This study was aimed at evaluating the effectiveness of osteopathic visceral manipulation (OVM) combined with physical therapy in pain, depression, and functional impairment in patients with chronic mechanical low back pain (LBP).
A total of 118 patients with chronic mechanical LBP were assessed, and 86 who met the inclusion criteria were included in the randomized clinical trial (RCT). The patients were randomized to either:
- Group 1 (n=43), who underwent physical therapy (5 days/week, for a total of 15 sessions) combined with OVM (2 days/week with three-day intervals),
- or Group 2 (n=43), which underwent physical therapy (5 days/week, for a total of 15 sessions) combined with sham OVM (2 days/week with three-day intervals).
Both groups were assessed before and after treatment and at the fourth week post-treatment.
Seven patients were lost to follow-up, and the study was completed with 79 patients. Pain, depression, and functional impairment scores were all improved in both groups (p=0.001 for all). This improvement was sustained at week four after the end of treatment. However, improvement in the pain, depression, and functional impairment scores was significantly higher in Group 1 than in Group 2 (p=0.001 for all).
The authors concluded that the results suggest that OVM combined with physical therapy is useful to improve pain, depression, and functional impairment in patients with chronic mechanical low back pain. We believe that OVM techniques should be combined with other physical therapy modalities in this patient population.
OVM was invented by the French osteopath, Jean-Piere Barral. In the 1980s, he stated that through his clinical work with thousands of patients, he discovered that many health issues were caused by our inner organs being entrapped and immobile. According to its proponents, OVM is based on the specific placement of soft manual forces that encourage the normal mobility, tone and function of our inner organs and their surrounding tissues. In this way, the structural integrity of the entire body is allegedly restored.
I am not aware of good evidence to show that OVM is effective – and this, sadly, includes the study above.
In my view, the most plausible explanation for its findings have little to do with OVM itself: sham OVM was applied “by performing light pressure and touches with the palm of the hand on the selected points for OVM without the intention of treating the patient”. This means that most likely patients were able to tell OVM from sham OVM and thus de-blinded. In other words, their expectation of receiving an effective therapy (and not the OVM per se) determined the outcome.
Autogenic training (AT) is a relaxation technique that has garnered attention for its potential to reduce anxiety and improve psychological well-being. This review aimed to synthesize the findings from a diverse range of studies investigating the relationship between AT and anxiety disorder across different populations and settings.
A comprehensive review of 162 studies, including randomised controlled trials (RCTs), non-randomized controlled trials (N-RCTs), surveys, and meta-analysis, was conducted and 29 studies were selected. Participants in the studies were patients with:
- bulimia nervosa,
- coronary angioplasty,
Others were nursing students, healthy volunteers, athletes, etc.
Anxiety levels were measured before and after the AT intervention using a variety of anxiety assessment scales, including the State Trait Anxiety Inventory (STAI) and the Hospital Anxiety and Depression Scale (HADS). The formats, duration, and delivery of the interventions varied, with some studies utilising guided sessions by professionals and other self-administered practises.
The combined findings of these studies revealed consistent trends in the beneficial effects of AT on anxiety reduction. AT was found to be effective in reducing anxiety symptoms across a wide range of populations and settings. Following AT interventions, participants reported reduced anxiety, improved mood states, and improved coping mechanisms. AT was found to be superior to no treatment or a comparable intervention in a number of cases.
The authors conclused that the body of evidence supports autogenic training as a non-pharmacological approach to reducing anxiety and improving psychological well-being. Despite differences in methodology and participant profiles, the studies show that AT has a positive impact on a wide range of populations. The findings merit further investigation and highlight AT’s potential contribution to anxiety management strategies.
I was taught AT many years ago and have practised it occasionally ever since. I have also co-authored several papers of AT that showed encouraging results, e.g.:
- Autogenic training for tension type headaches: a systematic review of controlled trials. Complement Ther Med. 2006 Jun;14(2):144-50.
- Autogenic training for stress and anxiety: a systematic review. Complement Ther Med. 2000 Jun;8(2):106-10.
- Autogenic training to reduce anxiety in nursing students: randomized controlled trial. Kanji N, White A, Ernst E.J Adv Nurs. 2006 Mar;53(6):729-35.
- Autogenic training to manage symptomology in women with chest pain and normal coronary arteries. Menopause. 2009 Jan-Feb;16(1):60-5.
- Autogenic training reduces anxiety after coronary angioplasty: a randomized clinical trial. Am Heart J. 2004 Mar;147(3)
Thus, I feel that the conclusions of this review might be correct.
Several further recent papers seem to support the notion that AT is a treatment worth trying, e.g.:
- A review concluded that as an add-on intervention psychotherapy technique with beneficial outcome on psychophysiological functioning, AT represents a promising avenue towards expanding research findings of brain-body links beyond the current limits of the prevention and clinical management of number of mental disorders.
- A clinical trial showed that AT seems to improve sleep quality and could improve some dimensions of quality of life and other symptoms among people living with HIV. Further studies are needed to confirm these results.
Why then AT is not better studied and more popular? A short paragraph of my next book (to be published in about 6 months) on the inventors of so-called alternative medicines (SCAMs), including the German psychiatry professor Johannes Schulz (1884-1970), inventor of AT, might give you a clue:
Schultz supported the euthanasia program of the Nazis, i.e. the extermination of disabled and other people considered ‘unworthy of living’ during the Third Reich. He passed death sentences on “hysterical women” through his diagnoses. In 1933, Schultz began research on a guide-book on sexual education in which he focused on homosexuality and explored the topics of sterilization and euthanasia. In 1935, he published an essay about the psychological consequences of sterilization and castration among men; in it he supported compulsory sterilization of men in order to eliminate hereditary illnesses. With a diagnostic scheme developed by him in 1940, Schulz advocated the execution of mentally ill patients by stating: “I personally have to align myself with Mr. Hoche […], by recalling the ‘annihilation of life unworthy of life’ and by raising the hope that the madhouses will soon become emptied and remodelled according to this principle.” Schultz was fully aware of the consequences of his diagnostic assessment and even used the term “death sentence in the form of a diagnosis”.
I came across this evidence only years after having published my papers on AT. Would I have developed an interest in AT, if I had known about Schulz’s Nazi past? Probably not.
We have discussed the currently fashionable herbal remedy, ‘kratom‘, before:
A quick recap:
Kratom is made of the leaves of Mitragyna speciosa, a tree endogenous to parts of Southeast Asia. It has been used traditionally for its stimulant, mood-elevating, and analgesic effects. The plant’s active constituents, mitragynine and 7-hydroxymitragynine, have been shown to modulate opioid receptors, acting as partial agonists at mu-opioid receptors and competitive antagonists at kappa- and delta-opioid receptors. Both alkaloids are G protein-biased agonists of the mu-opioid receptor and therefore, may induce less respiratory depression than classical opioid agonists. The Mitragyna alkaloids also appear to exert diverse activities at other brain receptors (including adrenergic, serotonergic, and dopaminergic receptors), which may explain the complex pharmacological profile of raw kratom extracts. By the early 2000s, kratom was increasingly used in the US as a substitute for prescription and illicit opioids for managing pain and opioid withdrawal by people seeking abstinence from opioids. There are numerous assessments where people have been unable to stop using kratom and withdrawal signs and symptoms are problematic. Kratom does not appear in normal drug screens and, when taken with other substances of abuse, may not be recognized.
Now it has been reported that the family of a Florida woman who died in 2021 after ingesting kratom has been awarded more than $11m from a distributor of the herbal extract. “There is of course no amount of money that will make up for the pain and suffering that Ms Talavera’s children are enduring because of their mother’s death,” Middlebrooks wrote in court records addressing the sanction against Kratom Distro. “The law nonetheless recognizes that the defendant must pay something, however inadequate.”
The US Drug Enforcement Agency in 2016 had imposed its strictest restrictions on kratom, which is made from the leaves of an evergreen tree and is often used by people to self-treat pain, anxiety, depression, and opioid addiction as well as withdrawal. There was an intense, immediate public backlash to that approach, however, and it prompted the DEA to rescind its prohibition of kratom, which is sold in stores and online.
The US Food and Drug Administration nonetheless has warned consumers over possible safety and addiction risks associated with kratom, and it has spoken in favor of more research aimed at gaining a better understanding of “the substance and its components”.
Friends of Talavera, a resident of the Florida community of Boynton Beach, introduced her to kratom years before her death. Her family said she regarded it as a safe, natural supplement and had taken some after buying it online from the Kratom Distro when her partner and the father of her youngest child – Biagio Vultaggio – found her unconscious in the living room on 20 June 2021. The 39-year-old Talavera was face down on the ground next to an open bag of a kratom derivative marketed as a “space dust”, her family has said. Vultaggio called paramedics, and they took Talavera to a hospital where she was pronounced dead. An autopsy later listed Talavera’s cause of death as acute intoxication from mitragynine, the main kratom component. The local coroner wrote in a report that “at high concentrations, mitragynine produces opioid-like effects, such as respiratory failure”.
Kratom Disro claims that
- Our kratom powder is sourced directly from Indonesia monthly. Your order was literally on a farm in Indonesia two months ago. No old powder.
- Our kratom extracts are produced in the US by a licensed chemist and a professionally trained staff.
- We only use delicious flavors and quality ingredients.
- Every batch of products we receive is lab tested and will not ship out without meeting our meticulous quality standards.
- Current labs – We will never show you an out-of-date lab with our products.
- Guaranteed purity levels and free of all toxins.
Get It When You Want It
- Many orders shipped same day.
- USPS shipping on all orders under 6 pounds.
- Larger orders can ship USPS Priority for a small additional charge.
Back to the above lawsuit:
One of the attorneys for Talavera’s family, Tamara Williams, said in a statement that the judgment won by her clients “should be a wakeup call to the kratom industry”. Williams’s law firm had also recently won a $2.5m jury verdict against a kratom manufacturer in Washington state after a separate lawsuit alleging wrongful death. A colleague of Williams called on government officials to take steps “to protect other families from having to deal with unnecessary kratom overdose deaths”.
Low back pain is the leading cause of years lived with disability globally, but most interventions have only short-lasting, small to moderate effects. Cognitive functional therapy (CFT) is an individualized approach that targets unhelpful pain-related cognitions, emotions, and behaviors that contribute to pain and disability. Movement sensor biofeedback might enhance treatment effects.
This study aimed to compare the effectiveness and economic efficiency of CFT, delivered with or without movement sensor biofeedback, with usual care for patients with chronic, disabling low back pain.
RESTORE was a randomized, three-arm, parallel-group, phase 3 trial, done in 20 primary care physiotherapy clinics in Australia. The researchers recruited adults (aged ≥18 years) with low back pain lasting more than 3 months with at least moderate pain-related physical activity limitation. Exclusion criteria were serious spinal pathology (eg, fracture, infection, or cancer), any medical condition that prevented being physically active, being pregnant or having given birth within the previous 3 months, inadequate English literacy for the study’s questionnaires and instructions, a skin allergy to hypoallergenic tape adhesives, surgery scheduled within 3 months, or an unwillingness to travel to trial sites. Participants were randomly assigned (1:1:1) via a centralized adaptive schedule to
- usual care,
- CFT only,
- CFT plus biofeedback.
The primary clinical outcome was activity limitation at 13 weeks, self-reported by participants using the 24-point Roland Morris Disability Questionnaire. The primary economic outcome was quality-adjusted life-years (QALYs). Participants in both interventions received up to seven treatment sessions over 12 weeks plus a booster session at 26 weeks. Physiotherapists and patients were not masked.
Between Oct 23, 2018, and Aug 3, 2020, the researchers assessed 1011 patients for eligibility. After excluding 519 (51·3%) ineligible patients, they randomly assigned 492 (48·7%) participants; 164 (33%) to CFT only, 163 (33%) to CFT plus biofeedback, and 165 (34%) to usual care. Both interventions were more effective than usual care (CFT only mean difference –4·6 [95% CI –5·9 to –3·4] and CFT plus biofeedback mean difference –4·6 [–5·8 to –3·3]) for activity limitation at 13 weeks (primary endpoint). Effect sizes were similar at 52 weeks. Both interventions were also more effective than usual care for QALYs, and much less costly in terms of societal costs (direct and indirect costs and productivity losses; –AU$5276 [–10 529 to –24) and –8211 (–12 923 to –3500).
The authors concluded that CFT can produce large and sustained improvements for people with chronic disabling low back pain at considerably lower societal cost than that of usual care.
This is a well-designed and well-reported study. It shows that CFT is better than usual care. The effect sizes are not huge and seem similar to many other treatments for chronic LBP, including the numerous so-called alternative medicine (SCAM) options that are available.
Faced with a situation where we have virtually dozens of therapies of similar effectiveness, what should we recommend to patients? I think this question is best and most ethically answered by accounting for two other important determinants of usefulness:
CFT is both low in risk and cost. So is therapeutic exercise. We would therefore need a direct comparison of the two to decide which is the optimal approach.
Until we have such a study, patients might just opt for one or both of them. What seems clear, meanwhile, is this: SCAM does not offer the best solution to chronic LBP. In particular, chiropractic, osteopathy, or acupuncture – which are neither low-cost nor risk-free – are, contrary to what some try so very hard to convince us of, sensible options.
Social prescribing (SP) has been mentioned here several times before. It seems important to so-called alternative medicine (SCAM), as some enthusiasts – not least King Charles – are trying to use it as a means to smuggle nonsensical treatments into routine healthcare.
SP is supposed to enable healthcare professionals to link patients with non-medical interventions available in the community to address underlying socioeconomic and behavioural determinants. The question, of course, is whether it has any relevant benefits.
This systematic review included all randomised controlled trials of SP among community-dwelling adults recruited from primary care or community setting, investigating any chronic disease risk factors defined by the WHO (behavioural factors: smoking, physical inactivity, unhealthy diet and excessive alcohol consumption; metabolic factors: raised blood pressure, overweight/obesity, hyperlipidaemia and hyperglycaemia). Random effect meta-analyses were performed at two time points: completion of intervention and follow-up after trial.
The researchers identified 9 reports from 8 trials totalling 4621 participants. All studies evaluated SP exercise interventions which were highly heterogeneous regarding the content, duration, frequency and length of follow-up. The majority of studies had some concerns about the risk of bias. A meta-analysis revealed that SP likely increased physical activity (completion: mean difference (MD) 21 min/week, 95% CI 3 to 39, I2=0%; follow-up ≤12 months: MD 19 min/week, 95% CI 8 to 29, I2=0%). However, SP may not improve markers of adiposity, blood pressure, glucose and serum lipid. There were no eligible studies that primarily target unhealthy diet, smoking or excessive alcohol-drinking behaviours.
The authors concluded that SP exercise interventions probably increased physical activity slightly; however, no benefits were observed for metabolic factors. Determining whether SP is effective in modifying the determinants of chronic diseases and promotes sustainable healthy behaviours is limited by the current evidence of quantification and uncertainty, warranting further rigorous studies.
Great! Regular exercise improves physical fitness.
But do we need SP for this?
Don’t get me wrong, I have nothing against connecting patients with social networks to improve their health and quality of life. I do, however, object if SP is used to smuggle unproven or disproven SCAMs into EBM. In addition, I ask myself whether we really need the new profession of a ‘link worker’ to facilitate SP. I remember being taught that a good doctor should look after his/her patients holistically, and surely that includes mentioning and facilitating social networks for those who need them.
I, therefore, fear that SP is taking something valuable out of the hands of doctors. And the irony is that SP is favoured by those who are all too quick to turn around and say: LOOK AT HOW FRIGHTFULLY REDUCTIONIST AND HEARTLESS DOCTORS HAVE BECOME. WE NEED MORE HOLISM IN MEDICINE AND THAT CAN ONLY BE PROVIDED BY SCAM PRACTITIONERS!
Irritable bowel syndrome (IBS) is a common chronic disorder associated with psychological distress and reduced health-related quality of life (HRQoL). Therefore, stress management is often employed in the hope of alleviating IBS symptoms. But does it work?
This systematic review investigated the effects of stress management for adults with IBS on typical symptoms, HRQoL, and mental health. The predefined criteria included:
- patients: adults with IBS;
- intervention: stress management;
- control: care as usual or waitlist;
- outcome: patient-relevant;
- study-type: controlled trials.
Two researchers independently reviewed the publications retrieved through electronic searches and assessed the risk of bias using the Scottish Intercollegiate Guidelines Network checklist. The researchers performed a meta-analysis with homogeneous trials of acceptable quality.
After screening 6656 publications, 10 suitable randomized trials of acceptable (n = 5) or low methodological quality (n = 5) involving 587 patients were identified. The meta-analysis showed no effect of stress management on IBS severity 1-2 months after the intervention (Hedges’ g = -0.23, 95%-CI = -0.84 to -0.38, I2 = 86.1%), and after 3-12 months (Hedges’ g = -0.77, 95%-CI = -1.77 to -0.23, I2 = 93.3%). One trial found a short-term reduction of symptoms, and one trial found symptom relief in the long term (at 6 months). One of two studies that examined HRQoL found an improvement (after 2 months). One of two studies that examined depression and anxiety found a reduction of these symptoms (after 3 weeks).
The authors concluded that stress management may be beneficial for patients with IBS regarding the short-term reduction of bowel and mental health symptoms, whereas long-term benefits are unclear. Good quality RCTs with more than 6 months follow-up are needed.
Considering the actual evidence, I find the conclusions rather odd. Would it not have been more honest to state something along the following lines?:
There is currently no convincing evidence to suggest that stress management benefits IBS patients.
So why, be not more open and less misleading?
Could some of the authors’ affiliations provide a clue?
- Department for Internal and Integrative Medicine, Sozialstiftung Bamberg Hospital, Bamberg, Germany.
- Department for Integrative Medicine, University of Duisburg-Essen, Medical Faculty, Bamberg, Germany.
Quite possibly, yes!
Reiki is a Japanese form of energy healing used predominantly for stress reduction and relaxation. It is based on the notion that a mystical “life force energy” flows through us and is what causes us to be alive.
This study was conducted by researchers from the Department of Elderly Care, Vocational School of Health Services, Mardin Artuklu University, Mardin, Turkey, and the Internal Medicine Nursing Department, Mersin University Faculty of Nursing, Mersin, Turkey. Its aim was to determine the effect of Reiki when applied before upper gastrointestinal endoscopy on levels of anxiety, stress, and comfort. It was designed as a single-blind, randomized, sham-controlled study and conducted between February and July 2021.
- sham Reiki,
- control (no intervention).
A total of 159 patients participated in the study. In groups 1 and 2, Reiki and sham Reiki was applied once for approximately 20 to 25 minutes before gastrointestinal endoscopy.
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.
The authors concluded that Reiki applied to patients before upper gastrointestinal endoscopy was effective in reducing stress and anxiety and in increasing comfort.
As this paper is behind a paywall, I wrote to the authors and asked for a reprint. Unfortunately, I received no reply at all. Thus, I find it difficult to comment. Yet, the study might be important, particularly because there are not many sham-controlled trials of Reiki.
The abstract merely informs us that Reiki was better than sham Reiki. It does not tell us what constituted the sham intervention. Crucially, we also cannot know whether the patients were adequately blinded or whether they were able to tell the sham from the verum.
In the absence of this information, I am merely able to state that Reiki lacks plausibility and is most unlikely, in my view, to have any specific therapeutic effects. This means that the most likely explanation for the extraordinary results of this study is the de-blinding of some of the patients in group 2 or some other source of bias that cannot be identified from just studying the abstract.
If someone can send me the full paper, I’d be more than happy to clarify the apparent mystery.
Acupuncture is questionable.
Acupressure is highly questionable.
Auricular acupressure is extremely questionable.
This study investigated the effect of auricular acupressure on the severity of postpartum blues. A randomized sham-controlled trial was conducted from February to November 2021, with 74 participants who were randomly allocated into two groups of either routine care + auricular acupressure (n = 37), or routine care + sham control (n = 37). Vacaria seeds with special non-latex adhesives were used to perform auricular acupressure on seven ear acupoints. There were two intervention sessions with an interval of five days. In the sham group, special non-latex adhesives without vacaria seeds were attached in the same acupoints as the intervention group. The severity of postpartum blues, fatigue, maternal-infant attachment, and postpartum depression was assessed.
Auricular acupressure was associated with a significant effect in the reduction of postpartum blues on the 10th and 15th days after childbirth (SMD = −2.77 and −2.15 respectively), postpartum depression on the 21st day after childbirth (SMD = −0.74), and maternal fatigue on 10th, 15th and 21st days after childbirth (SMD = −2.07, −1.30 and −1.32, respectively). Also, the maternal-infant attachment was increased significantly on the 21st day after childbirth (SMD = 1.95).
The authors concluded that auricular acupressure was effective in reducing postpartum blues and depression, reducing maternal fatigue, and increasing maternal-infant attachment in the short-term after childbirth.
Let me put my doubts about these conclusions in the form of a few questions:
- If you had sticky tape on your ear, would you sometimes touch it?
- If you touched it, would you feel whether a vacaria seed was contained in it or not?
- Would you, therefore, say that such a trial could be properly blinded (not to forget the therapists who were, of course, in the know)?
- If the trial was thus de-blinded, would you claim that patient expectation did not influence the outcomes?
If you answered all of these questions with NO, you are – like I – of the opinion that the results of this trial could have easily been brought about, not by the alleged effects of acupressure, but by placebo and other non-specific effects.
Guided imagery is said to distract patients from disturbing feelings and thoughts, positively affects emotional well-being, and reduce pain by producing pleasing mental images.
This study aimed to determine the effects of guided imagery on postoperative pain management in patients undergoing lower extremity surgery. This randomized controlled study was conducted between April 2018 and May 2019. It included 60 patients who underwent lower extremity surgery. After using guided imagery, the posttest mean Visual Analog Scale score of patients in the intervention group was found to be 2.56 (1.00 ± 6.00), whereas the posttest mean score of patients in the control group was 4.10 (3.00 ± 6.00), and the difference between the groups was statistically significant (p <.001).
The authors concluded that guided imagery reduces short-term postoperative pain after lower extremity surgery.
I did not want to spend $52 to access the full article. Therefore, I can only comment on what the abstract tells me – and that is regrettably not a lot.
In fact, we don’t even learn what treatment was given to the control group. I guess that both groups receive standard post-op care and the control group received nothing in addition. This would mean that the observed effect might be entirely due to placebo and other non-specific effects. If that is so, the authors’ conclusion is not accurate.
I happen to think that guided imagery is a promising albeit under-researched therapy. Therefore, I am particularly frustrated to see that the few trials that do emerge of this option are woefully inadequate to determine its value.
It has been reported that King Charles refused to pay Prince Andrew’s £ 32,000-a-year bill for his personal healing guru. The Duke of York has allegedly submitted the claim to the Privy Purse as a royal expense having sought the help of a yoga teacher.
However, the claim has reportedly been denied by the King, who is said to have told Andrew the bill will need to be covered using his own money. It comes after sources claimed Andrew has been using the Indian yogi for a number of years for chanting, massages, and holistic therapy in the privacy of his mansion. The healer has reportedly enjoyed month-long stays at a time at the £30 million Royal Lodge in Windsor.
Previously, the Queen seems to have passed the claims. But now Charles is in control. A source said: “While the Queen was always happy to indulge her son over the years, Charles is far less inclined to fund such indulgences, particularly in an era of a cost-of-living crisis. “Families are struggling and would rightly baulk at the idea of tens of thousands paid to an Indian guru to provide holistic treatment to a non-working royal living in his grace and favour mansion. This time the King saw the bill for the healer submitted by Andrew to the Privy Purse and thought his brother was having a laugh.”
How is he going to cope without his guru?
Will he be able to recover from the mysterious condition that prevents him to sweat?
Will his ego take another blow?
How will he be able to afford even the most basic holistic wellness?
How can Charles – who knows only too well about its benefits – be so cruel to his own brother?
Should I start a collection so that Andrew can pay for his most basic needs?
Yes, these are the nagging questions and deep concerns that keep me awake at night!
I have just been asked if, by any chance, the yoga teacher is a 16-year-old female. I have to admit that I cannot answer this question.