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

methodology

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According to its authors, this study‘s objective was to demonstrate that acupuncture is beneficial for decreasing the risk of ischaemic stroke in patients with rheumatoid arthritis (RA).

The investigation was designed as a propensity score-matched cohort nationwide population-based study. Patients with RA diagnosed between 1 January 1997 and 31 December 2010, through the National Health Insurance Research Database in Taiwan. Patients who were administered acupuncture therapy from the initial date of RA diagnosis to 31 December 2010 were included in the acupuncture cohort. Patients who did not receive acupuncture treatment during the same time interval constituted the no-acupuncture cohort. A Cox regression model was used to adjust for age, sex, comorbidities, and types of drugs used. The researchers compared the subhazard ratios (SHRs) of ischaemic stroke between these two cohorts through competing-risks regression models.

After 1:1 propensity score matching, a total of 23 226 patients with newly diagnosed RA were equally subgrouped into acupuncture cohort or no-acupuncture cohort according to their use of acupuncture. The basic characteristics of these patients were similar. A lower cumulative incidence of ischaemic stroke was found in the acupuncture cohort (log-rank test, p<0.001; immortal time (period from initial diagnosis of RA to index date) 1065 days; mean number of acupuncture visits 9.83. In the end, 341 patients in the acupuncture cohort (5.95 per 1000 person-years) and 605 patients in the no-acupuncture cohort (12.4 per 1000 person-years) experienced ischaemic stroke (adjusted SHR 0.57, 95% CI 0.50 to 0.65). The advantage of lowering ischaemic stroke incidence through acupuncture therapy in RA patients was independent of sex, age, types of drugs used, and comorbidities.

The authors concluded that this study showed the beneficial effect of acupuncture in reducing the incidence of ischaemic stroke in patients with RA.

It seems obvious that the editors of ‘BMJ Open’, the peer reviewers of the study and the authors are unaware of the fact that the objective of such an investigeation is not to to demonstrate that acupuncture is beneficial but to test whether acupuncture is beneficial. Starting a study with the intention to to show that my pet therapy works is akin to saying: “I am intending to mislead you about the value of my intervention”.

One needs therefore not be surprised that the authors of the present study draw very definitive conclusions, such as “acupuncture therapy is beneficial for ischaemic stroke prevention”. But every 1st year medical or science student should know that correlation is not the same as causation. What the study does, in fact, show is an association between acupuncture and stroke. This association might be due to dozens of factors that the ‘propensity score matching’ could not control. To conclude that the results prove a cause effect relationship is naive bordering on scientific misconduct. I find it most disappointing that such a paper can pass all the hurdles to get published in what pretends to be a respectable journal.

Personally, I intend to use this study as a good example for drawing the wrong conclusions on seemingly rigorous research.

 

 

There are many variations of acupuncture. Electroacupuncture (EA) and Laseracupuncture (LA) are but two examples both of which are commonly used. However, it remains uncertain whether LA is as effective as EA. This study aimed to compare EA and LA head to head in dysmenorrhea.

A crossover, randomized clinical trial was conducted. EA or LA was applied to selected acupuncture points. Participants were randomized into two sequence treatment groups who received either EA or LA twice per week in luteal phase for 3 months followed by 2-month washout, then shifted to other groups (sequence 1: EA > LA; sequence 2: LA > EA). Outcome measures were heart rate variability (HRV), prostaglandins (PGs), pain, and quality-of-life (QoL) assessment (QoL-SF12). We also compared the effect of EA and LA in low and high LF/HF (low frequency/high frequency) status.

43 participants completed all treatments. Both EA and LA significantly improved HRV activity and were effective in reducing pain (Visual Analog Scale [VAS]; EA: p < 0.001 and LA: p = 0.010) and improving QoL (SF12: EA: p < 0.001, LA, p = 0.017); although without intergroup difference. EA reduced PGs significantly (p < 0.001; δ p = 0.068). In low LF/HF, EA had stronger effects than LA in increasing parasympathetic tone in respect of percentage of successive RR intervals that differ by more than 50 ms (pNN50; p = 0.053) and very low-frequency band (VLF; p = 0.035).

The authors concluded that there is no significant difference between EA and LA in improving autonomic nervous system dysfunction, pain, and QoL in dysmenorrhea. EA is prominent in PGs changing and preserving vagus tone in low LF/HF; yet LA is noninvasive for those who have needle phobia. Whether LA is equivalent with EA and the mechanism warrants further study.

Looking at the affiliations of the authors, one might expect that they should be able to design a meaningful study:

  • 1Division of Hemato-Oncology, Department of Internal Medicine, Branch of Zhong-Zhou, Taipei City Hospital, Taipei, Taiwan.
  • 2Institute of Traditional Medicine, National Yang-Ming Chiao Tung University, Taipei, Taiwan.
  • 3Department of Traditional Medicine, Branch of Yang-Ming, Taipei City Hospital, Taipei, Taiwan.
  • 4Department of Traditional Medicine, Branch of Kunming, Taipei City Hospital, Taipei, Taiwan.
  • 5Department of Gynecology and Obstetrics, Branch of Yang-Ming, Taipei City Hospital, Taipei, Taiwan.

Sadly, this assumption is evidently mistaken.

The trial certainly does not show what they claim and neither had it ever the chance to show anything relevent. A clinical trial is comparable to a mathematical equation. It can be solved, if it has one unkown; it cannot produce a result, if it has two unknowns.

The efficacy of EA and LA for dysmenorrhea are both unknown. A comparative study with two unknowns cannot produce a meaningful result. EA and LA did not both improve autonomic nervous system dysfunction, pain, and QoL in dysmenorrhea but most likely they both had no effect. What caused the improvement was not the treatment per se but the ritual, the placebo effect, the TLC or other non-specific factors. The maginal differences in other parameters are meaningless; they are due to the fact that – as an equivalence trial – the study was woefully underpowered and thus open to coincidental differences.

Clinical trials should be about contributing to our knowledge and not about contributing to confusion.

Acute Otitis Media (AOM) is one of the most common acute infections in children and often injudiciously treated by antibiotics. Homeopathy has been claimed to work but is it really effective?

This open label, randomized, controlled, parallel arm trial was conducted on children (aged 0–12 years), suffering from AOM. The primary outcome was changes in Tympanic Membrane Examination scale (TMES) and Acute Otitis Media-Severity of Symptoms (AOM-SOS) scale, time to improvement in pain through Facial Pain Scale-Revised (FPS-R) over 10 days. The need for antibiotics in both groups and the recurrence of subsequent episodes of AOM over 12 months were also compared.

Intention-to-treat analysis was performed on 222 children; Homeopathy (n = 117) (H-group), Allopathy (A-group) (n = 105). There was a statistically significant reduction of scores in H-group compared with A-group at each time point: at day 3 (mean diff. ± sd: 1.71 ± 0.19; 95% CI: 1.34 to 2.07; p = 0.0001), at day 7 (mean diff. ± sd: 1.29 ± 0.24; 95% CI: 0.82 to 1.76; p = 0.0001) and at day 10 (mean diff. ± sd: 1.23 ± 0.25; 95% CI = 0.74 to 1.71; p = 0.0001) favoring homeopathy. Clinical failure by the third day of treatment was observed in 11% and 24% of children in H-group vs A-group (OR: 0.03; 95% CI: 0.001 to 0.52; p = 0.03). None of the children in the H-group required antibiotics, whereas 14 children in the A-group did.

The authors concluded that both therapies seemed to produce comparable effects and appeared safe. The study consolidated the findings observed during a pilot study, i.e., homeopathy is non-inferior to allopathy in managing AOM in children and antibiotics in children can be avoided.

This study was published in the journal ‘Homeopathy’ and originates from the Central Council for Research in Homeopathy, New Delhi, India. Sadly, I do not have the full text of the paper and cannot therefore scrutinize it adequately.

Let me just mention these three facts:

  1.  The journal ‘Homeopathy’ never publishes negative results.
  2. Indian researchers of homeopathy publish as good as no negative results.
  3. As far as I can see, the Central Council for Research in Homeopathy, New Delhi, has never published a negative result.

These points do, of course, not necessarily mean that the study is false-positive, but they do not inspire me with confidence. In any case, it seems wise to insist on better evidence. To render it credible, we would need:

  1. Several rigorous RCTs that test homeopathy for AOM against placebo.
  2. If (and only then) they show that homeopathy is better than placebo, at least one independent replication of the present study.

As the biological plausibility of all this is close to zero, the chances that this will happen are also zero.

Jennifer Jacobs started publishing peer-reviewed papers on homeopathy in the early 1990s. This happens to be around the same time as I did. So, we both have about 30 years of research into homeopathy behind us.

Jennifer just authored a paper entitled “Thirty Years of Homeopathic Research – Lessons Learned“. Here is its abstract:

Conducting double-blind randomized controlled trials is difficult, even in the allopathic medical system. Doing so within the paradigm of classical homeopathy is even more challenging. More than thirty years of experience in carrying out such trials has taught me much about the pitfalls to avoid as well as the factors that can lead to success. The initial steps of putting together a research protocol, securing funding, and obtaining human subjects’ approval can be daunting. After that comes developing questionnaires and surveys, hiring study personnel, and recruitment of subjects. The actual implementation of the research comes with its own set of possible missteps. Sample size determination, entry criteria, as well as type, frequency and duration of treatment are all crucial. Finally, statistical analysis must be performed to a high standard and a manuscript prepared to submit for publication. Even then there can be one or more manuscript revisions to make, based on feedback from reviewers, before a study is actually published. The entire process can take at least two years and is usually much longer.

Mistakes at any one of these steps can damage the outcome, as well as the impact of the study. With examples from my body of research, I will discuss some of the things that I wish I had done differently, as well as those that turned out to be correct. Homeopathic research is held to a much higher standard than conventional trials. Any flaws in study design, implementation, and analysis can be used by critics to negate the results. I am hopeful that the next generation of homeopathic researchers will learn from my experiences and carry on with great success.

Jennifer’s example motivated me to follow suit and contribute some very brief thoughts about my 30 years of homeopathy research and the lessons I have learnt:

  Conducting double-blind randomized controlled trials is difficult in any area of medicine. Yet these types of studies are by far the best way to find out which treatments work and which don’t. Therefore, they need doing, regardless of the obstacles they may pose.

In homeopathy, we now have a large body of such trials. Sadly, not all of them are reliable. Those that are, according to accepted criteria, tend to fail to show that homeopathy works better than a placebo. Understandably, homeopaths are disappointed with this overall result and have made numerous attempts to invalidate it.

The main problem with research into homeopathy is not the research methodology. It is well established for clinical trials and can be easily modified to fit all the demands made by individualised treatment or other pecularities that may apply to homeopathy. The main problem is the homeopath who finds it impossible to accept the truth, namely that highly diluted homeopathic remedies are pure placebos and any observed benefits of homeopathy are due to non-specific effects such as the empathetic encounter or a placebo response.

The lesson to be learned from the past is that, in medicine, even the most obsessive belief, conviction or wishful thinking will eventually have to give way to the scientific evidence. In the case of homeopathy, this process has taken an extraordinary amount of time and effort but, finally, we are almost there and the writing is on the wall for everyone to see.

Two resumes of 30 years of work, research and experience!

And what a difference between them!

Who do you think gets closer to the truth,

Jennifer or I?

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.]

 

Yes, I often moan about the abundance of poor-quality prevalence surveys that we are confronted with when scanning the literaturee on so-called alternative medicine (SCAM), e.g.:

Here is another example that recently appeared on my screen and that allows me to explain (yet again) why these surveys are such a waste of space:

The Use of Traditional and Complementary Medicine Among Patients With Multiple Sclerosis in Morocco

Let’s assume the survey is done perfectly (a condition that most are very far from meeting). If the information generated by such a perfect survey were worthwhile, we would also need to consider possible mutations that would be just as relevant:

  • We have just over 200 nations (other than Morocco) on the planet.
  • I assume there are about 1000 conditions (other than multiple sclerosis) for which SCAM is used.
  • There are, I estimate, 100 different definitions of SCAM (other than ‘traditional and complementary medicine’) that all include different modalities.

So, this alone would make 20 000 000 surveys that would be important enough to get published. But that’s not all. The usage and nature of SCAM change fairly quickly. That means we would need these 20 million surveys to be repeated every 2 to 3 years to be up-to-date.

For all this, we would need, I estimate, 200 000 research groups doing the work and about 20 000 SCAM journals to publish their results.

I think we can agree that this would be a nonsensical effort for producing millions of papers reaching dramatic conclusions that read something like this:

Our survey shows that patients suffering from xy  living in yz use much SCAM. This level of popularity suggests that SCAM is much appreciated and needs to be made available more widely and free of charge. 

I rest my case.

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.

 

A recent post of mine started an interesting discussion about the research of the NCCIH. Richard Rasker made the following comment:

The NCCIH was initially established as the Office for Alternative Medicine (OAM) for mostly the same reason that Edzard’s department at Exeter was founded, i.e. to study alternative modalities, and determine once and for all which ones were effective and which ones weren’t. Unfortunately, OAM and its subsequent incarnations were taken over by SCAM proponents almost right away, with its core mission changed into validating (NOT ‘studying’) SCAM modalities – a small but crucial difference that will all but guarantee that even long-obsolete and totally ineffective quackery will continue to be ‘researched’ and promoted.

So what’s the score now, after more than 30 years and well over 4 billion dollars in taxpayers’ money? How many SCAM modalities have they managed to ‘validate’, i.e. definitively proven to be effective? The answer is: none, for all intents and purposes. Even their research into herbal medicine – one of the most effective (or should I say: least ineffective) SCAMs out there – is best described as woefully lacking. Their list of herbs and plants names just 55 species of plants, and the individual descriptions are mostly to the tune of ‘a lot of research was done, but we can’t say anything definite’.

I think I can contribute meaningfully to this important comment and topic. Several years ago, my Exeter team – together with several other researches – systematically reviewed the NCCIH (formerly NCCAM)-sponsored clinical trials. Specifically, we focussed on 4 different subject areas. Here are the conclusions of our articles reporting the findings:

      1. ACUPUNCTURE

Seven RCTs had a low risk of bias. Numerous methodological shortcomings were identified. Many NCCAM-funded RCTs of acupuncture have important limitations. These findings might improve future studies of acupuncture and could be considered in the ongoing debate regarding NCCAM-funding. [Focus on Alternative and Complementary Therapies Volume 17(1) March 2012 15–21]

       2. HERBAL MEDICINE

This independent assessment revealed a plethora of serious concerns related to NCCAM studies of herbal medicine. [Perfusion 2011; 24: 89-102]

       3. ENERGY MEDICINE

In conclusion, the NCCAM-funded RCTs of energy medicine are prime examples of misguided investments into research. In our opinion, NCCAM should not be funding poor-quality studies of implausible practices. The impact of any future studies of energy medicine would be negligible or even detrimental. [Focus on Alternative and Complementary Therapies Volume 16(2) June 2011 106–109 ]

       4. CHIROPRACTIC

In conclusion, our review demonstrates that several RCTs of chiropractic have been funded by the NCCAM. It raises numerous concerns in relation to these studies; in particular, it suggests that many of these studies are seriously flawed. [https://www.ncbi.nlm.nih.gov/pubmed/21207089]

The overall conclusion that comes to my mind is this:

The NCCIH has managed to spend more money on SCAM research than any other institution in the world (in the 20 years that I ran the Exeter research unit, we spent around £2 million in total). The NCCIH has wasted precious funds on plenty of dubious studies; arguably, this is unethical. It has misappropriated its role from testing to validating SCAMs. And it has validated none.

PS

As some of the above-cited papers are not easily accessible, I offer to send copies to interested individuals on request.

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.

A recent post of mine seems to have galvanized concerns about my image and general attitude towards so-called alternative medicine (SCAM). Here are the comments I am referring to:

Hanjo Lehmann

…you should take care of your image: not being a man who just hates anything that smells like “alternative medicine” but rather an experienced scientist and physician who sees things with appropriate skepticism.

Eelco_G

Edzard preaches for his own parish and does not reach the people he would like to reach. A little more wisdom and ability to put things into perspective would earn him much more respect.

Mike Grant

Hanjo made some valid points Edzard. Perhaps you should suppress your ego?

Socrates

If you want to persuade people it’s not enough just to be right. There are times to be antagonistic and times to be more understanding. And sweeping generalisations can get people’s backs up unnecessarily.

Please allow me to take this opportunity to explain my attitude, motivation, image, etc. a little better.

After SCAM and SCAM-research had previously been a mere hobby of mine, I took the Exeter chair in ‘complementary medicine’ in 1993. Ever since, I spent my time studying the subject. Between 1993 and 2012, I headed the worldwide most productive department of SCAM research. My team published several books for healthcare professionals and well over 1 000 peer-reviewed papers on SCAM. I personally gave about 500 lectures on SCAM to all sorts of audiences all over the world. None of these books, papers, lectures, etc. are in any way dismissive of SCAM. They are, I hope, rigorously scientific.

What I am trying to point out is this: for 20 odd years I have done more that anyone else to persuade, to be understanding, to promote sound evidence, to abstain from opinion, to suppress my “ego”, to reach people interested in SCAM, to see things with “appropriate skepticism”, to be polite, to avoid stepping on anyone’s toes, to be politically correct – while conducting the best science that the circumstances allowed.

What did it get me?

Was my work acclaimed by the SCAM community?

No.

Did my research receive the funding I had been promised?

No.

Did I manage to persuade the SCAM-community to think more critically?

No.

Did even my own university show any appreciation?

No, more than once, my peers even tried to influence the nature and/or direction of my research.

In 2012, I retired from my Exeter post because Charles’ intervention had been allowed to completely destroy my department.

Was I disappointed?

Yes, the only department worldwide that independently and critically investigated SCAM had ceased to exist. This certainly is disappointing!

Was I bitter?

No, on the contrary, I had voluntarily taken the decision to retire and I soon felt relieved to no longer have anyone breathing down my neck. I was looking forward to carrying on my work, free of the pressures and irritating voices trying to tell me what outcomes were expected of me. I was delighted to be free of the tedious task to fund-raise. I was happy to be relieved of all the tedious amount of admin.

Now, more than 10 years later, my work gives me great fun every day and often laugh tears about certain aspects of SCAM. Those who think or hope that I am a bitter old fool I must disappoint bitterly.

After retiring, I wrote a series of books and started this blog. On the very first post, dated 14/10/2012, I explained my decision:

Why another blog offering critical analyses of the weird and wonderful stuff that is going on in the world of alternative medicine? The answer is simple: compared to the plethora of uncritical misinformation on this topic, the few blogs that do try to convey more reflected, sceptical views are much needed; and the more we have of them, the better.

I am telling you all this to explain that

  • I have little patience with people who feel compelled to tell me what to do.
  • For me a blog is something entirely different than a peer-reviewed paper – the former is written quickly and tends to be be light-hearted, ironic, sarcastic, provocative, exaggerated, journalistic, etc., while the latter usually is carefully worded, scientific and bone-dry.
  • With my blog, I try to create an entertaining counterbalance to the plethora of uncritical misinformation on SCAM.
  • Therefore, I am deliberately critical of SCAM.
  • I do not hate anyone or anything.
  • I am not in the slightest concerned about my image.
  • I know very well what I am doing and quite confident that, during the last 30 years, I have reflected on issues around SCAM more deeply than most.

So, to those who still are concerned about my image or my approach to SCAM I say THANKS for your advice – but no thanks. And of those who doubt my science I ask, please study my peer-reviewed papers.

PS

Of course, none of this means that I make no mistakes, or that am not frequently troubled by self-doubt. So, please do carry on criticising me and my work, but don’t assume that I worry about my image.

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