Edzard Ernst

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

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”)

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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.

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”.

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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.

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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:

 

 

In response to criticism voiced against Australian chiropractors’ decision to re-commence manipulating children, the Australian Chiropractors Association (ACA) president, David Cahill, welcomed the updated statement on paediatric care by the Chiropractic Board of Australia. “The statement serves to reinforce the confidence the Australian public has in chiropractic care provided by registered ACA member chiropractors,” said Cahill.

The Safer Care Victoria Review has shown chiropractic care for children to be extremely safe. Of the 29,599 online submissions received from across Australia (the largest survey of its kind), there were no reports of harm to a child receiving chiropractic healthcare. Of those submissions, 21,824 responses were from parents who had accessed chiropractic healthcare for their children, and there was not a single report of significant harm in these submissions. “In a particularly strong endorsement, 99.6% of those parental submissions affirmed that chiropractic healthcare benefitted their child highlighting the exemplary safety record of chiropractic healthcare,” Cahill said.

ACA member chiropractors are healthcare professionals who effectively treat a wide range of musculoskeletal disorders. Chiropractors are 5-year university degree educated healthcare professionals, equipped with expertise enabling them to tailor the appropriate care for people of all ages including children. Established in 1938, the Australian Chiropractors Association (ACA) is the peak body representing chiropractors. The ACA promotes the importance of maintaining spinal health to improve musculoskeletal health through non-invasive, drug-free spinal health and lifestyle advice to help Australians of all ages lead and maintain healthy lives.

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Mr Cahill and the Australian Chiropractors Association have thus demonstrated that they fail to understand how one needs to establish the benefits and harms of a therapy. That chiropractic spinal manipulations are “extremely safe” cannot be established by an online survey which might or might not have been manipulated by the chiropractors who have an interest in not loosing the lucrative option of treating children. It cannot even establish “the confidence the Australian public has in chiropractic care”.

Mr Cahill and the Australian Chiropractors Association should know that chiropractic spinal manipulation – just like any other intervention – must be evaluated according to accepted principles of risk-benefit analyses. No proven benefit and a possibility of harm mean that the risk-benefit balance fails to be positive. And this means that it is irresponsible to use chiropractic spinal manipulations.

Mr Cahill and the Australian Chiropractors Association, however, seem to not know even the essentials of ethical healthcare. The obvious conclusion, therefore, is to send the lot of them back to school.

On 8 March 2019, the Council of Australian Governments (COAG) Health Council (CHC) noted community concerns about spinal manipulation on children performed by chiropractors and agreed that there was a need to consider whether public safety was at risk.

On behalf of the CHC, the Victorian Minister for Health, the Hon. Jenny Mikakos MP, instructed Safer Care Victoria (SCV) to undertake an independent review of the practice of chiropractic spinal manipulation on children under 12 years. The findings of this review are to be provided to the Minister for reporting to the CHC. To provide expert guidance and advice to inform the review, SCV established an independent advisory panel. The panel included expertise in chiropractic care, academic allied health, health practitioner regulation, healthcare evidence, governance, paediatrics and paediatric surgery, and musculoskeletal care, and had consumer representation.

The main conclusions were as follows:

  • … spinal manipulation in children is not wholly without risk. Any risk associated
    with care, no matter how uncommon or minor, must be considered in light of any potential or likely
    benefits. This is particularly important in younger children, especially those under the age of 2 years in
    whom minor adverse events may be more common.
  • … the evidence base for spinal manipulation in children is very poor. In particular, no studies have been performed in Australia … The possible, but unlikely, benefits of spinal manipulation in the management of colic or enuresis should be balanced by the possibility, albeit rare, of minor harm.

The main recommendation was straight forward: “Spinal manipulation, as defined in Section 123 of National Law, should not be provided to children under 12 years of age, by any practitioner, for general wellness or for the management of the following conditions: developmental and behavioural disorders, hyperactivity disorders, autism spectrum disorders, asthma, infantile colic, bedwetting, ear infections, digestive problems, headache, cerebral palsy and torticollis.”

The Chiropractic Board of Australia nevertheless decided they would re-start manipulationg babies. On 11/6/2024 The Sydney Morning Harald reported:

Chiropractors have given themselves the green light to resume manipulating the spines of babies following a four-year interim ban supported by the country’s health ministers. In a move slammed by doctors as irresponsible, the Chiropractic Board of Australia has quietly released new guidelines permitting the controversial treatment for children under two. The Royal Australian College of General Practitioners (RACGP) hit out at the decision, saying there was no evidence supporting the spinal manipulation of babies and children and that the practice should be outlawed. ‘‘There is no way in the world I would let anyone manipulate a child’s spine,’’ said Dr James Best, the college’s Specific Interests Child and Young Person’s Health chair. ‘‘The fact that it hasn’t been ruled out by this organisation is very disappointing and concerning. It’s irresponsible.’’ …

Subsequently, it was reported that the federal health minister has intervened in the Chiropractic Board of Australia’s controversial decision to allow practitioners to resume spinal manipulation of children under two and is seeking an urgent explanation.

As pressure mounts on chiropractors to ditch the treatment, federal Health Minister Mark Butler confirmed on Thursday that he would also raise the issue with his state and territory colleagues at a meeting of health ministers in South Australia on Friday.

“The Health Minister is writing to the Chiropractic Board seeking an urgent explanation on its decision to allow a resumption of spinal manipulation of infants under two, in spite of two reviews concluding there was no evidence to support that practice,” a spokeswoman said.

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This course of events can only be surprising to those who are not familiar with the chiropractors’ general attitude. Chiropractors have always put income before ethics and safety. This, I fear, is not a phenomenon confined to Australia or to the care of children but one that beleagues this profession worldwide from the days of DD Palmer to the present.

In November 2022, we discussed a dodgy acupuncture review. Let me show you my post from back then again:

Acupuncture is emerging as a potential therapy for relieving pain, but the effectiveness of acupuncture for relieving low back and/or pelvic pain (LBPP) during pregnancy remains controversial. This meta-analysis aimed to investigate the effects of acupuncture on pain, functional status, and quality of life for women with LBPP pain during pregnancy.

The authors included all RCTs evaluating the effects of acupuncture on LBPP during pregnancy. Data extraction and study quality assessments were independently performed by three reviewers. The mean differences (MDs) with 95% CIs for pooled data were calculated. The primary outcomes were pain, functional status, and quality of life. The secondary outcomes were overall effects (a questionnaire at a post-treatment visit within a week after the last treatment to determine the number of people who received good or excellent help), analgesic consumption, Apgar scores >7 at 5 min, adverse events, gestational age at birth, induction of labor and mode of birth.

Ten studies, reporting on a total of 1040 women, were included. Overall, acupuncture

  • relieved pain during pregnancy (MD=1.70, 95% CI: (0.95 to 2.45), p<0.00001, I2=90%),
  • improved functional status (MD=12.44, 95% CI: (3.32 to 21.55), p=0.007, I2=94%),
  • improved quality of life (MD=−8.89, 95% CI: (−11.90 to –5.88), p<0.00001, I2 = 57%).

There was a significant difference in overall effects (OR=0.13, 95% CI: (0.07 to 0.23), p<0.00001, I2 = 7%). However, there was no significant difference in analgesic consumption during the study period (OR=2.49, 95% CI: (0.08 to 80.25), p=0.61, I2=61%) and Apgar scores of newborns (OR=1.02, 95% CI: (0.37 to 2.83), p=0.97, I2 = 0%). Preterm birth from acupuncture during the study period was reported in two studies. Although preterm contractions were reported in two studies, all infants were in good health at birth. In terms of gestational age at birth, induction of labor, and mode of birth, only one study reported the gestational age at birth (mean gestation 40 weeks).

The authors concluded that acupuncture significantly improved pain, functional status and quality of life in women with LBPP during the pregnancy. Additionally, acupuncture had no observable severe adverse influences on the newborns. More large-scale and well-designed RCTs are still needed to further confirm these results.

What should we make of this paper?

In case you are in a hurry: NOT A LOT!

In case you need more, here are a few points:

  • many trials were of poor quality;
  • there was evidence of publication bias;
  • there was considerable heterogeneity within the studies.

The most important issue is one studiously avoided in the paper: the treatment of the control groups. One has to dig deep into this paper to find that the control groups could be treated with “other treatments, no intervention, and placebo acupuncture”. Trials comparing acupuncture combined plus other treatments with other treatments were also considered to be eligible. In other words, the analyses included studies that compared acupuncture to no treatment at all as well as studies that followed the infamous ‘A+Bversus B’ design. Seven studies used no intervention or standard of care in the control group thus not controlling for placebo effects.

Nobody can thus be in the slightest surprised that the overall result of the meta-analysis was positive – false positive, that is! And the worst is that this glaring limitation was not discussed as a feature that prevents firm conclusions.

Dishonest researchers?

Biased reviewers?

Incompetent editors?

Truly unbelievable!!!

In consideration of these points, let me rephrase the conclusions:

The well-documented placebo (and other non-specific) effects of acupuncture improved pain, functional status and quality of life in women with LBPP during the pregnancy. Unsurprisingly, acupuncture had no observable severe adverse influences on the newborns. More large-scale and well-designed RCTs are not needed to further confirm these results.

PS

I find it exasperating to see that more and more (formerly) reputable journals are misleading us with such rubbish!!!

Now, it has been announced that the paper has been 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.

One down, dozens of further SCAM papers to go!

Whenever I report a case of arterial dissection after spinal manipulation, a defender of the indefensible comments that the case does not prove anything.

Let’s try again, shall we?

It has been reported that Nerissa E. Weeks has filed a negligence complaint against Dr. Jack J. Cacic and his business, Lake Worth Chiropractic & Wellness (LWCW). Weeks, a resident of Lake Worth, alleges that she suffered permanent neurological injuries due to the negligence of Dr. Cacic during chiropractic treatments at LWCW. Weeks initially sought treatment from Cacic on January 12, 2023, for low back pain related to a herniated disc in her lumbar spine. Following this initial visit, she returned to Cacic’s office several months later on June 26, 2023, complaining of neck pain and headaches.

During subsequent visits on June 26 and June 28, Cacic performed cervical manipulations and other treatments without obtaining appropriate informed consent from Weeks regarding the risks involved. On June 30, following another session of cervical manipulations by Cacic, Weeks experienced severe dizziness and vertigo shortly after the procedure. She was subsequently hospitalized and diagnosed with an acute right vertebral artery dissection and an ischemic stroke.

Weeks contends that Cacic failed to recognize symptoms indicative of a vertebral artery dissection and did not provide adequate care consistent with professional standards. The complaint states: “As a direct and proximate result of the negligence of the Defendants, WEEKS suffered permanent neurologic injuries due to an acute thromboembolic cerebrovascular accident.”

The plaintiff is seeking damages exceeding $50,000 for medical expenses, loss of earnings, pain and suffering, mental anguish, disability, impairment, and other related costs incurred due to the alleged negligence. Represented by attorney Hector Buigas from Morgan & Morgan P.A., Weeks demands compensatory damages along with interest, taxable costs, attorneys’ fees, prejudgment interest on medical bills as well as any other relief deemed proper by the court.

____________________

How many more such cases do we need before chiropractors admit that cervical manipulations do more harm than good?

How long until all chiropractors explain to their patients that cervical manipulations do more harm than good?

How long until cervical manipulations become obsolete?

 

Conspiracy theories have become a frequent theme on this blog, e.g.:

 

In fact, I have previously postulated that so-called alternative medicine (SCAM) can be understood as a conspiracy theory.

A new paper asked a relevant question: who believes in conspiracy theories? Conspiracy theories are ubiquitous and can have negative consequences. Thus, there is an increasing need for evidence-based recommendations with respect to interventions and prevention measures. Present Bayesian three-level meta-analysis includes a synthesis of the extant literature with respect to 12 personality correlates and their relationship with conspiracy beliefs. On average, people who believe in pseudoscience, suffer from paranoia or schizotypy, are narcissistic or religious/spiritual and have relatively low cognitive ability, are more likely to believe in conspiracy theories. Heterogeneity was partially explained by the examined moderators and no strong evidence for publication bias was found. Implications for developing tailored interventions are discussed in the article.

Conspiracy is a “secret plot by two or more powerful actors … Conspiracies typically attempt to usurp political or economic power, violate rights, infringe upon established agreements, withhold vital secrets, or alter bedrock institutions”. Conspiracy theories are used to describe and explain purported conspiracies.

People who believe in conspiracy theories are, according to this meta-analysis, more likely than other people to hold pseudoscientific beliefs, exhibit paranoid ideation, suffer from schizotypy, be narcissistic, be religious/spiritual and have lower cognitive ability.

Reading the comments sections of my blog, I agree with this conclusion.

It has been reported that HomeoCare Laboratories Inc. is recalling two batches of Homeopathic StellaLife Oral Care Products citing microbial contamination. The recall involves Homeopathic Stella Life Vega Oral Care Spray Unflavored and Advanced Formula Peppermint Oral Care Rinse manufactured in 2024, which are marketed to promote oral health, hydrate oral cavities and support healthy gums. The recall is to be performed at the consumer level.

StellaLife VEGA Oral Care, Spray Unflavored comes with NDC 69685-121-01, lot no. 2552 and expiration date of 02-2026. StellaLife Advanced Formula Peppermint VEGA Oral Care Rinse comes with NDC 69685-143-16, lot no. 2550, and expiration date of 02- 2026.

The affected products were manufactured at HomeoCare Laboratories, shipped nationwide, and distributed through various dental practices. As per the FDA, higher than acceptable levels of TAMC was found in the Advanced Formula Peppermint Vega Oral Care Rinse, while Bacillus sp was found in the StellaLife Vega Oral Spray, Unflavored. Bacillus is a common species found in the environment and are generally non-pathogenic, while patients with oral disease, undergoing dental surgical procedures or with compromised immune systems hold potential risks. In the immunocompromised population, the impacted product may cause severe or life-threatening adverse events due to the introduction of bacteria to the disrupted oral mucosa, possibly leading to bacteremia and sepsis. However, the manufacturer of homeopathic products has not received any reports of adverse events related to these two recalled products so far.

Dental practices and consumers, who have the recalled products, are urged to return the impacted products to HomeoCare Laboratories or to the place of purchase or discard them. The company said it is implementing enhanced quality control measures to prevent recurrence.

On the manufacturer’s website, we find the following:

Homeopathy is a safe, gentle, and natural system of healing that works with your body to relieve symptoms, restore itself, and improve your overall health. It is safe to use and has none of the side effects of many traditional medications, because it is made from the natural substances and is FDA regulated. Homeopathic medicines – known as “remedies” – are made from natural sources (e.g., plants, minerals), and are environmentally friendly and cruelty free.

Homeopathic remedies when used as directed, are completely safe for everyone. They are given in such small doses that they don’t cause side effects.* Homeopathy is not a general or “umbrella” term that describes a variety of different natural therapies. Although homeopathic remedies are derived from natural substances, homeopathy should not be confused with herbal medicine, Chinese medicine, or other types of natural medicines. It is its own, unique therapeutic system.

The FDA’s present policy does not require homeopathic medicines to go through the FDA approval process.  The homeopathic ingredients monographed in the Homeopathic Pharmacopoeia of the United States have been reviewed for homeopathic efficacy, toxicology, adverse effects and clinical use. The historical safety record with the use of homeopathic drugs, some for close to 200 years. The FDA drug monitoring process does not reveal any significant instances of problems with homeopathic drug products, thus establishing a positive safety profile.

Homeopathy’s Basic Principle: The Law of Similars It is accepted knowledge that every plant, mineral, and chemical can cause in overdose its own unique set of physical, emotional, and mental symptoms. It also is readily acknowledged that individuals, when ill, have their own idiosyncratic physical, emotional, and mental symptom patterns, even when people have the same disease. Homeopathic medicine is a natural pharmaceutical science in which a practitioner seeks to find a substance which would cause in overdose similar symptoms to those a sick person is experiencing. When the match is made, that substance then is given in very small, safe doses, often with dramatic effects.

Homeopaths define the underlying principle for this matching process as the “law of similars.” The “law” is not unknown to conventional medicine. Immunizations are based on the principle of similars. No less a person as Dr. Emil Adolph Von Behring, the “father of immunology,” directly pointed to the origins of immunizations when he asserted, “By what technical term could we more appropriately speak of this influence than by Hahnemann’s word “homeopathy.”

Homeopathy is a natural form of medicine used by over 200 million people worldwide.  The holistic nature of homeopathy means each person is treated as a unique individual and their body, mind, spirit and emotions are all considered in the management and prevention of disease. Taking all these factors into account a homeopath will select the most appropriate medicine based on the individual’s specific symptoms and personal level of health to stimulate their own healing ability.

Homeopathic medicines are safe to use as they rarely cause side-effects. This means when used appropriately under the guidance of a qualified homeopath they can be taken by people of all ages*.

* Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated. Individual results may vary.

__________________________

I feel like congratulating the manufacturer: not only have they managed to produce normally harmless products in such a way that they are dangerous, but also they are promoting a plethora of untruth and misleading statements about homeopathy. A most remarkable effort!

 

The over-use of X-ray diagnostics by chiropractors has been the topic of previous posts, e.g.:

The authors of this review state that many clinicians use radiological imaging in efforts to locate and diagnose the cause of their patient’s pain, relying on X-rays as a leading tool in clinical evaluation. This is fundamentally flawed because an X-ray represents a “snapshot” of the structural appearance of the spine and gives no indication of the current function of the spine. The health and well-being of any system, including the spinal motion segments, depend on the inter-relationship between structure and function. Pain, tissue damage, and injury are not always directly correlated. Due to such a high incidence of abnormalities found in asymptomatic patients, the diagnostic validity of X-rays can be questioned, especially when used in isolation of history and/or proper clinical assessment. The utility of routine X-rays is, therefore, questionable. One may posit that their application promotes overdiagnosis, and unvalidated treatment of X-ray findings (such as changes in postural curvature), which may mislead patients into believing these changes are directly responsible for their pain. A substantial amount of research has shown that there is no association between pain and reversed cervical curves. Accuracy can also be questioned, as X-ray measurements can vary based on the patient’s standing position, which research shows is influenced by an overwhelming number of factors, such as patient positioning, patient physical and morphological changes over time, doctor interreliability, stress, pain, the patient’s previous night’s sleep or physical activity, hydration, and/or emotional state. Furthermore, research has concluded that strong evidence links various potential harms with routine, repeated X-rays, such as altered treatment procedures, overdiagnosis, radiation exposure, and unnecessary costs. Over the past two decades, medical boards and health associations worldwide have made a substantial effort to communicate better “when” imaging is required, with most education around reducing radiographic imaging. In this review, we describe concerns relating to the high-frequency, routine use of spinal X-rays in the primary care setting for spine-related pain in the absence of red-flag clinical signs.

Many chiropractors over-use X-rays (not least because it is a significant source of income) and claim to be able diagnose subluxations with X-ray diagnostics. The authors of the review state are unimpressed by this habit:

Spinal X-rays can lead to the detection of radiographic findings that can be used as an overdiagnosis for the patient, even though they may be asymptomatic. These include spinal anomalies, osteophytes, reduced disc heights, low-grade spondylolisthesis, transitional segments, and spina bifida occulta. The chiropractor can use all radiographic findings as “scare tactics” or “fear-mongering” to retain a patient under a specific frequency of care, thus creating unnecessary concern for the patient. Multiple studies have concluded that radiographic findings do not always correlate with a patient’s symptomatology. Brinjikji et al. (2015) concluded that disc degeneration was present in asymptomatic individuals, ranging from 37% in 20 year olds to 96% in 80 year olds.

Many chiropractors use “phases of degeneration” as a method of communication in order for patients to adhere to excessive treatment plans. It is unnecessary and unethical to scare patients to obtain compliance with chiropractic care. These “scare tactics” can negatively influence patients’ behavior, especially those who already experience reduced levels of self-efficacy. This unnecessary use of communication can cause negative thoughts, leading to fear of avoidance of physical activity and management advice as there is a concern for further damage. In addition, the likelihood that a patient will experience chronic pain may arise due to the belief that they won’t get better until the radiographic findings are resolved.

Vertebral subluxation is a term and condition created by chiropractors that refers to misalignment of the vertebra, a bone out of place, causing pressure on the spinal nerve and interference with mental impulses. Subluxation is a legitimate medical condition; however, this completely differs from the condition used by chiropractors. Over the years, there have been numerous definitions and takes on what “vertebral subluxation” is – even though the term and concept date back to 1902, it is still commonly used in the chiropractic community. It has been described that the misalignment of the vertebra causes occlusion of where the spinal nerve travels, thus causing nerve pressure and disrupting the “mental impulse,” which is part “intelligence,” a synonym for “spirit” and part of the “mental realm,” and part neural impulse; which is part of the physical realm. Many chiropractors believe that when bones press on nerves, the corresponding organ on the other end of the nerve will suffer disease. At this point, it appears more like religion; however, it is crucial that we include this as many clinicians use this “condition” as grounds to order unnecessary radiographic imaging. Extensive medical research has shown that bones do not slip out of place, squishing nerves causing various and different pathologies – and there is certainly no way to scientifically prove the interference of a “spirit” or life force. Nonetheless, none of this is grounds for ordering an X-ray and does not qualify as any type of “red flag,” raising concern about how and when chiropractors are using radiographic imaging.

The authors conclude that the importance of medical imaging cannot be overstated. Medical professionals, on the other hand, must adhere to ethical and responsible standards. These guidelines may be ambiguous in some situations, professions, and countries, resulting in many gray areas of practice. As discussed in this review, the ongoing justification many use to justify the excessive, repetitive, and ongoing use of X-rays for reasons that research does not support is highly concerning. This article highlights potential unvalidated practices within the chiropractic field relating to poor utility imaging.

 

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.

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