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

anxiety

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We have discussed the LIGHTNING PROCESS before:

Now, the BBC reports that it is promoted as a treatment of Long-COVID. Oonagh Cousins was offered a free place on a course run by the Lightning Process, which teaches people they can rewire their brains to stop or improve long Covid symptoms quickly. Ms Cousins, who contracted Covid in March 2020, said it “exploits” people.

Ms Cousins had reached a career goal many athletes can only dream of – being selected for the Olympics – when she developed long Covid. By the time the cancelled 2020 Olympic Games in Tokyo were rescheduled for 2021, Ms Cousins was too ill to take part. When she went public with her struggles, she was approached by the Lightning Process. It offered her a free place on a three-day course, which usually costs around £1,000.

“They were trying to suggest that I could think my way out of the symptoms, basically. And I disputed that entirely,” the former rower said. “I had a very clearly physical illness. And I felt that they were blaming my negative thought processes for why I was ill.” She added: “They tried to point out that I had depression or anxiety. And I said ‘I’m not, I’m just very sick’.

In secret recordings by the BBC, coaches can be heard telling patients that almost anyone can recover from long Covid by changing their thoughts, language and actions. Over three days on Zoom, the course taught the ritual that forms the basis of the programme. Every time you experience a symptom or negative thought, you say the word “stop”, make a choice to avoid these symptoms and then do a positive visualisation of a time you felt well. You do this while walking around a piece of paper printed with symbols – a ritual the BBC was told to do as many as 50 times a day.

In some cases the Lightning Process has encouraged participants to increase their activity levels without medical supervision, against official advice – which could make some more unwell, according to NHS guidelines. Lightning Process founder, Dr Phil Parker, who’s not a medical doctor but has a PhD in psychology of health, told us his course was “not a mindset or positive thinking approach,” but one that uses “the brain to influence physiological changes”, backed by peer-reviewed evidence. The coach on the course the BBC attended said “thoughts about your symptoms, your worry about whether it’s ever going to go – that’s what keeps the neurology going. Being in those kind of thoughts is what’s maintaining your symptoms. They’re not caused by a physical thing any more.”

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As I pointed out previously, The Lightning Process  (LP) is a therapy based on ideas from osteopathy, life coaching, and neuro-linguistic programming. LP is claimed to work by teaching people to use their brains to “stimulate health-promoting neural pathways”.

LP teaches individuals to recognize when they are stimulating or triggering unhelpful physiological responses and to avoid these, using a set of standardized questions, new language patterns, and physical movements with the aim of improving a more appropriate response to situations.

Proponents of the ‘LP’ in Norway claim that 90% of all ME patients get better after trying it. However, such claims seem to be more than questionable.

  • In the Norwegian ME association’s user survey from 2012 with 1,096 participants, 164 ME patients stated that they had tried LP. 21% of these patients experienced improvement or great improvement and 48% got worse or much worse.
  • In Norway’s National Research Center in Complementary and Alternative Medicine, NAFKAM’s survey from 2015 amongst 76 patients 8 had a positive effect and 5 got worse or much worse.
  • A survey by the Norwegian research foundation, published in the journal Psykologisk, with 660 participants, showed that 62 patients had tried LP, and 5 were very or fairly satisfied with the results.

Such figures reflect the natural history of the condition and are no evidence that the LP works.

Is there any evidence supporting the LP specifically for long COVID?

My Medline search retrieved just one single paper. Here is the abstract:

As a result of the COVID-19 pandemic, Long COVID (LC) is now prevalent in many countries. Little evidence exists regarding how this chronic condition should be treated, but guidelines suggest for most people it can be managed symptomatically in primary care. The Lightning Process is a trademarked positive psychology focused self-management programme which has shown to be effective in reducing fatigue and accompanying symptoms in other chronic conditions including Chronic Fatigue Syndrome/Myalgic Encephalomyelitis. Here we outline its novel application to two patients with LC who both reported improvements in fatigue and a range of physical and emotional symptoms post-treatment and at 3 months follow-up.

Well, that surely convinced everyone! Except me and, of course, anyone else who can think critically.

So, I look further and find this on the company’s website:

Do you know how it feels to…

  • …be exhausted and tired no matter how much rest you get?
  • …be stuck with re-occurring pain, health symptoms and issues?
  • …get so stressed by almost everything?
  • …feel low and upset much of the time?
  • …want a better life and health but just can’t find anything that works?

If any, or all, of these sound familiar then the Lightning Process, designed by Phil Parker, PhD, could be the answer that you’re looking for.  There are lots of ways you can find out more about the suitability of the Lightning Process for you, have a look through below…

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Let me try to summarise:

  • The LP is promoted as a cure for long-Covid.
  • There is no evidence that LP is effective for it.
  • The claim is that it has been shown to work for ME.
  • There is no evidence that LP is effective for it.
  • A 3-day course costs £1 000.
  • Their website claims it is good for practically everyone.

Does anyone think that LP or its promoters are remotely serious?

Many forms of so-called alternative medicine (SCAM) involve touch, and touch is of critical importance: many studies have shown that it promotes mental and physical well-being.

A team of researchers conducted a pre-registered (PROSPERO: CRD42022304281) systematic review and multilevel meta-analysis encompassing 137 studies in the meta-analysis and 75 additional studies in the systematic review (n = 12,966 individuals, search via Google Scholar, PubMed and Web of Science until 1 October 2022) to identify critical factors moderating touch intervention efficacy.

Included studies always featured a touch versus no touch control intervention with diverse health outcomes as dependent variables. Risk of bias was assessed via small study, randomization, sequencing, performance and attrition bias.

The results show that touch interventions were especially effective in:

  • regulating cortisol levels (Hedges’ g = 0.78, 95% confidence interval (CI) 0.24 to 1.31),
  • increasing weight (0.65, 95% CI 0.37 to 0.94) in newborns,
  • reducing pain (0.69, 95% CI 0.48 to 0.89),
  • reducing feelings of depression (0.59, 95% CI 0.40 to 0.78),
  • reducing state (0.64, 95% CI 0.44 to 0.84) or trait anxiety (0.59, 95% CI 0.40 to 0.77) for adults.

Comparing touch interventions involving objects or robots resulted in similar physical (0.56, 95% CI 0.24 to 0.88 versus 0.51, 95% CI 0.38 to 0.64) but lower mental health benefits (0.34, 95% CI 0.19 to 0.49 versus 0.58, 95% CI 0.43 to 0.73). Adult clinical cohorts profited more strongly in mental health domains compared with healthy individuals (0.63, 95% CI 0.46 to 0.80 versus 0.37, 95% CI 0.20 to 0.55).

The authors found no difference in health benefits in adults when comparing touch applied by a familiar person or a health care professional (0.51, 95% CI 0.29 to 0.73 versus 0.50, 95% CI 0.38 to 0.61), but parental touch was more beneficial in newborns (0.69, 95% CI 0.50 to 0.88 versus 0.39, 95% CI 0.18 to 0.61). Small but significant small study bias and the impossibility to blind experimental conditions need to be considered.

The authors concluded that leveraging factors that influence touch intervention efficacy will help maximize the benefits of future interventions and focus research in this field.

It seems obvious to me that these findings are relevant to several SCAMs, e.g.:

  • acupuncture,
  • Alexander technique,
  • applied kinesiology,
  • aromatherapy,
  • Bowen technique,
  • chiropractic,
  • craniosacral therapy,
  • cupping,
  • Dorn method,
  • Feldenkrais method,
  • gua sha,
  • kinesiology taping,
  • lymph drainage,
  • massage in all its variations,
  • naprapathy,
  • osteopathy,
  • rebirthing,
  • reflexology,
  • Rolfing,
  • shiatsu,
  • slapping therapy,
  • therapeutic touch.

This also means that the effects of these SCAMs will be at least to some extend non-specific, i.e. not related to the treatment per se but to touch. Finally, it means that clinical trials testing these SCAMs need to be designed such that the touch element is adequately accounted for.

This randomized controlled, pretest-post-test intervention study examined the effect of distance reiki on state test anxiety and test performance.
First-year nursing students (n = 71) were randomized into two groups. One week before the examination,

  • the intervention group participants received reiki remotely for 20 minutes for 4 consecutive days,
  • the control group participants received no intervention.
The intervention group had lower posttest cognitive and psychosocial subscale scores than pretest scores (p > .05). The control group had a significantly higher mean posttest physiological subscale score than pretest score (p < .05). Final grade point averages were not significantly different between the intervention and control groups (p > .05). One quarter of the intervention group participants noted reiki reduced their stress and helped them perform better on the examination.The authors concluded that Reiki is a safe and easy-to-practice method to help students cope with test anxiety.What a conclusion!What a study!

A controlled clinical trial has the purpose of comparing outcomes of two or more treatments. Therefore, intra-group changes are utterly irrelevant. The only thing of interest is the comparison between the intervention and control groups. In the present study, this did not show a significant difference. In other words, distant Reiki had no effect.

This means that the bit in the conclusion telling us that Reiki helps students cope with test anxiety is quite simply not true.

This leaves us with the first part of the conclusion: Reiki is a safe and easy-to-practice method. This may well be true – yet it is meaningless. Apart from the fact that the study was not aimed at assessing safety or ease of practice, the statement is true for far too many things to be meaningful, e.g.:

  • Not having Reiki (the control group) is a safe and easy-to-practice method.
  • Going for a walk is a safe and easy-to-practice method.
  • Cooking a plate of spagetti is a safe and easy-to-practice method.
  • Having a nap is a safe and easy-to-practice method.
  • Reading a book is a safe and easy-to-practice method.

(I think you get my gist)

To make the irony complete, let me tell you that this trial was published in Journal of Nursing Education. On the website, the journal states: The Journal of Nursing Education is a monthly, peer-reviewed journal publishing original articles and new ideas for nurse educators in various types and levels of nursing programs for over 60 years. The Journal enhances the teaching-learning process, promotes curriculum development, and stimulates creative innovation and research in nursing education.

I suggest that the journal urgently embarks on a program of educating its editors, reviewers, contributors and readers about science, pseudoscience, minimal standards, scientific rigor, and medical ethics.

 

 

In the previous two parts of this series (see here and here), we discussed the following SCAM diagnoses:

  • adrenal fatigue,
  • candidiasis hypersensitivity,
  • chronic intoxications,
  • chronic Lyme disease,
  • electromagnetic hypersensitivity,
  • homosexuality.

Today, I will add three further fake diagnoses to the list.

Leaky gut syndrome

Leaky gut syndrome is allegedly caused by the passage of harmful substances from the gut wall into the body. SCAM proponents claim it is the origin of many conditions, including multiple sclerosis and autism. However, there is no evidence to show that these claims are true. SCAM practitioners nevertheless recommend many types of SCAM to treat the non-existing entity, e.g. SCAM diets, supplements, etc. It goes without saying that none of them have been shown to be effective.

Multiple chemical sensitivity

Multiple chemical sensitivity is allegedly caused by a hypersensitivity to commonly used chemicals. The symptoms are vague such as headache, dizziness, fatigue. Even those who believe that the condition exist are unable to offer a generally accepted definition of the syndrome.

The SCAMs recommended include:

  • Nutritional supplements
  • Digestive aids
  • Hormone balancing
  • Detoxification
  • Desensitization
  • Eliminating occult infections
  • Oxygen
  • Immune stimulation

Naturally, none of them is supported by sound evidence.

Neurasthenia

In 1869, physician George Miller Beard developed a diagnostic profile for a mental disorder that appeared to be common in the US. Neurasthenia was allegedly characterised by migraines, fatigue, depression, and digestive problems.

The cure, according to Beard, was to flee the city – because it was the stresses of city life that caused the condition. Women were encouraged to rest, while men were asked to engage in outdoor activities. By the early 20th century, this mental disorder had become a status symbol, and it soon spread to other parts of the world. But this pandemic was short-lived: by 1930, neurasthenia had virtually disappeared from conventional medicine.

In SCAM, however, neurasthenia is still a well-establisged money earner. SCAM practitioners do not hesitate to recomment virually every SCAM under the sun for it. They all have one thing in common: they do not work.

 

This study evaluated and compared the effectiveness of Reiki and Qi-gong therapy techniques in improving diabetic patients’ negative emotional states. This quas-experimental research design was carried out at the National Institute of Diabetes and Endocrinology’s Hospital in Cairo, Egypt. It included 200 Type 2 diabetes patients randomized into two equal groups, one for Qigong and one for Reiki techniques. A self-administered questionnaire with a standardized tool (Depression Anxiety Stress Scales [DASS[) was used in data collection. The intervention programs were administered in the form of instructional guidelines through eight sessions for each group.

The results showed that the two study groups had similar socio-demographic characteristics. After implementation of the intervention, most patients in the two groups were having no anxiety, no depression, and no stress. Statistically significant improvements were seen in all three parameters in both groups (p<0.001). The multivariate analysis identified the study intervention as the main statistically significant independent negative predictor of the patients’ scores of anxiety, depression, and stress. Reiki technique was also a statistically significant independent negative predictor of these scores.

The authors conclused that both Reiki and Qi-gong therapy techniques were effective in improving diabetic patients’ negative emotional states of anxiety, depression, and stress, with slight superiority of the Reiki technique. The inclusion of these techniques in the management plans of Type-2 diabetic patients is recommended.

This is an excellent example of how NOT to design a clinical trial!

  • If your aim is to test the efficacy of Reiki, conduct a trial of Reiki versus sham-Reiki.
  • If your aim is to test the efficacy of Qi-gong, conduct a trial of Qi-gong versus sham-Qi-gong.
  • If you compare two therapies in one trial, one has to be of proven and undoubted efficacy.
  • Comparing two treatments of unproven efficacy cannot normally lead to a meaningful result.
  • It is like trying to solve a mathematical equasion with two unknowns.
  • A study that cannot produce a meaningful result is a waste of resorces.
  • It arguably also is a neglect of research ethics.
  • Even if we disregarded all these flaws and problems, recommending therapies for routine use on the basis of one single study is irresponsible nonsense.

All this is truly elementary and should be known by any researcher (not to mention research supervisor). Yet, in the realm of so-called alternative medicine (SCAM), it needs to be stressed over and over again. The ‘National Institute of Diabetes and Endocrinology’s Hospital in Cairo’ (and all other institutions that produce such shameful pseudoscience) urgently need to get their act together:

you are doing nobody a favour!

Of all the forms of so-called alternative medicine (SCAM), Reiki is amongst the least plausible. It is a form of paranormal or ‘energy healing’ popularised by Japanese Mikao Usui (1865–1926). Reiki is based on the assumptions of Traditional Chinese Medicine and the existence of ‘chi’, the life-force that is assumed to determine our health.

Reiki practitioners believe that, with their hands-on healing method, they can transfer ‘healing energy’ to a patient which, in turn, stimulates the self-healing properties of the body. They assume that the therapeutic effects of this technique are obtained from a ‘universal life energy’ that provides strength, harmony, and balance to the body and mind.

Despite its implausibility, Reiki is used for a very wide range of conditions. Some people are even convinced that it has positive effects on sexuality. But is that really so?

This randomised clinical trial was aimed at finding out. Specifically, its authors wanted to determine the effect of Reiki on sexual function and sexual self-confidence in women with sexual distress*. It was was conducted with women between the ages of 15–49 years who were registered at a family health center in the eastern region of Turkey and had sexual distress.

The sample of the study consisted of 106 women, 53 in the experimental group and 53 in the control group. Women in the experimental group received Reiki once a week for four weeks, while no intervention was applied to those in the control group. Data were collected using the Female Sexual Distress Scale-Revised (FSDS-R), the Arizona Sexual Experiences Scale (ASEX), and the Sexual Self-confidence Scale (SSS).

The levels of sexual distress, sexual function, and sexual self-confidence of women in both groups were similar before the intervention, and the difference between the groups was not statistically significant (p > 0.05). After the Reiki application, the FSDS-R and ASEX mean scores of women in the experimental group significantly decreased, while their SSS mean score significantly increased, and the difference between the groups was statistically significant (p < 0.05).

The authors concluded that Reiki was associated with reduced sexual distress, positive outcomes in sexual functions, and increase sexual self-confidence in women with sexual distress. Healthcare professionals may find Reiki to positively enhance women’s sexuality.

Convinced?

I hope not!

The study has the most obvious of all design flaws: it does not control for a placebo effect, nor the effect of empaty/sympathy received from the therapist, nor the negative impact of learning that you are in the control group and will thus not receive any treatment or attention.

To me, it is obvious that these three factors combined must be able to bring about the observed outcomes. Therefore, I suggest to re-write the conclusions as follows:

The intervention was associated with reduced sexual distress, positive outcomes in sexual functions, and increase sexual self-confidence in women with sexual distress. Considering the biological plausibility of a specific effect of Reiki, the most likely cause for the outcome are non-specific effects of the ritual.

*[Sexual distress refers to persistent, recurrent problems with sexual response, desire, orgasm or pain that distress you or strain your relationship with your partner. Yes, I had to look up the definition of that diagnosis.]

 

Current interventions for posttraumatic stress disorder (PTSD) are efficacious, yet effectiveness may be limited by adverse effects and high withdrawal rates. Acupuncture is an intervention with some positive preliminary but methodologically flawed data for PTSD.  Therefore a new study compared verum acupuncture with sham acupuncture (minimal needling) on clinical and physiological outcomes.

This was a 2-arm, parallel-group, prospective blinded randomized clinical trial hypothesizing superiority of verum to sham acupuncture. The study was conducted at a single outpatient-based site, the Tibor Rubin VA Medical Center in Long Beach, California, with recruitment from April 2018 to May 2022, followed by a 15-week treatment period. Following exclusion for characteristics that are known PTSD treatment confounds, might affect biological assessment, indicate past nonadherence or treatment resistance, or indicate risk of harm, 93 treatment-seeking combat veterans with PTSD aged 18 to 55 years were allocated to group by adaptive randomization and 71 participants completed the intervention protocols.

Verum and sham were provided as 1-hour sessions, twice weekly, and participants were given 15 weeks to complete up to 24 sessions. The primary outcome was pretreatment to posttreatment change in PTSD symptom severity on the Clinician-Administered PTSD Scale-5 (CAPS-5). The secondary outcome was pretreatment to posttreatment change in fear-conditioned extinction, assessed by fear-potentiated startle response. Outcomes were assessed at pretreatment, midtreatment, and posttreatment. General linear models comparing within- and between-group were analyzed in both intention-to-treat (ITT) and treatment-completed models.

A total of 85 male and 8 female veterans (mean [SD] age, 39.2 [8.5] years) were randomized. There was a large treatment effect of verum (Cohen d, 1.17), a moderate effect of sham (d, 0.67), and a moderate between-group effect favoring verum (mean [SD] Δ, 7.1 [11.8]; t90 = 2.87, d, 0.63; P = .005) in the intention-to-treat analysis. The effect pattern was similar in the treatment-completed analysis: verum d, 1.53; sham d, 0.86; between-group mean (SD) Δ, 7.4 (11.7); t69 = 2.64; d, 0.63; P = .01). There was a significant pretreatment to posttreatment reduction of fear-potentiated startle during extinction (ie, better fear extinction) in the verum but not the sham group and a significant correlation (r = 0.31) between symptom reduction and fear extinction. Withdrawal rates were low.

The authors concluded that the acupuncture intervention used in this study was clinically efficacious and favorably affected the psychobiology of PTSD in combat veterans. These data build on extant literature and suggest that clinical implementation of acupuncture for PTSD, along with further research about comparative efficacy, durability, and mechanisms of effects, is warranted.

I am not sure that the authors’ enthusiastic verdict is correct. Its lead author was even quoted stating that his study, which used improved controls, was needed to “definitively” support acupuncture for PTSD. He noted that “acupuncture ought to be considered a potential first-line treatment for PTSD.”

While the study is an improvement on the previous research in this area, it is by no means compelling. My main point of criticism is the nature of the sham acupuncture. Such controls are used to account for placebo effects which, of course, can be considerable in the case of acupuncture.

For this concept to work adequately, the patient and the therapist need to be blinded. In the case of acupuncture, therapist blinding is difficult (but not impossible). In this study, therepists were not blinded. Thus they could have influenced the outcome by verbal and non-verbal clues given to the patient. As acupuncturists inevitably have an interest in the positive result of their study, this effect seems inevitable to me.

More important, however, is the adequate blinding of the patient. In this study, it was attempted by using shallow needling as a sham intervention. Yet, shallow needling can easily distinguished from real acupuncture by the patient. At the very least, patients should be asked what treatment – sham or real – they thought they had received. This did not happen, and we therefore might assume that the effect of patient de-blinding – combined with the confounder described above – was sufficient to bring about the relatively small effect sizes observed by the authors.

One might argue that this does not really matter; all that counts is to alleviate the suffering of the patients, never mind by what mechanism. I think, this would be erroneous. It matters because, if acupuncture itself is ineffective (which I suggest), settling for acupuncture as a first line therapy for PTSD is in nobody’s interest and a disservice to severely suffering patients. It would inhibit meaningful research aimed at finding an optimal therapy (one that works beyond placebo) and be a waste of resources.

 

These days – 11 years after the closure of my department at Exeter – it is not often that I co-author a peer-reviewed paper. All the more reason, I think, to celebrate when it does happen:

Our review was aimed at determining the effectiveness of meditation, primarily mindfulness-based interventions (MBIs) and transcendental meditation (TM), for the primary and secondary prevention of CVD.

We searched CENTRAL, MEDLINE, Embase, three other databases, and two trials registers on 14 November 2021, together with reference checking, citation searching, and contact with study authors to identify additional studies. We included randomised controlled trials (RCTs) of 12 weeks or more in adults at high risk of CVD and those with established CVD. We explored four comparisons: MBIs versus active comparators (alternative interventions); MBIs versus non-active comparators (no intervention, wait list, usual care); TM versus active comparators; TM versus non-active comparators. We used standard Cochrane methods. Our primary outcomes were CVD clinical events (e.g. cardiovascular mortality), blood pressure, measures of psychological distress and well-being, and adverse events. Secondary outcomes included other CVD risk factors (e.g. blood lipid levels), quality of life, and coping abilities. We used GRADE to assess the certainty of evidence.

We included 81 RCTs (6971 participants), with most studies at unclear risk of bias. MBIs versus active comparators (29 RCTs, 2883 participants) Systolic (SBP) and diastolic (DBP) blood pressure were reported in six trials (388 participants) where heterogeneity was considerable (SBP: MD -6.08 mmHg, 95% CI -12.79 to 0.63, I2 = 88%; DBP: MD -5.18 mmHg, 95% CI -10.65 to 0.29, I2 = 91%; both outcomes based on low-certainty evidence). There was little or no effect of MBIs on anxiety (SMD -0.06 units, 95% CI -0.25 to 0.13; I2 = 0%; 9 trials, 438 participants; moderate-certainty evidence), or depression (SMD 0.08 units, 95% CI -0.08 to 0.24; I2 = 0%; 11 trials, 595 participants; moderate-certainty evidence). Perceived stress was reduced with MBIs (SMD -0.24 units, 95% CI -0.45 to -0.03; I2 = 0%; P = 0.03; 6 trials, 357 participants; moderate-certainty evidence). There was little to no effect on well-being (SMD -0.18 units, 95% CI -0.67 to 0.32; 1 trial, 63 participants; low-certainty evidence). There was little to no effect on smoking cessation (RR 1.45, 95% CI 0.78 to 2.68; I2 = 79%; 6 trials, 1087 participants; low-certainty evidence). None of the trials reported CVD clinical events or adverse events. MBIs versus non-active comparators (38 RCTs, 2905 participants) Clinical events were reported in one trial (110 participants), providing very low-certainty evidence (RR 0.94, 95% CI 0.37 to 2.42). SBP and DBP were reduced in nine trials (379 participants) but heterogeneity was substantial (SBP: MD -6.62 mmHg, 95% CI -13.15 to -0.1, I2 = 87%; DBP: MD -3.35 mmHg, 95% CI -5.86 to -0.85, I2 = 61%; both outcomes based on low-certainty evidence). There was low-certainty evidence of reductions in anxiety (SMD -0.78 units, 95% CI -1.09 to -0.41; I2 = 61%; 9 trials, 533 participants; low-certainty evidence), depression (SMD -0.66 units, 95% CI -0.91 to -0.41; I2 = 67%; 15 trials, 912 participants; low-certainty evidence) and perceived stress (SMD -0.59 units, 95% CI -0.89 to -0.29; I2 = 70%; 11 trials, 708 participants; low-certainty evidence) but heterogeneity was substantial. Well-being increased (SMD 0.5 units, 95% CI 0.09 to 0.91; I2 = 47%; 2 trials, 198 participants; moderate-certainty evidence). There was little to no effect on smoking cessation (RR 1.36, 95% CI 0.86 to 2.13; I2 = 0%; 2 trials, 453 participants; low-certainty evidence). One small study (18 participants) reported two adverse events in the MBI group, which were not regarded as serious by the study investigators (RR 5.0, 95% CI 0.27 to 91.52; low-certainty evidence). No subgroup effects were seen for SBP, DBP, anxiety, depression, or perceived stress by primary and secondary prevention. TM versus active comparators (8 RCTs, 830 participants) Clinical events were reported in one trial (201 participants) based on low-certainty evidence (RR 0.91, 95% CI 0.56 to 1.49). SBP was reduced (MD -2.33 mmHg, 95% CI -3.99 to -0.68; I2 = 2%; 8 trials, 774 participants; moderate-certainty evidence), with an uncertain effect on DBP (MD -1.15 mmHg, 95% CI -2.85 to 0.55; I2 = 53%; low-certainty evidence). There was little or no effect on anxiety (SMD 0.06 units, 95% CI -0.22 to 0.33; I2 = 0%; 3 trials, 200 participants; low-certainty evidence), depression (SMD -0.12 units, 95% CI -0.31 to 0.07; I2 = 0%; 5 trials, 421 participants; moderate-certainty evidence), or perceived stress (SMD 0.04 units, 95% CI -0.49 to 0.57; I2 = 70%; 3 trials, 194 participants; very low-certainty evidence). None of the trials reported adverse events or smoking rates. No subgroup effects were seen for SBP or DBP by primary and secondary prevention. TM versus non-active comparators (2 RCTs, 186 participants) Two trials (139 participants) reported blood pressure, where reductions were seen in SBP (MD -6.34 mmHg, 95% CI -9.86 to -2.81; I2 = 0%; low-certainty evidence) and DBP (MD -5.13 mmHg, 95% CI -9.07 to -1.19; I2 = 18%; very low-certainty evidence). One trial (112 participants) reported anxiety and depression and found reductions in both (anxiety SMD -0.71 units, 95% CI -1.09 to -0.32; depression SMD -0.48 units, 95% CI -0.86 to -0.11; low-certainty evidence). None of the trials reported CVD clinical events, adverse events, or smoking rates.

We concluded that despite the large number of studies included in the review, heterogeneity was substantial for many of the outcomes, which reduced the certainty of our findings. We attempted to address this by presenting four main comparisons of MBIs or TM versus active or inactive comparators, and by subgroup analyses according to primary or secondary prevention, where there were sufficient studies. The majority of studies were small and there was unclear risk of bias for most domains. Overall, we found very little information on the effects of meditation on CVD clinical endpoints, and limited information on blood pressure and psychological outcomes, for people at risk of or with established CVD. This is a very active area of research as shown by the large number of ongoing studies, with some having been completed at the time of writing this review. The status of all ongoing studies will be formally assessed and incorporated in further updates.

Some people will say that meditation is not a form of so-called alternative medicine (SCAM) but rather an aspect of lifestyle used for relaxation and well-being. As such, it should not be scrutinized like a therapy. This might be partly true, but as soon as proper health claims are made for meditation or similar modalities, they do need to be tested like any other therapy, in my view.

As our review demonstrates, meditation and similar treatments are not nearly as well supported by evidence as their proponents try to make us believe. In other words, the often-voiced claims that such therapies are effective for the primary and secondary prevention of cardiovascular disease are largely unfounded.

This pilot study is “delving into the potential benefits of Reiki therapy as a complementary intervention for the treatment and management of stress and anxiety”.

A total of 31 volunteers self-reporting stress, anxiety, or psychological disorders were enrolled. Health-related quality of life (HRQoL) was assessed using the 36-Item Short Form Health Survey (SF-36) Questionnaire for anxiety and depression. Pre- and post-treatment HRQoL scores were meticulously compared, and the significance of the disparities in these scores was meticulously computed.

Analysis was restricted to volunteers who completed the 3-day Reiki sessions. Statistically significant enhancements were discerned across all outcome measures, encompassing positive affect, negative affect, pain, drowsiness, tiredness, nausea, appetite, shortness of breath, anxiety, depression, and overall well-being (P<0.0001).

The authors concluded that the constancy and extensive scope of these improvements suggest that Reiki therapy may not only address specific symptoms but also contribute significantly to a predominant escalation of mental and physical health.

This study is almost comical.

Amongst all the many forms of so-called alternative medicine (SCAM), Reiki is perhaps the most ridiculous scam. It is a form of paranormal or ‘energy healing’ popularised by Japanese Mikao Usui (1865–1926). Rei means universal spirit (sometimes thought of as a supreme being) and ki is the assumed universal life energy. It is based on the assumptions of Traditional Chinese Medicine and the existence of ‘chi’, the life-force that is assumed to determine our health.

Reiki practitioners believe that, with their hands-on healing method, they can transfer ‘healing energy’ to a patient which, in turn, stimulates the self-healing properties of the body. They assume that the therapeutic effects of this technique are obtained from a ‘universal life energy’ that provides strength, harmony, and balance to the body and mind. There is no scientific basis for such notions, and reiki is therefore not plausible.

Reiki is used for a number of conditions, including the relief of stress, tension and pain. There have been several clinical trials testing its effectiveness. Those that are rigorous fail to show that the treatment is effective – and those that are dripping with bias, like the one discussed here, tend to produce false-positive results.

The present study has many flaws that are too obvious to even mention. While reading it, I asked myself the following questions:

  • How could a respectable university ever allow this pseudo-research to go ahead?
  • How could a respectable ethics committee ever permit it?
  • How could a respectable journal ever publish it?

The answers must be that, quite evidently, they are not respectable.

 

Supportive care is often assumed to be beneficial in managing the anxiety symptoms common in patients in sterile hematology unit. The authors of this study hypothesize that personal massage can help the patient, particularly in this isolated setting where physical contact is extremely limited.

The main objective of this study therefore was to show that anxiety could be reduced after a touch-massage performed by a nurse trained in this therapy.

A single-center, randomized, unblinded controlled study in the sterile hematology unit of a French university hospital, validated by an ethics committee. The patients, aged between 18 and 65 years old, and suffering from a serious and progressive hematological pathology, were hospitalized in sterile hematology unit for a minimum of three weeks. They were randomized into either a group receiving 15-minute touch-massage sessions or a control group receiving an equivalent amount of quiet time once a week for three weeks.

In the treated group, anxiety was assessed before and after each touch-massage session, using the State-Trait Anxiety Inventory questionnaire with subscale state (STAI-State). In the control group, anxiety was assessed before and after a 15-minute quiet period. For each patient, the difference in the STAI-State score before and after each session (or period) was calculated, the primary endpoint was based on the average of these three differences. Each patient completed the Rosenberg Self-Esteem Questionnaire before the first session and after the last session.

Sixty-two patients were randomized. Touch-massage significantly decreased patient anxiety: a mean decrease in STAI-State scale score of 10.6 [7.65-13.54] was obtained for the massage group (p ≤ 0.001) compared with the control group. The improvement in self-esteem score was not significant.

The authors concluded that this study provides convincing evidence for integrating touch-massage in the treatment of patients in sterile hematology unit.

I find this conclusion almost touching (pun intended). The wishful thinking of the amateur researchers is almost palpable.

Yes, I mean AMATEUR, despite the fact that, embarrassingly, the authors are affiliated with prestigeous institutions:

  • 1Nantes Université, CHU Nantes, Service Interdisciplinaire Douleur, Soins Palliatifs et de Support, Médecine intégrative, UIC 22, Nantes, F-44000, France.
  • 2Université Paris Est, EA4391 Therapeutic and Nervous Excitability, Creteil, F-93000, France.
  • 3Nantes Université, CHU Nantes, Hematology Department, Nantes, F-44000, France.
  • 4Nantes Université, CHU Nantes, CRCI2NA – INSERM UMR1307, CNRS UMR 6075, Equipe 12, Nantes, F-44000, France.
  • 5Institut Curie, Paris, France.
  • 6Université Paris Versailles Saint-Quentin, Versailles, France.
  • 7Nantes Université, CHU Nantes, Direction de la Recherche et l’Innovation, Coordination Générale des Soins, Nantes, F-44000, France.
  • 8Methodology and Biostatistics Unit, DRCI CHU Nantes CHD Vendée, La Roche Sur Yon, F-85000, France.
  • 9Nantes Université, CHU Nantes, Service Interdisciplinaire Douleur, Soins Palliatifs et de Support, Médecine intégrative, UIC 22, Nantes, F-44000, France. [email protected].

So, why do I feel that they must be amateurs?

  • Because, if they were not amateurs, they would know that a clinical trial should not aim to show something, but to test something.
  • Also, if they were not amateurs, they would know that perhaps the touch-massage itself had nothing to do with the outcome, but that the attention, sympathy and empathy of a therapist or a placebo effect can generate the observed effect.
  • Lastly, if they were not amateurs, they would not speak of convincing evidence based on a single, small, and flawed study.
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