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

anxiety

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The global market for dietary supplements has grown continuously during the past years. In 2019, it amounted to around US$ 353 billion. The pandemic led to a further significant boost in sales. Evidently, many consumers listened to the sly promotion by the supplement industry. Thus they began to be convinced that supplements might stimulate their immune system and thus protect them against COVID-19 infections.

During the pre-pandemic years, the US sales figures had typically increased by about 5% year on year. In 2020, the increase amounted to a staggering 44 % (US$435 million) during the six weeks preceding April 5th, 2020 relative to the same period in 2019. The demand for multivitamins in the US reached a peak in March 2020 when sales figures had risen by 51.2 %. Total sales of vitamins and other supplements amounted to almost 120 million units for that period alone. In the UK, vitamin sales increased by 63 % and, in France, sales grew by around 40–60 % in March 2020 compared to the same period of the previous year.

Vis a vis such impressive sales figures, one should ask whether dietary supplements really do produce the benefit that consumers hope for. More precisely, is there any sound evidence that these supplements protect us from getting infected by COVID-19? In an attempt to answer this question, I conducted several Medline searches. Here are the conclusions of the relevant clinical trials and systematic reviews that I thus found:

Confused?

Me too!

Does the evidence justify the boom in sales of dietary supplements?

More specifically, is there good evidence that the products the US supplement industry is selling protect us against COVID-19 infections?

No, I don’t think so.

So, what precisely is behind the recent sales boom?

It surely is the claim that supplements protect us from Covid-19 which is being promoted in many different ways by the industry. In other words, we are being taken for a (very expensive) ride.

Some used to think that Deepak Chopra is amongst the biggest charlatans on the planet. Well, they were wrong! And his new venture proves it beyond doubt.

The Lovetuner is a revolutionary approach to reduce stress, relieve anxiety and arrive in the present moment, connecting your exhale with the power of the 528hz frequency. That’s what the ad says, and Dr. Deepak Chopra agrees!

The website contains a short video which is a ‘MUST WATCH’. Please do have a look at it. Deepak will show you how to use the ‘LOVETUNER’. I promise you, it is impressive! In the video, Deepak also states that he is enthusiastic about the LOVETUNER and promises that:

  • the LOVETUNER creates the frequency of love;
  • the LOVETUNER can replace meditation;
  • the LOVETUNER is inviting love into your life;
  • the LOVETUNER increases your lung capacity;
  • the LOVETUNER increases the coherence of your biofield;
  • the LOVETUNER changes the biofield of the surroundings.

I am sure all these claims are based on the most solid of evidence. The fact that none of it has been published should not disturb us; on the contrary, it means that the evidence is so important that BIG PHARMA does not allow it to be published through the usual peer-reviewed channels – hence the video.

For those who are still not convinced, Deepak adds a written text:

“We want the world to be a more loving, peaceful, harmonious, happier and healthier place, right? First, we need to start with ourselves and be the change we want to see in this world. With the Lovetuner this is an easy and fun way to connect with ourselves and the world around us. The Lovetuner is more than just a meditation device – it is a mindset and a global peace and love movement. The Lovetuner teaches you the breath that spiritual gurus across the globe are going to recommend to you. It’s what you’ll find at your yoga retreat, sound bath, and guided meditation, but with the Lovetuner you can be your own guru.”

So, how does the LOVETUNER work? The website provides a most plausible explanation:

The Lovetuner is a revolutionary mindfulness tool that aligns you with the 528hz frequency, the vibration of love. In music, tuning means adjusting the pitch of a tone. In humans, it means adjusting your emotional and physical state to align with your environment – literally “tuning in” and harmonizing with yourself and what is around you. The Lovetuner has a profound effect on the body, mind and spirit.

Our entire universe is comprised of light and sound, frequency and vibration. The connections between music, cosmos and nature have been known since ancient times. In 1978 Hans Cousto, a Swiss mathematician and musicologist, compared the frequencies in planetary orbits, in architectural works, in old and modern measuring systems, in the human body, in music and in medicine and “discovered” their connection. John Lennon used the 528hz frequency for his song “Imagine.” In music, the 528Hz frequency refers to the note “Mi” and is traced back to the expression “Mi-ra gestorum” on the scale, which in Latin means “miracle”.

The 528hz frequency has a healing and health-promoting effect on our body, mind, and soul. Our cells and organs resonate with this frequency. The vibration is transferred to our entire organism where it can unfold its positive effect. It activates and strengthens our natural self-healing powers.

The 528hz frequency has a very special physical and biological importance.

The medical pioneer Dr. Royal Raymond Rife, who researched at the beginning of the 20th century, used many frequencies in his practice of radionics or electromagnetic therapy, but he specifically referred to 528 because of its ability to repair DNA. Dr. Rife used this frequency among hundreds of others for use with his Rife Machine – “Radionics.” He referred to 528 as “DNA repair.”

Molecular genetic investigations have shown that this frequency can be used to repair defective DNA strands or to restore human DNA to its original state. Scientific studies further showed that it increases the UV light absorption in DNA and can cure DNA by removing impurities that cause disease.

Today, the use of non-pharmacological and non-invasive agents is quite common. Sound waves, which are classified as non-invasive means for stimulating auditory cells, also affect non-auditory cells. Since the frequency of 528hz is related to the musical note Mi, effects such as an increase in the ability to repair DNA are observed.

 

I know, you are dying to know how much the LOVETUNER costs. For just $ 62, it can be yours! I do think that this is a bargain and am deeply thankful to Deepak for alerting me to this life-changing device. Yes, some used to think that Deepak Chopra is amongst the biggest charlatans on the planet. I am sure that his support for the LOVETUNER will make these people change their minds.

Past life regression therapy (PLRT) is, according to one practitioner, a therapeutic technique for accessing and re-experiencing your past lives directly.  A branch of hypnotherapy, past life regression therapy has grown over the last 50 years to be an important addition to the healing arts. This website also informs us that:

Past life regression is an amazing, full-sensory experience.  You might experience the memory as a vivid movie, or see only vague flashes of images that prompt the narrative.  You might hear gunshots or explosions on a battlefield, or music at a dance.  It is possible to recall smells too:  smoke from a fire, leather from a saddle, or the sweat of a dirty body.

As the story unfolds, you feel real emotions appropriate to the story.  You may cry when you re-experience deep sadness at the death of a beloved child, feel despair in the pit of your stomach as you witness a massacre, or elation at a long-awaited homecoming from war.  And just as you can recall strong emotions, you feel the pain of an arrow piercing your body as you are dying, or the heaviness of a load you’re carrying on your back.  These physical sensations and emotions are very real in the moment, but pass quickly as you move through the past life story and death.

PLRT is used by some clinicians for anxiety disorders, mood disorders, gender dysphoria, and other conditions. One survey suggested that 22% of European cancer patients use PLRT as a so-called alternative medicine (SCAM) to treat their illness. Some proponents argue that, since the exploration of the event/memory is actually helping the client resolve the challenge, the overall process can have immense therapeutic benefit, provided it is done responsibly and effectively.

So, it is effective because it is effective??? Such assurances make my alarm bells ring loud and clear. And I am not alone. It has been argued that PLRT is unethical:

  • First, it is not evidence-based. Past life regression is based on the reincarnation hypothesis, but this hypothesis is not supported by evidence, and in fact, it faces some insurmountable conceptual problems. If patients are not fully informed about these problems, they cannot provide informed consent, and hence, the principle of autonomy is violated.
  • Second, past life regression therapy has the great risk of implanting false memories in patients, and thus, causing significant harm. This is a violation of the principle of non-malfeasance, which is surely the most important principle in medical ethics.

I was unable to find convincing evidence that PLRT is effective. Furthermore, PLRT is by no means cheap; a typical session lasts two hours and costs $350. This suggests that PLRT is

  • unproven,
  • expensive,
  • and unsafe.

In other words, it is not a therapeutic option that I would recommend to anyone for any condition.

Multiple sclerosis (MS) causes a range of different symptoms. Patients with MS have looked for alternative therapies to control their MS progress and treat their symptoms. Non-invasive therapeutic approaches such as massage can have benefits to mitigate some of these symptoms. However, there is no rigorous review of massage effectiveness for patients suffering from MS.

The present systematic review was aimed at examining the effectiveness of different massage approaches on common MS symptoms, including fatigue, pain, anxiety, depression, and spasticity.

A total of 12 studies met the inclusion criteria. The authors rated 5 studies as being of fair and 7 studies of good methodological quality. Fatigue was improved by different massage styles, such as reflexology, nonspecific therapeutic massage, and Swedish massage. Pain, anxiety, and depression were effectively improved by reflexology techniques. Spasticity was reduced by Swedish massage and reflexology techniques.

The authors concluded that different massage approaches effectively improved MS symptoms such as fatigue, pain, anxiety, depression, and spasticity.

Clinical trials of massage therapy face formidable obstacles including:

  • difficulties in obtaining funding,
  • difficulties in finding expert researchers who are interested in the subject,
  • difficulties to control for placebo effects,
  • difficulties in blinding patients,
  • impossibility of blinding therapists,
  • confusion about the plethora of different massage techniques.

Thus, the evidence is often less convincing than one would hope. This, however, does not mean that massage therapy does not have considerable potential for a range of indications. One could easily argue that this situation is similar to spinal manipulation. Yet, there are at least three important differences:

  • massage therapy is not as heavily burdened with frequent adverse effects and potentially life-threatening complications,
  • massage therapy has a rational basis,
  • the existing evidence is more uniformly encouraging.

Consequently, massage therapy (particularly, classic or Swedish massage) is more readily being accepted even in the absence of solid evidence. In fact, in some countries, e.g. Germany and Austria, massage therapy is considered to be a conventional treatment.

While working on yesterday’s post, I discovered another recent and remarkable article co-authored by Prof Harald Walach. It would surely be unforgivable not to show you the abstract:

The aim of this study is to explore experiences and perceived effects of the Rosary on issues around health and well-being, as well as on spirituality and religiosity. A qualitative study was conducted interviewing ten Roman Catholic German adults who regularly practiced the Rosary prayer. As a result of using a tangible prayer cord and from the rhythmic repetition of prayers, the participants described experiencing stability, peace and a contemplative connection with the Divine, with Mary as a guide and mediator before God. Praying the Rosary was described as helpful in coping with critical life events and in fostering an attitude of acceptance, humbleness and devotion.

The article impressed me so much that it prompted me to design a virtual study for which I borrowed Walach’s abstract. Here it is:

The aim of this study is to explore experiences and perceived effects of train-spotting on issues around health and well-being, as well as on spirituality. A qualitative study was conducted interviewing ten British adults who regularly practiced the art of train-spotting. As a result of using a tangible train-spotter diary and from the rhythmic repetition of the passing trains, the participants described experiencing stability, peace, and a contemplative connection with the Divine, with Mary as a guide and mediator before the almighty train-spotter in the sky. Train-spotting was described as helpful in coping with critical life events and in fostering an attitude of acceptance, humbleness, and devotion.

These virtual results are encouraging and encourage me to propose the hypothesis that Rosary use and train-spotting might be combined to create a new wellness program generating a maximum holistic effect. We are grateful to Walach et al for the inspiration and are currently applying for research funds to test our hypothesis in a controlled clinical trial.

 

Bach flower remedies were invented in the 1920s by Dr. Edward Bach (1886-1936), a doctor homeopath who had previously worked in the London Homeopathic Hospital. They have since become very popular in Europe and beyond. Bach flower remedies are clearly inspired by homeopathy; however, they are not the same because they do not follow the ‘like cures like’ principle and are they potentized. 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 amounts of the plant printed on the bottle.

The aim of this new randomized, double-blind, placebo-controlled trial was to compare the efficacy of flower therapy for the treatment of anxiety in overweight or obese adults with that of a placebo. The authors examined improvement in sleep patterns, reduction in binge eating, and change in resting heart rate (RHR).

The study included 40 participants in the placebo group and 41 in the intervention group. Participants were of both genders, from 20 to 59 years of age, overweight or obese, with moderate to high anxiety. They were randomized into two groups:

  1. one group was treated with Bach flower remedies (BFR) (bottles containing 30 mL of 30% hydro-brandy solution with two drops each of Impatiens, White Chestnut, Cherry Plum, Chicory, Crab Apple, and Pine), purchased from Healing® Flower Essences (São Paulo, Brazil)
  2. the other group was given a placebo (same solution without BFR).

All patients were instructed to orally ingest the solutions by placing four drops directly in the mouth four times a day for 4 weeks.

The primary outcome was anxiety (State-Trait Anxiety Inventory [STAI]). Secondary outcomes were sleep (Pittsburgh Sleep Quality Index [PSQI]), binge eating (Binge Eating Scale [BES]), and RHR (electrocardiogram).

Multivariate analysis showed significant reductions in scores for the following variables in the intervention group when compared with the placebo group: STAI (β = −0.190; p < 0.001), PSQI (β = −0.160; p = 0.027), BES (β = −0.226; p = 0.001), and RHR (β = −0.07; p = 0.003).

The authors concluded that anxiety symptoms, binge eating, and RHRs of the individuals treated with flower therapy decreased, and their sleep patterns improved when compared with those treated with the placebo.

Did the alcohol in the verum preparation had a relaxing effect? No, I was teasing. The amount would have been too small and the effect would have been the same in both groups. But what could have caused the observed outcome? I have to admit that I have no idea.

I read the study several times and could not find a major flaw. Hence it must have been the flower remedy that caused the positive outcome? No, I am teasing again. I find this impossible to imagine. These remedies contain nothing that might explain the results and all previous systematic reviews of all the available trials have all reached a negative conclusion. Before I seriously consider the option that flower remedies are more than placebos, I would like to see an independent replication.

Ever since I published a post about the irresponsible and aggressive advertising campaign of LYMA (“the world’s 1st super-supplement”), I am pursued by them with emails informing me about the wonders of this supplement. Here is one I received recently:

Here at LYMA we are firm believers that optimal productivity depends on good quality sleep and your day is only as good as the previous night.

Suffering from bad sleep is debilitating whether it’s ourselves or we’re watching someone we love suffer, the search for good rest is something we’re all united in.

Energy levels, positive mindset and strong cognitive function all come from sleep, which is why we spent so long formulating the LYMA supplement. Our patented KSM-66® Ashwagandha is the highest-quality, zero toxicity, concentrated Ashwagandha root in the world. The hefty combination of purity and potency make it unrivalled in its ability to reduce inflammation, neutralise anxiety and promote deep, restful sleep, night after night.

Thousands of customers have told us that after years of bad sleep, they’re finally getting the rest they need and feeling transformed as a result. In fact, it’s one of the very first benefits most people notice. We’re happy to hear it.

And the knock-on effects of a good night’s sleep in how we feel, how we perform and our overall health are far reaching. Which is why we are so delighted to welcome Michael Grandner, world-renowned sleep expert and Director of the Behavioural Sleep Medicine Clinic, Arizona to the LYMA team.

Michael is one of the most cited sleep experts in the world and has himself published over 175 articles on issues relating to sleep and health. We plan on tapping into every area of his expertise to understand our own sleep habits and how we can all become the best at rest.

To introduce Michael to the LYMA community we’re hosting a seminar dedicated to understanding sleep on Tuesday 22nd June…

I was tempted to discard all this as rather pathetic advertising hype. But then I had second thoughts. This text does after all make several medical claims, and the question is: ARE THEY SUPPORTED BY EVIDENCE?

It claims that KSM-66® Ashwagandha:

  1. is the highest-quality, zero toxicity, concentrated Ashwagandha root in the world.
  2. That the hefty combination of purity and potency makes it unrivalled in its ability to reduce inflammation.
  3. That the product neutralises anxiety.
  4. That it promotes deep, restful sleep, night after night.

I ran a few searches to find out whether there is any sound evidence for any of these claims.

  1. There seem to be several supplements that contain,KSM-66® Ashwagandha’. The impression that LYMA is the only one is thus wrong. Zero toxicity must also be wrong; not even water has zero toxicity. In fact, epigastric pain/discomfort and loose stools were reported as most common (>5%); and giddiness, drowsiness, hallucinogenic, vertigo, nasal congestion (rhinitis), cough, cold, decreased appetite, nausea, constipation, dry mouth, hyperactivity, nocturnal cramps, blurring of vision, hyperacidity, skin rash and weight gain have all been associated with the herbal remedy. Moreover, if it is true that Ashwagandha stimulates the immune system, it might cause problems for people with autoimmune diseases.
  2. I found no compelling evidence from clinical trials to show that KSM-66® Ashwagandha reduces inflammatory conditions in humans.
  3. I found a study concluding that Ashwagandha given as an adjunct offered some potential advantages as a safe and effective adjunctive therapy to SSRIs in GAD. Yet, I found no compelling evidence from clinical trials to show that KSM-66® Ashwagandha as a single supplement reduces anxiety in otherwise healthy individuals.
  4. A 2021 study suggested that Ashwagandha root extract can improve sleep quality and can help in managing insomnia. Yet the authors cautioned that additional clinical trials are required to generalize the outcome.

So, what does that tell us?

It could mean that:

  1. My searches were not sufficiently thorough and that I have missed compelling evidence. If so, I would appreciate, if the LYMA promoters would show me their evidence so that I can assess it.
  2. The LYMA people are irresponsible and mislead the public with untenable claims.

I am looking forward to their response.

Qigong can be described as a mind-body-spirit practice that improves one’s mental and physical health by integrating posture, movement, breathing technique, self-massage, sound, and focused intent. But does it really improve health?

The purpose of this review was to evaluate the effectiveness of Qigong in improving the quality of life and relieving fatigue, sleep disturbance, and cancer-related emotional disturbances (distress, depression, and anxiety) in women with breast cancer.

The PubMed, Cochrane Central Register of Controlled Trials, Web of Science, Sinomed, Wanfang, VIP, and China National Knowledge Infrastructure databases were searched from their inceptions to March 2020 for controlled clinical trials. Two reviewers selected relevant trials that assessed the benefit of Qigong for breast cancer patients independently. A methodological quality assessment was conducted according to the criteria of the 12 Cochrane Back Review Group for risk of bias independently. A meta-analysis was performed using Review Manager 5.3.

A total of 17 trials were found in which 1236 cases were enrolled. The quality of the included trials was generally low, as only 5 of them were rated high quality. 14 studies were conducted in China. The types of qigong included Baduanjin Qigong (9 trials), Chan-Chuang Qigong (1 trial), Goulin New Qigong (2 Trials), Tai Chi Qigong (2 Trials), and Kuala Lumpur Qigong (1 trial). The course of qigong ranged from 21 days to more than 6 months. Four trials compared qigong to no treatment, one sham Qigong, seven compared to other types of exercise, and 6 to usual care.

The results showed significant positive effects of Qigong on quality of life (n = 950, standardized mean difference (SMD), 0.65, 95 % confidence interval (CI) 0.23–1.08, P =  0.002). Depression (n = 540, SMD = −0.32, 95 % CI −0.59 to −0.04, P =  0.02) and anxiety (n = 439, SMD = −0.71, 95 % CI −1.32 to −0.10, P =  0.02) were also significantly relieved in the Qigong group. There was no significant benefit on fatigue (n = 401, SMD = −0.32, 95 % CI  0.71 to 0.07, P = 0.11) or sleep disturbance relief compared to that observed in the control group (n = 298, SMD = −0.11, 95 % CI  0.74 to 0.52, P = 0.73).

The authors concluded that this review shows that Qigong is beneficial for improving quality of life and relieving depression and anxiety; thus, Qigong should be encouraged in women with breast cancer.

No, this review does not show that Qigong is beneficial for improving quality of life and relieving depression and anxiety!

Why?

  1. Most primary studies were of very poor quality.
  2. Most were from China, and we know (and have often discussed) that such trials are most unreliable.
  3. No trial even attempted to control for placebo effects.

A better conclusion would therefore be something like this:

Even though most trials conclude positively, the value of Qigong can, for a range of reasons, not be determined on the basis of the evidence available to date.

Post-traumatic stress disorder (PTSD), previously known as battle fatigue syndrome or shell shock, is a condition that can be triggered by the experience of some frightening event. PTSD can be debilitating leading to the production of feelings of helplessness, intense fear, and horror. Numerous treatments of PTSD exist but few have been shown to be truly effective. A team of Canadian researchers explored the effects of cannabis on PTSD symptoms, quality of life (QOL), and return to work (RTW). Their systematic review also investigated harms such as adverse effects and dropouts due to adverse effects, inefficacy, and all-cause dropout rates.

Their electronic searches located one RCT and 10 observational studies (n = 4672). Risk of bias (RoB) was assessed with the Cochrane risk of bias tool and ROBINS-I. Evidence from the included studies was mainly based on studies with no comparators. Results from unpooled, high RoB studies suggested that cannabis was associated with a reduction in overall PTSD symptoms and improved QOL. Dry mouth, headaches, and psychoactive effects such as agitation and euphoria were the most commonly reported adverse effects. In most studies, cannabis was well tolerated. A small proportion of patients experienced a worsening of PTSD symptoms.

The authors concluded that the evidence in the current study primarily stems from low quality and high RoB observational studies. Further RCTs investigating cannabis effects on PTSD treatment should be conducted with larger sample sizes and explore a broader range of patient-important outcomes.

Various drugs are currently used for the treatment of PTSD including selective serotonin reuptake inhibitors; tricyclic antidepressants (amitriptyline and isocarboxazid); mood stabilizers (Divalproex and lamotrigine); atypical antipsychotics (aripiprazole and quetiapine) but their effectiveness has not been proven. A recent systematic review included 30 RCTs of a range of heterogeneous non-psychological and non-pharmacological interventions. There was emerging evidence for 6 different approaches:

  • acupuncture,
  • neurofeedback,
  • saikokeishikankyoto (a herbal preparation),
  • somatic experiencing,
  • transcranial magnetic stimulation,
  • yoga.

This list makes me wonder: are these treatments, including cannabis, truly promising, or is PTSD one of those conditions for which nearly every treatment works a little because of its placebo effect?

By guest blogger Michael Scholz

For several years, the “flower essences” invented by Dr. Edward Bach had a difficult time in the European Union and especially Germany. The manufacturers were regularly taken to court for violating the EU Health Claim Regulation. This now culminates in the fact that the manufacturer, Nelsons, who sells the “Original Bach Flowers” in Germany, was forced to rename its popular “Rescue” remedies.

What happened?

The “Rescue” remedies were promoted with statements such as “calm and strong through the day” and “recommended use in emotionally exciting situations, e.g. at work” or to “face emotional challenges”. The competitor, Annoyax Nutripharm, regarded this as a health-related statement that is prohibited according to the EU Health Claim Regulation. Since the “Bach Flower Remedies” are not considered to be medicinal products in Germany, they are treated as food supplements, according to a ruling by the Oberlandesgericht (Higher Regional Court) Hamburg in 2007.

As it is strictly forbidden to advertise food supplements with health-related claims that are unproven, Annoyax Nutripharm filed a lawsuit against Nelsons that all the way to the Bundesgerichtshof (Federal High Court of Justice) in Karlsruhe. Since the case concerned European law, the judges in Karlsruhe referred it to the European Court of Justice in Luxemburg.

The judges wanted two questions clarified: 1. Are the “Rescue” remedies to be regarded simply as Brandy due to their alcohol content of 27%? (in which case, health-related claims would be strictly forbidden). 2. Does the product’s name “Rescue” itself constitute a violation of the Health Claims Regulation?

The Luxemburg judges ruled “No” and “Yes”. “No”, it is not Brandy, although the „essences“ consist of a considerable quantity of alcohol, the recommended dose is too small to be intoxicating. But “Yes”, the term “Rescue” does indeed violate the Health Claim Regulation. So the plaintiff won – and what is the result?

When the Health Claims Regulation was enacted in 2005, a transition period until 2022 was established. This applied to all products that were sold using the same brand name and composition before 2005. This now gave the defendant – Nelsons – the opportunity to use Edward Bach’s 135th anniversary for launching an advertising campaign that praises the court-ordered renaming as „modernization“ for the 21st century. And as you see, the new name is a paragon of creativity, innovation & modernism, indeed (//irony:off): “Rescue” becomes – drum roll – “Rescura”. Yes, I looked just like that too…

This pyrrhic victory for the plaintiffs shows how important it is to protect the European citizens against misleading advertising. And – far more important – it is now established through a ruling of the Federal High Court of Justice that “Bach Flowers” are an esoterical concept devoid of medical evidence.

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