MD, PhD, FMedSci, FRSB, FRCP, FRCPEd

causation

Can conventional therapy (CT) be combined with herbal therapy (CT + H) in the management of Alzheimer’s disease (AD) to the benefit of patients? This was the question investigated by Chinese researchers in a recent retrospective cohort study funded by grants from China Ministry of Education, National Natural Science Foundation of China, Beijing Municipal Science and Technology Commission, and Beijing Municipal Commission of Health and Family Planning.

In total, 344 outpatients diagnosed as probable dementia due to AD were collected, who had received either CT + H or CT alone. The GRAPE formula was prescribed for AD patients after every visit according to TCM theory. It consisted mainly (what does ‘mainly’ mean as a description of a trial intervention?) of Ren shen (Panax ginseng, 10 g/d), Di huang (Rehmannia glutinosa, 30 g/d), Cang pu (Acorus tatarinowii, 10 g/d), Yuan zhi (Polygala tenuifolia, 10 g/d), Yin yanghuo (Epimedium brevicornu, 10 g/d), Shan zhuyu (Cornus officinalis, 10 g/d), Rou congrong (Cistanche deserticola, 10 g/d), Yu jin (Curcuma aromatica, 10 g/d), Dan shen (Salvia miltiorrhiza, 10 g/d), Dang gui (Angelica sinensis, 10 g/d), Tian ma (Gastrodia elata, 10 g/d), and Huang lian (Coptis chinensis, 10 g/d), supplied by Beijing Tcmages Pharmaceutical Co., LTD. Daily dose was taken twice and dissolved in 150 ml hot water each time. Cognitive function was quantified by the mini-mental state examination (MMSE) every 3 months for 24 months.

The results show that most of the patients were initially diagnosed with mild (MMSE = 21-26, n = 177) and moderate (MMSE = 10-20, n = 137) dementia. At 18 months, CT+ H patients scored on average 1.76 (P = 0.002) better than CT patients, and at 24 months, patients scored on average 2.52 (P < 0.001) better. At 24 months, the patients with improved cognitive function (△MMSE ≥ 0) in CT + H was more than CT alone (33.33% vs 7.69%, P = 0.020). Interestingly, patients with mild AD received the most robust benefit from CT + H therapy. The deterioration of the cognitive function was largely prevented at 24 months (ΔMMSE = -0.06), a significant improvement from CT alone (ΔMMSE = -2.66, P = 0.005).

 

The authors concluded that, compared to CT alone, CT + H significantly benefited AD patients. A symptomatic effect of CT + H was more pronounced with time. Cognitive decline was substantially decelerated in patients with moderate severity, while the cognitive function was largely stabilized in patients with mild severity over two years. These results imply that Chinese herbal medicines may provide an alternative and additive treatment for AD.

Conclusions like these render me speechless – well, almost speechless. This was nothing more than a retrospective chart analysis. It is not possible to draw causal conclusions from such data.

Why?

Because of a whole host of reasons. Most crucially, the CT+H patients were almost certainly a different and therefore non-comparable population to the CT patients. This flaw is so elementary that I need to ask, who are the reviewers letting such utter nonsense pass, and which journal would publish such rubbish? In fact, I can be used for teaching students why randomisation is essential, if we aim to find out about cause and effect.

Ahhh, it’s the ! I think the funders, editors, reviewers, and authors of this paper should all go and hide in shame.

The title of this post is a statement recently made in an article by Mike Adams in ‘Alternative Medicine News’:

The cancer industry goes to great lengths to deny patients access to any information that they might use to prevent, treat or cure cancer without requiring expensive (and highly toxic) medical interventions. That’s what makes the BMJ documentation of this curcumin cancer cure so astonishing: In years past, the BMJ never would have even tolerated the publishing of such a scientific assessment. So what changed? In truth, the evidence of natural cures for cancer is now so overwhelming that even the BMJ cannot remain in a state of denial without appearing to be hopelessly out of touch with scientific reality.

The story is based on one single patient who apparently was cured of cancer using curcumin (turmeric). The case was also recently (3/1/18) featured on BBC’s ‘YOU AND YOURS’ (http://www.bbc.co.uk/programmes/b09k0ng7) in a similarly uncritical way: no expert was asked to provide an evidence-based assessment and bring some reason into the discussion. Even the DAILY FAIL reported about the story, and predictably, critical assessment had to make way for sensationalism.

So what?

We hear about such nonsense almost every day!

True, but this case is different; it is based on a publication in the highly-respected BMJ (well, actually, it was the ‘BMJ CASE REPORTS’ and not the BMJ, as reported). Here is the article:

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A woman aged 57 years was initially diagnosed with monoclonal gammopathy of undetermined significance (MGUS) in 2007 following an incidental finding of M-protein (18 g/L) during investigation for hypertension.

Within 15 months, the patient had rapidly progressed to ISS stage 3 myeloma with M-protein 49 g/L, urinary protein 1.3 g/24-hour, Bence-Jones protein 1.0 g/24-hour, Hb 9.7 g/dL and increasing back pain. She initially declined antimyeloma treatment but 6 months later, following vertebral collapse at T5 and T12, started cyclophosphamide, thalidomide and dexamethasone (CTD) treatment. However, after a week, the patient was admitted with idiosyncratic syndrome including hyponatraemia, a fall in albumin and worsening of blood counts. She received red cell transfusion and her electrolyte abnormalities were carefully corrected.

Although there was evidence of a response to CTD (M-protein 34 g/L), bortezomib and dexamethasone treatment was initiated as an alternative, but this was discontinued after three cycles due to progressive disease (M-protein 49 g/L). The patient was then treated with lenalidomide and dexamethasone with the aim of reducing disease burden prior to high-dose therapy and autologous stem cell transplantation. Treatment was frequently interrupted and dose adjusted to account for neutropenia and despite a minor response after six cycles (starting M-protein 47 g/L, finishing M-protein 34 g/L), in October 2009, she proceeded with stem cell mobilisation. However, neither cyclophosphamide nor plerixafor/GCSF priming were successful. A bone marrow biopsy revealed 50% myeloma cells and a course of CTD was restarted with cautious titration of thalidomide.

The patient achieved a partial response with CTD retreatment over the course of 17 cycles (M-protein 13 g/L) with no further episodes of idiosyncratic syndrome. However, attempts to harvest stem cells in February 2011 and again there months later, both failed. By then, her M-protein had risen to 24 g/L and the patient was too neutropenic to be considered for a clinical trial.

At this point, the patient began a daily regime of oral curcumin complexed with bioperine (to aid absorption), as a single dose of 8 g each evening on an empty stomach. A few months later, she also embarked on a once-weekly course of hyperbaric oxygen therapy (90 min at 2 ATA) which she has maintained ever since. Her paraprotein levels gradually declined to a nadir of 13 g/L, her blood counts steadily improved and there was no evidence of further progressive lytic bone disease.

Outcome and follow-up

The patient continues to take oral curcumin 8 g daily without further antimyeloma treatment. Over the last 60 months, her myeloma has remained stable with minimal fluctuation in paraprotein level, her blood counts lie within the normal range and she has maintained good quality of life throughout this period. Repeat bone imaging in 2014 identified multiple lucencies <1 cm in the right hip and degenerative changes in both hips, but these were attributed to osteoarthritis rather than the myeloma. Recent cytogenetic analysis revealed she had no abnormal cytogenetics by fluorescent in situ hybridisation.

Discussion

A small but significant number of myeloma patients consume dietary supplements in conjunction with conventional treatment primarily to help cope with the side effects of treatment, manage symptoms and enhance general well-being. Few, if any, use dietary supplementation as an alternative to standard antimyeloma therapy. Here, we describe a case in which curcumin has maintained long-term disease control in a multiply-relapsed myeloma patient. To the best of our knowledge, this is the first report in which curcumin has demonstrated an objective response in progressive disease in the absence of conventional treatment.

Curcumin is a polyphenol derived from the perennial herb Curcuma longa (turmeric) and has, for centuries, been used as a traditional Indian medicine. Several reports published over the two decades have claimed various health benefits of curcumin and this has led to its increasing popularity as a dietary supplement to prevent or treat a number of different diseases.

The biological activity of curcumin is indeed remarkable. It is a highly pleiotropic molecule which possesses natural antioxidant, anti-inflammatory, antiseptic and analgesic properties. More recently, it has demonstrated antiproliferative effects in a wide variety of tumour cells including myeloma cells and exerts its antiproliferative effects through multiple cellular targets that regulate cell growth and survival.

In vitro, curcumin prevents myeloma cell proliferation through inhibition of IL-6-induced STAT-3 phosphorylation and through modulation of the expression of NF-kB-associated proteins such as IkB〈,Bcl-2, Bcl-xL, cyclin D1 and IL-6 and apoptosis-related molecules including p53 and Bax. In other studies, curcumin was shown to circumvent resistance to dexamethasone, doxorubicin and melphalan as well as potentiate the effects of bortezomib, thalidomide and lenalidomide. Furthermore, curcumin-induced cell death was not influenced by myeloma molecular heterogeneity.

The antimyeloma effects of curcumin in the clinical setting however are less clear. Only one phase I/II study has evaluated curcumin treatment in myeloma patients. These patients were either asymptomatic, relapsed or had plateau phase disease. Treatment with curcumin downregulated the expression of NFkB, COX-2 and STAT3 in peripheral blood mononuclear cells, but no objective responses were observed in any subgroup of patients. This may be as a result of small sample size in this study, follow-up was limited to 3 months and clinical responses may have been observed with longer follow-up. However, downregulation of NFkB, COX-2 and STAT3 expression may not correlate with the clinical activity of curcumin and there may be further mechanisms of action that remain unclear, possibly through the modulation of another target. We would not be able to identify any patient-specific mechanisms of activity in this case study, as the patient has been taking curcumin for some time now and baseline bone marrow or peripheral blood samples are not available. However, in the setting of a clinical trial, it may be possible to use next-generation sequencing to help identify a mutation that may be a potential target for curcumin.

Another study examined its effects in preventing the progression of MGUS and smouldering myeloma to myeloma. The results showed that curcumin exerted a trace of biological activity with modest decreases in free light chain and paraprotein levels and a reduction in a marker of bone resorption with curcumin treatment, suggesting the therapeutic potential of curcumin in MGUS and smouldering myeloma. However, more studies are needed to address this further.

Whether such effects are observed in patients with active disease remains to be seen. The fact that our patient, who had advanced stage disease and was effectively salvaged while exclusively on curcumin, suggests a potential antimyeloma effect of curcumin. She continues to take daily curcumin and remains in a very satisfactory condition with good quality of life. This case provides further evidence of the potential benefit for curcumin in myeloma. We would recommend further evaluation of curcumin in myeloma patients in the context of a clinical trial.

END OF QUOTE

What should we make of this?

I think that much of the reporting around the story was grossly irresponsible. It is simply not possible to conclude that curcumin was the cause of the remission. It could be due to a whole host of other factors. And a case report is just an anecdote; it never can prove anything and can only be used to stimulate further research.

I fully agree with the authors of the case report: curcumin seems worthy of further investigation. But recommending it to patients for self-medication is vastly premature and quite simply dangerous, unethical and naïve bordering on stupid.

And, of course, the above-cited drivel of Mike Adams is just beyond the pale – the evidence for ‘alternative cancer cures‘ is very, very far from ‘overwhelming’; and the ‘cancer industry’ is doing what they can to determine whether turmeric or any other natural remedy can be used to treat cancer and other diseases.

If they are ever successful, the Adams of this world will shout ‘EXPLOITATION!!!’

If their endeavours are not successful, they will complain ‘CONSPIRACY!!!’

The question whether chiropractic is a truly valuable option for people suffering from back pain has been addressed repeatedly on this blog. My answer was usually negative, but proponents of chiropractic tended to argue that I am biased. Therefore I find it constructive to see what an organisation that hardly can be accused of bias says on this topic. An article by ‘SHOW ME THE EVIDENCE’ has recently provided a comprehensive overview of treatments for back pain. This is what they wrote about chiropractic:

START OF QUOTE

Spinal manipulation, the cranking and tweaking on offer when you visit a traditional chiropractor, is among the most popular approaches to back pain. Practitioners lay their hands on the patient and move their joints to or beyond their range of motion — a technique that’s often accompanied by a pop or crack.

There is some evidence the approach can help people with chronic back pain — but not any more than over-the-counter painkillers or exercise, and you need to take precautions when seeking out a chiropractor.

First, a quick look at the evidence. There are two recent Cochrane reviews on spinal manipulation for low back pain: one focused on people with acute (again, episodic/short duration) pain and the other on chronic pain. The 2011 review on chronic low back pain found that spinal manipulation had small, short-term effects on reducing pain and improving the patient’s functional status — but this effect was about the same as other common therapies for chronic low back pain, such as exercise. That review was published in 2011; UpToDate reviewed the randomized trials that have come out since — and also found that spinal manipulation delivered modest, short-term benefits for chronic back pain sufferers.

The Cochrane review on acute pain found that spinal manipulation worked no better than placebo. So people with a short episode of back pain should probably not bother seeing a chiropractor.

“Based on the evidence,” University of Amsterdam assistant professor Sidney Rubinstein, who is the lead author on the Cochrane reviews, told me, “it would appear [spinal manipulation] works as well as other accepted conservative therapies for chronic low back pain, such as non-prescription medication or exercise, but less well for patients with acute low back pain.”

As a chiropractor himself, he had some advice for patients: They should avoid chiropractors who routinely make X-rays or do advanced diagnostics for low back pain because this adds nothing to the clinical picture, particularly in the case of nonspecific low back pain. Patients should also beware chiropractors who put them on extended programs of care.

“Patients who respond to chiropractic care traditionally respond rather quickly,” he said. “My advice is those patients who have not responded to a short course of chiropractic care or manipulation should consider another type of therapy.”

While the risks of serious side effects from spinal manipulation for back pain are rare — about one in 10 million — the risks associated with chiropractic therapy for neck pain tend to be slightly higher: 1.46 strokes for every million neck adjustments.

The issue is the vertebral artery, which travels from the neck down through the vertebrae. Manipulating the neck can put patients at a higher risk of arterial problems, including stroke or vertebral artery dissection, or the tearing of the vertebral artery (though Rubinstein noted that people in the initial stages of stroke or dissection may also seek out care for their symptoms, such as neck pain, which makes it difficult to untangle how many of health emergencies are brought on by the adjustments).

END OF QUOTE

This all seems fairly reasonable to me – except for the following not entirely unimportant points:

  • I am not sure where the evidence about risks of spinal manipulation comes from. In my view, it is not entirely correct: as there is no effective post-marketing surveillance, we cannot possibly name the incidence figures.
  • Neck manipulations are clearly more risky than manipulations lower down. But this does not necessarily mean that back patients are safer than those with neck pain. Chiropractors view the spine as a whole organ and will regularly manipulate the neck (if they sense ‘subluxations’ in this area), even if the patient comes with low back pain.
  • There are also indirect risks with consulting a chiropractor; for instance, they often give incompetent advice about healthcare. This can include discouraging immunisations or treating serious diseases, such as asthma, colic etc., with chiropractic.
  • I think the article should point out that exercise is not just as effective (or as ineffective) as chiropractic, but it is much safer and less expensive.
  • What Rubinstein says about responders is debatable, in my view. In particular, most chiropractors will convince their patients to continue treatment, even if they do not ‘respond’. And ‘responding’ might be simply the natural history of the condition and therefore totally unrelated to the therapy.

The bottom line: Chiropractic is not the best treatment for back pain!

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.

Park Sham Device Set

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.

WRONG!

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.

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