MD, PhD, FMedSci, FRSB, FRCP, FRCPEd.

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You might remember my post from last October:

On Twitter and elsewhere, homeopaths have been celebrating: FINALLY A PROOF OF HOMEOPATHY HAS BEEN PUBLISHED IN A TOP SCIENCE JOURNAL!!!

Here is just one example:

#homeopathy under threat because of lack of peer reviewed studies in respectable journals? Think again. Study published in the most prestigious journal Nature shows efficacy of rhus tox in pain control in rats.

But what exactly does this study show (btw, it was not published in ‘Nature’)?

The authors of the paper in question evaluated antinociceptive efficacy of Rhus Tox in the neuropathic pain and delineated its underlying mechanism. Initially, in-vitro assay using LPS-mediated ROS-induced U-87 glioblastoma cells was performed to study the effect of Rhus Tox on reactive oxygen species (ROS), anti-oxidant status and cytokine profile. Rhus Tox decreased oxidative stress and cytokine release with restoration of anti-oxidant systems. Chronic treatment with Rhus Tox ultra dilutions for 14 days ameliorated neuropathic pain revealed as inhibition of cold, warm and mechanical allodynia along with improved motor nerve conduction velocity (MNCV) in constricted nerve. Rhus Tox decreased the oxidative and nitrosative stress by reducing malondialdehyde (MDA) and nitric oxide (NO) content, respectively along with up regulated glutathione (GSH), superoxide dismutase (SOD) and catalase activity in sciatic nerve of rats. Notably, Rhus Tox treatment caused significant reductions in the levels of tumor necrosis factor (TNF-α), interleukin-6 (IL-6) and interleukin-1β (IL-1β) as compared with CCI-control group. Protective effect of Rhus Tox against CCI-induced sciatic nerve injury in histopathology study was exhibited through maintenance of normal nerve architecture and inhibition of inflammatory changes. Overall, neuroprotective effect of Rhus Tox in CCI-induced neuropathic pain suggests the involvement of anti-oxidative and anti-inflammatory mechanisms.

END OF QUOTE

I am utterly under-whelmed by in-vitro experiments (which are prone to artefacts) and animal studies (especially those with a sample size of 8!) of homeopathy. I think they have very little relevance to the question whether homeopathy works.

But there is more, much more!

It has been pointed out that there are several oddities in this paper which are highly suspicious of scientific misconduct or fraud. It has been noted that the study used duplicated data figures that claimed to show different experimental results, inconsistently reported data and results for various treatment dilutions in the text and figures, contained suspiciously identical data points throughout a series of figures that were reported to represent different experimental results, and hinged on subjective, non-blinded data from a pain experiment involving just eight rats.

Lastly, others pointed out that even if the data is somehow accurate, the experiment is unconvincing. The fast timing differences of paw withdraw is subjective. It’s also prone to bias because the researchers were not blinded to the rats’ treatments (meaning they could have known which animals were given the control drug or the homeopathic dilution). Moreover, eight animals in each group is not a large enough number from which to draw firm conclusions, they argue.

As one consequence of these suspicions, the journal has recently added the following footnote to the publication:

10/1/2018 Editors’ Note: Readers are alerted that the conclusions of this paper are subject to criticisms that are being considered by the editors. Appropriate editorial action will be taken once this matter is resolved.

_____________________________________________________

Well, it took a while, but now there is some news about this case:

‘Science Reports’, just published a retraction note:

Retraction of: Scientific Reports https://doi.org/10.1038/s41598-018-31971-9, published online 10 September 2018

Following publication, the journal received criticisms regarding the rationale of this study and the plausibility of its central conclusions. Expert advice was obtained, and the following issues were determined to undermine confidence in the reliability of the study.

The in vitro model does not support the main conclusion of the paper that Rhus Tox reduces pain. The qualitative and quantitative composition of the Rhus Tox extract is unknown. Figures 1G and 1H are duplicates; and figures 1I and 1J are duplicates. The majority of experimental points reported in figure 3 panel A are duplicated in figure 3 panel B. The collection, description, analysis and presentation of the behavioural data in Figure 3 is inadequate and cannot be relied upon.

As a result the editors are retracting the Article. The authors do not agree with the retraction.

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Does that mean the suspect paper has been declared fraudulent?

I think so.

In any case: another victory of reason over unreason!

A new paper reminds us that so-called alternative medicine (SCAM) has been increasing in the United States and around the world, particularly at medical institutions known for providing rigorous evidence-based care. The use of SCAM may cause harm to patients through interactions with prescribed medications or by patients choosing to forego evidence-based care. SCAM may also put financial strain on patients as most SCAM expenditures are paid out-of-pocket.

Despite these drawbacks, patients continue to use SCAM due to a range of reasons, e.g. media promotion of SCAM therapies, dissatisfaction with conventional healthcare, a desire for more holistic care. Given the increasing demand for SCAM, many medical institutions now offer SCAM services. Several leaders of SCAM centres based at a highly respected academic medical institution have publicly expressed anti-vaccination views, and non-evidence-based philosophies run deep within SCAM.

Although there are financial incentives for institutions to provide SCAM, it is important to recognize that this legitimizes SCAM and may cause harm to patients. The poor regulation of SCAM allows for the continued distribution of products and services that have not been rigorously tested for safety and efficacy.

As I have tried to point out many times, the potential for harm caused by the increasing integration of SCAM can thus be summarised as follows:

  1. direct harm due to adverse effects such as toxicity of an herbal remedy, stroke after chiropractic manipulation, pneumothorax after acupuncture;
  2. direct harm through the use of bogus diagnostic techniques;
  3. direct harm by using materials from endangered species;
  4. indirect harm through incompetent advice such as recommendation not to immunize or discontinue prescribed medications;
  5. neglect due to using SCAM instead of an effective therapy for a serious condition;
  6. harm due to medicalising trivial states of reduced well-being;
  7. financial harm due to the costs of SCAM;
  8. harm through making a mockery of evidence-based medicine;
  9. harm caused by undermining rational thinking in the society at large;
  10. harm caused by inhibiting medical progress and research.

In case you see other ways in which SCAM can cause harm, please let me know by posting a comment.

One of the most difficult things in so-called alternative medicine (SCAM) can be having a productive discussion with patients about the subject, particularly if they are deeply pro-SCAM. The task can get more tricky, if a patient is suffering from a serious, potentially life-threatening condition. Arguably, the discussion would become even more difficult, if the SCAM in question is relatively harmless but supported only by scarce and flimsy evidence.

An example might be the case of a cancer patient who is fond of mindfulness cognitive therapy (MBCT), a class-based program designed to prevent relapse or recurrence of major depression. To contemplate such a situation, let’s consider the following hypothetical exchange between a patient (P) and her oncologist (O).

P: I often feel quite low, do you think I need some treatment for depression?

O: That depends on whether you are truly depressed or just a bit under the weather.

P: No, I am not clinically depressed; it’s just that I am worried and sometimes see everything in black.

O: I understand, that’s not an unusual thing in your situation.

P: Someone told me about MBCT, and I wonder what you think about it.

O: Yes, I happen to know about this approach, but I’m not sure it would help you.

P: Are you sure? A few years ago, I had some MBCT; it seemed to work and, at least, it cannot do any harm.

O: Yes, that’s true; MBCT is quite safe.

P: So, why are you against it?

O: I am not against it; I just doubt that it is the best treatment for you.

P: Why?

O: Because there is little evidence for it and even less for someone like you.

P: But I have seen some studies that seem to show it works.

O: I know, there have been trials but they are not very reliable.

P: But the therapy has not been shown to be ineffective, has it?

O: No, but the treatment is not really for your condition.

P: So, you admit that there is some positive evidence but you are still against it because of some technicalities with the science?

O: No, I am telling you that this treatment is not supported by good evidence.

P: And therefore you want me to continue to suffer from low mood? I don’t call that very compassionate!

O: I fully understand your situation, but we ought to find the best treatment for you, not just one that you happen to be fond of.

P: I don’t understand why you are against giving MBCT a try; it’s safe, as you say, and there is some evidence for it. And I have already had a good experience with it. Is that not enough?

O: My role as your doctor is to provide you with advice about which treatments are best in your particular situation. There are options that are much better than MBCT.

P: But if I want to try it?

O: If you want to try MBCT, I cannot prevent you from doing so. I am only trying to tell you about the evidence.

P: Fine, in this case, I will give it a go.

___________________________________________________

Clearly this discussion did not go all that well. It was meant to highlight the tension between the aspirations of a patient and the hope of a responsible clinician to inform his patient about the best available evidence. Often the evidence is not in favour of SCAM. Thus there is a gap that can be difficult to breach. (Instead of using MBCT, I could, of course, have used dozens of other SCAMs like homeopathy, chiropractic, Reiki, etc.)

The pro-SCAM patient thinks that, as she previously has had a good experience with SCAM, it must be fine; at the very minimum, it should be tried again, and she wants her doctor to agree. The responsible clinician thinks that he ought to recommend a therapy that is evidence-based. The patient feels that scientific evidence tells her nothing about her experience. The clinician insists that evidence matters. The patient finds the clinician lacks compassion. The clinician feels that the most compassionate and ethical strategy is to recommend the most effective therapy.

As the discussion goes on, the gap is not closing but seems to be widening.

What can be done about it?

I wish I knew the answer!

Do you?

I am being told to educate myself and rethink the subject of NAPRAPATHY by the US naprapath Dr Charles Greer. Even though he is not very polite, he just might have a point:

Edzard, enough foolish so-called scientific, educated assesments from a trained Allopathic Physician. When asked, everything that involves Alternative Medicine in your eyesight is quackery. Fortunately, every Medically trained Allopathic Physician does not have your points of view. I have partnered with Orthopaedic Surgeons, Medical Pain Specialists, General practitioners, Thoracic Surgeons, Forensic Pathologists and Others during the course, whom appreciate the Services that Naprapaths provide. Many of my current patients are Medical Physicians. Educate yourself. Visit a Naprapath to learn first hand. I expect your outlook will certainly change.

I have to say, I am not normally bowled over by anyone who calls me an ‘allopath’ (does Greer not know that Hahnemann coined this term to denigrate his opponents? Is he perhaps also in favour of homeopathy?). But, never mind, perhaps I was indeed too harsh on naprapathy in my previous post on this subject.

So, let’s try again.

Just to remind you, naprapathy was developed by the chiropractor Oakley Smith who had graduated under D D Palmer in 1899. Smith was a former Iowa medical student who also had investigated Andrew Still’s osteopathy in Kirksville, before going to Palmer in Davenport. Eventually, Smith came to reject Palmer’s concept of vertebral subluxation and developed his own concept of “the connective tissue doctrine” or naprapathy.

Dr Geer published a short article explaining the nature of naprapathy:

Naprapathy- A scientific, Evidence based, integrative, Alternative form of Pain management and nutritional assessment that involves evaluation and treatment of Connective tissue abnormalities manifested in the entire human structure. This form of Therapeutic Regimen is unique specifically to the Naprapathic Profession. Doctors of Naprapathy, pronounced ( nuh-prop-a-thee) also referred to as Naprapaths or Neuromyologists, focus on the study of connective tissue and the negative factors affecting normal tissue. These factors may begin from external sources and latently produce cellular changes that in turn manifest themselves into structural impairments, such as irregular nerve function and muscular contractures, pulling its’ bony attachments out of proper alignment producing nerve irritability and impaired lymphatic drainage. These abnormalities will certainly produce a pain response as well as swelling and tissue congestion. Naprapaths, using their hands, are trained to evaluate tissue tension findings and formulate a very specific treatment regimen which produces positive results as may be evidenced in the patients we serve. Naprapaths also rely on information obtained from observation, hands on physical examination, soft tissue Palpatory assessment, orthopedic evaluation, neurological assessment linked with specific bony directional findings, blood and urinalysis laboratory findings, diet/ Nutritional assessment, Radiology test findings, and other pertinent clinical data whose information is scrutinized and developed into a individualized and specific treatment plan. The diagnostic findings and results produced reveal consistent facts and are totally irrefutable. The deductions that formulated these concepts of theory of Naprapathic Medicine are rationally believable, and have never suffered scientific contradiction. Discover Naprapathic Medicine, it works.

What interests me most here is that naprapathy is evidence-based. Did I perhaps miss something? As I cannot totally exclude this possibility, I did another Medline search. I found several trials:

1st study (2007)

Four hundred and nine patients with pain and disability in the back or neck lasting for at least 2 weeks, recruited at 2 large public companies in Sweden in 2005, were included in this randomized controlled trial. The 2 interventions were naprapathy, including spinal manipulation/mobilization, massage, and stretching (Index Group) and support and advice to stay active and how to cope with pain, according to the best scientific evidence available, provided by a physician (Control Group). Pain, disability, and perceived recovery were measured by questionnaires at baseline and after 3, 7, and 12 weeks.

RESULTS:

At 7-week and 12-week follow-ups, statistically significant differences between the groups were found in all outcomes favoring the Index Group. At 12-week follow-up, a higher proportion in the naprapathy group had improved regarding pain [risk difference (RD)=27%, 95% confidence interval (CI): 17-37], disability (RD=18%, 95% CI: 7-28), and perceived recovery (RD=44%, 95% CI: 35-53). Separate analysis of neck pain and back pain patients showed similar results.

DISCUSSION:

This trial suggests that combined manual therapy, like naprapathy, might be an alternative to consider for back and neck pain patients.

2nd study (2010)

Subjects with non-specific pain/disability in the back and/or neck lasting for at least two weeks (n = 409), recruited at public companies in Sweden, were included in this pragmatic randomized controlled trial. The two interventions compared were naprapathic manual therapy such as spinal manipulation/mobilization, massage and stretching, (Index Group), and advice to stay active and on how to cope with pain, provided by a physician (Control Group). Pain intensity, disability and health status were measured by questionnaires.

RESULTS:

89% completed the 26-week follow-up and 85% the 52-week follow-up. A higher proportion in the Index Group had a clinically important decrease in pain (risk difference (RD) = 21%, 95% CI: 10-30) and disability (RD = 11%, 95% CI: 4-22) at 26-week, as well as at 52-week follow-ups (pain: RD = 17%, 95% CI: 7-27 and disability: RD = 17%, 95% CI: 5-28). The differences between the groups in pain and disability considered over one year were statistically significant favoring naprapathy (p < or = 0.005). There were also significant differences in improvement in bodily pain and social function (subscales of SF-36 health status) favoring the Index Group.

CONCLUSIONS:

Combined manual therapy, like naprapathy, is effective in the short and in the long term, and might be considered for patients with non-specific back and/or neck pain.

3rd study (2016)

Participants were recruited among patients, ages 18-65, seeking care at the educational clinic of Naprapathögskolan – the Scandinavian College of Naprapathic Manual Medicine in Stockholm. The patients (n = 1057) were randomized to one of three treatment arms a) manual therapy (i.e. spinal manipulation, spinal mobilization, stretching and massage), b) manual therapy excluding spinal manipulation and c) manual therapy excluding stretching. The primary outcomes were minimal clinically important improvement in pain intensity and pain related disability. Treatments were provided by naprapath students in the seventh semester of eight total semesters. Generalized estimating equations and logistic regression were used to examine the association between the treatments and the outcomes.

RESULTS:

At 12 weeks follow-up, 64% had a minimal clinically important improvement in pain intensity and 42% in pain related disability. The corresponding chances to be improved at the 52 weeks follow-up were 58% and 40% respectively. No systematic differences in effect when excluding spinal manipulation and stretching respectively from the treatment were found over 1 year follow-up, concerning minimal clinically important improvement in pain intensity (p = 0.41) and pain related disability (p = 0.85) and perceived recovery (p = 0.98). Neither were there disparities in effect when male and female patients were analyzed separately.

CONCLUSION:

The effect of manual therapy for male and female patients seeking care for neck and/or back pain at an educational clinic is similar regardless if spinal manipulation or if stretching is excluded from the treatment option.

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I don’t know about you, but I don’t call this ‘evidence-based’ – especially as all the three trials come from the same research group (no, not Greer; he seems to have not published at all on naprapathy). Dr Greer does clearly not agree with my assessment; on his website, he advertises treating the following conditions:

Anxiety
Back Disorders
Back Pain
Cervical Radiculopathy
Cervical Spondylolisthesis
Cervical Sprain
Cervicogenic Headache
Chronic Headache
Chronic Neck Pain
Cluster Headache
Cough Headache
Depressive Disorders
Fibromyalgia
Headache
Hip Arthritis
Hip Injury
Hip Muscle Strain
Hip Pain
Hip Sprain
Joint Clicking
Joint Pain
Joint Stiffness
Joint Swelling
Knee Injuries
Knee Ligament Injuries
Knee Sprain
Knee Tendinitis
Lower Back Injuries
Lumbar Herniated Disc
Lumbar Radiculopathy
Lumbar Spinal Stenosis
Lumbar Sprain
Muscle Diseases
Musculoskeletal Pain
Neck Pain
Sciatica (Not Due to Disc Displacement)
Sciatica (Not Due to Disc Displacement)
Shoulder Disorders
Shoulder Injuries
Shoulder Pain
Sports Injuries
Sports Injuries of the Knee
Stress
Tendonitis
Tennis Elbow (Lateral Epicondylitis)
Thoracic Disc Disorders
Thoracic Outlet Syndrome
Toe Injuries

Odd, I’d say! Did all this change my mind about naprapathy? Not really.

But nobody – except perhaps Dr Greer – can say I did not try.

And what light does this throw on Dr Greer and his professionalism? Since he seems to be already quite mad at me, I better let you answer this question.

Once again, I am indebted to the German homeopathy lobbyist, Jens Behnke (research officer at the Karl and Veronica Carstens-Foundation); this time for alerting me via a tweet to the existence of the ‘Institute for Scientific Homeopathy’ run by Dr K Lenger. Anyone who combines the terms ‘scientific’ and ‘homeopathy’ has my full attention.

The institution seems to be small (too small to have its own website); in fact, it seems to have just one member: Dr Karin Lenger. But size is not everything! Lenger has achieved something extraordinary: she has answered the questions that have puzzled many of us for a long time; she has found the ‘modus operandi’ of homeopathy by discovering that:

  • Homeopathy is a regulation therapy that acts (and reacts) as per the principle of resonance to deal hypo- and hyper-functions of pathological pathways.
  • As per resonance principle, the fundamental principles of homeopathy have the same frequencies so that the resonance principle can work.
  • Pathological pathways are cured by using their highly potentized substrates, inhibitors, and enzymes.
  • The efficacy of homeopathy now has a scientific base and is completely explained by applying biochemical and biophysical laws.

Progress at last!

If that is not noteworthy, what is?

But there is more!

This website, for instance, explains that Lenger Karin Dr.rer.nat., pursued Diploma in Biochem, studied Biochemistry at the Universities of Tubingen and Cologne. Her research topics revolved around enzymatic gene regulation, cancer research, enzymatic mechanisms of steroid hormones at the Medical University of Lubeck. In 1987 she became a Lecturer for Homeopathy at DHU ((Deutsche Homöopathie Union = German Homeopathy Union). Since 1995 she worked as a Homeopathic Practitioner and developed the “biochemical homeopathy” by using highly potentized substrates of pathological enzymes for her patients. She detected magnetic photons in high homeopathic potencies by two magnetic resonance methods and developed a model of physical and biochemical function of homeopathy.

Karin Lenger detected magnetic photons in highly diluted and potentized homeopathic remedies. Since the living body is an electromagnetic wavepackage (Einstein), the homeopathic law of Similars (Hahnemann 1755-1843) can be expressed as: the frequencies of the patient must match the frequencies of the remedies. Homeopathy is a regulation therapy curing hypo and hyperfunction of a pathological pathway by resonance: highly potentized substrates, inhibitors, enzymes, receptors of the distinct pathological pathways cure according to biochemical rules: A homeopathic symptom picture is obtained by poisoning a volunteer with a toxin. Simultaneously he develops psychological symptoms, the toxicological pathway and e.g. frequencies I-V. The highly potentized toxin has the frequencies I-V. The patient has symptoms as if he was poisoned by the toxin: during his illness he developed the toxicological pathway, frequencies I-V and psychological symptoms. The potentized toxin cures simultaneously the patient’s frequencies by resonance, his pathological pathway and the psychological symptoms. A stitch of honey bee, apis mellifica, causes a red oedema; a patient developing a red oedema at the finger-joint by rheumatism is cured by highly potentized Apis mellifica. Paralyses caused by a lack of the neurotransmitter acetylcholine bound to the acetylcholine-receptor at the post-synapsis can be healed by using these potentized remedies: the venom of cobra, Naja tripudians containing the receptor’s irreversible inhibitor cobrotoxin, the reversible inhibitor Atropine and Acetylcholine, daily applied. The availability of acetylcholine is maintained by glycolysis and fatty acid oxidation. This can be supported by giving these remedies: Lecithin, Lipasum, Glycerinum, Glucosum and Coenzyme A.

And in case, you are not yet fully convinced, a recent publication is bound to ball you over. Here is its abstract, if you need more, the link allows you to read the full paper as well:

Homeopathy, a holistic therapy, is believed to cure only acute symptoms of a beginning illness according to the Laws of Similars; but not deep, bleeding, septic wounds. The homeopaths refuse to heal according to special medical indications. Based on Lenger’s detection of magnetic photons in homeopathic remedies a biochemical and biophysical model of homeopathic healing was developed Biochemical, pathological pathways can be treated by their highly potentized substrates and inhibitors. Three groups of patients with moderate, severe and septic wounds had been successfully treated with the suitable remedies depending on the biochemical pathological state.

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Do I sense a Nobel Prize in the offing?

Surely!

Lenger’s clinical trial is baffling. But much more impressive are the ‘magnetic photons’ and the reference to Einstein. This is even more significant, if we consider what the genius (Einstein, not Lenger!) is reported to have said about homeopathy:  Einstein reflected for a little while and then said: “If one were to lock up 10 very clever people in a room and told them they were only allowed out once they had come up with the most stupid idea conceivable, they would soon come up with homeopathy.”

In the latest issue of ‘Simile’ (the Faculty of Homeopathy‘s newsletter), the following short article with the above title has been published. I took the liberty of copying it for you:

Members of the Faculty of Homeopathy practising in the UK have the opportunity to take part in a trial of a new homeopathic remedy for treating infant colic. An American manufacturer of homeopathic remedies has made a registration application for the new remedy to the MHRA (Medicines and Healthcare products Regulatory Agency) under the UK “National Rules” scheme. As part of its application the manufacturer is seeking at least two homeopathic doctors who would be willing to trial the product for about a year, then write a short report about using the remedy and its clinical results. If you would like to take part in the trial, further details can be obtained from …

END OF QUOTE

A homeopathic remedy for infant colic?

Yes, indeed!

The British Homeopathic Association and many similar ‘professional’ organisations recommend homeopathy for infant colic: Infantile colic is a common problem in babies, especially up to around sixteen weeks of age. It is characterised by incessant crying, often inconsolable, usually in the evenings and often through the night. Having excluded underlying pathology, the standard advice given by GPs and health visitors is winding technique, Infacol or Gripe Water. These measures are often ineffective but for­tunately there are a number of homeo­pathic medicines that may be effective. In my experience Colocynth is the most successful; alternatives are Carbo Veg, Chamomilla and Nux vomica.

SO, IT MUST BE GOOD!

But hold on, I cannot find a single clinical trial to suggest that homeopathy is effective for infant colic.

Ahhhhhhhhhhhhhhhhhhh, I see, that’s why they now want to conduct a trial!

They want to do the right thing and do some science to see whether their claims are supported by evidence.

How very laudable!

After all, the members of the Faculty of Homeopathy are doctors; they have certain ethical standards!

After all, the Faculty of Homeopathy aims to provide a high level of service to members and members of the public at all times.

Judging from the short text about the ‘homeopathy for infant colic trial’, it will involve a few (at least two) homeopaths prescribing the homeopathic remedy to patients and then writing a report. These reports will unanimously state that, after the remedy had been administered, the symptoms improved considerably. (I know this because they always do improve – with or without treatment.)

These reports will then be put together – perhaps we should call this a meta-analysis? – and the overall finding will be nice, positive and helpful for the American company.

And now, we all understand what homeopaths, more precisely the Faculty of Homeopathy, consider to be evidence.

 

 

The ‘Schwaebische Tageblatt’ is not on my regular reading list. But this article of yesterday (16/10/2018) did catch my attention. For those who read German, I will copy it below, and for those who don’t I will provide a brief summary and comment thereafter:

Die grün-schwarze Landesregierung lässt 2019 den ersten Lehrstuhl für Naturheilkunde und Integrative Medizin in Baden-Württemberg einrichten. Lehrstuhl für Naturheilkunde und Integrative Medizin

Ihren Schwerpunkt soll die Professur im Bereich Onkologie haben. Strömungen wie Homöopathie oder Anthroposophie sollen nicht gelehrt, aber innerhalb der Lehre beleuchtet werden, sagte Ingo Autenrieth, Dekan der Medizinischen Fakultät in Tübingen am Dienstag der Deutschen Presse-Agentur. «Ideologien und alles, was nichts mit Wissenschaft zu tun hat, sortieren wir aus.»

Die Professur soll sich demnach mit Themen wie Ernährung, Probiotika und Akupunktur beschäftigten. Geplant ist laut Wissenschaftsministerium, die Lehre in Tübingen anzusiedeln; die Erforschung der komplementären Therapien soll vorwiegend am Centrum für Tumorerkrankungen des Robert-Bosch-Krankenhauses in Stuttgart stattfinden. Die Robert-Bosch-Stiftung finanziert die Professur in den ersten fünf Jahren mit insgesamt 1,84 Millionen Euro, danach soll das Land die Mittel dafür bereitstellen.

«Naturheilkunde und komplementäre Behandlungsmethoden werden von vielen Menschen ganz selbstverständlich genutzt, beispielsweise zur Ergänzung konventioneller Therapieangebote», begründete Wissenschaftsministerin Theresia Bauer (Grüne) das Engagement. Sogenannte sanfte oder natürliche Methoden könnten schwere Krankheiten wie etwa Krebs alleine nicht heilen, heißt es in einer Mitteilung des Ministeriums. Wissenschaftliche Ergebnisse zeigten aber, dass sie häufig zu Therapieerfolgen beitragen könnten, da sie den Patienten helfen, schulmedizinische Therapien gut zu überstehen – etwa die schweren Nebenwirkungen von Chemotherapien mindern.

Im Gegensatz zur Schulmedizin gebe es bisher aber kaum kontrollierte klinische Studien zur Wirksamkeit solcher Therapien, ergänzte Ingo Autenrieth. Ihre Erforschung am neuen Lehrstuhl solle Patienten Sicherheit bringen und ermöglichen, dass die gesetzlichen Krankenkassen die Kosten dafür übernehmen.

Hersteller alternativer Arzneimittel loben den Schritt der Politik. «Baden-Württemberg nimmt damit eine Vorreiterrolle in Deutschland und in Europa ein», heißt es beim Unternehmen Wala Heilmittel GmbH in Bad Boll. Die Landesregierung trage mit der Entscheidung dem Wunsch vieler Patienten und Ärzte nach umfassenden Behandlungskonzepten Rechnung.

Auch hoffen die Unternehmen, dass Licht in die oft kritische Debatte um Homöopathie gebracht wird. «Wir sehen mit Erstaunen und Befremden, dass eine bewährte Therapierichtung wie die Homöopathie, die Teil der Vielfalt des therapeutischen Angebots in Deutschland ist, diskreditiert werden soll», sagte ein Sprecher des Herstellers Weleda AG mit Sitz in Schwäbisch Gmünd der Deutschen Presse-Agentur. Deshalb begrüße man den Lehrstuhl: «Es ist gut, dass Forschung und Lehre ausgebaut werden, da eine Mehrheit der Bevölkerung Komplementärmedizin wünscht und nachfragt. Es braucht Ärzte, die in diesen Bereichen auch universitär ausgebildet werden.»

Laut Koalitionsvertrag will Baden-Württemberg künftig eine Vorreiterrolle in der Erforschung der Komplementärmedizin einnehmen. Bisher gab es im Südwesten mit dem Akademischen Zentrum für Komplementäre und Integrative Medizin (AZKIM) zwar einen Verbund der Unikliniken Tübingen, Freiburg, Ulm und Heidelberg, aber keinen eigenen Lehrstuhl. Bundesweit existieren nach Angaben der Hufelandgesellschaft, dem Dachverband der Ärztegesellschaften für Naturheilkunde und Komplementärmedizin, Lehrstühle für Naturheilkunde noch an den Universitäten Duisburg-Essen, Rostock und Witten/Herdecke sowie drei Stiftungsprofessuren an der Berliner Charité.

END OF QUOTE

And here is my English summary:

The black/green government of Baden-Wuerttemberg has decided to create a ‘chair of naturopathy and integrated medicine’ at the university of Tuebingen in 2019. The chair will focus in the area of oncology. Treatments such as homeopathy and anthroposophical medicine will not be taught but merely mentioned in lectures. Ideologies and everything that is not science will be omitted.

The chair will thus deal with nutrition, acupuncture and probiotics. The teaching activities will be in the medical faculty at Tuebingen, while the research will be located at the Robert-Bosch Hospital in Stuttgart. The funds for the first 5 years – 1.84 million Euro – will come from the Robert-Bosch Foundation; thereafter they will be provided by the government of the county.

So-called gentle or natural therapies cannot cure serious diseases on their own, but as adjuvant treatments they can be helful, for instance, in alleviating the adverse effects of chemotherapy. There are only few studies on this, and the new chair will increase patient safety and facilitate the reimbursement of these treatments by health insurances.

Local anthroposophy manufacturers like Wala welcomed the move stating it would be in accordance with the wishes of many patients and doctors. They also hope that the move will bring light in the current critical debate about homeopathy. A spokesperson of Weleda added that they ‘note with surprise that time-tested therapies like homeopathy are being discredited. Therefore, it is laudable that research and education in this realm will be extended. The majority of the public want complementary medicine and need doctors who are also university-trained.’

Baden-Wurttemberg aims for a leading role in researching complementary medicine. Thus far, chairs of complementary medicine existed only at the universities of Duisburg-Essen, Rostock und Witten/Herdecke as well as three professorships at the Charité in Berlin.

END OF MY SUMMARY

As I have occupied a chair of complementary medicine for 19 years, I am tempted to add a few points here.

  • In principle, a new chair can be a good thing.
  • The name of the chair is odd, to say the least.
  • As the dean of the Tuebingen medical school pointed out, it has to be based on science. But how do they define science?
  • Where exactly does the sponsor, the Robert-Bosch Stiftung, stand on alternative medicine. Do they have a track-record of being impractical and scientific?
  • In order to prevent this becoming a unrealistic prospect, it is essential that the new chair needs to fall into the hands of a scientist with a proven track record of critical thinking.
  • Rigorous scientist with a proven track record of critical thinking are very rare in the realm of alternative medicine.
  • The ridiculous comments by Wala and Weleda, both local firms with considerable local influence, sound ominous and let me suspect that proponents of alternative medicine aim to exert their influence on the new chair.
  • The above-voiced notion that the new chair is to facilitate the reimbursement of alternative treatments by the health insurances seems even more ominous. Proper research has to be objective and could, depending on its findings, have the opposite effect. To direct it in this way seems to determine its results before the research has started.
  • I miss a firm commitment to medical ethics, to the principles of EBM, and to protecting the independence of the new chair.

Thus, I do harbour significant anxieties about this new chair. It is in danger of becoming a chair of promoting pseudoscience. I hope the dean of the Tuebingen medical school might read these lines.

I herewith offer him all the help I can muster in keeping pseudoscience out of this initiative, in defining the remit of the chair and, crucially, in finding the right individual for doing the job.

Medline is the biggest electronic databank for articles published in medicine and related fields. It is therefore the most important source of information in this area. I use it regularly to monitor what new papers have been published in the various fields of alternative medicine.

As the number of Medline-listed papers dated 2018 on homeopathy has just reached 100, I thought it might be the moment to run a quick analysis on this material. The first thing to note is that it took until August for 100 articles dated 2018 to emerge. To explain how embarrassing this is, we need a few comparative figures. At the same moment (6/9/18), we have, for instance:

  • 126576 articles for surgery
  • 5001 articles or physiotherapy
  • 30215 articles for psychiatry
  • 60161 articles for pharmacology

Even compared to other types of alternative medicine, homeopathy is being dwarfed. Currently the figures are, for instance:

  • 2232 for herbal medicine
  • 1949 for dietary supplements
  • 1222 for acupuncture

This does not look as though homeopathy is a frightfully active area of research, if I may say so. Looking at the type of articles (yes, I did look at all the 100 papers and categorised them the best I could) published in homeopathy, things get even worse:

  • 29 were comments, letters, editorials, etc.
  • 16 were basic and pre-clinical papers,
  • 12 were non-systematic reviews,
  • 10 were surveys,
  • 7 were case-reports,
  • 5 were pilot or feasibility studies,
  • 5 were systematic reviews,
  • 5 were controlled clinical trials,
  • 2 were case series,
  • the rest of the articles was not on homeopathy at all.

I find this pretty depressing. Most of the 100 papers turn out to be no real research at all. Crucial topics are not being covered. There was, for example, not a single paper on the risks of homeopathy (no, don’t tell me it is harmless; it can and does regularly cost the lives of patients who trust the bogus claims of homeopaths). There was no article investigating the important question whether the practice of homeopathy does not violate the rules of medical ethics (think of informed consent or the imperative to do more harm than good). And a mere 5 clinical trials is just a dismal amount, in my view.

In a previous post, I have already shown that, in 2015, homeopathy research was deplorable. My new analysis suggests that the situation has become much worse. One might even go as far as asking whether 2018 might turn out to be the year when homeopathy research finally died a natural death.

PROGRESS AT LAST!!!

Bacterial vaginosis is a common condition which is more than a triviality. It can have serious consequences including pelvic inflammatory disease, endometritis, postoperative vaginal cuff infections, preterm labor, premature rupture of membranes, and chorioamnionitis. Therefore, it is important to treat it adequately with antibiotics. But are there other options as well?

There are plenty of alternative or ‘natural’ treatments on offer. But do they work?

This trial was conducted on 127 women with bacterial vaginosis to compare a vaginal suppository of metronidazole with Forzejeh, a vaginal suppository of herbal Persian medicine combination of

  • Tribulus terrestris,
  • Myrtus commuis,
  • Foeniculum vulgare,
  • Tamarindus indica.

The patients (63 in metronidazole group and 64 in Forzejeh group) received the medications for 1 week. Their symptoms including the amount and odour of discharge and cervical pain were assessed using a questionnaire. Cervical inflammation and Amsel criteria (pH of vaginal discharge, whiff test, presence of clue cells and Gram staining) were investigated at the beginning of the study and 14 days after treatment.

The amount and odour of discharge, Amsel criteria, pelvic pain and cervical inflammation significantly decreased in Forzejeh and metronidazole groups (p = <.001). There was no statistically significant difference between the metronidazole and Fozejeh groups with respect to any of the clinical symptoms or the laboratory assessments.

The authors concluded that Forzejeh … has a therapeutic effect the same as metronidazole in bacterial vaginosis.

The plants in Fozejeh are assumed to have antimicrobial activities. Forzejeh has been used in folk medicine for many years but was only recently standardised. According to the authors, this study shows that the therapeutic effects of Forzejeh on bacterial vaginosis is similar to metronidazole.

Yet, I am far less convinced than these Iranian researchers. As this trial compared two active treatments, it was an equivalence study. As such, it requires a different statistical approach and a much larger sample size. The absence of a difference between the two groups is most likely due to the fact that the study was too small to show it.

If I am correct, the present investigation only demonstrates yet again that, with flawed study-designs, it is easy to produce false-positive results.

In one of his many comments, our friend Iqbal just linked to an article that unquestionably is interesting. Here is its abstract (the link also provides the full paper):

Objective: The objective was to assess the usefulness of homoeopathic genus epidemicus (Bryonia alba 30C) for the prevention of chikungunya during its epidemic outbreak in the state of Kerala, India.

Materials and Methods: A cluster- randomised, double- blind, placebo -controlled trial was conducted in Kerala for prevention of chikungunya during the epidemic outbreak in August-September 2007 in three panchayats of two districts. Bryonia alba 30C/placebo was randomly administered to 167 clusters (Bryonia alba 30C = 84 clusters; placebo = 83 clusters) out of which data of 158 clusters was analyzed (Bryonia alba 30C = 82 clusters; placebo = 76 clusters) . Healthy participants (absence of fever and arthralgia) were eligible for the study (Bryonia alba 30 C n = 19750; placebo n = 18479). Weekly follow-up was done for 35 days. Infection rate in the study groups was analysed and compared by use of cluster analysis.

Results: The findings showed that 2525 out of 19750 persons of Bryonia alba 30 C group suffered from chikungunya, compared to 2919 out of 18479 in placebo group. Cluster analysis showed significant difference between the two groups [rate ratio = 0.76 (95% CI 0.14 – 5.57), P value = 0.03]. The result reflects a 19.76% relative risk reduction by Bryonia alba 30C as compared to placebo.

Conclusion: Bryonia alba 30C as genus epidemicus was better than placebo in decreasing the incidence of chikungunya in Kerala. The efficacy of genus epidemicus needs to be replicated in different epidemic settings.

________________________________________________________________________________

I have often said the notion that homeopathy might prevent epidemics is purely based on observational data. Here I stand corrected. This is an RCT! What is more, it suggests that homeopathy might be effective. As this is an important claim, let me quickly post just 10 comments on this study. I will try to make this short (I only looked at it briefly), hoping that others complete my criticism where I missed important issues:

  1. The paper was published in THE INDIAN JOURNAL OF RESEARCH IN HOMEOPATHY. This is not a publication that could be called a top journal. If this study really shows something as revolutionarily new as its conclusions imply, one must wonder why it was published in an obscure and inaccessible journal.
  2. Several of its authors are homeopaths who unquestionably have an axe to grind, yet they do not declare any conflicts of interest.
  3. The abstract states that the trial was aimed at assessing the usefulness of Bryonia C30, while the paper itself states that it assessed its efficacy. The two are not the same, I think.
  4. The trial was conducted in 2007 and published only 7 years later; why the delay?
  5. The criteria for the main outcome measure were less than clear and had plenty of room for interpretation (“Any participant who suffered from fever and arthralgia (characteristic symptoms of chikungunya) during the follow-up period was considered as a case of chikungunya”).
  6. I fail to follow the logic of the sample size calculation provided by the authors and therefore believe that the trial was woefully underpowered.
  7. As a cluster RCT, its unit of assessment is the cluster. Yet the significant results seem to have been obtained by using single patients as the unit of assessment (“At the end of follow-ups it was observed that 12.78% (2525 out of 19750) healthy individuals, administered with Bryonia alba 30 C, were presented diagnosed as probable case of chikungunya, whereas it was 15.79% (2919 out of 18749) in the placebo group”).
  8. The p-value was set at 0.05. As we have often explained, this is far too low considering that the verum was a C30 dilution with zero prior probability.
  9. Nine clusters were not included in the analysis because of ‘non-compliance’. I doubt whether this was the correct way of dealing with this issue and think that an intention to treat analysis would have been better.
  10. This RCT was published 4 years ago. If true, its findings are nothing short of a sensation. Therefore, one would have expected that, by now, we would see several independent replications. The fact that this is not the case might mean that such RCTs were done but failed to confirm the findings above.

As I said, I would welcome others to have a look and tell us what they think about this potentially important study.

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