study design
Diabetic peripheral neuropathy (DPN) is a common complication of diabetes mellitus and can lead to serious complications. Therapeutic strategies for pain control are available but there are few approaches that influence neurological deficits such as numbness.
This study investigated the effectiveness of acupuncture on improving neurological deficits in patients suffering from type 2 DPN.
The acupuncture in DPN (ACUDPN) study was a two-armed, randomized, controlled, parallel group, open, multicenter clinical trial. Patients were randomized in a 1:1 ratio into two groups: The acupuncture group received 12 acupuncture treatments over 8 wk, and the control group was on a waiting list during the first 16 wk, before it received the same treatment as the other group. Both groups received routine care.
Outcome parameters were evaluated after 8, 16 and 24 wk. They included:
- neurological scores, such as an 11-point numeric rating scale (NRS) for hypesthesia,
- neuropathic pain symptom inventory (NPSI),
- neuropathy deficit score (NDS),
- neuropathy symptom score (NSS);
- nerve conduction studies (NCS) as assessed with a handheld point-of-care device.
Sixty-two participants were included. The NRS for numbness showed a difference of 2.3 (P < 0.001) in favor of the acupuncture group, the effect persisted until week 16 with a difference of 2.2 (P < 0.001) between groups and 1.8 points at week 24 compared to baseline. The NPSI was improved in the acupuncture group by 12.6 points (P < 0.001) at week 8, the NSS score at week 8 with a difference of 1.3 (P < 0.001); the NDS and the TNSc score improved for the acupuncture group in week 8, with a difference of 2.0 points (P < 0.001) compared to the control group. Effects were persistent in week 16 with a difference of 1.8 points (P < 0.05). The NCS showed no meaningful changes. In both groups only minor side effects were reported.
The authors concluded that acupuncture may be beneficial in type 2 diabetic DPN and seems to lead to a reduction in neurological deficits. No serious adverse events were recorded and the adherence to treatment was high. Confirmatory randomized sham-controlled clinical studies with adequate patient numbers are needed to confirm the results.
That “acupuncture may be beneficial” has been known before and presumably was the starting point of the present study. So, why conduct an open, under-powered trial with non-blind assessors and without defining a primary outcome measure?
Could the motivation be to add yet another false-positive study to the literature of acupuncture?
False-positive, you ask?
Yes, let me explain by having a look at the outcome measures:
- NRS = a subjective endpoint.
- NPSI = a subjective endpoint.
- NDS = a subjective endpoint.
- NSS = a subjective endpoint.
- NCS = the only objective endpoint.
And what is remarkable about that?
- Subjective endpoints are likely to respond to placebo effects.
- Objective endpoints are not likely to respond to placebo effects.
In other words, what the authors of this study have, in fact, confirmed with their study is this:
acupuncture is a theatrical placebo!
In total, 404 respondents completed the survey, of which 254 (62.9%) treated cancer patients. Most practitioners were acupuncturists and herbalists (57.1%), had (16.8 ± 9.9) years of clinical experience and see a median of 2 (1, 4) cancer patients per week. Breast cancer (61.8%) is the most common cancer type seen in SCAM clinics. Adjunctive SCAM treatments are frequently concurrent with the patient’s cancer specific treatment (39.9%), which is also reflected by the main goal of a SCAM treatment to alleviate side effects (52.4%). However, only 28.0% of the respondents are in contact with the treating oncologist. According to the respondents, pain is most effectively treated using acupuncture, while herbal medicine is best for cancer-related fatigue. SCAM practitioners mostly use certified courses (33.1%) or online databases (28.3%) but often believe that experts are more reliable to inform their practice (37.0%) than research publications (32.7%).
The authors concluded that acupuncturists and herbalists commonly treat cancer patients. Most practitioners use SCAM as an adjunct to biomedicine as supportive care and use it largely in accordance with current oncological guidelines.
You would think that the combined expertise of these institutions are capable of producing a decent survey:
- Palliative Care Unit, Division of Oncology, Department of Internal Medicine, Medical University of Graz, 8036 Graz, Austria
- Northern College of Acupuncture, York YO1 6LJ, United Kingdom
- School of Health and Society, Faculty of Education, Health and Wellbeing, University of Wolverhampton, Wolverhampton WV1 1LY, United Kingdom
- National Institute of Complementary Medicine Health Research Institute, Western Sydney University, Penrith NSW 2751, Australia
- Translational Health Research Institute, Western Sydney University, Penrith NSW 2751, Australia
- Medical Research Institute of New Zealand, Wellington 6021, New Zealand
- Translational Oncology, University Hospital of Augsburg, 86156 Augsburg, Germany
Well, you would have been mistaken! This surely is one of the worst investigations I have seen for a while. Here are just three reasons why:
- The researchers designed an anonymous self-completion questionnaire collecting data about the participating practitioners’ demographics and clinical practice of integrative oncology. Someone should tell them that one ought to validate questionnairs before using them and that validated questionnairs exist. Unvalidated questionnairs cannot tell us much of value.
- The researchers invited SCAM practitioners in Austria, Germany, USA, Australia, and New Zealand to participate in this study. Invitations were distributed through social media and emails between October 2022 and December 2022 by professional organizations. Someone should tell them that research needs to be reproducible and surveys need to cover a representative population – both criteria that are not met here.
- The survey participants had to hold a valid license to perform acupuncture, herbal medicine, or both. That excludes all other SCAM practitioners.
Despite these serious flaws, the survey shows two findings that might be worth mentioning:
- only 28.0% of the SCAM practitioners were in contact with the treating oncologist;
- SCAM practitioners believe that “experts” are more reliable to inform their practice than research publications.
For me, these two points alone would be sufficient reason to run a mile!
Due to the common adverse effects of motion sickness pharmaceuticals (e.g., drowsiness), medication options to treat the condition are limited. Thus many non-pharmacological therapies are being advocated for it. One of them is osteopathy.
The purpose of this study was to explore the potential utility of a nonpharmaceutical method for motion sickness prevention, specifically an osteopathic manipulative technique (OMT). A novel OMT protocol for the reduction of motion sickness symptoms and severity was evaluated using a sham-controlled, counterbalanced, between-subjects study design. The independent variable was OMT treatment administered prior to the motion sickness-inducing procedure (rotating chair). The primary dependent measures were total and subscale scores from the Motion Sickness Assessment Questionnaire.
The OMT treatment group experienced significantly fewer gastrointestinal (mean scores postprocedure, treatment M = 20.42, sham M = 41.67) and sopite-related (mean scores postprocedure, treatment M = 12.81, sham M = 20.68) symptoms than the sham group while controlling for motion sickness susceptibility. There were no differences between groups with respect to peripheral and central symptoms.
The authors concluded that the results suggest that the treatment may prevent gastrointestinal (nausea) and sopite-related symptoms (sleepiness). These preliminary findings support further exploration of OMT for the prevention of motion sickness. A more precise evaluation of the mechanism of action is needed. Additionally, the duration of the effects needs to be investigated to determine the usefulness of this technique in training and operational settings.
Motion sickness is one of those conditions for which many forms of so-called alternative medicine (SCAM) have been tried and found in dodgy studies to be promissing, e.g.:
And now even OMT!
But before we rush into doing further research on this topic, we should perhaps ask whether the trial really does show OMT to be effective. Unfortunately, the article is behind a paywall, and I can therefore only speculate and ask whether the sham procedure was credible. Was the success of patient-blinding tested? I suspect it wasn’t. If that is so, it could mean that the OMT itself was not the reason for the results but that patient expectation caused the reported outcomes.
In any case, if nothing else, this paper shows yet again that the notion of OMT being an option purely for spinal problems is fantasy. Its advocates try everything to get it accepted as a cure all.
Every now and then, I come across a paper that is so remarkable that I feel like copying it for you in its full and untouched beauty. The recent article entitled “Revisiting the therapeutic potential of homeopathic medicine Rhus Tox for herpes simplex virus and inflammatory conditions” falls in this category. Let me present to you its unchanged abstract as recently published in the ‘J Ayurveda Integr Med’:
Background: Herpes simplex virus type-1 and type-2 cause a viral disease named Herpes. Genital herpes is mainly caused by HSV-2 with symptoms of painful and itchy blisters on the vagina, cervix, buttocks, anus, penis, or inner thighs with blisters that rupture and convert into sores. The homeopathic remedy Rhus Tox has been widely used to treat herpes and has shown invitro anti-inflammatory effects in previous studies.
Purpose: The presented review focuses on relapses and harmful effects caused by acyclovir in modern medicine and the probable antiherpetic activity of Rhus Tox on HSV infection based on its pathophysiology, preclinical findings, on primary cultured mouse chondrocytes, mouse cell line MC3T3e1 and a comparative study of Natrum Mur with Rhus Tox on HSV infection.
Study design: The design of the study focuses mainly on the descriptive data available in various literature articles.
Method: Databases such as PubMed, Google Scholar, Medline and ScienceDirect were used to search the articles. Articles are selected from 1994 to 2022 focusing solely on the competence of Rhus Tox against herpes. Keywords used for the study are antiviral, Herpes, Rhus Tox, in vitro and homeopathy.
Results: The review includes fifteen articles, including 4 full-text articles on HSV, 6 in vitro studies of homeopathic compounds performed on the herpes virus, and 5 articles based on the pathophysiology and effects of Rhus tox. The review article proposes the anti-inflammatory and antiviral action of the homeopathic remedy Rhus Tox which can be used in crisis conditions when the physician doubts the simillimum, as it prevents further outbreaks of HSV infection.
Conclusion: The homeopathic medicine Rhus Tox has no cytotoxicity observed under in vitro conditions and can be used to treat herpes infection. Further studies are needed to confirm the results under in vitro and in vivo conditions as well as in clinical trials.
Considering that the paper was based on ‘descriptive data available in various literature articles’, the conclusion that “Rhus Tox … can be used to treat herpes infection” is surprising, to say the least.
In the paper itself we find many more baffling statements, e.g.:
- Modern medicines target only specific organs at a time, but there is a risk of widespread infection which influence complications such as meningitis or HSV-2 radiculopathy which are not observed after the use of homeopathy as the disease progression does not involve vital organs and the disease level stays on the skin layer itself.
- Homeopathy treats patients holistically taking into consideration all the physical, mental and characteristic ailments of the patient. Rhus tox can effectively relieve all the symptoms of herpes infection, including pain, blisters, redness, restlessness, etc. Rhus Tox can effectively penetrate the capsid structure of the infected cells and cure the patient. Rhus tox in different potencies is currently being used to treat inflammatory and viral diseases
- In homeopathy, many treatments have been clinically proven to have some impact, and in individual cases a solution for herpes viruses. Homeopathy can prevent further outbreaks of herpes simplex infection.
- Homeopathy strengthens immunity to fight infections and contributes to mental, physical, and social well-being, hence complementary therapies should be used along with the traditional antiviral drugs to give maximum comfort to the patient.
I am sure that some readers of the paper are impressed. These statments leave little doubt about the notion that homeopathy is the best thing since sliced bread. What a pity though that, for none of them, the authors (who incedently are affiliated with prestigeous sounding institutions: Homeopathic Materia Medica Department, Bharti Vidyapeeth, Homoeopathic Medical College and Hospital, Dept. of Postgraduate & Research Centre, Pune-Satara Road, Dhankawadi, Pune, 411043, India, ICMR-National AIDS Research Institute, 73 G MIDC Bhosari, Pune, India, ICMR-National AIDS Research Institute, 73 G MIDC Bhosari, Pune, India) provide any evidence whatsoever.
Homeopathy, it seems to me, is a cult characterised not just by a total lack of active ingredients but also by an equally total void of proper evidence supporting the delusions of its proponents.
So-called alternative medicine (SCAM) interventions are often being discussed as possible treatments for long COVID symptoms. However, comprehensive analysis of current evidence in this setting is still lacking. This review aims to review existing published studies on the use of SCAM interventions for patients experiencing long COVID through a systematic review.
A comprehensive electronic literature search was performed in multiple databases and clinical trial registries from September 2019 to January 2023. RCTs evaluating efficacy and safety of SCAM for long COVID were included. Methodological quality of each included trial was appraised with the Cochrane ‘risk of bias’ tool. A qualitative analysis was conducted due to heterogeneity of included studies.
A total of 14 RCTs with 1195 participants were included in this review. Study findings demonstrated that SCAM interventions could benefit patients with long COVID, especially those suffering from neuropsychiatric disorders, olfactory dysfunction, cognitive impairment, fatigue, breathlessness, and mild-to-moderate lung fibrosis. The main interventions reported were self-administered transcutaneous auricular vagus nerve stimulation, neuro-meditation, dietary supplements, olfactory training, aromatherapy, inspiratory muscle training, concurrent training, and an online breathing and well-being program.
The authors concluded that SCAM interventions may be effective, safe, and acceptable to patients with symptoms of long COVID. However, the findings from this systematic review should be interpreted with caution due to various methodological limitations. More rigorous trials focused on SCAM for long COVID are warranted in the future.
The review’s aim is, in my view, nonsense. SCAM is a diverse field which means that the review must capture a wide range of therapies each represented by just one or two primary studies. In turn, this means that general conclusions across all SCAM will be highly questionable, if not misleading.
Furthermore, I find these conclusions odd and irresponsibly misleading. My main reason for this is the poor methodological quality of the primary studies:
- Four trials were considered to have unknown bias risk for generating the random sequence due to insufficient information about the specific method of randomization used.
- Only 5 of the trials provided appropriate random allocation concealment.
- Only 5 trials were blinded to both participants and personnel.
- Three trials were rated as unknown risk of bias since insufficient information was provided.1
- Four trials failed to performed outcome assessment blinding.
- One trial did not report detailed information about drop-out cases and was defined as high risk of bias.
- Three study protocols were unavailable and had relevant outcomes that were not reported in the pre-specified way.
Moreover, safety cannot possibly be reliably estimated on the basis of the data. And finally, the statement that SCAM interventions may be effective, as the authors put it, is in my view not a valid conclusion but a silly platitude.
I therefore suggest to re-formulate the conclusion of this review as follows:
At present there is no sound evidence to assume that any SCAM intervention is effective in the management of long COVID.
Despite effective vaccines, there is still a need for effective treatments for COVID, especially for people in the community. Dietary supplements have long been used to treat respiratory infections, and preliminary evidence indicates some may be effective in people with COVID-19. This study tested whether a combination of vitamin C, vitamin D3, vitamin K2 and zinc would improve overall health and decrease symptom burden in outpatients diagnosed with COVID-19.
Participants were randomised to receive either vitamin C (6 g), vitamin D3 (1000 units), vitamin K2 (240 μg) and zinc acetate (75 mg) or placebo daily for 21 days and were followed for 12 weeks. An additional loading dose of 50 000 units vitamin D3 (or placebo) was given on day one. The primary outcome was participant-reported overall health using the EuroQol Visual Assessment Scale summed over 21 days. Secondary outcomes included health status, symptom severity, symptom duration, delayed return to usual health, frequency of hospitalisation and mortality.
A total of 90 patients (46 control, 44 treatment) were randomised. The study was stopped prematurely due to insufficient capacity for recruitment. The mean difference (control-treatment) in cumulative overall health was -37.4 (95% CI -157.2 to 82.3), p=0.53 on a scale of 0-2100. No clinically or statistically significant differences were seen in any secondary outcomes.
The authors concluded that, in this double-blind, placebo-controlled, randomised trial of outpatients diagnosed with COVID-19, the dietary supplements vitamin C, vitamin D3, vitamin K2 and zinc acetate showed no clinically or statistically significant effects on the documented measures of health compared with a placebo when given for 21 days. Termination due to feasibility limited our ability to demonstrate the efficacy of these supplements for COVID-19. Further research is needed to determine clinical utility.
In several ways I am puzzled by this study. On the other hand, I should congratulate the naturopathic authors for honestly reporting such a squarely negative result. One could, of course, argue that the study was under-powered and that thus the findings are not conclusive. However, the actual survival curve depicting the results show clearly that there was not even the tiniest trend for the supplement to show any effect. In other words, a larger sample would have most likely yielded the same result.
Participants randomised to the treatment arm received:
- Vitamin D3 50 000 units orally once on day 1 of the study (capsule).
- Vitamin K2/D3 120 μg/500 units orally two times per day for 21 days (liquid).
- Vitamin C/Zinc acetate 2 g/25 mg orally three times daily for 21 days (capsule).
I fail to understand why the researchers might have conceived the hypothesis that such a mixture would be effective. Only 90 of a planned 200 participants were enrolled in this study which ran between September 2021 and April 2022. I fail to understand why recruitment was so poor that the study eventually had to be aborted. My speculation is that the naturopaths in charge of running the trial were too inexperienced in conducting such research to make it a success.
The study was supported by the Ottawa Integrative Cancer Centre Foundation and by Mavis and Martin Sacher. All investigational products for this study were provided in-kind by New Roots Herbal. Perhaps in future these sponsors should think again before they support amateurs pretending to be scientists?
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.
NICE helps practitioners and commissioners get the best care to patients, fast, while ensuring value for the taxpayer. Internationally, NICE has a reputation for being reliable and trustworthy. But is that also true for its recommendations regarding the use of acupuncture? NICE currently recommends that patients consider acupuncture as a treatment option for the following conditions:
- chronic (long-term) pain
- chronic tension-type headaches
- migraines
- prostatitis symptoms
- hiccups
Confusingly, on a different site, NICE also recommends acupuncture for retinal migraine, a very specific type of migraine that affect normally just one eye with symptoms such as vision loss lasting up to one hour, a blind spot in the vision, headache, blurred vision and seeing flashing lights, zigzag patterns or coloured spots or lines, as well as feeling nauseous or being sick.
I think this perplexing situation merits a look at the evidence. Here I quote the conclusions of recent, good quality, and (where possible) independent reviews:
- Chronic pain: Acupuncture is efficacious for reducing pain in patients with LBP… Further research needs to be done to evaluate acupuncture’s efficacy in these conditions, especially for abdominal pain, as many of the current studies have a risk of bias due to lack of blinding and small sample size.
- Chronic tension-type headaches (TTH): Acupuncture may be an effective and safe treatment for TTH patients. Due to low or very low certainty of evidence and high heterogeneity, more rigorous RCTs are needed to verify the effect and safety of acupuncture in the management of TTH.
- Migraines: Many studies suggest that acupuncture is a safe, helpful and available alternative therapy that may be beneficial to certain migraine patients. Nevertheless, further large-scale RCTs are warranted to further consolidate these findings and provide further support for the clinical value of acupuncture. Despite previous studies that have analyzed the effects of acupuncture on migraine, there is still a need for further investigation to ensure that the incorporation of acupuncture into migraine treatment management will have a positive outcome on patients.
- Prostatitis: This meta-analysis indicated that acupuncture has measurable benefits on CP/CPPS, and security has also been ensured. However, this meta-analysis only included 10 RCTs; thus, RCTs with a larger sample size and longer-term observation are required to verify the effectiveness of acupuncture further in the future.
- Hiccups: All of these studies sought to determine the effectiveness of different acupuncture techniques in the treatment of persistent and intractable hiccups. All four studies had a high risk of bias, did not compare the intervention with placebo, and failed to report side effects or adverse events for either the treatment or control groups.
- Retinal migraine: no evidence
So, what do we make of this? I think that, on the basis of the evidence:
- a positive recommendation for all types of chromic pain is not warranted;
- a positive recommendation for the treatment of TTH is questionable;
- a positive recommendation for migraine is questionable;
- a positive recommendation for prostatitis is questionable;
- a positive recommendation for hiccups is not warranted;
- a positive recommendation for retinal migraine is not warranted.
But why did NICE issue positive recommendations despite weak or even non-existent evidence?
SEARCH ME!
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Omega-3 fatty acids (fish oil) supplementation reduces the occurrence of cardiovascular disease (CVD) and CVD-related mortality in patients at high-risk of CVD and in patients with elevated plasma triglyceride level. Yet, some studies have found an increased risk of atrial fibrillation (AF). AF is the most common sustained cardiac arrhythmia worldwide. It is associated with high morbidity and mortality rates and significant public health burden. Previous studies of the effect of omega-3 fatty acids on AF occurrence have reported contradictory results.
This review evaluated the effect of omega-3 fatty acids on the risk of AF. The results suggest that omega-3 fatty acids supplementation is associated with increased AF risk, particularly in trials that used high doses. Therefore, several factors should be considered before prescribing omega-3 fatty acids, including their dose, type, and formulation (fish, dietary fish oil supplements, and purified fatty acids), as well as patient-related factors and atrial mechanical milieu. Because the benefits of omega-3 fatty acids are dose-dependent, the associated AF risk should be balanced against the benefit for CVD. Patients who take omega-3 fatty acids, particularly at high doses, should be informed of the risk of AF and followed up for the possible development of this common and potentially hazardous arrhythmia.
Another recent review included 54,799 participants from 17 cohorts. A total of 7,720 incident cases of AF were ascertained after a median 13.3 years of follow-up. In multivariable analysis, EPA levels were not associated with incident AF, HR per interquintile range (ie, the difference between the 90th and 10th percentiles) was 1.00 (95% CI: 0.95-1.05). HRs for higher levels of DPA, DHA, and EPA+DHA, were 0.89 (95% CI: 0.83-0.95), 0.90 (95% CI: 0.85-0.96), and 0.93 (95% CI: 0.87-0.99), respectively.
The authors concluded that in vivo levels of omega-3 fatty acids including EPA, DPA, DHA, and EPA+DHA were not associated with increased risk of incident AF. Our data suggest the safety of habitual dietary intakes of omega-3 fatty acids with respect to AF risk. Coupled with the known benefits of these fatty acids in the prevention of adverse coronary events, our study suggests that current dietary guidelines recommending fish/omega-3 fatty acid consumption can be maintained.
Faced with contradictory results based on non-RCT evidence, we clearly need an RCT. Luckily such a trial has recently been published. It was an ancillary study of a 2 × 2 factorial randomized clinical trial involving 25 119 women and men aged 50 years or older without prior cardiovascular disease, cancer, or AF. Participants were recruited directly by mail between November 2011 and March 2014 from all 50 US states and were followed up until December 31, 2017.
Participants were randomized to receive EPA-DHA (460 mg/d of EPA and 380 mg/d of DHA) and vitamin D3 (2000 IU/d) (n = 6272 analyzed); EPA-DHA and placebo (n = 6270 analyzed); vitamin D3 and placebo (n = 6281 analyzed); or 2 placebos (n = 6296 analyzed). The primary outcome was incident AF confirmed by medical record review.
Among the 25 119 participants who were randomized and included in the analysis (mean age, 66.7 years; 50.8% women), 24 127 (96.1%) completed the trial. Over a median 5.3 years of treatment and follow-up, the primary end point of incident AF occurred in 900 participants (3.6% of study population). For the EPA-DHA vs placebo comparison, incident AF events occurred in 469 (3.7%) vs 431 (3.4%) participants, respectively (hazard ratio, 1.09; 95% CI, 0.96-1.24; P = .19). For the vitamin D3 vs placebo comparison, incident AF events occurred in 469 (3.7%) vs 431 (3.4%) participants, respectively (hazard ratio, 1.09; 95% CI, 0.96-1.25; P = .19). There was no evidence for interaction between the 2 study agents (P = .39).
The authors concluded that among adults aged 50 years or older, treatment with EPA-DHA or vitamin D3, compared with placebo, resulted in no significant difference in the risk of incident AF over a median follow-up of more than 5 years. The findings do not support the use of either agent for the primary prevention of incident AF.
So, does the regular supplementation with omega-3 fatty acids increase the risk of atrial fibrillation? The evidence is not entirely clear but, on balance, I conclude that the risk is low or even non-existent.
The utilization of certain forms of so-called alternative medicine (SCAM) is prevalent among adults. While researchers have extensively studied the factors influencing SCAM use in Western countries, significant barriers to its adoption remain. This paper draws attention to the obstacles faced by individuals in their journey to using SCAM.
Qualitative interviews were conducted with 21 patients who had turned to SCAM for managing a chronic illness/condition and had been chosen through a ‘snowball sampling’ strategy. These in-depth, face-to-face interviews occurred in Miami, USA, during 2014-15. The sampling, data collection, and analysis processes of this study adhered to the principles outlined in Charmaz’s constructivist grounded theory approach.
From the data, three central barriers to SCAM utilization in the US emerged: 1) Financial barriers: A significant portion of SCAM treatments is not covered by insurance, making them cost-prohibitive for many. 2) Skepticism and discouragement: Both conventional medical practitioners and a segment of the public exhibited a noticeable trend towards discouraging SCAM use. 3) Evaluation challenges: Patients expressed difficulty in assessing the efficacy and benefits of various SCAM treatments compared to their costs.
The author concluded that despite the widespread interest in and use of SCAM in the US, numerous barriers hinder its broader integration into mainstream healthcare. These obstacles not only restrict healthcare choices for the general public but also appear to favor a select demographic, potentially based on income and availability of information.
So, 21 individuals chosen via a snowball sampling strategy located in Miami feel that there were obstacles to using SCAM.
No!
These obstacles existed about 10 myears ago.
No!
The obstacles only existed in the imagination of these 21 guys.
No!
The alleged obstacles are hardly relevant and therefore are not truly obstacles.
The only truly relevant obstacle to SCAM-use is the fact that most SCAMs have either not been shown to work, or shown not to work!
Perhaps surprisingly, the author concedes that their study has certain limitations: “This study had some inherent limitations. The sample, while chosen based on theoretical sampling to achieve theoretical saturation, was both small and self-selected. This limits the broad applicability of the findings. Moreover, individuals from lower socio-economic backgrounds were not represented in the sample, which may have overlooked important perspectives on affordable SCAM options. The sample did not offer a detailed exploration of SCAM perceptions across diverse demographic categories, such as social class or ethnicity. It’s also essential to highlight that this research was conducted exclusively in Miami, a city with a significant population of ethnic minorities in the US. This demographic context could have uniquely influenced the feedback from SCAM users.”
If I may, I will another limitation: This study was utter nonsense from its conception to its publication!
You might think that all of this is quite trivial and that I am rather petty. If you look into Medline and realize how many such useless and counter-productive SCAM studies are being published, you might change your mind.
