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

Monthly Archives: September 2019

I have often discussed the fact that many proponents of so-called alternative medicine (SCAM) have in recent years adopted the following argument: even if our SCAM were just a placebo, it would still be useful. After all, placebo effects are real and increasingly backed by sound science. The argument is deeply flawed, yet it convinces many lay people.

A recent article by Fabrizio Benedetti, the leading researcher in the area of placebo, is addressing exactly this issue. I feel that it is sufficiently important to quote it extensively here:

… a number of biochemical pathways, such as endogenous opioids and cannabinoids,5,6 and brain regions, like the prefrontal cortex, have been found to be involved in placebo analgesia. Likewise, dopamine and the basal ganglia circuitry have been found to mediate placebo responses in Parkinson’s disease. Although this is wonderful news for science, this may not be the case for society. The number of nonmedical organizations and healers that rely on this hard science, and actually justify their odd and bizarre procedures, has increased over the past few years. The main claim is that any procedure boosting patients’ expectations, which represent the main mediator of placebo effects, is acceptable because it can activate the same biochemical pathways and neural networks that have been made credible by hard science…

The crucial point here is that when hard science started investigating placebo effects, it unconsciously produced a shift in quackery thinking. In fact, charlatans are becoming more and more aware that their bizarre interventions could work through a placebo effect. Indeed, whereas hard science has so far denied any scientific basis for nonconventional therapies, now the very same hard science certifies that the placebo effect has scientific grounds. Therefore, quacks are no longer interested in showing that their pseudo-interventions work; rather, they justify their use on the basis of the possibility that these bizarre interventions may induce strong placebo effects…

… A first point that should be emphasized is that placebos do not cure, but rather, they may sometimes improve quality of life. There is plenty of confusion on this point, and unfortunately, many claim that they can cure virtually all illnesses with placebos. Hard science tells us that placebos can reduce symptoms such as pain and muscle rigidity in Parkinson’s disease, yet the progression of the disease is not affected; for example, in Parkinson’s disease, neurons keep degenerating even though some symptoms can be reduced for a short time.4 The second point is related to the first. The type of disease is crucial, and we need to make people understand that pain is different from cancer and that anxiety differs from infectious diseases. The psychological component of some illnesses can indeed be modulated by placebos, but placebos cannot stop cancer growth, nor can they kill the bacteria of pneumonia. The third point is related to the difference between real placebo effects and spontaneous remissions. So far, hard science has studied the placebo effect within a time span of hours/days, thereby limiting our knowledge to short-lasting effects. Consequently, long-lasting effects can be often attributed to spontaneous remissions.

In addition to these three important points, we should also make patients understand that a diagnosis is required before any sort of therapy. An apparently trivial pain may conceal a danger; thus, it must never be treated unless a diagnosis has been made before, and this can be made only by physicians. Moreover, not only should we discuss and consider the positive effects of placebos and the impact they may have in clinical trials and medical practice, but we should also pay much of our attention to the negative counterpart, that is, the misuse and abuse by quacks, charlatans, shamans, and nonmedical organizations. Thus, we need to inform the whole society that the benefits following a nonconventional healing procedure are attributable to a placebo effect in most of the cases. Last but not least, we need to be more honest on the real efficacy of many pharmacological and nonpharmacological treatments, acknowledging that some of them are useful whereas some others are not: This will boost patients’ trust and confidence in medicine further, which I believe are the best foes of quackery…

…Unfortunately, quackery has today one more weapon on its side, which is paradoxically represented by the hard science–supported placebo mechanisms. This new “scientific quackery” can do a lot of damage; thus, we must be very cautious and vigilant as to how the findings of hard science are exploited. The study of the biology of these vulnerable aspects of mankind may unravel new mechanisms of how our brain works, but it may have a profound negative impact on our society as well. We cannot accept a world where expectations can be enhanced with any means and by anybody. This is a perspective that would surely be worrisome and dangerous. I believe that some reflections are necessary in order to avoid a regression of medicine to past times, in which quackery and shamanism were dominant. Unfortunately, the new knowledge about placebos by hard science is now backfiring on it. What we need to do is to stop for a while and reflect on what we are doing and how we want to move forward. A crucial question to answer is, Does placebo research boost pseudoscience?

__________________________________________________________________

I am immensely thankful to Prof Benedetti to make such clear and long-overdue statements. They will be most helpful in refuting the myth that homeopathy, para-normal healing, reflexology, acupuncture, chiropractic, etc., etc. are legitimate and uselful therapies, even if they are not better than a placebo. Using placebo therapies in routine care is not in the best interest of either the patient or progress.

“There is a ton of chiropractor journals. If you want evidence then read some.”

This was the comment by a defender of chiropractic to a recent post of mine. And it’s true, of course: there are quite a few chiro journals, but are they a reliable source of information?

One way of quantifying the reliability of medical journals is to calculate what percentage of its published articles arrive at negative conclusion. In the extreme instance of a journal publishing nothing but positive results, we cannot assume that it is a credible publication. In this case, it would be not a scientific journal at all, but it would be akin to a promotional rag.

Back in 1997, we published our first analysis of journals of so-called alternative medicine (SCAM). It showed that just 1% of the papers published in SCAM journals reported findings that were not positive. In the years that followed, we confirmed this deplorable state of affairs repeatedly, and on this blog I have shown that the relatively new EBCAM journal is similarly dubious.

But these were not journals focussing specifically on chiropractic. Therefore, the question whether chiro journals are any different from the rest of SCAM is as yet unanswered. Enough reason for me to bite the bullet and test this hypothesis. I thus went on Medline and assessed all the articles published in 2018 in two of the leading chiro journals.

  1. JOURNAL OF CHIROPRACTIC MEDICINE (JCM)
  2. CHIROPRACTIC AND MANUAL THERAPY (CMT)

I evaluated them according to

  1. TYPE OF ARTICLE
  2. DIRECTION OF CONCLUSION

The results of my analysis are as follows:

  1. The JCM published 39 Medline-listed papers in 2018.
  2. The CMT published 50 such papers in 2018.
  3. Together, the 2 journals published:
  • 18 surveys,
  • 17 case reports,
  • 10 reviews,
  • 8 diagnostic papers,
  • 7 pilot studies,
  • 4 protocols,
  • 2 RCTs,
  • 2 non-randomised trials,
  • 2 case-series,
  • the rest are miscellaneous types of articles.

4. None of these papers arrived at a conclusion that is negative or contrary to chiropractors’ current belief in chiropractic care. The percentage of publishing negative findings is thus exactly 0%, a figure that is almost identical to the 1% we found for SCAM journals in 1997.

I conclude: these results suggest that the hypothesis of chiro journals publishing reliable information is not based on sound evidence.

Some of you might have followed my recent discussion with a homeopath. It followed a typical path, and I decided therefore to try and analyse this exchange here. Perhaps others can learn from this example when debating with homeopaths or other providers of so-called alternative medicine (SCAM).

THE START

These conversations often start ‘out of the blue’ by some falsehood being trumpeted on social media. In the present case, the encounter commenced by someone tweeting this message to me: “…remember that asthma trial whose results you faked?” As I did not even remember having ever met the man, I was perplexed. And as I have not faked the study in question nor any other results, I did not think his remark was credible or funny. My mention of the fact that the aggressor was being libellous seemed to bring an end to this unhappy dialogue.

But not for very long. When the man insulted me again – this time very publicly in a UK newspaper – I decided to look into it a bit closer. The aggressor turned out to be in charge of the well-known UK homeopathic pharmacy, Ainsworth, and thus had an overt conflict of interest in defaming my often critical stance on homeopathy. Intriguingly, he had also published his own study of homeopathy. When I assessed this research, it turned out to be both incompetent and unethical. I had hoped that he would defend his work and discuss its limitations with me in a rational fashion. Yet, at this stage, he remained silent.

I then decided to write a further post in the hope of getting some sort of response from him. Alas, my hope was disappointed again. Even when I challenged him and his ROYAL WARRANT directly, he remained silent.

THE BUILD-UP

It needed a seemingly unrelated post of mine for him to find his voice:

Dear Ezard
We can all go round in endless circles arguing whether the Earth is Flat, but eventually someone has to venture out in a boat to the horizon to determine the fact. A cursory reading of Hahnemann encourages every student of homoeopathy to gain their own experience empirically. We all know you and your friends on this blog are standing on the shore proclaiming the Earth to be flat, but when are you going to pedal out,to bravely cite actual cases you have treated with homoeopathy as evidence of your position? What the audience reading this wants to know is what experience and knowledge any of you actually have of the subject you spend so much time criticising?

At this stage a had grown a little weary of Mr Pinkus and his innuendos. My response was thus a little impatient:

Dear Tony
I don’t think highly of people who
1) are too daft to spell my name correctly,
2) imply I have no experience in homeopathy,
3) pretend that I make a secret of it, while, in fact, I published this multiple times (i.e. https://www.amazon.co.uk/Scientist-Wonderland-Searching-Finding-Trouble/dp/1845407776),
4) accuse others of being flat earthers, while evidently being one themselves,
5) do all this without declaring their massive conflict of interest.
Best regards
Edzard

What followed was Pinkus’ increasingly irrational attempts to defame me by revealing to the world that I (and other critics of homeopathy) lacked sufficient clinical experience with homeopathy and therefore were not competent to discuss the subject. Explanations by myself and others that,

  • firstly I did have knowledge and experience of homeopathy,
  • and secondly no experience is required for a critical evaluation of any treatment,

all fell on deaf ears.

THE END

The conclusion of this odd discussion was Pinkus’ triumphant declaration of victory:

I came to this blog to see if anyone in the discussion had any serious intention to discuss the subject of homoeopathy. In order to do this there are certain prerequisites for a sensible debate and one of these is actual knowledge and experience of the subject matter under discussion. To this end I asked if anyone has case they treated in order to discuss the merits and demerits of the experience. No one offered one. I repeated the request and the silence changed to attacks on me even asking.

Any scientist worthy of the challenge, and certainly someone who proudly styles himself as a Professor of CAM with experience and knowledge, would be only too glad to share this with others. Sadly though I have met with rebuke and insult but no evidence to support the opposition to homoeopathy saving some incoherent rant about the needlessness of empirical experience. The cornerstone of Hahnemann’s work on homoeopathy and the one thing he advocated to other doctors. “Don’t take my word for it, prove it to yourself”

When you find the need to attack me to defend your incessant argument that homoeopathy is implausible I really cannot take you seriously.

Here we have a blog hosted by a chap who claims to be an expert on the subject but now claims he hasn’t practiced it for over 40 years. Won’t say what he did when he practised, what he learned and when asked to give at least once case he treated, refuses and creates some diversion to cover his ignorance of the question. Now that’s what I call a charlatan.

I understand you have made a living out of this but it must be a miserable existence old chap

______________________________________________________________________

I find this exchange rather typical for an argument with  SCAM-fanatics. It follows a fairly standard strategy:

  • aggression form a complete stranger,
  • attempt of a rational defence,
  • more aggression and insults
  • attempts to debate the published evidence,
  • silence from the aggressor who seems unable to defend his evidence,
  • more aggression at an unexpected opportunity,
  • further attempts to rationalise and discuss the facts,
  • the aggressor questions his opponent’s competence,
  • more attempts to rationalise and provide valid explanations,
  • conclusion of the discussion with aggressor trying to occupy the moral high ground.

Of course, this is eerily similar to playing chess with a pigeon.

So, what, if anything, can we learn from this?

Mainly three things, I think:

  1. Either you don’t argue with fanatics at all,
  2. or you realise from the beginning what is about to happen; in this case, have fun exposing irrationality in the hope that others might profit from your experience.
  3. In any case, do not expect that your aggressor will be able to learn anything.

I wish people would think a bit before naming things! What is ‘natural health’? Is it the opposite of ‘unnatural health’ or of ‘natural illness’? But who am I to question the terminology of the NHS? I am not even a native English speaker!

Therefore, let me rather look at what this oddly-named school does. Here is how the ‘NHS Natural Health School‘ explain their work:

The NHS Natural Health School has been developed to meet the standards of practice, and experience that are essential for complementary therapists wishing to treat patients within an NHS healthcare setting. The school offers a wide range of approved and accredited courses, taught by highly qualified and clinically skilled lecturers who are experienced in working clinically within NHS Healthcare settings and providing complementary therapy treatments for patients with a range of complex needs including cancer diagnosis. By welcoming you into the multi-disciplinary care team, we not only prepare you as a confident, competent practitioner ready to meet the needs of a demanding industry, but we are able to support the provision of specialist care for a wide range of patients and clients who otherwise would miss out on beneficial treatments.

Courses include supervised clinical placements across hospital and community healthcare settings. All proceeds raised from the courses are reinvested into the Harrogate Hospital and Community Charity’s SROMC Complementary Therapy Fund to ensure the financial sustainability of the HDFT NHS Trust Complementary Therapy Service. For more information on the courses and education available please click the courses link above.

Naturally, I am intrigued and have a look at their courses. They include shiatsu, holistic massage and reflexology. Having published several papers on the latter, it is of particular interest to me. Reflexologists have maps of the sole of the foot where all the body’s organs are depicted. Numerous such maps have been published and, embarrassingly, they do not all agree with each other as to the location of the organs on the sole of the feet. By massaging specific zones which are assumed to be connected to specific organs, reflexologists believe to positively influence the function of these organs.  Here is what the NHS Natural Health School advertise about their reflexology course:

A combination of theory and practical modules designed to equip the learner with the skills required to provide Reflexology treatments for a wide range of clients. On successful completion of the course you will be able to register with the relevant regulatory and professional associations and gain full insurance to practice.

Course content includes;

  • Explore the history and origins of Reflexology
  • Explore the use of various mediums used in treatment including waxes, balms, powders and oils
  • Explore the philosophy of holism and its role within western bio medicine
  • Reading the feet/hands and mapping the reflex points
  • Relevant anatomy, physiology and pathology
  • Managing a wide range of conditions
  • Legal implications
  • Cautions and contraindications
  • Assessment and client care
  • Practical reflexology skills and routines
  • Treatment planning

Assessment: You will produce evidence of 30 reflexology treatments. An additional assessment of your competence will determine your readiness to undertake 72 in-depth case studies and complete a practical assessment.

Course Duration: Attendance is required at 8 Reflexology technical days over 12 months, during which time you will demonstrate a minimum of 100 practical hours.

Special Notes: The core modules; Anatomy, Physiology and Pathology, Business Practice and Principles and Practice of Complementary Therapy are normally completed concurrently as part of the diploma.

Learners who already have a Level 3 diploma in a complementary therapy may be exempt from the core modules.

A first aid certificate is required prior to completion of the diploma.

Fascinating! Personally I am most intrigued about the module on anatomy, physiology and pathology, because all of the three squarely contradict what reflexologists believe. But I wonder even more why there is no mention of the evidence. Have they forgotten to mention it? Unlikely; their other courses on SCAMs such as aromatherapy, holistic massage or shiatsu have similar omissions. Or does the ‘NHS Natural Health School’ not think that evidence matters to ‘competent practitioners’ of the NHS? Or perhaps this is where ‘natural health’ is different from unnatural health?

No, silly me! The reason clearly lies elsewhere: the evidence fails to show that reflexology generates more good than harm. So, the clever people from the ‘NHS Natural Health School’ decided to hide it discretely. Shrewd move! Albeit slightly embarrassing as well as just a little unethical, particularly for the NHS Harrogate, I’d say.

Just in case some readers do wonder nonetheless what the evidence does tell us about reflexology, here is the summary table from my recent book:

PLAUSIBILITY Negative
EFFICACY Negative
SAFETY Positive
COST Debatable
RISK/BENEFIT BALANCE negative

I cannot help but being reminded of something I stated many times before: EVEN THE MOST PROPER TEACHING OF NONSENSE CAN ONLY RESULT IN NONSENSE.

Guest post by Norbert Aust

 

Edzard invited me to review a recent paper on homeopathic treatment of women with pre-menstrual syndrome which he recently discussed on this blog (PMS) [1]. This is what I found:

With this study by Yakir et al. all requirements for low risk of bias are obviously met (blinding, randomisation, allocation concealment etc.) which would make it a high quality study. However, I would like to raise three concerns with increasing severity in that order:

  1. Publication history seems odd with a paper of today to report a trial from twenty years ago
  2.  It is unclear what the reported data imply for the condition of the women, therefore, it is hardly clear what the changes before to after really imply.
  3. A deeper analysis of the data points in the direction of small study bias.

(1) Trial and publication history

  • A first test of homeopathy for PMS was performed in the years 1992 to 1994 by the same team of researchers: 19 women finished the test in an outpatient clinic in Jerusalem/Israel before the trial was aborted for lack of funding.
  • A second trial was performed between 1996 and 1999 where 96 women completed the test.
  • The first trial of 19 women was published as pilot study in 2001 [2], well after data collection of the main study was completed.
  • In 2001 or 2002 the main trial was reported at a conference “Future Directions and Current Issues of research in Homeopathy”, which took place in Freiburg/Germany in 2002. The report was included in the proceedings book [3].
  • In the years 2015 to 2017 a Dutch team updated the original manuscript.
  • Now, a full 20 years after data collection was completed and 18 years after data evaluation was done, the current paper was published in a peer reviewed journal.

This seems odd. The homeopathic community is desperately looking for high quality trials with positive outcomes and here is one that is left ignored for a very long time. And why the authors elected to publish the pilot study in 2001 when the main study was at least very near to completion is unclear. The authors claim that the study was part of the PhD thesis of the lead author in 2002, but do not explain why this paper was not then published in a peer reviewed journal.

Honestly, I do not know what to make of it.

(2) Implication of data

The main outcome measure was assessed by the modified Moos Menstrual Distress Questionnaire, a 37 item questionnaire which the women completed daily for five months, two before treatment for baseline data, three for follow up after treatment. Each item had five options rated 0 to 4. Data from the last 12 days before menses were used for evaluation. However, the authors are not very clear about their procedure:

“Premenstrual symptom (PM) scores were defined as the total scores of 37 pre-specified symptoms in the MDQ during the last 12 premenstrual days ... The mean scores of all women for the various MDQ parameters were calculated before and after treatment, separately in both intervention groups.”

So the authors averaged 24 and 36 questionnaires respectively with a total rating between 0 and 4 X 37 = 148 points. But the scores as reported range between 0 and 2.00. So what are they? And if we do not know what they represent, what does the difference before to after treatment indicate?

Besides the implausible magnitude of the scores, there is a question what they would indicate. Apparently the scores combine two dimensions, namely intensity and duration of the syndrome. The data included 12 days for each cycle. It is hard to believe that any woman would suffer that long from her PMS condition. So any score might indicate an individual duration either long with low intensity or the opposite, a short period of extreme intensity. The score does not offer any clue as to what happened – and a reduction might not indicate an improvement at all: if a long period of low intensity before treatment is modified to a very short period of intense symptoms afterwards the woman might not really consider it an improvement, even if the score may be smaller.

The authors could have used other measures that would be more illuminating – maximum rating per cycle or number of days with a score exceeding a certain threshold – then their data would be much more illuminating on what really happened.

By the way: there is no hint about the timely scatter of the score of the individual women, which would allow us to judge the developments. And the sample size calculation seems to be performed post hoc: It was not included in the conference paper [3] and yields exactly the number of patients included in the study.

(3) Data evaluation

Let us assume for now that the scores transport some real meaning and a reduced score is connected to an improved condition of the patient. Even then there are questions.

The authors report that the mean of this ominous PMS score was reduced for the verum group from 0.443 to 0.287, a reduction by 0.156 score points, whereas the placebo group saw an smaller improvement from 0.426 at baseline to 0.340, a reduction by 0.086 points only. This implies a solid improvement by 35 % with verum, while the control group achieved an improvement of 20 % only. The authors include an image with all the mean PMS-Scores for all the women arranged for verum and controls (Fig. 3 in [3]). The black squares represent the baseline data for each woman, the light squares give the score after treatment (Fig 3 from [1]).

Even at first glance, the data do not look that different. Even with placebo, some women show marked improvement, though more frequent with verum. However, more women under verum encounter aggravation than under placebo, but a few women of the control group had this more intensely. About the same number of women in both groups reached low final scores.

To put this into a more solid state I digitized the above image and did a short analysis of the PMS scores. Here is what I found:

before after improvement*
Placebo
mean ** 0 .43 0.34 0.09
lower quartile 0.19 0.11 0.00
median 0.35 0.19 0.09
upper quartile 0.53 0.42 0.17
Verum
mean ** 0.45 0.29 0.16
lower quartile 0.19 0.14 -0.01
median 0.39 0.27 0.10
upper quartile 0.64 0.40 0.21

* Please note: The data given for the difference are quartiles and medians of the individual changes that occurred, not the changes of the quartiles and medians.

** The data for the mean values are given to check for accuracy which is good.

This table shows, that the inter-quartile portion of the women in both groups faired about the same with a slight advantage for placebo below median and for verum above. The difference in the mean values is due to the outliers, namely by a surplus 5 women in verum group who encountered a marked improvement under verum and a surplus of three women who suffered a marked deterioration under placebo.

Mere chance or not? Small study bias, where the impact of outliers dominate the outcome? Hard to say. This result differs greatly from the pilot study, where most of the women under verum achieved marked improvements and no deterioration occurred, while only minor improvement and some aggravations were recorded.

Conclusion 

The quality of the study looks fine, but the result is not as solid as it seems. The positive outcome is affected by the development of about 10 % of the combined study population only. This might indicate some kind of small study bias and would require replication by a rigorous trial with an increased number of participants – preferably independent from the original team.

References

[1] Yakir M, Klein-Laansma CT, Kreitler S et al.: A Placebo-Controlled Double-Blind Randomized Trial with individualizes Homeopathic Treatment using a Symptom Cluster Approach in Women with Premenstrual Syndrome. Homeopathy, doi 10.1055/s-0039-1691834 https://www.ncbi.nlm.nih.gov/pubmed/31434111

[2] Yakir M, Kreitler S, Brzezinski A et al.: Effects of homeopathic treatment in women with premenstrual syndrome: a pilot study, British Homeopathic Journal (2001); 90: 148-153 http://citeseerx.ist.psu.edu/viewdoc/download?doi=10.1.1.1014.5054&rep=rep1&type=pdf

[3] Yakir M, Kreitler S, Brzezinski A, Vithoulkas G, Bentwich Z: ‘Successful treatment of premenstrual syndrome by classical homeopathy’ in: Walach H.: Future directions and current issues of research in homeopathy’ (Conference proceedings), Freiburg/Germany 2002, S. 134-143

These days, I am often not sure what puzzles me more, Boris Johnson or homeopathy. Come to think of it, our PM seems, in fact, to have a lot in common with homeopathy/homeopaths. With my tongue lodged firmly in my cheek, I can see some communalities:

  • They are both popular in the UK but have their origins elsewhere.
  • They were both laughed at by people who are serious.
  • They have both been around for far too long.
  • They both are useless.
  • They both have plenty of charisma.
  • They both, however, have little more than that.
  • They have a long history of misleading the public.
  • They have both been taken to court.
  • They both failed to accept the judgement when it went against them.
  • They are both particularly successful with the female section of the population.
  • They both thrive on personal attacks.
  • They both make far-reaching claims which turn out to be false.
  • They both claim to want only the best for the public.
  • They both consider themselves as progressive.
  • In truth, however, they are both deeply regressive.
  • They both do not to think that ethics are all that important.
  • They both irritate people who are rational thinkers.
  • They both negate the evidence and act in overt contradiction to the evidence.
  • They both tend to think that popularity is a measure of efficacy.
  • They both managed to mislead even the Queen.
  • Nevertheless, they both enjoy royal support (at least for the time being).
  • They both seem to think that the laws (of the land/of nature) do not apply to them.
  • They are both only bearable when highly diluted.
  • They are both a complete waste of money.
  • They are both dangerous when the public follow their advice.

Have I forgotten anything?

Do tell me, please.

Reiki has been a regular topic on this blog (see for instance here, here and here). In my recent book (Alternative medicine, a critical assessment of 150 modalities), I evaluated it as follows:

Reiki is a form of paranormal or energy healing popularised by Japanese Mikao Usui (1865-1926). Rei means universal spirit (sometimes thought of as a supreme being) and ki is the assumed universal life energy.

  1. Reiki is based on the assumptions of Traditional Chinese Medicine and the existence of ‘chi’, the life-force that determines our health.
  2. Reiki practitioners believe that, with their hands-on healing method, they can transfer ‘healing energy’ to a patient which, in turn, stimulates the self-healing properties of the body. They assume that the therapeutic effects of this technique are obtained from a ‘universal life energy’ that provides strength, harmony, and balance to the body and mind.
  3. There is no scientific basis for such notions, and reiki is therefore not plausible.
  4. Reiki is used for a number of conditions, including the relief of stress, tension and pain.
  5. There have been several clinical trials testing the effectiveness of reiki. Unfortunately, their methodological quality is usually poor.
  6. A systematic review summarising this evidence concluded that the evidence is insufficient to suggest that reiki is an effective treatment for any condition. Therefore, the value of reiki remains unproven.[1] And a Cochrane review found that there is insufficient evidence to say whether or not Reiki is useful for people over 16 years of age with anxiety or depression or both.[2]
  7. Reiki appears to be generally safe, and serious adverse effects have not been reported. Some practitioners advise caution about using reiki in people with psychiatric illnesses because of the risk of bringing out underlying psychopathology.

 

 

PLAUSIBILITY Negative
EFFICACY Negative
SAFETY Positive
COST Positive
RISK/BENEFIT BALANCE Negative

 

[1] https://www.ncbi.nlm.nih.gov/pubmed/?term=lee+pittler+ernst%2C+reikiv

[2] https://www.ncbi.nlm.nih.gov/pubmed/25835541

____________________________________________________________

Now a new study has been published. Will it overturn my assessment?

This within-subject design experiment was conducted to test the feasibility and efficacy of Reiki to provide pain relief among paediatric patients undergoing hematopoietic stem cell transplantation (HSCT).

Paediatric patients undergoing HSCT during the inpatient phase in the Stem Cell Transplantation Unit were eligible to participate to the study. Short and medium effects were assessed investigating the increase or decrease of patient’s pain during three specific time periods of the day: morning of the Reiki session versus assessment before Reiki session (within subjects control period), assessment before Reiki session versus assessment after Reiki session (within subjects experimental period) and assessment after Reiki session versus morning the day after Reiki session (within subject follow-up period). The long-term effects were verified comparing the pain evolution in the day of the Reiki session with the following rest day.

The effect of 88 Reiki therapy sessions in nine patients was analysed following a short, medium, and long-term perspective. Repeated-measures analysis of variance revealed a significant difference among the three periods. A decrease of the pain occurred in the experimental period in short and medium term, while in the follow-up period, the pain level remained stable.

The authors concluded that this study demonstrates the feasibility of using Reiki therapy in pediatric cancer patients undergoing HSCT. Furthermore, these findings evidence that trained paediatric oncology nurses can insert Reiki into their clinical practice as a valid instrument for diminishing suffering from cancer in childhood.

This is basically an observational study without a control group. Therefore it cannot possibly test the efficacy of Reiki. The conclusion that Reiki is a valid instrument for diminishing suffering from cancer in childhood is therefore simply incorrect. The only rational verdict therefore remains this: REIKI FAILS TO GENERATE MORE GOOD THAN HARM.

The sooner we stop misleading the public about it, the better for us all.

On this blog, we have often noted that (almost) all TCM trials from China report positive results. Essentially, this means we might as well discard them, because we simply cannot trust their findings. While being asked to comment on a related issue, it occurred to me that this might be not so much different with Korean acupuncture studies. So, I tried to test the hypothesis by running a quick Medline search for Korean acupuncture RCTs. What I found surprised me and eventually turned into a reminder of the importance of critical thinking.

Even though I found pleanty of articles on acupuncture coming out of Korea, my search generated merely 3 RCTs. Here are their conclusions:

RCT No1

The results of this study show that moxibustion (3 sessions/week for 4 weeks) might lower blood pressure in patients with prehypertension or stage I hypertension and treatment frequency might affect effectiveness of moxibustion in BP regulation. Further randomized controlled trials with a large sample size on prehypertension and hypertension should be conducted.

RCT No2

The results of this study show that acupuncture might lower blood pressure in prehypertension and stage I hypertension, and further RCT need 97 participants in each group. The effect of acupuncture on prehypertension and mild hypertension should be confirmed in larger studies.

RCT No3

Bee venom acupuncture combined with physiotherapy remains clinically effective 1 year after treatment and may help improve long-term quality of life in patients with AC of the shoulder.

So yes, according to this mini-analysis, 100% of the acupuncture RCTs from Korea are positive. But the sample size is tiny and I many not have located all RCTs with my ‘rough and ready’ search.

But what are all the other Korean acupuncture articles about?

Many are protocols for RCTs which is puzzling because some of them are now so old that the RCT itself should long have emerged. Could it be that some Korean researchers publish protocols without ever publishing the trial? If so, why? But most are systematic reviews of RCTs of acupuncture. There must be about one order of magnitude more systematic reviews than RCTs!

Why so many?

Perhaps I can contribute to the answer of this question; perhaps I am even guilty of the bonanza.

In the period between 2008 and 2010, I had several Korean co-workers on my team at Exeter, and we regularly conducted systematic reviews of acupuncture for various indications. In fact, the first 6 systematic reviews include my name. This research seems to have created a trend with Korean acupuncture researchers, because ever since they seem unable to stop themselves publishing such articles.

So far so good, a plethora of systematic reviews is not necessarily a bad thing. But looking at the conclusions of these systematic reviews, I seem to notice a worrying trend: while our reviews from the 2008-2010 period arrived at adequately cautious conclusions, the new reviews are distinctly more positive in their conclusions and uncritical in their tone.

Let me explain this by citing the conclusions of the very first (includes me as senior author) and the very last review (does not include me) currently listed in Medline:

1st review

penetrating or non-penetrating sham-controlled RCTs failed to show specific effects of acupuncture for pain control in patients with rheumatoid arthritis. More rigorous research seems to be warranted.

Last review

Electroacupuncture was an effective treatment for MCI [mild cognitive impairment] patients by improving cognitive function. However, the included studies presented a low methodological quality and no adverse effects were reported. Thus, further comprehensive studies with a design in depth are needed to derive significant results.

Now, you might claim that the evidence for acupuncture has overall become more positive over time, and that this phenomenon is the cause for the observed shift. Yet, I don’t see that at all. I very much fear that there is something else going on, something that could be called the suspension of critical thinking.

Whenever I have asked a Chinese researcher why they only publish positive conclusions, the answer was that, in China, it would be most impolite to publish anything that contradicts the views of the researchers’ peers. Therefore, no Chinese researcher would dream of doing it, and consequently, critical thinking is dangerously thin on the ground.

I think that a similar phenomenon might be at the heart of what I observe in the Korean acupuncture literature: while I always tried to make sure that the conclusions were adequately based on the data, the systematic reviews were ok. When my influence disappeared and the reviews were done exclusively by Korean researchers, the pressure of pleasing the Korean peers (and funders) became dominant. I suggest that this is why conclusions now tend to first state that the evidence is positive and subsequently (almost as an after-thought) add that the primary trials were flimsy. The results of this phenomenon could be serious:

  • progress is being stifled,
  • the public is being misled,
  • funds are being wasted,
  • the reputation of science is being tarnished.

Of course, the only right way to express this situation goes something like this:

BECAUSE THE QUALITY OF THE PRIMARY TRIALS IS INADEQUATE, THE EFFECTIVENESS OF ACUPUNCTURE REMAINS UNPROVEN.

 

 

It is hard to deny that many practitioners of so-called alternative medicine (SCAM) advise their patients to avoid ‘dangerous chemicals’. By this they usually mean prescription drugs. If you doubt how strong this sentiment often is, you have not followed the recent posts and the comments that regularly followed. Frequently, SCAM practitioners will suggest to their patients to not take this or that drug and predict that patients would then see for themselves how much better they feel (usually, they also administer their SCAM at this point).

Lo and behold, many patients do indeed feel better after discontinuing their ‘chemical’ medicines. Of course, this experience is subsequently interpreted as a proof that the drugs were dangerous: “I told you so, you are much better off not taking synthetic medicines; best to use the natural treatments I am offering.”

But is this always interpretation correct?

I seriously doubt it.

Let’s look at a common scenario: a middle-aged man on several medications for reducing his cardiovascular risk (no, it’s not me). He has been diagnosed to have multiple cardiovascular risk factors. Initially, his GP told him to change his life-style, nutrition and physical activity – to which he was only moderately compliant. Despite the patient feeling perfectly healthy, his blood pressure and lipids remained elevated. His doctor now strongly recommends drug treatment and our chap soon finds himself on statins, beta-blockers plus ACE-inhibitors.

Our previously healthy man has thus been turned into a patient with all sorts of symptoms. His persistent cough prompts his GP to change the ACE-inhibitor to a Ca-channel blocker. Now the patients cough is gone, but he notices ankle oedema and does not feel in top form. His GP said that this is nothing to worry about and asks him to grin and bear it. But the fact is that a previously healthy man has been turned into a patient with reduced quality of life (QoL).

This fact takes our man to a homeopath in the hope to restore his QoL (you see, it certainly isn’t me). The homeopath proceeds as outlined above: he explains that drugs are dangerous chemicals and should therefore best be dropped. The homeopath also prescribes homeopathics and is confident that they will control the blood pressure adequately. Our man complies. After just a few days, he feels miles better, his QoL is back, and even his sex-life improves. The homeopath is triumphant: “I told you so, homeopathy works and those drugs were really nasty stuff.”

When I was a junior doctor working in a homeopathic hospital, my boss explained to me that much of the often considerable success of our treatments was to get rid of most, if not all prescription drugs that our patients were taking (the full story can be found here). At the time, and for many years to come, this made a profound impression on me and my clinical practice. As a scientist, however, I have to critically evaluate this strategy and ask: is it the correct one?

The answer is YES and NO.

YES, many (bad) doctors over-prescribe. And there is not a shadow of a doubt that unnecessary drugs must be scrapped. But what is unnecessary? Is it every drug that makes a patient less well than he was before?

NO, treatments that are needed should not be scrapped, even if this would make the patient feel better. Where possible, they might be altered such that side-effects disappear or become minimal. Patients’ QoL is important, but it is not the only factor of importance. I am sure this must sound ridiculous to lay people who, at this stage of the discussion, would often quote the ethical imperative of FIRST DO NO HARM.

So, let me use an extreme example to explain this a bit better. Imagine a cancer patient on chemo. She is quite ill with it and QoL is a thing of the past. Her homeopath tells her to scrap the chemo and promises she will almost instantly feel fine again. With some side-effect-free homeopathy see will beat the cancer just as well (please, don’t tell me they don’t do that, because they do!). She follows the advice, feels much improved for several months. Alas, her condition then deteriorates, and a year later she is dead.

I know, this is an extreme example; therefore, let’s return to our cardiovascular patient from above. He too followed the advice of his homeopath and is happy like a lark for several years … until, 5 years after discontinuing the ‘nasty chemicals’, he drops dead with a massive myocardial infarction at the age of 62.

I hope I made my message clear: those SCAM providers who advise discontinuing prescribed drugs are often impressively successful in improving QoL and their patients love them for it. But many of these practitioners haven’t got a clue about real medicine, and are merely playing dirty tricks on their patients. The advise to stop a prescribed drug can be a very wise move. But frequently, it improves the quality, while reducing the quantity of life!

The lesson is simple: find a rational doctor who knows the difference between over-prescribing and evidence-based medicine. And make sure you start running when a SCAM provider tries to meddle with necessary prescribed drugs.

Some people seem to think that all so-called alternative medicine (SCAM) is ineffective, harmful or both. And some believe that I am hell-bent to make sure that this message gets out there. I recommend that these guys read my latest book or this 2008 article (sadly now out-dated) and find those (admittedly few) SCAMs that demonstrably generate more good than harm.

The truth, as far as this blog is concerned, is that I am constantly on the lookout to review research that shows or suggests that a therapy is effective or a diagnostic technique is valid (if you see such a paper that is sound and new, please let me know). And yesterday, I have been lucky:

This paper has just been presented at the ESC Congress in Paris.

Its authors are: A Pandey (1), N Huq (1), M Chapman (1), A Fongang (1), P Poirier (2)

(1) Cambridge Cardiac Care Centre – Cambridge – Canada

(2) Université Laval, Faculté de Pharmacie – Laval – Canada

Here is the abstract in full:

Introduction: Regular physical activity may modulate the inflammatory process and be cardio-protective. Yoga is a form of exercise that may have cardiovascular benefits. The effects of yoga on global cardiovascular risk have not been adequately described. The purpose of this study is to determine whether the addition of yoga to a regular exercise regimen reduces global cardiovascular risk.
Methods: Sixty consecutive individuals with essential hypertension were recruited in a lifestyle intervention program. All individuals with known hypertensive end organ damage, known cardiovascular diseases, as well as those taking medications/supplements that affected blood pressure, blood sugar, cholesterol or vascular inflammation were excluded. Participants were randomized to either a yoga group or similar duration stretching control group. Participants, over the 3-month intervention regimen, performed 15 minutes of either yoga or stretching in addition to 30 minutes of aerobic exercises thrice weekly. Blood pressure, cholesterol levels and hs-CRP were measured, and Reynold’s Global Cardiovascular Risk Score was calculated at baseline and at the end of the 3-month intervention program.
Results: At screening, there were no statistically significant differences between the groups in any measured parameters or the 10-year risk of a cardiovascular event as measured by the Reynolds Risk Score. (8.2 vs. 9.0%; yoga vs. control group) After the 3-month intervention period, there was a statistically significantly greater decrease in the Reynold’s Risk Score in the yoga vs. the control group. (7.0 vs. 8.4%, p=0.003, relative reduction 13.2 vs. 6.5%, p<0.0001)
Conclusions: In patients with essential hypertension on no medications and with no known end organ damage, the practice of yoga incorporated into a 3-month exercise intervention program was associated with significant greater improvement in the Reynold’s Risk of a 10-year cardiovascular event, when compared to the control stretching group. If these results are validated in more diverse populations over a longer duration of follow up, yoga may represent an important addition to traditional cardiovascular disease prevention programs.

Yes, this study was small, too small to draw far-reaching conclusions. And no, we don’t know what precisely ‘yoga’ entailed (we need to wait for the full publication to get this information plus all the other details needed to evaluate the study properly). Yet, this is surely promising: yoga has few adverse effects, is liked by many consumers, and could potentially help millions to reduce their cardiovascular risk. What is more, there is at least some encouraging previous evidence.

But what I like most about this abstract is the fact that the authors are sufficiently cautious in their conclusions and even state ‘if these results are validated…’

SCAM-researchers, please take note!

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