MD, PhD, FMedSci, FRSB, FRCP, FRCPEd

conflict of interest

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.

 

Dr Peter Fisher (I have mentioned him several times before, see for instance here, here and here) claimed in his recent editorial (Fisher P, Homeopathy and intellectual honesty, Homeopathy (2017) – not yet available on Medline) that 43 systematic reviews of homeopathy have so far been published, and stated that “of these 21 were clearly or tentatively positive and 9 inconclusive”. In my book, this would mean that the majority of systematic reviews fail to be clearly positive. But Fisher seems to view this mini-statistic as a proof of homeopathy’s efficacy.

As evidence for his statement, Fisher cites this article from his own journal (‘Homeopathy’). However, the paper actually says this: “A total of 36 condition-specific systematic reviews have been identified in the peer-reviewed literature: 16 of them reported positive, or tentatively positive, conclusions about homeopathy’s clinical effectiveness; the other 20 were negative or non-conclusive.”

Odd?

Confused by this contradiction, I try to dig deeper. Medline provides currently 66 hits when searching systematic reviews of homeopathy. But this figure includes papers that are not really systematic reviews and excludes some relevant articles that are not Medline-listed.

The NHMRC report which Fisher also cites (see below) considered 57 systematic reviews of homeopathy. In his editorial, Fisher stated that the NHMRC report “seems to have missed some systematic reviews of homeopathy”. This can only mean that Fisher knows of more than 57 reviews. Why then does he claim that there are just 43?

Odd?

Yes, but Fisher’s editorial seems odd in several other ways as well.

  • He accuses the NHMRC-authors of ‘malpractice’.
  • He finds ‘shocking evidence of bias’.
  • He alleges that the EASAC-report ‘cherry-picks evidence’.
  • He accuses the EASAC-authors of ‘abuse of authority’.

Definitely odd!

Why does Dr Peter Fisher go this far, why is he so very aggressive?

I know Peter quite well. He is usually a fairly calm and collected sort of person who is not prone to irrational outbursts. This behaviour is therefore out of character.

So, why?

The only explanation that I have for his strange behaviour is that he feels cornered, has run out of rational arguments, and senses that homeopathy is now on its last leg.

What do you think?

The German Heilpraktiker (a phenomenon vaguely equivalent to the ‘naturopath’ in English speaking countries) has become a fairly regular feature on this blog – see, for instance here, here, and here. The nationally influential German Medical Journal, a weekly publication of the German Medical Association, recently published an article about the education of this profession.

In it, we are told that the German Ministry of Health has drafted a 9-page document to unify the examination of the Heilpraktiker throughout Germany. The German Medical Association, however, are critical about the planned reform. The draft document suggest that, in future, all Heilpraktiker should pass an exam consisting of 60 multiple choice questions, in addition to an oral examination in which 4 candidates are being interviewed simultaneously for one hour. The draft also stipulates that Heilpraktiker may only practice such that they present no danger for public health and only use methods they muster.

The German Medical Association feel that these reforms do not go far enough. They claim that the authors of the draft have ‘totally misunderstood the complexity of the medical context, particularly the amount of necessary knowledge necessary for risk-minimisation in clinical practice’. They furthermore feel that the document is ‘an effort that is in every respect insufficient for protecting the public or individuals from the practice of the Heilpraktiker’. They also state that it is unclear how the document might provide a means to test Heilpraktiker in respect of risk-minimisation. The Medical Association demands that ‘the practice of certain therapies by Heilpraktiker must be forbidden. Finally, they say that ‘the practice of invasive methods and the treatment of caner by Heilpraktiker must be urgently prohibited’.

The German Heilpraktiker has been a subject of much public debate recently, not least after the ‘Muenster Group’ suggested a comprehensive reform. (I reported about this at the time.)

For those who can read German, the original article from the German Medical Journal is copied below:

Das Bundesministerium für Gesundheit (BMG) will gemeinsam mit den Ländern die Heilpraktikerüberprüfung bundesweit vereinheitlichen und Patienten besser schützen. Dafür haben Bund und Länder einen neunseitigen Entwurf erarbeitet. Die Bundes­ärzte­kammer (BÄK) zeigt sich angesichts der Pläne besorgt und übt deutliche Kritik.

Der Entwurf sieht vor, dass zur Überprüfung der Kenntnisse von Heilpraktikern künftig eine Prüfung verpflichtend sein soll. Diese soll aus 60 Multiple-Choice-Fragen bestehen, von denen der Anwärter innerhalb von zwei Stunden 45 korrekt ankreuzen muss. Darüber hinaus ist ein mündlicher Prüfungsteil von einer Stunde vorgesehen – bei vier Prüflingen gleichzeitig.

Zusätzlich stellt der Entwurf klar, dass Heilpraktiker nur in dem Umfang Heilkunde ausüben dürfen, in dem von ihrer Tätigkeit keine Gefahr für die Gesundheit der Bevölkerung oder für Patientinnen und Patienten ausgeht. Sie müssten zudem „eventuelle Arztvorbehalte beachten und sich auf die Tätigkeiten beschränken, die sie sicher beherrschen“, heißt es in der Präambel des Bund-Länder-Entwurfes, der dem Deutschen Ärzteblatt vorliegt.

Der Bundes­ärzte­kammer geht der Text nicht weit genug. Die Autoren der Leitlinie für die Prüfung haben laut BÄK „die Komplexität des medizinischen Kontextes“ völlig verkannt, „insbesondere das Ausmaß des notwendigen medizinischen Wissens, das für eine gefahrenminimierte Ausübung der Heilkunde notwendig ist“, so die Kammer weiter. Die jetzt vorgelegten Leitlinien für die Überprüfung stelle „eine in jeder Hinsicht unzureichende Maßnahme zum Schutz der Bevölkerung oder gar einzelner Patienten vor möglichen Gesundheitsgefahren durch die Tätigkeit von Heilpraktikern dar.

Es sei nicht nachvollziehbar, „wie auf der Grundlage dieser Leitlinien eine Überprüfung von Heilpaktikeranwärtern unter dem Aspekt einer funktionierenden Gefahrenabwehr erfolgen soll“, so die Kammer weiter. Sie fordert, dass Heilpraktikern bestimmte Tätigkeiten verboten werden. „Konkret sieht die Bundes­ärzte­kammer insbesondere den Ausschluss aller invasiven Maßnahmen sowie der Behandlung von Krebserkrankungen als zwingend notwendig an“, heißt es in der Stellungnahme.

Der Bund-Länder-Entwurf ist Ergebnis einer Debatte darüber, was Heilpraktiker dürfen oder künftig nicht (mehr) dürfen sollten und wie die Regeln für den Gesundheitsberuf aussehen. Eine Expertengruppe, der „Münsteraner Kreis“, hatte unlängst Vorschläge für eine umfassende Reform erarbeitet. Das Thema war zuletzt in der Öffentlichkeit und auch der Ärzteschaft heftig diskutiert worden.

END OF QUOTE

So, how well should alt med practitioners be educated and trained?

The answer depends, I think, on what precisely they are allowed to do. Medical responsibility must always be matched to medical competence. If a massage therapist merely acts on the instructions of a doctor, she does not need to know the differential diagnosis of a headache, for instance.

If, however, practitioners independently diagnose diseases (and alt med practitioners often do exactly that!), they must have a knowledge-base similar to that of a GP. If they use potentially harmful treatments (and which therapy does not have the potential to do harm?), they must be aware of the evidence for or against these interventions, as well as the evidence for all other therapeutic options for the conditions in question. Again, this would mean having a knowledge close to GP-level. If there is a mismatch between responsibility and competence (as very often is the case), patients are exposed to avoidable risks.

It is clear from these considerations that an exam with 60 multiple-choice questions followed by an hour-long interview is woefully inadequate for testing whether a practitioner has sufficient medical competence to independently care for patients. It is also clear, I think, that practitioners who regularly diagnose and treat patients – usually without any supervision – ought to have an education that covers much of what doctors learn while in medical school. Finally, it is clear that even after an adequate education, practitioners need to gather experience and work under supervision for some time before they can responsibly practice independently.

In any case, uncritically teaching obsolete notions of vitalism, yin and yang, subluxation, detox, potentisation, millennia of experience etc. is certainly not good enough. Education has to be based on sound evidence; if not, it is not education but brain-washing. And the result would be that students do not become responsible healthcare professionals but irresponsible charlatans.

Of course, alt med practitioners will argue that these arguments are merely the expression of medics defending their lucrative patch. But even if this were true (which, in my view, it is not), it would not absolve them from the moral, ethical and legal duty to demonstrate that their educational standards are sufficiently rigorous to avoid harm to their patients.

In a nutshell: an education in nonsense must result in nonsense.

 

Gastro-oesophageal reflux disease (GORD) is a common, benign condition. It can be treated by changing eating habits or drugs. Many alternative therapies are also on offer, for instance, acupuncture. But does it work? Let’s find out.

The objective of this meta-analysis was to explore the effectiveness of acupuncture for the treatment of gastro-oesophageal reflux disease (GORD). Four English and four Chinese databases were searched through June 2016. Randomised controlled trials investigating the effectiveness of manual acupuncture or electroacupuncture (MA/EA) for GORD versus or as an adjunct to Western medicine (WM) were selected.

A total of 12 trials involving 1235 patients were included. The results demonstrated that patients receiving MA/EA combined with WM had a superior global symptom improvement compared with those receiving WM alone  with no significant heterogeneity. Recurrence rates of those receiving MA/EA alone were lower than those receiving WM  with low heterogeneity, while global symptom improvement (six studies) and symptom scores (three studies) were similar. Descriptive analyses suggested that acupuncture also improves quality of life in patients with GORD.

The authors concluded that this meta-analysis suggests that acupuncture is an effective and safe treatment for GORD. However, due to the small sample size and poor methodological quality of the included trials, further studies are required to validate our conclusions.

I am glad the authors used the verb ‘suggest’ in their conclusions. In fact, even this cautious terminology is too strong, in my view. Here are 9 reasons why:

  1. The hypothesis that acupuncture is effective for GORD lacks plausibility.
  2. All the studies were of poor or very poor methodological quality.
  3. All but one were from China, and we know that all acupuncture trials from this country are positive, thus casting serious doubt on their validity.
  4. Six trials had the infamous ‘A+B versus B’ design which never generates a negative result.
  5. There was evidence of publication bias, i. e. negative trials had disappeared and were thus not included in the meta-analysis.
  6. None of the trials made an attempt to control for placebo effects by using a sham-control procedure.
  7. None used patient-blinding.
  8. The safety of a therapy cannot be assessed on the basis of 12 trials
  9. Seven studies failed to report adverse effects, thus violating research ethics.

Considering these facts, I think that a different conclusion would have been more appropriate:  this meta-analysis provides no good evidence for the assumption that acupuncture is an effective and safe treatment for GORD.

This is the question asked by the American Chiropractic Association. And this is their answer [the numbers in square brackets were inserted by me and refer to my comments below]:

Chiropractic is widely recognized [1] as one of the safest drug-free, non-invasive therapies available for the treatment of neuromusculoskeletal complaints [2]. Although chiropractic has an excellent safety record [3], no health treatment is completely free of potential adverse effects. The risks associated with chiropractic, however, are very small [4]. Many patients feel immediate relief following chiropractic treatment [5], but some may experience mild soreness, stiffness or aching, just as they do after some forms of exercise [6]. Current research shows that minor discomfort or soreness following spinal manipulation typically fades within 24 hours [7]…

Some reports have associated high-velocity upper neck manipulation with a certain rare kind of stroke, or vertebral artery dissection [8]. However, evidence suggests that this type of arterial injury often takes place spontaneously in patients who have pre-existing arterial disease [9]. These dissections have been associated with everyday activities such as turning the head while driving, swimming, or having a shampoo in a hair salon [10]. Patients with this condition may experience neck pain and headache that leads them to seek professional care—often at the office of a doctor of chiropractic or family physician—but that care is not the cause of the injury. The best evidence indicates that the incidence of artery injuries associated with high-velocity upper neck manipulation is extremely rare—about one to three cases in 100,000 patients who get treated with a course of care [11]. This is similar to the incidence of this type of stroke among the general population [12]…

When discussing the risks of any health care procedure, it is important to look at that risk in comparison to other treatments available for the same condition [13]. In this regard, the risks of serious complications from spinal manipulation for conditions such as neck pain and headache compare very favorably with even the most conservative care options. For example, the risks associated with some of the most common treatments for musculoskeletal pain—over-the-counter or prescription nonsteroidal anti-inflammatory drugs (NSAIDS) and prescription painkillers—are significantly greater than those of chiropractic manipulation [14]…

Doctors of chiropractic are well trained professionals who provide patients with safe, effective care for a variety of common conditions. Their extensive education has prepared them to identify patients who have special risk factors [15] and to get those patients the most appropriate care, even if that requires referral to a medical specialist [16].

END OF QUOTE

  1. Appeal to tradition = fallacy
  2. and every other condition that brings in cash.
  3. Not true.
  4. Probably not true.
  5. The plural of anecdote is anecdotes, not evidence.
  6. Not true, the adverse effects of spinal manipulation are different and more severe.
  7. Not true, they last 1-3 days.
  8. Not just ‘some reports’ but a few hundred.
  9. Which does not mean that spinal manipulation cannot provoke such events.
  10. True, but this does not mean that spinal manipulation cannot provoke such events.
  11. There are other estimates that gives much higher figures; without a proper monitoring system, nobody can provide an accurate incidence figure.
  12. Not true, see above.
  13. ‘Available’ is meaningless – ‘effective’ is what we need here.
  14. The difference between different treatments is not merely their safety but also their effectiveness; in the end it is the risk/benefit balance that determines their value.
  15. Not true, there are no good predictors to identify at-risk populations.
  16. Chiropractors are notoriously bad at referring to other healthcare professionals; they have a huge conflict of interest in keeping up their cash-flow.

So, is chiropractic a safe treatment?

My advice here is not to ask chiropractors but independent experts.

 

According to its authors, the objective of this paper was “to demonstrate the need for using both alternative and conventional treatments to improve clinical outcomes in the treatment of schizoaffective disorder”.

Instead of doing anything remotely like this, the authors present two case histories:

  • a 23-y-old female (case 1)
  • and a 34-y-old female (case 2).

Both patients had been diagnosed with schizoaffective disorder of the bipolar type. Individualized homeopathic treatment was initiated for both patients, who were also on conventional medications. A Likert scale was used to evaluate the intensity of each patient’s symptoms at each follow-up, based on self-reporting.

During the course of treatment, both patients’ symptoms normalized, and they regained their ability to hold jobs, attend school (at the age of 23/34 ???), and maintain healthy relationships with their families and partners while requiring fewer pharmaceutical interventions.

The authors concluded that these two cases …  illustrate the value of individualized homeopathic prescriptions with proper case management in the successful treatment of that disorder. Future large-scale, double-blind, placebo-controlled studies should investigate individualized homeopathic treatments for mental health concerns, because the diseases cause great economic and social burden.

The article was published in Altern Ther Health Med.by Grise DE, Peyman T, and Langland J who seem to be from the ‘Southwest College of Naturopathic Medicine, Tempe, Arizona’. Two of the authors have recently published similarly odd case reports:

  1. This case report demonstrates a successful approach to managing patients with type 2 diabetes mellitus (DM2). Botanical herbs (including Gymnema sylvestre) and nutrients (including alpha lipoic acid and chromium) were used alongside metformin to help improve insulin sensitization; however, the greatest emphasis of treatment for this patient centered on a low-carbohydrate, whole-foods diet and regular exercise that shifted the focus to the patient’s role in controlling their disease. Research on DM2 often focuses on improving drug efficacy while diet and lifestyle are generally overlooked as both a preventive and curative tool. During the 7 months of treatment, the patient’s hemoglobin A1c and fasting glucose significantly decreased to within normal ranges and both cholesterol and liver enzyme markers normalized. A significant body of evidence already exists advocating for disease management using various diets, including Mediterranean, low-carb, and low-fat vegan diets; however, no clear dietary standards have been established. This study supports the use of naturopathic medicine as well as dietary and lifestyle changes to develop the most efficacious approach for the treatment of DM2.
  2. This case report illustrates the improvement of an acupuncture-treated patient who incurred a severe traumatic brain injury (TBI) from a snowboarding accident. Over 4 years, the patient progressed from initially not being able to walk, having difficulty with speech, and suffering from poor eyesight to where he has now regained significant motor function, speech, and vision and has returned to snowboarding. A core acupuncture protocol plus specific points added to address the patient’s ongoing concerns was used. This case adds to the medical literature by demonstrating the potential role of acupuncture in TBI treatment.
  3. The current case study intended to evaluate the benefits of an alternative, multifaceted approach-including botanical and homeopathic therapies in conjunction with a low-FODMAP diet-in the treatment of small intestinal bacterial overgrowth (SIBO) and its associated symptoms. Design • The research team performed a case study. Setting • The study was conducted at SCNM Medical Center (Tempe, AZ, USA). Participant • The participant was a female patient at the SCNM Medical Center with chronic, daily, severe abdominal bloating and pain that particularly worsened after meals and by the end of the day. The patient also had a significant history of chronic constipation that had begun approximately 10 y prior to her experiencing the daily abdominal pain. Intervention • Based on a lactulose breath test for hydrogen and methane, the research team diagnosed the patient with a case of mild SIBO. The treatment approach was multifaceted, involving a low-FODMAP diet, antimicrobial botanical therapy, and homeopathic medicine. Results • The patient’s abdominal pain and bloating resolved with the treatment of the SIBO, although her underlying constipation, which was likely associated with other factors, remained. Conclusions • This case study supports an alternative, multifaceted approach to the treatment of SIBO and commonly associated symptoms.
  4. The study intended to examine the benefits of treating plantar warts with a topical, botanical blend that has had clinical success treating herpes simplex virus cold sores. Methods • A synergistic botanical blend was applied topically. Setting • The case report was completed at the Southwest College of Naturopathic Medicine (Tempe, Arizona, USA). Participant • The participant was a 24-y-old male soccer player, 177.8 cm tall, and weighing 69 kg with previously diagnosed, viral mosaic warts. Intervention • The patient used a pumice stone during bathing for the first week to remove dead tissue and ensure sufficient contact and entry of the botanical gel into infected tissue. After drying the area, the patient applied the botanical gel blend 1 to 2 times daily postshower, spreading it evenly across the surface of the entire lesion. The patient discontinued the exfoliation technique after the first week. Results • Within the first week of treatment, the patient noted changes to the infected area of the hallux epidermal tissue. The combination of exfoliation and application of the gel caused marked, visible differences in presentation by the fifth day of treatment. At 1-mo postintervention, or day 90, the epidermal tissue was asymptomatic and devoid of petechiae, malformations, or visible infection. Conclusions • The results of the current case study directly contrast with the drawbacks of commonly accepted, first-line interventions in the treatment of viral plantar warts and, in many respects, demonstrate better efficacy and fewer side effects than the standard of care. The positive results also highlight the necessity for additional study in the fields of sports medicine and podiatry to further establish the botanical blend when treating viral plantar in athletes, an overall at-risk population for the condition.
  5. This study intended to examine the benefits of treatment of a pediatric patient with natural supplements and an elimination diet for IgG food allergies. Design • The research team reported a case study. Setting • The study was conducted at Southwest Naturopathic Medical Center (Tempe, AZ, USA). Participant • The participant was a 10-y-old Caucasian female who had diagnoses of allergic rhinitis and reactive bronchospasm, the second of which was exacerbated by allergens such as wheat, perfumes, and seasonal flora. Intervention • Following testing for IgE- and IgG-reactive foods, the patient was treated with natural supplements to reduce her allergic responses and was instructed to make dietary changes to eliminate the IgG-reactive foods. Outcome Measures • The patient’s symptom severity was tracked starting 1 mo after her initial visit to Southwest Naturopathic Medical Center. The severity was based on the patient’s subjective reports about her congestion to her mother and on her mother’s observations of the effect of symptoms on her attention and school performance. The bronchospasm severity was based on the frequency of a sensation of wheezing and chest tightness, the frequency of inhaler use, and the occurrence of any exacerbation of symptoms with acute respiratory illness Results • After 1 mo, in which the patient used the natural supplements, she experienced a 90% improvement in coughing; a 70% improvement in nasal congestion; less chest tightness; and no need for use of loratadine, diphenhydramine, or albuterol. At the 8-mo follow-up visit, her nasal congestion was reported to be entirely gone. Conclusions • The case demonstrates the effectiveness of natural supplements and a diet eliminating IgG-reactive foods in the treatment and management of pediatric allergic rhinitis and reactive bronchospasm.

These articles are all quite similarly ridiculous, but the first one reporting two patients who felt better after taking individualised homeopathic remedies (together with conventional medicines) is, I think, the ‘best’. I suggest the authors continue their high-flying careers by publishing a series of further case reports on similar themes:

  • How the crowing of the cock in the morning causes the sun to rise.
  • The danger of WW 3 causes Americans to elect an idiot as president.
  • Increase of CO2 emissions due to global warming.
  • Immunisation neglect caused by measles outbreaks.
  • Brexit vote due to economic downturn.
  • Excessive alcohol consumption caused by hangover.
  • Why does lying in bed cause tiredness?

Please feel free to suggest more ‘post hoc propter hoc’ research themes for our aspiring team of naturopathic pseudo-scientists to be published in Altern Ther Health Med.

 

 

 

Weleda, a leading manufacturer of homeopathic preparations, is, according to their own judgement, a ‘unique organisation – economically thriving, kind at heart and committed to the well-being of our planet, our environment and our people. We’ve grown into that role through the adoption of seven basic principles which are unchanging, binding for everyone who works with us, and which clearly underpin the way we work.’

The first of these 7 principles is the ‘Fair treatment of customers, partners and suppliers‘. Fair treatment and being ‘kind at heart’ would include telling the truth, wouldn’t it? But reading what Weleda state about homeopathy, one might wonder!

The Weleda article entitled ‘An introduction to Homeopathy’ contains many statements worthy of some critical analysis, I think. Here is a selection of 10 just quotes:

  1. … a [homeopathic] remedy [is] made from a natural substance… in a tiny dose which has been ‘potentised’ to be effective.
  2. Many people choose this approach for every-day family ailments, with a homeopathic ‘first aid kit’…
  3. … allopathic medicine works against the disease and its symptoms using “anti” drugs…
  4. Homeopathy works by stimulating the body’s own natural healing capacity.
  5. If you do experience complex, persistent or worrying symptoms then please seek the advice of a doctor who specialises in homeopathy.
  6. Today there are four homeopathic hospitals offering treatment under the National Health Service – in London, Glasgow, Liverpool and Bristol.
  7. Homeopathy can be used to treat the same wide range of illness as conventional medicine, and may even prove successful when all other forms of treatment have failed.
  8. … the fact that the remedies are widely used on animals dismisses the idea that the success of a treatment is all in the mind.
  9. Occasionally, symptoms become worse on first taking a homeopathic medicine. This is called an ‘aggravation’, and is a good sign that the remedy is working.
  10. … some homeopathic remedies will successfully treat many people with the same symptoms. For example, arnica is usually used for muscular bruising …

And here are my thoughts on these 10 statements:

  1. I had always thought that homeopathics can be made from any substance (including Berlin Wall) and not just natural ones. Moreover, the dose is often not ‘tiny’ but non-existent. Finally, the assumption that ‘potentisation’ renders remedies ‘effective’ is pure wishful thinking.
  2. A homeopathic ‘first aid kit’ is a contradiction in terms. If someone needs first aid, she surely must avoid homeopathy.
  3. The term ‘allopathy’ is a derogatory term created by Hahnemann to defame the heroic medicine of his time. The notion of ‘anti-drugs’ is popular in homeopathy, but evidently, it is pure nonsense.
  4. This notion is wishful thinking by homeopaths at its best; there is not a jot of evidence that it is true.
  5. If you do experience complex, persistent or worrying symptoms then please seek the advice of a doctor who practices evidence-based medicine but NOT homeopathy.
  6. This statement is untrue; a footnote to the article states ‘Copyright 2017 Weleda UK’, it is thus odd to see that Weleda is so ill-informed.
  7. The claim that homeopathy is a panacea is dangerous nonsense.
  8. This notion is endlessly being promoted by homeopaths. Sadly the repetition of a falsehood does not create a truth (see for instance here).
  9. ‘Homeopathic aggravations’ are a myth.
  10. Yes, homeopathic arnica is used for muscular bruising – but it not effective for that or any other indication.

It is only fair, I think, that I declare my conflicts of interest in relation to Weleda.

While at Exeter, I ran during 14 years an annual conference for researchers in alternative medicine. One year, I accepted a modest sponsorship from Weleda for this meeting [I forgot how much and which year precisely this was, possibly around 1999 and probably around £ 3 000].

More importantly, Weleda was one of the companies that financed the German journalist Claus Fritzsche who then spent much time and effort to attack and defame me. This story that ended tragically with Fritzsche’s suicide.

Needless to say that I regret both events.

Arguably, I therefore have two opposing conflicts of interest, one pro and one contra Weleda. This is why I tried to focus my comments purely on demonstrable facts. They show, I think, that Weleda’s claims about homeopathy should be take with more than a little pinch of salt – or perhaps even with a dose of NaCl, C200?

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.

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?

 

It has been announced that Susan and Henry Samueli have given US$ 200 million to medical research at the University of California, Irvine (UCI). Surely this is a generous and most laudable gift! How could anyone doubt it?

As with any gift, one ought to ask what precisely it is for. If someone made a donation to research aimed at showing that climate change is a hoax, that white supremacy is justified, or that Brexit is going to give Brits their country back, I doubt that it would be a commendable thing. My point is that research must always be aimed at finding the truth and discovering facts. Research that is guided by creed, belief or misinformation is bound to be counter-productive, and a donation to such activities is likely to be detrimental.

Back to the Samuelis! The story goes that Susan once had a cold, took a homeopathic remedy, and subsequently the cold went away. Ever since, the two Samuelis have been supporters not just of homeopathy but all sorts of other alternative therapies. I have previously called this strikingly common phenomenon an ‘epiphany‘. And the Samuelis’ latest gift is clearly aimed at promoting alternative medicine in the US. We only need to look at what their other major donation in this area has achieved, and we can guess what is now going to happen at UCI. David Gorski has eloquently written about the UCI donation, and I will therefore not repeat the whole, sad story.

Instead I want to briefly comment on what, in my view, should happen, if a wealthy benefactor donates a large sum of money to medical research. How can one maximise the effects of such a donation? Which areas of research should one consider? I think the concept of prior probability can be put to good use in such a situation. If I were the donor, I would convene a panel of recognised experts and let them advise me where there are the greatest chances of generating important breakthroughs. If one followed this path, alternative medicine would not appear anywhere near the top preferences, I dare to predict.

But often, like in the case of the Samuelis, the donors have concrete ideas about the area of research they want to invest in. So, what could be done with a large sum in the field of alternative medicine? I believe that plenty of good could come it. All one needs to do is to make absolutely sure that a few safeguards are in place:

  • believers in alternative medicine must be kept out of any decisions processes;
  • people with a solid background in science and a track-record in critical thinking must be put in charge;
  • the influence of the donor on the direction of the research must be minimised as much as possible;
  • a research agenda must be defined that is meaningful and productive (this could include research into the risks of alternative therapies, the ethical standards in alternative medicine, the fallacious thinking of promoters of alternative medicine, the educational deficits of alternative practitioners, the wide-spread misinformation of the public about alternative medicine, etc., etc.)

Under all circumstances, one needs to avoid that the many pseudo-scientists who populate the field of alternative or integrative medicine get appointed. This, I fear, will not be an easy task. They will say that one needs experts who know all about the subtleties of acupuncture, homeopathy, energy-healing etc. But such notions are merely smoke-screens aimed at getting the believers into key positions. My advice is to vet all candidates using my concept of the ‘trustworthiness index’.

How can I be so sure? Because I have been there, and I have seen it all. I have researched this area for 25 years and published more about it than any of the untrustworthy believers. During this time I trained about 90 co-workers, and I have witnessed one thing over and over again: someone who starts out as a believer, will hardly ever become a decent scientist and therefore never produce any worthwhile research; but a good scientist will always be able to acquire the necessary knowledge in this or that alternative therapy to conduct rigorous and meaningful research.

So, how should the UCI spend the $ 200 million? Apparently the bulk of the money will be to appoint 15 faculty chairs across medicine, nursing, pharmacy and population health disciplines. They envisage that these posts will go to people with expertise in integrative medicine. This sounds extremely ominous to me. If this project is to be successful, these posts should go to scientists who are sceptical about alternative medicine and their main remit should be to rigorously test hypotheses. Remember: testing a hypothesis means trying everything to show that it is wrong. Only when all attempts to do so have failed can one assume that perhaps the hypothesis was correct.

My experience tells me that experts in integrative medicine are quite simply intellectually and emotionally incapable of making serious attempts showing that their beliefs are wrong. If the UCI does, in fact, appoint people with expertise in integrative medicine, it is, I fear, unavoidable that we will see:

  • research that fails to address relevant questions;
  • research that is of low quality;
  • promotion masquerading as research;
  • more and more misleading findings of the type we regularly discuss on this blog;
  • a further boost of the fallacious concept of integrative medicine;
  • a watering down of evidence-based medicine;
  • irreversible damage to the reputation of the UCI.

In a nutshell, instead of making progress, we will take decisive steps back towards the dark ages.

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