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

placebo

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Prof. Fabricio Benedetti is one of the world’s leading experts in the study of placebo effects. I have mentioned his excellent work before, for instance, here where he cautioned that quackery has today one more weapon on its side, which is paradoxically represented by the hard science–supported placebo mechanisms. Now he has expressed his concerns even more clearly in an article entitled “Alternative and natural medicine quackery is on the rise. Here’s why the placebo effect is part of the problem”. Here are a few excerpts from this excellent paper:

For several decades now, many scientists, including me, have been working hard to reveal the full power and scope of the placebo effect — the amazing ability of a simple sugar pill or other non-pharmaceutical “fake intervention” to improve someone’s quality of life. This research has been crucial to giving scientific credibility to a powerful psychological effect. But the advances of science have also backfired, spawning an alternative industry that preys on the vulnerable…

All this means that some alternative medicines can indeed have positive outcomes for patients, though not necessarily through the mechanisms that the therapy’s inventors supposed, but rather through a placebo effect. This holds true for treatments ranging from strange talismans to acupuncture — studies have shown that pain relief is about the same for patients receiving true acupuncture with needles, for example, as for those receiving sham acupuncture with trick needles.

The scientific advances in understanding placebo are fascinating. But one unfortunate outcome of all this work is that profit-seeking companies and individuals now have a new weapon: It is no longer necessary to demonstrate the effectiveness of their proposed therapies; it is enough to assert that these work because of the placebo effect. I receive myriad eccentric proposals for new therapies, ranging from talismans and concoctions to mascots and weird rituals. Their inventors claim that these are capable of inducing substantial health benefits and often seek my endorsement. These proposals have stepped up sharply in recent years. Sadly, the science of the placebo effect is fueling this new breed of pseudoscience…

So, if a salesperson says: “This concoction (or ritual or talisman) will reduce your pain,” it is not necessarily a lie, as the placebo effect may indeed stimulate pain-relieving circuits in the brain. But anyone could truthfully use these words, within limits.

These marketers often overstate the size of the possible response, claim to provide a “cure” rather than pain relief or incorrectly suggest that only their own expensive products will have this effect. Even worse, they may present the products as an alternative to more effective traditional medications for serious conditions such as cancer. In other words, they prey on the vulnerable by making undeliverable promises, purportedly backed by the science of placebo.

Even if taking a placebo can reduce symptoms such as pain, this isn’t always the best course of action. An apparently trivial pain may, for example, be the first sign of something far more serious. Treating the pain alone may prevent diagnosis by a physician or delay important medical treatments…

…Education, communication and honesty are the best friends of medical practice. Patients and health care professionals deserve to know what placebos can and cannot do.

The research and medical communities must be more transparent about the efficacy of many conventional pharmacological and nonpharmacological treatments, by acknowledging that some of them are useful whereas some others are not. Many over-the-counter products have doubtful efficacy, for example. Honesty will boost patients’ trust and confidence in medicine, which are the best antidotes to quackery.

 

BRAVO PROF BENEDETTI!

Two million people in UK are estimated to be currently suffering from long COVID, says the Office for National Statistics. Fatigue continues to be the most common symptom – experienced by 55% of those with self-reported long COVID – followed by 32% with shortness of breath, 23% with a cough, and 23% with muscle ache. The problem is only going to increase in the near future. Thus, many people are frantically looking for an effective therapy. Practitioners of so-called alternative medicine (SCAM) are no exception.

This study aimed to evaluate the potential for inhalation of essential oils to improve energy levels among otherwise healthy female survivors of acute COVID-19 who experience a lack of energy more than five months after recovery.

This was a randomized double-blind, placebo-controlled trial to evaluate the potential for inhalation of Longevity™, a proprietary essential oil blend manufactured by Young Living Essential Oils (Lehi, Utah, USA), on energy levels among female survivors of COVID-19 who continue to experience fatigue more than 5 months recovery from the acute infection. Forty women were randomized to two groups: intervention and placebo. The placebo product contained an inert, odorless fractionated coconut oil. Both groups inhaled the assigned product twice daily for fourteen consecutive days. Fatigue scores were measured using the Multidimensional Fatigue Symptom Inventory (MFSI). Secondary outcomes included scores on each of the MFSI’s ten subscales.

Individuals who inhaled the essential oil blend for 2 weeks had significantly lower fatigue scores after controlling for baseline scores, employment status, BMI, olfactory function, and time since diagnosis, with a large effect size (F (1,39) = 6.15, p = .020, partial eta squared = 0.198). Subscale analysis identified subscales of vigor, as well as global, behavioral, general, and mental fatigue as benefiting from the intervention. This study provides evidence that a proprietary aromatherapy blend can significantly improve energy levels among women who are experiencing fatigue after recovering from COVID-19.

The authors concluded that the use of aromatherapy with Longevity™ essential oil blend to boost energy levels in women who have recovered from COVID-19 provides a novel, non-invasive approach to improving quality of life in this population. This intervention is particularly beneficial for global and mental fatigue, as well as vigor. Other subdomains may experience improvements to energy levels with a smaller effect size; future studies should be conducted to explore this potential.

This trial was funded by Young Living Essential Oils. Perhaps, this explains why there is no mention of the elephant in the room: the trial was not blind! Participants in the verum group knew that they received aromatherapy. Likewise, participants in the placebo group knew that they received the placebo.

Could this fact have influenced the outcome? Certainly!

Could the trial have been designed better? Certainly!

All the investigators needed to do is to use a nice-smelling oil that, according to aromatherapists, does not boost energy, as the placebo.

As it stands, we have no idea whether the authors’ assumption that the verum oil caused the effect is true.

Pity!

Or maybe not?

Perhaps Young Living Essential Oils, the sponsor of the study and producer of the oil never wanted to know the truth. Maybe they are happy to abuse science as a marketing tool?

Osteopathic visceral manipulation (VM) is a bizarre so-called alternative medicine (SCAM) that has been featured on this blog with some regularity, e.g.:

Rigorous trials fail to show that it works for anything. So, the obvious solution to this dilemma is to conduct dodgy trials!

This study tested the effects of VM on dysmenorrhea, irregular, delayed, and/or absent menses, and premenstrual symptoms in PCOS patients.

Thirty Egyptian women with polycystic ovary syndrome (PCOS), with menstruation-related complaints and free from systematic diseases and/or adrenal gland abnormalities, participated in a single-blinded, randomized controlled trial. They were recruited from the women’s health outpatient clinic in the faculty of physical therapy at Cairo University, with an age of 20-34 years, and a body mass index (BMI) ≥25, <30 kg/m2. Patients were randomly allocated into two equal groups (15 patients); the control group received a low-calorie diet for 3 months, and the study group that received the same hypocaloric diet added to VM to the pelvic organs and their related structures for eight sessions over 3 months. Evaluations for body weight, BMI, and menstrual problems were done by weight-height scale, and menstruation-domain of Polycystic Ovary Syndrome Health-Related Quality of Life Questionnaire (PCOSQ), respectively, at baseline and after 3 months from interventions. Data were described as mean, standard deviation, range, and percentage whenever applicable.

Of 60 Egyptian women with PCOS, 30 patients were included, with baseline mean age, weight, BMI, and a menstruation domain score of 27.5 ± 2.2 years, 77.7 ± 4.3 kg, 28.6 ± 0.7 kg/m2, and 3.4 ± 1.0, respectively, for the control group, and 26.2 ± 4.7 years, 74.6 ± 3.5 kg, 28.2 ± 1.1 kg/m2, and 2.9 ± 1.0, respectively, for the study group. Out of the 15 patients in the study group, uterine adhesions were found in 14 patients (93.3%), followed by restricted uterine mobility in 13 patients (86.7%), restricted ovarian/broad ligament mobility (9, 60%), and restricted motility (6, 40%). At baseline, there was no significant difference (p>0.05) in any of the demographics (age, height), or dependent variables (weight, BMI, menstruation domain score) among both groups. Post-study, there was a statistically significant reduction (p=0.000) in weight, and BMI mean values for the diet group (71.2 ± 4.2 kg, and 26.4 ± 0.8 kg/m2, respectively) and the diet + VM group (69.2 ± 3.7 kg; 26.1 ± 0.9 kg/m2, respectively). For the improvement in the menstrual complaints, a significant increase (p<0.05) in the menstruation domain mean score was shown in the diet group (3.9 ± 1.0), and the diet + VM group (4.6 ± 0.5). On comparing both groups post-study, there was a statistically significant improvement (p=0.024) in the severity of menstruation-related problems in favor of the diet + VM group.

The authors concluded that VM yielded greater improvement in menstrual pain, irregularities, and premenstrual symptoms in PCOS patients when added to caloric restriction than utilizing the low-calorie diet alone in treating that condition.

WHERE TO START?

  • Tiny sample size.
  • A trail design (A+B vs B) which will inevitably generate a positive result.
  • Questionable ethics.

VM is a relatively invasive and potentially embarrassing intervention for any woman; I imagine that this is all the more true in Egypt. In such circumstances, it is mandatory to ask whether a planned study is ethically justifiable. I would answer this question related to an implausible treatment like VM with a straight NO!

I realize that there may be people who disagree with me. But even those guys should accept that, at the very minimum, such a study must be designed such that it leads to a clear answer – is VM effective or not? The present trial merely suggests that the placebo effect associated with VM is powerful (which is hardly surprising for a therapy like VM).

A recent article in LE PARISIEN entitled “L’homéopathie vétérinaire, c’est sans effet… mais pas sans risque” – Veterinary homeopathy is without effect … but not without risk, tells it like it is. Here are a few excerpts that I translated for you.

More than 77% of French people have tried homeopathy in their lifetime. But have you ever given it to your pet? Harmless in most cases, its use can be dangerous when it replaces a treatment whose effectiveness is scientifically proven … from a safety point of view, the tiny granules are indeed irreproachable: their use does not induce any drug interaction or undesirable side effects, nor does it run the risk of overdosing or addiction … homeopathic preparations owe their harmlessness to their lack of proper effects. “Neither in human medicine nor in veterinary medicine, at the current stage, clinical studies of all levels do not provide sufficient scientific evidence to support the therapeutic efficacy of homeopathic preparations”, stated the French Veterinary Academy in May 2021. These conclusions are in line with those of the French Academies of Medicine and Pharmacy, the British Royal College of Veterinary Surgeons, and all the international scientific bodies that have given their opinion on the subject.

Therefore, when homeopathy delays diagnosis or is used in place of proven effective treatments, its use represents a “loss of opportunity” for your pet. The greatest danger of homeopathy is not that the remedies are ineffective, but that some homeopaths believe that their therapies can be used as a substitute for genuine medical treatment,” summarizes a petition to the UK veterinary regulatory body signed by more than 1,000 British veterinarians. At best, this claim is misleading and, at worst, it can lead to unnecessary suffering and death.”

But how can we explain the number of testimonies from pet owners who say that “it works”? “I am very satisfied with the Kalium Bichromicum granules for my cat with an eye ulcer, which is healing very well”… These improvements, real or supposed, can be explained by “contextual effects”, among which the famous placebo effect (which is not specific to humans), your subjective interpretation of his symptoms, or the natural history of the disease.

When these contextual effects are ignored or misunderstood, the spontaneous resolution or reduction of the disease can be wrongly attributed to homeopathy, and thus maintain the illusion of its effectiveness. This confusion is all the more likely because homeopathy owes much of its popularity to its use to treat “everyday ailments”: nausea, allergies, fatigue, bruises, nervousness, etc., which tend to get better on their own with time, or which have a fluctuating expression…

In April 2019, the association published an open letter addressed to the National Council of the Order of Veterinarians, calling on it to take a position on the compatibility of homeopathy with the “ethical and scientific requirements” of the profession. The organization, whose official function is to guarantee the quality of the service rendered to the public by the 20,000 veterinarians practicing in France, issued its conclusions last October. It invited veterinary training centers to remove homeopathy from their curricula, under penalty of having their accreditation withdrawn, and thus their ability to deliver training credits.

In my view, this is a remarkably good and informative text. How often do homeopathy fans claim IT WORKS FOR ANIMALS AND THUS CANNOT BE A PLACEBO! The truth is that, as we have so often discussed on this blog, homeopathy does not work beyond placebo for animals. This renders veterinary homeopathy:

  • a waste of money,
  • potentially dangerous,
  • in the worst cases a form of animal abuse.

My advice is that, as soon as a vet recommends homeopathy, you look for the exit.

Horticultural therapy (HT)?

What on earth is that?

Don’t worry, it was new to me too and I first thought of the treatment of plants.

HT is said to be a “time-proven practice. The therapeutic benefits of garden environments have been documented since ancient times. In the 19th century, Dr. Benjamin Rush, a signer of the Declaration of Independence and recognized as the “Father of American Psychiatry,” was first to document the positive effect working in the garden had on individuals with mental illness. In the 1940s and 1950s, rehabilitative care of hospitalized war veterans significantly expanded acceptance of the practice. No longer limited to treating mental illness, horticultural therapy practice gained in credibility and was embraced for a much wider range of diagnoses and therapeutic options. Today, horticultural therapy is accepted as a beneficial and effective therapeutic modality. It is widely used within a broad range of rehabilitative, vocational, and community settings. Horticultural therapy techniques are employed to assist participants to learn new skills or regain those that are lost. Horticultural therapy helps improve memory, cognitive abilities, task initiation, language skills, and socialization. In physical rehabilitation, horticultural therapy can help strengthen muscles and improve coordination, balance, and endurance. In vocational horticultural therapy settings, people learn to work independently, problem solve, and follow directions. Horticultural therapists are professionals with specific education, training, and credentials in the use of horticulture for therapy and rehabilitation. Read the formal definition of the role of horticultural therapists.”

As always, the question is DOES IT WORK?

This systematic review and meta-analysis aimed to evaluate HT for general health in older adults. Electronic databases as well as grey literature databases, and clinical trials registers were searched from inception to March 2021. Randomized controlled trials (RCTs), quasi-RCTs (QRCTs), and cohort studies about HT for adults aged over 60 were included in this review. Outcome measures were physical function, quality of life, BMI, mood tested by self-reported questionnaire and the expression of the immune cells.

Fifteen studies (thirteen RCTs and two cohort studies) involving 1046 older participants were included. Meta-analysis showed that HT resulted in better quality of life (MD 2.09, 95% CI [1.33, 2.85], P<0. 01) and physical function (SMD 0.82, 95% [0.36, 1.29], P<0.01) compared with no-gardener; the similar findings showed in BMI (SMD -0.30, 95% [-0.57, -0.04], P = 0.02) and mood tested by self-reported questionnaire (SMD 2.80, 95% CI [1.82, 3.79], P<0. 01). And HT might be beneficial for blood pressure and immunity, while all the evidence was moderate-quality judged by GRADE.

The authors concluded that HT may improve physical function and quality of life in older adults, reduce BMI and enhance positive mood. A suitable duration of HT may be between 60 to 120 minutes per week lasting 1.5 to 12 months. However, it remains unclear as to what constitutes an optimal recommendation.

I have considerable problems with this review and its conclusion:

  • It is simply untrue that there were 13 RCTs; several of these studies were clearly not randomized.
  • Most of the studies are of very poor quality. For instance, they often did not make the slightest attempt to control for non-specific effects, yet they concluded that the observed outcome was a specific effect of HT.

My biggest problem does, however, not relate to methodological issues. My main issue with this paper is one of definition. What is a ‘therapy’ and what not? If we call a bit of gardening a ‘therapy’ are we not descending to the level of those who call a bit of shopping ‘retail therapy’? To put it differently, is HT superior to retail therapy? And do we need RCTs to answer this question?

What is wrong with encouraging people who like gardening to just do it? I, for instance, like drumming; but I do not believe we need a few RCTs to prove that it is healthy. Not every past-time or hobby that makes you feel good is a therapy and needs to be scrutinized as such.

 

 

The new issue of the BMJ carries an article on acupuncture that cries out for a response. Here, I show you the original article followed by my short comments. For clarity, I have omitted the references from the article and added references that refer to my comments.

_________________________________________

Conventional allopathic medicine [1]—medications and surgery [2] used in conventional systems of medicine to treat or prevent disease [3]—is often expensive, can cause side effects and harm, and is not always the optimal treatment for long term conditions such as chronic pain [4]. Where conventional treatments have not been successful, acupuncture and other traditional and complementary medicines have potential to play a role in optimal patient care [5].

According to the World Health Organisation (WHO) 2019 global report, acupuncture is widely used across the world. [6] In some countries acupuncture is covered by health insurance and established regulations. [7] In the US, practitioners administer over 10 million acupuncture treatments annually. [6] In the UK, clinicians administer over 4 million acupuncture treatments annually, and it is provided on the NHS. [6]

Given the widespread use of acupuncture as a complementary therapy alongside conventional medicine, there has been an increase in global research interest and funding support over recent decades. In 2009, the European Commission launched a Good Practice in Traditional Chinese Medicine Research (GP-TCM) funding initiative in 19 countries. [7] The GP-TCM grant aimed to investigate the safety and efficacy of acupuncture as well as other traditional Chinese medicine interventions.

In China, acupuncture is an important focus of the national research agenda and receives substantial research funding. [8] In 2016, the state council published a national strategy supporting universal access to acupuncture by 2020. China has established more than 79 evidence-based traditional Chinese medicine or integrative medicine research centers. [9]

Given the broad clinical application and rapid increase in funding support for acupuncture research, researchers now have additional opportunities to produce high-quality studies. However, for this to be successful, acupuncture research must address both methodological limitations and unique research challenges.

This new collection of articles, published in The BMJ, analyses the progress of developing high quality research studies on acupuncture, summarises the current status, and provides critical methodological guidance regarding the production of clinical evidence on randomised controlled trials, clinical practice guidelines and health economic evidence. It also assesses the number and quality of systematic reviews of acupuncture. [10] We hope that the collection will help inform the development of clinical practice guidelines, health policy, and reimbursement decisions. [11]

The articles document the progress of acupuncture research. In our view, the emerging evidence base on the use of acupuncture warrants further integration and application of acupuncture into conventional medicine. [12] National, regional, and international organisations and health systems should facilitate this process and support further rigorous acupuncture research.

Footnotes

This article is part of a collection funded by the special purpose funds for the belt and road, China Academy of Chinese Medical Sciences, National Natural Science Foundation of China, the National Center for Complementary and Integrative Health, the Innovation Team and Talents Cultivation Program of the National Administration of Traditional Chinese Medicine, the Special Project of “Lingnan Modernization of Traditional Chinese Medicine” of the 2019 Guangdong Key Research and Development Program, and the Project of First Class Universities and High-level Dual Discipline for Guangzhou University of Chinese Medicine. The BMJ commissioned, peer reviewed, edited, and made the decision to publish. Kamran Abbasi was the lead editor for The BMJ. Yu-Qing Zhang advised on commissioning for the collection, designed the topic of the series, and coordinated the author teams. Gordon Guyatt provided valuable advice and guidance. [13]

1. Allopathic medicine is the term Samuel Hahnemann coined for defaming conventional medicine. Using it in the first sentence of the article sets the scene very well.

2. Medicine is much more than ‘medications and surgery’. To imply otherwise is a strawman fallacy.

3. What about rehabilitation medicine?

4. ‘Conventional medicine is not always the optimal treatment’? This statement is very confusing and wrong. It is true that conventional medicine is not always effective. However, it is by definition the best we currently have and therefore it IS optimal.

5. Another fallacy: non sequitur

6. Another fallacy: appeal to popularity.

7. Yet another fallacy: appeal to authority.

8. TCM is heavily promoted by China not least because it is a most lucrative source of income.

9. Several research groups have shown that 100% of acupuncture research coming out of China report positive results. This casts serious doubt on the reliability of these studies (see, for instance, here, here, and here).

10. It has been noted that more than 80 percent of clinical data from China is fabricated.

11. Based on the points raised above, it seems to me that the collection’s aim is not to provide objective information but uncritical promotion.

12. I find it telling that the authors do not even consider the possibility that rigorous research might demonstrate that acupuncture cannot generate more good than harm.

13. This statement essentially admits that the series of articles constitutes paid advertising for TCM. The BMJ’s peer-review process must have been less than rigorous in this case.

All this does not bode well for the rest of the collection. Looking at the two further acupuncture papers (see here and here) from the same BMJ issue, my fear that the uncritical promotion of acupuncture will be a prominent feature was amply confirmed.

Auriculotherapy (or ear acupuncture) is the use of electrical, mechanical, or other stimuli at specific points on the outer ear for therapeutic purposes. It was invented by the French neurologist Paul Nogier (1908–1996) who published his “Treatise of Auriculotherapy” in 1961. Auriculotherapy is based on the idea that the human outer ear is an area that reflects the entire body. Proponents of auriculotherapy refer to maps where our inner organs and body parts are depicted on the outer ear. These maps are not in line with our knowledge of anatomy and physiology. Auriculotherapy thus lacks plausibility.

This single-blind randomized, placebo-controlled study aimed to investigate the effect of auriculotherapy on the intensity of Premenstrual Syndrome (PMS) symptoms.

Ninety-one women were randomly assigned to

  • Auriculotherapy (AG),
  • Placebo (PG),
  • Control (CG) groups.

The intervention was 8 weeks long, done once per week. At each session in AG the microneedles were placed in seven points related to PMS symptoms (Anxiety; Endocrine; Muscle relaxation; Analgesia; Kidney; Shen Men; and Sympathetic). At PG the microneedles also were placed in seven points but unrelated to PMS symptoms (Tonsils; Vocal cords; Teeth; Eyes; Allergy; Mouth; and External nose). The women allocate in the CG received o intervention during the evaluation period.

Assessments of PMS symptoms (Premenstrual Syndrome Screening Tool), musculoskeletal pain (Nordic Musculoskeletal Questionnaire), anxiety (Beck Anxiety Inventory), and quality of life (WHOQOL-Bref) were done at baseline, before the 5th session, after program completion, and a month follow-up.

The AG and PG showed significantly lower scores of PMS symptoms, musculoskeletal pain, and anxiety. On the quality of life and follow-up analysis, the significance was observed only in PG.

The authors concluded that auriculotherapy can be used as adjunctive therapy to reduce the physical and mood PMS symptoms.

If I understand it correctly (the paper is unclear), verum and placebo were both better than no intervention but showed no significant differences when compared to each other. This is strong evidence that auriculotherapy is, in fact, a placebo. To make matters worse, in the follow-up analysis placebo seems to be superior to auriculotherapy.

Another issue might be adverse effects. Microneedle implants can cause severe complications. Thus it is mandatory to monitor adverse effects in clinical trials. This does not seem to have happened in this case.

The mind boggles!

How on earth could the authors conclude that auriculotherapy can be used as adjunctive therapy to reduce the physical and mood PMS symptoms.

The answer: a case of scientific misconduct?

This systematic review examined the efficacy of acupressure on depression. Literature searches were performed on PubMed, PsycINFO, Scopus, Embase, MEDLINE, and China National Knowledge (CNKI). Randomized clinical trials (RCTs) or single-group trials in which acupressure was compared with various control methods or baseline (i.e. no treatment) in people with depression were included. Data were synthesized using a random-effects or a fixed-effects model to analyze the impacts of acupressure treatment on depression and anxiety in people with depression. The primary outcome measures were depression symptoms quantified by various means. Subgroups were created, and meta-regression analyses were performed to explore which factors are relevant to the greater or lesser effects of treating symptoms.

A total of 14 RCTs (1439 participants) were identified. Analysis of the between-group showed that acupressure was effective in reducing depression [Standardized mean differences (SMDs) = -0.58, 95%CI: -0.85 to -0.32, P < 0.0001] and anxiety (SMD = -0.67, 95%CI: -0.99 to -0.36, P < 0.0001) in participants with mild-to-moderate primary and secondary depression. Subgroup analyses suggested that acupressure significantly reduced depressive symptoms compared with different controlled conditions and in participants with different ages, clinical conditions, and duration of intervention. Adverse events, including hypotension, dizziness, palpitation, and headache, were reported in only one study.

The authors concluded that the evidence of acupressure for mild-to-moderate depressive symptoms was significant. Importantly, the findings should be interpreted with caution due to study limitations. Future research with a well-designed mixed method is required to consolidate the conclusion and provide an in-depth understanding of potential mechanisms underlying the effects.

I think that more than caution is warranted when interpreting these data. In fact, it would have been surprising if the meta-analyses had NOT generated an overall positive result. This is because in several studies there was no attempt to control for the extra attention or the placebo effect of administering acupressure. In most of the trials where this had been taken care of (i.e. patient-blinded, sham-controlled studies), there were no checks for the success of blinding. Thus it is possible, even likely that many patients correctly guessed what treatment they received. In turn, this means that the outcomes of these trials were also largely due to placebo effects.

Overall, this paper is therefore a prime example of a biased review of biased primary studies. The phenomenon can be aptly described by the slogan:

RUBBISH IN, RUBBISH OUT!

Bach Flower Remedies are often mistaken for homeopathy. Yet they are quite different. They were invented about 100 years ago by Dr. Edward Bach (1886–1936), a doctor homeopath who had previously worked in the London Homeopathic Hospital. His remedies are clearly inspired by homeopathy; however, they are by no means the same because they do not follow the ‘like cures like’ principle and neither are they potentised. They are manufactured by placing freshly picked specific flowers or parts of plants in water which is subsequently mixed with alcohol, bottled, and sold. Like most homeopathic remedies, they are highly dilute and thus do not contain therapeutic concentrations of the plant printed on the bottle. In other words, flower remedies (or essences) are placebos. This does not stop enthusiasts to continue submitting them to clinical trials.

This study tested the effects of flower essence bouquets on the signs and symptoms of stress in nursing students. The study was designed as a randomized clinical trial, triple blind, with two groups (flower essence group and placebo group), carried out with 101 nursing students. Bach’s flower essences Cerato (Ceratostigma wilimottianum)Cherry Plum (Prunus cerasifera)Elm (Ulmus procera)Impatients (Impatiens glandulifera), Larch (Larix decidua), Olive (Olea europaea) and White Chestnut (Aesculus hippocastanum) were selected by the researcher based on the experience of attending nursing students on flower essence therapy. The formulas were prepared in a 30 ml amber glass bottle with a perforated cap with a white seal and bulbs, and labeled according to randomization (Group 1 or Group 2). The groups applied the treatments for 60 days at a dosage of 4 drops 4 times a day. The outcome was evaluated using the Baccaro Test and the Perceived Stress Scale applied at the beginning and at the end of the intervention.

The results demonstrated no significant difference between the groups in stress reduction (p > 0.05). Both groups showed a reduction in scale scores (p < 0.001) with a large effect size. There was an influence of the COVID-19 pandemic in the reduction of Baccaro Test scores.

The authors (who seem to have been advocates of Bach Flower Remedies) concluded that the intervention with flower essence therapy was not more effective than placebo in reducing stress signs and symptoms.

Is anyone surprised?

I am not!

Shiatsu is a (mostly) manual therapy that was popularised by Japanese Tokujiro Namikoshi (1905–2000). It developed out of the Chinese massage therapy, ‘tui na’. The word shiatsu means finger pressure in Japanese; however, a range of devices is also being promoted for shiatsu. The evidence that shiatsu is effective for any condition is close to non-existent.

This study aimed to investigate the effect of Shiatsu massage on agitation in mechanically ventilated patients.

A total of 68 mechanically ventilated patients were randomly assigned to two groups. Patients in the intervention group received three 5-minute periods of Shiatsu massage with a 2-minute break between them, while patients in the control group only received a touch on the area considered for the message. Data were collected before and after the intervention using the Richmond Agitation-Sedation Scale (RASS) and then analyzed.

The results showed that the level of agitation significantly decreased in the intervention group compared to the control group (p=.001).

The authors concluded that the application of shiatsu massage seems to be effective in managing agitation in mechanically ventilated patients. Further studies with greater sample size and longer follow-up period are needed to confirm the current findings.

It is good to see that, as far as I know for the first time, an attempt was made to control for placebo and other non-specific effects in a trial of shiatsu. However, in itself, the attempt is not convincing. What we need to know is whether the attempt was successful or not. Were the patients fully blinded and unable to tell the difference between verum and sham? From reading not just the abstract but the full paper, I do not get the impression that patients were successfully blinded. This means that the results might be entirely due to the effect of deblinding.

 

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