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

anxiety

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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.

Energy healing is an umbrella term for a range of paranormal healing practices. Their common denominator is the belief in a mystical ‘energy’ that can be used for therapeutic purposes. Forms of energy healing have existed in many ancient cultures. The ‘New Age’ movement has brought about a revival of these ideas, and today energy healing systems are amongst the most popular alternative therapies in the US as well as in many other countries.

Energy healing relies on the esoteric belief in some form of ‘energy’ which is distinct from the concept of energy understood in physics and refers to some life force such as chi in Traditional Chinese Medicine, or prana in Ayurvedic medicine. Some proponents employ terminology from quantum physics and other ‘cutting-edge’ science to give their treatments a scientific flair which, upon closer scrutiny, turns out to be but a veneer of pseudo-science. The ‘energy’ that energy healers refer to is not measurable and lacks biological plausibility.

The purpose of this study was to evaluate the effects of energy healing (EH) therapy prior to and following posterior surgical correction for adolescent idiopathic scoliosis (AIS) compared to controls.

Patients were prospectively randomized to one of two groups: standard operative care for surgery (controls) vs. standard care with the addition of three EH sessions. The outcomes included visual analog scales (VAS) for pain and anxiety (0-10), days until conversion to oral pain medication, and length of hospital stay. For the experimental group, VAS was assessed pre- and post-EH session.

Fifty patients were enrolled-28 controls and 22 EH patients. The controls had a median of 12 levels fused vs. 11 in the EH group (p = 0.04). Pre-operative thoracic and lumbar curve magnitudes were similar (p > 0.05). Overall VAS pain scores increased from pre- to post-operative (p < 0.001), whereas the VAS anxiety scores decreased immediately post-operative (p < 0.001). The control and pre-EH assessments were statistically similar. Significant decreases in VAS pain and anxiety scores from pre to post-EH assessments were noted for the EH group. Both groups transitioned to oral pain medication a median of 2 days post-operative (p = 0.11). The median days to discharge were four in the controls and three in the EH group (p = 0.07).

The authors concluded that EH therapy resulted in a decrease in patient’s pre-operative anxiety. Offering this CAM modality may enhance the wellbeing of the patient and their overall recovery when undergoing posterior surgical correction for AIS.

I am getting tired of explaining that this trial design tells us as good as nothing about the effects of the tested therapy per se. As we have discussed ad nauseam on this blog, A+B is always more than B alone. Such trials appear to be rigorous and fool many people, but they are unable to control for context effects, like placebo or attention. Therefore, I need to re-write the conclusions:

The placebo effect and the extra attention associated with EH therapy resulted in a decrease in patients’ pre-operative anxiety. EH itself is most likely bar any effect. Further studies in this area are not required.

The use of homeopathy in oncological supportive care seems to be progressing. The first French prevalence study, performed in 2005 in Strasbourg, showed that only 17% of the subjects were using it. This descriptive study, using a questionnaire identical to that used in 2005, investigated whether the situation has changed since then.

A total of 633 patients undergoing treatment in three anti-cancer centers in Strasbourg were included. The results of the “homeopathy” sub-group were extracted and studied.

Of the 535 patients included, 164 (30.7%) used homeopathy. The main purpose of its use was to reduce the side effects of cancer treatments (75%). Among the users,

  • 82.6% were “somewhat” or “very” satisfied,
  • 15.5% were “quite” satisfied,
  • 1.9% were “not at all” satisfied.

The homeopathic treatment was prescribed by a doctor in 75.6% of the cases; the general practitioner was kept informed in 87% of the cases and the oncologist in 82%. Fatigue, pain, nausea, anxiety, sadness, and diarrhea were improved in 80% of the cases. Hair-loss, weight disorders, and loss of libido were the least improved symptoms. The use of homeopathy was significantly associated with the female sex.

The authors concluded that with a prevalence of 30.7%, homeopathy is the most used complementary medicine in integrative oncology in Strasbourg. Over 12 years, we have witnessed an increase of 83% in its use in the same city. Almost all respondents declare themselves satisfied and tell their doctors more readily than in 2005.

There is one (possibly only one) absolutely brilliant statement in this abstract:

The use of homeopathy was significantly associated with the female sex.

Why do I find this adorable?

Because to claim that any of the observed outcomes of this study are causally related to homeopathy seems like claiming that homeopathy turns male patients into women.

PS

In case you do not understand my clumsy attempt at humor and satire, rest assured: I do not truly believe that homeopathy turns men into women, and neither do I believe that it improves fatigue, pain, nausea, anxiety, sadness, and diarrhea. Remember: correlation is not causation.

Therapeutic touch (TT) is a form of paranormal or energy healing developed by Dora Kunz (1904-1999), a psychic and alternative practitioner, in collaboration with Dolores Krieger, a professor of nursing. According to Kunz, TT has its origins in ancient Yogic texts. TT is popular and practiced predominantly by US nurses; it is currently being taught in more than 80 colleges and universities in the U.S., and in more than seventy countries. According to one TT-organisation, TT is a holistic, evidence-based therapy that incorporates the intentional and compassionate use of universal energy to promote balance and well-being. It is a consciously directed process of energy exchange during which the practitioner uses the hands as a focus to facilitate the process.

The assumptions that form the basis for TT are not biologically plausible. But that does not necessarily mean it is ineffective.

This study was conducted to assess the effect of therapeutic touch on stress, daytime sleepiness, sleep quality, and fatigue among students of nursing and midwifery.

A total of 96 students were randomized into three groups: the therapeutic touch (TT) group, the sham therapeutic touch (STT) group, and the control group. The TT group was subjected to therapeutic touch twice a week for 4 weeks with each session lasting 20 min.

When the TT group was compared to the STT and control groups following the intervention, the decrease in the levels of stress, fatigue, and daytime sleepiness, as well as the increase in the sleep quality were found to be significant.

The authors concluded that TT, which is one form of complementary therapy, was relatively effective in decreasing the levels of stress, fatigue and daytime sleepiness, and in increasing the sleep quality of university students of nursing and midwifery.

Several previous trials and reviews of TT are available. However, many of them were conducted ardent proponents of TT, seriously flawed, and thus less than reliable. One rigorous pre-clinical study, co-designed by a 9-year-old girl, found that experienced TT practitioners were unable to detect the investigator’s “energy field.” Their failure to substantiate TT’s most fundamental claim is unrefuted evidence that the claims of TT are groundless and that further professional use is unjustified.

In my recent book, I concluded that there are no reasons to assume that TT causes any meaningful effects beyond placebo. One could, however, argue that, like all forms of paranormal healing, it undermines rational thinking.

Does the new study change my judgment?

I am afraid not!

The objective of this review (entitled ‘Systematic Review on the Use of Homeopathy in Dentistry:
Critical Analysis of Clinical Trials‘) was to map the literature on homeopathy in dentistry and to evaluate the effectiveness of using homeopathy in dental practice through the critical analysis of clinical studies.

The search for scientific articles in any language, year, and place of publication was made in the databases of Public Medline (PUBMED), Web of Science, Cochrane, and Virtual Health Library; the articles selected were later classified according to the type of study. Gray literature was accessed through Google Scholar. Clinical trials were analyzed for methodological quality. Two trained reviewers accomplished the entire process independently.

Of the 281 studies retrieved by means of the search, 44 met the eligibility criteria. The included papers were:

  • literature reviews (56.8%),
  • clinical trials (34.1%),
  • cross-sectional studies (6.8%),
  • laboratory research (6.8%),
  • longitudinal observational studies (4.5%).

The clinical trials were published from 1965 to 2019, using homeopathy in several dental specialties:

  • Endodontics,
  • Periodontics,
  • Orofacial Pain,
  • Surgery,
  • Pediatric Dentistry,
  • Stomatology,
  • dental anxiety.

Qualitative failures, in all criteria investigated, and positive influences of the individual prescriptions on the results of treatments reported were observed.

The authors concluded that there is still a scarcity of studies about homeopathy and dentistry. The clinical trials selected showed positive effects on oral health; however, when they were critically evaluated, it was possible to recognize qualitative failures, mainly relative to double-blinding. It is necessary to encourage research on the subject, using standardized methodological procedures, to obtain better evaluation of the clinical applicability.

According to the authors, their review adhered to the PRISMA guideline of systematic reviews. This is, however, not the case. The authors correctly point out that the primary studies had many flaws: methodological failures were observed in the clinical trials, mainly related to double-blinding (66.7%). Significant failures were also observed in similarity (61.1%), randomization (27.8%), description of losses and exclusions (27.8%), and exclusion criteria (27.8%). They do not seem to realize that flaws of this nature and frequency should prevent positive conclusions.

So, what does this paper actually demonstrate? In my view, it shows that:

  • the peer-review process at the JACM continues to be a joke;
  • poor quality trials run by enthusiasts tend to produce false-positive results;
  • in so-called alternative medicine (SCAM), people get away with publishing even the most obvious falsehoods.
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