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

placebo

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I am glad to hear that the Vatican is issueing  new guidelines on supernatural phenomena. The document, compiled by the Vatican’s Dicastery for the Doctrine of the Faith, will lay out rules to assess the truthfulness of supernatural claims. Reports of such phenomena are said to have soared in recent years in an era of social media – sometimes spread through disinformation and rumour. The guidelines are likely to tighten criteria for the screening, analysis, and possible rejection of cases.

Apparitions have been reported across the centuries. Those recognised by the Church have prompted pilgrims, and popes, to visit spots where they are said to have taken place. Millions flock to Lourdes in France, for example, or Fatima in Portugal, where the Virgin Mary is alleged to have appeared to children, promising a miracle – after which crowds are said to have witnessed the sun zig-zagging through the sky. The visitation was officially recognised by the Church in 1930.

But other reports are found by church officials to be baloney. In 2016, an Italian woman began claiming regular apparitions of Jesus and Mary in a small town north of Rome after she brought back a statue from Medjugorje in Bosnia, where the Virgin Mary is also said to have appeared. Crowds prayed before the statue and received messages including warnings against same-sex marriage and abortion. It took eight years for the local bishop to debunk the story.

_________________________

 

Perhaps the Vatican should also have a look at faith healing*, the attempt to bring about healing through divine intervention. The Bible and other religious texts provide numerous examples of divine healing, and believers see this as a proof that faith healing is possible. There are also numerous reports of people suffering from severe diseases, including cancer and AIDS, who were allegedly healed by divine intervention.

Faith healing has no basis in science, is biologically not plausible. Some methodologically flawed studies have suggested positive effects, however, this is not confirmed by sound clinical trials. Several plausible explanations exist for the cases that have allegedly been healed by divine intervention, for instance, spontaneous remission or placebo response. Another explanation is fraud. For instance, the famous German faith healer, Peter Popoff, was exposed in 1986 for using an earpiece to receive radio messages from his wife giving him the home addresses and ailments of audience members which he purported had come from God during his faith healing rallies.

Faith healing may per se be safe, but it can nevertheless do untold indirect harm, and even fatalities are on record: “Faith healing, when added as an adjuvant or alternative aid to medical science, will not necessarily be confined to mere arguments and debates but may also give rise to series of complications, medical emergencies and even result in death.”

Alternatively, the Vatican might look at the healing potential of pilgrimages*, journeys to places considered to be sacred. The pilgrims often do this in the hope to be cured of a disease. The purpose of Christian pilgrimage was summarized by Pope Benedict XVI as follows:

To go on pilgrimage is not simply to visit a place to admire its treasures of nature, art or history. To go on pilgrimage really means to step out of ourselves in order to encounter God where he has revealed himself, where his grace has shone with particular splendour and produced rich fruits of conversion and holiness among those who believe.

There are only few scientific studies of pilgrimages. The purpose of this qualitative research was to explore whether pilgrims visiting Lourdes, France had transcendent experiences. The authors concluded that visiting Lourdes can have a powerful effect on a pilgrim and may include an “out of the ordinary” transcendent experience, involving a sense of relationship with the divine, or experiences of something otherworldly and intangible. There is a growing focus on Lourdes as a place with therapeutic benefits rather that cures: our analysis suggests that transcendent experiences can be central to this therapeutic effect. Such experiences can result in powerful emotional responses, which themselves may contribute to long term well-being. Our participants described a range of transcendent experiences, from the prosaic and mildly pleasant, to intense experiences that affected pilgrims’ lives. The place itself is crucially important, above all the Grotto, as a space where pilgrims perceive that the divine can break through into normal life, enabling closer connections with the divine, with nature and with the self.

Other researchers tested the effects of tap water labelled as Lourdes water versus tap water labelled as tap water found that placebos in the context of religious beliefs and practices can change the experience of emotional salience and cognitive control which is accompanied by connectivity changes in the associated brain networks. They concluded that this type of placebo can enhance emotional-somatic well-being, and can lead to changes in cognitive control/emotional salience networks of the brain.

The risks involved in pilgrimages is their often considerable costs. It is true, as the text above points out that “millions flock to Lourdes in France”. In other words, pilgrimiges are an important source of income, not least for the catholoc church.

A more important risk can be that they are used as an alternative to effective treatments. This, as we all know, can be fatal. As there is no good evidence that pilgrimiges cure diseases, their risk/benefit balance as a treatment of disease cannot be positive.

So, will the new rules of the Vatican curtail the risks on supernatural healing practises? I would not hold my breath!

_________________

* for references see my book from where this text has been borrowed and modified.

This systematic review and meta-analysis aimed to evaluate the effectiveness of spiritually based interventions on blood pressure (BP) among adults. A systematic search was performed using the PubMed, Scopus, and Cochrane databases to identify studies evaluating spiritual interventions, including:

  • meditation,
  • transcendental meditation,
  • mindfulness meditation,
  • yoga,

for high BP among adults up to January 1, 2022.

The inclusion criteria were:

  • (a) randomized controlled trials (RCTs),
  • (b) studies in English or Persian,
  • (c) studies conducted among adults (≥ 18 years),
  • (d) studies reporting systolic or diastolic BP.

Given the high heterogeneity of these studies, a random effect model was used to calculate the effect sizes for the RCTs.

In total, the systematic review included 24 studies and the meta-analysis included 23 studies. As some of studies reported two or more outcome measurements, separate estimates of each outcome were extracted for that study (24 datasets). Fifteen trials reported the mean (SD) systolic blood pressure (SBP), and 13 trials reported the mean (SD) diastolic blood pressure (DBP). In addition, 13 studies reported means (SDs) and six trials reported mean changes in DBP. A significant decrease was found in systolic BP following intervention ((WMD (weighted mean difference) =  − 7.63 [− 9.61 to − 5.65; P < 0.001]). We observed significant heterogeneity among the studies (I2 = 96.9; P < 0.001). A significant decrease was observed in DBP following the interventions (WMD =  − 4.75 [− 6.45 to − 3.05; P < 0.001]).

The authors concluded that spiritually based interventions including meditation and yoga had beneficial effects in reducing both SBP and DBP. Reducing BP can be expected to reduce the risk of cardiovascular diseases.

Q: What do the RCTs of these interventions have in common?

A: They cannot normally be placebo-controlled because no adequate placebos exist for these therapies.

Q: What does that mean?

A: It means that patients could not be blinded and that patient expectations influenced the outcome.

In view of the fact that blood pressure is an endpoint that is extremely sensitive to expectation, I think, the conclusions of this paper might need to be re-formulated:

This analysis confirms that expectation can have beneficial effects in reducing both SBP and DBP. Reducing BP can be expected to reduce the risk of cardiovascular diseases.

Whenever a journalist wants to discuss the subject of acupuncture with me, he or she will inevitably ask one question:

DOES ACUPUNCTURE WORK?

It seems a legitimate, obvious and simple question, particularly during ‘Acupuncture Awareness Week‘, and I have heard it hundreds of times. Why then do I hesitate to answer it?

Journalists – like most of us – would like a straight answer, like YES or NO. But straight answers are in short supply, particularly when we are talking about acupuncture.

Let me explain.

Acupuncture is part of ‘Traditional Chinese Medicine’ (TCM). It is said to re-balance the life forces that determine our health. As such it is seen as a panacea, a treatment for all ills. Therefore, the question, does it work?, ought to be more specific: does it work for pain, obesity, fatigue, hair-loss, addiction, anxiety, ADHA, depression, asthma, old age, etc.etc. As we are dealing with virtually thousands of ills, the question, does it work?, quickly explodes into thousands of more specific questions.

But that’s not all!

The question, does acupuncture work?, assumes that we are talking about one therapy. Yet, there are dozens of different acupuncture traditions and sites:

  • body acupuncture,
  • ear acupuncture,
  • tongue acupuncture,
  • scalp acupuncture,
  • etc., etc.

Then there are dozens of different ways to stimulate acupuncture points:

  • needle acupuncture,
  • electroacupuncture,
  • acupressure,
  • moxibustion,
  • ultrasound acupuncture,
  • laser acupuncture,
  • etc., etc.

And then there are, of course, different acupuncture ‘philosophies’ or cultures:

  • TCM,
  • ‘Western’ acupuncture,
  • Korean acupuncture,
  • Japanese acupuncture,
  • etc., etc.

If we multiply these different options, we surely arrive at thousands of different variations of acupuncture being used for thousands of different conditions.

But this is still not all!

To answer the question, does it work?, we today have easily around 10 000 clinical trials. One might therefore think that, despite the mentioned complexity, we might find several conclusive answers for the more specific questions. But there are very significant obstacles that are in our way:

  • most acupuncture trials are of lousy quality;
  • most were conducted by lousy researchers who merely aim at showing that acupuncture works rather that testing whether it is effective;
  • most originate from China and are published in Chinese which means that most of us cannot access them;
  • they get nevertheless included in many of the systematic reviews that are currently being published without non-Chinese speakers ever being able to scrutinise them;
  • TCM is a hugely important export article for China which means that political influence is abundant;
  • several investigators have noted that virtually 100% of Chinese acupuncture trials report positive results regardless of the condition that is being targeted;
  • it has been reported that about 80% of studies emerging from China are fabricated.

Now, I think you understand why I hesitate every time a journalist asks me:

DOES ACUPUNCTURE WORK?

Most journalists do not have the patience to listen to all the complexity this question evokes. Many do not have the intellectual capacity to comprehend an exhaustive reply. But all want to hear a simple and conclusive answer.

So, what do I say in this situation?

Usually, I respond that the answer would depend on who one asks. An acupuncturist is likely to say: YES, OF COURSE, IT DOES! An less biased expert might reply:

IT’S COMPLEX, BUT THE MOST RELIABLE EVIDENCE IS FAR FROM CONVINCING. 

There are many variations of acupuncture. Electroacupuncture (EA) and Laseracupuncture (LA) are but two examples both of which are commonly used. However, it remains uncertain whether LA is as effective as EA. This study aimed to compare EA and LA head to head in dysmenorrhea.

A crossover, randomized clinical trial was conducted. EA or LA was applied to selected acupuncture points. Participants were randomized into two sequence treatment groups who received either EA or LA twice per week in luteal phase for 3 months followed by 2-month washout, then shifted to other groups (sequence 1: EA > LA; sequence 2: LA > EA). Outcome measures were heart rate variability (HRV), prostaglandins (PGs), pain, and quality-of-life (QoL) assessment (QoL-SF12). We also compared the effect of EA and LA in low and high LF/HF (low frequency/high frequency) status.

43 participants completed all treatments. Both EA and LA significantly improved HRV activity and were effective in reducing pain (Visual Analog Scale [VAS]; EA: p < 0.001 and LA: p = 0.010) and improving QoL (SF12: EA: p < 0.001, LA, p = 0.017); although without intergroup difference. EA reduced PGs significantly (p < 0.001; δ p = 0.068). In low LF/HF, EA had stronger effects than LA in increasing parasympathetic tone in respect of percentage of successive RR intervals that differ by more than 50 ms (pNN50; p = 0.053) and very low-frequency band (VLF; p = 0.035).

The authors concluded that there is no significant difference between EA and LA in improving autonomic nervous system dysfunction, pain, and QoL in dysmenorrhea. EA is prominent in PGs changing and preserving vagus tone in low LF/HF; yet LA is noninvasive for those who have needle phobia. Whether LA is equivalent with EA and the mechanism warrants further study.

Looking at the affiliations of the authors, one might expect that they should be able to design a meaningful study:

  • 1Division of Hemato-Oncology, Department of Internal Medicine, Branch of Zhong-Zhou, Taipei City Hospital, Taipei, Taiwan.
  • 2Institute of Traditional Medicine, National Yang-Ming Chiao Tung University, Taipei, Taiwan.
  • 3Department of Traditional Medicine, Branch of Yang-Ming, Taipei City Hospital, Taipei, Taiwan.
  • 4Department of Traditional Medicine, Branch of Kunming, Taipei City Hospital, Taipei, Taiwan.
  • 5Department of Gynecology and Obstetrics, Branch of Yang-Ming, Taipei City Hospital, Taipei, Taiwan.

Sadly, this assumption is evidently mistaken.

The trial certainly does not show what they claim and neither had it ever the chance to show anything relevent. A clinical trial is comparable to a mathematical equation. It can be solved, if it has one unkown; it cannot produce a result, if it has two unknowns.

The efficacy of EA and LA for dysmenorrhea are both unknown. A comparative study with two unknowns cannot produce a meaningful result. EA and LA did not both improve autonomic nervous system dysfunction, pain, and QoL in dysmenorrhea but most likely they both had no effect. What caused the improvement was not the treatment per se but the ritual, the placebo effect, the TLC or other non-specific factors. The maginal differences in other parameters are meaningless; they are due to the fact that – as an equivalence trial – the study was woefully underpowered and thus open to coincidental differences.

Clinical trials should be about contributing to our knowledge and not about contributing to confusion.

Jennifer Jacobs started publishing peer-reviewed papers on homeopathy in the early 1990s. This happens to be around the same time as I did. So, we both have about 30 years of research into homeopathy behind us.

Jennifer just authored a paper entitled “Thirty Years of Homeopathic Research – Lessons Learned“. Here is its abstract:

Conducting double-blind randomized controlled trials is difficult, even in the allopathic medical system. Doing so within the paradigm of classical homeopathy is even more challenging. More than thirty years of experience in carrying out such trials has taught me much about the pitfalls to avoid as well as the factors that can lead to success. The initial steps of putting together a research protocol, securing funding, and obtaining human subjects’ approval can be daunting. After that comes developing questionnaires and surveys, hiring study personnel, and recruitment of subjects. The actual implementation of the research comes with its own set of possible missteps. Sample size determination, entry criteria, as well as type, frequency and duration of treatment are all crucial. Finally, statistical analysis must be performed to a high standard and a manuscript prepared to submit for publication. Even then there can be one or more manuscript revisions to make, based on feedback from reviewers, before a study is actually published. The entire process can take at least two years and is usually much longer.

Mistakes at any one of these steps can damage the outcome, as well as the impact of the study. With examples from my body of research, I will discuss some of the things that I wish I had done differently, as well as those that turned out to be correct. Homeopathic research is held to a much higher standard than conventional trials. Any flaws in study design, implementation, and analysis can be used by critics to negate the results. I am hopeful that the next generation of homeopathic researchers will learn from my experiences and carry on with great success.

Jennifer’s example motivated me to follow suit and contribute some very brief thoughts about my 30 years of homeopathy research and the lessons I have learnt:

  Conducting double-blind randomized controlled trials is difficult in any area of medicine. Yet these types of studies are by far the best way to find out which treatments work and which don’t. Therefore, they need doing, regardless of the obstacles they may pose.

In homeopathy, we now have a large body of such trials. Sadly, not all of them are reliable. Those that are, according to accepted criteria, tend to fail to show that homeopathy works better than a placebo. Understandably, homeopaths are disappointed with this overall result and have made numerous attempts to invalidate it.

The main problem with research into homeopathy is not the research methodology. It is well established for clinical trials and can be easily modified to fit all the demands made by individualised treatment or other pecularities that may apply to homeopathy. The main problem is the homeopath who finds it impossible to accept the truth, namely that highly diluted homeopathic remedies are pure placebos and any observed benefits of homeopathy are due to non-specific effects such as the empathetic encounter or a placebo response.

The lesson to be learned from the past is that, in medicine, even the most obsessive belief, conviction or wishful thinking will eventually have to give way to the scientific evidence. In the case of homeopathy, this process has taken an extraordinary amount of time and effort but, finally, we are almost there and the writing is on the wall for everyone to see.

Two resumes of 30 years of work, research and experience!

And what a difference between them!

Who do you think gets closer to the truth,

Jennifer or I?

Of all the forms of so-called alternative medicine (SCAM), Reiki is amongst the least plausible. It is a form of paranormal or ‘energy healing’ popularised by Japanese Mikao Usui (1865–1926). Reiki is based on the assumptions of Traditional Chinese Medicine and the existence of ‘chi’, the life-force that is assumed to determine our health.

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.

Despite its implausibility, Reiki is used for a very wide range of conditions. Some people are even convinced that it has positive effects on sexuality. But is that really so?

This randomised clinical trial was aimed at finding out. Specifically, its authors wanted to determine the effect of Reiki on sexual function and sexual self-confidence in women with sexual distress*. It was was conducted with women between the ages of 15–49 years who were registered at a family health center in the eastern region of Turkey and had sexual distress.

The sample of the study consisted of 106 women, 53 in the experimental group and 53 in the control group. Women in the experimental group received Reiki once a week for four weeks, while no intervention was applied to those in the control group. Data were collected using the Female Sexual Distress Scale-Revised (FSDS-R), the Arizona Sexual Experiences Scale (ASEX), and the Sexual Self-confidence Scale (SSS).

The levels of sexual distress, sexual function, and sexual self-confidence of women in both groups were similar before the intervention, and the difference between the groups was not statistically significant (p > 0.05). After the Reiki application, the FSDS-R and ASEX mean scores of women in the experimental group significantly decreased, while their SSS mean score significantly increased, and the difference between the groups was statistically significant (p < 0.05).

The authors concluded that Reiki was associated with reduced sexual distress, positive outcomes in sexual functions, and increase sexual self-confidence in women with sexual distress. Healthcare professionals may find Reiki to positively enhance women’s sexuality.

Convinced?

I hope not!

The study has the most obvious of all design flaws: it does not control for a placebo effect, nor the effect of empaty/sympathy received from the therapist, nor the negative impact of learning that you are in the control group and will thus not receive any treatment or attention.

To me, it is obvious that these three factors combined must be able to bring about the observed outcomes. Therefore, I suggest to re-write the conclusions as follows:

The intervention was associated with reduced sexual distress, positive outcomes in sexual functions, and increase sexual self-confidence in women with sexual distress. Considering the biological plausibility of a specific effect of Reiki, the most likely cause for the outcome are non-specific effects of the ritual.

*[Sexual distress refers to persistent, recurrent problems with sexual response, desire, orgasm or pain that distress you or strain your relationship with your partner. Yes, I had to look up the definition of that diagnosis.]

 

Current interventions for posttraumatic stress disorder (PTSD) are efficacious, yet effectiveness may be limited by adverse effects and high withdrawal rates. Acupuncture is an intervention with some positive preliminary but methodologically flawed data for PTSD.  Therefore a new study compared verum acupuncture with sham acupuncture (minimal needling) on clinical and physiological outcomes.

This was a 2-arm, parallel-group, prospective blinded randomized clinical trial hypothesizing superiority of verum to sham acupuncture. The study was conducted at a single outpatient-based site, the Tibor Rubin VA Medical Center in Long Beach, California, with recruitment from April 2018 to May 2022, followed by a 15-week treatment period. Following exclusion for characteristics that are known PTSD treatment confounds, might affect biological assessment, indicate past nonadherence or treatment resistance, or indicate risk of harm, 93 treatment-seeking combat veterans with PTSD aged 18 to 55 years were allocated to group by adaptive randomization and 71 participants completed the intervention protocols.

Verum and sham were provided as 1-hour sessions, twice weekly, and participants were given 15 weeks to complete up to 24 sessions. The primary outcome was pretreatment to posttreatment change in PTSD symptom severity on the Clinician-Administered PTSD Scale-5 (CAPS-5). The secondary outcome was pretreatment to posttreatment change in fear-conditioned extinction, assessed by fear-potentiated startle response. Outcomes were assessed at pretreatment, midtreatment, and posttreatment. General linear models comparing within- and between-group were analyzed in both intention-to-treat (ITT) and treatment-completed models.

A total of 85 male and 8 female veterans (mean [SD] age, 39.2 [8.5] years) were randomized. There was a large treatment effect of verum (Cohen d, 1.17), a moderate effect of sham (d, 0.67), and a moderate between-group effect favoring verum (mean [SD] Δ, 7.1 [11.8]; t90 = 2.87, d, 0.63; P = .005) in the intention-to-treat analysis. The effect pattern was similar in the treatment-completed analysis: verum d, 1.53; sham d, 0.86; between-group mean (SD) Δ, 7.4 (11.7); t69 = 2.64; d, 0.63; P = .01). There was a significant pretreatment to posttreatment reduction of fear-potentiated startle during extinction (ie, better fear extinction) in the verum but not the sham group and a significant correlation (r = 0.31) between symptom reduction and fear extinction. Withdrawal rates were low.

The authors concluded that the acupuncture intervention used in this study was clinically efficacious and favorably affected the psychobiology of PTSD in combat veterans. These data build on extant literature and suggest that clinical implementation of acupuncture for PTSD, along with further research about comparative efficacy, durability, and mechanisms of effects, is warranted.

I am not sure that the authors’ enthusiastic verdict is correct. Its lead author was even quoted stating that his study, which used improved controls, was needed to “definitively” support acupuncture for PTSD. He noted that “acupuncture ought to be considered a potential first-line treatment for PTSD.”

While the study is an improvement on the previous research in this area, it is by no means compelling. My main point of criticism is the nature of the sham acupuncture. Such controls are used to account for placebo effects which, of course, can be considerable in the case of acupuncture.

For this concept to work adequately, the patient and the therapist need to be blinded. In the case of acupuncture, therapist blinding is difficult (but not impossible). In this study, therepists were not blinded. Thus they could have influenced the outcome by verbal and non-verbal clues given to the patient. As acupuncturists inevitably have an interest in the positive result of their study, this effect seems inevitable to me.

More important, however, is the adequate blinding of the patient. In this study, it was attempted by using shallow needling as a sham intervention. Yet, shallow needling can easily distinguished from real acupuncture by the patient. At the very least, patients should be asked what treatment – sham or real – they thought they had received. This did not happen, and we therefore might assume that the effect of patient de-blinding – combined with the confounder described above – was sufficient to bring about the relatively small effect sizes observed by the authors.

One might argue that this does not really matter; all that counts is to alleviate the suffering of the patients, never mind by what mechanism. I think, this would be erroneous. It matters because, if acupuncture itself is ineffective (which I suggest), settling for acupuncture as a first line therapy for PTSD is in nobody’s interest and a disservice to severely suffering patients. It would inhibit meaningful research aimed at finding an optimal therapy (one that works beyond placebo) and be a waste of resources.

 

This study tested whether trigger point acupuncture (TrPA) is beneficial for office workers who have reduced job performance (presenteeism) due to chronic neck and shoulder pain (katakori).

A 4-week single-center randomized clinical trial was conducted on 20 eligible female office workers with chronic neck and shoulder pain of at least 3-month duration. The control group implemented only workplace-recommended presenteeism measures, whereas the intervention group received TrPA up to 4 times per month in addition to the presenteeism measures recommended by each workplace. The major outcome measure was the relative presenteeism score on the World Health Organization Health and Work Performance (WHO-HPQ). The secondary outcome measures were pain intensity (numerical rating scale), absolute presenteeism (WHO-HPQ), anxiety and depression (Hospital Anxiety and Depression Scale; HADS), catastrophic thoughts related to pain (Pain Catastrophizing Scale; PCS), and sleep (Athens Insomnia Scale; AIS).

All 9 cases in the intervention group and 11 cases in the control group were analyzed. TrPA up to 4 times per month reduced the intensity of neck and shoulder pain by 20% (P < .01, d = 1.65) and improved labor productivity (relative presenteeism value) by 0.25 (P < .01, d = 1.33) compared with the control group over 1 month. No significant differences were observed between the 2 groups in terms of absolute presenteeism score, HADS, PCS, or AIS.

The authors concluded that these results suggest that regular intervention with TrPA may be effective in the relative presenteeism score before and after the intervention and the degree of neck and shoulder pain over 28 days compared with the control group.

Sure, TrPA may be effective.

But is it?

I thought the trial was aimed at answering that question!

But it didn’t!

Why not?

Because, as we have discussed ad nauseam on this blog, the A+B versus B study design cannot answer it. On the contrary, it will always generate a positive result without determining whether the treatment or a nonspecific (placebo) effect caused the outcome (which, of course, is the reason why this study design is so popular in SCAM research).

In view of this, I suggest to re-formulate the conclusions as follows:

The study suggests that the researchers were ill-informed when designing it. Therefore, the findings show nothing of value.

Supportive care is often assumed to be beneficial in managing the anxiety symptoms common in patients in sterile hematology unit. The authors of this study hypothesize that personal massage can help the patient, particularly in this isolated setting where physical contact is extremely limited.

The main objective of this study therefore was to show that anxiety could be reduced after a touch-massage performed by a nurse trained in this therapy.

A single-center, randomized, unblinded controlled study in the sterile hematology unit of a French university hospital, validated by an ethics committee. The patients, aged between 18 and 65 years old, and suffering from a serious and progressive hematological pathology, were hospitalized in sterile hematology unit for a minimum of three weeks. They were randomized into either a group receiving 15-minute touch-massage sessions or a control group receiving an equivalent amount of quiet time once a week for three weeks.

In the treated group, anxiety was assessed before and after each touch-massage session, using the State-Trait Anxiety Inventory questionnaire with subscale state (STAI-State). In the control group, anxiety was assessed before and after a 15-minute quiet period. For each patient, the difference in the STAI-State score before and after each session (or period) was calculated, the primary endpoint was based on the average of these three differences. Each patient completed the Rosenberg Self-Esteem Questionnaire before the first session and after the last session.

Sixty-two patients were randomized. Touch-massage significantly decreased patient anxiety: a mean decrease in STAI-State scale score of 10.6 [7.65-13.54] was obtained for the massage group (p ≤ 0.001) compared with the control group. The improvement in self-esteem score was not significant.

The authors concluded that this study provides convincing evidence for integrating touch-massage in the treatment of patients in sterile hematology unit.

I find this conclusion almost touching (pun intended). The wishful thinking of the amateur researchers is almost palpable.

Yes, I mean AMATEUR, despite the fact that, embarrassingly, the authors are affiliated with prestigeous institutions:

  • 1Nantes Université, CHU Nantes, Service Interdisciplinaire Douleur, Soins Palliatifs et de Support, Médecine intégrative, UIC 22, Nantes, F-44000, France.
  • 2Université Paris Est, EA4391 Therapeutic and Nervous Excitability, Creteil, F-93000, France.
  • 3Nantes Université, CHU Nantes, Hematology Department, Nantes, F-44000, France.
  • 4Nantes Université, CHU Nantes, CRCI2NA – INSERM UMR1307, CNRS UMR 6075, Equipe 12, Nantes, F-44000, France.
  • 5Institut Curie, Paris, France.
  • 6Université Paris Versailles Saint-Quentin, Versailles, France.
  • 7Nantes Université, CHU Nantes, Direction de la Recherche et l’Innovation, Coordination Générale des Soins, Nantes, F-44000, France.
  • 8Methodology and Biostatistics Unit, DRCI CHU Nantes CHD Vendée, La Roche Sur Yon, F-85000, France.
  • 9Nantes Université, CHU Nantes, Service Interdisciplinaire Douleur, Soins Palliatifs et de Support, Médecine intégrative, UIC 22, Nantes, F-44000, France. [email protected].

So, why do I feel that they must be amateurs?

  • Because, if they were not amateurs, they would know that a clinical trial should not aim to show something, but to test something.
  • Also, if they were not amateurs, they would know that perhaps the touch-massage itself had nothing to do with the outcome, but that the attention, sympathy and empathy of a therapist or a placebo effect can generate the observed effect.
  • Lastly, if they were not amateurs, they would not speak of convincing evidence based on a single, small, and flawed study.

After the nationwide huha created by the BBC’s promotion of auriculotherapy and AcuSeeds, it comes as a surprise to learn that, in Kent (UK), the NHS seems to advocate and provide this form of quackery. Here is the text of the patient leaflet:

Kent Community Health, NHS Foundation Trust

Auriculotherapy

This section provides information to patients who might benefit from auriculotherapy, to complement their acupuncture treatment, as part of their chronic pain management plan.

What is auriculotherapy?

In traditional Chinese medicine, the ear is seen as a microsystem representing the entire body. Auricular acupuncture focuses on ear points that may help a wide variety of conditions including pain. Acupuncture points on the ear are stimulated with fine needles or with earseeds and massage (acupressure).

How does it work?

Recent research has shown that auriculotherapy stimulates the release of natural endorphins, the body’s own feel good chemicals, which may help some patients as part of their chronic pain management plan.

What are earseeds?

Earseeds are traditionally small seeds from the Vaccaria plant, but they can also be made from different types of metal or ceramic. Vaccaria earseeds are held in place over auricular points by a small piece of adhesive tape, or plaster. Applying these small and barely noticeable earseeds between acupuncture treatments allows for patient massage of the auricular points. Earseeds may be left in place for up to a week.

Who can use earseeds?

Earseeds are sometimes used by our Chronic Pain Service to prolong the effects of standard acupuncture treatments and may help some patients to self manage their chronic pain.

How can I get the most out my treatment with earseeds?

It is recommended that the earseeds are massaged two to three times a day or when symptoms occur by applying gentle pressure to the earseeds and massaging in small circles.

Will using earseeds cure my chronic pain?

As with any treatment, earseeds are not a cure but they can reduce pain levels for some patients as part of their chronic pain management programme.

________________________

What the authors of the leaflet forgot to tell the reader is this:

  • Auriculotherapy is based on ideas that fly in the face of science.
  • The evidence that auriculotherapy works is flimsy, to say the least.
  • The evidence earseeds work is even worse.
  • To arrive at a positive recommendation, the NHS had to heavily indulge in the pseudo-scientific art of cherry-picking.
  • The positive experience that some patients report is due to a placebo response.
  • For whichever condition auriculotherapy is used, there are treatments that are much more adequate.
  • Advocating auriculotherapy is therefore not in the best interest of the patient.
  • Arguably, it is unethical.
  • Definitely, it is not what the NHS should be doing.
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