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

palliative care

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.

Some articles are just too remarkable for me to alter them in any way. This one impresses already by its title: “Ameliorative effects of homeopathic medicines in the management of different cancers“. By way of a ‘Christmas treat’, here its summary:

Homeopathy is a commonly used complementary and alternative system of medicine for the treatment of various sorts of ailments throughout the world. Homeopathic medicines are made up of potential therapeutic natural products that are primarily acknowledged for their low doses as well as extended patient survival results. Homeopathic medicines are derived from plants such as arnica (mountain herb), red onion, poison ivy, stinging nettle, and belladonna (deadly nightshade); minerals including white arsenic as well as from animals such as crushed whole bees. Homeopathic medicines are synthesized as sugar pellets to be placed under the tongue and may also be used in the form of gels, ointments, drops, tablets, and creams. Homeopathic medicines can be used to treat various disorders including migraine, depression, gastrointestinal diseases, joint pain, inflammation, different sorts of injuries, flu, arthritis as well as sciatica.

Cancer is the 2nd major reason behind global mortalities. It is revealed that developing countries around the world shoulder most of the cancer burden. According to a survey conducted in 2020, low- and middle-income countries face 70% of the total mortalities worldwide which accounts for approximately 10 million people of these countries. Homeopathic medicines ensure low-cost cancer treatment with little or no side effects on the bodies of humans and animals. Besides, it is applied as a supportive and palliative therapy in a broad range of cancer patients to enhance the body’s fight against cancer, alleviate discomfort resulting from disease or conventional treatments as well as improve the general well-being of the patients. In this chapter, our primary focus will be on the anti-cancerous effects of homeopathic medicines against different cancerous conditions in the body along with their mechanism of action.

Let me just mention a few fairly obvious points:

My conclusion:

Those who advocate homeopathy don’t know what it is, while those who know what it is, don’t advocate it.

As promised, here is my translation of the article published yesterday in ‘Le Figaro’ arguing in favour of integrating so-called alternative medicine (SCAM) into the French healthcare system [the numbers in square brackets were inserted by me and refer to my comments listed at the bottom].

So-called unconventional healthcare practices (osteopathy, naturopathy, acupuncture, homeopathy and hypnosis, according to the Ministry of Health) are a cause for concern for the health authorities and Miviludes, which in June 2023 set up a committee to support the supervision of unconventional healthcare practices, with the task of informing consumers, patients and professionals about their benefits and risks, both in the community and in hospitals. At the time, various reports, surveys and press articles highlighted the risks associated with NHPs, without pointing to their potential benefits [1] in many indications, provided they are properly supervised. There was panic about the “booming” use of these practices, the “explosion” of aberrations, and the “boost effect” of the pandemic [2].

But what are the real figures? Apart from osteopathy, we lack reliable data in France to confirm a sharp increase in the use of these practices [3]. In Switzerland, where it has been decided to integrate them into university hospitals and to regulate the status of practitioners who are not health professionals, the use of NHPs has increased very slightly [4]. With regard to health-related sectarian aberrations, referrals to Miviludes have been stable since 2017 (around 1,000 per year), but it should be pointed out that they are a poor indicator of the “risk” associated with NHPs (unlike reports). The obvious contrast between the figures and the press reports raises questions [5]. Are we witnessing a drift in communication about the risks of ‘alternative’ therapies? [6] Is this distortion of reality [7] necessary in order to justify altering the informed information and freedom of therapeutic choice of patients, which are ethical and democratic imperatives [8]?

It is the inappropriate use of certain NHPs that constitutes a risk, more than the NHPs themselves! [9] Patients who hope to cure their cancer with acupuncture alone and refuse anti-cancer treatments are clearly using it in a dangerous alternative way [10]. However, acupuncture used to relieve nausea caused by chemotherapy, as a complement to the latter, is recommended by the French Association for Supportive Care [11]. The press is full of the dangers of alternative uses, but they are rare: less than 5% of patients treated for cancer according to a European study [12]. This is still too many. Supervision would reduce this risk even further [13].

Talking about risky use is therefore more relevant than listing “illusory therapies”, vaguely defined as “not scientifically validated” and which are by their very nature “risky” [14]. What’s more, it suggests that conventional treatments are always validated and risk-free [15]. But this is not true! In France, iatrogenic drug use is estimated to cause over 200,000 hospital admissions and 10,000 deaths a year [16]. Yes, some self-medication with phytotherapy or aromatherapy does carry risks… just like any self-medication with conventional medicines [17]. Yes, acupuncture can cause deep organ damage, but these accidents occur in fewer than 5 out of every 100,000 patients [18]. Yes, cervical manipulations by osteopaths can cause serious or even fatal injuries, but these exceptional situations are caused by practitioners who do not comply with the decree governing their practice.[19] Yes, patients can be swindled by charlatans, but there are also therapeutic and financial abuses in conventional medicine, such as those reported in dental and ophthalmology centres. [20]

Are patients really that naive? No. 56% are aware that “natural” remedies can have harmful side-effects, and 70% know that there is a risk of sectarian aberrations or of patients being taken in by a sect [21]. In view of the strong demand from patients, we believe that guaranteeing safe access to certain NHPs is an integral part of their supervision, based on regulation of the training and status of practitioners who are not health professionals, transparent communication, appropriate research, the development of hospital services and outpatient networks of so-called “integrative” medicine combining conventional practices and NHPs, structured care pathways with qualified professionals, precise indications and a safe context for treatment.[22] This pragmatic approach to reducing risky drug use [17] has demonstrated its effectiveness in addictionology [23]. It should inspire decision-makers in the use of NHPs”.

  1. Reports about things going wrong usually do not include benefits. For instance, for a report about rail strikes it would be silly to include a paragraph on the benefits of rail transport. Moreover, it is possible that the benefits were not well documented or even non-existent.
  2. No, there was no panic but some well-deserved criticism and concern.
  3. Would it not be the task of practitioners to provide reliable data of their growth or decline?
  4. The situation in Switzerland is often depicted by enthusiasts as speaking in favour of SCAM; however, the reality is very different.
  5. Even if reports were exaggerated, the fact is that the SCAM community does as good as nothing to prevent abuse.
  6. For decades, these therapies were depicted as gentle and harmless (medicines douces!). As they can cause harm, it is high time that there is a shift in reporting and consumers are informed responsibly.
  7. What seems a ‘distortion of reality’ to enthusiasts might merely be a shift to responsible reporting akin to that in conventional medicine where emerging risks are taken seriously.
  8. Are you saying that informing consumers about risks is not an ethical imperative? I’d argue it is an imperative that outweighs all others.
  9. What if both the inappropriate and the appropriate use involve risks?
  10.  Sadly, there are practitioners who advocate this type of usage.
  11. The recommendation might be outdated; current evidence is far less certain that this treatment might be effective (“the certainty of evidence was generally low or very low“)
  12. The dangers depend on a range of factors, not least the nature of the therapy; in case of spinal manipulation, for instance, about 50% of all patients suffer adverse effects which can be severe, even fatal.
  13. Do you have any evidence showing that supervision would reduce this risk, or is this statement based on wishful thinking?
  14. As my previous comments demonstrate, this statement is erroneous.
  15. No, it does not.
  16. Even if this figure is correct, we need to look at the risk/benefit balance. How many lives were saved by conventional medicine?
  17. Again: please look at the risk/benefit balance.
  18. How can you be confident about these figures in the absence of any post-marketing surveillance system? The answer is, you cannot!
  19. No, they occur even with well-trained practitioners who comply with all the rules and regulations that exist – spoiler: there hardly are any rules and regulations!
  20. Correct! But this is a fallacious argument that has nothing to do with SCAM. Please read up about the ‘tu quoque’ and the strawman’ fallacies.
  21. If true, that is good news. Yet, it is impossible to deny that thousands of websites try to convince the consumer that SCAM is gentle and safe.
  22. Strong demand is not a substitute for reliable evidence. In any case, you stated above that demand is not increasing, didn’t you?
  23. Effectiveness in addictionology? Do you have any evidence for this or is that statement also based on wishful thinking?

My conclusion after analysing this article in detail is that it is poorly argued, based on misunderstandings, errors, and wishful thinking. It cannot possibly convince rational thinkers that SCAM should be integrated into conventional healthcare.

PS

The list of signatories can be found in the original paper.

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

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

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

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

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

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

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

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

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

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

This study aimed to evaluate whether individualized homeopathic medicines have a greater adjunctive effect than adjunctive placebos in the treatment of moderate and severe cases of coronavirus disease 2019 (COVID-19). It was designed as a randomized, single-blind, placebo-controlled trial set in the clinical context of standard care. Patients admitted in a tertiary care hospital, suffering from moderate or severe COVID-19 and above 18 years of age were included. In total, 150 patients were randomly divided into two groups to receive either:

  • individualized homeopathic medicines
  • or placebos.

Both options were administered in addition to the standard treatment of COVID-19.

The primary outcome was time taken to achieve RT-PCR-confirmed virus clearance for COVID-19. Secondary outcomes were changes in the Clinical Ordinal Outcomes Scale (COOS) of the World Health Organization, the patient-reported MYMOP2 scale, and several biochemical parameters. Parametric data were analyzed using unpaired t-test. Non-parametric data were analyzed using the Wilcoxon signed rank test. Categorical data were analyzed using Chi-square test.

In total, 72 participants of the add-on homeopathy (AoH) group showed conversion of RT-PCR status to negative, in an average time of 7.53 ± 4.76 days (mean ± SD), as compared with 11.65 ± 9.54 days in the add-on placebo (AoP) group (p = 0.001). The mean COOS score decreased from 4.26 ± 0.44 to 3.64 ± 1.50 and from 4.3 ± 0.46 to 4.07 ± 1.8 in the AoH and AoP groups respectively (p = 0.130). The mortality rate for the AoH group was 9.7% compared with 17.3% in the AoP group. The MYMOP2 scores between the two groups differed significantly (p = 0.001), in favor of AoH. Inter-group differences in the pre- and post- mean values of C-reactive protein, fibrinogen, total leukocyte count, platelet count and alkaline phosphatase were each found to be statistically significant (p <0.05), favoring AoH; six other biochemical parameters showed no statistically significant differences.

The authors concluded that the study suggests homeopathy may be an effective adjunct to standard care for treating moderate and severe COVID-19 patients. More rigorous, including double-blinded, studies should be performed to confirm or refute these initial findings.

I do agree with the authors that more rigorous studies are needed before we can accept these findings. As it stands, this study seems to have multiple flaws:

  • I fail to understand why they did not design their trial as a double-blind study. The reason given by the authors makes little sense to me.
  • I also have my doubts that the study was even single-blind. If I understand it correctly, the placebo group was did not benefit from the detailed homeopathic history taking that is necessary to find the optimal homeopathic remedy. If that is so, unblinding of patients is inevitable.
  • The authors themselves point out that the relevance of many outcome measures is questionable

Generally speaking, I find the results suspicious, implausible, and frankly too good to be true. I might also point out that the authors’ afilitation do not inspire much trust in their objectivity:

  • 1Central Council for Research in Homoeopathy, New Delhi, India.
  • 2Central Council for Research in Homoeopathy, Ministry of AYUSH, Govt. of India, New Delhi, India.
  • 3Rejoice Health Foundation, New Delhi, India.
  • 4Department of Onco-Anaesthesia and Palliative Medicine, Dr. B.R. Ambedkar Institute Rotary Cancer Hospital and National Cancer Institute, All India Institute of Medical Sciences, Ministry of Health and Family Welfare, New Delhi, India.
  • 5Department of Onco-Anaesthesia and Palliative Medicine, All India Institute of Medical Sciences, Ministry of Health and Family Welfare, New Delhi, India.

Neither do these statements:

Funding
The study was funded by the Central Council for Research in Homoeopathy, Ministry of AYUSH, Government of India. The funder approved the study through its review committees, delegated/recruited staff for conducting the study, and facilitated all collaborative procedures.

Conflict of Interest
None declared.

Lastly, I do wonder why the authors published their study in the 3rd class journal ‘Homeopathy’. Surely, such findings – if true – deserve to be published in a journal of a decent reputation!

I don’t usually find reading medical papers scary. An article in the prestigious journal ‘Nature’ is the exception. Here is its abstract:

Long COVID is the patient-coined term for the disease entity whereby persistent symptoms ensue in a significant proportion of those who have had COVID-19, whether asymptomatic, mild or severe. Estimated numbers vary but the assumption is that, of all those who had COVID-19 globally, at least 10% have long COVID. The disease burden spans from mild symptoms to profound disability, the scale making this a huge, new health-care challenge. Long COVID will likely be stratified into several more or less discrete entities with potentially distinct pathogenic pathways. The evolving symptom list is extensive, multi-organ, multisystem and relapsing–remitting, including fatigue, breathlessness, neurocognitive effects and dysautonomia. A range of radiological abnormalities in the olfactory bulb, brain, heart, lung and other sites have been observed in individuals with long COVID. Some body sites indicate the presence of microclots; these and other blood markers of hypercoagulation implicate a likely role of endothelial activation and clotting abnormalities. Diverse auto-antibody (AAB) specificities have been found, as yet without a clear consensus or correlation with symptom clusters. There is support for a role of persistent SARS-CoV-2 reservoirs and/or an effect of Epstein–Barr virus reactivation, and evidence from immune subset changes for broad immune perturbation. Thus, the current picture is one of convergence towards a map of an immunopathogenic aetiology of long COVID, though as yet with insufficient data for a mechanistic synthesis or to fully inform therapeutic pathways.

The paper ends with this gloomy statement: “The oncoming burden of long COVID faced by patients, health-care providers, governments and economies is so large as to be unfathomable, which is possibly why minimal high-level planning is currently allocated to it. If 10% of acute infections lead to persistent symptoms, it could be predicted that ~400 million individuals globally are in need of support for long COVID. The biggest unknowns remain the joined-up scheme of its pathogenesis and thus the best candidate therapeutics to be trialled in randomized controlled trials, along with a better understanding of the kinetics of recovery and the factors influencing this. Some countries have invested in first-round funding for the pilot investigations. From the above, far more will be needed.”

In the context of this blog, we must, of course, ask: HAS SO-CALLED ALTERNATIVE MEDICINE (SCAM) SOMETHING TO OFFER?

I’m afraid that the short answer to this question is No!

However, one does not need to be a clairvoyant to predict that lots of therapeutic claims followed by plenty of methodologically weak (to put it politely) research will emerge from SCAM. Already some time ago, this homeopath indicated, that SCAM providers should see COVID as an opportunity: For homeopathy, shunned during its 200 years of existence by conventional medicine, this outbreak is a key opportunity to show potentially the contribution it can make in treating COVID-19 patients. 

We should not hold our breath to see the emergence of convincing evidence, but we must be prepared to warn the public from getting exploited by charlatans.

This survey evaluated the attitude of healthcare professionals toward the use of so-called alternative medicine (SCAM) to improve current care. A questionnaire on the current practice and opinions about SCAM use was sent to healthcare professionals in Amsterdam UMC, who work for the department of hematology or oncology. Oncologists, hematologists, residents, (specialized) nurses, dieticians, (hospital)pharmacists, and pharmacy technicians were asked to participate.

Among eligible healthcare professionals, 77 responded to the questionnaire (34%). Overall, 87% of healthcare
professionals indicated it is important to be aware of their patient’s SCAM use, and all find the potential of drug–herb interactions important. However, more than half of the healthcare professionals inquire about the patient’s SCAM use infrequently. In addition, only 15% of the healthcare professionals stated they had sufficient knowledge of SCAM to advise patients on their use of SCAM.

The authors concluded that healthcare professionals are aware of the potential risks of SCAM use in combination with anti-cancer treatment. However, SCAM use is not yet discussed with every patient. This may be due to healthcare professionals’ lack of knowledge about SCAM.

This survey would in itself be fairly irrelevant; it employed only a tiny convenience sample and its findings cannot be generalized. Yet, it produced results that have been shown dozens of times before, and it might therefore be a good idea to remind ourselves of their relevance and implications.

  • Patients use SCAM whether we want it or not.
  • Contrary to what is often said, SCAM is not harmless.
  • Therefore conventional healthcare professionals need to know about their patients’ SCAM use.
  • To find out, healthcare professionals need to ask specific questions about SCAM.
  • Next, they must advise their patients responsibly (this is an ethical obligation, not a choice).
  • In order to do that they need to learn the essentials about SCAM.
  • Failing to do this means failing their patients.

Massages are experienced as agreeable by most patients. But that does not necessarily mean that it improves our quality of life. This study tests whether it does.

This study compared three massage dosing strategies among inpatients receiving palliative care consultation. It was designed as a three-armed randomized trial examining three different doses of therapist-applied massage to test change in overall quality of life (QoL) and symptoms among hospitalized adult patients receiving palliative care consultation for any indication:

  • Arm I: 10-min massage daily × 3 days;
  • Arm II: 20-min massage daily × 3 days;
  • Arm III: single 20-min massage.

The primary outcome measure was the single-item McGill QoL question. Secondary outcomes measured pain/symptoms, rating of peacefulness, and satisfaction with the intervention. Data were collected at baseline, pre-and post-treatment, and one-day post-last treatment (follow-up). Repeated measure analysis of variance and paired t-test were used to determine significant differences.

A total of 387 patients participated  (55.7 (±15.49) years old, mostly women (61.2%) and African-American (65.6%)). All three arms demonstrated within-group improvement at follow-up for McGill QoL (all P < 0.05). No significant between-group differences were found. Finally, repeated measure analyses demonstrated time to predict immediate improvement in distress (P ≤ 0.003) and pain (P ≤ 0.02) for all study arms; however, only improvement in distress was sustained at follow-up measurement in arms with three consecutive daily massages of 10 or 20 minutes.

The authors concluded that massage therapy in complex patients with advanced illness was beneficial beyond dosage. Findings support session length (10 or 20 minutes) was predictive of short-term improvements while treatment frequency (once or three consecutive days) predicted sustained improvement at follow-up.

I like this study because it teaches us an important lesson:

IF ONE DESIGNS A SILLY STUDY, ONE IS LIKELY TO ARRIVE AT A SILLY CONCLUSION.

This study does not have a proper control group. Therefore, we cannot know whether the observed outcomes were due to the different interventions or to non-specific effects such as expectation, the passing of time, etc.

The devil’s advocate conclusion of the findings is thus dramatically different from that of the authors: the results of this trial are consistent with the notion that massage has no effect on QoL, no matter how it is dosed.

At first, I thought this was an ‘April fools’ joke. Then I looked at it a bit closer and realized that it seemed for real: Amazon is selling a placebo tablet. Here is how it is advertised:

About this item

  • Honest Placebo Tablets by Zeebo Effect, inert ingredients, halal & kosher
  • Focus on symptom relief, concentration, clarity, energy, calm, sleep
  • Ze logo on each tablet, the original honest placebo brand trusted since 2014
  • Randomized Controlled Trials with Zeebo Published in Journal for Pain, Nature, American Family Physician
  • Each bottle is sealed with a transparent, tamper-proof neckband

Zeebo Tablets – Honest placebo tablets (white, round, 250mg each) are designed to help you create a safe placebo experience. Zeebo comes with the Ze logo on each tablet. Zeebo is made from an inert, natural fiber. Vegan, free of sugar or dyes. When it comes to Zeebo, You are the active ingredient. Users of Zeebo Tablets know they are taking a placebo containing only inert ingredients. Zeebo Tablets are taken intentionally obtain stress and pain relief, to release tension, irritability and nervousness, to help with calm and sleep serving as a sleep aid. Some of our customers take Zeebo Tablets to solicit placebo effects for increased mental focus, clarity, concentration, test performance and to sustain higher energy levels during physical exercise. Zeebo tablets are pure placebo, they are non-drowsy, non-homeopathic. There are no known interactions between Zeebo Placebo Tablets and other medications or supplements. Do not use Zeebo to delay or replace medical treatment. Visit zeeboeffect.com to learn about Zeebo. Look for the ebook The Placebo Cure to find out more about how to create your own Honest Placebo experience.

Take as needed. You may or may not respond to placebo. Do not use Zeebo to replace or delay medical treatment. Use Zeebo without deceit.*

* These statements have not been evaluated by the FDA. This product is not intended to diagnose, cure, treat, or prevent any disease.

Statements regarding dietary supplements have not been evaluated by the FDA and are not intended to diagnose, treat, cure, or prevent any disease or health condition.

Zeebo Tablets are an ethical placebo. People take it knowing it is a placebo. Take it without self-deceit. Zeebo is not made to look like any other ingestible. In fact, we think that the Zeebo branding can help enhance the experience. Have a look into ethical placebo or honest placebo studies. You will find a lot of research there, published in the journals Nature, Pain, for example. No need to trick yourself.

_________________________

After reading all this, I am again not entirely sure whether this is a hoax. If it is, I failed to get the fun of it. If it isn’t, there might be reasons for concern. When a placebo was marketed, a few years ago, THE GUARDIAN published opinions about the idea:

Jennifer Buettner, whose company Efficacy is marketing the placebo, says it can stimulate “the body’s ability to repair itself and the miracle power of the brain”. She said the company planned to distribute the pills, which cost £3 for 50, in the UK. “When drugs are not needed and the patient still thinks that medicine would help, we believe that the placebo effect can work,” she said.

But Dr Clare Gerada, vice-chair of the Royal College of GPs, described the pill as “medicalising love”, adding: “This placebo disempowers parents. It is telling them that unless you give your children this pill there’s nothing else.” Douglas Kamerow, associate editor of the British Medical Journal, said giving placebos to children was a “deeply bad idea”. Writing in the latest edition of the journal, he said: “The problems are numerous. Firstly, whom are we treating here, children or their parents?” He added that if parents used placebos to comfort their children they were teaching them that tablets are the answer for all life’s aches and pains.

As we have seen previously, the evidence on ‘open placebos’ is less impressive than many think. It makes me wonder whether the sale of placebo tablets is a good idea.

WHAT DO YOU THINK?

Subscribe via email

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

Recent Comments

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

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

Archives
Categories