An intercessory prayer (IP) is an intervention characterized by one or more individuals praying for the well-being or a positive outcome of another person. There have been several trials of IP, but the evidence is far from clear-cut. Perhaps this new study will bring clarity?
The goal of this double-blind RCT was to assess the effects of intercessory prayer on psychological, spiritual and biological scores of breast 31 cancer patients who were undergoing radiotherapy (RT). The experimental group was prayed for, while the controla group received no such treatment. The intercessory prayer was performed by a group of six Christians, who prayed daily during 1 h while participant where under RT. The prayers asked for calm, peace, harmony and recovery of health and spiritual well-being of all participants. Data collection was performed in three time points (T0, T1 and T2).
Significant changes were noted in the intra-group analysis, concerning the decrease in spiritual distress score; negative religious/spiritual coping prevailed, while the total religious/spiritual coping increased between the posttest T2 to T0.
The authors concluded that begging a higher being for health recovery is a common practice among people, regardless of their spirituality and religiosity. In this study, this practice was performed through intercessory prayer, which promoted positive health effects, since spiritual distress and negative spiritual coping have reduced. Also, spiritual coping has increased, which means that participants facing difficult situations developed strategies to better cope and solve the problems. Given the results related to the use of intercession prayer, as a complementary therapeutic intervention, holistic nursing care should integrate this intervention, which is included in the Nursing Interventions Classification. Additionally, further evidence and research is needed about the effect of this nursing spiritual intervention in other cultures, in different clinical settings and with larger samples.
The write-up of this study is very poor and most confusing – so much so that I find it hard to make sense of the data provided. If I understand it correctly, the positive findings relate to changes within the experimental group. As RCTs are about compating one group to another, these changes are irrelevant. Therefore (and for several other methodological flaws as well), the conclusion that IP generates positive effects is not warranted by these new findings.
Like all other forms of paranormal healing, IP is implausible and lacks support of clinical effectiveness.
I have recently gone to the trouble of evaluating 150 different modalities from the realm of so-called alternative medicine (SCAM) in a book. This is what it tells you about Reiki:
Reiki 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.
- Reiki is based on the assumptions of Traditional Chinese Medicine and the existence of ‘chi’, the life-force that determines 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 the effectiveness of reiki. Unfortunately, their methodological quality is usually poor.
- A systematic review summarising this evidence concluded that the evidence is insufﬁcient to suggest that reiki is an effective treatment for any condition. Therefore, the value of reiki remains unproven. And a Cochrane review found that there is insufficient evidence to say whether or not Reiki is useful for people over 16 years of age with anxiety or depression or both.
- Reiki appears to be generally safe, and serious adverse effects have not been reported. Some practitioners advise caution about using reiki in people with psychiatric illnesses because of the risk of bringing out underlying psychopathology.
So, Reiki is both implausible and unproven. Now a new, large trial has emerged that might change this verdict. The main purpose of this study (published in JCAM) was to measure the effect of a single session of Reiki on physical and psychological health in a large nonclinical sample.
The study design was a single arm effectiveness trial with measures at pre-and postintervention. The study took place at private Reiki practices across the United States. Reiki practitioners were recruited from an online mailing list to participate in the study with their Reiki clients. A total of 99 Reiki practitioners met the inclusion criteria and participated in the study. Reiki practitioners were instructed to give a flyer to each of their Reiki clients that contained information about the study and invited the client to complete a survey before and after their Reiki session.
Trained and certified Reiki Masters conducted the Reiki sessions in person, with each session lasting between 45 and 90 min. The 20-item Positive and Negative Affect Schedule was used to assess affect, and brief, single-item self-report measures were used to assess a wide range of physical and psychological variables immediately before (pre) and after (post) the Reiki session.
A total of N = 1411 Reiki sessions were conducted and included in the analysis. Statistically significant improvements were observed for all outcome measures, including positive affect, negative affect, pain, drowsiness, tiredness, nausea, appetite, shortness of breath, anxiety, depression, and overall well-being (all p-values <0.001).
The authors concluded that the results from this large-scale multisite effectiveness trial suggest that a single session of Reiki improves multiple variables related to physical and psychological health.
This ‘large scale’ effectiveness trial’ could make you laugh and cry at the same time.
- Laugh, because it is almost comically daft.
- Cry, because the conclusion is bound to mislead a lot of gullible people.
Without a control group, the study cannot even attempt to determine anything like the effectiveness of Reiki. What the results truly show is that consumers who consult (and pay) a Reiki master expect to have a positive effect. The expectation translates into a sizable placebo response. The investigators seem to be clueless scientists, or they wilfully mislead the public (the senior author is from the ‘The Center for Reiki Research‘ which, according to its mission statement, is dedicated to gaining acceptance for the practice of Reiki by the medical community).
The only conclusion that can honestly be drawn from the data is that consumers who pay for a serivce often like this service (otherwise they would not use it!). It’s a bit like the thing with the hamburger joint that I often cite: if you ask people eating in a McDonalds whether they enjoy hamburgers, most will answer in the affirmative.
But there might be a valuable lesson in this paper after all: never trust the JACM further than you can throw it.
Burning mouth syndrome (BMS) is a rare but potentially debilitating condition. So far, individualised homeopathy (iHOM) has not been evaluated or reported in any peer-reviewed journal as a treatment option. Here is a recently published case-report of iHOM for BMS.
At the Centre of Complementary Medicine in Bern, Switzerland, a 38-year-old patient with BMS and various co-morbidities was treated with iHOM between July 2014 and August 2018. The treatment involved prescription of individually selected homeopathic single remedies. During follow-up visits, outcome was assessed with two validated questionnaires concerning patient-reported outcomes. To assess whether the documented changes were likely to be associated with the homeopathic intervention, an assessment using the modified Naranjo criteria was performed.
Over an observation period of 4 years, an increasingly beneficial result from iHOM was noted for oral dysaesthesia and pains as well as for the concomitant symptoms.
The authors concluded that considering the multi-factorial aetiology of BMS, a therapeutic approach such as iHOM that integrates the totality of symptoms and complaints of a patient might be of value in cases where an association of psychological factors and the neuralgic complaints is likely.
BMS can have many causes. Some of the possible underlying conditions that can cause BMS include:
- hormonal imbalances
- acid reflux
- infections in the mouth
- various medications
- nutritional deficiencies in iron or zinc
Threatemnt of BMS consists of identifying and eliminating the underlying cause. If no cause of BMS can be found, we speak of primary BMS. This condition can be difficult to treat; the following approaches to reduce the severity of the symptoms are being recommended:
- avoiding acidic or spicy foods
- reducing stress
- avoiding any other known food triggers
- exercising regularly
- changing toothpaste
- avoiding mouthwashes containing alcohol
- sucking on ice chips
- avoiding alcohol if it triggers symptoms
- drinking cool liquids throughout the day
- smoking cessation
- eating a balanced diet
- checking medications for potential triggers
The authors of the above case-report state that no efficient treatment of BMS is known. This does not seem to be entirely true. They also seem to think that iHOM benefitted their patient (the post hoc ergo propter hoc fallacy!). This too is more than doubtful. The natural history of BMS is such that, even if no effective therapy can be found, the condition often disappears after weeks or months.
The authors of the above case-report treated their patient for about 4 years. The devil’s advocate might assume that not only did iHOM contribute nothing to the patient’s improvement, but that it had a detrimental effect on BMS. The data provided are in full agreement with the notion that, without iHOM, the patient would have been symptom-free much quicker.
The use of so-called alternative medicine (SCAM) are claimed to be associated with preventive health behaviors. However, the role of SCAM use in patients’ health behaviors remains unclear.
This survey aimed to determine the extent to which patients report that SCAM use motivates them to make changes to their health behaviours. For this purpose, a secondary analysis of the 2012 National Health Interview Survey data was undertaken. It involved 10,201 SCAM users living in the US who identified up to three SCAM therapies most important to their health. Analyses assessed the extent to which participants reported that their SCAM use motivated positive health behaviour changes, specifically: eating healthier, eating more organic foods, cutting back/stopping drinking alcohol, cutting back/quitting smoking cigarettes, and/or exercising more regularly.
Overall, 45.4% of SCAM users reported being motivated by SCAM to make positive health behaviour changes, including exercising more regularly (34.9%), eating healthier (31.4%), eating more organic foods (17.2%), reducing/stopping smoking (16.6% of smokers), or reducing/stopping drinking alcohol (8.7% of drinkers). Individual SCAM therapies motivated positive health behaviour changes in 22% (massage) to 81% (special diets) of users. People were more likely to report being motivated to change health behaviours if they were:
- aged 18-64 compared to those aged over 65 years;
- of female gender;
- not in a relationship;
- of Hispanic or Black ethnicity, compared to White;
- reporting at least college education, compared to people with less than high school education;
- without health insurance.
The authors concluded that a sizeable proportion of respondents were motivated by their SCAM use to undertake health behavior changes. CAM practices and practitioners could help improve patients’ health behavior and have potentially significant implications for public health and preventive medicine initiatives; this warrants further research attention.
This seems like an interesting finding! SCAM might be ineffective, but it motivates people to lead a healthier life. Thus SCAM has something to show for itself after all.
Except, there is another explanation of the results, one that might be much more plausible.
What if some consumers, particularly females who are well-educated and have no health insurance, one day decide that it’s time to do something for their health. Thus they initiate several things:
- they start using SCAM;
- they exercise more regularly;
- they eat more healthily;
- they consume organic food;
- they stop smoking;
- they stop boozing.
The motivation common to all these changes is their determination to do something about their health. Contrary to the authors’ wishful thinking, SCAM has little or even nothing to do with it. The notion was induced by SCAM practitioners who like to think that they play a role in disease prevention, by the leading questions of the interviewer, by recall bias, or by other factors..
What did the wise man say once upon a time?
CORRELATION IS NOT CAUSATION!
Some people seem to think that all so-called alternative medicine (SCAM) is ineffective, harmful or both. And some believe that I am hell-bent to make sure that this message gets out there. I recommend that these guys read my latest book or this 2008 article (sadly now out-dated) and find those (admittedly few) SCAMs that demonstrably generate more good than harm.
The truth, as far as this blog is concerned, is that I am constantly on the lookout to review research that shows or suggests that a therapy is effective or a diagnostic technique is valid (if you see such a paper that is sound and new, please let me know). And yesterday, I have been lucky:
This paper has just been presented at the ESC Congress in Paris.
Its authors are: A Pandey (1), N Huq (1), M Chapman (1), A Fongang (1), P Poirier (2)
(1) Cambridge Cardiac Care Centre – Cambridge – Canada
(2) Université Laval, Faculté de Pharmacie – Laval – Canada
Here is the abstract in full:
Yes, this study was small, too small to draw far-reaching conclusions. And no, we don’t know what precisely ‘yoga’ entailed (we need to wait for the full publication to get this information plus all the other details needed to evaluate the study properly). Yet, this is surely promising: yoga has few adverse effects, is liked by many consumers, and could potentially help millions to reduce their cardiovascular risk. What is more, there is at least some encouraging previous evidence.
But what I like most about this abstract is the fact that the authors are sufficiently cautious in their conclusions and even state ‘if these results are validated…’
SCAM-researchers, please take note!
An abstract from the recent ‘2nd OFFICIAL SIPS CONFERENCE ON PLACEBO STUDIES’ caught my attention. It is not available on-line; therefore let me reproduce it here in full:
The role of placebo effects in mindfulness-based analgesia 1. Jonathan Davies. University of Sydney, Sydney, NSW, Australia. 2. Louise Sharpe. University of Sydney, Sydney, NSW, Australia. 3. Melissa Day. University of Queensland, Brisbane, QLD, Australia. 4. Ben Colagiuri. University of Sydney, Sydney, NSW, Australia.
Background: Mindfulness meditation can reduce pain both in experimental and clinical settings, though it is not known to what extent mindfulness-specific vs placebo-like expectancy effects account for these changes. This study aimed to: 1. establish whether placebo effects contribute to mindfulness-mediated analgesia; and 2. identify putative cognitive mechanisms responsible for placebo- vs mindfulness-mediated analgesia. Methods: We compared the effects of focussed-attention mindfulness training (6 x 20 min), sham mindfulness, and a no-treatment in a double-blind RCT for experimental heat pain. Sham mindfulness instructions lacked the ‘active ingredients’ of the real training but were matched on all other contextual factors. Results: Both real and sham mindfulness training led to greater pain tolerance relative to no treatment, but there was no difference between the real and sham training. This was accompanied by increased expectancy, beliefs, and pain-related cognitive processes in the two mindfulness groups relative to no treatment, but again there were no differences between real and sham training on these outcomes. There were no effects on pain intensity, pleasantness or threshold. Conclusion: These findings suggest that mindfulness training – at least those involving focused-attention – may lead to improved pain tolerance via the placebo effect rather than any specific mindfulness-related mechanisms. Potential mediators of these effects will be discussed.
I find this study remarkable in two ways:
- It shows that, with a bit of fantasy, ingenuity and will, one can design and use sham procedures even in clinical trials of mind/body therapies.
- Its results suggest that, if one does control for placebo effects, these treatments may not prove to be more than a placebo therapy.
What implications might this have for clinical practice?
Mindfulness is currently hugely popular. It would not be surprising, if the news that it might rely purely on placebo effects would calm down the enthusiasm about this treatment. Many might ask, does it matter? As long as patients benefit, the mechanism of action seems irrelevant. This, of course, is an interesting debate which we have had on this blog many times before.
What do you think?
The Society of Homeopaths (SoH) is the professional organisation of UK lay homeopaths (those with no medical training). The SoH has recently published a membership survey. Here are some of its findings:
- 89% of all respondents are female,
- 70% are between the ages of 35 and 64.
- 91% of respondents are currently in practice.
- 87% are RSHoms.
- The majority has been in practice for an average of 11 – 15 years.
- 64% identified their main place of work as their home.
- 51% work within a multidisciplinary clinic.
- 43% work in a beauty clinic.
- 85% oﬀer either telephone or video call consultations.
- Just under 50% see 5 or fewer patients each week.
- 38% are satisfied with the number of patients they are seeing.
- 80% felt conﬁdent or very conﬁdent about their future.
- 65% feel supported by the SoH.
Because this truly homeopathic survey is based on exactly 132 responses which equates to 14% of all SoH members.
If, however, we were able to conclude anything at all, it would be that the amateur researchers at the SoH cause Hahnemann to turn in his grave. Offering telephone/video consultations and working in a beauty salon would probably have annoyed the old man. But what would have definitely made him jump with fury in his Paris grave is a stupid survey like this one.
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 . 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 , where the aggravation period was evaluated as a negative sign and the homoeopathic group was pronounced worse than the placebo . (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 . 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 , 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 . (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.
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 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?
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.
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.
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.
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!