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

systematic review

The concept that the outcomes of spinal manipulation therapy (SMT) – the hallmark intervention of chiropractors which they use on practically every patient – are optimized when the treatment is aimed at a clinically relevant joint is commonly assumed and central to teaching and clinical use of chiropractic. But is the assumption true?

This systematic review investigated whether clinical effects are superior when this is the case compared to SMT applied elsewhere. Eligible study designs were randomized controlled trials that investigated the effect of SMT applied to candidate versus non-candidate sites for spinal pain.

The authors obtained studies from four different databases. Risk of bias was assessed using an adjusted Cochrane risk of bias tool, adding four items for study quality. Between-group differences were extracted for any reported outcome or, when not reported, calculated from the within-group changes. Outcomes were compared for SMT applied at a ‘relevant’ site to SMT applied elsewhere. The authors prioritized methodologically robust studies when interpreting results.

Ten studies were included. They reported 33 between-group differences; five compared treatments within the same spinal region and five at different spinal regions.

None of the nine studies with low or moderate risk of bias reported statistically significant between-group differences for any outcome. The tenth study reported a small effect on pain (1.2/10, 95%CI – 1.9 to – 0.5) but had a high risk of bias. None of the nine articles of low or moderate risk of bias and acceptable quality reported that “clinically-relevant” SMT has a superior outcome on any outcome compared to “not clinically-relevant” SMT. This finding contrasts with ideas held in educational programs and clinical practice that emphasize the importance of joint-specific application of SMT.

The authors concluded that the current evidence does not support that SMT applied at a supposedly “clinically relevant” candidate site is superior to SMT applied at a supposedly “not clinically relevant” site for individuals with spinal pain.

I came across this study when I searched for the published work of Prof Stephen Perle, a chiropractor and professor at the School of Chiropractic, College of Health Sciences, University of Bridgeport, US, who recently started trolling me on this blog. Against my expectation, I find his study interesting and worthwhile.

His data quite clearly show that the effects of SMT are non-specific and mainly due to a placebo response. That in itself is not hugely remarkable and has been suspected to some time, e.g.:

What is remarkable, however, is the fact that Perle and his co-authors offer all sorts of other explanation for their findings without even seriously considering what is stareing in their faces:

SPINAL MANIPULATIONS ARE PLACEBOS

CHIROPRACTIC IS A PLACEBO THERAPY

This might be almost acceptable, if chiropractic would not also be burdened with significant risks (as we have discussed ad nauseam on this blog) – another fact of which chiros like Perle are in denial.

What does all that mean for patients?

The practical implication is fairly straight forward: the risk/benefit balance of chiropractic is negative. And this surely means the only responsible advice to patients is this:

NEVER CONSULT A CHIRO!

The BBC has a popular program entitled JUST ONE THING presented by Dr, Michael Mosely. In each of these short broadcasts, Mosely presents JUST ONE THING that will make your life more healthy. Whenever I listen to them, I get slightly irritated. Mosely is clearly a very skilled presenter and makes complicated things easy to understand; but for my taste his approach is totally devoid of critical thinking. This is obviously the point of the series and probably one reason for its success. So, maybe it needs to be tolerated – perhaps, but surely not if it seriously misleads the public on important health issues.

The most recent broadcast was entitled EMBRACE THE RAIN and, in my view, it did cross this crucial line. Mosely explained that after it has rained, the air is full of negative ions and these ions are effective against depression. The center piece was his interview with Prof Michael Terman who explained some of his research on the subject, in particular a clinical trial which showed that intensely ionized air was effective against depression. Terman explained that this was more than a placebo effect, that it worked even for serious chronic depressed patients, and that the effect was better than standard treatments.

At no stage was there an even mildly critical question from Mosely. Consequently many depressed patients might now abandon their standard treatments and opt for air ionizers in their homes or walks in the rain which was deemed to be just as effective. In view of the fact that chronic depression, through its suicide risk, can be a life-threatening condition, I find this rather concerning.

My concerns were not exactly alleviated when I did a quick search for the evidence. The most recent review on the subject states that there has been considerable interest in the potential effects of negative air ions (NAIs) on human health and well-being, but the conclusions have been inconsistent and the mechanisms remain unclear. So, why does Terman promote NAIs as though they are the best thing since sliced bread? It took me less than a minute to find a possible answer: he holds a patent for a NEGATIVE ION GENERATOR!

It is laudable of the BBC and Michael Mosely to present aspects of healthcare in a simple, understandable way. Yet, it would be even more laudable, if they did their homework a bit better and, crucially, tried to also educate the public in critical thinking. After all ’embracing the rain’ will not change lives but critical thinking most certainly does!

If you assumed that the best management of a child by chiropractors is not to treat this patient and refer to a proper doctor, think again. This paper was aimed at building upon existing recommendations on best practices for chiropractic management of children by conducting a formal consensus process and best evidence synthesis. Its authors composed a best practice guide based on recommendations from current best available evidence and formal consensus of a panel of experienced practitioners, consumers, and experts for chiropractic management of pediatric patients. They thus syntheized results of a literature search to inform the development of recommendations from a multidisciplinary steering committee, including experts in pediatrics, followed by a formal Delphi panel consensus process.

The consensus process was conducted June to August 2022. All 60 panelists completed the process and reached at least 80% consensus on all recommendations after three Delphi rounds. Recommendations for best practices for chiropractic care for children addressed the following aspects of the clinical encounter:

  • patient communication, including informed consent;
  • appropriate clinical history, including health habits;
  • appropriate physical examination procedures;
  • red flags/contraindications to chiropractic care and/or spinal manipulation;
  • aspects of chiropractic management of pediatric patients, including infants;
  • modifications of spinal manipulation and other manual procedures for pediatric patients;
  • appropriate referral and comanagement;
  • appropriate health promotion and disease prevention practices.

The authors concluded that this set of recommendations represents a general framework for an evidence-informed and reasonable approach to the management of pediatric patients by chiropractors.

Whenever I read the term ‘evidence-informed’ I need to giggle. Why not evidence-based? Evidence-informed might mean that chiros are informed that their treatments are useless or even dangerous for children … but, on reflection and taking their own need for earning a living, they subsequently ignore these facts. And sure enough, the authors of the present paper do mention that a Cochrane review concluded that spinal manipulation is not recommended for children under 12, for a number of conditions, or for general wellness … only to then go on and ignore the very fact.

In doing so, the authors issue a string of self-evident platitudes which occasionally border on the irresponsible. For instance, under the heading of ‘primary prevention’, vaccinations are mentioned as the very last item with the following words:

If parents ask for advice or information about childhood vaccinations, explain that they have the right to make their own health decisions. They should be adequately informed about the benefits and risks to both their child and the broader community associated with these decisions. Consider referral to a health professional whose scope of practice includes vaccinations to address patient questions or concerns.

What that really means in practice, I fear, might be summarized like this: If parents ask for advice or information about childhood vaccinations, explain that they are dangerous, and that even D. D. Palmer recognized as early as 1894 that vaccination is ‘…the monstrous delusion … fastened on us by the medical profession, enforced by the state boards, and supported by the mass of unthinking people …’

Altogether, the ‘Clinical Practice Guideline for Best Practice Management of Pediatric Patients by Chiropractors’ is a thoroughly disreputable document. It was constructed in the way all charlatans tend to construct their consensus documents:

  • convene a few people who are all in favour of a certain motion,
  • discuss the motion,
  • agree with it,
  • write up the process
  • publish your paper in a third class journal,
  • boast that there is a consensus,
  • stress that the motion must thereefore be ethical, correct and valuable.

Do chiropractors know that, using this methodology, the ‘flat earth society’ can easily pass a consensus that the earth is indeed flat?

I am sure they do!

This study investigated whether Tongxinluo,a traditional Chinese medicine compound that has shown promise in in vitro, animal, and small human studies for myocardial infarction, could improve clinical outcomes in patients with ST-segment elevation myocardial infarction (STEMI). The randomized, double-blind, placebo-controlled clinical trial was conducted among patients with STEMI within 24 hours of symptom onset from 124 hospitals in China. Patients were enrolled from May 2019 to December 2020; the last date of follow-up was December 15, 2021.

Patients were randomized 1:1 to receive either Tongxinluo or placebo orally for 12 months. A loading dose of 2.08 g was given after randomization, followed by the maintenance dose of 1.04 g, 3 times a day, in addition to STEMI guideline-directed treatments. The primary end point was 30-day major adverse cardiac and cerebrovascular events (MACCEs), a composite of cardiac death, myocardial reinfarction, emergent coronary revascularization, and stroke. Follow-up for MACCEs occurred every 3 months to 1 year.

Among 3797 patients who were randomized, 3777 (Tongxinluo: 1889 and placebo: 1888; mean age, 61 years; 76.9% male) were included in the primary analysis. Thirty-day MACCEs occurred in 64 patients (3.4%) in the Tongxinluo group vs 99 patients (5.2%) in the control group. Individual components of 30-day MACCEs, including cardiac death, were also significantly lower in the Tongxinluo group than the placebo group. By 1 year, the Tongxinluo group continued to have lower rates of MACCEs and cardiac death. There were no significant differences in other secondary end points including 30-day stroke; major bleeding at 30 days and 1 year; 1-year all-cause mortality; and in-stent thrombosis. More adverse drug reactions occurred in the Tongxinluo group than the placebo group, mainly driven by gastrointestinal symptoms.

The authors concluded that in patients with STEMI, the Chinese patent medicine Tongxinluo, as an adjunctive therapy in addition to STEMI guideline-directed treatments, significantly improved both 30-day and 1-year clinical outcomes. Further research is needed to determine the mechanism of action of Tongxinluo in STEMI.

Tongxinluo is mixture of various active ingredients, including

  • ginseng,
  • leech,
  • scorpion,
  • Paeonia lactiflora,
  • cicada slough,
  • woodlouse bug,
  • centipede,
  • sandalwood.

With chaotic mixtures of this type, it is impossible to name all the potentially active ingredients, list their actions, or identify the ones that are truly relevant. According to the thinking of TCM proponents, this would also be the wrong way to go about it – such mixtures work as a whole, they would insist.

Tongxinluo is by no means a mixture that has not been studied before.

A previous systematic review of 12 studies found that Tongxinluo capsule is superior to conventional treatment in improving clinical overall response rate and hemorheological indexes and is relatively safe. Due to the deficiencies of the existing studies, more high-quality studies with rigorous design are required for further verification.

A 2022 meta-analysis indicated that the mixture had beneficial effects on the prevention of cardiovascular adverse events, especially in TVR or ISR after coronary revascularization and may possibly lower the incidence of first or recurrent MI and HF within 12 months in patients with CHD, while insufficient sample size implied that these results lacked certain stability. And the effects of TXLC on cardiovascular mortality, cerebrovascular events, and unscheduled readmission for CVDs could not be confirmed due to insufficient cases. Clinical trials with large-sample sizes and extended follow-up time are of interest in the future researches.

A further meta-analysis suggested beneficial effects on reducing the adverse cardiovascular events without compromising safety for CHD patients after PCI on the 6-month course.

Finally, a systematic review of 10 studies found that the remedy is an effective and safe therapy for CHD patients after percutaneous coronary interventions.

So, should we believe the new study with its remarkable findings? On the one hand, the trial seems rigorous and is reported in much detail. On the other hand, the study (as all previous trials of this mixture) originates from China. We know how important TCM is for that country as an export item, and we know how notoriously unreliable Chinese research sadly has become. In view of this, I would like to see an independent replication of this study by an established research group outside China before I recommend Tongxinluo to anyone.

Let’s not forget:

if it sound too good to be true, it probably is!

 

Mistletoe, an anthroposophical medicine, is often recommended as a so-callled alternative medicine (SCAM) for cancer patients. But what type of cancer, what type of mistletoe preparation, what dosage regimen, what form of application?

The aim of this systematic analysis was to assess the concept of mistletoe treatment in published clinical studies with respect to indication, type of mistletoe preparation, treatment schedule, aim of treatment, and assessment of treatment results. The following databases were systematically searched: Medline, Embase, Cochrane Central Register of Controlled Trials (CENTRAL), PsycINFO, CINAHL, and “Science Citation Index Expanded” (Web of Science). The researchers assessed all studies for study types, methods, endpoints and mistletoe preparations including their ways of application, host trees and dosage schedules.

The searches revealed 3296 hits. Of these, 102 publications with a total of 19.441 patients were included. The researchers included several study types investigating the application of mistletoe in different groups of participants: cancer patients with any type of cancer were included as well as studies conducted with healthy volunteers and pediatric patients. The most common types of cancer were:

  • breast cancer,
  • pancreatic cancer,
  • colorectal cancer,
  • malignant melanoma.

Randomized controlled studies, cohort studies and case reports make up most of the included studies. A huge variety was observed concerning the type and composition of mistletoe extracts (differing pharmaceutical companies and host trees), ways of applications and dosage schedules. Administration varied widely, e. g. between using mistletoe extract as sole treatment and as concomitant therapy to cancer treatment. The researchers found no relationship between the mistletoe preparation used, host tree, dosage, and cancer type.

A variety of different mistletoe preparations was used to treat cancer patients. Due to the heterogeneity of the mistletoe preparations used, no comparability between different studies or within single studies using different types of mistletoe preparations or host trees is possible. Moreover, no relationship between mistletoe preparation and type of cancer can be observed. This results in a severely limited comparability of studies with regard to the different cancer entities and mistletoe therapy in oncology in general. Analyzing the methods sections of all articles, there are no information on how the selection of the respective mistletoe preparation took place. None of the articles provided any argument which type of preparation (homeopathic, anthroposophic, standardized) or which host tree was chosen due to which selection criteria. Considering preparations from different companies, funding may have been the reason of the selection.

Dosage or dosage regimens varied strongly in the studies. Due to the heterogeneity of dosage and dosage regimens within studies and between studies of the endpoints the comparability of the different studies is severely limited. Duration of mistletoe treatment varied strongly in the studies ranging from a single dose given on one day to the application of mistletoe preparations for several years. Moreover, the duration of treatment frequently varied within the studies. Mistletoe preparations were administered by different ways of application. Most frequently, the patients received mistletoe preparations subcutaneously. The second most common way was intravenous administration of mistletoe preparations. According to the respective manufacturers, this type of application is only recommended for Lektinol® and Eurixor®. Other preparations were given as off-label intravenous applications. No dosage recommendations from the respective manufacturers were available. Only in two studies the dose schedules were mentioned: according to the classical phase I 3 + 3 dose escalation schedule or in ratio to the body surface area.

The authors concluded that despite a large number of clinical studies and reports, there is a complete lack of transparently reported, structured procedures considering all fields of mistletoe therapy. This applies to type of mistletoe extract, host tree, preparation, treatment schedules as well as indication with respect of type of cancer and the respective treatment aim. All in all, despite several decades of clinical mistletoe research, no clear concept of usage is discernible and, from an evidence-based point of view, there are serious concerns on the scientific base of this part of anthroposophical treatment.

A long time ago, I worked as a junior doctor in a hospital where we used subcutaneous misteloe injections regularly to treat cancer. I remember being utterly confused: none of my peers was able to explain to me what preparation to use and how to does it. There simply were no rules and the manufacurer’s instructions made little sense. I suspected then that mistletoe therapy was a danerous nonsense. Today, after much research has been published on mistletoe, I do no longer suspect it, I know it.

I would urge every cancer patient to stay well clear of mistletoe and those practitioners who recommend it.

Autogenic training (AT) is a relaxation technique that has garnered attention for its potential to reduce anxiety and improve psychological well-being. This review aimed to synthesize the findings from a diverse range of studies investigating the relationship between AT and anxiety disorder across different populations and settings.

A comprehensive review of 162 studies, including randomised controlled trials (RCTs), non-randomized controlled trials (N-RCTs), surveys, and meta-analysis, was conducted and 29 studies were selected. Participants in the studies were patients with:

  • cancer,
  • bulimia nervosa,
  • stroke,
  • coronary angioplasty,

Others were nursing students, healthy volunteers, athletes, etc.

Anxiety levels were measured before and after the AT intervention using a variety of anxiety assessment scales, including the State Trait Anxiety Inventory (STAI) and the Hospital Anxiety and Depression Scale (HADS). The formats, duration, and delivery of the interventions varied, with some studies utilising guided sessions by professionals and other self-administered practises.

The combined findings of these studies revealed consistent trends in the beneficial effects of AT on anxiety reduction. AT was found to be effective in reducing anxiety symptoms across a wide range of populations and settings. Following AT interventions, participants reported reduced anxiety, improved mood states, and improved coping mechanisms. AT was found to be superior to no treatment or a comparable intervention in a number of cases.

The authors conclused that the body of evidence supports autogenic training as a non-pharmacological approach to reducing anxiety and improving psychological well-being. Despite differences in methodology and participant profiles, the studies show that AT has a positive impact on a wide range of populations. The findings merit further investigation and highlight AT’s potential contribution to anxiety management strategies.

I was taught AT many years ago and have practised it occasionally ever since. I have also co-authored several papers of AT that showed encouraging results, e.g.:

Thus, I feel that the conclusions of this review might be correct.

Several further recent papers seem to support the notion that AT is a treatment worth trying, e.g.:

Why then AT is not better studied and more popular? A short paragraph of my next book (to be published in about 6 months) on the inventors of so-called alternative medicines (SCAMs), including the German psychiatry professor Johannes Schulz (1884-1970), inventor of AT, might give you a clue:

Schultz supported the euthanasia program of the Nazis, i.e. the extermination of disabled and other people considered ‘unworthy of living’ during the Third Reich. He passed death sentences on “hysterical women” through his diagnoses. In 1933, Schultz began research on a guide-book on sexual education in which he focused on homosexuality and explored the topics of sterilization and euthanasia. In 1935, he published an essay about the psychological consequences of sterilization and castration among men; in it he supported compulsory sterilization of men in order to eliminate hereditary illnesses. With a diagnostic scheme developed by him in 1940, Schulz advocated the execution of mentally ill patients by stating: “I personally have to align myself with Mr. Hoche […], by recalling the ‘annihilation of life unworthy of life’ and by raising the hope that the madhouses will soon become emptied and remodelled according to this principle.” Schultz was fully aware of the consequences of his diagnostic assessment and even used the term “death sentence in the form of a diagnosis”.

I came across this evidence only years after having published my papers on AT. Would I have developed an interest in AT, if I had known about Schulz’s Nazi past? Probably not.

This systematic review aimed to assess the impact of Tai Chi on individuals with essential hypertension and to compare the effects of Tai Chi with other therapies. The researchers conducted a systematic literature search of the Medline, Scholar, Elsevier, Wiley Online Library, Chinese Academic Journal (CNKI) and Wanfang databases from January 2003 to August 2023. Using the methods of the Cochrane Collaboration Handbook, a meta-analysis was conducted to assess the collective impact of Tai Chi exercise in controlling hypertension. The primary outcomes measured included blood pressure and nitric oxide levels.

A total of 32 RCTs were included. The participants consisted of adults with an average age of 57.1 years who had hypertension (mean ± standard deviation systolic blood pressure at 148.2 ± 12.1 mmHg and diastolic blood pressure at 89.2 ± 8.3 mmHg). Individuals who practiced Tai Chi experienced reductions in systolic blood pressure of 10.6 mmHg, diastolic blood pressure of 4.7 mmHg and an increase in nitric oxide levels.

The authors concluded that Tai Chi can be a viable lifestyle intervention for managing hypertension. Greater promotion of Tai Chi by medical professionals could extend these benefits to a larger patient population.

Tai Chi allegedly incorporates principles rooted in the Yin and Yang theory, Chinese medicine meridians and breathing techniques, and creates a unique form of exercise characterized by its inward focus, continuous flow, the balance of strength and gentleness, and alternation between fast and slow movements.  What sets Tai Chi apart from other forms of excercise is the requirement for mindful guidance during practice. This aspect may, according to the authors, be the reason why Tai Chi also outperforms general aerobic exercise in managing hypertension.

I can well imagine that any form of relaxation reduces blood pressure. What I find hard to believe is that Tai Chi is better than any other relaxing SCAMs. The 32 RCTs included in this new review fail to impress me because they are all from China, and – as we have often mentioned before – studies from China are to be taken with a pinch of salt.

Yet, the subject is important enough, in my view, to merit a few rigorous trials conducted by independent researchers. Until such data are available, I think, I prefer to rely on our own systematic review which conculded that the evidence for tai chi in reducing blood pressure … is limited. Whether tai chi has benefits over exercise is still unclear. The number of trials and the total sample size are too small to draw any firm conclusions.

 

 

 

So-called alternative medicine (SCAM) interventions are growing in popularity and are even advocated as treatments for long COVID symptoms. However, comprehensive analysis of current evidence in this setting is still lacking. This study aims to review existing published studies on the use of SCAM interventions for patients experiencing long COVID through a systematic review of randomized controlled trials (RCTs).
A comprehensive electronic literature search was performed in multiple databases and clinical trial registries from September 2019 to January 2023. RCTs evaluating efficacy and safety of SCAM for long COVID were included. Methodological quality of each included trial
was appraised with the Cochrane ‘risk of bias’ tool. A qualitative analysis was conducted due to heterogeneity of included studies.

A total of 14 RCTs with 1195 participants were included in this review. Study findings demonstrated that SCAM interventions could benefit patients with long COVID, especially those suffering from

  • neuropsychiatric disorders,
  • olfactory dysfunction,
  • cognitive impairment,
  • fatigue,
  • breathlessness,
  • mild-to-moderate lung fibrosis.

The main interventions reported were:

  • self-administered transcutaneous auricular vagus nerve stimulation,
  • neuro-meditation,
  • dietary supplements,
  • olfactory training,
  • aromatherapy,
  • inspiratory muscle training,
  • concurrent training,
  • online breathing programs,
  • online well-being programs.

The authors concluded that SCAM interventions may be effective, safe, and acceptable to patients with symptoms of long COVID. However, the findings from this systematic review should be interpreted with caution due to various methodological limitations. More rigorous trials focused on CAM for long COVID are warranted in the future.

Such wishy-washy conclusions seem to be popular in the fantasy land of SCAM. Yet, they are, in my view, most ojectionable because:

  1. they tell us nothing of value;
  2. that something “MAY BE EFFECTIVE” has been known before and cannot be the result of but is the reason for a systematic review;
  3. a review of 14 RCTs of almost as many interventions cannot possibly tell us anything about the SAFETY of these treatments;
  4. it also does not provide evidence of effectiveness and merely indicates a lack of independent replications;
  5. if the abstract mentions an assessment of the study rigor, one expects that it also informs us about this important aspect.

Once we do come around looking at the methodological quality of the primary studies we realize that it is mostly miserable. This means that the conclusions of the review are not just irritating but plainly misleading. Responsible researchers should have concluded along the following lines:

The quantity and the quality of the evidence are both low. Therefore, the effectiveness and safety of SCAM interventions for long COVID remains unproven.

PS

This project was financially supported by The HEAD Foundation, Singapore and in part by the grant from the NIH R61 AT01218.

Shame on the authors, journal editors, peer-reviewers, and funders of this dangerous nonsense!

Many of you will be familiar with the ‘ALTERNATIVE MEDICINE HALL OF FAME’. It is my creation and meant to honour reserchers who have dedicated much of their professional career to investigating a form of so-called alternative medicine (SCAM) without ever publishing negative conclusions about it. Obviously, if anyone studies any therapy, he/she will occasionally produce a negative finding. This would be the case, even if he/she tests an effective treatment. However, if the treatment in question comes from the realm of SCAM, one would expect negative results fairly regularly. No therapy works well under all conditions, and to the best of my knowledge, no SCAM is a panacea!

This is why researchers who defy this inevitability are remarkable. If someone tests a treatment that is at best dubious and at worst bogus, we are bound to see some studies that are not positive. He/she would thus have a high or normal ‘TRUSTWORTHINESS INDEX‘ (another creation of mine which, I think, is fairly self-explanatory). Conversely, any researcher who does manage to publish nothing but positive results of a SCAM is bound to have a very low ‘TRUSTWORTHINESS INDEX‘. In other words, these people are special, so much so that  I decided to honour such ‘geniuses’ by admitting them to my ALTERNATIVE MEDICINE OF FAME.

So far, this elite group of people comprises the following individuals:

  1. Helge Franke (osteopathy, Germany)
  2. Tery Oleson (acupressure , US)
  3. Jorge Vas (acupuncture, Spain)
  4. Wane Jonas (homeopathy, US)
  5. Harald Walach (various SCAMs, Germany)
  6. Andreas Michalsen ( various SCAMs, Germany)
  7. Jennifer Jacobs (homeopath, US)
  8. Jenise Pellow (homeopath, South Africa)
  9. Adrian White (acupuncturist, UK)
  10. Michael Frass (homeopath, Austria)
  11. Jens Behnke (research officer, Germany)
  12. John Weeks (editor of JCAM, US)
  13. Deepak Chopra (entrepreneur, US)
  14. Cheryl Hawk (chiropractor, US)
  15. David Peters (osteopathy, homeopathy, UK)
  16. Nicola Robinson (TCM, UK)
  17. Peter Fisher (homeopathy, UK)
  18. Simon Mills (herbal medicine, UK)
  19. Gustav Dobos (various SCAMs, Germany)
  20. Claudia Witt (homeopathy, Germany/Switzerland)
  21. George Lewith (acupuncture, UK)
  22. John Licciardone (osteopathy, US)

You will notice that the group does not yet contain a representative of anthroposophic medicine. Today, I intend to rectify this oversight by admitting Helmut Kiene (1952-). He has published plenty of studies and reviews on his pet subject; here are the ones that I found on Medline:

  1. Anthroposophic therapies in chronic disease: the Anthroposophic Medicine Outcomes Study (AMOS). Hamre HJ, Becker-Witt C, Glockmann A, Ziegler R, Willich SN, Kiene H.Eur J Med Res. 2004 Jul 30;9(7):351-60.
  2. Anthroposophic medical therapy in chronic disease: a four-year prospective cohort study. Hamre HJ, Witt CM, Glockmann A, Ziegler R, Willich SN, Kiene H.BMC Complement Altern Med. 2007 Apr 23;7:10. doi: 10.1186/1472-6882-7-10.
  3. Anthroposophic art therapy in chronic disease: a four-year prospective cohort study. Hamre HJ, Witt CM, Glockmann A, Ziegler R, Willich SN, Kiene H.Explore (NY). 2007 Jul-Aug;3(4):365-71. doi: 10.1016/j.explore.2007.04.008.
  4. Rhythmical massage therapy in chronic disease: a 4-year prospective cohort study. Hamre HJ, Witt CM, Glockmann A, Ziegler R, Willich SN, Kiene H.J Altern Complement Med. 2007 Jul-Aug;13(6):635-42. doi: 10.1089/acm.2006.6345
  5. Anthroposophic vs. conventional therapy for chronic low back pain: a prospective comparative study. Hamre HJ, Witt CM, Glockmann A, Wegscheider K, Ziegler R, Willich SN, Kiene H.Eur J Med Res. 2007 Jul 26;12(7):302-10.
  6. Viscum album L. extracts in breast and gynaecological cancers: a systematic review of clinical and preclinical research. Kienle GS, Glockmann A, Schink M, Kiene H.J Exp Clin Cancer Res. 2009 Jun 11;28(1):79. doi: 10.1186/1756-9966-28-79.
  7. Anthroposophic therapy for children with chronic disease: a two-year prospective cohort study in routine outpatient settings. Hamre HJ, Witt CM, Kienle GS, Meinecke C, Glockmann A, Willich SN, Kiene H.BMC Pediatr. 2009 Jun 19;9:39. doi: 10.1186/1471-2431-9-39
  8. Predictors of outcome after 6 and 12 months following anthroposophic therapy for adult outpatients with chronic disease: a secondary analysis from a prospective observational study. Hamre HJ, Witt CM, Kienle GS, Glockmann A, Willich SN, Kiene H.BMC Res Notes. 2010 Aug 3;3:218. doi: 10.1186/1756-0500-3-218.
  9. Pulpa dentis D30 for acute reversible pulpitis: A prospective cohort study in routine dental practice. Hamre HJ, Mittag I, Glockmann A, Kiene H, Tröger W.Altern Ther Health Med. 2011 Jan-Feb;17(1):16-21.
  10. Use and safety of anthroposophic medications for acute respiratory and ear infections: a prospective cohort study. Hamre HJ, Glockmann A, Fischer M, Riley DS, Baars E, Kiene H.
  11. [Clinical research on anthroposophic medicine:update of a health technology assessment report and status quo]. Kienle GS, Glockmann A, Grugel R, Hamre HJ, Kiene H.Forsch Komplementmed. 2011;18(5):269-82. doi: 10.1159/000331812. Epub 2011 Oct 4.
  12. Anthroposophical medicine: a systematic review of randomised clinical trials. Kienle GS, Hamre HJ, Kiene H.Wien Klin Wochenschr. 2004 Jun 30;116(11-12):407-8; author reply 408. doi: 10.1007/BF03040923.
  13. Eurythmy therapy in chronic disease: a four-year prospective cohort study. Hamre HJ, Witt CM, Glockmann A, Ziegler R, Willich SN, Kiene H.BMC Public Health. 2007 Apr 23;7:61. doi: 10.1186/1471-2458-7-61.
  14. Long-term outcomes of anthroposophic therapy for chronic low back pain: A two-year follow-up analysis. Hamre HJ, Witt CM, Kienle GS, Glockmann A, Ziegler R, Willich SN, Kiene H.J Pain Res. 2009 Jun 25;2:75-85. doi: 10.2147/jpr.s5922.
  15. Health costs in anthroposophic therapy users: a two-year prospective cohort study. Hamre HJ, Witt CM, Glockmann A, Ziegler R, Willich SN, Kiene H.BMC Health Serv Res. 2006 Jun 2;6:65. doi: 10.1186/1472-6963-6-65.
  16. Use and safety of anthroposophic medications in chronic disease: a 2-year prospective analysis. Hamre HJ, Witt CM, Glockmann A, Tröger W, Willich SN, Kiene H.Drug Saf. 2006;29(12):1173-89. doi: 10.2165/00002018-200629120-00008.
  17. Anthroposophic therapy for chronic depression: a four-year prospective cohort study. Hamre HJ, Witt CM, Glockmann A, Ziegler R, Willich SN, Kiene H.BMC Psychiatry. 2006 Dec 15;6:57. doi: 10.1186/1471-244X-6-57.
  18. Health costs in patients treated for depression, in patients with depressive symptoms treated for another chronic disorder, and in non-depressed patients: a two-year prospective cohort study in anthroposophic outpatient settings. Hamre HJ, Witt CM, Glockmann A, Ziegler R, Kienle GS, Willich SN, Kiene H.Eur J Health Econ. 2010 Feb;11(1):77-94. doi: 10.1007/s10198-009-0203-0.
  19. Outcome of anthroposophic medication therapy in chronic disease: a 12-month prospective cohort study. Hamre HJ, Witt CM, Glockmann A, Ziegler R, Kienle GS, Willich SN, Kiene H.Drug Des Devel Ther. 2009 Feb 6;2:25-37.
  20. Clinical research in anthroposophic medicine. Hamre HJ, Kiene H, Kienle GS.Altern Ther Health Med. 2009 Nov-Dec;15(6):52-5.
  21. Anthroposophic therapy for attention deficit hyperactivity: a two-year prospective study in outpatients. Hamre HJ, Witt CM, Kienle GS, Meinecke C, Glockmann A, Ziegler R, Willich SN, Kiene H.Int J Gen Med. 2010 Aug 30;3:239-53. doi: 10.2147/ijgm.s11725.
  22. Anthroposophic therapy for asthma: A two-year prospective cohort study in routine outpatient settings. Hamre HJ, Witt CM, Kienle GS, Schnürer C, Glockmann A, Ziegler R, Willich SN, Kiene H.J Asthma Allergy. 2009 Nov 24;2:111-28.
  23. Anthroposophic therapy for migraine: a two-year prospective cohort study in routine outpatient settings. Hamre HJ, Witt CM, Kienle GS, Glockmann A, Ziegler R, Rivoir A, Willich SN, Kiene H.Open Neurol J. 2010;4:100-10. 
  24. Antibiotic Use in Children with Acute Respiratory or Ear Infections: Prospective Observational Comparison of Anthroposophic and Conventional Treatment under Routine Primary Care Conditions. Hamre HJ, Glockmann A, Schwarz R, Riley DS, Baars EW, Kiene H, Kienle GS.Evid Based Complement Alternat Med. 2014;2014:243801. 
  25. An assessment of the scientific status of anthroposophic medicine, applying criteria from the philosophy of science. Baars EW, Kiene H, Kienle GS, Heusser P, Hamre HJ.Complement Ther Med. 2018 Oct;40:145-150.
  26. Anthroposophic vs. conventional therapy of acute respiratory and ear infections: a prospective outcomes study. Hamre HJ, Fischer M, Heger M, Riley D, Haidvogl M, Baars E, Bristol E, Evans M, Schwarz R, Kiene H.Wien Klin Wochenschr. 2005 Apr;117(7-8):256-68. doi: 10.1007/s00508-005-0344-9.
  27. Long-term outcomes of anthroposophic treatment for chronic disease: a four-year follow-up analysis of 1510 patients from a prospective observational study in routine outpatient settings. Hamre HJ, Kiene H, Glockmann A, Ziegler R, Kienle GS.BMC Res Notes. 2013 Jul 13;6:269. doi: 10.1186/1756-0500-6-269
  28. Eurythmy Therapy in anxiety. Kienle GS, Hampton Schwab J, Murphy JB, Andersson P, Lunde G, Kiene H, Hamre HJ.Altern Ther Health Med. 2011 Jul-Aug;17(4):56-63
  29. Mistletoe in cancer – a systematic review on controlled clinical trials. Kienle GS, Berrino F, Büssing A, Portalupi E, Rosenzweig S, Kiene H.Eur J Med Res. 2003 Mar 27;8(3):109-19.
  30. Anthroposophic therapy of respiratory and ear infections. Hamre HJ, Fischer M, Heger M, Riley D, Haidvogl M, Baars E, Bristol E, Evans M, Schwarz R, Kiene H.Wien Klin Wochenschr. 2005 Jul;117(13-14):500-1. doi: 10.1007/s00508-005-0389-9
  31. Complementary cancer therapy: a systematic review of prospective clinical trials on anthroposophic mistletoe extracts.
    Kienle GS, Kiene H.Eur J Med Res. 2007 Mar 26;12(3):103-19.
  32. Review article: Influence of Viscum album L (European mistletoe) extracts on quality of life in cancer patients: a systematic review of controlled clinical studies. Kienle GS, Kiene H.Integr Cancer Ther. 2010 Jun;9(2):142-57. 
  33. [Anthroposophic medicine: health technology assessment report – short version].
    Kienle GS, Kiene H, Albonico HU.Forsch Komplementmed. 2006;13 Suppl 2:7-18. doi: 10.1159/000093481. Epub 2006 Jun 26.
  34. Bilateral Asynchronous Renal Cell Carcinoma With Lung Metastases: A Case Report of a Patient Treated Solely With High-dose Intravenous and Subcutaneous Viscum album Extract for a Second Renal Lesion. Reynel M, Villegas Y, Kiene H, Werthmann PG, Kienle GS.Anticancer Res. 2019 Oct;39(10):5597-5604. doi: 10.21873/anticanres.13754.
  35. Long-term survival of a patient with an inoperable thymic neuroendocrine tumor stage IIIa under sole treatment with Viscum album extract: A CARE compliant clinical case report. Reynel M, Villegas Y, Werthmann PG, Kiene H, Kienle GS.Medicine (Baltimore). 2020 Jan;99(5):e18990. doi: 10.1097/MD.0000000000018990
  36. Long-Term Survival of a Patient with Recurrent Dedifferentiated High-Grade Liposarcoma of the Retroperitoneum Under Adjuvant Treatment with Viscum album L. Extract: A Case Report. Reynel M, Villegas Y, Werthmann PG, Kiene H, Kienle GS.Integr Cancer Ther. 2021 Jan-Dec;20:1534735421995258. doi: 10.1177/1534735421995258.
  37. Intralesional and subcutaneous application of Viscum album L. (European mistletoe) extract in cervical carcinoma in situ: A CARE compliant case report. Reynel M, Villegas Y, Kiene H, Werthmann PG, Kienle GS.Medicine (Baltimore). 2018 Nov;97(48):e13420. 
  38. High-Dose Viscum album Extract Treatment in the Prevention of Recurrent Bladder Cancer: A Retrospective Case Series.
    von Schoen-Angerer T, Wilkens J, Kienle GS, Kiene H, Vagedes J.Perm J. 2015 Fall;19(4):76-83. doi: 10.7812/TPP/15-018.
  39. Disappearance of an advanced adenomatous colon polyp after intratumoural injection with Viscum album (European mistletoe) extract: a case report. von Schoen-Angerer T, Goyert A, Vagedes J, Kiene H, Merckens H, Kienle GS.J Gastrointestin Liver Dis. 2014 Dec;23(4):449-52. doi: 10.15403/jgld.2014.1121.234.acpy.
  40. Viscum Album in the Treatment of a Girl With Refractory Childhood Absence Epilepsy. von Schoen-Angerer T, Madeleyn R, Kienle G, Kiene H, Vagedes J.J Child Neurol. 2015 Jul;30(8):1048-52. doi: 10.1177/0883073814541473. Epub 2014 Jul 17.
  41. Improvement of Asthma and Gastroesophageal Reflux Disease With Oral Pulvis stomachicus cum Belladonna, a Combination of Matricaria recutita, Atropa belladonna, Bismuth, and Antimonite: A Pediatric Case Report. von Schoen-Angerer T, Madeleyn R, Kiene H, Kienle GS, Vagedes J.Glob Adv Health Med. 2016 Jan;5(1):107-11. doi: 10.7453/gahmj.2015.019. Epub 2016 Jan 1.
  42. Use of Iscador, an extract of European mistletoe (Viscum album), in cancer treatment: prospective nonrandomized and randomized matched-pair studies nested within a cohort study. Grossarth-Maticek R, Kiene H, Baumgartner SM, Ziegler R.Altern Ther Health Med. 2001 May-Jun;7(3):57-66, 68-72, 74-6 passim

WHAT A LIST!

It makes several things very clear to me:

  • Kiene is a productive researcher
  • He likes observational studies and case reports
  • He dislikes the idea of rigorously testing a hypothesis
  • He never publishes a negative finding about anthroposophical medicine
  • He certainly deserves to be admitted to the ALTERNATIVE MEDICINE HALL OF FAME!

Welcome Helmut

This review evaluated the magnitude of the placebo response of sham acupuncture in trials of acupuncture for nonspecific LBP, and assessed whether different types of sham acupuncture are associated with different responses. Four databases including PubMed, EMBASE, MEDLINE, and the Cochrane Library were searched through April 15, 2023, and randomized controlled trials (RCTs) were included if they randomized patients with LBP to receive acupuncture or sham acupuncture intervention. The main outcomes included the placebo response in pain intensity, back-specific function and quality of life. Placebo response was defined as the change in these outcome measures from baseline to the end of treatment. Random-effects models were used to synthesize the results, standardized mean differences (SMDs, Hedges’g) were applied to estimate the effect size.

A total of 18 RCTs with 3,321 patients were included. Sham acupuncture showed a noteworthy pooled placebo response in pain intensity in patients with LBP [SMD −1.43, 95% confidence interval (CI) −1.95 to −0.91, I2=89%]. A significant placebo response was also shown in back-specific functional status (SMD −0.49, 95% CI −0.70 to −0.29, I2=73%), but not in quality of life (SMD 0.34, 95% CI −0.20 to 0.88, I2=84%). Trials in which the sham acupuncture penetrated the skin or performed with regular needles had a significantly higher placebo response in pain intensity reduction, but other factors such as the location of sham acupuncture did not have a significant impact on the placebo response.

The authors concluded that sham acupuncture is associated with a large placebo response in pain intensity among patients with LBP. Researchers should also be aware that the types of sham acupuncture applied may potentially impact the evaluation of the efficacy of acupuncture. Nonetheless, considering the nature of placebo response, the effect of other contextual factors cannot be ruled out in this study.

As the authors stated in their conclusion: the effect of other contextual factors cannot be ruled out. I would go much further and say that the outcomes noted here are mostly due to effects other than placebo. Obvious candidates are:

  • regression towards the mean;
  • natural history of the condition;
  • success of patient blinding;
  • social desirability.

To define the placebo effect in acupuncture trials as the change in the outcome measures from baseline to the end of treatment – as the authors of the review do – is not just naive, it is plainly wrong. I would not be surprised, if different sham acupuncture treatments have different effects. To me this would be an expected, plausible finding. But such differences just cannot be estimated in the way the authors suggest. For that, we would need an RCT in which patients are randomized to be treated in the same setting with a range of different types of sham acupuncture. The results of such a study might be revealing but I doubt that many ethics committees would be happy to grant their approval for it.

In the absence of such data, the best we can do is to design trials such that the verum is tested against a credible placebo which, for patients, is indistinguishable from the verum, while demonstrating that blinding is successful.

Subscribe via email

Enter your email address to receive notifications of new blog posts by email.

Recent Comments

Note that comments can be edited for up to five minutes after they are first submitted but you must tick the box: “Save my name, email, and website in this browser for the next time I comment.”

The most recent comments from all posts can be seen here.

Archives
Categories