conflict of interest
The public is often impressed by scenes shown on TV where surgeons in China operate patients apparently with no other anaesthesia than acupuncture. Such films have undoubtedly contributed significantly to the common belief that acupuncture cannot possibly be a placebo (every single time I give a public talk about acupuncture, the issue comes up, and someone asks me: how can you doubt the efficacy of acupuncture when, in China, they use it for major operations?).
Some years ago, I have myself been involved is such a BBC broadcast and had to learn the hard way that such scenes are more than just a bit misleading.
Unfortunately, the experts rarely object to any of this. They seem to have become used to the false claims and overt propaganda that is rife in the promotion of acupuncture, and have resigned to the might of poor journalism.
The laudable exception is a team of French authors of a recent and excellent paper.
This unusual article analysed a clip from the program “Acupuncture, osteopathy, hypnosis: do complementary medicines have superpowers?” about acupuncture as an anaesthetic for surgical procedures in China. Their aim was to propose a rational explanation for the phenomena observed and to describe the processes leading a public service broadcasting channel to offer this type of content at prime time and the potential consequences in terms of public health. For this purpose, they used critical thinking attitudes and skills, along with a bibliographical search of Medline, Google Scholar and Cochrane Library databases.
Their results reveal that the information delivered in the television clip is ambiguous. It did not allow the viewer to form an informed opinion on the relevance of acupuncture as an anaesthetic for surgical procedures. It is reasonable to assume that the clip shows surgery performed with undisclosed epidural anaesthesia coupled with mild intravenous anaesthesia, sometimes performed in other countries.
What needs to be highlighted, the authors of this critique state, is the overestimation of acupuncture added to the protocol. The media tend to exaggerate the risks and expected effects of the treatments they report on, which can lead patients to turn to unproven therapies.
The authors concluded that broadcasting such a clip at prime time underlines the urgent need for the public and all health professionals to be trained in sorting and critically analysing health information.
In my view, broadcasting such misleading films also underlines the urgent need for journalists to be conscious of their responsibility not to mislead the public and do more rigorous research before reporting on matters of health.
The Clinic for Complementary Medicine and Diet in Oncology was opened, in collaboration with the oncology department, at the Hospital of Lucca (Italy) in 2013. It uses a range of alternative therapies aimed at reducing the adverse effects of conventional oncology treatments.
Their latest paper presents the results of complementary medicine (CM) treatment targeted toward reducing the adverse effects of anticancer therapy and cancer symptoms, and improving patient quality of life. Dietary advice was aimed at the reduction of foods that promote inflammation in favour of those with antioxidant and anti-inflammatory properties.
This is a retrospective observational study on 357 patients consecutively visited from September 2013 to December 2017. The intensity of symptoms was evaluated according to a grading system from G0 (absent) to G1 (slight), G2 (moderate), and G3 (strong). The severity of radiodermatitis was evaluated with the Radiation Therapy Oncology Group (RTOG) scale. Almost all the patients (91.6%) were receiving or had just finished some form of conventional anticancer therapy.
The main types of cancer were breast (57.1%), colon (7.3%), lung (5.0%), ovary (3.9%), stomach (2.5%), prostate (2.2%), and uterus (2.5%). Comparison of clinical conditions before and after treatment showed a significant amelioration of all symptoms evaluated: nausea, insomnia, depression, anxiety, fatigue, mucositis, hot flashes, joint pain, dysgeusia, neuropathy.
The authors concluded that the integration of evidence-based complementary treatments seems to provide an effective response to cancer patients’ demand for a reduction of the adverse effects of anticancer treatments and the symptoms of cancer itself, thus improving patient’s quality of life and combining safety and equity of access within public healthcare systems. It is, therefore, necessary for physicians (primarily oncologists) and other healthcare professionals in this ﬁeld to be appropriately informed about the potential beneﬁts of CMs.
Why do I call this ‘wishful thinking’?
I have several reasons:
- A retrospective observational study cannot establish cause and effect. It is likely that the findings were due to a range of factors unrelated to the interventions used, including time, extra attention, placebo, social desirability, etc.
- Some of the treatments in the therapeutic package were not CM, reasonable and evidence-based. Therefore, it is likely that these interventions had positive effects, while CM might have been totally useless.
- To claim that the integration of evidence-based complementary treatments seems to provide an effective response to cancer patients’ is pure fantasy. Firstly, some of the CMs were certainly not evidence-based (the clinic’s prime focus is on homeopathy). Secondly, as already pointed out, the study does not establish cause and effect.
- The notion that it is necessary for physicians (primarily oncologists) and other healthcare professionals in this ﬁeld to be appropriately informed about the potential beneﬁts of CMs is not what follows from the data. The paper shows, however, that the authors of this study are in need to be appropriately informed about EBM as well as CM.
I stumbled across this paper because a homeopath cited it on Twitter claiming that it proves the effectiveness of homeopathy for cancer patients. This fact highlights why such publications are not just annoyingly useless but acutely dangerous. They mislead many cancer patients to opt for bogus treatments. In turn, this demonstrates why it is important to counterbalance such misinformation, critically evaluate it and minimise the risk of patients getting harmed.
Acupuncture is a branch of alternative medicine where pseudo-science abounds. Here is yet another example of this deplorable phenomenon.
This study was conducted to evaluate the efficacy of acupuncture in the management of primary dysmenorrhea.
Sixty females aged 17-23 years were randomly assigned to either a study group or a control group.
- The study group received acupuncture for the duration of 20 minutes/day, for 15 days/month, for the period of 90 days.
- The control group did not receive acupuncture for the same period.
Both groups were assessed on day 1; day 30 and day 60; and day 90. The results showed a significant reduction in all the variables such as the visual analogue scale score for pain, menstrual cramps, headache, dizziness, diarrhoea, faint, mood changes, tiredness, nausea, and vomiting in the study group compared with those in the control group.
The authors concluded that acupuncture could be considered as an effective treatment modality for the management of primary dysmenorrhea.
These findings contradict those of a recent Cochrane review (authored by known acupuncture-proponents) which included 42 RCTs and concluded that there is insufficient evidence to demonstrate whether or not acupuncture or acupressure are effective in treating primary dysmenorrhoea, and for most comparisons no data were available on adverse events. The quality of the evidence was low or very low for all comparisons. The main limitations were risk of bias, poor reporting, inconsistency and risk of publication bias.
The question that I ask myself is this: why do researchers bother to conduct studies that contribute NOTHING to our knowledge and progress? The new study had a no-treatment control group which means it cannot control for the effects of placebo, the extra attention, social desirability etc. In view of the fact that already 42 poor quality trials exist, it is not just useless to add a 43rd but, in my view, it is scandalous! A 43rd useless trial:
- tells us nothing of value;
- misleads the public;
- pollutes the medical literature;
- is a waste of resources;
- undermines the trust in clinical research;
- is deeply unethical.
It is high time to stop such redundant, foolish, wasteful and unethical pseudo-science.
On this blog, I have repeatedly discussed chiropractic research that, on closer examination, turns out to be some deplorable caricature of science. Today, I have another example of what I would call pseudo-research.
This RCT compared short-term treatment (12 weeks) versus long-term management (36 weeks) of back and neck related disability in older adults using spinal manipulative therapy (SMT) combined with supervised rehabilitative exercises (SRE).
Eligible participants were aged 65 and older with back and neck disability for more than 12 weeks. Co-primary outcomes were changes in Oswestry and Neck Disability Index after 36 weeks. An intention to treat approach used linear mixed-model analysis to detect between group differences. Secondary analyses included other self-reported outcomes, adverse events and objective functional measures.
A total of 182 participants were randomized. The short-term and long-term groups demonstrated significant improvements in back and neck disability after 36 weeks, with no difference between groups. The long-term management group experienced greater improvement in neck pain at week 36, self-efficacy at week 36 and 52, functional ability and balance.
The authors concluded that for older adults with chronic back and neck disability, extending management with SMT and SRE from 12 to 36 weeks did not result in any additional important reduction in disability.
What renders this paper particularly fascinating is the fact that its authors include some of the foremost researchers in (and most prominent proponents of) chiropractic today. I therefore find it interesting to critically consider the hypothesis on which this seemingly rigorous study is based.
As far as I can see, it essentially is this:
36 weeks of chiropractic therapy plus exercise leads to better results than 12 weeks of the same treatment.
I find this a most remarkable hypothesis.
Imagine any other form of treatment that is, like SMT, not solidly based on evidence of efficacy. Let’s use a new drug as an example, more precisely a drug for which there is no solid evidence for efficacy or safety. Now let’s assume that the company marketing this drug publishes a trial based on the hypothesis that:
36 weeks of therapy with the new drug plus exercise leads to better results than 12 weeks of the same treatment.
Now let’s assume the authors affiliated with the drug manufacturer concluded from their findings that for patients with chronic back and neck disability, extending drug therapy plus exercise from 12 to 36 weeks did not result in any additional important reduction in disability.
WHAT DO YOU THINK SUCH A TRIAL CAN TELL US?
My answer is ‘next to nothing’.
I think, it merely tells us that
- daft hypotheses lead to daft research,
- even ‘top’ chiropractors have problems with critical thinking,
- SMT might not be the solution to neck and back related disability.
I REST MY CASE.
The researcher who proves that highly diluted homeopathics work beyond placebo might be in for a Nobel Prize. The scientist who finds a cure for addictions probably also deserves one. The investigator who does both might get two Nobels. The question is, do these Brazilian homeopaths fulfil these criteria?
Their study investigated the effectiveness and tolerability of homeopathic Q-potencies of opium and E. coca in the integrative treatment of cocaine craving in a community-based psychosocial rehabilitation setting. A randomized, double-blind, placebo-controlled, parallel-group, eight-week pilot trial was performed at the Psychosocial Attention Center for Alcohol and Other Drugs (CAPS-AD), Sao Carlos/SP, Brazil. Eligible subjects included CAPS-AD patients between 18 and 65 years of age, with an International Classification of Diseases-10 diagnosis of cocaine dependence. The patients were randomly assigned to two treatment groups: psychosocial rehabilitation plus homeopathic Q-potencies of opium and E. coca (homeopathy group), and psychosocial rehabilitation plus indistinguishable placebo (placebo group). The main outcome measure was the percentage of cocaine-using days. Secondary measures were the Minnesota Cocaine Craving Scale and 12-Item Short-Form Health Survey scores. Adverse events were recorded in both groups.
The study population comprised 54 patients who attended at least one post-baseline assessment, out of the 104 subjects initially enrolled. The mean percentage of cocaine-using days in the homeopathy group was 18.1% compared to 29.8% in the placebo group (P < 0.01). Analysis of the Minnesota Cocaine Craving Scale scores showed no between-group differences in the intensity of cravings, but results significantly favored homeopathy over placebo in the proportion of weeks without craving episodes and the patients’ appraisal of treatment efficacy for reduction of cravings. Analysis of 12-Item Short-Form Health Survey scores found no significant differences. Few adverse events were reported: 0.57 adverse events/patient in the homeopathy group compared to 0.69 adverse events/patient in the placebo group.
The authors concluded that a psychosocial rehabilitation setting improved recruitment but was not sufficient to decrease dropout frequency among Brazilian cocaine treatment seekers. Psychosocial rehabilitation plus homeopathic Q-potencies of opium and E. coca were more effective than psychosocial rehabilitation alone in reducing cocaine cravings. Due to high dropout rate and risk of bias, further research is required to confirm our findings, with specific focus on strategies to increase patient retention.
I am glad that the authors mention the high dropout rate which clearly is a serious limitation of this fascinating trial. Had they analysed the data according to an intention to treat analysis – which, I think, would have been a better statistical approach – the results would almost certainly have been negative.
But there are other puzzling issues about this study:
- The authors say they used homeopathic remedies. I think, however, that this is not the case. Homeopathy is defined as a therapy that follows the ‘like cures like’ principle. If the remedy is based on the causative agent, as in the case of the present study, it follows a different principle (identical cures identical) and is not called homeopathy but isopathy (here an explanation from my book: “Isopathy is the use of potentised remedies which are derived from the causative agent of the disease that is being treated. It thus does not follow the supreme law of homeopathy; instead of ‘like cures like’, instead it postulates that identical cures identical. An example of isopathy is the use of potentised grass pollen to treat patients suffering from hay fever. Some of the methodologically best trials that generated a positive result were done using isopathy; they therefore did not test homeopathy and its principal assumption, the ‘like cures like’ theory. They are nevertheless regularly used by proponents of homeopathy to argue that homeopathy is effective”). This means that the above trial does, in fact, NOT test the defining principle of homeopathy.
- Moreover, I fail to understand why the authors called their trial a PILOT study. It does not explore the feasibility of a more definitive trial, but tests the effectiveness of the intervention. It is thus NOT a pilot study.
- I cannot help being suspicious of authors who, based on an extremely implausible, such as homeopathy, publish one paper after the next with positive or encouraging results.
- I am also puzzled by the fact that, in 2012 and 2013, the authors have published two previous studies along the same lines that produced encouraging results. Surely 6/5 years are a long enough period for INDEPENDENT replications to be carried out and published. And surely, a finding like this would have been replicated several times by now.
- I furthermore find it odd that the authors chose to publish their findings in the JOURNAL OF INTEGRATIVE MEDICINE. This is a 3rd class journal read only by those who promote alternative therapies. The notion that a treatment of addiction has finally be found should appear in journals like SCIENCE, NATURE, NEJM, etc.
- Considering the extremely low prior probability of their hypothesis, the authors should perhaps have not used the conventional 5% probability threshold, but one two dimensions lower.
- I have not found a statement regarding informed consent of the study participants.
So, are these Brazilian homeopaths likely to be on the next list of Nobel laureates?
I have my doubts.
What do you think?
Homeopathy for depression? A previous review concluded that the evidence for the effectiveness of homeopathy in depression is limited due to lack of clinical trials of high quality. But that was 13 years ago. Perhaps the evidence has changed?
A new review aimed to assess the efficacy, effectiveness and safety of homeopathy in depression. Eighteen studies assessing homeopathy in depression were included. Two double-blind placebo-controlled trials of homeopathic medicinal products (HMPs) for depression were assessed.
- The first trial (N = 91) with high risk of bias found HMPs were non-inferior to fluoxetine at 4 and 8 weeks.
- The second trial (N = 133), with low risk of bias, found HMPs was comparable to fluoxetine and superior to placebo at 6 weeks.
The remaining research had unclear/high risk of bias. A non-placebo-controlled RCT found standardised treatment by homeopaths comparable to fluvoxamine; a cohort study of patients receiving treatment provided by GPs practising homeopathy reported significantly lower consumption of psychotropic drugs and improved depression; and patient-reported outcomes showed at least moderate improvement in 10 of 12 uncontrolled studies. Fourteen trials provided safety data. All adverse events were mild or moderate, and transient. No evidence suggested treatment was unsafe.
The authors concluded that limited evidence from two placebo-controlled double-blinded trials suggests HMPs might be comparable to antidepressants and superior to placebo in depression, and patients treated by homeopaths report improvement in depression. Overall, the evidence gives a potentially promising risk benefit ratio. There is a need for additional high quality studies.
I beg to differ!
What these data really show amounts to far less than the authors imply:
- The two ‘double-blind’ trials are next to meaningless. As equivalence studies they were far too small to produce meaningful results. Any decent review should discuss this fact in full detail. Moreover, these studies cannot have been double-blind, because the typical adverse-effects of anti-depressants would have ‘de-blinded’ the trial participants. Therefore, these results are almost certainly false-positive.
- The other studies are even less rigorous and therefore do also not allow positive conclusions.
This review was authored by known proponents of homeopathy. It is, in my view, an exercise in promotion rather than a piece of research. I very much doubt that a decent journal with a responsible peer-review system would have ever published such a biased paper – it had to appear in the infamous EUROPEAN JOURNAL OF INTEGRATIVE MEDICINE.
Who cares? No harm done!
Again, I beg to differ.
The conclusion that homeopathy has a ‘promising risk/benefit profile’ is frightfully dangerous and irresponsible. If seriously depressed patients follow it, many lives might be lost.
Yet again, we see that poor research has the potential to kill vulnerable individuals.
Mini-scalpel acupuncture or acupotomy is a relatively new type of non-invasive acupuncture/ micro surgery using a small needle-scalpel invented by Professor Zhu Hanzhang around 30 years ago in China. It is a slightly thicker and more blunt instrument that gets under the skin and is able to break apart adhesions and muscle knots more effectively than a regular acupuncture needle would.
Never mind, the question is does it work!
A systematic review showed that almost all studies reported an effect of acupotomy on joint pain compared to a variety of controls. On reflection, this is hardly surprising:
- all the trials were from China;
- all had major methodological flaws.
This means that we need better studies to decide the efficacy question.
This new study investigated the efficacy and safety of mini-scalpel acupuncture (MA) for knee osteoarthritis (KOA) in an assessor-blinded randomized controlled pilot trial; this would provide information for a large-scale randomized controlled trial.
Participants (n = 24) were recruited and randomly allocated to the MA group (experimental) or acupuncture group (control). The MA group received treatment once a week for 3 weeks (total of 3 treatments), while the acupuncture group received treatment two times per week for 3 weeks (total of 6 treatments). The primary outcome was pain as assessed by a visual analogue scale (VAS). The secondary outcomes (intensity of current pain, stiffness, and physical function) were assessed using the short-form McGill Pain Questionnaire (SF-MPQ) and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). Assessments were performed at baseline, 1, 2, and 3 during treatment and at week 5 (2 weeks after the end of treatment).
Of the 24 participants, 23 completed the study. Both groups showed significant improvements in VAS, SF-MPQ, and WOMAC. There were no significant differences between the MA and acupuncture groups. No serious adverse event occurred and blood test results were within normal limits.
The authors concluded that although both MA and acupuncture provide similar effects with regard to pain control in patients with KOA, MA may be more effective in providing pain relief because the same relief was obtained with fewer treatments. A large-scale clinical study is warranted to further clarify these findings.
I can recommend this article to anyone who wants a quick introduction into the critical analysis of clinical trials. It is a veritable treasure trove of mistakes, flaws, errors, fallacies etc. Here are just a few:
- The authors aim of investigating the safety of MA is unobtainable. It would require not 24 but probably 24 000 patients.
- The authors aim of investigating the efficacy of MA is equally unobtainable. It would require a much larger sample than 24, a sham control arm, identical treatment schedules, patient-blinding, etc.
- Calling the trial a ‘pilot’ is endearing but, except for the title and the insufficient sample size, this study has none of the characteristics of a pilot study.
- In their ‘introduction’, the authors state that miniscalpel acupuncture (MA) is a new subtype of acupuncture that is effective in treating chronic soft tissue injuries such as adhesions and contractures. This is clearly wrong but discloses their bias very plainly.
- The authors statement that both MA and acupuncture provide similar effects with regard to pain control in patients with KOA is misleading. It implies that both interventions had specific effects. Without a sham control arm, this is pure speculation.
- Similarly their assumption that MA may be more effective in providing pain relief because the same relief was obtained with fewer treatments, is pure fantasy.
- In fact, as MA requires injections of local anaesthetics, any outcome is heavily confounded by this addition.
- In the discussion section, the authors state that because MA is invasive and provides a strong stimulus, some participants complained of stiff and dull pain for few days after treatment. Yet, when reporting adverse effects in the results section, this was not mentioned.
- The way this study was designed, it should have been clear from the start that it would not produce any meaningful findings. Seen from this perspective, running the trial could even be seen as a breach of research ethics.
- According to the aims of a pilot study and the authors hope that their study would provide information for a large-scale randomized controlled trial, all reporting of outcomes is misplaced and should be replaced by information as to how a definitive trial should be conducted.
The following footnote is worth mentioning: This study is supported by a grant from the Ministry of Health & Welfare, Korea. It suggests to me that this ministry should urgently re-think its funding strategy and recruit some reviewers who are capable of critical analysis.
In my view, this is a lousy study which the authors decides to call ‘a pilot’ in order to get it published in a lousy journal.
Acupuncture research does not have a good name; if it originates from China, even less so.
And this note in ‘ACUPUNCTURE IN MEDICINE’ is not likely to change this image:
Fang J, Keller CL, Chen L, et al. Effect of acupuncture and Chinese herbal medicine on subacute stroke outcomes: a single-centre randomised controlled trial. Acupuncture in Medicine Published online first 10 November 2017. doi: 10.1136/acupmed-2016-011167.
This article is retracted by the Editor-in-Chief on grounds of redundant publication.
The above article reports that a trial originally planned to be carried out at three hospitals was reduced to a single centre for reasons of cost. This is incorrect. The full three-centre trial was run and reported elsewhere (Scientific Reports 6, Article number: 25850 (2016) DOI: 10.1038/srep25850).
The Scientific Reports paper was accepted for publication prior to submission of the above paper to Acupuncture in Medicine. The third author takes responsibility for the mistake. All authors have agreed to this retraction.
The abstract of the paper in SCIENTIFIC REPORTS is here:
To determine whether integrative medicine rehabilitation (IMR) that combines conventional rehabilitation (CR) with acupuncture and Chinese herbal medicine has better effects for subacute stroke than CR alone, we conducted a multicenter randomized controlled trial that involved three hospitals in China. Three hundred sixty patients with subacute stroke were randomized into IMR and CR groups. The primary outcome was the Modified Barthel Index (MBI). The secondary outcomes were the National Institutes of Health Stroke Scale (NIHSS), the Fugl-Meyer Assessment (FMA), the mini-mental state examination (MMSE), the Montreal Cognitive Assessment (MoCA), Hamilton’s Depression Scale (HAMD), and the Self-Rating Depression Scale (SDS). All variables were evaluated at week 0 (baseline), week 4 (half-way of intervention), week 8 (after treatment) and week 20 (follow-up). In comparison with the CR group, the IMR group had significantly better improvements (P < 0.01 or P < 0.05) in all the primary and secondary outcomes. There were also significantly better changes from baseline in theses outcomes in the IMR group than in the CR group (P < 0.01). A low incidence of adverse events with mild symptoms was observed in the IMR group. We conclude that conventional rehabilitation combined with integrative medicine is safe and more effective for subacute stroke rehabilitation.
I find all this odd in several ways:
- The publication of the ACUPUNCTURE IN MEDICINE article does not seem to have been a ‘mistake‘ but plain scientific fraud, in my view.
- The paper in SCIENTIFIC REPORTS (SR) was published in May 2016. Therefore the reviewers and editor of AIM could and should have spotted the fraud.
- In the SR paper, the authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article. As the authors were affiliated to three different departments of acupuncture, I feel this to be debatable.
What do you think?
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.
Bee venom acupuncture is a form of acupuncture in which bee venom is applied to the tips of acupuncture needles, stingers are extracted from bees, or bees are held with an instrument exposing the stinger, and applied to acupoints on the skin.
Bee venom consisting of multiple anti-inflammatory compounds such as melittin, adolapin, apamin. Other substances such as phospholipase A2 can be anti-inflammatory in low concentrations and pro-inflammatory in others. However, bee venom also contains proinflammatory substances, melittin, mast cell degranulation peptide 401, and histamine.
Bee venom acupuncture has been used to treat a number of conditions such as lumbar disc disease, osteoarthritis of the knee, rheumatoid arthritis, adhesive capsulitis, lateral epicondylitis, peripheral neuropathies, stroke and Parkinson’s Disease. The quality of these studies tends to be so poor that any verdict on the effectiveness of bee venom acupuncture would be premature.
A new clinical trial of bee-venom acupuncture for rheumatoid arthritis (RA) might change this situation. A total of 120 cases of RA patients were randomized into bee-sting acupuncture group (treatment) and western medicine group (control). The patients of the control group were treated by oral administration of Methotrexate (10 mg, once a week) and Celecoxlb (0.2 g, once a day). Those of the treatment group received 5 to 15 bee stings of Ashi-points or acupoints according to different conditions and corporeity, and with the bee-sting retained for about 5 min every time, once every other day. The treatment lasted for 8 weeks. The therapeutic effect was assessed by examining:
- symptoms and signs of the affected joints as morning stiffness duration,
- swollen/tender joint counts (indexes),
- handgrip strength,
- 15 m-walking time,
- visual analogue scale (VAS),
- Disease Activity Score including a 28-joint count (DAS 28),
- rheumatoid factor (RF),
- erythrocyte sedimentation rate (ESR),
- C-reactive protein (CRP),
- anti-cyclic citrullinated peptide antibody (ACCPA).
For assessing the safety of bee-venom acupuncture, the patients’ responses of fever, enlargement of lymph nodes, regional red and swollen, itching, blood and urine tests for routine were examined.
Findings of DAS 28 responses displayed that of the two 60 cases in the control and bee-venom acupuncture groups, 15 and 18 experienced marked improvement, 33 and 32 were effective, 12 and 10 ineffective, with the effective rates being 80% and 83. 33%, respectively. No significant difference was found between the two groups in the effective rate (P>0.05). After the treatment, both groups have witnessed a marked decrease in the levels of morning stiffness duration, arthralgia index, swollen joint count index, joint tenderness index, 15 m walking time, VAS, RF, ESR, CRP and ACCPA, and an obvious increase of handgrip strength relevant to their own levels of pre-treatment in each group (P<0.05). There were no significant differences between the two groups in the abovementioned indexes (P>0.05). The routine blood test, routine urine test, routine stool test, electrocardiogram result, the function of liver and kidney and other security index were within the normal range, without any significant adverse effects found after bee-stinging treatment.
The authors (from the Department of Acupuncture and Moxibustion, Bao’an Hospital of Traditional Chinese Medicine, Shenzhen, China) concluded that bee-venom acupuncture therapy for RA patients is safe and effective, worthy of popularization and application in clinical practice.
Where to start? There is so much – perhaps I just comment on the conclusion:
- Safety cannot be assessed on the basis of such a small sample. Bee venom can cause anaphylaxis, and several deaths have been reported in patients who successfully received the therapy prior to the adverse event. Because there is no adverse-effect monitoring system, the incidence of adverse events is unknown. Stating that it is safe, is therefore a big mistake.
- The trial was a non-superiority study. As such, it needs a much larger sample to be able to make claims about effectiveness.
- From the above two points, it follows that popularization and application in clinical practice would be a stupid exercise.
So, what is left over from this seemingly rigorous RCT?
(except perhaps a re-affirmation of my often-voiced fear that we must take TCM-studies from China with more than just one pinch of salt)