clinical trial. Two months baseline assessment with post-intervention follow-up for 3 months was conducted at Hadassah Hospital outpatient gynaecology clinic in Jerusalem in Israel 1992-1994. The subjects were 20 women, aged 20-48, suffering from PMS. Homeopathic intervention was chosen individually for each patient, according to a model of symptom clusters. Recruited volunteers with PMS were treated randomly with one oral dose of a homeopathic medication or placebo. The main outcome measure was scores of a daily menstrual distress questionnaire (MDQ) before and after treatment. Psychological tests for suggestibility were used to examine the possible effects of suggestion. Mean MDQ scores fell from 0.44 to 0.13 (P<0.05) with active treatment, and from 0.38 to 0.34 with placebo (NS). (Between group P=0.057). Improvement >30% was observed in 90% of patients receiving active treatment and 37.5% receiving placebo (P=0.048). Homeopathic treatment was found to be effective in alleviating the symptoms of PMS in comparison to placebo. The use of symptom clusters in this trial may offer a novel approach that will facilitate clinical trials in homeopathy. Further research is in progress.
I find this intriguing, particularly because the ‘further research’ mentioned prominently in the conclusions never did surface! Perhaps its results turned out to be unfavourable to homeopathy? Perhaps this is why GV dislikes RCTs these days? Perhaps this is why he prefers case reports such as this one which he recently published:
START OF QUOTE
An 81-year-old female patient was admitted in July 2015 to the Cardiovascular Surgery Department of a hospital in Bucharest for an aortic valve replacement surgery.
The patient had a history of mild hypertension, insulin-dependent type 2 diabetes, coronary artery disease, congestive heart failure NYHA 2, severe aortic stenosis, moderate mitral regurgitation, mild pulmonary hypertension, bilateral carotid atheromatosis with a 50% stenosis of the left internal carotid artery, complete right mastectomy for breast cancer (at that moment in remission).
After a preoperative evaluation and preparation, the surgery was completed with the replacement of the aortic valve with a bioprosthesis (Medtronic Hancock II Ultra no. 23) and myocardial revascularization by using a double aortic-coronary bypass.
The post-operatory evolution was a good one in terms of the heart disease. However, the patient did not regain consciousness after the anaesthesia, maintaining a deep comatose state (GCS 7 points – E1V2M4).
A brain CT was performed the third day postoperatively, showing no recent ischemic or haemorrhagic cerebral lesions, moderate diffuse cerebral atrophy and carotid atheromatosis.
After the surgery, the patient was admitted to the Intensive Care Unit and was treated by using a multidisciplinary approach. The patient was treated with inotropic, antiarrhythmic, and diuretic drugs, insulin and antidiabetic drugs were used in order to keep the blood sugar levels under control. The patient was kept hydrated and the electrolytes balanced by using an i.v. line, prophylaxis for deep vein thrombosis, and pulmonary thromboembolism was performed by using low molecular weight heparin. Prophylaxis for bedsores was also performed by using a pressure relieve air mattress.
The patient went into acute respiratory distress, needing mechanical ventilation in order to maintain oxygenation.
Despite these complex and correctly performed therapeutic efforts, the patient did not regain consciousness and was still in a deep coma in the fourteenth day post-operatory (GCS 7 points – E1V2M4), without having a confirmed medical explanation.
At that point, the patient’s family requested a consult from a homeopathic specialist.
The homeopathic examination, which was performed in the fourteenth day postoperatively, revealed the following: old, comatose, tranquil patient, with pale and cold skin, with the need to uncover herself (the few movements that she made with her hands were to remove her blanket and clothes, as if she wanted more air – “thirst for air”), abdominal distension, and bloating.
The thorough evaluation of the patient and the analysis of her symptoms led us to the remedy most appropriate for this critical situation – Carbo Vegetabilis.
Homeopathic treatment was initiated the same day, by using Carbo Vegetabilis 200CH 7 granules twice a day, administered diluted in 20ml of water by using a nasogastric tube.
The patient’s evolution was spectacular. The next day after the initiation of the treatment (fifteenth day postoperatively) the patient was in a superficial coma (GCS 11 points – E2V4M5), and the following day she regained consciousness. Carbo Vegetabilis was administered in the same dose for a total of five days (including the nineteenth day postoperatively).
After these five days, the case was reassessed from a homeopathically point of view and the second evaluation revealed the following: severely dyspnoeic patient (even talking caused exhaustion) with pale skin, severe fatigue aggravated by the slightest movements, a weakness sensation located in the chest area, extreme lack of energy, the wish “to be left alone”.
Considering the state of general exhaustion the patient was in at that moment and her lack of energy, the homeopathic treatment was changed to a new remedy: Stanum metallicum 30CH 7 granules administered sublingually twice a day for a week.
After the administration of the second remedy, the patient’s general condition improved dramatically: she started eating, she was able to get up in a sitting position with only little help, her fatigue diminished significantly.
The patient was then transferred to a recovery clinic in Cluj-Napoca in order to continue the cardiovascular recovery treatment. During her three-week admission in the clinic, she followed an individualized cardiovascular recovery program, which led to her ability to walk short distances with minimal support and has was released from the hospital in September 2015.
The following weeks after release, the patient recovered almost entirely, both physically and mentally. She was able to retake her place in her family and in society in general.
END OF QUOTE
One has to be a homeopath (one who is ignorant of the ‘post hoc propter hoc fallacy’) to believe in a causal link between the intake of the homeopathic remedy and the recovery of this patient. Thankfully, comatose patients do re-gain consciousness all the time! Even without homeopathy! But GV seems to not know that. In the discussion of this paper, he even states this: “… even after a well-conducted therapy, this condition leads to the death of the patient.” Is it ethical to publish such falsehoods, I wonder?
As far as the case report goes, the homeopathic remedy might even have delayed the process – perhaps the patient would have re-gained consciousness quicker and more completely without it! My hypothesis (homeopathy cased harm) is exactly as strong and silly as the one (homeopathy cased benefit) of GV. Anecdotes will never be able to answer the question as to who is correct.
One has to be a homeopath (and a daft one at that) to believe that this sort of evidence will lead to the acceptance of homeopathy by the scientific community. No journal will take GV seriously. No editor can be that stupid!
Oooops! Hold on, I might be wrong here.
Dr Peter Fisher, editor of the journal ‘Homeopathy’ just published an editorial ( Fisher P, Homeopathy and intellectual honesty, Homeopathy (2017), see also my previous post) stating that, in future, ‘we will increase publication of well-documented case-reports’.
Did I just claim that no editor can be that stupid?
- I should declare a conflict of interest: when he got his ‘Right Livelihood Award’, GV sent me (and other prominent homeopathy-researchers) some of the prize money (I think it was around £ 1000) to support my research in homeopathy. I used it for exactly that purpose.
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.