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

systematic review

Rapidly rising in popularity, kratom is hailed by some as a readily available pain remedy that is safer than traditional opioids, an effective addiction withdrawal aid and a pleasurable recreational tonic. But kratom also is assailed as a dangerous and unregulated drug that can be purchased on the Internet, a habit-forming substance that authorities say can result in opioid-like abuse and death.

Last week, the Food and Drug Administration announced that the herbal supplement kratom possesses the properties of an opioid, thus escalating the government’s effort to slow usage of this alternative pain reliever. The FDA states that the number of deaths associated with kratom use has increased to a total of 44, up from a total of 36 since the FDA’s November 2017 report. In the majority of deaths that FDA attributes to kratom, subjects ingested multiple substances with known risks, including alcohol. The presence of multiple drugs makes it difficult to determine the role any one of them played.

So, what is kratom, and why might it be dangerous?

A recent review explains that the leaves of Mitragyna speciosa (commonly known as kratom), a tree endogenous to parts of Southeast Asia, have been used traditionally for their stimulant, mood-elevating, and analgesic effects. The plant’s active constituents, mitragynine and 7-hydroxymitragynine, have been shown to modulate opioid receptors, acting as partial agonists at mu-opioid receptors and competitive antagonists at kappa- and delta-opioid receptors. Both alkaloids are G protein-biased agonists of the mu-opioid receptor and therefore, may induce less respiratory depression than classical opioid agonists. The Mitragyna alkaloids also appear to exert diverse activities at other brain receptors (including adrenergic, serotonergic, and dopaminergic receptors), which may explain the complex pharmacological profile of raw kratom extracts. Kratom exposure alone has not been causally associated with human fatalities to date. However, further research is needed to clarify the complex mechanism of action of the Mitragyna alkaloids and unlock their full therapeutic potential.

Another review adds that, by the early 2000s, kratom was increasingly used in the US as a natural remedy to improve mood and quality of life and as substitutes for prescription and illicit opioids for managing pain and opioid withdrawal by people seeking abstinence from opioids. There has been no documented threat to public health that would appear to warrant emergency scheduling of the products and placement in Schedule I of the CSA carries risks of creating serious public health problems. Banning kratom, risks creating public health problems that do not presently exist.

A third review explains that there are no published human pharmacologic, pharmacokinetic, or drug interaction studies on kratom or mitragynine, making it virtually impossible to fully understand kratom‘s therapeutic potential and risks and the populations most likely to benefit or experience harm from its use. Kratom has been used to ameliorate opioid withdrawal symptoms but also induces withdrawal. Human pharmacologic, pharmacokinetic and clinical data are of low quality precluding any firm conclusions regarding safety and efficacy. Kratom does cause a host of adverse effects without clear guidance for how they should be treated. There are numerous assessments where people have been unable to stop using kratom therapy and withdrawal signs and symptoms are problematic. Kratom does not appear in normal drug screens and, when taken with other substances of abuse, may not be recognized.

A systematic review evaluated all studies on kratom use and mental health published between January 1960 and July 2017. Its findings indicate kratom‘s potential as a harm reduction tool, most notably as a substitute for opioids among people who are addicted. Kratom also enhances mood and relieves anxiety among many users. For many, kratom‘s negative mental health effects – primarily withdrawal symptoms – appear to be mild relative to those of opioids. For some users, however, withdrawal is highly uncomfortable and maintaining abstinence becomes difficult.

In Europe, as of 2011, kratom has become a controlled drug in Denmark, Latvia, Lithuania, Poland, Romania and Sweden. In the UK, since 2016, the sale, import, and export of kratom are prohibited.

On balance, my conclusion is that we urgently need more data and meanwhile should avoid this ‘herbal drug’.

 

Many hard-nosed sceptics might claim that there is no herbal treatment for upper respiratory infections that makes the slightest difference difference. But is this assumption really correct?

According to my own research of 2004, it is not. Here is the abstract of our systematic review:

Acute respiratory infections represent a significant cause of over-prescription of antibiotics and are one of the major reasons for absence from work. The leaves of Andrographis paniculata (Burm. f.) Wall ex Nees (Acanthaceae) are used as a medicinal herb in the treatment of infectious diseases. Systematic literature searches were conducted in six computerised databases and the reference lists of all papers located were checked for further relevant publications. Information was also requested from manufacturers, the spontaneous reporting schemes of the World Health Organisation and national drug safety bodies. No language restrictions were imposed. Seven double-blind, controlled trials (n = 896) met the inclusion criteria for evaluation of efficacy. All trials scored at least three, out of a maximum of five, for methodological quality on the Jadad scale. Collectively, the data suggest that A. paniculata is superior to placebo in alleviating the subjective symptoms of uncomplicated upper respiratory tract infection. There is also preliminary evidence of a preventative effect. Adverse events reported following administration of A. paniculata were generally mild and infrequent. There were few spontaneous reports of adverse events. A. paniculata may be a safe and efficacious treatment for the relief of symptoms of uncomplicated upper respiratory tract infection; more research is warranted.

A. Paniculata (Burm.f.) Wall ex Nees (Acanthaceae family), also known as nemone chinensi, Chuān Xīn Lián, has traditionally been used in Indian and Chinese herbal medicine mostly as an antipyretic for relieving and reducing the severity and duration of symptoms of common colds and alleviating fever, cough and sore throats, or as a tonic to aid convalescence after uncomplicated respiratory tract infections. The active constituents of A. paniculata include the diterpene, lactones commonly known as the andrographolides which have shown anti-inflammatory, antiviral, anti-allergic, and immune-stimulatory activities. A. Paniculata has also been shown, in vitro, to be effective against avian influenza A (H9N2 and H5N1) and human influenza A H1N1 viruses, possibly through blocking the binding of viral hemagglutinin to cells, or by inhibiting H1N1 virus-induced cell death.

But our systematic review was published 14 years ago!

We need more up-to-date information!

And I am pleased to report that a recent paper provided exactly that.

This systematic review included published and unpublished RCTs. Quasi-RCTs, crossover trials, controlled before and after studies, interrupted time series (ITS) studies, and non-experimental studies were not included due to their potential high risk of bias.

Thirty-three trials involving 7175 patients with ARTIs were included. Their methodological quality was restricted as randomisation was not well documented; 73% of the trials included were not blinded; where ITT analysis were performed, loss to follow-up data were counted as no effect; and most trials were published without a protocol available.

Findings suggested limited but consistent evidence that A. Paniculata improved cough and sore throat when compared with placebo. A. Paniculata (alone or plus usual care) had a statistically significant effect in improving overall symptoms of ARTIs when compared to placebo, usual care, and other herbal therapies. A. Paniculata in pillule tended to be more effective in improving overall symptoms over A. Paniculata in tablet. Evidence also suggested that A. Paniculata (alone or plus usual care) shortens the duration of cough, sore throat and sick leave/time to resolution when compared versus usual care. Reduction in antibiotic usage was seldom evaluated in the included trials.

The authors concluded that A. Paniculata appears beneficial and safe for relieving ARTI symptoms and shortening time to symptom resolution. However, these findings should be interpreted cautiously owing to poor study quality and heterogeneity. Well-designed trials evaluating the effectiveness and potential to reduce antibiotic use of A. Paniculata are warranted.

In case you wonder about conflicts of interest: there were none with my 2004 paper, and the authors of the new review state that this paper presents independent research funded by the National Institute for Health Research School for Primary Care Research (NIHR SPCR). The views expressed are those of the author(s) and not necessarily those of the NIHR, the NHS or the Department of Health.

Yes, the RCTs are not all of top quality.

And yes, the effect size is not huge.

But maybe – just maybe – we do have here an alternative therapy that does help against a condition for which conventional drugs are fairly useless!?!

Some of you will remember the saga of the British Chiropractic Association suing my friend and co-author Simon Singh (eventually losing the case, lots of money and all respect). One of the ‘hot potatoes’ in this case was the question whether chiropractic is effective for infant colic. This question is settled, I thought: IT HAS NOT BEEN SHOWN TO WORK BETTER THAN A PLACEBO.

Yet manipulators have not forgotten the defeat and are still plotting, it seems, to overturn it. Hence a new systematic review assessed the effect of manual therapy interventions for healthy but unsettled, distressed and excessively crying infants.

The authors reviewed published peer-reviewed primary research articles in the last 26 years from nine databases (Medline Ovid, Embase, Web of Science, Physiotherapy Evidence Database, Osteopathic Medicine Digital Repository , Cochrane (all databases), Index of Chiropractic Literature, Open Access Theses and Dissertations and Cumulative Index to Nursing and Allied Health Literature). The inclusion criteria were: manual therapy (by regulated or registered professionals) of unsettled, distressed and excessively crying infants who were otherwise healthy and treated in a primary care setting. Outcomes of interest were: crying, feeding, sleep, parent-child relations, parent experience/satisfaction and parent-reported global change. The authors included the following types of peer-reviewed studies in our search: RCTs, prospective cohort studies, observational studies, case–control studies, case series, questionnaire surveys and qualitative studies.

Nineteen studies were selected for full review: seven randomised controlled trials, seven case series, three cohort studies, one service evaluation study and one qualitative study. Only 5 studies were rated as high quality: four RCTs (low risk of bias) and a qualitative study.

The authors found moderate strength evidence for the effectiveness of manual therapy on: reduction in crying time (favourable: -1.27 hours per day (95% CI -2.19 to -0.36)), sleep (inconclusive), parent-child relations (inconclusive) and global improvement (no effect).

Reduction in crying: RCTs mean difference.

The risk of reported adverse events was low (only 8 studies mentioned adverse effects at all, meaning that the rest were in breach of research and publication ethics): seven non-serious events per 1000 infants exposed to manual therapy (n=1308) and 110 per 1000 in those not exposed.

The authors concluded that some small benefits were found, but whether these are meaningful to parents remains unclear as does the mechanisms of action. Manual therapy appears relatively safe.

For several reasons, I find this review, although technically sound, quite odd.

Why review uncontrolled data when RCTs are available?

How can a qualitative study be rated as high quality for assessing the effectiveness of a therapy?

How can the authors categorically conclude that there were benefits when there were only 4 RCTs of high quality?

Why do they not explain the implications of none of the RCTs being placebo-controlled?

How can anyone pool the results of all types of manual therapies which, as most of us know, are highly diverse?

How can the authors conclude about the safety of manual therapies when most trials failed to report on this issue?

Why do they not point out that this is unethical?

My greatest general concern about this review is the overt lack of critical input. A systematic review is not a means of promoting an intervention but of critically assessing its value. This void of critical thinking is palpable throughout the paper. In the discussion section, for instance, the authors state that “previous systematic reviews from 2012 and 2014 concluded there was favourable but inconclusive and weak evidence for manual therapy for infantile colic. They mention two reviews to back up this claim. They conveniently forget my own review of 2009 (the first on this subject). Why? Perhaps because it did not fit their preconceived ideas? Here is my abstract:

Some chiropractors claim that spinal manipulation is an effective treatment for infant colic. This systematic review was aimed at evaluating the evidence for this claim. Four databases were searched and three randomised clinical trials met all the inclusion criteria. The totality of this evidence fails to demonstrate the effectiveness of this treatment. It is concluded that the above claim is not based on convincing data from rigorous clinical trials.

Towards the end of their paper, the authors state that “this was a comprehensive and rigorously conducted review…” I beg to differ; it turned out to be uncritical and biased, in my view. And at the very end of the article, we learn a possible reason for this phenomenon: “CM had financial support from the National Council for Osteopathic Research from crowd-funded donations.”

Few people would argue that Cochrane reviews tend to be the most rigorous, independent and objective assessments of therapeutic interventions we currently have. Therefore, it is relevant to see what they tell us about the value of acupuncture.

Here is a fascinating overview of all Cochrane reviews of acupuncture. It was compiled by the formidable guys at ‘FRIENDS OF SCIENCE-BEASED MEDICINE‘ in Australia. They gave me the permission to publish it here (thanks Loretta!).

 

Considering this collective evidence, it would be hard to dispute the conclusion that there is no convincing evidence that acupuncture is an effective therapy, I believe.

What do you think?

As I have stated repeatedly, I am constantly on the look-out for positive news about alternative medicine. Usually, I find plenty – but when I scrutinise it, it tends to crumble in the type of misleading report that I often write about on this blog. Truly good research in alternative medicine is hard to find, and results that are based on rigorous science and show a positive finding are a bit like gold-dust.

But hold on, today I have something!

This systematic review was aimed at determining whether physical exercise is effective in improving cognitive function in the over 50s. The authors evaluated all randomised controlled trials of physical exercise interventions in community-dwelling adults older than 50 years with an outcome measure of cognitive function.

39 studies were included in the systematic review. Analysis of 333 dependent effect sizes from 36 studies showed that physical exercise improved cognitive function. Interventions of aerobic exercise, resistance training, multicomponent training and tai chi, all had significant point estimates. When exercise prescription was examined, a duration of 45–60 min per session and at least moderate intensity, were associated with benefits to cognition. The results of the meta-analysis were consistent and independent of the cognitive domain tested or the cognitive status of the participants.

The authors concluded that physical exercise improved cognitive function in the over 50s, regardless of the cognitive status of participants. To improve cognitive function, this meta-analysis provides clinicians with evidence to recommend that patients obtain both aerobic and resistance exercise of at least moderate intensity on as many days of the week as feasible, in line with current exercise guidelines.

But this is not alternative medicine, I hear you say.

You are right, mostly, it isn’t. There were a few RCTs of tai chi and yoga, but the majority was of conventional exercise. Moreover, most of these ‘alternative’ RCTs were less convincing than the conventional RCTs; here is one of the former category:

Community-dwelling older adults (N = 118; mean age = 62.0) were randomized to one of two groups: a Hatha yoga intervention or a stretching-strengthening control. Both groups participated in hour-long exercise classes 3×/week over the 8-week study period. All participants completed established tests of executive function including the task switching paradigm, n-back and running memory span at baseline and follow-up. Analysis of covariances showed significantly shorter reaction times on the mixed and repeat task switching trials (partial η(2) = .04, p < .05) for the Hatha yoga group. Higher accuracy was recorded on the single trials (partial η(2) = .05, p < .05), the 2-back condition of the n-back (partial η(2) = .08, p < .001), and partial recall scores (partial η(2) = .06, p < .01) of running span task.

I just wanted to be generous and felt the need to report a positive result. I guess, this just shows how devoid of rigorous research generating a positive finding alternative medicine really is.

Of course, there are many readers of this blog who are convinced that their pet therapy is supported by excellent evidence. For them, I have this challenge: if you think you have good evidence for an alternative therapy, show it to me (send it to me via the ‘contact’ option of this blog or post the link as a comment below). Please note that any evidence I would consider analysing in some detail (writing a full blog post about it) would need to be recent, peer-reviewed and rigorous.

This systematic review aimed to identify and explore published studies on the health, wellbeing and economic impact of retreat experiences. Three electronic databases were searched for residential retreat studies published in English. Studies were included, if they involved an intervention program in a residential setting of one or more nights, and included before-and-after data related to the health of participants.

A total of 23 studies including 8 randomised controlled trials, 6 non-randomised controlled trials and 9 longitudinal cohort studies met the inclusion criteria. These studies included a total of 2592 participants from diverse geographical and demographic populations and a great heterogeneity of outcome measures, with 7 studies examining objective outcomes such as blood pressure or biological makers of disease, and 16 studies examining subjective outcomes that mostly involved self-reported questionnaires on psychological and spiritual measures.

All studies reported post-retreat health benefits ranging from immediately after to five-years post-retreat. Study populations varied widely and most studies had small sample sizes, poorly described methodology and little follow-up data, and no studies reported on health economic outcomes or adverse effects, making it difficult to make definite conclusions about specific conditions, safety or return on investment.

The authors concluded that health retreat experiences appear to have health benefits that include benefits for people with chronic diseases such as multiple sclerosis, various cancers, HIV/AIDS, heart conditions and mental health. Future research with larger numbers of subjects and longer follow-up periods are needed to investigate the health impact of different retreat experiences and the clinical populations most likely to benefit. Further studies are also needed to determine the economic benefits of retreat experiences for individuals, as well as for businesses, health insurers and policy makers.

In the article, the authors also state that the findings from the reviewed studies suggest there are many positive health benefits from retreat experiences that includes improvements in both subjective and objective measures… The results from the most rigorous studies that used randomized controlled designs were consistent with less rigorous studies and suggest that retreat experiences can produce benefits that include positive changes in metabolic and neurological pathways, loss of weight, blood pressure and abdominal girth, reduction in health symptoms and improvements in quality of life and subjective wellbeing.

As it happens, we have discussed one of their ‘most rigorous’ RCTs on this blog. Here is what I wrote about it when it was first published:

The ‘study‘ in question allegedly examined the effects of a comprehensive residential mind–body program on well-being. The authors describe it as “a quasi-randomized trial comparing the effects of participation in a 6-day Ayurvedic system of medicine-based comprehensive residential program with a 6-day residential vacation at the same retreat location.” They included 69 healthy women and men who received the Ayurvedic intervention addressing physical and emotional well-being through group meditation and yoga, massage, diet, adaptogenic herbs, lectures, and journaling. Key components of the program include physical cleansing through ingestion of herbs, fiber, and oils that support the body’s natural detoxification pathways and facilitate healthy elimination; two Ayurvedic meals daily (breakfast and lunch) that provide a light plant-based diet; daily Ayurvedic oil massage treatments; and heating treatments through the use of sauna and/or steam. The program includes lectures on Ayurvedic principles and lifestyle as well as lectures on meditation and yoga philosophy. The study group also participated in twice-daily group meditation and daily yoga and practiced breathing exercises (pranayama) as well as emotional expression through a process of journaling and emotional support. During the program, participants received a 1-hour integrative medical consultation with a physician and follow-up with an Ayurvedic health educator.

The control group simply had a vacation without any of the above therapies in the same resort. They were asked to do what they would normally do on a resort vacation with the additional following restrictions: they were asked not to engage in more exercise than they would in their normal lifestyle and to refrain from using La Costa Resort spa services. They were also asked not to drink ginger tea or take Gingko biloba during the 2 days before and during the study week.

Recruitment was via email announcements on the University of California San Diego faculty and staff and Chopra Center for Wellbeing list-servers. Study flyers stated that the week-long Self-Directed Biological Transformation Initiative (SBTI) study would be conducted at the Chopra Center for Wellbeing, located at the La Costa Resort in Carlsbad, California, in order to learn more about the psychosocial and physiologic effects of the 6-day Perfect Health (PH) Program compared with a 6-day stay at the La Costa Resort. The study participants were not blinded, and site investigators and study personnel knew to which group participants were assigned.

Participants in the Ayurvedic program showed significant and sustained increases in ratings of spirituality and gratitude compared with the vacation group, which showed no change. The Ayurvedic participants also showed increased ratings for self-compassion as well as less anxiety at the 1-month follow-up.

The authors arrived at the following conclusion: Findings suggest that a short-term intensive program providing holistic instruction and experience in mind–body healing practices can lead to significant and sustained increases in perceived well-being and that relaxation alone is not enough to improve certain aspects of well-being.

This ‘study’ had ethical approval from the University of California San Diego and was supported by the Fred Foundation, the MCJ Amelior Foundation, the National Philanthropic Trust, the Walton Family Foundation, and the Chopra Foundation. The paper’s first author is director of research at the Chopra Foundation… Just for the record, let me formulate a short conclusion that actually fits the data from this ‘study’: Lots of TLC, attention and empathy does make some people feel better… 

END OF QUOTE FROM MY OWN POST

The subject of health retreats could be relevant and important. Educating people and teaching them the essentials about healthy life-styles is potentially a good thing. It could well turn out that health retreats benefit many individuals, while saving money for society.

Yet, do we need all sorts of quackery for achieving this aim?

No, we don’t!

A rational programme would need to teach and motivate people about diet, weight control, smoking cessation, regular sleep, relaxation, exercise, etc. It could prevent disease and save funds. This approach has existed in Europe long before the US ‘New Agers’ with their flimflam jumped on this bandwagon. Health education is a good idea, but it does not require the use of alternative therapies or luxury retreats.

As it turns out, the new systematic review is a disappointment. It fails to stress that no firm conclusions can be drawn from flimsy data and degenerates into little more than an embarrassing advertisement for Deepak Chopra’s and similar entrepreneurs’ money-making retreats. It totally ignores the sizable body of Non-English literature on the subject, and is focussed on promoting fashionable retreats and wellness centres in the US and Australia.

To be fair to the authors, they almost admit as much when they state: “Competing interests: MC is a board member of the Global Wellness Summit and has previously been a paid presenter at the Gwinganna Health Retreat. RMIT University has received donations from Danubius Hotel Group, Lapinha, Sunswept Resorts, Sheenjoy and The Golden Door for ongoing retreat research.”

I rest my case.

We have discussed the NHMRC report on homeopathy several times – see, for instance, here, here and here. Perhaps understandably, homeopaths have great difficulties accepting its negative findings, and have complained about it ever since it was published. Now, a very detailed and well-researched analysis has become available of both the report and its criticism. Here I take the liberty to copy and (clumsily) translate its conclusions; if you can read German, I highly recommend studying the full document.

START OF MY TRANSLATION

The criticism of the NHMRC review is very voluminous and highlights many different aspects of the background, the methodology, the execution and the unwanted results from a homeopathic perspective. The very engaging discussions in the general public about this document and its flaws are, however, relatively meaningless: the NHMRC arrives at exactly the same conclusions as the employee of the Homeopathic Research Institute (HRI), Mathie, in his reviews of 2014 and 2017.

In both reviews, Mathie evaluated a total of 107 primary studies and found only 2 trials that could be rated as qualitatively good, that is to say constituting reliable evidence. Mathie did upgrade 2 further studies to the category of reliable evidence, however, this was in violation of the procedures proscribed in the study protocol.

The criticism of the NHMRC review was not able to make a single valid rebuttal. No condition could be identified for which homeopathy is clearly superior to placebo. This is all the more important, as Mathie avoided the mistakes that constituted the most prominent alleged criticisms of the NHMRC report.

  • Since Mathie and most of his co-authors are affiliated with organisations of homeopathy, an anti-homeopathy bias can be excluded.
  • Mathie conducted classic reviews and even differentiated between individualised and non-individualised homeopathy.
  • Mathie did not exclude studies below a certain sample size.

Yet, in both reviews, he draws the same conclusion.

In view of the truly independent replications of an employee of the HRI, we can be sure that there are, in fact, no solid proofs for the effectiveness of homeopathy. The claim of a  strong efficacy, equivalent to conventional medicines, that is made by homeopathy’s advocates is therefore not true.

END OF MY TRANSLATION

And here is the original German text:

Die Kritik an dem Review des NHMRC ist sehr umfangreich und beleuchtet sehr viele verschiedene Facetten über das Umfeld, die Methodik und die Durchführung sowie das aus Sicht der Homöopathen unerwünschte Ergebnis selbst. Die in der Öffentlichkeit sehr engagierte Diskussion um diese Arbeit und ihre möglichen Unzulänglichkeiten sind jedoch relativ bedeutungslos: Das NHMRC kommt zu genau dem gleichen Ergebnis wie Mathie als Mitarbeiter des HRI in seinen in 2014 und 2017 veröffentlichten systematischen Reviews:

Insgesamt hat Mathie in beiden Reviews 107 Einzelstudien untersucht und fand nur zwei Studien, die als qualitativ gut („low risk of bias“), also als zuverlässige Evidenz betrachtet werden können. Mathie hat zwar vier weitere Studien zur zuverlässigen Evidenz aufgewertet, was allerdings im Widerspruch zu den üblichen Vorgehensweisen steht und im Studienprotokoll nicht vorgesehen war.

Die Kritik am Review des NHMRC hat keinen einzigen Punkt fundiert widerlegen können. Man konnte keine Indikation finden, bei der sich die Homöopathie als klar über Placebo hinaus wirksam erwiesen hätte. Diese Punkte sind umso bedeutsamer, weil Mathie die am NHMRC hauptsächlich kritisierten Fehler nicht gemacht hat:

  • Als Mitarbeiter des HRI und mit Autoren, die überwiegend für Homöopathie-affine Organisationen arbeiten, ist eine Voreingenommenheit gegen die Homöopathie auszuschließen.
  • Mathie hat klassische Reviews ausgeführt, sogar getrennt zwischen einzelnen Ausprägungen (individualisierte Homöopathie und nicht-individualisierte Homöopathie).
  • Mathie hat keine Größenbeschränkung der Studien berücksichtigt.

Er kommt aber dennoch zweimal zum gleichen Ergebnis wie das NHMRC.

Angesichts der wirklich als unabhängig anzusehenden Bestätigung der Ergebnisse des NHMRC durch einen Mitarbeiter des Homeopathy Research Institute kann man sicher davon ausgehen, dass es tatsächlich keine belastbaren Wirkungsnachweise für die Homöopathie gibt und dass die von ihren Anhängern behauptete starke, der konventionellen Medizin gleichwertige oder gar überlegene Wirksamkeit der Homöopathie nicht gegeben ist.

I do apologise for my clumsy translation and once again encourage those who can to study the detailed original in full.

My conclusion of this (and indeed of virtually all criticism of homeopathy) is that homeopaths are just as unable to accept criticism as an evangelic believer is going to accept any rational argument against his belief. In other words, regardless of how convincing the evidence, homeopaths will always dismiss it – or, to put it in a nutshell: HOMEOPATHY IS A CULT.

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

START OF QUOTE

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

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

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

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

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

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

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

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

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

END OF QUOTE

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

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

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

How often have we heard the claim from proponents of alternative medicine that one strength of their approach is disease prevention (see for instance my previous post or this, this and this) and that conventional medicine neglects prevention almost completely? Such claims annoy me because they are demonstrably false.

I know, to some readers, this may seem like a bold statement; let me therefore try to justify it.

  1. So far, I have seen no good evidence that any alternative therapy might be effective in preventing any disease.
  2. Practically everything we know today about disease prevention originates from conventional medicine and science.
  3. There are thousands of papers that address prevention and, as far as I can see, they all originate from the realm of conventional medicine. Below is a list of just 7 recent reviews on the subject.

This paper is an update of the evidence for exercise as a prevention of heart failure. It concluded that exercise provides protective benefit in preventing HF (primary prevention). With HF present: exercise improvement with training provides benefits in HF (secondary prevention). The prediction of future in HF patients: exercise impairment, as a leading characteristic of HF, is used as a prognostic factor.

The aim of this review was to update evidence for the US Preventive Services Task Force on the benefits and harms of hormone therapy in reducing risks for chronic conditions. The authors found that hormone therapy for the primary prevention of chronic conditions in menopausal women is associated with some beneficial effects but also with a substantial increase of risks for harms. The available evidence regarding benefits and harms of early initiation of hormone therapy is inconclusive.

This paper reviewed the evidence for Implantable Cardiac Defibrillators (ICDs). The authors stated that individuals with stable ischemic heart disease (no recent myocardial infarction), especially those with inducible arrhythmias, seem to derive the highest mortality benefit from prophylactic ICD use.

These authors investigated whether neuromuscular and proprioceptive training is effective in preventing knee and anterior cruciate ligament (ACL) injuries. They concluded that neuromuscular and proprioceptive training appeared to decrease the incidence of injury to the knee and specifically the AC.

Other researchers summarized current evidence about real-world studies on apixaban for stroke prevention in atrial fibrillation. They concluded that the use of apixaban in real-life is associated with an overall similar effectiveness in reducing stroke and any thromboembolic events when compared with warfarin. A better safety profile was found with apixaban compared with warfarin, dabigatran, and rivaroxaban.

Finally, a review assessed the evidence of blood pressure (BP) lowering treatments as a means of reducing cardiovascular morbidity and mortality. The authors concluded that primary preventive BP lowering is associated with reduced risk for death and CVD if baseline SBP is 140 mm Hg or higher. At lower BP levels, treatment is not associated with any benefit in primary prevention but might offer additional protection in patients with CHD.

Testing preventative treatments is, of course, far from easy. Ideally, one would want to do an RCT, but often this is not possible, for instance, because the sample size would need to be prohibitively huge and the observation period prohibitively long (think of cholesterol-lowering for reducing cardiovascular risks, or smoking cessation for preventing cancer). Thus we rely frequently on other types of investigations such as epidemiological studies. This type of research is, however, rarely undertaken in alternative medicine, and when it does cover subjects related to this area, it is almost never done by proponents of alternative medicine.

The long and short of all this is depressingly simple: the often-heard claim that alternative medicine is strong on prevention is quite simply false. Proponents of alternative medicine like to talk about prevention (presumably because it is good for business), but when it comes to applying prevention and showing that their preventative interventions are effective, all this talk turns out to be little more than hot air.

I am sure – even hope – that some readers will disagree, and I look forward to their evidence proving me wrong.

 

The common cold is a perfect condition for providers of alternative medicine:

  • it is prevalent (good money to be earned),
  • it is not normally dangerous,
  • it nevertheless reduces quality of life and thus patients look for a treatment,
  • there probably is not a single alternative therapy that does not claim to be effective for it,
  • it is gone after about a week, treated or not.

But is there an alternative therapy that does actually work? An article by the Cochrane Collaboration provides an excellent overview. It includes conventional as well as alternative treatments; here I have merely copied the passages related to the latter:

VITAMIN C

There was great excitement in the 1970s when Linus Pauling, (a Nobel laureate twice over), concluded from placebo-controlled trials that Vitamin C could prevent and alleviate the common cold. Further research followed and a Cochrane review, published in 2013, found 29 clinical trials, involving 11,306 participants. Unfortunately, the review did not confirm Pauling’s findings. Taking regular Vitamin C did not reduce the incidence of colds in the general population, although there was a modest reduction in the duration and severity of symptoms. The only people who appeared to derive some benefit were those who undertook short bursts of extreme exercise, such as marathon runners and skiers. In this group the risk of getting a cold was halved.

Trials looking at taking high dose Vitamin C at the onset of cold symptoms showed no consistent effect on the duration and severity of symptoms and more research is needed to clarify these findings.

ECHINACEA

Echinacea is widely used in Europe and North America for common colds. A Cochrane review (2014) showed that some Echinacea products may be more effective than placebo in treating colds but the overall evidence for clinically relevant effects was weak. There was some evidence of a small preventative effect.

INHALATIONS

Inhaled steam has been used for decades (see earlier reference to my childhood humiliation!) thinking that it helps drain away mucus more effectively and possibly destroys the cold virus. A Cochrane review (2017) of six trials with 387 participants showed no consistent benefit for this intervention.

GARLIC

A single trial with 146 participants showed that taking garlic every day for three months might prevent occurrences of the common cold but the evidence was of low quality and more research is needed to validate this finding. (Cochrane review 2014.)

END OF QUOTE

The article obviously focuses only on such therapies for which Cochrane reviews have been published. What about other treatments? As I already mentioned, if we believe the promoters of alternative medicine, the list is long. But fortunately, we do not believe them and want to see the evidence.

HOMEOPATHY

Unsurprisingly, the evidence is not good. One of my posts even expressed the fear that it might involve scientific misconduct.

CHIROPRACTIC

Yes, some chiropractors claim that their manipulations are effective for the common cold. But, as with almost all of their claims, this cannot be taken seriously; the assumption is bogus.

CHINESE HERBAL MEDICINES

A systematic review concluded that their use for common cold is not supported by robust evidence.

SAUNA

Ages ago, I published a small study with promising results:

Twenty-five volunteers were submitted to sauna bathing, with 25 controls abstaining from this or comparable procedures. In both groups the frequency, duration and severity of common colds were recorded for six months. There were significantly fewer episodes of common cold in the sauna group. This was found particularly during the last three months of the study period when the incidence was roughly halved compared to controls. The mean duration and average severity of common colds did not differ significantly between the groups. It is concluded that regular sauna bathing probably reduces the incidence of common colds, but further studies are needed to prove this.

Sadly, the findings were never replicated.

 

MY CONCLUSION

Grin and bear it!

(That is the cold as well as the myriad of false claims made by enthusiasts of alternative medicine)

 

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