causation
Today is the start of chiropractic awareness week 2022. On this occasion the BCA states most categorically: First and foremost, chiropractic is a statutorily regulated healthcare profession, supported by evidence, which offers a safe form of treatment for patients with a range of conditions. Here I am tempted to cite my friend Simon Singh:
THEY HAPPILY PROMOTE BOGUS TREATMENTS
I am, of course, particularly impressed by the BCA’s assurance of safety. In my view, the safety issue needs to be addressed more urgently than any other in the realm of chiropractic. So, to make a meaningful contribution to the current chiropractic awareness week, I conducted a few Medline searches to identify all publications of 2022 on chiropractic/spinal manipulation risks.
This is what I found:
Objective: Patients can be at risk of carotid artery dissection and ischemic stroke after cervical chiropractic manipulation. However, such risks are rarely reported and raising awareness can increase the safety of chiropractic manipulations.
Case report: We present two middle-aged patients with carotid artery dissection leading to ischemic stroke after receiving chiropractic manipulation in Foshan, Guangdong Province, China. Both patients had new-onset pain in their necks after receiving chiropractic manipulations. Excess physical force during chiropractic manipulation may present a risk to patients. Patient was administered with recombinant tissue plasminogen activator after radiological diagnoses. They were prescribed 100 mg and clopidogrel 75 mg daily for 3 months as dual antiplatelet therapy. There were no complications over the follow-up period.
Conclusion: These cases suggest that dissection of the carotid artery can occur as the result of chiropractic manipulations. Patients should be diagnosed and treated early to achieve positive outcomes. The safety of chiropractic manipulations should be increased by raising awareness about the potential risks.
Spontaneous intracranial hypotension (SIH) still remains an underdiagnosed etiology of new-onset headache. Important risk factors include chiropractic manipulation (CM). We present a case of a 36-year-old Filipino woman who presented with severe bifrontal and postural headache associated with dizziness, vomiting, and doubling of vision. A cranial computed tomography scan was done which showed an acute subdural hematoma (SDH) at the interhemispheric area. Pain medications were given which afforded minimal relief. On history, the headaches occurred 2 weeks after cervical CM. Cranial and cervical magnetic resonance imaging revealed findings supportive of intracranial hypotension and neck trauma, respectively. The patient improved with conservative management. We found 12 articles on SIH and CM after a systematic review of literature. Eleven patients (90.9%) initially presented with orthostatic headache. Eight patients (66.7%) were initially treated conservatively but only 5 (62.5%) had complete recovery. Recovery was achieved within 14 days from start of supportive therapy. Among the 3 patients who failed conservative treatment, 2 underwent non-directed epidural blood patch and one required neurosurgical intervention. This report highlights that a thorough history is warranted in patients with new onset headache. A history of CM must be actively sought. The limited evidence from the case reports showed that patients with SIH and SDH but with normal neurologic examination and minor spinal pathology can be managed conservatively for less than 2 weeks. This review showed that conservative treatment in a closely monitored environment may be an appropriate first line treatment.
Introduction: Cranio-cervical artery dissection (CeAD) is a common cause of cerebrovascular events in young subjects with no clear treatment strategy established. We evaluated the incidence of major adverse cardiovascular events (MACE) in CeAD patients treated with and without stent placement.
Methods: COMParative effectiveness of treatment options in cervical Artery diSSection (COMPASS) is a single high-volume center observational, retrospective longitudinal registry that enrolled consecutive CeAD patients over a 2-year period. Patients were ≥ 18 years of age with confirmed extra- or intracranial CeAD on imaging. Enrolled participants were followed for 1 year evaluating MACE as the primary endpoint.
Results: One-hundred ten patients were enrolled (age 53 ± 15.9, 56% Caucasian, and 50% male, BMI 28.9 ± 9.2). Grade I, II, III, and IV blunt vascular injury was noted in 16%, 33%, 19%, and 32%, respectively. Predisposing factors were noted in the majority (78%), including sneezing, carrying heavy load, chiropractic manipulation. Stent was placed in 10 (10%) subjects (extracranial carotid n = 9; intracranial carotid n = 1; extracranial vertebral n = 1) at the physician’s discretion along with medical management. Reasons for stent placement were early development of high-grade stenosis or expanding pseudoaneurysm. Stented patients experienced no procedural or in-hospital complications and no MACE between discharge and 1 year follow up. CeAD patients treated with medical management only had 14% MACE at 1 year.
Conclusion: In this single high-volume center cohort of CeAD patients, stenting was found to be beneficial, particularly with development of high-grade stenosis or expanding pseudoaneurysm. These results warrant confirmation by a randomized clinical trial.
Background: Manipulation and mobilisation for low back pain are presented in an evidence-based manner with regard to mechanisms of action, indications, efficacy, cost-effectiveness ratio, user criteria and adverse effects. Terms such as non-specific or specific are replaced by the introduction of “entities” related to possible different low back pain forms.
Efficacy: MM is effective for acute and chronic low back pain in terms of pain relief, recovery of function and relapse prevention. It is equally effective but less risky compared to other recommended therapies. MM can be used alone in acute cases and not only in the case of chronic low back pain where it is always and necessarily part of a multimodal therapy programme, especially in combination with activating measures. The users of MM should exclusively be physician specialists trained according to the criteria of the German Medical Association (Bundesärztekammer) with an additional competence in manual medicine or appropriately trained certified therapists. The application of MM follows all rules of Good Clinical Practice.
Adverse effects: Significant adverse effects of MM for low back pain are reported in the international literature with a frequency of 1 per 50,000 to 1 per 3.7 million applications, i.e. MM for low back pain is practically risk-free and safe if performed according to the rules of the European Training Requirements of the UEMS.
Studies have reported that mild adverse events (AEs) are common after manual therapy and that there is a risk of serious injury. We aimed to assess the safety of Chuna manipulation therapy (CMT), a traditional manual Korean therapy, by analysing AEs in patients who underwent this treatment. Patients who received at least one session of CMT between December 2009 and March 2019 at 14 Korean medicine hospitals were included. Electronic patient charts and internal audit data obtained from situation report logs were retrospectively analysed. All data were reviewed by two researchers. The inter-rater agreement was assessed using the Cohen’s kappa coefficient, and reliability analysis among hospitals was assessed using Cronbach’s Alpha coefficient. In total, 2,682,258 CMT procedures were performed in 289,953 patients during the study period. There were 50 AEs, including worsened pain (n = 29), rib fracture (n = 11), falls during treatment (n = 6), chest pain (n = 2), dizziness (n = 1), and unpleasant feeling (n = 1). The incidence of mild to moderate AEs was 1.83 (95% confidence interval [CI] 1.36-2.39) per 100,000 treatment sessions, and that of severe AEs was 0.04 (95% CI 0.00-0.16) per 100,000 treatment sessions. Thus, AEs of any level of severity were very rare after CMT. Moreover, there were no instances of carotid artery dissection or spinal cord injury, which are the most severe AEs associated with manual therapy in other countries.
_______________________________
This is not too bad after all!
Five papers are clearly better than nothing.
What conclusions might be drawn from my mini-review?
I think it might be safe to say:
- There is not much but at least some research going on in this area.
- The risks of chiropractic/spinal manipulation are real and are being recognized.
- BUT NOT BY CHIROPRACTORS! The most remarkable feature of the 5 papers, I think, is that none originates from a chiropractic team.
Thus, allow me to make a suggestion to chiropractors worldwide: Instead of continuing with HAPPILY PROMOTING BOGUS TREATMENTS, what about using the ‘chiropractic awareness week’ to raise awareness of the urgent necessity to research the safety of your treatments?
No 10-year follow-up study of so-called alternative medicine (SCAM) for lumbar intervertebral disc herniation (LDH) has so far been published. Therefore, the authors of this paper performed a prospective 10-year follow-up study on the integrated treatment of LDH in Korea.
One hundred and fifty patients from the baseline study, who initially met the LDH diagnostic criteria with a chief complaint of radiating pain and received integrated treatment, were recruited for this follow-up study. The 10-year follow-up was conducted from February 2018 to March 2018 on pain, disability, satisfaction, quality of life, and changes in a herniated disc, muscles, and fat through magnetic resonance imaging.
Sixty-five patients were included in this follow-up study. Visual analogue scale score for lower back pain and radiating leg pain were maintained at a significantly lower level than the baseline level. Significant improvements in Oswestry disability index and quality of life were consistently present. MRI confirmed that disc herniation size was reduced over the 10-year follow-up. In total, 95.38% of the patients were either “satisfied” or “extremely satisfied” with the treatment outcomes and 89.23% of the patients claimed their condition “improved” or “highly improved” at the 10-year follow-up.
The authors concluded that the reduced pain and improved disability was maintained over 10 years in patients with LDH who were treated with nonsurgical Korean medical treatment 10 years ago. Nonsurgical traditional Korean medical treatment for LDH produced beneficial long-term effects, but future large-scale randomized controlled trials for LDH are needed.
This study and its conclusion beg several questions:
WHAT DID THE SCAM CONSIST OF?
The answer is not provided in the paper; instead, the authors refer to 3 previous articles where they claim to have published the treatment schedule:
The treatment package included herbal medicine, acupuncture, bee venom pharmacopuncture and Chuna therapy (Korean spinal manipulation). Treatment was conducted once a week for 24 weeks, except herbal medication which was taken twice daily for 24 weeks; (1) Acupuncture: frequently used acupoints (BL23, BL24, BL25, BL31, BL32, BL33, BL34, BL40, BL60, GB30, GV3 and GV4)10 ,11 and the site of pain were selected and the needles were left in situ for 20 min. Sterilised disposable needles (stainless steel, 0.30×40 mm, Dong Bang Acupuncture Co., Korea) were used; (2) Chuna therapy12 ,13: Chuna is a Korean spinal manipulation that includes high-velocity, low-amplitude thrusts to spinal joints slightly beyond the passive range of motion for spinal mobilisation, and manual force to joints within the passive range; (3) Bee venom pharmacopuncture14: 0.5–1 cc of diluted bee venom solution (saline: bee venom ratio, 1000:1) was injected into 4–5 acupoints around the lumbar spine area to a total amount of 1 cc using disposable injection needles (CPL, 1 cc, 26G×1.5 syringe, Shinchang medical Co., Korea); (4) Herbal medicine was taken twice a day in dry powder (2 g) and water extracted decoction form (120 mL) (Ostericum koreanum, Eucommia ulmoides, Acanthopanax sessiliflorus, Achyranthes bidentata, Psoralea corylifolia, Peucedanum japonicum, Cibotium barometz, Lycium chinense, Boschniakia rossica, Cuscuta chinensis and Atractylodes japonica). These herbs were selected from herbs frequently prescribed for LBP (or nerve root pain) treatment in Korean medicine and traditional Chinese medicine,15 and the prescription was further developed through clinical practice at Jaseng Hospital of Korean Medicine.9 In addition, recent investigations report that compounds of C. barometz inhibit osteoclast formation in vitro16 and A. japonica extracts protect osteoblast cells from oxidative stress.17 E. ulmoides has been reported to have osteoclast inhibitive,18 osteoblast-like cell proliferative and bone mineral density enhancing effects.19 Patients were given instructions by their physician at treatment sessions to remain active and continue with daily activities while not aggravating pre-existing symptoms. Also, ample information about the favourable prognosis and encouragement for non-surgical treatment was given.
The traditional Korean spinal manipulations used (‘Chuna therapy’ – the references provided for it do NOT refer to this specific way of manipulation) seemed interesting, I thought. Here is an explanation from an unrelated paper:
Chuna, which is a traditional manual therapy practiced by Korean medicine doctors, has been applied to various diseases in Korea. Chuna manual therapy (CMT) is a technique that uses the hand, other parts of the doctor’s body or other supplementary devices such as a table to restore the normal function and structure of pathological somatic tissues by mobilization and manipulation. CMT includes various techniques such as thrust, mobilization, distraction of the spine and joints, and soft tissue release. These techniques were developed by combining aspects of Chinese Tuina, chiropratic, and osteopathic medicine.[13] It has been actively growing in Korea, academically and clinically, since the establishment of the Chuna Society (the Korean Society of Chuna Manual Medicine for Spine and Nerves, KSCMM) in 1991.[14] Recently, Chuna has had its effects nationally recognized and was included in the Korean national health insurance in March 2019.[15]
This almost answers the other questions I had. Almost, but not quite. Here are two more:
- The authors conclude that the SCAM produced beneficial long-term effects. But isn’t it much more likely that the outcomes their uncontrolled observations describe are purely or at least mostly a reflection of the natural history of lumbar disc herniation?
- If I remember correctly, I learned a long time ago in medical school that spinal manipulation is contraindicated in lumbar disc herniation. If that is so, the results might have been better, if the patients of this study had not received any SCAM at all. In other words, are the results perhaps due to firstly the natural history of the condition and secondly to the detrimental effects of the SCAM the investigators applied?
If I am correct, this would then be the 4th article reporting the findings of a SCAM intervention that aggravated lumbar disc herniation.
PS
I know that this is a mere hypothesis but it is at least as plausible as the conclusion drawn by the authors.
Ginseng plants belong to the genus Panax and include:
- Panax ginseng (Korean ginseng),
- Panax notoginseng (South China ginseng),
- and Panax quinquefolius (American ginseng).
They are said to have a range of therapeutic activities, some of which could render ginseng a potential therapy for viral or post-viral infections. Ginseng has therefore been used to treat fatigue in various patient groups and conditions. But does it work for chronic fatigue syndrome (CFS), also often called myalgic encephalomyelitis (ME)? This condition is a complex, little-understood, and often disabling chronic illness for which no curative or definitive therapy has yet been identified.
This systematic review aimed to assess the current state of evidence regarding ginseng for CFS. Multiple databases were searched from inception to October 2020. All data was extracted independently and in duplicates. Outcomes of interest included the effectiveness and safety of ginseng in patients with CFS.
A total of two studies enrolling 68 patients were deemed eligible: one randomized clinical trial and one prospective observational study. The certainty of evidence in the effectiveness outcome was low and moderate in both studies, while the safety evidence was very low as reported from one study.
The authors concluded that the study findings highlight a potential benefit of ginseng therapy in the treatment of CFS. However, we are not able to draw firm conclusions due to limited clinical studies. The paucity of data warrants limited confidence. There is a need for future rigorous studies to provide further evidence.
To get a feeling of how good or bad the evidence truly is, we must of course look at the primary studies.
The prospective observational study turns out to be a mere survey of patients using all sorts of treatments. It included 155 subjects who provided information on fatigue and treatments at baseline and follow-up. Of these subjects, 87% were female and 79% were middle-aged. The median duration of fatigue was 6.7 years. The percentage of users who found a treatment helpful was greatest for coenzyme Q10 (69% of 13 subjects), dehydroepiandrosterone (DHEA) (65% of 17 subjects), and ginseng (56% of 18 subjects). Treatments at 6 months that predicted subsequent fatigue improvement were vitamins (p = .08), vigorous exercise (p = .09), and yoga (p = .002). Magnesium (p = .002) and support groups (p = .06) were strongly associated with fatigue worsening from 6 months to 2 years. Yoga appeared to be most effective for subjects who did not have unclear thinking associated with fatigue.
The second study investigated the effect of Korean Red Ginseng (KRG) on chronic fatigue (CF) by various measurements and objective indicators. Participants were randomized to KRG or placebo group (1:1 ratio) and visited the hospital every 2 weeks while taking 3 g KRG or placebo for 6 weeks and followed up 4 weeks after the treatment. The fatigue visual analog score (VAS) declined significantly in each group, but there were no significant differences between the groups. The 2 groups also had no significant differences in the secondary outcome measurements and there were no adverse events. Sub-group analysis indicated that patients with initial fatigue VAS below 80 mm and older than 50 years had significantly greater reductions in the fatigue VAS if they used KRG rather than placebo. The authors concluded that KRG did not show absolute anti-fatigue effect but provided the objective evidence of fatigue-related measurement and the therapeutic potential for middle-aged individuals with moderate fatigue.
I am at a loss in comprehending how the authors of the above-named review could speak of evidence for potential benefit. The evidence from the ‘observational study’ is largely irrelevant for deciding on the effectiveness of ginseng, and the second, more rigorous study fails to show that ginseng has an effect.
So, is ginseng a promising treatment for ME?
I doubt it.
Micronutrient supplements such as vitamin D, vitamin C, and zinc have been used in managing viral illnesses. However, the clinical significance of these individual micronutrients in patients with Coronavirus disease 2019 (COVID-19) remains unclear. A team of researchers conducted this meta-analysis to provide a quantitative assessment of the clinical significance of these individual micronutrients in COVID-19.
They performed a literature search using MEDLINE, Embase, and Cochrane databases through December 5th, 2021. All individual micronutrients reported by ≥ 3 studies and compared with standard-of-care (SOC) were included. The primary outcome was mortality. The secondary outcomes were intubation rate and length of hospital stay (LOS). Pooled risk ratios (RR) and mean difference (MD) with corresponding 95% confidence intervals (CI) were calculated using the random-effects model.
The authors identified 26 studies (10 randomized controlled trials and 16 observational studies) involving 5633 COVID-19 patients that compared three individual micronutrient supplements (vitamin C, vitamin D, and zinc) with SOC.
Vitamin C
Nine studies evaluated vitamin C in 1488 patients (605 in vitamin C and 883 in SOC). Vitamin C supplementation had no significant effect on mortality (RR 1.00, 95% CI 0.62–1.62, P = 1.00), intubation rate (RR 1.77, 95% CI 0.56–5.56, P = 0.33), or LOS (MD 0.64; 95% CI -1.70, 2.99; P = 0.59).
Vitamin D
Fourteen studies assessed the impact of vitamin D on mortality among 3497 patients (927 in vitamin D and 2570 in SOC). Vitamin D did not reduce mortality (RR 0.75, 95% CI 0.49–1.17, P = 0.21) but reduced intubation rate (RR 0.55, 95% CI 0.32–0.97, P = 0.04) and LOS (MD -1.26; 95% CI -2.27, −0.25; P = 0.01). Subgroup analysis showed that vitamin D supplementation was not associated with a mortality benefit in patients receiving vitamin D pre or post COVID-19 diagnosis.
Zinc
Five studies, including 738 patients, compared zinc intake with SOC (447 in zinc and 291 in SOC). Zinc supplementation was not associated with a significant reduction of mortality (RR 0.79, 95% CI 0.60–1.03, P = 0.08).
The authors concluded that individual micronutrient supplementations, including vitamin C, vitamin D, and zinc, were not associated with a mortality benefit in COVID-19. Vitamin D may be associated with lower intubation rate and shorter LOS, but vitamin C did not reduce intubation rate or LOS. Further research is needed to validate our findings.
Horticultural therapy (HT)?
What on earth is that?
Don’t worry, it was new to me too and I first thought of the treatment of plants.
HT is said to be a “time-proven practice. The therapeutic benefits of garden environments have been documented since ancient times. In the 19th century, Dr. Benjamin Rush, a signer of the Declaration of Independence and recognized as the “Father of American Psychiatry,” was first to document the positive effect working in the garden had on individuals with mental illness. In the 1940s and 1950s, rehabilitative care of hospitalized war veterans significantly expanded acceptance of the practice. No longer limited to treating mental illness, horticultural therapy practice gained in credibility and was embraced for a much wider range of diagnoses and therapeutic options. Today, horticultural therapy is accepted as a beneficial and effective therapeutic modality. It is widely used within a broad range of rehabilitative, vocational, and community settings. Horticultural therapy techniques are employed to assist participants to learn new skills or regain those that are lost. Horticultural therapy helps improve memory, cognitive abilities, task initiation, language skills, and socialization. In physical rehabilitation, horticultural therapy can help strengthen muscles and improve coordination, balance, and endurance. In vocational horticultural therapy settings, people learn to work independently, problem solve, and follow directions. Horticultural therapists are professionals with specific education, training, and credentials in the use of horticulture for therapy and rehabilitation. Read the formal definition of the role of horticultural therapists.”
As always, the question is DOES IT WORK?
This systematic review and meta-analysis aimed to evaluate HT for general health in older adults. Electronic databases as well as grey literature databases, and clinical trials registers were searched from inception to March 2021. Randomized controlled trials (RCTs), quasi-RCTs (QRCTs), and cohort studies about HT for adults aged over 60 were included in this review. Outcome measures were physical function, quality of life, BMI, mood tested by self-reported questionnaire and the expression of the immune cells.
Fifteen studies (thirteen RCTs and two cohort studies) involving 1046 older participants were included. Meta-analysis showed that HT resulted in better quality of life (MD 2.09, 95% CI [1.33, 2.85], P<0. 01) and physical function (SMD 0.82, 95% [0.36, 1.29], P<0.01) compared with no-gardener; the similar findings showed in BMI (SMD -0.30, 95% [-0.57, -0.04], P = 0.02) and mood tested by self-reported questionnaire (SMD 2.80, 95% CI [1.82, 3.79], P<0. 01). And HT might be beneficial for blood pressure and immunity, while all the evidence was moderate-quality judged by GRADE.
The authors concluded that HT may improve physical function and quality of life in older adults, reduce BMI and enhance positive mood. A suitable duration of HT may be between 60 to 120 minutes per week lasting 1.5 to 12 months. However, it remains unclear as to what constitutes an optimal recommendation.
I have considerable problems with this review and its conclusion:
- It is simply untrue that there were 13 RCTs; several of these studies were clearly not randomized.
- Most of the studies are of very poor quality. For instance, they often did not make the slightest attempt to control for non-specific effects, yet they concluded that the observed outcome was a specific effect of HT.
My biggest problem does, however, not relate to methodological issues. My main issue with this paper is one of definition. What is a ‘therapy’ and what not? If we call a bit of gardening a ‘therapy’ are we not descending to the level of those who call a bit of shopping ‘retail therapy’? To put it differently, is HT superior to retail therapy? And do we need RCTs to answer this question?
What is wrong with encouraging people who like gardening to just do it? I, for instance, like drumming; but I do not believe we need a few RCTs to prove that it is healthy. Not every past-time or hobby that makes you feel good is a therapy and needs to be scrutinized as such.
- COVID vaccinations are not 100% harmless but they generate much more good than harm.
- They are certainly far less dangerous than the disease.
- COVID infections are not ‘just a flu’ but have serious consequences.
The last point was well-documented in a recent Lancet paper. Here is its abstract in full
Mortality statistics are fundamental to public health decision making. Mortality varies by time and location, and its measurement is affected by well known biases that have been exacerbated during the COVID-19 pandemic. This paper aims to estimate excess mortality from the COVID-19 pandemic in 191 countries and territories, and 252 subnational units for selected countries, from Jan 1, 2020, to Dec 31, 2021.
Methods
All-cause mortality reports were collected for 74 countries and territories and 266 subnational locations (including 31 locations in low-income and middle-income countries) that had reported either weekly or monthly deaths from all causes during the pandemic in 2020 and 2021, and for up to 11 year previously. In addition, we obtained excess mortality data for 12 states in India. Excess mortality over time was calculated as observed mortality, after excluding data from periods affected by late registration and anomalies such as heat waves, minus expected mortality. Six models were used to estimate expected mortality; final estimates of expected mortality were based on an ensemble of these models. Ensemble weights were based on root mean squared errors derived from an out-of-sample predictive validity test. As mortality records are incomplete worldwide, we built a statistical model that predicted the excess mortality rate for locations and periods where all-cause mortality data were not available. We used least absolute shrinkage and selection operator (LASSO) regression as a variable selection mechanism and selected 15 covariates, including both covariates pertaining to the COVID-19 pandemic, such as seroprevalence, and to background population health metrics, such as the Healthcare Access and Quality Index, with direction of effects on excess mortality concordant with a meta-analysis by the US Centers for Disease Control and Prevention. With the selected best model, we ran a prediction process using 100 draws for each covariate and 100 draws of estimated coefficients and residuals, estimated from the regressions run at the draw level using draw-level input data on both excess mortality and covariates. Mean values and 95% uncertainty intervals were then generated at national, regional, and global levels. Out-of-sample predictive validity testing was done on the basis of our final model specification.
Findings
Although reported COVID-19 deaths between Jan 1, 2020, and Dec 31, 2021, totalled 5·94 million worldwide, we estimate that 18·2 million (95% uncertainty interval 17·1–19·6) people died worldwide because of the COVID-19 pandemic (as measured by excess mortality) over that period. The global all-age rate of excess mortality due to the COVID-19 pandemic was 120·3 deaths (113·1–129·3) per 100 000 of the population, and excess mortality rate exceeded 300 deaths per 100 000 of the population in 21 countries. The number of excess deaths due to COVID-19 was largest in the regions of south Asia, north Africa and the Middle East, and eastern Europe. At the country level, the highest numbers of cumulative excess deaths due to COVID-19 were estimated in India (4·07 million [3·71–4·36]), the USA (1·13 million [1·08–1·18]), Russia (1·07 million [1·06–1·08]), Mexico (798 000 [741 000–867 000]), Brazil (792 000 [730 000–847 000]), Indonesia (736 000 [594 000–955 000]), and Pakistan (664 000 [498 000–847 000]). Among these countries, the excess mortality rate was highest in Russia (374·6 deaths [369·7–378·4] per 100 000) and Mexico (325·1 [301·6–353·3] per 100 000), and was similar in Brazil (186·9 [172·2–199·8] per 100 000) and the USA (179·3 [170·7–187·5] per 100 000).
Interpretation
The full impact of the pandemic has been much greater than what is indicated by reported deaths due to COVID-19 alone. Strengthening death registration systems around the world, long understood to be crucial to global public health strategy, is necessary for improved monitoring of this pandemic and future pandemics. In addition, further research is warranted to help distinguish the proportion of excess mortality that was directly caused by SARS-CoV-2 infection and the changes in causes of death as an indirect consequence of the pandemic.
I am posting this in the hope that the many proponents of so-called alternative medicine (SCAM) who deny proven facts about COVID might learn and stop falling victim to proctophasia.
The present study investigated the impact of a purposefully designed Islamic religion-based intervention on reducing depression and anxiety disorders among Muslim patients using a randomised controlled trial design. A total of 62 Muslim patients (30 women and 32 men) were divided by gender into two groups, with each group assigned randomly to either treatment or control groups. The participants who received the Islamic-based intervention were compared to participants who received the control intervention.
The Islamic-Based Intervention that was applied to the two experimental groups (i.e. one male, one female) has several components. These components were based on moral and religious concepts and methods, including moral confession, repentance, insight, learning, supplication, seeking Allah’s mercy, seeking forgiveness, remembrance of Allah, patience, trust in Allah, self-consciousness, piety, spiritual values, and moral principles. The techniques implemented in the intervention included the art of asking questions, clarifying, listening, interacting, summarising, persuading, feedback, empathy, training practice, reflecting feelings, discussion, and dialogue, lecturing, brainstorming, reinforcement, modeling, positive self-talk, evaluation, homework, practical applications, activation games (play through activities), emotional venting, stories, presentation, correction of thoughts, and relaxation. The two control groups (i.e. one male, one female) received the energy path program provided by the Al-Nour Centre. This program aimed to enhance self-confidence and modify people’s behavior with anxiety disorders, depression, and obsessive-compulsive disorder. Both interventions comprised 30 sessions over 30 h; two sessions were conducted per week, and each session lasted for 60 min (one hour). The duration of the intervention was 15 weeks.
Taylor’s manifest anxiety scale and Steer and Beck’s depression scale were used for examining the effects on depression and anxiety levels. The results revealed that the Islamic intervention significantly reduced anxiety levels in women and depression levels in men compared to the typical care control groups.
The authors concluded that religious intervention played a vital role in lowering the patients’ level of anxiety among women and depression among men. In general, religious practices prevent individuals from becoming subject to mental disorders, i.e. anxiety and depression.
The authors comment that the Islamic religion-based intervention (RSAFI) significantly reduced the levels of depression and anxiety among the participants. Also, there was a substantial improvement in the patients’ general health after the intervention. They were satisfied and believed that everything happening to them was destined by Allah. These results could be attributed to the different intervention practices that relied on the guidance of the Holy Quran and Sunnah. For instance, Saged et al. (2020) confirmed that the Holy Quran significantly impacts healing patients who suffer from physical, psychological, and mental disorders. In this respect, Moodley et al. (2018) concluded that having faith in Allah offers a relatively quick approach to healing patients suffering from heartache and depression. This goes hand in hand because the recitation of the Quran and remembrance of Allah help patients feel relaxed and peaceful. Muslims believe that the Quran is the word of Allah and that Allah’s words exert a significant impact on the healing of mental health patients, as, ultimately, Almighty Allah is the one who cures illnesses.
When discussing the limitations of their study, the authors state that the sample of this study was limited to the patients with anxiety and depression disorders at the Al-Nour Centre in Kuala Lumpur, so the results cannot be generalized to other samples. Furthermore, the treatment of anxiety was restricted to females, whereas the treatment of depression was restricted to males. Additionally, the selection of females and males as samples for the study was based on their pre-measurement of anxiety and depression, which serve as self-report measures.
The authors seem to be unconcerned about the fact that the 2 interventions (verum and control) were clearly distinguishable and their patients thus were not blinded (and neither were the evaluators). This obviously means that the observed effect might have nothing at all to do with the Islamic-Based Intervention but could be entirely due to expectation and persuasion.
Why might the authors not even bother to discuss such an obvious possibility?
A look at their affiliations might provide the answer:
- 1Academy of Islamic Studies, University of Malaya, 50603, Kuala Lumpur, Malaysia. [email protected].
- 2Academy of Islamic Studies, University of Malaya, 50603, Kuala Lumpur, Malaysia.
- 3Faculty of Education, Universiti Teknologi Malaysia, Johor, Malaysia.
- 4Faculty of Education, University of Malaya, 50603, Kuala Lumpur, Malaysia.
- 5Islamic Banking and Finance, International Islamic University Malaysia, Selangor, Malaysia.
- 6Department of Hadith and Associated Sciences, Nourah Bint Abdulrahman University, Riyadh, Saudi Arabia.
Chronic low back pain (CLBP) is among the most common types of pain in adults. It is also the domain for many types of so-called alternative medicine (SCAM). However, their effectiveness remains questionable, and the optimal approach to CLBP remains elusive. Meditation-based therapies constitute a form of SCAM with high potential for widespread availability.
This systematic review and meta-analysis of randomized clinical trials evaluated the efficacy of meditation-based therapies for CLBP management. The primary outcomes were pain intensity, quality of life, and pain-related disability; the secondary outcomes were the experienced distress or anxiety and pain bothersomeness in the patients. The PubMed, Embase, and Cochrane databases were searched for studies published from their inception until July 2021, without language restrictions.
A total of 12 randomized clinical trials with 1153 patients were included. In 10 trials, meditation-based therapies significantly reduced the CLBP pain intensity compared with nonmeditation therapies (standardized mean difference [SMD] -0.27, 95% CI = -0.43 to – 0.12, P = 0.0006). In 7 trials, meditation-based therapies also significantly reduced CLBP bothersomeness compared with nonmeditation therapies (SMD -0.21, 95% CI = -0.34 to – 0.08, P = 0.002). In 3 trials, meditation-based therapies significantly improved patient quality of life compared with nonmeditation therapies (SMD 0.27, 95% CI = 0.17 to 0.37, P < 0.00001).
The authors concluded that meditation-based therapies constitute a safe and effective alternative approach for CLBP management.
The problem with this conclusion is that the primary studies are mostly of poor quality. For instance, they do not control for placebo effects (which is obviously not easy in this case). Thus, we need to take the conclusion with a pinch of salt.
However, since the same limitations apply to chiropractic and osteopathy, and since meditation has far fewer risks than these approaches, I would gladly recommend meditation over manipulative therapies. Or, to put it plainly: in terms of risk/benefit balance, meditation seems preferable to spinal manipulation.
Stress is associated with a multitude of physical and psychological health impairments. To tackle these health disorders, over-the-counter (OTC) products like Neurodoron® are popular since they are considered safe and tolerable. One tablet of this anthroposophic remedy contains the following active ingredients:
- 83.3 mg Aurum metallicum praeparatum trituration (trit.) D10,
- 83.3 mg Kalium phosphoricicum trit. D6,
- 8.3 mg Ferrum-Quarz trit. D2.
Experience reports and first studies indicate that Neurodoron® is efficient in the treatment of stress-associated health symptoms. “To confirm this” (!!!), a non-interventional study (NIS) with pharmacies was conducted.
The NIS was planned to enroll female and male patients who suffered from nervous exhaustion with symptoms caused by acute and/or chronic stress. The main outcome measures were characteristic stress symptoms, stress burden, and perceived stress. Further outcome measures included perceived efficacy and tolerability of the product as assessed by the patients and collection of adverse drug reactions (ADRs). A study duration of about 21 days with a recommended daily dose of 3–4 tablets was set.
In total, 279 patients were enrolled at 74 German pharmacies. The analyzed set (AS) included 272 patients (mean age 44.8 ± 14.4 years, 73.9% female). 175 patients of the AS completed the NIS. During the study, all stress symptoms declined significantly (total score 18.1 vs. 12.1 (of max. 39 points), < 0.0001). Furthermore, a reduction of stress burden (relative difference in stress burden, VAS = −29.1%, < 0.0001) was observed. For most patients, perceived stress was reduced at the study end (PSQ total score decreased in 70.9% of the patients). 75.9% of the study population rated the product efficacy as “good” or “very good” and 96.6% rated its tolerability as “good” or “very good.” One uncritical ADR was reported.
The authors concluded that this study adds information on the beneficial effects of Neurodoron® in self-medication. The results from this NIS showed a marked reduction in stress burden and perceived stress, along with an excellent safety profile of the medicinal product (MP) Neurodoron®. Further trials are required to confirm these results.
I beg to differ!
The study had no control group and therefore one cannot possibly attribute any of the observed changes to the anthroposophic remedy. They are more likely to be due to:
- the natural history of the condition,
- regression towards the mean,
- a placebo effects,
- other treatments administered during the trial period.
Sadly, the authors discuss none of these possibilities in their paper.
In view of this, I am tempted to rephrase their conclusions as follows:
This study adds no valuable information on the effects of Neurodoron® in self-medication. The results from this NIS showed what utter nonsense the Weleda marketing team is capable of producing in an attempt to boost sales.
PS
These declarations of the 4 study authors and the sponsorship are revealing, I thought:
RH and CS are employees of Weleda AG, Germany. JH and KS work for daacro GmbH & Co. KG, a clinical research organization, Germany. The authors declare that there are no conflicts of interest.
This study was financed by the pharmaceutical company Weleda AG, Arlesheim, the employer of RH and CS. Weleda commissioned the CRO daacro for their contribution to the manuscript.
Bioresonance is an alternative therapeutic and diagnostic method employing a device developed in Germany by Scientology member Franz Morell in 1977. The bioresonance machine was further developed and marketed by Morell’s son-in-law Erich Rasche and is also known as ‘MORA’ therapy (MOrell + RAsche). Bioresonance is based on the notion that one can diagnose and treat illness with electromagnetic waves and that, via resonance, such waves can influence disease on a cellular level.
On this blog, we have discussed the idiocy bioresonance several times (for instance, here and here). My favorite study of bioresonance is the one where German investigators showed that the device cannot even differentiate between living and non-living materials. Despite the lack of plausibility and proof of efficacy, research into bioresonance continues.
The aim of this study was to evaluate if bioresonance therapy can offer quantifiable results in patients with recurrent major depressive disorder and with mild, moderate, or severe depressive episodes.
The study included 140 patients suffering from depression, divided into three groups.
- The first group (40 patients) received solely bioresonance therapy.
- The second group (40 patients) received pharmacological treatment with antidepressants combined with bioresonance therapy.
- The third group (60 patients) received solely pharmacological treatment with antidepressants.
The assessment of depression was made using the Hamilton Depression Rating Scale, with 17 items, at the beginning of the bioresonance treatment and the end of the five weeks of treatment.
The results showed a statistically significant difference for the treatment methods applied to the analyzed groups (p=0.0001). The authors also found that the therapy accelerates the healing process in patients with depressive disorders. Improvement was observed for the analyzed groups, with a decrease of the mean values between the initial and final phase of the level of depression, of delta for Hamilton score of 3.1, 3.8 and 2.3, respectively.
The authors concluded that the bioresonance therapy could be useful in the treatment of recurrent major depressive disorder with moderate depressive episodes independently or as a complementary therapy to antidepressants.
One could almost think that this is a reasonably sound study. But why did it generate such a surprising result?
When reading the full paper, the first thing one notices is that it is poorly presented and badly written. Thus there is much confusion and little clarity. The questions keep coming until one comes across this unexpected remark: the study was a retrospective study…
This explains some of the confusion and it certainly explains the surprising results. It remains unclear how the patients were selected/recruited but it is obvious that the groups were not comparable in several ways. It also becomes very clear that with the methodology used, one can make any nonsense look effective.
In the end, I am left with the impression that mutton is being presented as lamb, even worse: I think someone here is misleading us by trying to convince us that an utterly bogus therapy is effective. In my view, this study is as clear an example of scientific misconduct as I have seen for a long time.
