clinical trial
Cupping is a so-called alternative medicine (SCAM) that has existed in several ancient cultures. It recently became popular when US Olympic athletes displayed cupping marks on their bodies, and it was claimed that cupping is used for enhancing their physical performance. There are two distinct forms: dry and wet cupping.
Wet cupping involves scarring the skin with a sharp instrument and then applying a cup with a vacuum to suck blood from the wound. It can thus be seen (and was traditionally used) as a form of blood-letting. Wet cupping is being recommended by enthusiasts for a wide range of conditions. But does it work?
This study compared the effects of wet-cupping therapy with conventional therapy on persistent nonspecific low back pain (PNSLBP). In this randomized clinical trial, 180 participants with the mean age of 45±10 years old, who had been suffering from PNSLBP were randomly assigned to wet-cupping or conventional treatment. The wet-cupping group was treated with two separate sessions (4 weeks in total) on the inter-scapular and sacrum area. In the conventional treatment group, patients were conservatively treated using rest (6 weeks) and oral medications (3 weeks). The primary and the secondary outcome were the quantity of disability using Oswestry Disability Index (ODI), and pain intensity using Visual Analogue Scale (VAS), respectively.
The results show that there was no significant difference in demographic characteristics (age, gender, and body mass index) between the two groups. Therapeutic effect of wet-cupping therapy was comparable to conventional treatment in the 1st month follow-up visits. The functional outcomes of wet-cupping at the 3rd and 6th month visits were significantly superior compared to the conventional treatment group. The final ODI scores in the wet-cupping and conventional groups were 16.7 ± 5.7 and 22.3 ± 4.5, respectively (P<0.01).
The authors concluded that wet-cupping may be a proper method to decrease PNSLBP without any conventional treatment. The therapeutic effects of wet-cupping can be longer lasting than conventional therapy.
Perhaps the authors were joking? In any case, their conclusions cannot be taken seriously. Why? There are several reasons, but the most obvious ones are:
- There was no adequate control of the presumably substantial placebo effects of wet cupping.
- The control group received a treatment that is known to be ineffective or even detrimental.
For people with acute low back pain, advice to rest in bed is less effective than advice to stay active. Thus comparing wet cupping to a control group treated with bed rest is bound to generate a false-positive outcome for wet cupping.
My final point is perhaps the most important: wet cupping can lead to serious complication, and I therefore do not recommend it to anyone – other than masochists, perhaps.
The effectiveness of spinal manipulative therapy (SMT) for improving athletic performance in healthy athletes (or anything else for that matter) is unclear. The objective of this systematic review was to systematically review the literature on the effect of SMT on performance-related outcomes in asymptomatic adults.
The authors searched electronic databases from 1990 to March, 2018. Inclusion criteria was any study examining a performance-related outcome of SMT in asymptomatic adults. Methodological quality was assessed using the SIGN criteria. Studies with a low risk of bias were considered scientifically admissible for a best evidence synthesis.
Of 1415 articles screened, 20 studies had low risk of bias, seven were randomized crossover trials, 10 were randomized controlled trials (RCT) and three were RCT pilot trials. Four studies showed SMT had no effect on physiological parameters at rest or during exercise. There was no effect of SMT on scapular kinematics or transversus abdominus thickness. Three studies identified changes in muscle activation of the upper or lower limb, compared to two that did not. Five studies showed changes in range of motion (ROM). One study showed an increase lumbar proprioception and two identified changes in baropodometric variables after SMT. Sport-specific studies showed no effect of SMT except for a small increase in basketball free-throw accuracy.
The authors, who are all affiliated to the Canadian Memorial Chiropractic College, concluded that the preponderance of evidence suggests that SMT in comparison to sham or other interventions does not enhance performance-based outcomes in asymptomatic adult population. All studies are exploratory with immediate effects. In the few studies suggesting a positive immediate effect, the importance of such change is uncertain. Further high-quality performance specific studies are required to confirm these preliminary findings.
I think, this says it (almost) all: yet another lucrative claim made by many chiropractors and osteopaths turns out to be not backed up by good evidence. The only thing worth adding is the fact that only 4 of the studies mentioned adverse effects. This means the vast majority of studies failed to comply with this basic requirement of research ethics – and this really says it all!
George Vithoulkas, has been mentioned on this blog repeatedly. He is a lay homeopath – one that has no medical background – and has, over the years, become an undisputed hero within the world of homeopathy. Yet, Vithoulkas’ contribution to homeopathy research is perilously close to zero. Judging from a recent article in which he outlines the rules of rigorous research, his understanding of research methodology is even closer to zero. Here is a crucial excerpt from this paper intercepted by a few comment from me in brackets and bold print.
Which are [the] homoeopathic principles to be respected [in clinical trials and meta-analyses]?
1. Homoeopathy does not treat diseases, but only diseased individuals. Therefore, every case may need a different remedy although the individuals may be suffering from the same pathology. This rule was violated by almost all the trials in most meta-analyses. (This statement is demonstrably false; there even has been a meta-analysis of 32 trials that respect this demand)
2. In the homoeopathic treatment of serious chronic pathology, if the remedy is correct usually a strong initial aggravation takes place [14–16]. Such an aggravation may last from a few hours to a few weeks and even then we may have a syndrome-shift and not the therapeutic results expected. If the measurements take place in the aggravation period, the outcome will be classified negative. (Homeopathic aggravations exist only in the mind of homeopaths; our systematic review failed to find proof for their existence.)
This factor was also ignored in most trials [10]. At least sufficient time should be given in the design of the trial, in order to account for the aggravation period. The contrary happened in a recent study [17], where the aggravation period was evaluated as a negative sign and the homoeopathic group was pronounced worse than the placebo [18]. (There are plenty of trials where the follow-up period is long enough to account for this [non-existing] phenomenon.)
3. In severe chronic conditions, the homoeopath may need to correctly prescribe a series of remedies before the improvement is apparent. Such a second or third prescription should take place only after evaluating the effects of the previous remedies [11]. Again, this rule has also been ignored in most studies. (Again, this is demonstrably wrong; there are many trials where the homeopath was able to adjust his/her prescription according to the clinical response of the patient.)
4. As the prognosis of a chronic condition and the length of time after which any amelioration set in may differ from one to another case [11], the treatment and the study-design respectively should take into consideration the length of time the disease was active and also the severity of the case. (This would mean that conditions that have a short history, like post-operative ileus, bruising after injury, common cold, etc. should respond well after merely a short treatment with homeopathics. As this is not so, Vithoulkas’ argument seems to be invalid.)
5. In our experience, Homeopathy has its best results in the beginning stages of chronic diseases, where it might be possible to prevent the further development of the chronic state and this is its most important contribution. Examples of pathologies to be included in such RCTs trials are ulcerative colitis, sinusitis, asthma, allergic conditions, eczema, gangrene rheumatoid arthritis as long as they are within the first six months of their appearance. (Why then is there a lack of evidence that any of the named conditions respond to homeopathy?)
In conclusion, three points should be taken into consideration relating to trials that attempt to evaluate the effectiveness of homoeopathy.
First, it is imperative that from the point of view of homoeopathy, the above-mentioned principles should be discussed with expert homoeopaths before researchers undertake the design of any homoeopathic protocol. (I am not aware of any trial where this was NOT done!)
Second, it would be helpful if medical journals invited more knowledgeable peer-reviewers who understand the principles of homoeopathy. (I am not aware of any trial where this was NOT done!)
Third, there is a need for at least one standardized protocol for clinical trials that will respect not only the state-of-the-art parameters from conventional medicine but also the homoeopathic principles [13]. (Any standardised protocol would be severely criticised; a good study protocol must always take account of the specific research question and therefore cannot be standardised.)
Fourth, experience so far has shown that the therapeutic results in homeopathy vary according to the expertise of the practitioner. Therefore, if the objective is to validate the homeopathic therapeutic modality, the organizers of the trial have to pick the best possible prescribers existing in the field. (I am not aware of any trial where this was NOT done!)
Only when these points are transposed and put into practice, the trials will be respected and accepted by both homoeopathic practitioners and conventional medicine and can be eligible for meta-analysis.
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I suspect what the ‘GREAT VITHOULKAS’ really wanted to express are ‘THE TWO ESSENTIAL PRINCIPLES OF HOMEOPATHY RESEARCH’:
- A well-designed study of homeopathy can always be recognised by its positive result.
- Any trial that fails to yield a positive finding is, by definition, wrongly designed.
A bibliometric or scientometric evaluation of the homeopathy literature has been published by a Turkish author (someone who I do not know and have never before heard of). He (of maybe she?) collected data from 4 electronic databases. All documents published between 1975 and 2017 were included. The keywords searched for in detail were “homeopathy“, “homeopathic”, “homoeopathy” and “homoeopathic”. He used Spearman’s correlation test to investigate a possible correlation between publication numbers or the productivity and features of the countries. We created infographics and infomaps by using GunnMap and VOSviewer sources. Gross domestic product (GDP) ranking data of countries was procured from The World Data Bank.
A total of 4183 articles were found. The great majority of documents were original articles (n = 3043, 72.75%). The UK dominated homeopathy literature with 950 articles followed by the USA, Germany, India and Brazil (n = 636, 590, 277 and 246 items, respectively). Switzerland was found to be most productive country (20.41) followed by the UK, Norway and Israel (14.35, 11.31 and 8.41, respectively). University of Exeter (UK) was the leading institution with 204 items (4.88%).
The most productive journal was ‘Homeopathy’ dominating which had published 24% of all the articles. A very high correlation was detected between publication number and citation number by year (r = 0.95, p < 0.001). A high correlation was also seen between gross domestic product (GDP) per capita and productivity of the countries. A moderate correlation was found between GDP and publication number of the countries (r = 0.66 and p < 0.001). In scientometric network analysis, the USA, the UK and Germany were noted to be three major association centres.
University of Exeter (UK) was the leading institution!
As far as I know, all homeopathy papers from Exeter are (co)authored by me …
… I must be the HOMEOPATHIC WORLD CHAMPION!
(Sorry guys)
A team from Israel conducted a pragmatic trial to evaluate the impact of So-called Alternative Medicine (SCAM) treatments on postoperative symptoms. Patients ≥ 18 years referred to SCAM treatments by surgical medical staff were allocated to standard of care with SCAM treatment (SCAM group) or without SCAM. Referral criteria were patient preference and practitioner availability. SCAM treatments included Acupuncture, Reflexology, or Guided Imagery. The primary outcome variable was the change from baseline in symptom severity, measured by Visual Analogue Scale (VAS).
A total of 1127 patients were enrolled, 916 undergoing 1214 SCAM treatments and 211 controls. Socio-demographic characteristics were similar in both groups. Patients in the SCAM group had more severe baseline symptoms. Symptom reduction was greater in the SCAM group compared with controls. No significant adverse events were reported with any of the CAM therapies.
The authors concluded that SCAM treatments provide additional relief to Standard Of Care (SOC) for perioperative symptoms. Larger randomized control trial studies with longer follow-ups are needed to confirm these benefits.
Imagine a situation where postoperative patients are being asked “do you want merely our standard care or do you prefer having a lot of extra care, fuss and attention? Few would opt for the former – perhaps just 211 out of a total of 1127, as in the trial above. Now imagine being one of those patients receiving a lot of extra care and attention; would you not feel better, and would your symptoms not improve faster?
I am sure you have long guessed where I am heading. The infamous A+B versus B design has been discussed often enough on this blog. Researchers using it can be certain that they will generate a positive result for their beloved SCAM – even if the SCAM itself is utterly ineffective. The extra care and attention plus the raised expectation will do the trick. If the researchers want to make extra sure that their bogus treatments come out of this study smelling of roses, they can – like our Israeli investigators – omit to randomise patients to the two groups and let them chose according to their preference.
To cut a long story short: this study had zero chance to yield a negative result.
- As such it was not a test but a promotion of SCAM.
- As such it was not science but pseudo science.
- As such it was not ethical but unethical.
WHEN WILL WE FINALLY STOP PUBLISHING SUCH MISLEADING NONSENSE?
Tian Jiu (TJ) therapy is a so-called alternative medicine (SCAM) that has been widely utilized in the management of allergic rhinitis (AR). TJ is also known as “drug moxibustion” or “vesiculating moxibustion.” Herbal patches are applied on the selected acupoints or the diseased body part. In TCM, this treatment is said to regulate the functions of meridians and zang-fu organs, warm the channels, disperse coldness, invigorate qi movement, harmonize nutrient absorption and defence mechanisms, and resolve stagnation in the body and stasis of the blood.
But does it work? This single-blinded, three-arm, randomized controlled study evaluated the efficacy of TJ therapy in AR. A total of 138 AR patients were enrolled. The TJ group and placebo group both received 4-weeks of treatment with either TJ or placebo patches for 2 hours. The patches were applied to Dazhui (GV 14), bilateral Feishu (UB 13), and bilateral Shenshu (UB 23) points. Patients received one session per week and then underwent a 4-week follow-up. The waitlist group received no treatment during the corresponding treatment period, but would be given compensatory TJ treatment in the next 4 weeks.
The primary outcome was the change of the Total Nasal Symptom Score (TNSS) after treatment. The secondary outcomes included the changes of Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) and rescue medication score (RMS).
After the treatment period, the total TNSS in TJ group was significantly reduced compared with baseline, but showed no statistical difference compared with placebo. Among the four domains of TNSS, the change of nasal obstruction exhibited statistical difference compared with placebo group. The total RQLQ score in TJ group was significantly reduced compared with both placebo and waitlist groups. The needs of rescue medications were not different between the two groups.
There were no serious adverse events. The common adverse events included flush, pruritus, blister, and pigmentation, occurring in 17, 23, 3, and 36 person-times among TJ group, and 3, 7, 1, and 4 person-times among placebo group, respectively. These adverse events were generally tolerated and disappeared quickly after removing the patches.
The authors (from the Hong Kong Chinese Medicine Clinical Study Centre, School of Chinese Medicine, Hong Kong Baptist University) concluded that this randomized, single-blinded, controlled trial served primary evidence of the efficacy and safety of TJ therapy on AR in Hong Kong. This pilot study provided a fundamental TJ protocol for future research. Through adjusting treatment timing, frequency, retention time, and even body response settings, it has the potential to develop into an optimal therapeutic method for future application.
The authors of this poorly written paper seem to ignore their own findings by concluding as they do. The fact is that the primary endpoint of this trial failed to show a significant difference between TJ and placebo. Moreover, TJ does have considerable adverse effects. Therefore, this study fails to demonstrate both the effectiveness and the safety of TJ as a treatment of AR.
PS
I often hesitate whether or not to discuss the plethora such frightfully incompetent research. The reason I sometimes do it is to alert the public to the fact that so much utter rubbish is published by incompetent researchers in trashy (but Medline-listed) journals, passed by incompetent ethics committees, supported by naïve funding agencies, accepted by reviewers and editors who evidently do not do their job properly. Do all these people have forgotten that they have a responsibility towards the public?
It is time to stop this nonsense!
It gives a bad name to science, misleads the public and inhibits progress.
I have become used to lamentably poor research in the realm of SCAM, particularly homeopathy. Thus, there is little that can amaze me these days; at least this is what I had thought. But this paper is an exception. The new trial is entitled ‘ETHICAL CLINICAL TRIAL OF LESSER KNOWN HOMEOPATHIC REMEDIES IN INFERTILITY IN FEMALES’, and it is truly outstanding. Here is the abstract:
Background & Objective: Homoeopathy with time honoured results, has a great number of cured cases of infertility, but without much evidence. So, it is imperative to show scientifically the scope of homoeopathy in treating infertility cases. Materials and Methodology: 7 lesser known medicines (Alteris farinosa, Janosia Ashoka, Viburnum opulus, Euphonium, Ustilago, Bacillus sycocuss, Bacillus morgan) were prescribed to the sample size (n=23), at the project site O.P.D/I.P.D. of Homoeopathy university, Saipura, Jaipur and Dr Madan Pratap Khunteta Homoeopathic Medical College, Hospital & Research Centre, Station Road, Jaipur & its extension O.P.D.’s. for study within 12 months. Result-In the present study 7 (30.43%) patients were prescribed Janosia Ashoka amongst whom 2(28.57%) showed marked improvement, while 5(71.43%) remained in the state of status quo. Conclusion- Study has shown encouraging and effective treatment in infertility in females.
It does not tell us much; therefore, let me copy several crucial passages from the paper itself:
Objectives of the study-
- To study the efficacy of homoeopathic medicines in the treatment of infertility in females.
- To enhance the knowledge of materia medica in cases of infertility in females.
Material and Methodology-
The study was conducted at O.P.D./I.P.D.of Homoeopathy University, Saipura, Sanganer and Dr M.P.K. Homoeopathic Medical College &Research Centre, Station Road, Jaipur from 2010 to 2013 for a total period of 3 Years. A sample size of n=23 and 7 lesser known remedies were selected for the studies.
Result-
Inferences- Based on clinical symptoms and pathological investigations. It was inferred that out of 23 patients taken for study, 2 (8.69%) patients showed marked improvement, while 21 (91.31%) patients remained in the state of status quo.
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No, I am not kidding you. There is no further relevant information about the trial methodology nor about the results. Therefore, I feel unable to even criticise this study; it is even too awful for a critique.
As I said: outstanding!
And all this could be quite funny – except, of course, some nutter will undoubtedly use this paper for claiming that there is evidence for homeopathy to efficiently treat female infertility.
You have to be a homeopath to call this an ethical trial!
So-called alternative medicine (SCAM) is a seriously dangerous option for cancer patients who aim at curing their cancer with it. One cannot warn patients often and strongly enough, I believe. But when it comes to supportive cancer treatment (care that does not aim at changing the natural history of the disease), SCAM might have a place. I said ‘might’ because its exact role is far from clear.
The aim of this study was to investigate the effects of a complex, nurse-led, supportive care intervention using SCAM on patients’ quality of life (QoL) and associated patient-reported outcomes. In this prospective, pragmatic, bicentric, randomized controlled trial, women with breast or gynaecologic cancers undergoing a new regimen of chemotherapy (CHT) were randomly assigned to routine supportive care plus intervention (intervention group, IG) or routine care alone (control group, CG). The intervention consisted of SCAM applications and counseling for symptom management, as well as SCAM information material. The primary endpoint was global QoL measured with the EORTC-QLQ-C30 before and after SCAM.
In total, 126 patients were randomly assigned into the IG and 125 patients into the CG. The patients’ medical and socio-demographic characteristics were homogenous at baseline and at follow-up. No group effects on QoL were found upon completion of CHT, but there was a significant group difference in favour of the IG, 6 months later. IG patients did also experience significant better emotional functioning and less fatigue.
The authors concluded that the tested supportive intervention did not improve patients’ QoL outcomes directly after CHT (T3), but was associated with significant QoL improvements when considering the change from baseline to the time point T4, which could be assessed 6 months after patients’ completion of CHT. This delayed effect may have resulted due to a strengthening of patients’ self-management competencies.
A prospective, pragmatic, bicentric, randomized controlled trial! Doesn’t this sound rigorous? In fact, this term merely hides a trial that was destined to generate a positive result. As it followed the infamous A+B versus B design, it hardly had a chance to not come out positive.
The only thing I find amazing is that the short-term results failed to be statistically significant. Far too many SCAM researchers, it seems to me, view science as a tool for promoting their dubious ideas.
The use of SCAM with the aim of improving QoL might be helpful. But this assumption cannot be accepted on the basis of opinion; we need good science to find out which forms of SCAM are worth employing. Sadly, studies like the above are not in this category.
If you ask me, it is high time that this misleading nonsensical and unethical pseudo-research stops!
Sophrology is big in France, but almost unknown in English-speaking countries.
What is it?
According to a recent article in ‘The Guardian‘, Sophrology is a system of mind and body, a little bit meditative, a little bit mindful, eastern principles of centredness and focus fed through a European system of rules that can feel just as exotic. It’s been around since the 50s, when a Spanish medical student, Alfonso Caycedo, had the task of administering electroshock treatment to mentally ill patients; sometimes, if that sounds barbaric, inducing insulin comas beforehand. He was an early asker of a question that medicine has confronted more widely since: why does consciousness have to be shaken so violently in order to heal? Implicitly having decided that maybe western medicine may not have all the answers, he concocted this improbable-sounding mix of Tibetan Buddhism, Japanese Zen and yoga, neurology, hypnosis, psychology, psychiatry and relaxation techniques to produce sophrology. It’s huge in Europe – especially in Spain – but it has also been prescribed by Swiss GPs and reportedly used by the French rugby team. It has never cracked the UK.
A bit vague?
Here is a different, perhaps more reliable source.
Sophrology is a non medication-based method which involves both the body and mind. It combines relaxing the muscles, increasing awareness of breathing and positive thinking, and leads to the search for improved well-being through the integration of the body percept. It generates a feeling of “letting go” and helps to relieve physical, psychological and spiritual suffering.
Is there any reliable evidence?
Very little, it seems.
This study (entitled ‘Efficiency of physiotherapy with Caycedian Sophrology on children with asthma: A randomized controlled trial’) aimed to assess whether in children with asthma, peak expiratory flow (PEF) improved more after a sophrology session alongside standard treatment than after standard treatment alone.
The researchers carried out a prospective randomized controlled clinical trial among 74 children aged 6-17 years old, hospitalized for an asthma attack. Group 1: conventional treatment (oxygen, corticosteroids, bronchodilators, physiotherapy) added to one session of sophrology. Group 2: conventional treatment alone. The primary outcome was the PEF variation between the initial and final evaluations (PEF2 -PEF1 ).
Demographic and clinical characteristics were similar in both groups at baseline. Measures before and after the sophrology session showed that the PEF increased by mean 30 L/min in the sophrology group versus 20 L/min in the control group (P = 0.02). Oxygen saturation increased by 1% versus 0% (P = 0.02) and the dyspnea score with visual analogue scale improved by two points point (P = 0.01). No differences were observed between the two groups in terms of duration of hospitalization, use and doses of conventional medical treatment (oxygen, corticosteroids, and bronchodilators), and quality of life scores.
The authors concluded that Sophrology appears as a promising adjuvant therapy to current guideline-based treatment for asthma in children.
The purpose of the only other study was to evaluate the efficiency of sophrology to improve conditions for the realization of non-invasive ventilation (NIV) in patients with acute respiratory failure (ARF). In this prospective randomized and controlled study, consecutive patients with ARF were included. From the very first NIV session, they received either sophrology during the first 30 min of NIV (S group), or standard care by the same nurse during 30 min (T group). The hemodynamic and ventilatory data were recorded continuously; pain, respiratory difficulty and discomfort were measured with a numeric scale at the end of the session.
Thirty patients were included in the study, 27 have been analysed. Each patient received an average of four sessions NIV during the protocol. There was no significant difference between the two groups in terms of improvement in gas exchange. In contrast, there was a significant difference in terms of reduction of difficulty in breathing (-76%), discomfort (-60%) and decrease the pain (-40%) in the sophrology group (p<0.001). Respiratory rate, heart rate and systolic arterial blood pressure were decrease during NIV.
The authors concluded that Sophrology constitutes aid for the achievement of the meetings of NIV in patients’ IRA.
As both studies followed the infamous A+B vs B design, they tell us nothing about the effectiveness of the treatment. This means that sophrology is a therapy that is totally unproven.
Why then is it so popular in France? Search me!
Does its popularity imply that it is effective? No.
The UK Reiki Federation (UKRF) is an independent organisation of individuals who have been attuned to Reiki, with the objective of providing support and guidance to Reiki professionals and to the public, with particular reference to education and training, and the public practice of Reiki. Some of their members give of their time each week to send Reiki healing to anyone who makes a request from anywhere in the world.
Each week the volunteers receive a list of those people/animals/events that have requested healing and they all collectively send positive Reiki healing to everyone on the list.
The UKRF claim that Reiki distant healing (RDH) has now been scientifically proven by Lynne McTaggart in these articles http://www.shareguide.com/McTaggart.html and https://lynnemctaggart.com/the-intention-experiment/ that healing is magnified when many healers are involved, so we are contributing an amazing vibration of positivity into our world and doing so much good, with so little effort. Imagine how brilliant it would be if even more members decided they too wanted to support other people, with minimum effort. It’s so simple just to place your hands on the list and send Reiki to everyone on it. It can be so quick if time is an issue for you and yet so powerful.
A group of UKRF members send Reiki to each other at specific times of the week. They state that we have a list of members’ names and allocated time slots in the week when we can send and receive Reiki energy to each other. The intention is to send Reiki for all the different time slots and then sit down and receive the energy whenever it is convenient for us to do so. Those members who have given me feedback all say they can feel the energy flowing during these times.
I urge you to look up the two ‘scientific proofs’ by McTaggart – I promise, you will not regret the effort. For those who might like to see real evidence for or against RDH, I ran a quick Medline search. Somewhat to my surprise, I did find a rigorous study RDH. Here is its abstract:
In this randomised, double-blinded study, women who underwent an elective C-section were allocated to either usual care (control, n=40) or three distant reiki sessions in addition to usual care (n=40). Pain was assessed using a visual analogue scale (VAS). The primary endpoint was the Area Under the VAS-Time Curve (AUC) for days 1-3. Secondary measures included: the proportion of women who required opioid medications and dose consumed, rate of healing and vital signs.
AUC for pain was not significantly different in the distant reiki and control groups (mean ± SD; 212.1 ± 104.7 vs 223.1 ± 117.8; p=0.96). There were no significant differences in opioid consumption or rate of healing; however, the distant reiki group had a significantly lower heart rate (74.3 ± 8.1 bpm vs 79.8 ± 7.9 bpm, p=0.003) and blood pressure (106.4 ± 9.7 mmHg vs 111.9 ± 11.0 mmHg, p=0.02) post surgery.
CONCLUSION: Distant reiki had no significant effect on pain following an elective C-section.
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This begs at least three questions, in my view:
- Which evidence should I trust, that of McTaggart or that from what seems to be the only RCT on RDH?
- The UK Reiki Foundation state on their website: As the largest Reiki-only professional organisation in the UK and Europe we are setting the highest standard for Reiki. Is the promotion of the McTaggart ‘proof’ combined with the omission from the UKRF site of the only trial of RDH truly in accordance with the highest standards?
- Is a professional organisation that does such things really professional?
