causation
What is it about Reiki that fascinates me?
It must be the exemplary poor science that its proponents use trying to convince us that it is valid.
This randomized controlled trial investigated the effect of Reiki on pain, functional status, and holistic well-being in patients with knee osteoarthritis (OA). The sample consisted of 42 patients.
- The control group received standardized treatment only.
- The intervention group received face-to-face Reiki (nine positions; 39 minutes) and distance Reiki on two consecutive days in addition to standardized treatment in addition to standard treatment.
The results show that the Reiki group had lower pain scores than the control group as measured by the Visual Analog Scale (p < .001) and the Western Ontario and McMaster Universities Arthritis Index pain score (p < .001). Those participating in the Reiki group had improved holistic well-being scores specifically for the subscales of Sadness, Perception of Sadness, Spiritual Disruption, Cognitive Awareness, and General mood.
The authors concluded that Reiki is a safe, noninvasive, and cost-effective alternative treatment technique that has the potential to reduce symptoms of pain and improve holistic well-being in patients with knee OA.
So many falsehoods in one sentence!
Is this a new record?
Let’s analyse these conclusions a little, shall we?
- Reiki is safe: this does not follow from the data because the sample was far too small for assessing rare safety issues, safety was not measured, and half of the Reiki group might have dropped dead a week after the study.
- Reiki is non-invasive: that might be true.
- Reiki is cost-effective: cost-effectiveness was not an endpoint; the statement is thus not supported by the data.
- Reiki reduces the symptoms of pain and improve holistic well-being in patients with knee OA: I disagree! The observed outcomes are much more likely caused by the considerable amount of extra attention and treatment time given to the Reiki group, and the results were entirely unrelated to any specific effects of the therapy.
So, I feel the need for re-phrasing the conclusions as follows:
Reiki is an implausible treatment and the outcomes of this study are unrelated to any alleged specific effects of this therapy.
International guidelines have recommended cognitive behavioural therapy, including acceptance and commitment therapy (ACT), as it offers validated benefits for managing fibromyalgia; however, it is inaccessible to most patients. This study aimed to evaluate the effect of a 12-week, self-guided, smartphone-delivered digital ACT programme on fibromyalgia management.
In the PROSPER-FM randomised clinical trial conducted at 25 US community sites, adult participants aged 22–75 years with fibromyalgia were recruited and randomly assigned (1:1) to the digital ACT group or an active control group that offered daily symptom tracking and monitoring and access to health-related and fibromyalgia-related educational materials. Randomisation was done with a web-based system in permuted blocks of four at the site level. We used a blind-to-hypothesis approach in which participants were informed they would be randomly assigned to one of two potentially effective therapies under evaluation. Research staff were not masked to group allocation, with the exception of a masked statistics group while preparing statistical programming for the interim analysis. The primary endpoint was patient global impression of change (PGIC) response rate at week 12. Analyses were by intention to treat. The trial was registered with ClinicalTrials.gov, NCT05243511 (now fully closed).
Between Feb 8, 2022, and Feb 2, 2023, 590 individuals were screened, of whom 275 (257 women and 18 men) were randomly assigned to the digital ACT group (n=140) and the active control group (n=135). At 12 weeks, 99 (71%) of 140 ACT participants reported improvement on PGIC versus 30 (22%) of 135 active control participants, corresponding to a difference in proportions of 48·4% (95% CI 37·9–58·9; p<0·0001). No device-related safety events were reported.
The authors concluded that digital ACT was safe and efficacious compared with digital symptom tracking in managing fibromyalgia in adult patients.
___________________
These conclusions might well be valid – but then again, they might not!
Here is why I have my doubts:
- The patients treated with digital ACT knew that they were getting a novel and thus exciting treatment.
- The patients randomised to the control group, on the other hand, would most likely be disappointed not to receive this therapy. In other words, there were high expectations in the experimental group and disappointment in the control group.
- In addition, the unmasked researchers would have had the ambition that their innovation would be successful. Thus they would have used verbal and non-verbal communications with the ACT patients to bring about the desired result.
It is therefore conceivable – I think even likely – that these factors would add up to generate a false-positive finding, particularly since the endpoint was entirely subjective.
In view of all this, I am surprised that a journal like THE LANCET has published such a flimsy study with such a over-optimistic conclusion, and I suggest re-phrasing the conclusions as follows:
Digital ACT seemed safe and effective compared with digital symptom tracking in managing fibromyalgia in adult patients. However, due to the design of the study, it is possible that digital ACT is entirely ineffective and the positive outcome is caused by a number of context effects.
To accuse anyone of an abuse of science is a hefty charge, I know. In the case of proponents of so-called alternative medicine (SCAM) doing science, it is, however, often justified. Let me explain this by using the example of chiropractors (I could have chosen homeopathy, faith heaalers, acupuncturists or almost any other type of SCAM professional, but in recent times it was the chiros who provided the clearest examples of abuse).
Science can be seen as a set of tools that is used to estabish the truth. In therapeutics, science is employed foremost to answer three questions:
- Is the therapy plausible?
- Is the therapy effective?
- Is the therapy safe?
The way to answer them is to falsify the underlying hypotheses, i.e. to demonstrate that:
- The therapy is not plausible.
- The therapy is not effective.
- The therapy is not safe.
Only if rigorous attempts at falsifying these hypotheses have falied can we conclude that:
- The therapy is plausible.
- The therapy is effective.
- The therapy is safe.
I know, this is rather elementary stuff. It is taught during the first lessons of any decent science course. Yet, proponents of SCAM are either not being properly taught or they are immune to even the most basic facts about science. On this blog, we regularly have the opportunity to observe exactly that when we read and are bewildered by the comments made by SCAM proponents. This is often clearest in the case of chiropractors.
- They cherry-pick the evidence to persuade us that their hallmark intervention, spinal manipulation, is plausible.
- They cherry-pick the evidence to persuade us that their hallmark intervention, spinal manipulation, is effective.
- They cherry-pick the evidence to persuade us that their hallmark intervention, spinal manipulation, is safe.
If they conduct research, they set up their investigations in such a way that they confirm their beliefs:
- Spinal manipulations are plausible.
- Spinal manipulations are effective.
- Spinal manipulations are safe.
In other words, they do not try to falsify hypotheses, but they do their very best to confirm them. And this, I am afraid, is nothing other than an abuse of science.
QED
And how can the average consumer (who may not always be in a position to realize whether a study is reliable or not) tell when such abuse of science is occurring? How can he or she decide who to trust and who not?
A simplest but sadly not fool-proof advice might consist in 2 main points:
- Never rely on a single study.
- Check whether there is a discrepancy in the results and views of SCAM proponents and independent experts; e.g.:
- Chiropractors claim one thing, while independent scientists disagree or are unconvinced.
- Homeopath claim one thing, while independent scientists disagree or are unconvinced.
- Acupuncturists claim one thing, while independent scientists disagree or are unconvinced.
- Energy healers claim one thing, while independent scientists disagree or are unconvinced.
- Naturopaths claim one thing, while independent scientists disagree or are unconvinced.
- Etc., etc.
In all of those cases, your alarm bells should ring and it might be wise to be cautious and avoid the treatment in question.
This review was aimed at quantifying the proportion attributable to contextual effects of physical therapy interventions for musculoskeletal pain. Randomized placebo-controlled trials evaluating the effect of physical therapy interventions on musculoskeletal pain.
Risk of bias was evaluated using the Cochrane risk-of-bias tool for randomized trials (ROB 2.0). The proportion of physical therapy interventions effect that is explained by contextual effects was calculated, and a quantitative summary of the data from the studies was conducted using the random-effects inverse-variance model (Hartung-Knapp-Sidik-Jonkman method).
Sixty-eight studies were included in the systematic review (total number of participants: n=5,238), and 54 placebo-controlled trials informed our meta-analysis (participants: n=3,793). Physical therapy interventions included:
- soft tissue techniques,
- mobilization,
- manipulation,
- taping,
- exercise therapy,
- dry needling.
Placebo interventions included manual, non-manual interventions, or both.
The results show the following:
- The type of treatment with the largest proportion not attributable to the specific effects (PCE) for pain intensity assessed immediately after the intervention was mobilization, which represented 87% of the overall treatment effect (PCE = 0.87, 95% CI: 0.54, 1.19).
- For soft tissue techniques, the PCE was 81% of the overall treatment effect (PCE = 0.81, 95% CI: 0.64, 0.97).
- For dry needling, the PCE was 75% (PCE = 0.75, 95% CI: 0.36, 1.15).
- For manipulation techniques the PCE was 74% (PCE = 0.74, 95% CI: 0.33, 1.14).
- For taping the PCE was 69% of the overall treatment effect (PCE = 0.69, 95% CI: 0.48, 0.89).
- The smallest proportion not attributable to the specific intervention itself for pain intensity was exercise therapy accounting for 46% of the overall treatment effect (PCE = 0.46, 95% CI: 0.41, 0.52).
The authors concluded that the outcomes of physical therapy interventions for musculoskeletal pain were significantly influenced by contextual effects. Boosting contextual effects consciously to enhance therapeutic outcomes represents an ethical opportunity that could benefit patients.
This sounds as though most of the treatments in question rely mainly on placebo effects. But what about conventional therapies? The authors point out that the PCEs of general medicine and surgery in pain-related conditions are also large. In particular, the overall proportion not attributable to the specific effects of general medicine interventions is high (PCE = 65%), with higher values observed in semi-objective and objective outcomes (PCE = 78 and 94%, respectively) than in subjective outcomes (PCE = 50%).
What does that mean for healthcare routine?
As placebo and other context effects are unreliable, usually short-lived, and not normally affecting the cause of the problem (but merely the symptoms), I would say that those treatments with a very high PCE are of limited value, paticularly if they are also expensive or burdened with risks. Of the treatments studied here, I would – based on the current analysis – avoid the following therapies for pain management:
- mobilization,
- soft tissue techniques,
- dry needling,
- manipulation,
- taping.
By and large, these are also the conclusions drawn from various other strands of evidence that we have repeatedly discussed in previous posts.
This retrospective cohort study investigated the effect of reflexology on immunological parameters of people living with HIV (PLWH). All patients who received at least one reflexology treatment were included and compared with the group of PLWH who were not treated with reflexology. Measured parameters included CD4 count, CD4%, CD8 count, CD8%, CD4/CD8 ratio, and HIV viral load (VL). Changes in these parameters before and after the treatment were compared with changes in two consecutive measurements in the control group.
In total, 74 patients who received reflexology treatments were matched by age and sex to 144 controls. There was a male predominance of 86% in both groups. Patients in the control group were slightly older, with a median age of 45 versus 43 in the treatment group (p = 0.022). The median baseline CD4 count (730 vs. 795, p = 0.187) and CD8 count (890 vs. 832, p = 0.32) did not differ between the groups. Baseline CD4% tended to be lower in the treatment group (34% vs. 36%, p = 0.058), CD8% was higher in the treatment group (40% vs. 38%, p = 0.03), and the
CD4/CD8 ratio was lower in the treatment group (0.8 vs. 1, p = 0.002).
After therapy, there was a significantly higher increase in CD4, CD4%, and CD4/CD8 in the treatment group (p = 0.006, 0.0004, <0.001, respectively), whereas CD8% decreased significantly and CD8 tended to decrease in the treatment group (p < 0.001, 0.054, respectively).
The authors concluded that reflexology showed a positive impact on the immunological parameters of PLWH.
Who on earth conceives such a study?
Who funds such offensive rubbish?
Who publishes it?
We may well ask these questions, because the paper is pure nonsense!
The authors are very clear about their conviction that the observed differences were caused by the reflexology treatment. They don’t even discuss other options. Yet, there are several plausible explanations that have nothing to do with reflexology.
The patients in the control group originate from the hospital’s register from the time before reflexology had been introduced in the standard care package. Thus these patients differ in numerous ways from those of the experimental group. To name just one possibility, these patients were treated at a time when the treatment of PLWH was less sophicticated and thus had worse outcomes.
The two patient groups are clearly not comparable! This is also shown by the data published in the paper. So why compare them?
The only sensible conclusion of this paper is in my view:
In an effort to prove that their SCAM works, enthusiasts without research expertise often go to great lengths. As a result they mislead us all and do a great disservice to science and medicine.
Post-COVID-19 fatigue is becoming increasingly common as the pandemic evolves. Plenty of so-called alternative medicines (SCAMs) are on offer, including homeopathy. But is homeopathy really helpful?
This trial attempted to identify the preliminary evidence of the efficacy of individualized homeopathic medicines (IHMs) against placebos in the treatment of post-COVID-19 fatigue in adults.
A 3-month, single-blind, randomized, placebo-controlled, parallel-arm trial was conducted at the outpatient department of The Calcutta Homoeopathic Medical College and Hospital, India. Sixty participants were randomized in a 1:1 ratio to receive either IHMs (n = 30) or identical-looking placebos (n = 30). The primary and secondary outcome measures were the Fatigue Assessment Scale (FAS) and Outcome in Relation to Impact on Daily Living (ORIDL), respectively, measured every month, for up to 3 months. Comparative analysis was carried out on the intention-to-treat sample to detect group differences.
Group differences in both the primary (FAS total: F1, 58 = 14.356, p < 0.001) and secondary outcomes (ORIDL: F1, 58 = 210.986, p < 0.001) after 3 months favored IHMs against placebos. Lycopodium clavatum (11.7%), sulfur (11.7%), Arsenicum album (10%), and Thuja occidentalis (10%) were the most frequently indicated medicines. No harm, unintended effects, homeopathic aggravations, or any serious adverse events were reported from either of the groups.
The authors concluded that IHMs produced significantly better effects than placebos in the treatment of post-COVID-19 fatigue in adults. Definitive robust trials may be undertaken to confirm the findings.
A glance at the authors’ affiliations is, I think, revealing:
- 1Department of Organon of Medicine and Homeopathic Philosophy, D. N. De Homoeopathic Medical College and Hospital, Kolkata, India.
- 2Department of Pathology and Microbiology, The Calcutta Homoeopathic Medical College and Hospital, Kolkata, India.
- 3The Calcutta Homoeopathic Medical College and Hospital, Kolkata, India.
- 4Department of Practice of Medicine, The Calcutta Homoeopathic Medical College and Hospital, Kolkata, India.
- 5Department of Repertory, D. N. De Homoeopathic Medical College and Hospital, Kolkata, India.
We are currently being bombarded with false-positive homeopathy trials from India. Why am I sure that the trial is false-positive? Well, I am not sure, of course. But I have suspicions:
- Homeopathy is not a plausible form of SCAM.
- The most reliable studies fail to show that is is more than a placebo.
- The journal that published this paper is 3rd class; if the findings were valid, they would get published in one of the top science journals.
- The authors were clearly biased and even admitted as much; they stated that they wanted “to identify the preliminary evidence of the efficacy” of IHM. But this is not how unbiased researcher conduct clinical trials. Such investigations are for testing hypotheses and not for identifying effects.
- Most importantly, the trial design is flawed. Even the authors realize this, and the 1st sentence of the conclusions should therefore have been far less definitive.
And what are the main flaws?
As far as I can see they were:
- The sample size was to small for a far-reaching conclusion.
- The study was not double blind. In other words the therapists had the opportunity to exert their influence on the patient to produce the desired outcome. Occam’s Razor demands that we assume this to be the real explanation of the positive effects observed here.
In view of all this, I suggest to change the conclusions as follows:
IHMs produced significantly better effects than placebos in the treatment of post-COVID-19 fatigue in adults which most likely is not due to the efficacy of the treatment applied but to the residual bias not controlled for in this study.
The objective of this paper was to review the 10 most recent case reports of cervical spine manipulation and cervical artery dissection for convincing evidence of the causation of cervical artery dissection by cervical spine manipulation. The author, Steven P. Brown, a chiropractor (who is quoted as “the authors have declared that no competing interests exist”), lists the following 10 cases:
Case 1: Yeung et al. (2023) [17]
Yeung et al. [17] reported that a “48-year-old female went to a chiropractor for chronic neck pain and developed right-sided weakness, nausea, dizziness, and vomiting immediately after neck manipulation.” Imaging showed occlusion of the V1 segment of the right vertebral artery and cerebellar stroke.
The adverse event immediately following cervical spine manipulation (CSM) was the cerebellar stroke, not the cerebral artery dissection (CAD). Right-sided weakness, nausea, dizziness, and vomiting are symptoms of cerebellar ischemia, not right VAD. The neck pain prior to the CSM is consistent with a CAD being present prior to CSM, not caused by CSM.
Even if CSM had caused the CAD, it is not biologically possible for a thrombus large enough to occlude the vertebral artery to form immediately [6]. Therefore, the CAD was likely pre-existing to CSM. While an existing thrombus may have been aggravated by the CSM, it was not caused by the CSM. In this case, it is plausible that CSM may have suddenly repositioned an already large thrombus in such a way that it blocked the V1 segment of the right vertebral artery, resulting in thrombotic ischemic stroke from vascular occlusion [26]. The practitioner failed to exclude CAD and performed CSM when it was contraindicated [7]. So, while thrombotic stroke may have been causally related to the CSM, the CAD was not.
Cases 2 and 3: Chen et al. (2022) [18]
Chen et al. [18] reported that “a 51-year-old man with a history of mild hypertension noted new-onset right neck pain two days following chiropractic manipulation.” Imaging revealed dissection of the C3 segment of the right ICA and right-sided stroke.
Chen et al. [18] also reported a second case in which “a 55-year-old man with a history of cigarette smoking, no other cerebrovascular risk factors, received chiropractic cervical manipulation 1 day prior to presentation to the emergency department with new onset of left hemiparesis, facial paralysis, right neck pain, and dysarthria lasting for 5 hours.” Imaging revealed dissection of the C3 segment of the right ICA and right-sided cerebral stroke.
In these two case reports, the symptoms that prompted the patients to seek CSM were not documented. In the first case, neck pain started two days after CSM. In the second case, neck pain started 19 hours after CSM.
In these two cases, there was no adverse event immediately following CSM. As there was no neck pain, headache, or ischemic symptoms noted immediately after CSM, it is not likely that CSM caused the ICA dissection or the stroke. Furthermore, the C3 segment of the ICA is intracranial and has not been identified as an area for strain by CSM.
Case 4: Arning et al. (2022) [19]
Arning et al. [19] reported the case of a 47-year-old female with a two-week history of non-traumatic right neck pain who had increased, severe right neck pain immediately after CSM, and paresis of the right deltoid muscle and hypalgesia in the right C3 and right C4 dermatomes. MRI revealed a dissection of the V2 segment of the right vertebral artery.
The adverse event immediately following CSM was a stroke, not a CAD. Paresis and hypalgesia are symptoms of brain ischemia, not right VAD. The right neck pain prior to the CSM is consistent with a right VAD being present prior to CSM, not caused by CSM.
Prior to CSM, cervical spine disc herniation had been ruled out by MRI. Upon review, the pre-CSM MRI also showed dissection of the right V2 segment, which had initially been overlooked by the radiologist. The practitioner performed CSM when it was contraindicated. Therefore, while the CSM may have caused the ischemic stroke by a thromboembolic mechanism, the CSM did not cause the CAD.
Case 5: Abidoye et al. (2022) [20]
Abidoye et al. [20] reported, “This is a 40-year-old male with a medical history of migraine headaches and cervicalgia, evaluated for a sudden onset of headache, associated with nausea, vomiting, blurred vision, and dizziness, two months after a chiropractic manipulation. He also reported rigorous exercise and sexual intercourse prior to the headache onset. Vital sign is significant for a 10/10, non-radiating right-sided headache. Neurological examination revealed right ptosis and miosis. Labs were unremarkable. CTA of neck showed tapering of the right ICA with near occlusion at the skull base.” No imaging evidence or diagnosis of stroke was documented. However, with ischemic symptoms of nausea, vomiting, blurred vision, dizziness, right ptosis, and right miosis, it is likely that this patient suffered a stroke.
In this case, there was no adverse event immediately following CSM, and the most recent CSM was two months prior to the onset of symptoms. As there was no neck pain, headache, or ischemic symptoms noted immediately after CSM, it is not likely that CSM caused the ICA dissection or the stroke.
The patient’s medical history of neck pain and headaches are risk factors for CAD. If there was existing right ICA dissection, it is plausible that rigorous exercise and sexual intercourse could have dislodged a loosely adherent ICA thrombus and caused immediate stroke by a thromboembolic mechanism. However, this is not possible to determine as the temporality from exercise and intercourse to ischemic symptoms of stroke was vaguely documented as “prior to.”
Case 6: Yap et al. (2021) [21]
Yap et al. [21] reported a 35-year-old male who presented with a two-day history of expressive dysphasia and a one-day history of right-sided weakness. The patient reported having CSM for pain relief sometime in the prior two weeks. Imaging showed left ICA dissection and left middle cerebral artery stroke. The dissected segment of the left ICA was not documented.
In this case, there was no adverse event immediately following CSM. As there was no neck pain, headache, or ischemic symptoms noted immediately after CSM, it is not likely that CSM caused the ICA dissection or the stroke.
Case 7: Xia et al. (2021) [22]
Xia et al. [22] reported a case of a 44-year-old male with chronic neck pain who reported sudden-onset left homonymous hemianopia after CSM a few days prior. The patient reported progression from a left homonymous hemianopia to a left homonymous inferior quadrantanopia. Imaging revealed bilateral VAD at the left V2 and right V3 segments, and right medial occipital lobe stroke. The authors noted that a right posterior communicating artery stroke was likely embolic from the right V3 and left V2 dissections. They also noted that the patient likely had a migrating embolus as evidenced by the progression from a homonymous hemianopia to a quadrantanopia.
The adverse event immediately following CSM was the stroke, not the CAD. Left homonymous hemianopia is a symptom of brain ischemia, not VAD. The neck pain prior to the CSM is consistent with VAD being present prior to CSM, not caused by CSM.
Even if CSM had caused the CAD, it is not biologically possible for a thrombus to instantly form and dislodge to cause sudden-onset thromboembolic stroke [6]. Therefore, the CAD was likely pre-existing to CSM. While an existing thrombus may have been aggravated by the CSM, it was not caused by the CSM. In this case, it is possible that CSM dislodged a loosely adherent vertebral artery thrombus to cause thromboembolic stroke [26]. The practitioner failed to exclude CAD and performed CSM when it was contraindicated [7]. So, while thromboembolic stroke may have been causally related to the CSM, the CAD was not.
Case 8: Lindsay et al. (2021) [23]
Lindsay et al. [23] reported a case of a 47-year-old male who presented with left neck pain and headache. His medical history was notable for dyslipidemia and a cerebellar stroke six years prior. Imaging revealed dissections of the left vertebral artery extending from the origin of the artery to the V3 segment. The patient also had a dissection of his right renal artery. There was no evidence of a stroke.
Six years prior, the patient had presented with a one-week history of left neck pain and headache, as well as left facial numbness and dizziness. The pain was not relieved with ibuprofen and previously been evaluated and treated by a chiropractor. Imaging done six years prior showed no evidence of CAD but did show a left cerebellar stroke.
There is no plausible biological mechanism by which CSM six years prior could cause a current VAD. Therefore, it is not likely that there was a causal relationship between CSM and CAD in this case.
Ultimately, the patient was diagnosed with vascular Ehlers-Danlos syndrome, a disorder that causes connective tissue weakness and makes a patient susceptible to arterial dissection. This diagnosis is consistent with the left VAD and right renal artery dissection.
Case 9: Monari et al. (2021) [24]
Monari et al. [24] reported a case of a 39-year-old pregnant female with a history of tension headaches presenting with vertigo, vomiting, nystagmus, dizziness, and hindrance in the execution of fine movements of the right arm. The patient reported having CSM by an osteopathic specialist “in the days preceding the beginning of the symptoms.” Imaging showed a dissection of the V2 segment of the right vertebral artery and a right-sided stroke.
In this case, there was no adverse event immediately following CSM. As there was no neck pain, headache, or ischemic symptoms noted immediately after CSM, it is not likely that CSM caused the right vertebral artery dissection or the stroke. Medical history of headache prior to the CSM is consistent with a VAD being present prior to CSM, not caused by CSM. Pregnancy is also a risk factor for CAD.
Case 10: Ramos et al. (2021) [25]
Ramos et al. [25] reported a case of a 48-year-old female with a history of chronic neck pain who experienced sudden neck pain and generalized weakness during CSM. Imaging showed bilateral VAD and occlusion and bilateral acute cerebellar stroke. There was also tetraplegia noted at the C5 sensory level, C5 and C6 vertebral fracture, spinal cord injury, epidural hematoma, and acute disc herniation.
There is convincing evidence that CSM caused CAD and stroke in this case. This case is exceptional as the CSM was contraindicated by pre-existing cervical spine pathology. Cervical spine bony ankylosis was noted which existed prior to the CSM. The CSM appears to have been a posterior-anterior manipulation of the cervical spine at the level of C5-C6, which was contraindicated due to the presence of the bony ankylosis [27].
The practitioner failed to exclude cervical spine pathology and performed CSM when it was contraindicated. The spinal pathology in this case could have been diagnosed with a cervical spine X-ray examination.
As the Ramos et al. [25] study provided limited case information, a case report from Macêdo et al. [28] provides additional information on this exceptional case.
“A 47-year-old Afro-Brazilian woman with long-standing back pain sought chiropractic care for symptomatic relief. Until then, she had never consulted a doctor to treat her axial pain and was not aware of having any specific spinal pathology. Since childhood, she had a moderate cognitive deficit, which probably compromised her ability to adequately describe the pain and, thus, led the family to seek medical advice. During her last session of spinal manipulation, she mentioned new-onset paresthesia beginning on the upper limbs and progressing to the lower limbs. Her complaint was disregarded, and the session continued, at the end of which she was unable to stand. Urinary retention ensued a little after. The patient was referred to our service only a week after, completely bedridden. Spine MRI revealed a transdiscal fracture at C5-C6, resulting in critical stenosis and compressive myelopathy. CT angiography revealed traumatic thrombosis of the vertebral arteries emerging on this level. Whole spine-imaging evidenced multiple syndesmophytes giving a characteristic bamboo spine appearance, as well as ankylosis in sacroiliac joints, uncovering the diagnosis of ankylosing spondylitis. She underwent laminectomy from C2 to C6 and arthrodesis from C2 to T2 for spine stabilization but did not recover mobility. Even though a systematic review did not find an increased risk of significant adverse events related to spine manipulation therapy, there have been descriptions of vertebral fracture following a session on patients with ankylosing spondylitis and unsuspected multiple myeloma.”
The author concluded that nine out of the 10 case reports of CSM and CAD did not provide convincing evidence of the causal relationship between CSM and CAD. Only one case report provided convincing evidence of a causal relationship between CAD and CSM. This case was exceptional as the CSM was contraindicated by pre-existing cervical spine pathology. Therefore, we conclude that practitioners of CSM should exclude cervical spine pathology before performing CSM.
I must say that I find it difficult or even impossible to follow most of the arguments of Mr Brown. Do they teach them a different kind of physiology and pathophysiology in chiro-school? Foremost, he seems to think that case-reports can/should establish cause and effect. Do they teach research methodology at all in chiro-school?
Here is what Wiki tells us, for instance:
In medicine, a case report is a detailed report of the symptoms, signs, diagnosis, treatment, and follow-up of an individual patient. Case reports may contain a demographic profile of the patient, but usually describe an unusual or novel occurrence. Some case reports also contain a literature review of other reported cases. Case reports are professional narratives that provide feedback on clinical practice guidelines and offer a framework for early signals of effectiveness, adverse events, and cost.
So, case reports “offer a framework for early signals of adverse events”. To expect that they demonstrate a causal link is ill-informed. Their significance in relation to risks lies mostly in providing a signal, particularly if the signal becomes loud and clear due to numerous repetitions, as is the case in chiropractic manipulations. Once the signal is noted, it needs further investigation to determine its nature. In the absence of conclusive further studies, a signal that has emerged hundreds of times, as in chiropractic, it has to be taken seriously. In fact, the precautionary principle demands that we then assume causality until proven otherwise.
As to the research effort of Mr Brown in assembling 10 case reports, I must say it is frightfully daft for the following reasons:
- Most cases do probably not get connected to a CSM at all.
- Many lead to litigation and are not published.
- In the end, very few get published in the medical literature.
- Being retrospective, they all lack important detail and are thus incomplete.
- None prove causation and only some render it likely.
- A sample size of 10 is laughable.
- Brown’s desire to white-wash chiropractic is plapable.
- So is his naivety.
This study tested the efficacy and safety of individualized homeopathic medicines (IHMs) in treating hemorrhoids compared with placebo. The double-blind, randomized (1:1), two parallel arms, placebo-controlled trial was conducted at the surgery outpatient department of the State National Homoeopathic Medical College and Hospital, Lucknow, Uttar Pradesh, India.
Patients were 140 women and men, aged between 18 and 65 years, with a diagnosis of primary hemorrhoids grades I-III for at least 3 months. Excluded were the patients with grade IV hemorrhoids, anal fissure, and fistula, hypertrophic anal papillae, inflammatory bowel disease, coagulation disorders, rectal malignancies, obstructed portal circulation, patients requiring immediate surgical intervention, and vulnerable samples.
Patients were randomized to Group 1 (n = 70; IHMs plus concomitant care; verum) and Group 2 (n = 70; placebos plus concomitant care; control). Primary-the anorectal symptom severity and quality-of-life (ARSSQoL) questionnaire, and secondary-the EuroQol 5-dimensions 5-levels (EQ-5D-5L) questionnaire and EQ visual analogue scale (VAS); all of them were measured at baseline, and every month, up to 3 months.
Out of the 140 randomized patients, 122 were protocol compliant. Intention-to-treat sample (n = 140) was analyzed. The level of significance was set at p < 0.05 two tailed. Statistically significant between-group differences were elicited in the ARSSQoL total (Mann-Whitney U [MWU]: 1227.0, p < 0.001) and EQ-5D-5L VAS (MWU: 1228.0, p = 0.001) favoring homeopathy against placebos. Sulfur was the most frequently prescribed medicine. No harm or serious adverse events were reported from either of the groups.
The authors concluded that IHMs demonstrated superior results over placebo in the short-term treatment of hemorrhoids of grades I-III. The findings are promising, but need to be substantiated by further phase 3 trials.
Yes, I know: it is not easy to keep a straight face when reading such a paper. And the task is not made easier when considering the affiliations of its authors:
- 1East Bishnupur State Homoeopathic Dispensary, Chandi Daulatabad Block Primary Health Centre, Under Department of Health & Family Welfare, Government of West Bengal, India, South 24 Parganas, India.
- 2Department of Organon of Medicine and Homoeopathic Philosophy, State National Homoeopathic Medical College and Hospital, Lucknow, India.
- 3Department of AYUSH, Government of Uttar Pradesh, Lucknow, India.
- 4State National Homoeopathic Medical College and Hospital, Lucknow, India.
- 5Department of Materia Medica, State National Homoeopathic Medical College and Hospital, Lucknow, India.
- 6Department of Pathology & Microbiology, D. N. De Homoeopathic Medical College & Hospital, Government of West Bengal, Kolkata, India.
- 7Department of Pathology & Microbiology, Mahesh Bhattacharyya Homoeopathic Medical College & Hospital, Government of West Bengal, Howrah, India.
- 8Department of Repertory, D. N. De Homoeopathic Medical College and Hospital, Kolkata, India.
Let’s nevertheless ask three serious questions:
- According to classical homeopathy, for a cure, one needs a remedy that, when given to a healthy volunteer, causes the symptom one wants to treat. So, does sulfur etc.cause the symptoms of hemorrhoids?
- According to classical homeopathy, the remedy is supposed to cure the condition, not alleviate the symptoms. Is that what the results show?
- Is it plausible that homeopathy can have any effects on hemorrhoids?
I am confident that the answers are: no, no and no.
And this leads me to ask my final question: do we believe these findings?
I let you answer this one!
An article in ‘METRO’ caught my eye – not least because it quotes me. Here are a few edited excerpts:
Peter Stott lost his first wife to cancer in 1998. Her death, he believes, was due to geopathic stress (GS) – harmful energies that originate from the Earth. ‘I found out that the house where we had lived had a serious GS problem,’ he says. The discovery prompted him to become a professional ‘dowser’, devoting his life to finding and managing geopathic stress.
But what exactly is this mysterious force erupting from the surface of the Earth – and can it really harm people?Geopathic stress is said to cause discomfort and health issues for certain individuals. These energies, also called ‘harmful Earth rays’ by believers, can be detrimental, beneficial or neutral according to those who think they are ‘in the know’.
The word ‘geopathic’ is derived from the Greek words ‘Geo’ meaning the Earth and ‘pathos’, meaning disease or suffering – hence the term pathogens, the medical terms for bugs that make us ill.
Dowsing, practitioners say, is a method used to detect the presence of various subtle Earth energies and assess their nature and quality. They argue that some of these energies can be linked to geomagnetic anomalies caused by flowing underground water, dry faults and fissures, subterranean cavities, or mineral and crystal deposits.
Dowsing is carried out by a dowser, practitioners who try to find the source of these energies using special tools, such as pendulums, rods, and bobbers – essentially sexed-up tree branches. The person holds the tool, waiting for it to move or react, which they take as a sign that they’ve found what they’re looking for. The odd practice can allegedly also be used to identify leaks, stress fractures, environmental pollutants, electromagnetic fields, nutritional deficiencies, black spots, and, rather oddly, sexing pigeons.
Peter claims that a skilled dowser effectively advises on the optimal placement of buildings and structures to mitigate the impact of geopathic stress, and often possesses the ability to reduce or eliminate it through the use of various methods. He emphasises the fact that GS ‘does not affect everybody in the same way. Cancer has been described as “a disease of location”,’ he says. ‘And if there is a family history of cancer – as there was in my late wife’s case – a person can be more susceptible to GS being a contributing factor in succumbing to the disease.’ Peter believes that GS impacts our immune system, depleting its resources and hindering its ability to function optimally. By eliminating GS from our surroundings, we allow our immune system to operate more efficiently, he contends. Our susceptibility to GS varies, he says, with some experiencing mild symptoms like sleep disturbances and fatigue, while others may face more severe health issues such as arthritis, multiple sclerosis and cancer.
In 2017, rather incredibly, a report revealed that 10 out of 12 water companies in the UK were employing the practice of water dowsing to identify and locate leaks. Even more incredibly, last year, it emerged that Thames Water and Severn Trent Water were still using this form of ‘witchcraft’ for leak detection, despite scientific research indicating its lack of efficacy.
But water companies aren’t the only ones turning to dowsers for help. Peter believes that ‘it is also possible to carry a token or amulet on your person that has been imbued with the powers of protection by someone who is proficient in [dowsing]’. ‘This can protect you from GS and other detrimental energies wherever you go anywhere throughout the world,’ he claims. ‘Other protection techniques can also offer a degree of protection.’
However, Dr Edzard Ernst, a man who has dedicated years of his life to examining questionable, science-based claims, won’t be enlisting the services of a GS specialist or house healer anytime soon. ‘Geopathic stress cannot cause health problems for the simple reason that it does not exist,’ says the retired physician. ‘It is a sly invention of quacks who exploit gullible consumers. The methods to diagnose GS are as bogus as the ones that allegedly treat it. But the quacks don’t mind – as long as the consumer pays.’
Peter fully acknowledges ‘that dowsing and this work in general is not a catch-all solution for every ailment or every person’s situation’. ‘However, often we are approached by people who are “at the end of their tether” due to their exasperation of experiencing events or circumstances in their lives that are not well catered for in the mainstream wellbeing sector,’ he says. ‘I can only speak personally, I cannot speak for the possibly tens of thousands of dowsers around the world. If our work can help ease a person’s experience of life then that is a good enough reason to continue to help where I can’. He adds that ‘we are never going to change the minds of people like Dr Edzard Ernst’, someone ‘who seems to focus exclusively on debunking anything for which there is not a scientific explanation’. Moreover, science, he notes, ‘is moving on with research done into quantum physics and the theory that everything in the universe is connected and is also accessible to everyone’.
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Oh, dear Peter!
Perhaps you should learn the difference between critical evaluation and debunking (this ‘debunker’ has shown more forms of so-called alternative medicine (SCAM) to be worthy of integrating into the NHS than anyone else).
Perhaps you should read up about the difference between evidence and belief?
And perhaps the chapter on dowsing in my book could help you in this endeavour:
Dowsing is a common but unproven method for divining water and other materials. In alternative medicine, it is sometimes used as a technique for diagnosing diseases or the causes of health problems.
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- Dowsers employ a motor automatism, amplified through a pendulum, divining rod or similar device. The effect is that the device seemingly provides an independent, visible reaction, while the dowser is, in fact, its true cause.
- Dowsing is used by some homeopaths as an aid to prescribe the optimal remedy and as a tool for identify a miasm or toxin load.
- The assumptions upon which dowsing is based lack plausibility.
- Dowsing has not often been submitted to clinical trials.
- All rigorous attempts to test water dowsing have failed, and it is no longer considered a viable method for this purpose.
- The only randomized double-blind trial that has tested whether homeopaths are able to distinguish between a homeopathic remedy and placebo by dowsing failed to show that it is a valid method. Its authors (well-known homeopaths) drew the following conclusion: “These results, wholly negative, add to doubts whether dowsing in this context can yield objective information.”[1]
- If dowsing is employed for differentiating between truly effective treatments (rather than homeopathic remedies), the risk of false choices would be intolerably high, and serious harm would inevitably be the result.
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This review aimed to assess the therapeutic efficacy of Reiki therapy in alleviating anxiety.
In adherence to academic standards, a thorough search was conducted across esteemed databases such as PubMed, Web of Science, Science Direct, and the Cochrane Library. The primary objective of this search was to pinpoint peer-reviewed articles published in English that satisfied specific criteria: (1) employing an experimental or quasi-experimental study design, (2) incorporating Reiki therapy as the independent variable, (3) encompassing diverse patient populations along with healthy individuals, and (4) assessing anxiety as the measured outcome.
The study involved 824 participants, all of whom were aged 18 years or older. Reiki therapy was found to have a significant effect on anxiety intervention(SMD=-0.82, 95CI -1.29∼-0.36, P = 0.001). Subgroup analysis indicated that the types of subjects (chronically ill individuals and the general adult population) and the dosage/frequency of the intervention (≤ 3 sessions and 6–8 sessions) were significant factors influencing the variability in anxiety reduction.
The authors concluded that short-term Reiki therapy interventions of ≤ 3 sessions and 6–8 sessions have demonstrated effectiveness in reducing health and procedural anxiety in patients with chronic conditions such as gastrointestinal endoscopy inflammation, fibromyalgia, and depression, as well as in the general population. It is important to note that the efficacy of Reiki therapy in decreasing preoperative anxiety and death-related anxiety in preoperative patients and cancer patients is somewhat less consistent. These discrepancies may be attributed to individual pathophysiological states, psychological conditions, and treatment expectations.
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This is a truly stunning finding considering that few treatments are less plausible that Reiki. I strongly suspect that these conclusions are not tenable. To see whether this is true, we must look at the primary studies (tedious, I know, but can’t be helped). Here are the abstracts of the 13 studies included in this review:
Purpose: The purpose of the study was to investigate changes in the anxiety levels of patients receiving preoperative Reiki.
Material and methods: This study used a quasi-experimental model with a pretest-posttest control group.
Methods: Subjects (n = 210) were recruited from a hospital in Turkey, from June 2013 to July 2014. Subjects were then assigned to experimental (n = 105) and control (n = 105) groups.
Results: The level of anxiety of experimental group patients did not change according to their state anxiety scores (p > 0.10); however, the anxiety level of control group patients increased (p < 0.001).
Conclusion: The results of this study imply that the administration of Reiki is effective in controlling preoperative anxiety levels and in preventing them from increasing.
I am not sure what is meant by “a quasi-experimental model with pretest- posttest control group”. Yet, I suspect this was not a properly randomised trial and should thus have been exclused from the review. There was no control of placebo effects.
Fatigue is an extremely common side effect experienced during cancer treatment and recovery. Limited research has investigated strategies stemming from complementary and alternative medicine to reduce cancer-related fatigue. This research examined the effects of Reiki, a type of energy touch therapy, on fatigue, pain, anxiety, and overall quality of life. This study was a counterbalanced crossover trial of 2 conditions: (1) in the Reiki condition, participants received Reiki for 5 consecutive daily sessions, followed by a 1-week washout monitoring period of no treatments, then 2 additional Reiki sessions, and finally 2 weeks of no treatments, and (2) in the rest condition, participants rested for approximately 1 hour each day for 5 consecutive days, followed by a 1-week washout monitoring period of no scheduled resting and an additional week of no treatments. In both conditions, participants completed questionnaires investigating cancer-related fatigue (Functional Assessment of Cancer Therapy Fatigue subscale [FACT-F]) and overall quality of life (Functional Assessment of Cancer Therapy, General Version [FACT-G]) before and after all Reiki or resting sessions. They also completed a visual analog scale (Edmonton Symptom Assessment System [ESAS]) assessing daily tiredness, pain, and anxiety before and after each session of Reiki or rest. Sixteen patients (13 women) participated in the trial: 8 were randomized to each order of conditions (Reiki then rest; rest then Reiki). They were screened for fatigue on the ESAS tiredness item, and those scoring greater than 3 on the 0 to 10 scale were eligible for the study. They were diagnosed with a variety of cancers, most commonly colorectal (62.5%) cancer, and had a median age of 59 years. Fatigue on the FACT-F decreased within the Reiki condition (P=.05) over the course of all 7 treatments. In addition, participants in the Reiki condition experienced significant improvements in quality of life (FACT-G) compared to those in the resting condition (P <.05). On daily assessments (ESAS) in the Reiki condition, presession 1 versus postsession 5 scores indicated significant decreases in tiredness (P <.001), pain (P <.005), and anxiety (P<.01), which were not seen in the resting condition. Future research should further investigate the impact of Reiki using more highly controlled designs that include a sham Reiki condition and larger sample sizes.
This was a pilot study which should not report efficacy outcomes merely test the feasibility of a definitive trial. There was no control of placebo effects.
Purpose: This study’s aim is to determine the effect of Reiki when applied before upper gastrointestinal endoscopy on levels of anxiety, stress, and comfort.
Design: This single-blind, a pretest and post-test design, randomized, sham-controlled study was held between February and July 2021.
Methods: Patients who met the inclusion criteria were separated by randomization into three groups: Reiki, sham Reiki, and control. A total of 159 patients participated in the study. In the intervention groups (Reiki and sham Reiki), Reiki and sham Reiki were applied once for approximately 20 to 25 minutes before gastrointestinal endoscopy.
Findings: When the Reiki group was compared to the sham Reiki and control groups following the intervention, the decrease in the levels of patient stress (P < .001) and anxiety (P < .001) and the increase in patient comfort (P < .001) were found to be statistically significant.
Conclusions: Reiki applied to patients before upper gastrointestinal endoscopy was effective in reducing stress and anxiety and in increasing comfort.
Here an attempt was made to control for placebo effects and to blind patients. Whether the latter was successful was not tested. Thus a placebo effects cannot be excluded.
The purpose of this study was to evaluate the effect of Reiki as an alternative and complementary approach to treating community-dwelling older adults who experience pain, depression, and/or anxiety. Participants (N = 20) were randomly assigned to either an experimental or wait list control group. The pre- and posttest measures included the Hamilton Anxiety Scale, Geriatric Depression Scale-Short Form, Faces Pain Scale, and heart rate and blood pressure. The research design included an experimental component to examine changes in these measures and a descriptive component (semi-structured interview) to elicit information about the experience of having Reiki treatments. Significant differences were observed between the experimental and treatment groups on measures of pain, depression, and anxiety; no changes in heart rate and blood pressure were noted. Content analysis of treatment notes and interviews revealed five broad categories of responses: Relaxation; Improved Physical Symptoms, Mood, and Well-Being; Curiosity and a Desire to Learn More; Enhanced Self-Care; and Sensory and Cognitive Responses to Reiki.
No attempt to control for placebo effects.
Purpose: The purpose of this randomized pilot was to determine feasibility of testing Reiki, a complementary therapy intervention, for women undergoing breast biopsy (BB).
Background: Increasingly women face the possibility of BB, the definitive test for breast cancer. Psychological distress associated with BB includes anxiety and depression. Reiki was proposed as an intervention to decrease anxiety and promote relaxation.
Method: Thirty-two women scheduled for BB were randomized to Reiki intervention versus conventional care control. Anxiety and depression were evaluated using self-report questionnaires.
Findings: Analysis found no significant mean differences between groups over time. Comparably low baseline anxiety levels (possible selection bias) decreased naturally with time allowing little room for observing treatment effect.
Conclusions: Reiki, when administered in the naturalistic setting of a complementary therapy office, did not suggest evidence of efficacy. An intervention offered within the bounds of the conventional care setting may be more feasible for addressing BB distress.
The study failed to produce a positive finding.
The aim of this study was to investigate the effect of Reiki on pain, anxiety, and hemodynamic parameters on postoperative days 1 and 2 in patients who had undergone cesarean delivery. The design of this study was a randomized, controlled clinical trial. The study took place between February and July 2011 in the Obstetrical Unit at Odemis Public Hospital in Izmir, Turkey. Ninety patients equalized by age and number of births were randomly assigned to either a Reiki group or a control group (a rest without treatment). Treatment applied to both groups in the first 24 and 48 hours after delivery for a total of 30 minutes to 10 identified regions of the body for 3 minutes each. Reiki was applied for 2 days once a day (in the first 24 and 48 hours) within 4-8 hours of the administration of standard analgesic, which was administered intravenously by a nurse. A visual analog scale and the State Anxiety Inventory were used to measure pain and anxiety. Hemodynamic parameters, including blood pressure (systolic and diastolic), pulse and breathing rates, and analgesic requirements also were recorded. Statistically significant differences in pain intensity (p = .000), anxiety value (p = .000), and breathing rate (p = .000) measured over time were found between the two groups. There was a statistically significant difference between the two groups in the time (p = .000) and number (p = .000) of analgesics needed after Reiki application and a rest without treatment. Results showed that Reiki application reduced the intensity of pain, the value of anxiety, and the breathing rate, as well as the need for and number of analgesics. However, it did not affect blood pressure or pulse rate. Reiki application as a nursing intervention is recommended as a pain and anxiety-relieving method in women after cesarean delivery.
No control for placebo effects.
Objective: to evaluate the effectiveness of massage and reiki in the reduction of stress and anxiety in clients at the Institute for Integrated and Oriental Therapy in Sao Paulo (Brazil).
Method: clinical tests randomly done in parallel with an initial sample of 122 people divided into three groups: Massage + Rest (G1), Massage + Reiki (G2) and a Control group without intervention (G3). The Stress Systems list and the Trace State Anxiety Inventory were used to evaluate the groups at the start and after 8 sessions (1 month), during 2015.
Results: there were statistical differences (p = 0.000) according to the ANOVA (Analysis of Variance) for the stress amongst the groups 2 and 3 (p = 0.014) with a 33% reductions and a Cohen of 0.78. In relation to anxiety-state, there was a reduction in the intervention groups compared with the control group (p < 0.01) with a 21% reduction in group 2 (Cohen of 1.18) and a 16% reduction for group 1 (Cohen of 1.14).
Conclusion: Massage + Reiki produced better results amongst the groups and the conclusion is for further studies to be done with the use of a placebo group to evaluate the impact of the technique separate from other techniques.
No control for placebo effects.
This randomized controlled study aimed to determine the effect of Reiki and aromatherapy on vital signs, oxygen saturation, and anxiety level in patients undergoing upper gastrointestinal endoscopy. The sample consisted of 100 patients divided into Reiki (n = 34), aromatherapy (n = 33), and control (n = 33) groups. Data were collected 3 times (before, during, and after the procedure) using a descriptive characteristics questionnaire, a follow-up form, and the State Anxiety Subscale. The Reiki group had a mean State Anxiety Subscale score of 53.59 ± 2.98 and 43.94 ± 4.31 before and after the procedure, respectively. The aromatherapy group had a mean State Anxiety Subscale score of 54.03 ± 4.03 and 43.85 ± 3.91 before and after the procedure, respectively. The control group had a mean State Anxiety Subscale score of 38.79 ± 4.68 and 53.30 ± 7.26 before and after the procedure, respectively (P < .05). The results showed that the Reiki and aromatherapy groups had significantly lower State Anxiety Subscale scores than the control group after the procedure, indicating that Reiki and aromatherapy help reduce anxiety levels. There was a significant difference in the mean respiratory rates and oxygen saturation levels between the groups (P < .05). In conclusion, patients who do Reiki or undergo aromatherapy are less likely to experience anxiety before upper gastrointestinal endoscopy.
No control for placebo effects.
The aim of this study is to investigate the effects of Reiki application on pain, anxiety, and quality of life in patients with fibromyalgia. The study was completed with a total of 50 patients: 25 in the experimental group and 25 in the control group. Reiki was applied to the experimental group and sham Reiki to the control group once a week for 4 weeks. Data were collected from the participants using the Information Form, Visual Analog Scale, McGill-Melzack Pain Questionnaire, State-Trait Anxiety Inventory, and Short Form-36. There was a significant difference between the mean Visual Analog Scale pain scores during and before the first week (P = .012), second week (P = .002), and fourth week (P = .020) measurements of the individuals in the experimental and control groups, after application. In addition, at the end of the 4-week period, the State Anxiety Inventory (P = .005) and the Trait Anxiety Inventory (P = .003) were significantly decreased in the Reiki group compared with the control group. Physical function (P = .000), energy (P = .009), mental health (P = .018), and pain (P = .029) subdimension scores of quality of life in the Reiki group increased significantly compared with the control group. Reiki application to patients with fibromyalgia may have positive effects on reducing pain, improving quality of life, and reducing state and trait anxiety levels.
Here an attempt was made to control for placebo effects and to blind patients. Whether the latter was successful was not tested. Thus a placebo effects cannot be excluded. The sample size was small.
Background: Reiki is a biofield therapy which is based on the explanatory model that the fields of energy and information of living systems can be influenced to promote relaxation and stimulate a healing response.
Objective: To conduct a pragmatic within-subject pilot trial of a remote Reiki program for frontline healthcare workers’ health-related symptoms during the COVID-19 pandemic.
Methods: Healthcare professionals in the UK (eg, physicians, nurses, and paramedics) were eligible to sign up for a distance Reiki program and were also invited to participate in the research study. Eight Reiki practitioners simultaneously gave each participant Reiki remotely for 20 minutes on 4 consecutive days. Feasibility of the research was assessed, including recruitment, data completeness, acceptability and intervention fidelity, and preliminary evaluation of changes in outcome measures. Participants’ stress, anxiety, pain, wellbeing, and sleep quality were evaluated with 7-point numerical rating scales. Measures were completed when signing up to receive Reiki (pre) and following the final Reiki session (post). Pre and post data were analyzed using Wilcoxon signed ranks tests.
Results: Seventy-nine healthcare professionals signed up to receive Reiki and took the baseline measures. Of those, 40 completed post-measures after the 4-day intervention and were therefore included in the pre-post analysis. Most participants were female (97.5%), and the mean age was 43.9 years old (standard deviations = 11.2). The study was feasible to conduct, with satisfactory recruitment, data completeness, acceptability, and fidelity. Wilcoxon signed ranks tests revealed statistically significant decreases in stress (M = -2.33; P < .001), anxiety (M = -2.79; P < .001) and pain (M = -.79; P < .001), and significant increases in wellbeing (M = -1.79; P < .001) and sleep quality (M = -1.33; P = .019).
Conclusions: The Reiki program was feasible and was associated with decreased stress, anxiety and pain, and increased wellbeing and sleep quality in frontline healthcare workers impacted by the COVID-19 pandemic.
Pilot study should not report efficacy findings and should be excluded.
Background: There is a scarcity of studies in the international literature regarding alternative treatment to the pharmacological and psychotherapeutic intervention in the face of depression symptoms. This study aimed to test a protocol based on natural therapy, alternatives to pharmacological and psychotherapeutic, through Mindfulness Meditation, Reiki, Acupuncture and Auriculotherapy, to treat the symptoms of depression for those who were with no pharmacological or psychotherapeutic treatment for these symptoms.
Methods: this is a randomized single-blind controlled pilot study. The final sample was 21 participants divided in two groups: experimental and control. Participants were evaluated by validated instruments during the screening process and after the intervention. The instruments were: Depression, Anxiety and Stress Scale and Beck Depression Inventory. Intervention was performed in eight sessions, during two months. All the techniques were used in the experimental group. Analysis of variance with repeated measures was used to compare pre-intervention to post-intervention moments.
Results: the result of analysis indicates a significant reduction in the symptoms of depression after the intervention among the experimental group.
Limitations: there is no way to determine which of the techniques used produced the most significant result.
Conclusions: The protocol proposed in this study was effective in reducing the symptoms of depression to whom are not eligible for traditional treatment.
This is a pilot study and should not report efficacy findings. It is also not a study of just Reiki. It should have been excluded.
This is a constructive replication of a previous trial conducted by Bowden et al. (2010), where students who had received Reiki demonstrated greater health and mood benefits than those who received no Reiki. The current study examined impact on anxiety/depression. 40 university students-half with high depression and/or anxiety and half with low depression and/or anxiety-were randomly assigned to receive Reiki or to a non-Reiki control group. Participants experienced six 30-minute sessions over a period of two to eight weeks, where they were blind to whether noncontact Reiki was administered as their attention was absorbed in a guided relaxation. The efficacy of the intervention was assessed pre-post intervention and at five-week follow-up by self-report measures of mood, illness symptoms, and sleep. The participants with high anxiety and/or depression who received Reiki showed a progressive improvement in overall mood, which was significantly better at five-week follow-up, while no change was seen in the controls. While the Reiki group did not demonstrate the comparatively greater reduction in symptoms of illness seen in our earlier study, the findings of both studies suggest that Reiki may benefit mood.
No control for placebo effects
This is a constructive replication of a previous trial conducted by Bowden et al. (2010), where students who had received Reiki demonstrated greater health and mood benefits than those who received no Reiki. The current study examined impact on anxiety/depression. 40 university students-half with high depression and/or anxiety and half with low depression and/or anxiety-were randomly assigned to receive Reiki or to a non-Reiki control group. Participants experienced six 30-minute sessions over a period of two to eight weeks, where they were blind to whether noncontact Reiki was administered as their attention was absorbed in a guided relaxation. The efficacy of the intervention was assessed pre-post intervention and at five-week follow-up by self-report measures of mood, illness symptoms, and sleep. The participants with high anxiety and/or depression who received Reiki showed a progressive improvement in overall mood, which was significantly better at five-week follow-up, while no change was seen in the controls. While the Reiki group did not demonstrate the comparatively greater reduction in symptoms of illness seen in our earlier study, the findings of both studies suggest that Reiki may benefit mood.
This is the only rigorous study included in the review. Its findings are not easy to interpret (“For the sample as a whole, as can be seen from the total group means, there was little change over the course of the study”)
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Even though I did not have access to the full text of all of these RCTs, this analysis tells me a few important things; here are some of the main points I discovered:
- the new review is fatally flawed;
- the authors’ statement that their “article presents a systematic review of randomized controlled trials (RCTs) that were conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines” is nonsensical;
- PRISMA guidelines were certainly not adhered to;
- there is no truly critical assessment of the primary studies;
- the literature searches were incomplete;
- the risk of bias tool for evaluating the primary studies was employed incorrectly;
- the review did not include all RCTs of Reiki (our own 2008 review included several trials that are not included here, and this blog has a few more);
- the review includes several studies that should have been excluded;
- most Reiki studies are of poor quality;
- with both the review and most of the primary studies, one feels a strong bias towards trying to prove that Reiki works;
- Reiki research is firmly in the hands of nurses (almost all the studies were conducted by nurses);
- almost all of the RCTs test Reiki versus no treatment, and this means that most do not control for placebo (or other non-specific) effects. In other words, the conclusions stating that Reiki is effective are simply wrong.
I am dismayed to see that a decent journal (BMC Palliative Care) published such a fatally flawed review. The paper fails to discuss any of its obvious flaws. Specifically, it does not even specify what interventions were used in the various control groups. Do the journal editors, peer-reviewers and authors not appreciate that, without such information, the findings are uninterpretable? Or do they perhaps deliberately try to mislead us?
If you ask me, this paper should be best withdrawn.
Our own review of Reiki is no longer up-to-date. Yet, it’s conclusion is, in my view, far more accurate than the one offered by the authors of the fatally flawed new review:
the evidence is insufficient to suggest that reiki is an effective treatment for any condition. Therefore the value of reiki remains unproven.
