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

pseudo-science

This randomized, double-blind, placebo-controlled trial investigated whether homeopathic Hypericum leads to a reduction in postoperative pain and a decrease in pain medication compared with placebo. Inpatients undergoing lumbar sequestrectomy surgery were given the homeopathic treatment Hypericum C200 or a placebo in addition to usual pain management. The primary endpoint was pain relief measured with a visual analog scale. Secondary endpoints were the reduction of inpatient postoperative analgesic medication and change in sensory and affective pain perception.

The baseline characteristics were comparable between the two groups. Pain perception between baseline and day 3 did not significantly differ between the study arms. With respect to pain medication, total morphine equivalent doses did not differ significantly. However, a statistical trend and a moderate effect (d = 0.432) in the decrease of pain medication consumption in favor of the Hypericum group was observed.

The authors concluded that this is the first trial of homeopathy that evaluated the efficacy of Hypericum C200 after lumbar monosegmental spinal sequestrectomy. Although no significant differences between the groups could be shown, we found that patients who took potentiated Hypericum in addition to usual pain management showed lower consumption of analgesics. Further investigations, especially with regard to pain medication, should follow to better classify the described analgesic reduction.

I applaud the authors from the Institute of Integrative Medicine, Witten/Herdecke University, Herdecke, Germany (not an institution known for its objectivity in SCAM) to have published this negative study in a journal that is so clearly pro-SCAM that it very rarely contains anything in its pages that is not positive about SCAM. Yet, I am baffled by two things:

  1. The plant Hypericum is used in SCAM as a painkiller. According to the ‘like cures like’ axiom of homeopathy, it should thus INCREASE the pain of post-op patients.
  2. The researchers used a C 200 potency. I ask myself, how can anyone assume that such a dilution has any effect at all? C200 means that the plant tincture is diluted at a ratio of 1: 00000000000000000000 00000000000000000000 00000000000000000000 00000000000000000000 00000000000000000000 00000000000000000000 00000000000000000000 00000000000000000000 00000000000000000000 00000000000000000000 00000000000000000000 00000000000000000000 00000000000000000000 00000000000000000000 00000000000000000000 00000000000000000000 00000000000000000000 00000000000000000000 00000000000000000000 00000000000000000000. Less than one molecule of the plant per several universes!

To believe that such a dilution might work, one really needs to be a convinced disciple of Hahnemann. Yet, to disregard the ‘like cures like’ axiom, one needs to be what he called ‘a traitor’ to his true art of healing.

Today, several UK dailies report about a review of osteopathy just published in BMJ-online. The aim of this paper was to summarise the available clinical evidence on the efficacy and safety of osteopathic manipulative treatment (OMT) for different conditions. The authors conducted an overview of systematic reviews (SRs) and meta-analyses (MAs). SRs and MAs of randomised controlled trials evaluating the efficacy and safety of OMT for any condition were included.

The literature searches revealed nine SRs or MAs conducted between 2013 and 2020 with 55 primary trials involving 3740 participants. The SRs covered a wide range of conditions including

  • acute and chronic non-specific low back pain (NSLBP, four SRs),
  • chronic non-specific neck pain (CNSNP, one SR),
  • chronic non-cancer pain (CNCP, one SR),
  • paediatric (one SR),
  • neurological (primary headache, one SR),
  • irritable bowel syndrome (IBS, one SR).

Although with different effect sizes and quality of evidence, MAs reported that OMT is more effective than comparators in reducing pain and improving the functional status in acute/chronic NSLBP, CNSNP and CNCP. Due
to the small sample size, presence of conflicting results and high heterogeneity, questionable evidence existed on OMT efficacy for paediatric conditions, primary headaches and IBS. No adverse events were reported in most SRs. The methodological quality of the included SRs was rated low or critically low.

The authors concluded that based on the currently available SRs and MAs, promising evidence suggests the possible effectiveness of OMT for musculoskeletal disorders. Limited and inconclusive evidence occurs for paediatric conditions, primary headache and IBS. Further well-conducted SRs and MAs are needed to confirm and extend the efficacy and safety of OMT.

This paper raises several questions. Here a just the two that bothered me most:

  1. If the authors had truly wanted to evaluate the SAFETY of OMT (as they state in the abstract), they would have needed to look beyond SRs, MAs or RCTs. We know – and the authors of the overview confirm this – that clinical trials of so-called alternative medicine (SCAM) often fail to mention adverse effects. This means that, in order to obtain a more realistic picture, we need to look at case reports, case series and other observational studies. It also means that the positive message about safety generated here is most likely misleading.
  2. The authors (the lead author is an osteopath) might have noticed that most – if not all – of the positive SRs were published by osteopaths. Their assessments might thus have been less than objective. The authors did not include one of our SRs (because it fell outside their inclusion period). Yet, I do believe that it is one of the few reviews of OMT for musculoskeletal problems that was not done by osteopaths. Therefore, it is worth showing you its abstract here:

The objective of this systematic review was to assess the effectiveness of osteopathy as a treatment option for musculoskeletal pain. Six databases were searched from their inception to August 2010. Only randomized clinical trials (RCTs) were considered if they tested osteopathic manipulation/mobilization against any control intervention or no therapy in human with any musculoskeletal pain in any anatomical location, and if they assessed pain as an outcome measure. The selection of studies, data extraction, and validation were performed independently by two reviewers. Studies of chiropractic manipulations were excluded. Sixteen RCTs met the inclusion criteria. Their methodological quality ranged between 1 and 4 on the Jadad scale (max = 5). Five RCTs suggested that osteopathy compared to various control interventions leads to a significantly stronger reduction of musculoskeletal pain. Eleven RCTs indicated that osteopathy compared to controls generates no change in musculoskeletal pain. Collectively, these data fail to produce compelling evidence for the effectiveness of osteopathy as a treatment of musculoskeletal pain.

It was published 11 years ago. But I have so far not seen compelling evidence that would make me change our conclusion. As I state in the newspapers:

OSTEOPATHY SHOULD BE TAKEN WITH A SIZABLE PINCH OF SALT.

 

 

This study explored the curative effects of remote home management combined with ‘Feng’s spinal manipulation’ on the treatment of elderly patients with lumbar disc herniation (LDH). (LDH is understood by the investigators to be a condition where lumbar disc degeneration or trauma causes the nucleus pulposus and annulus fibrosus to protrude towards the spinal canal and to constrict the spinal cord or nerve root.)

The clinical data of 100 patients with LDH were retrospectively reviewed. The 100 patients were equally divided into a routine treatment group and an interventional group according to the order of admission. The routine treatment group received conventional rehabilitation training, and the interventional group received remote home management combined with Feng’s spinal manipulation. The Oswestry disability index (ODI) and straight leg raising test were adopted for the assessment of the degrees of dysfunction and straight leg raising angles of the two groups after intervention. The curative effects of the two rehabilitation programs were evaluated.

Compared TO the routine treatment group, the interventional group had a remarkably higher excellent and good rate (P < 0.05), a significantly lower average ODI score after intervention (P < 0.001), notably higher straight leg raising angle, surface AEMG (average electromyogram) during stretching and tenderness threshold after intervention (P < 0.001), markedly lower muscular tension, surface AEMG during buckling, and flexion-extension relaxation ratio (FRR; (P < 0.001)), and much higher quality of life scores after intervention (P < 0.001).

The authors concluded that remote home management combined with Feng’s spinal manipulation, as a reliable method to improve the quality of life and the back muscular strength of the elderly patients with LDH, can substantially increase the straight leg raising angle and reduce the degree of dysfunction. Further study is conducive to establishing a better solution for the patients with LDH.

The authors state that “Feng’s spinal manipulation adopts spinal fixed-point rotation reduction to correct the vertebral displacement, and its curative effects have been confirmed in the treatment of sequestered LDH.” This is an odd statement: firstly, there is no vertebral displacement in LDH; secondly, if the treatment had been confirmed to be curative, why conduct this study?

Chart of Feng’s Spinal Manipulative Therapy (FSM). See the difference among the spinal manipulation (SMA), spinal mobilization (SMO) and sham spinal manipulation (SSM).

Moreover, I don’t quite understand how the authors conducted a retrospective chart review and equally divide the 100 patients into two groups treated differently. What I do understand, however, is this:

  1. a retrospective review does not lend itself to conclusions about the effectiveness of any therapy;
  2. no type of spinal manipulation can hope to cure a lumbar disc degeneration or trauma that causes a herniation of the nucleus pulposus and annulus fibrosus.

Thus, I recommend we take this study with a sizable pinch of salt.

The Anglo-European College of Chiropractic (AECC) has been promoting pediatric chiropractic for some time, and I have posted about the subject before  (see, for instance, here). Now the AECC has gone one decisive step further. On the website, the AECC announced an MSc ‘Musculoskeletal Paediatric Health‘:

The MSc Musculoskeletal Paediatric Health degree is designed to develop your knowledge and skills in the safe and competent care of children of all ages. Our part-time, distance-based course blends live online classes with ready to use resources through our virtual learning environment. In addition, you will have the opportunity to observe in the AECC University College clinical services at our Bournemouth campus. The course covers topics in paediatric musculoskeletal practice with specific units on paediatric development, paediatric musculoskeletal examination, paediatric musculoskeletal interventions, and paediatric musculoskeletal management. You will address issues such as risk factors and public health, including breastfeeding, supine sleep in infancy, physical activity in children and conditions affecting the musculoskeletal health of children from birth. The paediatric specific topics are completed by other optional units such as professional development, evidence-based practice, and leadership and inter-professional collaboration. In the dissertation unit you will conduct a study relevant to musculoskeletal paediatric health.

Your learning will happen through a mix of live and recorded lectures, access to online reading materials, and access to the literature through our learning services. You will also engage with the contents taught through guided activities with your peers and staff. Clinical paediatric experience is recommended to fully engage with the course. For students with limited access to a suitable clinical environment to support their studies, or for student who wants to add to their clinical experience, we are able to offer a limited number of opportunities to observe and work alongside our clinical educators within the AECC University College clinical services. Assessments are tailor made to each unit and may include a variety of methods such as critical reviews, reflective accounts, portfolios and in the last year a research dissertation.

___________________________

The AECC emphasizes its commitment to being a leading higher education institution in healthcare disciplines, nationally and internationally recognised for quality and excellence. Therefore, it seems only fair to have another look at the science behind pediatric chiropractic. Specifically, is there any good science to show that would justify a Master of Science in ‘Musculoskeletal Paediatric Health’?

So, let’s have a look and see whether there are any good review articles supporting such a degree. Here is what I found with several Medline searches (date of the review on chiropractic for any pediatric conditions, followed by its conclusion + link [so that the reader can look up the evidence]):

2008

I am unable to find convincing evidence for any of the above-named conditions. 

2009

Previous research has shown that professional chiropractic organisations ‘make claims for the clinical art of chiropractic that are not currently available scientific evidence…’. The claim to effectively treat otitis seems to
be one of them. It is time now, I think, that chiropractors either produce the evidence or abandon the claim.

2009

The … evidence is neither complete nor, in my view, “substantial.”

2010

Although the major reason for pediatric patients to attend a chiropractor is spinal pain, no adequate studies have been performed in this area. It is time for the chiropractic profession to take responsibility and systematically investigate the efficiency of joint manipulation of problems relating to the developing musculoskeletal system.

2018

Some small benefits were found, but whether these are meaningful to parents remains unclear as does the mechanisms of action. Manual therapy appears relatively safe.

What seems to emerge is rather disappointing:

  1. There are no really new reviews.
  2. Most of the existing reviews are not on musculoskeletal conditions.
  3. All of the reviews cast considerable doubt on the notion that chiropractors should go anywhere near children.

But perhaps I was too ambitious. Perhaps there are some new rigorous clinical trials of chiropractic for musculoskeletal conditions. A few further searches found this (again year and conclusion):

2019

We found that children with long duration of spinal pain or co-occurring musculoskeletal pain prior to inclusion as well as low quality of life at baseline tended to benefit from manipulative therapy over non-manipulative therapy, whereas the opposite was seen for children reporting high intensity of pain. However, most results were statistically insignificant.

2018

Adding manipulative therapy to other conservative care in school children with spinal pain did not result in fewer recurrent episodes. The choice of treatment-if any-for spinal pain in children therefore relies on personal preferences, and could include conservative care with and without manipulative therapy. Participants in this trial may differ from a normal care-seeking population.

I might have missed one or two trials because I only conducted rather ‘rough and ready’ searches, but even if I did: would this amount to convincing evidence? Would it be good science?

No! and No!

So, why does the AECC offer a Master of Science in ‘Musculoskeletal Paediatric Health’?

Search me!

It wouldn’t have something to do with the notion that it is good for business?

Or perhaps they just want to give science a bad name?

A press release informs us that the World Health Organization (WHO) and the Government of India recently signed an agreement to establish the ‘WHO Global Centre for Traditional Medicine’. This global knowledge centre for traditional medicine, supported by an investment of USD 250 million from the Government of India, aims to harness the potential of traditional medicine from across the world through modern science and technology to improve the health of people and the planet.

“For many millions of people around the world, traditional medicine is the first port of call to treat many diseases,” said Dr Tedros Adhanom Ghebreyesus, WHO Director-General. “Ensuring all people have access to safe and effective treatment is an essential part of WHO’s mission, and this new center will help to harness the power of science to strengthen the evidence base for traditional medicine. I’m grateful to the Government of India for its support, and we look forward to making it a success.”

The term traditional medicine describes the total sum of the knowledge, skills and practices indigenous and different cultures have used over time to maintain health and prevent, diagnose and treat physical and mental illness. Its reach encompasses ancient practices such as acupuncture, ayurvedic medicine and herbal mixtures as well as modern medicines.

“It is heartening to learn about the signing of the Host Country Agreement for the establishment of Global Centre for Traditional Medicine (GCTM). The agreement between Ministry of Ayush and World Health Organization (WHO) to establish the WHO-GCTM at Jamnagar, Gujarat, is a commendable initiative,” said Narendra Modi, Prime Minister of India. “Through various initiatives, our government has been tireless in its endeavour to make preventive and curative healthcare, affordable and accessible to all. May the global centre at Jamnagar help in providing the best healthcare solutions to the world.”

The new WHO centre will concentrate on building a solid evidence base for policies and standards on traditional medicine practices and products and help countries integrate it as appropriate into their health systems and regulate its quality and safety for optimal and sustainable impact.

The new centre focuses on four main strategic areas: evidence and learning; data and analytics; sustainability and equity; and innovation and technology to optimize the contribution of traditional medicine to global health and sustainable development.

The onsite launch of the new WHO global centre for traditional medicine in Jamnagar, Gujarat, India will take place on April 21, 2022.

__________________________

Of course, one must wait and see who will direct the unit and what work the new centre produces. But I cannot help feeling a little anxious. The press release is full of hot air and platitudes and the track record of the Indian Ministry of Ayush is quite frankly abominable. Here are a few of my previous posts that, I think, justify this statement:

 

WATCH THIS SPACE!

No 10-year follow-up study of so-called alternative medicine (SCAM) for lumbar intervertebral disc herniation (LDH) has so far been published. Therefore, the authors of this paper performed a prospective 10-year follow-up study on the integrated treatment of LDH in Korea.

One hundred and fifty patients from the baseline study, who initially met the LDH diagnostic criteria with a chief complaint of radiating pain and received integrated treatment, were recruited for this follow-up study. The 10-year follow-up was conducted from February 2018 to March 2018 on pain, disability, satisfaction, quality of life, and changes in a herniated disc, muscles, and fat through magnetic resonance imaging.

Sixty-five patients were included in this follow-up study. Visual analogue scale score for lower back pain and radiating leg pain were maintained at a significantly lower level than the baseline level. Significant improvements in Oswestry disability index and quality of life were consistently present. MRI confirmed that disc herniation size was reduced over the 10-year follow-up. In total, 95.38% of the patients were either “satisfied” or “extremely satisfied” with the treatment outcomes and 89.23% of the patients claimed their condition “improved” or “highly improved” at the 10-year follow-up.

The authors concluded that the reduced pain and improved disability was maintained over 10 years in patients with LDH who were treated with nonsurgical Korean medical treatment 10 years ago. Nonsurgical traditional Korean medical treatment for LDH produced beneficial long-term effects, but future large-scale randomized controlled trials for LDH are needed.

This study and its conclusion beg several questions:

WHAT DID THE SCAM CONSIST OF?

The answer is not  provided in the paper; instead, the authors refer to 3 previous articles where they claim to have published the treatment schedule:

12. Park JJ, Shin J, Choi Y, Youn Y, Lee S, Kwon SR, et al. Integrative package for low back pain with leg pain in Korea: a prospective cohort study. Complement Ther Med. 2010;18(2):78–86. [PubMed[]
13. Shin JS, Lee J, Kim MR, Shin BC, Lee MS, Ha IH. The long-term course of patients undergoing alternative and integrative therapy for lumbar disc herniation: 3-year results of a prospective observational study. BMJ open. 2014;4(9) []
14. Shin JS, Lee J, Lee YJ, Kim MR, Ahn YJ, Park KB, et al. Long-term course of alternative and integrative therapy for lumbar disc herniation and risk factors for surgery: a prospective observational 5-year follow-up study. Spine. 2016;41(16):E955–EE63. [PubMed[]
I could only access the BMJ Open article, and it tells is this:

The treatment package included herbal medicine, acupuncture, bee venom pharmacopuncture and Chuna therapy (Korean spinal manipulation). Treatment was conducted once a week for 24 weeks, except herbal medication which was taken twice daily for 24 weeks; (1) Acupuncture: frequently used acupoints (BL23, BL24, BL25, BL31, BL32, BL33, BL34, BL40, BL60, GB30, GV3 and GV4)10 ,11 and the site of pain were selected and the needles were left in situ for 20 min. Sterilised disposable needles (stainless steel, 0.30×40 mm, Dong Bang Acupuncture Co., Korea) were used; (2) Chuna therapy12 ,13: Chuna is a Korean spinal manipulation that includes high-velocity, low-amplitude thrusts to spinal joints slightly beyond the passive range of motion for spinal mobilisation, and manual force to joints within the passive range; (3) Bee venom pharmacopuncture14: 0.5–1 cc of diluted bee venom solution (saline: bee venom ratio, 1000:1) was injected into 4–5 acupoints around the lumbar spine area to a total amount of 1 cc using disposable injection needles (CPL, 1 cc, 26G×1.5 syringe, Shinchang medical Co., Korea); (4) Herbal medicine was taken twice a day in dry powder (2 g) and water extracted decoction form (120 mL) (Ostericum koreanum, Eucommia ulmoides, Acanthopanax sessiliflorus, Achyranthes bidentata, Psoralea corylifolia, Peucedanum japonicum, Cibotium barometz, Lycium chinense, Boschniakia rossica, Cuscuta chinensis and Atractylodes japonica). These herbs were selected from herbs frequently prescribed for LBP (or nerve root pain) treatment in Korean medicine and traditional Chinese medicine,15 and the prescription was further developed through clinical practice at Jaseng Hospital of Korean Medicine.9 In addition, recent investigations report that compounds of C. barometz inhibit osteoclast formation in vitro16 and A. japonica extracts protect osteoblast cells from oxidative stress.17 E. ulmoides has been reported to have osteoclast inhibitive,18 osteoblast-like cell proliferative and bone mineral density enhancing effects.19 Patients were given instructions by their physician at treatment sessions to remain active and continue with daily activities while not aggravating pre-existing symptoms. Also, ample information about the favourable prognosis and encouragement for non-surgical treatment was given.

The traditional Korean spinal manipulations used (‘Chuna therapy’ – the references provided for it do NOT refer to this specific way of manipulation) seemed interesting, I thought. Here is an explanation from an unrelated paper: Image result for chuna therapy

Chuna, which is a traditional manual therapy practiced by Korean medicine doctors, has been applied to various diseases in Korea. Chuna manual therapy (CMT) is a technique that uses the hand, other parts of the doctor’s body or other supplementary devices such as a table to restore the normal function and structure of pathological somatic tissues by mobilization and manipulation. CMT includes various techniques such as thrust, mobilization, distraction of the spine and joints, and soft tissue release. These techniques were developed by combining aspects of Chinese Tuina, chiropratic, and osteopathic medicine.[] It has been actively growing in Korea, academically and clinically, since the establishment of the Chuna Society (the Korean Society of Chuna Manual Medicine for Spine and Nerves, KSCMM) in 1991.[] Recently, Chuna has had its effects nationally recognized and was included in the Korean national health insurance in March 2019.[]

This almost answers the other questions I had. Almost, but not quite. Here are two more:

  • The authors conclude that the SCAM produced beneficial long-term effects. But isn’t it much more likely that the outcomes their uncontrolled observations describe are purely or at least mostly a reflection of the natural history of lumbar disc herniation?
  • If I remember correctly, I learned a long time ago in medical school that spinal manipulation is contraindicated in lumbar disc herniation. If that is so, the results might have been better, if the patients of this study had not received any SCAM at all. In other words, are the results perhaps due to firstly the natural history of the condition and secondly to the detrimental effects of the SCAM the investigators applied?

If I am correct, this would then be the 4th article reporting the findings of a SCAM intervention that aggravated lumbar disc herniation.

 

 

PS

I know that this is a mere hypothesis but it is at least as plausible as the conclusion drawn by the authors.

 

Ginseng plants belong to the genus Panax and include:

  • Panax ginseng (Korean ginseng),
  • Panax notoginseng (South China ginseng),
  • and Panax quinquefolius (American ginseng).

They are said to have a range of therapeutic activities, some of which could render ginseng a potential therapy for viral or post-viral infections. Ginseng has therefore been used to treat fatigue in various patient groups and conditions. But does it work for chronic fatigue syndrome (CFS), also often called myalgic encephalomyelitis (ME)? This condition is a complex, little-understood, and often disabling chronic illness for which no curative or definitive therapy has yet been identified.

This systematic review aimed to assess the current state of evidence regarding ginseng for CFS. Multiple databases were searched from inception to October 2020. All data was extracted independently and in duplicates. Outcomes of interest included the effectiveness and safety of ginseng in patients with CFS.

A total of two studies enrolling 68 patients were deemed eligible: one randomized clinical trial and one prospective observational study. The certainty of evidence in the effectiveness outcome was low and moderate in both studies, while the safety evidence was very low as reported from one study.

The authors concluded that the study findings highlight a potential benefit of ginseng therapy in the treatment of CFS. However, we are not able to draw firm conclusions due to limited clinical studies. The paucity of data warrants limited confidence. There is a need for future rigorous studies to provide further evidence.

To get a feeling of how good or bad the evidence truly is, we must of course look at the primary studies.

The prospective observational study turns out to be a mere survey of patients using all sorts of treatments. It included 155 subjects who provided information on fatigue and treatments at baseline and follow-up. Of these subjects, 87% were female and 79% were middle-aged. The median duration of fatigue was 6.7 years. The percentage of users who found a treatment helpful was greatest for coenzyme Q10 (69% of 13 subjects), dehydroepiandrosterone (DHEA) (65% of 17 subjects), and ginseng (56% of 18 subjects). Treatments at 6 months that predicted subsequent fatigue improvement were vitamins (p = .08), vigorous exercise (p = .09), and yoga (p = .002). Magnesium (p = .002) and support groups (p = .06) were strongly associated with fatigue worsening from 6 months to 2 years. Yoga appeared to be most effective for subjects who did not have unclear thinking associated with fatigue.

The second study investigated the effect of Korean Red Ginseng (KRG) on chronic fatigue (CF) by various measurements and objective indicators. Participants were randomized to KRG or placebo group (1:1 ratio) and visited the hospital every 2 weeks while taking 3 g KRG or placebo for 6 weeks and followed up 4 weeks after the treatment. The fatigue visual analog score (VAS) declined significantly in each group, but there were no significant differences between the groups. The 2 groups also had no significant differences in the secondary outcome measurements and there were no adverse events. Sub-group analysis indicated that patients with initial fatigue VAS below 80 mm and older than 50 years had significantly greater reductions in the fatigue VAS if they used KRG rather than placebo. The authors concluded that KRG did not show absolute anti-fatigue effect but provided the objective evidence of fatigue-related measurement and the therapeutic potential for middle-aged individuals with moderate fatigue.

I am at a loss in comprehending how the authors of the above-named review could speak of evidence for potential benefit. The evidence from the ‘observational study’ is largely irrelevant for deciding on the effectiveness of ginseng, and the second, more rigorous study fails to show that ginseng has an effect.

So, is ginseng a promising treatment for ME?

I doubt it.

Brite is an herbal energy drink that is currently being marketed aggressively. It is even for sale in one leading UK supermarket. It comes in various flavors the ingredients of which vary slightly.

The pineapple/mango drink, for instance, contains:

  • guarana extract,
  • green tea extract,
  • guayusa extract,
  • ashwagandha extract,
  • matcha tea,
  • ascorbic acid (vitamin C),
  • natural caffeine.

The website of the manufacturer tells us that Brite uses ingredients and dosages that are safe and effective, utilising the power of nootropic superfoods organic Matcha, Guarana and Guayusa to provide a long-lasting boost.

Brite is based on peer reviewed, double-blind, placebo-controlled clinical trials and studies that can be found here.

It does not tell us the dosages of the ingredients, and I am puzzled by the claim that the drink is safe. A quick search seems to cast considerable doubt on it.

_____________________________

Guarana (Paullinia cupana) is a plant from the Amazon region with a high content of bioactive compounds. It is by no means free of adverse effects. It is known to interact with:

And it can cause the following adverse effects:

Green tea is made from the leaves of the Camellia sinensis plant. It can cause the following adverse effects:

  • headache,
  • nervousness,
  • sleep problems,
  • vomiting,
  • diarrhea,
  • irritability,
  • irregular heartbeat,
  • tremor,
  • heartburn,
  • dizziness,
  • ringing in the ears,
  • convulsions,
  • confusion.

Guayusa is a plant native to the Amazon rainforest that contains plenty of caffeine. Its adverse effects include:

  • High Blood Pressure
  • Rapid Heartbeat
  • Anxiety
  • Jitters
  • Energy Crashes
  • Insomnia
  • Headaches
  • Upset Stomach

Ashwagandha is a plant from India; the root and berry are used in Ayurvedic medicine. Its adverse effects include:

  • stomach upset,
  • diarrhea,
  • vomiting.

Matcha tea also contains a high amount of caffeine. It is associated with the following adverse effects:

Caffeine is a chemical found in coffee, tea, cola, guarana, mate, and other products. Adverse effects include:

  • insomnia,
  • nervousness,
  • restlessness,
  • stomach irritation,
  • nausea and vomiting,
  • increased heart rate and respiration,
  • headache,
  • anxiety,
  • agitation,
  • chest pain,
  • ringing in the ears.

A case report documented a case of myocardial infarction in a 25-year-old man who presented to the emergency department with chest pain. The patient had been consuming massive quantities of caffeinated energy drinks daily for the past week. This case report and previously documented studies support a possible connection between caffeinated energy drinks and myocardial infarction.

________________________

Yes, the adverse effects are predominantly (but not exclusively) caused by high doses. Yet, the claim that Brite is safe should nevertheless be taken with a very large pinch of salt. If I like the taste of the drink and thus consume a few bottles per day, the dosages of the ingredients would surely be high!

And what about the claim that it is effective? Here the pinch of salt must be even larger, I am afraid. I could not find a single trial that confirmed the notion. For backing up their claims, the manufacturers offer a few references, but if you look them up, you will find that they were not done with the mixture of ingredients contained in Brite.

So, what is the conclusion?

Based on the evidence that I have seen, the herbal drink ‘Brite’ has not been shown to be an effective nootropic. In addition, there are legitimate concerns about the safety of the product. I for one will therefore not purchase the (rather expensive) drink.

You haven’t heard of religious/spiritual singing and movement as a treatment for mental health?

Me neither!

But it does exist. This review explored the evidence of religious/spiritual (R/S) singing and R/S movement (dynamic meditation and praise dance), in relation to mental health outcomes.

After registering with PROSPERO (CRD42020189495), a systematic search of three major databases (CINAHL, MEDLINE, and PsycINFO) was undertaken using predetermined eligibility criteria. Reference lists of identified papers and additional sources such as Google Scholar were searched. The quality of studies was assessed using the Mixed Method Appraisal Tool (MMAT). Data were extracted, tabulated, and synthesized according to the Preferred Reporting Items for Systematic Reviews (PRISMA) guidelines.

Seven of the 259 identified articles met inclusion criteria. Three studies considered R/S singing, while four considered R/S movement. In R/S movements, three studies considered dynamic meditation while one investigated praise dance. Although moderate to poor in quality, included studies indicated a positive trend for the effectiveness of R/S singing and movement in dealing with mental health concerns.

The authors concluded that, while R/S singing and R/S movement (praise dance and dynamic meditation) may be of value as mental health strategies, findings of the review need to be considered with caution due to methodological constraints. The limited number and poor quality of included studies highlight the need for further quality research in these R/S practices in mental health.

I am glad the authors caution us not to take their findings seriously. To be honest, I was not in danger of making this mistake. Neither do I feel the need for further research in this area. Mental health is a serious issue, and personally, I think we should research it not by conducting ridiculous studies of implausible modalities.

PS

I do not doubt that the experience of singing or movement can help in certain situations. However, I have my doubts about religious/spiritual singing and movement therapy.

Yes, Today is ‘WORLD SLEEP DAY‘ and you are probably in bed hoping this post will put you back to sleep.

I’ll do my best!

This study aimed to synthesise the best available evidence on the safety and efficacy of using moxibustion and/or acupuncture to manage cancer-related insomnia (CRI).

The PRISMA framework guided the review. Nine databases were searched from its inception to July 2020, published in English or Chinese. Randomised clinical trials (RCTs) of moxibustion and or acupuncture for the treatment of CRI were selected for inclusion. The methodological quality was assessed using the method suggested by the Cochrane collaboration. The Cochrane Review Manager was used to conduct a meta-analysis.

Fourteen RCTs met the eligibility criteria; 7 came from China. Twelve RCTs used the Pittsburgh Sleep Quality Index (PSQI) score as continuous data and a meta-analysis showed positive effects of moxibustion and or acupuncture (n = 997, mean difference (MD) = -1.84, 95% confidence interval (CI) = -2.75 to -0.94, p < 0.01). Five RCTs using continuous data and a meta-analysis in these studies also showed significant difference between two groups (n = 358, risk ratio (RR) = 0.45, 95% CI = 0.26-0.80, I 2 = 39%).

The authors concluded that the meta-analyses demonstrated that moxibustion and or acupuncture showed a positive effect in managing CRI. Such modalities could be considered an add-on option in the current CRI management regimen.

Even at the risk of endangering your sleep, I disagree with this conclusion. Here are some of my reasons:

  • Chinese acupuncture trials invariably are positive which means they are as reliable as a 4£ note.
  • Most trials were of poor methodological quality.
  • Only one made an attempt to control for placebo effects.
  • Many followed the A+B versus B design which invariably produces (false-) positive results.
  • Only 4 out of 14 studies mentioned adverse events which means that 10 violated research ethics.

Sorry to have disturbed your sleep!

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