meta-analysis
This update of a systematic review evaluated the effectiveness of spinal manipulations as a treatment for migraine headaches.
Amed, Embase, MEDLINE, CINAHL, Mantis, Index to Chiropractic Literature, and Cochrane Central were searched from inception to September 2023. Randomized clinical trials (RCTs) investigating spinal manipulations (performed by various healthcare professionals including physiotherapists, osteopaths, and chiropractors) for treating migraine headaches in human subjects were considered. Other types of manipulative therapy, i.e., cranial, visceral, and soft tissue were excluded. The Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach was used to evaluate the certainty of evidence.
Three more RCTs were published since our first review; amounting to a total of 6 studies with 645 migraineurs meeting the inclusion criteria. Meta-analysis of six trials showed that, compared with various controls (placebo, drug therapy, usual care), SMT (with or without usual care) has no superior effect on migraine intensity/severity measured with a range of instruments (standardized mean difference [SMD] − 0.22, 95% confidence intervals [CI] − 0.65 to 0.21, very low certainty evidence), migraine duration (SMD − 0.10; 95% CI − 0.33 to 0.12, 4 trials, low certainty evidence), or emotional quality of life (SMD − 14.47; 95% CI − 31.59 to 2.66, 2 trials, low certainty evidence) at post-intervention. A meta-analysis of two trials showed that compared with various controls, SMT (with or without usual care) increased the risk of adverse effects (risk ratio [RR] 2.06; 95% CI 1.24 to 3.41, numbers needed to harm = 6; very low certainty evidence). The main reasons for downgrading the evidence were study limitations (studies judged to be at an unclear or high risk of bias), inconsistency (for pain intensity/severity), imprecision (small sizes and wide confidence intervals around effect estimates) and indirectness (methodological and clinical heterogeneity of populations, interventions, and comparators).
We cocluded that the effectiveness of SMT for the treatment of migraines remains unproven. Future, larger, more rigorous, and independently conducted studies might reduce the existing uncertainties.
The only people who might be surprised by these conclusions are chiropractors who continue to advertise and use SMT to treat migraines. Here are a few texts by chiropractors (many including impressive imagery) that I copied from ‘X’ just now (within less that 5 minutes) to back up this last statement:
- So many people are suffering with Dizziness and migraines and do not know what to do. Upper Cervical Care is excellent at realigning the upper neck to restore proper blood flow and nerve function to get you feeling better!
- Headache & Migraine Relief! Occipital Lift Chiropractic Adjustment
- Are migraines affecting your quality of life? Discover effective chiropractic migraine relief at…
- Neck Pain, Migraine & Headache Relief Chiropractic Cracks
- Migraine Miracle: Watch How Chiropractic Magic Erases Shoulder Pain! Y-Strap Adjustments Unveiled
- Tired of letting migraines control your life? By addressing underlying issues and promoting spinal health, chiropractors can help reduce the frequency and severity of migraines. Ready to experience the benefits of chiropractic for migraine relief?
- Did you know these conditions can be treated by a chiropractor? Subluxation, Back Pain, Chronic Pain, Herniated Disc, Migraine Headaches, Neck Pain, Sciatica, and Sports Injuries.
- When a migraine comes on, there is not much you can do to stop it except wait it out. However, here are some holistic and non-invasive tips and tricks to prevent onset. Check out that last one! In addition to the other tips, chiropractic care may prevent migraines in your future!
Evidence-based chiropractic?
MY FOOT!
Dry needling (DN) is a treatment used by various healthcare practitioners, including physical therapists, physicians, and chiropractors. It involves the use of either solid filiform needles or hollow-core hypodermic needles for therapy of muscle pain, including pain related to myofascial pain syndrome. DN is mainly used to treat myofascial trigger points, but it is also used to target connective tissue, neural ailments, and muscular ailments. There is conflicting evidence regarding the effectiveness of DN for any condition.
Orofacial pain (OFP) typically has a musculoskeletal, dental, neural, or sinogenic origin. Our systematic review was aimed at evaluating the evidence base for the effectiveness of DN for OFP.
We searched Medline, Cochrane Central, and Web of Science (from their respective inceptions to February 2024) for RCTs evaluating the effectiveness of DN in patients with OFP. Studies with patients suffering from cervicogenic or tension type headaches as well as observational studies were excluded. Primary outcomes were pain intensity and severity; secondary outcomes were disability, quality of life, and adverse effects (AEs). The review adhered to the methods described by in the Cochrane Handbook.
Twenty-four RCTs with a total of 1,318 patients suffering from OFP could be included. Most had an unclear or high risk of bias, and the quality of the evidence ranged from very low to low for all comparisons and outcomes. A meta-analysis suggested that, compared with usual care alone, DN + usual care had no effect on pain intensity (visual analogue scale) (standardized mean difference = −1.89, 95% confidence intervals −5.81 to 2.02, very low certainty evidence) at follow-ups of up to 6 weeks. Only 6 RCTs (25%) mentioned AEs, and none of them reported that AEs had occurred. The remaining 18 (75%) studies failed to report AEs.
We concluded that DN cannot be considered as an effective treatment option for OFP. This is due to the uncertainties of the available evidence. We believe that larger, rigorous, and better reported trials with more homogeneous comparators might potentially reduce the current uncertainties. Such trials should strictly adhere to the classifications provided by the International Headache Society and published in the International Classification of Orofacial Pain.
Yet again, I need to stress that the vast majority od RCTs failed to mention AEs. When will the last (pseudo-) researcher have learnt that the non-reporting of AEs is a violation of research ethics?
Spanish colleagues and I just published an article entitled “Is Osteopathic Manipulative Treatment Clinically Superior to Sham or Placebo for Patients with Neck or Low-Back Pain? A Systematic Review with Meta-Analysis”. Here is its abstract:
The aim of this systematic review and meta-analysis was to compare whether osteopathic manipulative treatment (OMT) for somatic dysfunctions was more effective than sham or placebo interventions in improving pain intensity, disability, and quality of life for patients with neck pain (NP) or low-back pain (LBP). Methods: A systematic review and meta-analysis was carried out. Searches were conducted in PubMed, Physiotherapy Evidence Database, Cochrane Library, and Web of Science from inception to September 2024. Studies applying a pragmatic intervention based on the diagnosis of somatic dysfunctions in patients with NP or LBP were included. The methodological quality was assessed with the PEDro scale. The quantitative synthesis was performed using random-effect meta-analysis calculating the standardized mean difference (SMD) with RevMan 5.4. The certainty of evidence was evaluated using GRADEPro. Results: Nine studies were included in the qualitative synthesis, and most of them showed no superior effect of OMTs compared to sham or placebo in any clinical outcome. The quantitative synthesis reported no statistically significant differences for pain intensity (SMD = −0.15; −0.38, 0.08; seven studies; 1173 patients) or disability (SMD = −0.09; −0.25, 0.08; six studies; 1153 patients). The certainty of evidence was downgraded to moderate, low, or very low. Conclusions: The findings of this study reveal that OMT is not superior to sham or placebo for improving pain, disability, and quality of life in patients with NP or LBP.
As always, it seems important to stress that our review has several limitations. Firstly, the searches were conducted in the most relevant databases; however, some studies not indexed in these sources may have been missed. Secondly, the diverse NP and LBP diagnosis, as well as the lack of data reported by some studies, complicates the interpretation of the results and may weaken our conclusion. Thirdly, the primary studies pragmatically applied interventions based on diagnoses of various somatic dysfunctions, resulting in a high degree of heterogeneity among the treatments applied.
Despite these limitations, it is fair to say, I think, that OMT is not nearlly as solidly supported by reliable evidence as most osteopaths try to make us believe. In essence, this means that, if you suffer from NP or LBP, you best concult a proper doctor or physiotherapist.
Cupping is a from of so-called alternative medicine (SCAM) that has featured already many times on this blog, e.g.:
- Wet cupping in the management of cervical spondylosis? No!
- The effectiveness of cupping therapy for low back pain
- Cupping: “the propagation of ancient, scientifically unsound techniques that may cause more harm than benefit”
- Cupping therapy for non-specific chronic low back pain
- Cupping for Olympic swimmers. Or: why breaking your shoulder is not necessarily good for writing a successful book
- Wet cupping and dry humour
- Cupping for athletes: rubbish trials, rubbish review, rubbish journal
- The future of cupping: it’s bright, profitable and vacuous
Now a new and interesting paper has been published on the subject
This review aimed to investigate the effectiveness of cupping therapy on low back pain (LBP). Medline, Embase, Scopus and WANFANG databases were searched for relevant cupping RCTs on low back pain articles up to 2023. A complementary search was manually made on 27 September for update screening. Full-text English and Chinese articles on all ethnic adults with LBP of cupping management were included in this study. Studies looking at acute low back pain only were excluded. Two independent reviewers screened and extracted data, with any disagreement resolved through consensus by a third reviewer. The methodological quality of the included studies was evaluated independently by two reviewers using an adapted tool. Change-from-baseline outcomes were treated as continuous variables and calculated according to the Cochrane Handbook. Data were extracted and pooled into the meta-analysis by Review Manager software (version 5.4, Nordic Cochrane Centre).
Eleven trials involving 921 participants were included (6 on dry and 5 on wet cupping). Five studies were assessed as being at low risk of bias, and six studies were of acceptable quality. High-quality evidence demonstrated cupping significantly improves pain at 2-8 weeks endpoint intervention (d=1.09, 95% CI: [0.35-1.83], p = 0.004). There was no continuous pain improvement observed at one month (d=0.11, 95% CI: [-1.02-1.23], p = 0.85) and 3-6 months (d=0.39, 95% CI: [-0.09-0.87], p = 0.11). Dry cupping did not improve pain (d=1.06, 95% CI: [-0.34, 2.45], p = 0.14) compared with wet cupping (d=1.5, 95% CI: [0.39-2.6], p = 0.008) at the endpoint intervention. There was no evidence indicating the association between pain reduction and different types of cupping (p = 0.2). Moderate- to low-quality evidence showed that cupping did not reduce chronic low back pain (d=0.74, 95% CI: [-0.67-2.15], p = 0.30) and non-specific chronic low back pain (d=0.27, 95% CI: [-1.69-2.24], p = 0.78) at the endpoint intervention. Cupping on acupoints showed a significant improvement in pain (d=1.29, 95% CI: [0.63-1.94], p < 0.01) compared with the lower back area (d=0.35, 95% CI: [-0.29-0.99], p = 0.29). A potential association between pain reduction and different cupping locations (p = 0.05) was found. Meta-analysis showed a significant effect on pain improvement compared to medication therapy (n = 8; d=1.8 [95% CI: 1.22 – 2.39], p < 0.001) and usual care (n = 5; d=1.07 [95% CI: 0.21- 1.93], p = 0.01). Two studies demonstrated that cupping significantly mediated sensory and emotional pain immediately, after 24 h, and 2 weeks post-intervention (d= 5.49, 95% CI [4.13-6.84], p < 0.001). Moderate evidence suggested that cupping improved disability at the 1-6 months follow-up (d=0.67, 95% CI: [0.06-1.28], p = 0.03). There was no immediate effect observed at the 2-8 weeks endpoint (d=0.40, 95% CI: [-0.51-1.30], p = 0.39). A high degree of heterogeneity was noted in the subgroup analysis (I2 >50%).
The authors concluded that high- to moderate-quality evidence indicates that cupping significantly improves pain and disability. The effectiveness of cupping for LBP varies based on treatment durations, cupping types, treatment locations, and LBP classifications. Cupping demonstrated a superior and sustained effect on pain reduction compared with medication and usual care. The notable heterogeneity among studies raises concerns about the certainty of these findings. Further research should be designed with a standardized cupping manipulation that specifies treatment sessions, frequency, cupping types, and treatment locations. The actual therapeutic effects of cupping could be confirmed by using objective pain assessments. Studies with at least six- to twelve-month follow-ups are needed to investigate the long-term efficacy of cupping in managing LBP.
A crucial point here is that only 3 of the included studies were ‘patient-blind’, i.e. tried to control for placebo effects by using a sham procedure:
- The first of these used leaking vaccum cups that failed to create sucction. This would therefore not have resulted in the typical circular hematoma. In other words, patients were easily de-blinded.
- The second trial compared two different wet cupping techniques which involved different procedures. This would have been easily identifiable by the patients. In other words, patients were easily de-blinded.
- The third (which showed no effectiveness of cupping) supposedly patient-blind study used a similar method as the first. In other words, patients were easily de-blinded.
In addition, we ought to remember that in no study was it possible to blind the therapists. Thus there is a danger of verbal or non-verbal communications impacting on the outcomes.
In my view, it follows that the effectiveness of cupping is far lass certain than the authors of this paper try to make us believe.
The aim of this study was to assess the effectiveness of different forms of walking in reducing symptoms of depression and anxiety. A systematic review and meta-analysis of randomized controlled trials (RCTs) was conducted assessing the effects of walking on depressive and anxiety symptoms. MEDLINE, Cochrane Central Register of Controlled Trials (CENTRAL), Embase, PsycINFO, Allied and Complementary Medicine Database (AMED), CINAHL, and Web of Science were searched on April 5, 2022. Two authors independently screened the studies and extracted the data. Random-effects meta-analysis was used to synthesize the data. Results were summarized as standardized mean differences (SMDs) with 95% CIs in forest plots. The risk of bias was assessed by using the Cochrane Risk of Bias tool.
This review included 75 RCTs with 8636 participants; 68 studies reported depressive symptoms, 39 reported anxiety symptoms, and 32 reported both as the outcomes. One study reported the results for adolescents and was not included in the meta-analysis. The pooled results for adults indicated that walking could significantly reduce depressive symptoms (RCTs: n=44; SMD −0.591, 95% CI −0.778 to −0.403; I2=84.8%; τ2=0.3008; P<.001) and anxiety symptoms (RCTs: n=26; SMD −0.446, 95% CI −0.628 to −0.265; I2=81.1%; τ2=0.1530; P<.001) when compared with the inactive controls. Walking could significantly reduce depressive or anxiety symptoms in most subgroups, including different walking frequency, duration, location (indoor or outdoor), and format (group or individual) subgroups (all P values were <.05). Adult participants who were depressed (RCTs: n=5; SMD −1.863, 95% CI −2.764 to −0.962; I2=86.4%; τ2=0.8929) and those who were not depressed (RCTs: n=39; SMD −0.442, 95% CI −0.604 to −0.280; I2=77.5%; τ2=0.1742) could benefit from walking effects on their depressive symptoms, and participants who were depressed could benefit more (P=.002). In addition, there was no significant difference between walking and active controls in reducing depressive symptoms (RCTs: n=17; SMD −0.126, 95% CI −0.343 to 0.092; I2=58%; τ2=0.1058; P=.26) and anxiety symptoms (14 RCTs, SMD −0.053, 95% CI −0.311 to 0.206, I2=67.7%, τ2=0.1421; P=.69).
The authors concluded that various forms of walking can be effective in reducing symptoms of depression and anxiety, and the effects of walking are comparable to active controls. Walking can be adopted as an evidence-based intervention for reducing depression and anxiety. More evidence on the effect of low-intensity walking is needed in the future.
Clinical trials of walking are encounter considerable methodological difficulties: there is no adequate placebo, for instance. Thus, such studies are often conducted against no treatment or against ‘active control’ which means that the control group receives a therapy of known effectiveness.
The former comparison is not very meaningful because it does not allow us to tell whether the effects are truly caused by walking or by some non-specific effect. The latter comparison is more rigorous but also not perfect because the patients cannot be blinded.
This means we have to accept a degree of uncertainty in estimating the benefit of walking. As walking is not expensive, not hazardous, and has many other health benefits, this caveat seems truly minor. In other words, the findings reported here are encouraging and should be accepted in clinical practice.
Yet, there is still one ‘hair in the soup’: depressed people find it often very hard to motivate themselves to do activities such as walking. Thus, compliance with this treatment might often be less than satisfactory. It might be worth researching how this obstacle can be best overcome.
Since it is a rare occurance these days – I retired more than a decade ago – that I publish something in the peer-reviewed literature, please allow me to make some brief comments of this review just published by Spanish researchers and myself. The aim of this systematic review with meta-analysis was to evaluate the clinical effectiveness of visceral osteopathy (VO) in musculoskeletal and non-musculoskeletal disorders.
Two independent reviewers searched in PubMed, Physiotherapy Evidence Database, Cochrane Library, Scopus, and Web of Science databases in November 2023 and extracted data for randomized controlled trials evaluating the clinical effectiveness of VO. The risk of bias and the certainty of evidence were assessed using the Risk-of-Bias tool 2 and the GRADE Profile, respectively. Meta-analyses were conducted using random effect models using RevMan 5.4. software.
Fifteen studies were included in the qualitative and seven in the quantitative synthesis. For musculoskeletal disorders, the qualitative and quantitative synthesis suggested that VO produces no statistically significant changes in any outcome variable for patients with low back pain, neck pain or urinary incontinence. For non-musculoskeletal conditions, the qualitative synthesis showed that VO was not effective for the treatment of irritable bowel syndrome, breast cancer, and very low weight preterm infants. Most of the studies were classified as high risk of bias and the certainty of evidence downgraded to low or very low.
We concluded that VO did not show any benefit in any musculoskeletal or non-musculoskeletal condition.
Yes, I agree: these findings are hardly surprising. Visceral osteopathy (or visceral manipulation) is an expansion of the general principles of osteopathy and involves the manual manipulation by a therapist of internal organs, blood vessels and nerves (the viscera) from outside the body. Visceral osteopathy was developed by the osteopath Jean-Piere Barral. He stated that through his clinical work with thousands of patients, he created this modality based on organ-specific fascial mobilization. And through work in a dissection lab, he was able to experiment with visceral manipulation techniques and see the internal effects of the manipulations.[1] According to its proponents, visceral manipulation is based on the specific placement of soft manual forces looking to encourage the normal mobility, tone and motion of the viscera and their connective tissues. These gentle manipulations may potentially improve the functioning of individual organs, the systems the organs function within, and the structural integrity of the entire body.[2]
Visceral osteopathy is being practised mostly by osteopaths and less commonly chiropractors and physiotherapists. It comprises of several different manual techniques firstly for diagnosing a health problem and secondly for treating it. Several studies have assessed the diagnostic reliability of the techniques involved. The totality of this evidence fails to show that they are sufficiently reliable to be od practical use.[3] Other studies have tested whether the therapeutic techniques used in visceral osteopathy are effective in curing disease or alleviating symptoms. The totality of this evidence fails to show that visceral osteopathy works for any condition.[4] The treatment itself seems to be safe, yet the risks of visceral osteopathy are nevertheless considerable: if a patient suffers from symptoms related to her inner organs, the therapist is likely to misdiagnose them and subsequently mistreat them. If the symptoms are due to a serious disease, this would amount to medical neglect and could, in extreme cases, cost the patient’s life.
[all references in brackets [] can be found in my recent book]While the results of our review might be unsurprising, one thing about it did, after all, surprise me a great deal: the journal that published it, the ‘INTERNATIONAL JOURNAL OF OSTEOPATHIC MEDICINE‘. I even lost a bet for a bottle of wine with the lead author, because I said they would never accept it for publication!
This review aimed to assess the therapeutic efficacy of Reiki therapy in alleviating anxiety.
In adherence to academic standards, a thorough search was conducted across esteemed databases such as PubMed, Web of Science, Science Direct, and the Cochrane Library. The primary objective of this search was to pinpoint peer-reviewed articles published in English that satisfied specific criteria: (1) employing an experimental or quasi-experimental study design, (2) incorporating Reiki therapy as the independent variable, (3) encompassing diverse patient populations along with healthy individuals, and (4) assessing anxiety as the measured outcome.
The study involved 824 participants, all of whom were aged 18 years or older. Reiki therapy was found to have a significant effect on anxiety intervention(SMD=-0.82, 95CI -1.29∼-0.36, P = 0.001). Subgroup analysis indicated that the types of subjects (chronically ill individuals and the general adult population) and the dosage/frequency of the intervention (≤ 3 sessions and 6–8 sessions) were significant factors influencing the variability in anxiety reduction.
The authors concluded that short-term Reiki therapy interventions of ≤ 3 sessions and 6–8 sessions have demonstrated effectiveness in reducing health and procedural anxiety in patients with chronic conditions such as gastrointestinal endoscopy inflammation, fibromyalgia, and depression, as well as in the general population. It is important to note that the efficacy of Reiki therapy in decreasing preoperative anxiety and death-related anxiety in preoperative patients and cancer patients is somewhat less consistent. These discrepancies may be attributed to individual pathophysiological states, psychological conditions, and treatment expectations.
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This is a truly stunning finding considering that few treatments are less plausible that Reiki. I strongly suspect that these conclusions are not tenable. To see whether this is true, we must look at the primary studies (tedious, I know, but can’t be helped). Here are the abstracts of the 13 studies included in this review:
Purpose: The purpose of the study was to investigate changes in the anxiety levels of patients receiving preoperative Reiki.
Material and methods: This study used a quasi-experimental model with a pretest-posttest control group.
Methods: Subjects (n = 210) were recruited from a hospital in Turkey, from June 2013 to July 2014. Subjects were then assigned to experimental (n = 105) and control (n = 105) groups.
Results: The level of anxiety of experimental group patients did not change according to their state anxiety scores (p > 0.10); however, the anxiety level of control group patients increased (p < 0.001).
Conclusion: The results of this study imply that the administration of Reiki is effective in controlling preoperative anxiety levels and in preventing them from increasing.
I am not sure what is meant by “a quasi-experimental model with pretest- posttest control group”. Yet, I suspect this was not a properly randomised trial and should thus have been exclused from the review. There was no control of placebo effects.
Fatigue is an extremely common side effect experienced during cancer treatment and recovery. Limited research has investigated strategies stemming from complementary and alternative medicine to reduce cancer-related fatigue. This research examined the effects of Reiki, a type of energy touch therapy, on fatigue, pain, anxiety, and overall quality of life. This study was a counterbalanced crossover trial of 2 conditions: (1) in the Reiki condition, participants received Reiki for 5 consecutive daily sessions, followed by a 1-week washout monitoring period of no treatments, then 2 additional Reiki sessions, and finally 2 weeks of no treatments, and (2) in the rest condition, participants rested for approximately 1 hour each day for 5 consecutive days, followed by a 1-week washout monitoring period of no scheduled resting and an additional week of no treatments. In both conditions, participants completed questionnaires investigating cancer-related fatigue (Functional Assessment of Cancer Therapy Fatigue subscale [FACT-F]) and overall quality of life (Functional Assessment of Cancer Therapy, General Version [FACT-G]) before and after all Reiki or resting sessions. They also completed a visual analog scale (Edmonton Symptom Assessment System [ESAS]) assessing daily tiredness, pain, and anxiety before and after each session of Reiki or rest. Sixteen patients (13 women) participated in the trial: 8 were randomized to each order of conditions (Reiki then rest; rest then Reiki). They were screened for fatigue on the ESAS tiredness item, and those scoring greater than 3 on the 0 to 10 scale were eligible for the study. They were diagnosed with a variety of cancers, most commonly colorectal (62.5%) cancer, and had a median age of 59 years. Fatigue on the FACT-F decreased within the Reiki condition (P=.05) over the course of all 7 treatments. In addition, participants in the Reiki condition experienced significant improvements in quality of life (FACT-G) compared to those in the resting condition (P <.05). On daily assessments (ESAS) in the Reiki condition, presession 1 versus postsession 5 scores indicated significant decreases in tiredness (P <.001), pain (P <.005), and anxiety (P<.01), which were not seen in the resting condition. Future research should further investigate the impact of Reiki using more highly controlled designs that include a sham Reiki condition and larger sample sizes.
This was a pilot study which should not report efficacy outcomes merely test the feasibility of a definitive trial. There was no control of placebo effects.
Purpose: This study’s aim is to determine the effect of Reiki when applied before upper gastrointestinal endoscopy on levels of anxiety, stress, and comfort.
Design: This single-blind, a pretest and post-test design, randomized, sham-controlled study was held between February and July 2021.
Methods: Patients who met the inclusion criteria were separated by randomization into three groups: Reiki, sham Reiki, and control. A total of 159 patients participated in the study. In the intervention groups (Reiki and sham Reiki), Reiki and sham Reiki were applied once for approximately 20 to 25 minutes before gastrointestinal endoscopy.
Findings: When the Reiki group was compared to the sham Reiki and control groups following the intervention, the decrease in the levels of patient stress (P < .001) and anxiety (P < .001) and the increase in patient comfort (P < .001) were found to be statistically significant.
Conclusions: Reiki applied to patients before upper gastrointestinal endoscopy was effective in reducing stress and anxiety and in increasing comfort.
Here an attempt was made to control for placebo effects and to blind patients. Whether the latter was successful was not tested. Thus a placebo effects cannot be excluded.
The purpose of this study was to evaluate the effect of Reiki as an alternative and complementary approach to treating community-dwelling older adults who experience pain, depression, and/or anxiety. Participants (N = 20) were randomly assigned to either an experimental or wait list control group. The pre- and posttest measures included the Hamilton Anxiety Scale, Geriatric Depression Scale-Short Form, Faces Pain Scale, and heart rate and blood pressure. The research design included an experimental component to examine changes in these measures and a descriptive component (semi-structured interview) to elicit information about the experience of having Reiki treatments. Significant differences were observed between the experimental and treatment groups on measures of pain, depression, and anxiety; no changes in heart rate and blood pressure were noted. Content analysis of treatment notes and interviews revealed five broad categories of responses: Relaxation; Improved Physical Symptoms, Mood, and Well-Being; Curiosity and a Desire to Learn More; Enhanced Self-Care; and Sensory and Cognitive Responses to Reiki.
No attempt to control for placebo effects.
Purpose: The purpose of this randomized pilot was to determine feasibility of testing Reiki, a complementary therapy intervention, for women undergoing breast biopsy (BB).
Background: Increasingly women face the possibility of BB, the definitive test for breast cancer. Psychological distress associated with BB includes anxiety and depression. Reiki was proposed as an intervention to decrease anxiety and promote relaxation.
Method: Thirty-two women scheduled for BB were randomized to Reiki intervention versus conventional care control. Anxiety and depression were evaluated using self-report questionnaires.
Findings: Analysis found no significant mean differences between groups over time. Comparably low baseline anxiety levels (possible selection bias) decreased naturally with time allowing little room for observing treatment effect.
Conclusions: Reiki, when administered in the naturalistic setting of a complementary therapy office, did not suggest evidence of efficacy. An intervention offered within the bounds of the conventional care setting may be more feasible for addressing BB distress.
The study failed to produce a positive finding.
The aim of this study was to investigate the effect of Reiki on pain, anxiety, and hemodynamic parameters on postoperative days 1 and 2 in patients who had undergone cesarean delivery. The design of this study was a randomized, controlled clinical trial. The study took place between February and July 2011 in the Obstetrical Unit at Odemis Public Hospital in Izmir, Turkey. Ninety patients equalized by age and number of births were randomly assigned to either a Reiki group or a control group (a rest without treatment). Treatment applied to both groups in the first 24 and 48 hours after delivery for a total of 30 minutes to 10 identified regions of the body for 3 minutes each. Reiki was applied for 2 days once a day (in the first 24 and 48 hours) within 4-8 hours of the administration of standard analgesic, which was administered intravenously by a nurse. A visual analog scale and the State Anxiety Inventory were used to measure pain and anxiety. Hemodynamic parameters, including blood pressure (systolic and diastolic), pulse and breathing rates, and analgesic requirements also were recorded. Statistically significant differences in pain intensity (p = .000), anxiety value (p = .000), and breathing rate (p = .000) measured over time were found between the two groups. There was a statistically significant difference between the two groups in the time (p = .000) and number (p = .000) of analgesics needed after Reiki application and a rest without treatment. Results showed that Reiki application reduced the intensity of pain, the value of anxiety, and the breathing rate, as well as the need for and number of analgesics. However, it did not affect blood pressure or pulse rate. Reiki application as a nursing intervention is recommended as a pain and anxiety-relieving method in women after cesarean delivery.
No control for placebo effects.
Objective: to evaluate the effectiveness of massage and reiki in the reduction of stress and anxiety in clients at the Institute for Integrated and Oriental Therapy in Sao Paulo (Brazil).
Method: clinical tests randomly done in parallel with an initial sample of 122 people divided into three groups: Massage + Rest (G1), Massage + Reiki (G2) and a Control group without intervention (G3). The Stress Systems list and the Trace State Anxiety Inventory were used to evaluate the groups at the start and after 8 sessions (1 month), during 2015.
Results: there were statistical differences (p = 0.000) according to the ANOVA (Analysis of Variance) for the stress amongst the groups 2 and 3 (p = 0.014) with a 33% reductions and a Cohen of 0.78. In relation to anxiety-state, there was a reduction in the intervention groups compared with the control group (p < 0.01) with a 21% reduction in group 2 (Cohen of 1.18) and a 16% reduction for group 1 (Cohen of 1.14).
Conclusion: Massage + Reiki produced better results amongst the groups and the conclusion is for further studies to be done with the use of a placebo group to evaluate the impact of the technique separate from other techniques.
No control for placebo effects.
This randomized controlled study aimed to determine the effect of Reiki and aromatherapy on vital signs, oxygen saturation, and anxiety level in patients undergoing upper gastrointestinal endoscopy. The sample consisted of 100 patients divided into Reiki (n = 34), aromatherapy (n = 33), and control (n = 33) groups. Data were collected 3 times (before, during, and after the procedure) using a descriptive characteristics questionnaire, a follow-up form, and the State Anxiety Subscale. The Reiki group had a mean State Anxiety Subscale score of 53.59 ± 2.98 and 43.94 ± 4.31 before and after the procedure, respectively. The aromatherapy group had a mean State Anxiety Subscale score of 54.03 ± 4.03 and 43.85 ± 3.91 before and after the procedure, respectively. The control group had a mean State Anxiety Subscale score of 38.79 ± 4.68 and 53.30 ± 7.26 before and after the procedure, respectively (P < .05). The results showed that the Reiki and aromatherapy groups had significantly lower State Anxiety Subscale scores than the control group after the procedure, indicating that Reiki and aromatherapy help reduce anxiety levels. There was a significant difference in the mean respiratory rates and oxygen saturation levels between the groups (P < .05). In conclusion, patients who do Reiki or undergo aromatherapy are less likely to experience anxiety before upper gastrointestinal endoscopy.
No control for placebo effects.
The aim of this study is to investigate the effects of Reiki application on pain, anxiety, and quality of life in patients with fibromyalgia. The study was completed with a total of 50 patients: 25 in the experimental group and 25 in the control group. Reiki was applied to the experimental group and sham Reiki to the control group once a week for 4 weeks. Data were collected from the participants using the Information Form, Visual Analog Scale, McGill-Melzack Pain Questionnaire, State-Trait Anxiety Inventory, and Short Form-36. There was a significant difference between the mean Visual Analog Scale pain scores during and before the first week (P = .012), second week (P = .002), and fourth week (P = .020) measurements of the individuals in the experimental and control groups, after application. In addition, at the end of the 4-week period, the State Anxiety Inventory (P = .005) and the Trait Anxiety Inventory (P = .003) were significantly decreased in the Reiki group compared with the control group. Physical function (P = .000), energy (P = .009), mental health (P = .018), and pain (P = .029) subdimension scores of quality of life in the Reiki group increased significantly compared with the control group. Reiki application to patients with fibromyalgia may have positive effects on reducing pain, improving quality of life, and reducing state and trait anxiety levels.
Here an attempt was made to control for placebo effects and to blind patients. Whether the latter was successful was not tested. Thus a placebo effects cannot be excluded. The sample size was small.
Background: Reiki is a biofield therapy which is based on the explanatory model that the fields of energy and information of living systems can be influenced to promote relaxation and stimulate a healing response.
Objective: To conduct a pragmatic within-subject pilot trial of a remote Reiki program for frontline healthcare workers’ health-related symptoms during the COVID-19 pandemic.
Methods: Healthcare professionals in the UK (eg, physicians, nurses, and paramedics) were eligible to sign up for a distance Reiki program and were also invited to participate in the research study. Eight Reiki practitioners simultaneously gave each participant Reiki remotely for 20 minutes on 4 consecutive days. Feasibility of the research was assessed, including recruitment, data completeness, acceptability and intervention fidelity, and preliminary evaluation of changes in outcome measures. Participants’ stress, anxiety, pain, wellbeing, and sleep quality were evaluated with 7-point numerical rating scales. Measures were completed when signing up to receive Reiki (pre) and following the final Reiki session (post). Pre and post data were analyzed using Wilcoxon signed ranks tests.
Results: Seventy-nine healthcare professionals signed up to receive Reiki and took the baseline measures. Of those, 40 completed post-measures after the 4-day intervention and were therefore included in the pre-post analysis. Most participants were female (97.5%), and the mean age was 43.9 years old (standard deviations = 11.2). The study was feasible to conduct, with satisfactory recruitment, data completeness, acceptability, and fidelity. Wilcoxon signed ranks tests revealed statistically significant decreases in stress (M = -2.33; P < .001), anxiety (M = -2.79; P < .001) and pain (M = -.79; P < .001), and significant increases in wellbeing (M = -1.79; P < .001) and sleep quality (M = -1.33; P = .019).
Conclusions: The Reiki program was feasible and was associated with decreased stress, anxiety and pain, and increased wellbeing and sleep quality in frontline healthcare workers impacted by the COVID-19 pandemic.
Pilot study should not report efficacy findings and should be excluded.
Background: There is a scarcity of studies in the international literature regarding alternative treatment to the pharmacological and psychotherapeutic intervention in the face of depression symptoms. This study aimed to test a protocol based on natural therapy, alternatives to pharmacological and psychotherapeutic, through Mindfulness Meditation, Reiki, Acupuncture and Auriculotherapy, to treat the symptoms of depression for those who were with no pharmacological or psychotherapeutic treatment for these symptoms.
Methods: this is a randomized single-blind controlled pilot study. The final sample was 21 participants divided in two groups: experimental and control. Participants were evaluated by validated instruments during the screening process and after the intervention. The instruments were: Depression, Anxiety and Stress Scale and Beck Depression Inventory. Intervention was performed in eight sessions, during two months. All the techniques were used in the experimental group. Analysis of variance with repeated measures was used to compare pre-intervention to post-intervention moments.
Results: the result of analysis indicates a significant reduction in the symptoms of depression after the intervention among the experimental group.
Limitations: there is no way to determine which of the techniques used produced the most significant result.
Conclusions: The protocol proposed in this study was effective in reducing the symptoms of depression to whom are not eligible for traditional treatment.
This is a pilot study and should not report efficacy findings. It is also not a study of just Reiki. It should have been excluded.
This is a constructive replication of a previous trial conducted by Bowden et al. (2010), where students who had received Reiki demonstrated greater health and mood benefits than those who received no Reiki. The current study examined impact on anxiety/depression. 40 university students-half with high depression and/or anxiety and half with low depression and/or anxiety-were randomly assigned to receive Reiki or to a non-Reiki control group. Participants experienced six 30-minute sessions over a period of two to eight weeks, where they were blind to whether noncontact Reiki was administered as their attention was absorbed in a guided relaxation. The efficacy of the intervention was assessed pre-post intervention and at five-week follow-up by self-report measures of mood, illness symptoms, and sleep. The participants with high anxiety and/or depression who received Reiki showed a progressive improvement in overall mood, which was significantly better at five-week follow-up, while no change was seen in the controls. While the Reiki group did not demonstrate the comparatively greater reduction in symptoms of illness seen in our earlier study, the findings of both studies suggest that Reiki may benefit mood.
No control for placebo effects
This is a constructive replication of a previous trial conducted by Bowden et al. (2010), where students who had received Reiki demonstrated greater health and mood benefits than those who received no Reiki. The current study examined impact on anxiety/depression. 40 university students-half with high depression and/or anxiety and half with low depression and/or anxiety-were randomly assigned to receive Reiki or to a non-Reiki control group. Participants experienced six 30-minute sessions over a period of two to eight weeks, where they were blind to whether noncontact Reiki was administered as their attention was absorbed in a guided relaxation. The efficacy of the intervention was assessed pre-post intervention and at five-week follow-up by self-report measures of mood, illness symptoms, and sleep. The participants with high anxiety and/or depression who received Reiki showed a progressive improvement in overall mood, which was significantly better at five-week follow-up, while no change was seen in the controls. While the Reiki group did not demonstrate the comparatively greater reduction in symptoms of illness seen in our earlier study, the findings of both studies suggest that Reiki may benefit mood.
This is the only rigorous study included in the review. Its findings are not easy to interpret (“For the sample as a whole, as can be seen from the total group means, there was little change over the course of the study”)
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Even though I did not have access to the full text of all of these RCTs, this analysis tells me a few important things; here are some of the main points I discovered:
- the new review is fatally flawed;
- the authors’ statement that their “article presents a systematic review of randomized controlled trials (RCTs) that were conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines” is nonsensical;
- PRISMA guidelines were certainly not adhered to;
- there is no truly critical assessment of the primary studies;
- the literature searches were incomplete;
- the risk of bias tool for evaluating the primary studies was employed incorrectly;
- the review did not include all RCTs of Reiki (our own 2008 review included several trials that are not included here, and this blog has a few more);
- the review includes several studies that should have been excluded;
- most Reiki studies are of poor quality;
- with both the review and most of the primary studies, one feels a strong bias towards trying to prove that Reiki works;
- Reiki research is firmly in the hands of nurses (almost all the studies were conducted by nurses);
- almost all of the RCTs test Reiki versus no treatment, and this means that most do not control for placebo (or other non-specific) effects. In other words, the conclusions stating that Reiki is effective are simply wrong.
I am dismayed to see that a decent journal (BMC Palliative Care) published such a fatally flawed review. The paper fails to discuss any of its obvious flaws. Specifically, it does not even specify what interventions were used in the various control groups. Do the journal editors, peer-reviewers and authors not appreciate that, without such information, the findings are uninterpretable? Or do they perhaps deliberately try to mislead us?
If you ask me, this paper should be best withdrawn.
Our own review of Reiki is no longer up-to-date. Yet, it’s conclusion is, in my view, far more accurate than the one offered by the authors of the fatally flawed new review:
the evidence is insufficient to suggest that reiki is an effective treatment for any condition. Therefore the value of reiki remains unproven.
This systematic review and meta-analysis investigated the effectiveness and safety of manual therapy (MT) interventions compared to oral or topical pain medications in the management of neck pain.
The investigators searched from inception to March 2023, in Cochrane Central Register of Controller Trials (CENTRAL), MEDLINE, EMBASE, Allied and Complementary Medicine (AMED) and Cumulative Index to Nursing and Allied Health Literature (CINAHL; EBSCO) for randomized controlled trials that examined the effect of manual therapy interventions for neck pain when compared to oral or topical medication in adults with self-reported neck pain, irrespective of radicular findings, specific cause, and associated cervicogenic headaches. Trials with usual care arms were also included if they prescribed medication as part of the usual care and they did not include a manual therapy component. The authors used the Cochrane Risk of Bias 2 tool to assess the potential risk of bias in the included studies, and the Grading of Recommendations, Assessment, Development, and Evaluations (GRADE) approach to grade the quality of the evidence.
Nine trials with a total of 779 participants were included in the meta-analysis.
- low certainty of evidence was found that MT interventions may be more effective than oral pain medication in pain reduction in the short-term (Standardized Mean Difference: -0.39; 95% CI -0.66 to -0.11; 8 trials, 676 participants),
- moderate certainty of evidence was found that MT interventions may be more effective than oral pain medication in pain reduction in the long-term (Standardized Mean Difference: −0.36; 95% CI −0.55 to −0.17; 6 trials, 567 participants),
- low certainty evidence that the risk of adverse events may be lower for patients who received MT compared to the ones that received oral pain medication (Risk Ratio: 0.59; 95% CI 0.43 to 0.79; 5 trials, 426 participants).
The authors conluded that MT may be more effective for people with neck pain in both short and long-term with a better safety profile regarding adverse events when compared to patients receiving oral pain medications. However, we advise caution when interpreting our safety results due to the different level of reporting strategies in place for MT and medication-induced adverse events. Future MT trials should create and adhere to strict reporting strategies with regards to adverse events to help gain a better understanding on the nature of potential MT-induced adverse events and to ensure patient safety.
Let’s have a look at the primary studies. Here they are with their conclusions (and, where appropriate, my comments in capital letters):
- For participants with acute and subacute neck pain, spinal manipulative therapy (SMT) was more effective than medication in both the short and long term. However, a few instructional sessions of home exercise with (HEA) resulted in similar outcomes at most time points. EXERCISE WAS AS EFFECTIVE AS SMT
- Oral ibuprofen (OI) pharmacologic treatment may reduce pain intensity and disability with respect to neural mobilization (MNNM and CLG) in patients with CP during six weeks. Nevertheless, the non-existence of between-groups ROM differences and possible OI adverse effects should be considered. MEDICATION WAS BETTER THAN MT
- It appears that both treatment strategies (usual care + MT vs usual care) can have equivalent positive influences on headache complaints. Additional studies with larger study populations are needed to draw firm conclusions. Recommendations to increase patient inflow in primary care trials, such as the use of an extended network of participating physicians and of clinical alert software applications, are discussed. MT DOES NOT IMPROVE OUTCOMES
- The consistency of the results provides, in spite of several discussed shortcomings of this pilot study, evidence that in patients with chronic spinal pain syndromes spinal manipulation, if not contraindicated, results in greater improvement than acupuncture and medicine. THIS IS A PILOT STUDY, A TRIAL TESTING FEASIBILITY, NOT EFFECTIVENESS
- The consistency of the results provides, despite some discussed shortcomings of this study, evidence that in patients with chronic spinal pain, manipulation, if not contraindicated, results in greater short-term improvement than acupuncture or medication. However, the data do not strongly support the use of only manipulation, only acupuncture, or only nonsteroidal antiinflammatory drugs for the treatment of chronic spinal pain. The results from this exploratory study need confirmation from future larger studies.
- In daily practice, manual therapy is a favorable treatment option for patients with neck pain compared with physical therapy or continued care by a general practitioner.
- Short-term results (at 7 weeks) have shown that MT speeded recovery compared with GP care and, to a lesser extent, also compared with PT. In the long-term, GP treatment and PT caught up with MT, and differences between the three treatment groups decreased and lost statistical significance at the 13-week and 52-week follow-up. MT IS NOT SUPERIOR [SAME TRIAL AS No 6]
- In this randomized clinical trial, for patients with chronic neck pain, Chuna manual therapy was more effective than usual care in terms of pain and functional recovery at 5 weeks and 1 year after randomization. These results support the need to consider recommending manual therapies as primary care treatments for chronic neck pain.
- In patients with chronic spinal pain syndromes, spinal manipulation, if not contraindicated, may be the only treatment modality of the assessed regimens that provides broad and significant long-term benefit. SAME TRIAL AS No 5
- An impairment-based manual physical therapy and exercise (MTE) program resulted in clinically and statistically significant short- and long-term improvements in pain, disability, and patient-perceived recovery in patients with mechanical neck pain when compared to a program comprising advice, a mobility exercise, and subtherapeutic ultrasound. THIS STUDY DID NOT TEST MT ALONE AND SHOULD NOT HAVE BEEN INCLUDED
I cannot bring myself to characterising this as an overall positive result for MT; anyone who can is guilty of wishful thinking, in my view. The small differences in favor of MT that (some of) the trials report have little to do with the effectiveness of MT itself. They are almost certainly due to the fact that none of these studies were placebo-controlled and double blind (even though this would clearly be possible). In contrast to popping a pill, MT involves extra attention, physical touch, empathy, etc. These factors easily suffice to bring about the small differences that some studies report.
It follows that the main conclusion of the authors of the review should be modified:
There is no compelling evidence to show that MT is more effective for people with neck pain in both short and long-term when compared to patients receiving oral pain medications.
This systematic review and meta-analysis aimed to evaluate the effectiveness of spiritually based interventions on blood pressure (BP) among adults. A systematic search was performed using the PubMed, Scopus, and Cochrane databases to identify studies evaluating spiritual interventions, including:
- meditation,
- transcendental meditation,
- mindfulness meditation,
- yoga,
for high BP among adults up to January 1, 2022.
The inclusion criteria were:
- (a) randomized controlled trials (RCTs),
- (b) studies in English or Persian,
- (c) studies conducted among adults (≥ 18 years),
- (d) studies reporting systolic or diastolic BP.
Given the high heterogeneity of these studies, a random effect model was used to calculate the effect sizes for the RCTs.
In total, the systematic review included 24 studies and the meta-analysis included 23 studies. As some of studies reported two or more outcome measurements, separate estimates of each outcome were extracted for that study (24 datasets). Fifteen trials reported the mean (SD) systolic blood pressure (SBP), and 13 trials reported the mean (SD) diastolic blood pressure (DBP). In addition, 13 studies reported means (SDs) and six trials reported mean changes in DBP. A significant decrease was found in systolic BP following intervention ((WMD (weighted mean difference) = − 7.63 [− 9.61 to − 5.65; P < 0.001]). We observed significant heterogeneity among the studies (I2 = 96.9; P < 0.001). A significant decrease was observed in DBP following the interventions (WMD = − 4.75 [− 6.45 to − 3.05; P < 0.001]).
The authors concluded that spiritually based interventions including meditation and yoga had beneficial effects in reducing both SBP and DBP. Reducing BP can be expected to reduce the risk of cardiovascular diseases.
Q: What do the RCTs of these interventions have in common?
A: They cannot normally be placebo-controlled because no adequate placebos exist for these therapies.
Q: What does that mean?
A: It means that patients could not be blinded and that patient expectations influenced the outcome.
In view of the fact that blood pressure is an endpoint that is extremely sensitive to expectation, I think, the conclusions of this paper might need to be re-formulated:
This analysis confirms that expectation can have beneficial effects in reducing both SBP and DBP. Reducing BP can be expected to reduce the risk of cardiovascular diseases.
These days, it has become a rare event – I am speaking of me publishing a paper in the peer-reviewed medical literature. But it has just happened: Spanish researchers and I published a meta-analysis on the effectiveness of craniosacral therapy. Here is its abstract:
The aim of this study was to evaluate the clinical effectiveness of craniosacral therapy (CST) in the management of any conditions. Two independent reviewers searched the PubMed, Physiotherapy Evidence Database, Cochrane Library, Web of Science, and Osteopathic Medicine Digital Library databases in August 2023, and extracted data from randomized controlled trials (RCT) evaluating the clinical effectiveness of CST. The PEDro scale and Cochrane Risk of Bias 2 tool were used to assess the potential risk of bias in the included studies. The certainty of the evidence of each outcome variable was determined using GRADEpro. Quantitative synthesis was carried out with RevMan 5.4 software using random effect models.
Fifteen RCTs were included in the qualitative and seven in the quantitative synthesis. For musculoskeletal disorders, the qualitative and quantitative synthesis suggested that CST produces no statistically significant or clinically relevant changes in pain and/or disability/impact in patients with headache disorders, neck pain, low back pain, pelvic girdle pain, or fibromyalgia. For non-musculoskeletal disorders, the qualitative and quantitative synthesis showed that CST was not effective for managing infant colic, preterm infants, cerebral palsy, or visual function deficits.
We concluded that the qualitative and quantitative synthesis of the evidence suggest that CST produces no benefits in any of the musculoskeletal or non-musculoskeletal conditions assessed. Two RCTs suggested statistically significant benefits of CST in children. However, both studies are seriously flawed, and their findings are thus likely to be false positive.
So, CST is not really an effective option for any condition.
Not a big surprise! After all, the assumptions on which CST is based fly in the face of science.
Since CST is nonetheless being used by many healthcare professionals, it is, I feel, important to state and re-state that CST is an implausible intervention that is not supported by clinical evidence. Hopefully then, one day, these practitioners will remember that their ethical obligation is to treat their patients not according to their beliefs but according to the best available evidence. And, hopefully, our modest paper will have helped rendering healthcare a little less irrational and somewhat more effective.
