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

study design

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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.

Yesterday, I stumbled across this remarkable notice. As it is in German, I took the libery of translating it for you:

Am 6. April 2024 war es wieder soweit: Die ÖGHM und die Schwabe Austria GmbH luden zur Verleihung des mit 4.000,- Euro dotierten Dr. Peithner Preises ein.

Dieses Mal wurde der Forschungspreis für die zwei eingereichte Arbeiten „Recommendations in the design and conduction of randomized controlled trials in human and veterinary homoeopathic medicine“ und „Recommendations for Designing, Conducting and Reporting Clinical Observational Studies in Homeopathic Veterinary Medicine“ an Katharina Gaertner, Klaus von Ammon, Philippa Fibert, Michael Frass, Martin Frei-Erb, Christien Klein-Laansma, Susanne Ulbrich-Zuerni und Petra Weiermayer vergeben.

Wir freuen uns sehr und gratulieren den Preisträger:innen zum verdienten Erfolg. Ein herzliches Dankeschön geht auch an die ÖGHM und die Schwabe Austria, die nicht nur mit diesem traditionellen Forschungspreis die Wissenschaft unterstützt.

Here is my translation:

On 6 April 2024, the time had come again: the ‘Austrian Society for Homeopathic Medicine’ (ÖGHM) and Schwabe Austria GmbH hosted the award ceremony for the Dr Peithner Prize, which is endowed with 4,000 euros.

This time, the research prize was awarded to Katharina Gaertner, Klaus von Ammon, Philippa Fibert, Michael Frass, Martin Frei-Erb, Christien Klein-Laansma, Susanne Ulbrich-Zuerni and Petra Weiermayer for the two submitted papers “Recommendations in the design and conduction of randomised controlled trials in human and veterinary homoeopathic medicine” and “Recommendations for Designing, Conducting and Reporting Clinical Observational Studies in Homeopathic Veterinary Medicine”.

We are delighted and congratulate the prizewinners on their well-deserved success. A big thank you also goes to the ÖGHM and Schwabe Austria, who support science with this traditional research prize.

______________________________

And where is the irony?

Firstly, homeopaths are not exactly the experts on how to conduct research.

Secondly, there are recommendations and guidelines for conducting clinical research (e.g. here), and there is no reason for homeopathy to not to adopt those.

Thirdly, and most importantly, to award a prize to Michael Frass for telling us how to do research is more than a little ironic. If anything, Frass could teach us a thing or two about how to falsify, fabricate and manipulate research results!

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 &lt; 0.001) and secondary outcomes (ORIDL: F1, 58 = 210.986, p &lt; 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:

  1. Homeopathy is not a plausible form of SCAM.
  2. The most reliable studies fail to show that is is more than a placebo.
  3. 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.
  4. 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.
  5. 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.

This study aimed to investigate the clinical effectiveness and cost-effectiveness of an individualised, progressive walking and education intervention to prevent the recurrence of low back pain.

WalkBack was a two-armed, randomised clinical trial, which recruited adults (aged 18 years or older) from across Australia who had recently recovered from an episode of non-specific low back pain that was not attributed to a specific diagnosis, and which lasted for at least 24 h. Participants were randomly assigned to an individualised, progressive walking and education intervention facilitated by six sessions with a physiotherapist across 6 months or to a no treatment control group (1:1). The randomisation schedule comprised randomly permuted blocks of 4, 6, and 8 and was stratified by history of more than two previous episodes of low back pain and referral method. Physiotherapists and participants were not masked to allocation. Participants were followed for a minimum of 12 months and a maximum of 36 months, depending on the date of enrolment. The primary outcome was days to the first recurrence of an activity-limiting episode of low back pain, collected in the intention-to-treat population via monthly self-report. Cost-effectiveness was evaluated from the societal perspective and expressed as incremental cost per quality-adjusted life-year (QALY) gained. The trial was prospectively registered (ACTRN12619001134112)

Between Sept 23, 2019, and June 10, 2022, 3206 potential participants were screened for eligibility, 2505 (78%) were excluded, and 701 were randomly assigned (351 to the intervention group and 350 to the no treatment control group). Most participants were female (565 [81%] of 701) and the mean age of participants was 54 years (SD 12). The intervention was effective in preventing an episode of activity-limiting low back pain (hazard ratio 0·72 [95% CI 0·60–0·85], p=0·0002). The median days to a recurrence was 208 days (95% CI 149–295) in the intervention group and 112 days (89–140) in the control group. The incremental cost per QALY gained was AU$7802, giving a 94% probability that the intervention was cost-effective at a willingness-to-pay threshold of $28 000. Although the total number of participants experiencing at least one adverse event over 12 months was similar between the intervention and control groups (183 [52%] of 351 and 190 [54%] of 350, respectively, p=0·60), there was a greater number of adverse events related to the lower extremities in the intervention group than in the control group (100 in the intervention group and 54 in the control group).

The authors concluded that an individualised, progressive walking and education intervention significantly reduced low back pain recurrence. This accessible, scalable, and safe intervention could affect how low back pain is managed.

Rigorous clinical trials of excercise therapy are difficult to conceive and conduct because of a range of methodological issues. For instance, there is no obvious placebo and thus it is hardly possible to control for placebo effects. Nonetheless, the benefits of exercise therapy for back pain is undoubted. As previously discussed on this blog, a recent systematic review concluded that “the relative benefit of individualized exercise therapy on chronic low back pain compared to other active treatments is approximately 38% which is of clinical importance.”

I have always been convinced of the health benefits of excercise. In fact, 40 years ago, when I did my inaugural lecture at the University of Munich (LMU), excercise was its topic and I concluded that, if exercise were a pharmaceutical product, it would out-sell any drug. The new study only confirms my view. It adds to our knowledge by suggesting that exercise also reduces the risk of recurrences.

Forget about spinal manipulation, acupuncture, etc., despite the undeniable weaknesses in the evidence, exercise is by far the most promissing treatment for back pain

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:

  1. 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?
  2. According to classical homeopathy, the remedy is supposed to cure the condition, not alleviate the symptoms. Is that what the results show?
  3. 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!

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:

STUDY No 1

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.

STUDY No 2

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.

STUDY No 3

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.

STUDY No 4

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.

STUDY No 5

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.

STUDY No 6

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.

STUDY No 7

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.

STUDY No 8

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.

STUDY No 9

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.

STUDY No 10

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.

STUDY No 11

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.

STUDY No 12

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

STUDY No 13

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”)

__________________________

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.

As pointed out previously on this blog, unethical research practices are prevalent in China, but little research has focused on the causes of these practices.

Drawing on the criminology literature on organisational deviance, as well as the concept of cengceng jiama, which illustrates the increase of pressure in the process of policy implementation within a top-down bureaucratic hierarchy, this article develops an institutional analysis of research misconduct in Chinese universities. It examines both universities and the policy environment of Chinese universities as contexts for research misconduct. Specifically, this article focuses on China’s Double First-Class University Initiative and its impact on elite universities that respond to the policy by generating new incentive structures to promote research quality and productivity as well as granting faculties and departments greater flexibility in terms of setting high promotion criteria concerning research productivity. This generates enormous institutional tensions and strains, encouraging and sometimes even compelling individual researchers who wish to survive to decouple their daily research activities from ethical research norms. The article is written based on empirical data collected from three elite universities as well as a review of policy documents, universities’ internal documents, and news articles.

The interviewer, sociologist Zhang Xinqu, and his colleague Wang Peng, a criminologist, both at the University of Hong Kong, suggest that researchers felt compelled, and even encouraged, to engage in misconduct to protect their jobs. This pressure, they conclude, ultimately came from a Chinese programme to create globally recognized universities. The programme prompted some Chinese institutions to set ambitious publishing targets, they say. In 2015, the Chinese government introduced the Double First-Class Initiative to establish “world-class” universities and disciplines. Universities selected for inclusion in the programme receive extra funding, whereas those that perform poorly risk being delisted, says Wang.

Between May 2021 and April 2022, Zhang conducted anonymous virtual interviews with 30 faculty members and 5 students in the natural sciences at three of these elite universities. The interviewees included a president, deans and department heads. The researchers also analysed internal university documents.

The university decision-makers who were interviewed at all three institutes said they understood it to be their responsibility to interpret the goals of the Double First-Class scheme. They determined that, to remain on the programme, their universities needed to increase their standing in international rankings — and that, for that to happen, their researchers needed to publish more articles in international journals indexed in databases such as the Science Citation Index. As the directive moved down the institutional hierarchy, pressure to perform at those institutes increased. University departments set specific and hard-to-reach publishing criteria for academics to gain promotion and tenure. Some researchers admitted to engaging in unethical research practices for fear of losing their jobs. In one interview, a faculty head said: “If anyone cannot meet the criteria [concerning publications], I suggest that they leave as soon as possible.”

Zhang and Wang describe researchers using services to write their papers for them, falsifying data, plagiarizing, exploiting students without offering authorship and bribing journal editors. One interviewee admitted to paying for access to a data set. “I bought access to an official archive and altered the data to support my hypotheses.” An associate dean emphasized the primacy of the publishing goal. “We should not be overly stringent in identifying and punishing research misconduct, as it hinders our scholars’ research efficiency.”

The larger problem, says Xiaotian Chen, a library and information scientist at Bradley University in Peoria, Illinois, is a lack of transparency and of systems to detect and deter misconduct in China. Most people do the right thing, despite the pressure to publish, says Chen, who has studied research misconduct in China. The pressure described in the paper could just be “an excuse to cheat”.

_________________________

It is hard not to be reminded of what I reported in a recent post where it has been announced that a Chinese acupuncture review was retracted:

The research “Acupuncture for low back and/or pelvic pain during pregnancy: a systematic review and meta-analysis of randomised controlled trials,” published in the open access journal BMJ Open in 2022, has been retracted.

This research was press released in November 2022 under the title of “Acupuncture can relieve lower back/pelvic pain often experienced during pregnancy.”

Following publication of the research, various issues concerning its design and reporting methods came to light, none of which was amenable to correction, prompting the decision to retract.

The full wording of the retraction notice, which will be published at 23.30 hours UK (BST) time Tuesday 11 June 2024, is set out below:

“After publication, multiple issues were raised with the journal concerning the design and reporting of the study. The editors and integrity team investigated the issues with the authors. There were fundamental flaws with the research, including the control group selection and data extraction, not amenable to correction.” doi:10.1136/bmjopen-2021-056878ret

Please ensure that you no longer cite this research in any future reporting.

____________________________

After studying Chinese TCM papers for more than 30 years, I feel increasingly concerned about the tsumani of either very poor quality or fabricated research coming out of China. For more details, please read the following posts:

 

 

Due to the unclear risk level of adverse events (AEs) associated with high-velocity, low-amplitude (HVLA) cervical manipulation, the aim of this study was to extract available information from randomized clinical trials (RCTs) and thereby synthesize the comparative risk of AEs following cervical manipulation to that of various control interventions.

 A systematic literature search was conducted in the PubMed and Cochrane databases. This search included RCTs in which cervical HVLA manipulations were applied and AEs were reported. Two independent reviewers performed the study selection, the methodological quality assessment, and the GRADE approach. Incidence rate ratios (IRR) were calculated. The study quality was assessed by using the risk of bias 2 (RoB-2) tool, and the certainty of evidence was determined by using the GRADE approach.

Fourteen articles were included in the systematic review and meta-analysis. The pooled IRR indicates no statistically significant differences between the manipulation and control groups. All the reported AEs were classified as mild, and none of the AEs reported were serious or moderate.

The authors concluded that HVLA manipulation does not impose an increased risk of mild or moderate AEs compared to various control interventions. However, these results must be interpreted with caution, since RCTs are not appropriate for detecting the rare serious AEs. In addition, future RCTs should follow a standardized protocol for reporting AEs in clinical trials.

I am more than a little puzzled by this paper. To explain why, I best show you our systematic review of a closely related subject:

Objective: To systematically review the reporting of adverse effects in clinical trials of chiropractic manipulation.

Data sources: Six databases were searched from 2000 to July 2011. Randomised clinical trials (RCTs) were considered, if they tested chiropractic manipulations against any control intervention in human patients suffering from any type of clinical condition. The selection of studies, data extraction, and validation were performed independently by two reviewers.

Results: Sixty RCTs had been published. Twenty-nine RCTs did not mention adverse effects at all. Sixteen RCTs reported that no adverse effects had occurred. Complete information on incidence, severity, duration, frequency and method of reporting of adverse effects was included in only one RCT. Conflicts of interests were not mentioned by the majority of authors.

Conclusions: Adverse effects are poorly reported in recent RCTs of chiropractic manipulations.

So, AEs are known to get seriously (and unethically) neglected in RCTs of chiropractic. Therefore, it must be expected that the new review finds only few of them in RCTs. No big deal! But why then conclude that HVLA manipulations do not impose an increased risk? Why do the authors claim that “case reports … do not imply causal relationships”? Why not be honest and simply state that RCTs are an inadequate tool for assessing the risks of spinal manipulation? And why ignore our review which, after all, is highly relevant and was published in a most visible journal? Did they perhaps read it and then decided to ignore it because it would have rendered their whole approach idiotic?

I don’t know the answer to any of these questions. What I do know, however, is that this new review arrives at a utterly misleading and possibly harmful conclusion. It thus is a significant disservice to our need to making progress in this important area.

Gastroesophageal reflux disease (GERD), also named Gastro-oesophageal reflux disease (GORD), is a common condition characterized by stomach contents flowing into the esophagus, causing distressing symptoms and potential complications. GERD is primarily linked to lower esophageal sphincter dysfunction, and its symptoms can impact quality of life. Treatment options include lifestyle changes, medications, and surgery. Homeopathy is sometimes advocated as an alternative to conventional orally administered drugs for GERD.

This review examined the clinical evaluation of homeopathic treatments for GERD, highlighting their potential role by analysing existing clinical studies. The authors conducted a comprehensive database search for clinical studies RCT, open label, retrospective, perspective, and observational studies on homeopathic treatments for GERD, adhering to inclusion criteria related to homeopathy in GERD treatment.

Six clinical studies were identified:

  • 1 open label study,
  • 3 retrospective studies,
  • 1 prospective study,
  • 1 observational study.

Renu Mittal’s study demonstrated significant symptom improvement and enhanced quality of life with homeopathic
treatment. Dr. Leena Dighe’s study reinforced the effectiveness of homeopathic medicines in GERD, Acid-Peptic Disorder (APD), and irritable bowel syndrome (IBS), while Sitharthan’s retrospective analysis supported the potential of homeopathy for gastrointestinal disorders. A study exploring Robinia pseudoacacia in GERD treatment showed positive results.

The authors conclused that these studies suggest the potential of homeopathic treatments in managing GERD and related gastrointestinal disorders. These findings encourage future studies and applications of homeopathic interventions in GERD management. Further research, including randomized trials, is needed to solidify homeopathy’s role in gastroenterological care.

Does anyone really think that this paper is worth publishing?

Its authors and the editors of the INTERNATIONAL JOURNAL OF HIGH DILUTION RESEARCH evidently do:

  • Parth AphaleDR D Y PATIL VIDYAPEETH PUNE
  • Dharmendra SharmaDr. D.Y. Patil Homoeopathic Medical College & Research Centre, Dr. D.Y. Patil Vidyapeeth (Deemed to be University), Pimpri, Pune, Maharashtra, India
  • Himanshu ShekharDr. D.Y. Patil Homoeopathic Medical College & Research Centre, Dr. D.Y. Patil Vidyapeeth (Deemed to be University), Pimpri, Pune, Maharashtra, India

But I don’t!

Why?

Because none of the primary studies come anywhere near of being reliable evidence.

I think that reviews of this nature drawing such unwarranted conclusions are counter-productive – counter-productive even to those people whose aim it is to promote homeopathy. Nobody with an ounce of critical thinking capacity can take such nonsense seriously. The only possible conclusion that can be drawn from the presented evidence is along the following lines:

This review failed to generate any sound evidence that homeopathy is an effective therapy for GERD.

 

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