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

alternative medicine

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Tian Jiu (TJ) therapy is a so-called alternative medicine (SCAM) that has been widely utilized in the management of allergic rhinitis (AR). TJ is also known as “drug moxibustion” or “vesiculating moxibustion.” Herbal patches are applied on the selected acupoints or the diseased body part. In TCM, this treatment is said to regulate the functions of meridians and zang-fu organs, warm the channels, disperse coldness, invigorate qi movement, harmonize nutrient absorption and defence mechanisms, and resolve stagnation in the body and stasis of the blood.

But does it work? This single-blinded, three-arm, randomized controlled study evaluated the efficacy of TJ therapy in AR. A total of 138 AR patients were enrolled. The TJ group and placebo group both received 4-weeks of treatment with either TJ or placebo patches for 2 hours. The patches were applied to Dazhui (GV 14), bilateral Feishu (UB 13), and bilateral Shenshu (UB 23) points. Patients received one session per week and then underwent a 4-week follow-up. The waitlist group received no treatment during the corresponding treatment period, but would be given compensatory TJ treatment in the next 4 weeks.

The primary outcome was the change of the Total Nasal Symptom Score (TNSS) after treatment. The secondary outcomes included the changes of Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) and rescue medication score (RMS).

After the treatment period, the total TNSS in TJ group was significantly reduced compared with baseline, but showed no statistical difference compared with placebo. Among the four domains of TNSS, the change of nasal obstruction exhibited statistical difference compared with placebo group. The total RQLQ score in TJ group was significantly reduced compared with both placebo and waitlist groups. The needs of rescue medications were not different between the two groups.

There were no serious adverse events. The common adverse events included flush, pruritus, blister, and pigmentation, occurring in 17, 23, 3, and 36 person-times among TJ group, and 3, 7, 1, and 4 person-times among placebo group, respectively. These adverse events were generally tolerated and disappeared quickly after removing the patches.

The authors (from the Hong Kong Chinese Medicine Clinical Study Centre, School of Chinese Medicine, Hong Kong Baptist University) concluded that this randomized, single-blinded, controlled trial served primary evidence of the efficacy and safety of TJ therapy on AR in Hong Kong. This pilot study provided a fundamental TJ protocol for future research. Through adjusting treatment timing, frequency, retention time, and even body response settings, it has the potential to develop into an optimal therapeutic method for future application.

The authors of this poorly written paper seem to ignore their own findings by concluding as they do. The fact is that the primary endpoint of this trial failed to show a significant difference between TJ and placebo. Moreover, TJ does have considerable adverse effects. Therefore, this study  fails to demonstrate both the effectiveness and the safety of TJ as a treatment of AR.

PS

I often hesitate whether or not to discuss the plethora such frightfully incompetent research. The reason I sometimes do it is to alert the public to the fact that so much utter rubbish is published by incompetent researchers in trashy (but Medline-listed) journals, passed by incompetent ethics committees, supported by naïve funding agencies, accepted by reviewers and editors who evidently do not do their job properly. Do all these people have forgotten that they have a responsibility towards the public?

It is time to stop this nonsense!

It gives a bad name to science, misleads the public and inhibits progress.

I recently received this unexpected and surprising email:

Dear Friend,

I wanted to point out an article that published last month in the New England Journal of Medicine Catalyst that gets to the root of why we are not solving the nation’s current epidemics of chronic pain, obesity, opioids, suicide, and cardiovascular disease.

My co-authors included Dr. Eric Schoomaker, the former surgeon general of the Army; Dr. Tracy Gaudet, who leads cultural transformation at the Veterans Health Administration; and Dr. James Marzolf, the chief health and data analyst in Dr. Gaudet’s office.

In the article Finding the Cause of the Crises: Opioids, Pain, Suicide, Obesity, and Other “Epidemics”, we show how our nation’s response to our current epidemics are tackling the wrong problems.

For example, take the opioid epidemic. The response has been to restrict opioids and focus on other drugs. This narrow approach is compounding the problem. The root cause is that we don’t manage chronic pain appropriately. We need a major roll out of non-pharmacological approaches for pain.

Instead of treating pain with a pill, we need to pay attention to the whole person in mind, body, and spirit. When we do this, we may find that non-drug approaches to treating the person are more appropriate, and treat not only the pain, but the suffering that often accompanies it.

The article describes how systems like the Military and Veterans Health Administration are doing this with transformative approaches that embrace whole person, integrative health.

The good news is that the answers are out there. The entire nation can do this, and we can start now.

Be well.

Dr. Wayne Jonas

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In case you don’t know who my ‘friend’ Wayne is (I did mention him before here and here, for instance), here is a concise summary of his background. As you doubtlessly do know, the NEJM is a (perhaps even the most) respected medical journal. I therefore tried to find the article there and was amazed not to find it. Then I realised that Wayne said it was published not in the NEJM but in the ‘New England Journal of Medicine Catalyst’, a very different proposition.

The New England Journal of Medicine Catalyst brings health care executives, clinical leaders, and clinicians together to share innovative ideas and practical applications for enhancing the value of health care delivery. From a network of top thought leaders, experts, and advisors, our digital publication, quarterly events, and qualified Insights Council provide real-life examples and actionable solutions to help organizations address urgent challenges affecting health care.

But what about the paper that Wayne so warmly recommends? It turns out to be little more than a promotional stunt for integrative medicine. Here is an excerpt from it:

It is often a surprise to people that two of the largest health care systems in the country are trying to radically redesign what they do to provide more whole-person and integrative care. These two systems are run by the Department of Defense (DoD) and the Veterans Health Administration (VHA) and collectively care for over 20 million people. The nation can learn from their efforts.

The need for reform emerged after the turn of this century when leaders in the DoD and VHA began to hold informal meetings under the title “From Healthcare to Health.” Over the course of those meetings, the participants recognized the failure of their health care systems to get at the underlying causes of chronic disease. In 2009, they secured the support of the Chairman of the Joint Chiefs of Staff to change overall military doctrine and guidance to a radically holistic approach called “Total Force Fitness,” which subsequently led to health and community innovations. An example of these redesign innovations was the Defense and Veterans’ Pain Management Task Force and Report and the resulting strategy that preceded the National Academy of Medicine’s report on pain in America.

Other innovations included the Healthy Base Initiative and the Performance Triad, the latter of which focuses on the importance of asking all patients about their sleep, nutrition, and physical activity. All services — Army, Navy, Air Force, Coast Guard, and Special Forces — continue to shift to whole-person models that seek to implement behavioral and complementary approaches. For example, >6000 providers have been trained in and routinely use Battlefield Acupuncture for pain.

The transformation currently underway in the VHA, which goes under the name “Whole Health,” is also an offshoot of that leadership dialogue from 20 years ago. In the Whole Health approach, the emphasis is to empower and equip people to take charge of their health and well-being. In this approach, trained peers help veterans explore their sense of mission and purpose, and well-being programs focus on skill-building and support for self-care. These elements, in addition to person-centered, holistic clinical care, create the Whole Health delivery system. VHA facilities are shifting from a system designed around points of clinical care (in which the primary focus is on disease management) to one that is based in a partnership across time (in which the primary focus is on whole health). Clinical encounters are essential but not sufficient. This health system is designed to focus not only on treatment, but also on self-empowerment, self-healing, and self-care.

This radical redesign is built on decades of VHA work enhancing its integrative approaches with innovations such as Patient-Aligned Care Teams, Primary Care Mental Health Integration, peer-to-peer support, group access to mental health services, and the increasing use of complementary medicine approaches. These changes laid the groundwork for the kind of radical redesign now underway in the VHA and that is needed in all national health care delivery systems.

In 2011, the VHA established an Office of Patient Centered Care and Cultural Transformation to further redefine health care delivery and to oversee this unique approach. Whole Health has begun rapid deployment across the entire VHA system, starting with 18 VHA medical centers in 2018 and with a planned expansion to all VHA medical centers by the end of 2022. System-wide implementation will require an estimated $556 million over 5 years.

When fully implemented, operating costs for this shift are projected to represent 1% of the VHA annual budget. This implementation will involve hiring almost 6,400 new staff, the majority for positions that did not previously exist in the VHA, including health coaches and peer health partners, nutritionists, acupuncturists, and yoga instructors. Whole Health is building access through group visits, peer-to-peer support, and the development of Personal Health Plans for every veteran — something everyone in the country could use. In addition, new payment codes have been created, allowing providers to capture and cover their time and efforts using relative value units (RVUs) and to track productivity.

Will Whole Health help to cure what ails health care? Current models suggest that it will. With improvement in health outcomes, there will be a reduction in the need for existing clinical and biomedical services. These models predict increased access and more proactive population health management. With the addition of these new Whole Health services, we project a 24.5% increase in access when fully deployed — without the addition of a single hospital bed or medical specialist. In addition, Whole Health exceeds cost neutrality and is conservatively estimated to return $2.19 for every dollar invested over 6 years.

These returns reflect net cost avoidance and are derived from reductions in the need and demand for existing clinical health services — exactly what the nation needs in order to reduce chronic disease crises and contain costs. The per capita savings or cost avoidance is modest, averaging $535 per veteran annually over the 6-year period. Cumulatively, however, this totals over $6.2 billion in cost avoidance. Given that the Whole Health approach will improve the health of veterans, many of whom are dealing with complex issues such as chronic pain, mental health conditions, and opioid use at a cost of about $1 per day per veteran, it is a financially sound, cost-effective change from the current health care paradigm.

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So, does this change my mind about integrative medicine?

I’m afraid not! And Wayne fails to provide the slightest evidence that his concepts amount to more than wishful thinking (note how he first mentions predictions of cost savings and, in the next paragraph, pretends they are a reality). I simply do not believe that adding a few unproven therapies to our routine healthcare and wrapping the mixture into politically correct platitudes will improve anything. This cannot work from a theoretical standpoint and, crucially, there is no empirical evidence that it does improve anything else but the income stream of charlatans.

If healthcare needs reform, then let’s reform it! Adding cow pie to apple pie is not a solution, it merely spoils what we have already. I am saying this now since 17 years when I published my first comment on integrative medicine. It was entitled Integrative medicine: not a carte blanche for untested nonsense. I do still think that it sums up the issue succinctly.

I have become used to lamentably poor research in the realm of SCAM, particularly homeopathy. Thus, there is little that can amaze me these days; at least this is what I had thought. But this paper is an exception. The new trial is entitled ‘ETHICAL CLINICAL TRIAL OF LESSER KNOWN HOMEOPATHIC REMEDIES IN INFERTILITY IN FEMALES’, and it is truly outstanding. Here is the abstract:

Background & Objective:  Homoeopathy with time honoured results, has a great number of cured cases of infertility, but without much evidence. So, it is imperative to show scientifically the scope of homoeopathy in treating infertility cases. Materials and Methodology: 7 lesser known medicines (Alteris farinosa, Janosia Ashoka, Viburnum opulus, Euphonium, Ustilago, Bacillus sycocuss, Bacillus morgan) were prescribed to the sample size (n=23), at the project site O.P.D/I.P.D. of Homoeopathy university, Saipura, Jaipur and Dr Madan Pratap Khunteta Homoeopathic Medical College, Hospital & Research Centre, Station Road, Jaipur & its extension O.P.D.’s. for study within 12 months. Result-In the present study 7 (30.43%) patients were prescribed Janosia Ashoka amongst whom 2(28.57%) showed marked improvement, while 5(71.43%) remained in the state of status quo. Conclusion- Study has shown encouraging and effective treatment in infertility in females.

It does not tell us much; therefore, let me copy several crucial passages from the paper itself:

Objectives of the study-

  • To study the efficacy of homoeopathic medicines in the treatment of infertility in females.
  • To enhance the knowledge of materia medica in cases of infertility in females.

Material and Methodology-

The study was conducted at O.P.D./I.P.D.of Homoeopathy University, Saipura, Sanganer and Dr M.P.K. Homoeopathic Medical College &Research Centre, Station Road, Jaipur from 2010 to 2013 for a total period of 3 Years. A sample size of n=23 and 7 lesser known remedies were selected for the studies.

Result-

Inferences- Based on clinical symptoms and pathological investigations. It was inferred that out of 23 patients taken for study, 2 (8.69%) patients showed marked improvement, while 21 (91.31%) patients remained in the state of status quo.

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No, I am not kidding you. There is no further relevant information about the trial methodology nor about the results. Therefore, I feel unable to even criticise this study; it is even too awful for a critique.

As I said: outstanding!

And all this could be quite funny – except, of course, some nutter will undoubtedly use this paper for claiming that there is evidence for homeopathy to efficiently treat female infertility.

You have to be a homeopath to call this an ethical trial!

My friend and colleague Willem Betz has died on 8 June 2019. He was a physician and professor emeritus at the Belgian university Vrije Universiteit Brussel. Willem was a leading sceptic and a founding member of the Belgian sceptic organization SKEPP.

After having worked 20 years as a general practitioner, he made a career change and became a teacher of general practice and a researcher. As a clinician, he received training in several alternative therapies and practiced them of a short while. Soon, he started questioning the validity of these methods and thus became a dedicated sceptic. He served SKEPP as vice-president and as president and became a fellow of the Committee for Scientific Inquiry.

His last paper was published less than a year ago. Here is its abstract:

Conventional treatment of multiple sclerosis (MS) is often disappointing. As a result, some of these patients seek salvation in traditional and complementary medicine (T&CM). The aim of this study is to describe how many patients with MS use T&CM and what their motives and expectations are in doing so. Methods. Ninety-nine patients with diagnosed MS, attending the service of ambulatory revalidation of the National Clinic for Multiple Sclerosis in Melsbroek (Belgium) were included in February 2004 in this retrospective study. All patients had MS resulting in motoric or psychosocial symptoms. The disability was not quantified for this study. Participants were interviewed by means of a structured questionnaire on their current treatment of MS including T&CM. Results. In total 44% of the participants had experiences with T&CM. The most frequently used T&CM were homeopathy and acupuncture. Participants using conventional treatment were more satisfied with the support (p=0.006) and the treatment outcome (0.018) than T&CM users. The use of T&CM was not related to gender, education, living conditions, causal treatment such as disease modifying-therapy (DMT), grade of disability or subtype of the disease. Conclusion. Patients diagnosed with MS seek hope in T&CM such as homeopathy or acupuncture. The results of this study suggest that MS patients need more professional support in their personal search for alternative therapies. Key point. 50% of patients diagnosed with multiple sclerosis search relief in traditional and complementary medicine such as homeopathy or acupuncture. These patients often feel compelled to try every opportunity to heal, often stimulated or urged on by friends or relatives. Multiple sclerosis patients are more satisfied with their conventional treatment than with the traditional and complementary medicine.

Through his personality, enthusiasm, analytical mind, humour and dedication, Willem has inspired an entire generation of sceptics. We will miss you Willem.

You might remember my post from last October:

On Twitter and elsewhere, homeopaths have been celebrating: FINALLY A PROOF OF HOMEOPATHY HAS BEEN PUBLISHED IN A TOP SCIENCE JOURNAL!!!

Here is just one example:

#homeopathy under threat because of lack of peer reviewed studies in respectable journals? Think again. Study published in the most prestigious journal Nature shows efficacy of rhus tox in pain control in rats.

But what exactly does this study show (btw, it was not published in ‘Nature’)?

The authors of the paper in question evaluated antinociceptive efficacy of Rhus Tox in the neuropathic pain and delineated its underlying mechanism. Initially, in-vitro assay using LPS-mediated ROS-induced U-87 glioblastoma cells was performed to study the effect of Rhus Tox on reactive oxygen species (ROS), anti-oxidant status and cytokine profile. Rhus Tox decreased oxidative stress and cytokine release with restoration of anti-oxidant systems. Chronic treatment with Rhus Tox ultra dilutions for 14 days ameliorated neuropathic pain revealed as inhibition of cold, warm and mechanical allodynia along with improved motor nerve conduction velocity (MNCV) in constricted nerve. Rhus Tox decreased the oxidative and nitrosative stress by reducing malondialdehyde (MDA) and nitric oxide (NO) content, respectively along with up regulated glutathione (GSH), superoxide dismutase (SOD) and catalase activity in sciatic nerve of rats. Notably, Rhus Tox treatment caused significant reductions in the levels of tumor necrosis factor (TNF-α), interleukin-6 (IL-6) and interleukin-1β (IL-1β) as compared with CCI-control group. Protective effect of Rhus Tox against CCI-induced sciatic nerve injury in histopathology study was exhibited through maintenance of normal nerve architecture and inhibition of inflammatory changes. Overall, neuroprotective effect of Rhus Tox in CCI-induced neuropathic pain suggests the involvement of anti-oxidative and anti-inflammatory mechanisms.

END OF QUOTE

I am utterly under-whelmed by in-vitro experiments (which are prone to artefacts) and animal studies (especially those with a sample size of 8!) of homeopathy. I think they have very little relevance to the question whether homeopathy works.

But there is more, much more!

It has been pointed out that there are several oddities in this paper which are highly suspicious of scientific misconduct or fraud. It has been noted that the study used duplicated data figures that claimed to show different experimental results, inconsistently reported data and results for various treatment dilutions in the text and figures, contained suspiciously identical data points throughout a series of figures that were reported to represent different experimental results, and hinged on subjective, non-blinded data from a pain experiment involving just eight rats.

Lastly, others pointed out that even if the data is somehow accurate, the experiment is unconvincing. The fast timing differences of paw withdraw is subjective. It’s also prone to bias because the researchers were not blinded to the rats’ treatments (meaning they could have known which animals were given the control drug or the homeopathic dilution). Moreover, eight animals in each group is not a large enough number from which to draw firm conclusions, they argue.

As one consequence of these suspicions, the journal has recently added the following footnote to the publication:

10/1/2018 Editors’ Note: Readers are alerted that the conclusions of this paper are subject to criticisms that are being considered by the editors. Appropriate editorial action will be taken once this matter is resolved.

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Well, it took a while, but now there is some news about this case:

‘Science Reports’, just published a retraction note:

Retraction of: Scientific Reports https://doi.org/10.1038/s41598-018-31971-9, published online 10 September 2018

Following publication, the journal received criticisms regarding the rationale of this study and the plausibility of its central conclusions. Expert advice was obtained, and the following issues were determined to undermine confidence in the reliability of the study.

The in vitro model does not support the main conclusion of the paper that Rhus Tox reduces pain. The qualitative and quantitative composition of the Rhus Tox extract is unknown. Figures 1G and 1H are duplicates; and figures 1I and 1J are duplicates. The majority of experimental points reported in figure 3 panel A are duplicated in figure 3 panel B. The collection, description, analysis and presentation of the behavioural data in Figure 3 is inadequate and cannot be relied upon.

As a result the editors are retracting the Article. The authors do not agree with the retraction.

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Does that mean the suspect paper has been declared fraudulent?

I think so.

In any case: another victory of reason over unreason!

Green tea is said to have numerous health benefits. Recently, a special green tea, matcha tea, is gaining popularity and is claimed to be more powerful than simple green tea. Matcha tea consumption is said to lead to higher intake of green tea phytochemicals compared to regular green tea.

But what is matcha tea? This article explains:

The word matcha literally means “powdered tea”. Drinking a cup or two of the tea made from this powder could help you tackle your day feeling clear, motivated and energized, rather than foggy, stressed out, and succumbing to chaos.

Matcha tea leaves are thrown a lot of shade (literally). They’re grown in the dark. The shade growing process increases matcha’s nutrients, especially chlorophyll, a green plant pigment that allows plants to absorb energy from sunlight. Chlorophyll is rich in antioxidants, and gives matcha it’s electrifying green colour. Shade growing also increases the amount of L-theanine, which is the amino acid known for promoting mental clarity, focus, and a sense of calm. It’s called nature’s “Xanax” for a reason.

The high amino acid content is also what gives matcha it’s signature umami taste. Umami is the “fifth” taste that describes the savory flavor of foods like miso, parmesan cheese, chicken broth, spinach, and soy sauce. You know you’ve got a premium matcha when you taste balanced umami flavors, hints of creaminess, and the slightest taste of fresh cut grass. You shouldn’t need to add any sweetener to enjoy sipping it. When choosing a high quality matcha powder, it’s important to remember: a strong umami flavour = higher in amino acids = the more L-theanine you’ll receive.

Once matcha leaves are harvested, they get steamed, dried, and ground up into a fine powder that you can mix with hot or cold water. The key difference here is that you’re actually consuming the nutrients from the entire leaf— which is most concentrated in antioxidants, amino acids, and umami flavour. This is unlike traditional brewed tea, where you’re only drinking the dissolvable portions of the leaf that have been steeped in water.

The article also names 5 effects of matcha tea:

1. Promotes Relaxation, Mood, and Mental Focus

2. Supports Healthy Cognitive Function

3. Supports Detoxification

4. Fights Physical Signs of Aging

5. Promotes a Healthy Heart

None of the sources provided do actually confirm that matcha tea conveys any of these benefits in humans. My favourite reference provided by the author is the one that is supposed to show that matcha tea is a detox remedy for humans. The article provided is entitled Low-dose dietary chlorophyll inhibits multi-organ carcinogenesis in the rainbow trout. Who said that SCAM-peddlers have no sense of humour?

Joking aside, is there any evidence at all to show that matcha tea has any health effects in humans? I found two clinical trials that tested this hypothesis.

Trial No1:

Intake of the catechin epigallocatechin gallate and caffeine has been shown to enhance exercise-induced fat oxidation. Matcha green tea powder contains catechins and caffeine and is consumed as a drink. We examined the effect of Matcha green tea drinks on metabolic, physiological, and perceived intensity responses during brisk walking. A total of 13 females (age: 27 ± 8 years, body mass: 65 ± 7 kg, height: 166 ± 6 cm) volunteered to participate in the study. Resting metabolic equivalent (1-MET) was measured using Douglas bags (1-MET: 3.4 ± 0.3 ml·kg-1·min-1). Participants completed an incremental walking protocol to establish the relationship between walking speed and oxygen uptake and individualize the walking speed at 5- or 6-MET. A randomized, crossover design was used with participants tested between Days 9 and 11 of the menstrual cycle (follicular phase). Participants consumed three drinks (each drink made with 1 g of Matcha premium grade; OMGTea Ltd., Brighton, UK) the day before and one drink 2 hr before the 30-min walk at 5- (n = 10) or 6-MET (walking speed: 5.8 ± 0.4 km/hr) with responses measured at 8-10, 18-20, and 28-30 min. Matcha had no effect on physiological and perceived intensity responses. Matcha resulted in lower respiratory exchange ratio (control: 0.84 ± 0.04; Matcha: 0.82 ± 0.04; p < .01) and enhanced fat oxidation during a 30-min brisk walk (control: 0.31 ± 0.10; Matcha: 0.35 ± 0.11 g/min; p < .01). Matcha green tea drinking can enhance exercise-induced fat oxidation in females. However, when regular brisk walking with 30-min bouts is being undertaken as part of a weight loss program, the metabolic effects of Matcha should not be overstated.

Trial No 2:

Matcha tea is gaining popularity throughout the world in recent years and is frequently referred to as a mood-and-brain food. Previous research has demonstrated that three constituents present in matcha tea, l-theanine, epigallocatechin gallate (EGCG), and caffeine, affect mood and cognitive performance. However, to date there are no studies assessing the effect of matcha tea itself. The present study investigates these effects by means of a human intervention study administering matcha tea and a matcha containing product. Using a randomized, placebo-controlled, single-blind study, 23 consumers participated in four test sessions. In each session, participants consumed one of the four test products: matcha tea, matcha tea bar (each containing 4g matcha tea powder), placebo tea, or placebo bar. The assessment was performed at baseline and 60min post-treatment. The participants performed a set of cognitive tests assessing attention, information processing, working memory, and episodic memory. The mood state was measured by means of a Profile of Mood States (POMS). After consuming the matcha products compared to placebo versions, there were mainly significant improvements in tasks measuring basic attention abilities and psychomotor speed in response to stimuli over a defined period of time. In contrast to expectations, the effect was barely present in the other cognitive tasks. The POMS results revealed no significant changes in mood. The influence of the food matrix was demonstrated by the fact that on most cognitive performance measures the drink format outperformed the bar format, particularly in tasks measuring speed of spatial working memory and delayed picture recognition. This study suggests that matcha tea consumed in a realistic dose can induce slight effects on speed of attention and episodic secondary memory to a low degree. Further studies are required to elucidate the influences of the food matrix.

Not impressed?

Me neither!

However, I was impressed when I looked up the costs of matcha tea: £17.95 for 30 g of powder does not exactly seem to be a bargain. So, matcha tea does after all help some people, namely all those engaged in flogging it to the gullible SCAM fraternity.

 

So-called alternative medicine (SCAM) is a seriously dangerous option for cancer patients who aim at curing their cancer with it. One cannot warn patients often and strongly enough, I believe. But when it comes to supportive cancer treatment (care that does not aim at changing the natural history of the disease), SCAM might have a place. I said ‘might’ because its exact role is far from clear.

The aim of this study was to investigate the effects of a complex, nurse-led, supportive care intervention using SCAM on patients’ quality of life (QoL) and associated patient-reported outcomes. In this prospective, pragmatic, bicentric, randomized controlled trial, women with breast or gynaecologic cancers undergoing a new regimen of chemotherapy (CHT) were randomly assigned to routine supportive care plus intervention (intervention group, IG) or routine care alone (control group, CG). The intervention consisted of SCAM applications and counseling for symptom management, as well as SCAM information material. The primary endpoint was global QoL measured with the EORTC-QLQ-C30 before and after SCAM.

In total, 126 patients were randomly assigned into the IG and 125 patients into the CG. The patients’ medical and socio-demographic characteristics were homogenous at baseline and at follow-up. No group effects on QoL were found upon completion of CHT, but there was a significant group difference in favour of the IG, 6 months later. IG patients did also experience significant better emotional functioning and less fatigue.

The authors concluded that the tested supportive intervention did not improve patients’ QoL outcomes directly after CHT (T3), but was associated with significant QoL improvements when considering the change from baseline to the time point T4, which could be assessed 6 months after patients’ completion of CHT. This delayed effect may have resulted due to a strengthening of patients’ self-management competencies.

A prospective, pragmatic, bicentric, randomized controlled trial! Doesn’t this sound rigorous? In fact, this term merely hides a trial that was destined to generate a positive result. As it followed the infamous A+B versus B design, it hardly had a chance to not come out positive.

The only thing I find amazing is that the short-term results failed to be statistically significant. Far too many SCAM researchers, it seems to me, view science as a tool for promoting their dubious ideas.

The use of SCAM with the aim of improving QoL might be helpful. But this assumption cannot be accepted on the basis of opinion; we need good science to find out which forms of SCAM are worth employing. Sadly, studies like the above are not in this category.

If you ask me, it is high time that this misleading nonsensical and unethical pseudo-research stops!

Spinal manipulation is an umbrella term for numerous manoeuvres chiropractors, osteopaths, physiotherapists and other clinicians apply to their patients’ vertebral columns.  Spinal manipulations are said to be effective for a wide range of conditions. But how do they work? What is their mode of action? A new article tries to address these questions. here is its abstract:

Spinal manipulation has been an effective intervention for the management of various musculoskeletal disorders. However, the mechanisms underlying the pain modulatory effects of spinal manipulation remain elusive. Although both biomechanical and neurophysiological phenomena have been thought to play a role in the observed clinical effects of spinal manipulation, a growing number of recent studies have indicated peripheral, spinal and supraspinal mechanisms of manipulation and suggested that the improved clinical outcomes are largely of neurophysiological origin. In this article, we reviewed the relevance of various neurophysiological theories with respect to the findings of mechanistic studies that demonstrated neural responses following spinal manipulation. This article also discussed whether these neural responses are associated with the possible neurophysiological mechanisms of spinal manipulation. The body of literature reviewed herein suggested some clear neurophysiological changes following spinal manipulation, which include neural plastic changes, alteration in motor neuron excitability, increase in cortical drive and many more. However, the clinical relevance of these changes in relation to the mechanisms that underlie the effectiveness of spinal manipulation is still unclear. In addition, there were some major methodological flaws in many of the reviewed studies. Future mechanistic studies should have an appropriate study design and methodology and should plan for a long-term follow-up in order to determine the clinical significance of the neural responses evoked following spinal manipulation.

I have to admit, this made me laugh. Any article that starts with the claim spinal manipulation is an effective intervention and speaks about its observed clinical effects without critically assessing the evidence for it must be ridiculous. The truth is that, so far, it is unclear whether spinal manipulations cause any therapeutic effects at all. To take them as a given, therefore discloses a bias that can only be a hindrance to any objective evaluation.

Yet, perhaps unwittingly, the paper raises an important question: do we need to search for a mode of action of treatments that are unproven? It is a question, of course, that is relevant to all or at least much of SCAM.

Do we need to research the mode of action of acupuncture?

Do we need to research the mode of action of energy healing?

Do we need to research the mode of action of reflexology?

Do we need to research the mode of action of homeopathy?

Do we need to research the mode of action of Bach flower remedies?

Do we need to research the mode of action of cupping?

Do we need to research the mode of action of qigong?

In the absence of compelling evidence that a mode of action (other than the placebo response) exists, I would say: no, we don’t. Such research might turn out to be wasteful and carries the risk of attributing credibility to treatments that do not deserve it.

What do you think?

 

Many cancer patients use so-called alternative medicine (SCAM) such as Traditional Chinese Medicine (TCM). On this blog, we have repeatedly discussed whether this does more good than harm. This study sheds new light on the question. Specifically, it aims to explore the benefits of TCM therapy in the long-term survival of patients with hepatocellular carcinoma in China.

In total, 3483 patients with HCC admitted to the Beijing Ditan Hospital of Capital Medical University were enrolled. The researchers used 1:1 frequency matching by sex, age, diagnosis time, Barcelona Clinic Liver Cancer staging, and type of treatments to compare the TCM users (n = 526) and non-TCM users (n = 526). A Cox multivariate regression model was employed to evaluate the effects of TCM therapy on the HR value and Kaplan-Meier survival curve for mortality risk in HCC patients. A log-rank test was performed to analyse the effect of TCM therapy on the survival time of HCC patients.

The Cox multivariate analysis indicated that TCM therapy was an independent protective factor for 5-year survival in patients with HCC. The Kaplan-Meier curve also showed that after PS matching, TCM users had a higher overall survival rate and a higher progression-free survival rate than non-TCM users. TCM users, regardless of the classification of etiology, tumor stage, liver function level, or type of treatment, all benefited significantly from TCM therapy. The most commonly used Chinese patent medications used were Fufang Banmao Capsule, Huaier Granule, and Jinlong Capsule.

The authors concluded that using traditional Chinese medications as adjuvant therapy can probably prolong median survival time and improve the overall survival among patients with HCC. Further scientific studies and clinical trials are needed to examine the efficiency and safety.

I was unable to access the full article and therefore am unable to provide a detailed critique of it. From reading the abstract, I should point out, however, that this was not an RCT. To minimise bias, the researchers used a matching technique to generate two comparable groups. Such methods can be successful in matching for the named parameters, but they cannot match for the plethora of variables that might be relevant but were not measured. Therefore, the survival difference between the two groups might be due not to the therapies they received, but to the fact that the groups were not comparable in terms of factors that impact on survival.

Another important point about this paper is the obvious fact that it originates from China. We know from several independent investigations that such studies almost never report negative findings. We also know that TCM is a hugely important export item for China. Adding two and two together should therefore make us sceptical. I for one take the present findings with more than a pinch of salt.

Indian doctors have just published the case of a 38-year old man with cirrhosis of the liver due to compensated non-alcoholic fatty-liver-disease. He presented with acute worsening of his chronic liver disease. The acute event was not discernible even after extensive work up. Eventually, a transjugular liver biopsy revealed features suggestive of severe alcoholic hepatitis.

The patient and the family denied occult alcohol use when questioned over multiple times. According to the authors, the culprit ‘alcohol’ was found to be the homoeopathy medicines: the patient had been consuming a homeopathic remedy over a month for treatment of Gilbert’s syndrome. The researchers retrieved and tested the homoeopathy drug for alcohol content and found it contained 18% of ethanol. This, they felt, confirmed their diagnosis of alcoholic liver disease caused by the regular consumption of a homeopathic remedy.

Why did the patient help from a homeopath? Gilbert’s syndrome doesn’t usually require any treatment at all. Two weeks into his new treatment, the patient claimed he was feeling drowsy and slurring his speech, as if intoxicated. The liquid homeopathic formulation was therefore reduced at this stage. A further two weeks passed when his eyes yellowed, his urine darkened, and his legs began to swell. A liver tests confirmed a spike in his bilirubin 10 times above normal, with liver enzymes also elevated. All signs were thus pointing to an acute form of hepatitis commonly associated with alcohol binges. With the patient adamant he hadn’t touched alcohol, the doctors looked for other causes of hepatitis. None were found. When the patient admitted using homeopathy, his doctors thought to have found an explanation for the problem.

Despite starting the patient on a range of treatments and referring him to a liver transplant centre for further management, the damage to the patient’s liver proved to be irreversible. One month and 12 days later, the patient developed multiple organ failure and passed away. The authors of this case report point out “at risk patients and the general population need to be educated regarding the fact that complementary and alternative medications are not without side-effects.”

I do agree with their comment, but I very much doubt that their diagnosis of homeopathy-induced liver disease was correct. If the alcohol in the homeopathic remedy truly had been the cause, the patient would have needed to consume well in excess of one litre of it per day. The authors do not tell us about the volume of consumption, but I doubt that a patient would be able to afford such an orgy in homeopathy.

Highly diluted homeopathic remedies contain nothing, it is often said. This is not entirely true. In the case of solid preparations (globuli), they do contain sugar, and in the case of liquid remedies, they contain alcohol. Yet, as a source of either ingredient, they are neither practical nor economical. I fear therefore that the medical team of the diseased man are mistaken when accusing homeopathy of being the cause of their patient’s death.

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