research
On this blog, we had more than our fair share of comments from the anti-vax clan. This article asked a question that I have often been pondering:
How to convince the unvaccinated proportion of the population of the benefits of a vaccination?
Designing more successful communication strategies, both in retrospect and looking ahead, requires a differentiated understanding of the concerns of those that remain unvaccinated. Guided by the elaboration likelihood model, this paper has two objectives: First, it explores by means of a latent class analysis how unvaccinated individuals might be characterized by their attitudes towards COVID-19 vaccination. Second, the researchers investigate to what extent (i) varying types of evidence (none/anecdotal/statistical) can be employed by (ii) different types of communicators (scientists/politicians) to improve vaccination intentions across these subgroups. To address these questions, the authors conducted an original online survey experiment among 2145 unvaccinated respondents from Germany where a substantial population share remains unvaccinated.
The results suggest three different subgroups, which differ regarding their openness towards a COVID-19 vaccination:
- vaccination opponents (N = 1184),
- sceptics (N = 572)
- those in principle receptive (N = 389) to be vaccinated.
On average, neither the provision of statistical nor anecdotal evidence increased the persuasiveness of information regarding the efficacy of a COVID-19 vaccine. However, scientists were, on average, more persuasive than politicians (relatively increase vaccination intentions by 0.184 standard deviations). With respect to heterogeneous treatment effects among the three subgroups, vaccination opponents seem largely unreachable, while sceptics value information by scientists, particularly if supported by anecdotal evidence (relatively increases intentions by 0.45 standard deviations). Receptives seem much more responsive to statistical evidence from politicians (relatively increases intentions by 0.38 standard deviations).
According to the authors, these insights suggest that, in the short term, receptives and sceptics are the most promising target groups for vaccination campaigns. Yet, in the medium term, opponents need not be forgotten. While mandatory vaccinations may appear as the only strategy to target strict vaccination opponents, politicians and researchers are advised to focus on ways how to rebuild trust and address beliefs in misinformation within this population group. The inconsistency in vaccine related communication has led to a loss of trust in political and scientific decision-makers. It is therefore important to rebuild this trust through evidence-based communication. The way we understand and perceive the credibility of a source significantly impacts our processing of messages and can also significantly affect related behaviours. Using evidence to validate relevant and reliable information can therefore also be vital to build trust and credibility in the vaccines themselves and their safety.
The authors concluded that our study employed sociopsychological theory to challenge the view of the existence of a single homogeneous group of unvaccinated citizens. By drawing on a large sample of unvaccinated citizens and combining latent class analysis with experimental methods, we encourage decision-makers to carefully consider heterogeneities in the effectiveness of their communication strategies, especially regarding their communicator and employed evidence type.
I don’t know why, but it was only recently that I came across RESEARCH.COM!
In case you don’t know what it is: essentially, it is a platform that offers rankings of:
- Universities,
- Journals,
- Conferences,
- Scientists
Research.com “really cares about the quality and visibility of research and our mission is to offer leading researchers better exposure of their achievements. Our rankings of scientists are based on transparent procedures based on well-established metrics gathered from trusted sources of data.
Our best scholars ranking is a credible list of leading scientists from the discipline of Medicine, established by means of a thorough analysis of 166,880 researchers determined from various bibliometric data sources. For the field of Medicine, as many as 68936 scientists were investigated.”
Like Oscar Wilde, I can resist everything except temptation. So, I typed in my name and found this:
World ranking: 938
National ranking: 103
D-Index: 140
Citations: 71,715
Obviously, I was pleased but also have to admit that I am unsure of what a ‘D-Index’ is and how it is derived (something that can be looked up, I’m sure).
Still tempted, I ventured to find the rankings of other researchers of so-called alternative medicine (SCAM). So, I spent quite some time searching the more well-known names in this field.
And the result? ZERO!
As far as I was able to determine, none of my fellow SCAM researchers have a ranking at all.
Does that mean that I am the only ‘leading’ scientist in my field?
Emboldened by this thought, I tried to find out whether any Exeter researcher is ranked higher than I am. The answer is YES: Andrew Hattersley is on rank 41. I know Andrew; he is a great scientist and person and deserves to be very high up on the list.
[I should add perhaps that I found the research.com site rather difficult to navigate. If I made errors, could someone more gifted than I please put me right?]____________________
In what way is any of this relevant?
In no way!
Yesterday, somone commented on this blog: “What have any of you so called scientists done for humans, on this site, besides throw your credentials around? Nothing, you are lifelong college students too scared to join real world.”
Now the author of these lines can be happy in the belief that he is correct.
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.
That proponents of anthroposophic medicine have strange attitudes towards established and effective immunizations is hardly a secret. The authors of this review defined anthroposophic communities as people following some/certain views more or less loosely connected to the philosophies of anthroposophy. Their systematic review firstly collated evidence documenting outbreaks linked to anthroposophic communities.
A total of 18 measles outbreaks occurred between 1997 and 2011 in European countries. Eight out of 18 measles outbreaks started at Waldorf schools throughout Germany, Switzerland, Austria, Netherlands, and the UK. Although data from community reporting was limited, the measles cases at Waldorf schools were predominantly higher than in mainstream private or state schools across the five countries. Offering measles vaccination catch-ups by public health authorities (which is an effective way to manage a measles outbreak) was described in several articles but was largely refused by both parents and Waldorf schools. The most effective outbreak control strategy was the immediate closure of the Waldorf school and strict rules regarding entry to the school upon reopening.
Secondly, the review summarized the literature on vaccination coverage in anthroposophic communities. Six articles described vaccine coverage in anthroposophic communities, and one article described the personal belief exception (PBE) rate at Waldorf school in the USA. The papers focussed predominantly on diphtheria, pertussis, tetanus and poliomyelitis (DPTP), and mumps, measles and rubella (MMR) vaccines. Two studies studying the vaccination coverage at Waldorf pre-schools/schools, demonstrated overall low immunization coverage at those schools. One article focusing on PBE rates demonstrated a proportionally high rate at Waldorf schools in California. Three studies from the Netherlands measure vaccination coverage in general and focussed specifically on whether there were special groups that showed specifically low coverage. In these studies, anthroposophic communities were identified as showing low coverage. However, one study suggested that anthroposophic communities are not as significant in terms of low coverage as low-income groups. One paper described rates of vaccination refusal in Switzerland. It showed that complementary alternative medicine users, including people who draw on anthroposophic medicine, are more likely to refuse vaccination. However, the paper also shows that this group was more likely to vaccinate against tick-borne diseases and encephalitis than the general population.
Thirdly, the review discussed the literature that summarized theories and factors influencing vaccine decision-making in anthroposophic communities. Eight articles examining factors and theories influencing vaccine decision-making in anthroposophic communities were included. Five articles focused on parents of children attending Waldorf schools or who considered themselves part of an anthroposophic community. Three articles focused on the perspectives of anthroposophic healthcare providers, although two of those articles mixed and compared views with other alternative/complementary providers or allopathic health providers. Of the eight articles, two were quantitative and did not provide an in-depth discussion. The qualitative findings from six articles were summarized in-depth and revealed four themes.
The authors concluded that this systematic review showed that there have been several measles outbreaks linked to anthroposophic communities in Europe. Although studies on vaccination coverage in anthroposophic communities are limited, it appears that coverage is lower than in the general population. Monitoring outbreak numbers and vaccination coverage could be important. Popular beliefs about the anthroposophic communities’ vaccination beliefs are challenged in this review. As the evidence shows the communities are not categorically against vaccines. Moreover, there are a myriad of factors that influence vaccine decision-making of parents belonging to an anthroposophic community. The importance of experiencing childhood illnesses and concerns over long-term side effects were mentioned. Moreover, parents want to be able to individually select vaccines for their children. They consider themselves actively engaged in vaccine decision-making and well-informed. Stigma regarding vaccine choices was mentioned repeatedly mostly by people outside of the anthroposophic community but also by people within the community. This review calls for a better understanding of vaccine choices and beliefs for vaccines beyond MMR, in particular HPV vaccines. The review also highlights a potentially important research gap, which constitutes understanding not only a belief system but the role that stigma may play in making decisions about vaccines.
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If you ask where this strange anti-vaccination stance of anthroposophic medicine comes from, you don’t need to look far:
“In the future, we will eliminate the soul with medicine.
Under the pretext of a ‘healthy point of view’, there will be a vaccine by which the human body will be treated as soon as possible directly at birth,
(1) so that the human being cannot develop the thought of the existence of soul and Spirit.
To materialistic doctors, will be entrusted with the task of removing the soul of humanity.
As today, people are vaccinated against this disease or disease, so in the future, children will
(2) be vaccinated with a substance that can be produced precisely in such a way that people, thanks to this vaccination, will be immune to being subjected to the “madness” of spiritual life.
He would be extremely smart, but he would not develop a conscience, and that is the
(3) true goal of some materialistic circles.
With such a vaccine, you can easily make the etheric body loose in the physical body.
Once the etheric body is detached, the relationship between the universe and the etheric body would become extremely unstable, and man would become
(4) an automaton, for the physical body of man must be polished on this Earth by spiritual will.
So, the vaccine becomes a kind of arymanique [Ahrimanic] force; man can no longer get rid of a given materialistic feeling.
(5) He becomes materialistic of constitution and can no longer rise to the spiritual “.
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?
How often have we seen it stated on this blog and elsewhere by enthusiasts of so-called alternative medicine (SCAM) that COVID vaccinations were useless or even harmful? Here is some rather compelling evidence that should make them think again.
This population based cohort study investigated the effectiveness of primary covid-19 vaccination (first two doses and first booster dose within the recommended schedule) against post-covid-19 condition (PCC).
All adults (≥18 years) participated from the Swedish Covid-19 Investigation for Future Insights (a Population Epidemiology Approach using Register Linkage (SCIFI-PEARL) project, a register based cohort study in Sweden) with covid-19 first registered between 27 December 2020 and 9 February 2022 (n=589 722) in the two largest regions of Sweden. Individuals were followed from a first infection until death, emigration, vaccination, reinfection, a PCC diagnosis (ICD-10 diagnosis code U09.9), or end of follow-up (30 November 2022), whichever came first. Individuals who had received at least one dose of a covid-19 vaccine before infection were considered vaccinated.
The primary outcome was a clinical diagnosis of PCC. Vaccine effectiveness against PCC was estimated using Cox regressions adjusted for age, sex, comorbidities (diabetes and cardiovascular, respiratory, and psychiatric disease), number of healthcare contacts during 2019, socioeconomic factors, and dominant virus variant at time of infection.
Of 299 692 vaccinated individuals with covid-19, 1201 (0.4%) had a diagnosis of PCC during follow-up, compared with 4118 (1.4%) of 290 030 unvaccinated individuals. Covid-19 vaccination with any number of doses before infection was associated with a reduced risk of PCC (adjusted hazard ratio 0.42, 95% confidence interval 0.38 to 0.46), with a vaccine effectiveness of 58%. Of the vaccinated individuals, 21 111 received one dose only, 205 650 received two doses, and 72 931 received three or more doses. Vaccine effectiveness against PCC for one dose, two doses, and three or more doses was 21%, 59%, and 73%, respectively.
The authors concluded that the results of this study suggest a strong association between covid-19 vaccination before infection and reduced risk of receiving a diagnosis of PCC. The findings highlight the importance of primary vaccination against covid-19 to reduce the population burden of PCC.
This study should make the anti-vaxers re-consider their views. Sadly, I have little hope that they will. If they don’t, they provide rational thinkers with yet further evidence that they are cultists who are beyond learning from compelling data.
I was alerted to a new book entitled “Handbook of Space Pharmaceuticals“. It contains a chapter on “Homeopathy as a Therapeutic Option in Space” (yes, I am not kidding!). Here is its abstract (the numbers were inserted by me and refer to the short comments below):
Homeopathy is one of the largest used unorthodox medicinal systems having a wide number of principles and logic to treat and cure various diseases [1]. Many successful concepts like severe dilution to high agitation have been applied in the homeopathic system [2]. Though many concepts like different treatment for same diseases and many more are contradictory to the allopathic system [3], homeopathy has proved its worth in decreasing drug-related side effects in many arenas [4]. Various treatments and researches are carried out on various diseases; mostly homeopathic treatment is used in joint diseases, respiratory diseases, cancer, and gastrointestinal tract diseases [5]. In this chapter, readers will have a brief idea about many meta-analysis results of most common respiratory diseases, i.e., asthma, incurable hypertension condition, rheumatoid arthritis, and diarrhea and a megareview of all the diseases to see their unwanted effects, uses of drugs, concepts, and issues related to homeopathy [6]. Various limitations of homeopathic treatments are also highlighted which can give a clear idea about the future scope of research [7]. Overall, it can be concluded that placebo and homeopathic treatments give almost the same effect [8], but the less severe side effects of homeopathic drugs in comparison to all other treatment groups catch great attention [9].
Apart from the very poor English of the text and the fact that it has as good as nothing to do with the subject of ‘Homeopathy as a Therapeutic Option in Space’, I have the following brief comments:
- I did not know that homeopathy has ‘a wide number of logic’ and had alwas assumed that there is only one logic.
- Successful concepts? Really?
- So, homeopaths believe that the ‘allopathic system’ treats the same diseases uniformly? In this case, they should perhaps read up what conventional medicine really does.
- I am not aware of good evidence showing that homeopathy reduces drug related adverse effects.
- No, homeopathy is used for all symptoms – Hahnemann did not believe in treating disease entities – and mostly for those that are self-limiting.
- I love the term ‘incurable hypertension condition’; can somebody please explain what it is?
- The main limitation is that homeopathy is nonsense and, as such, does not really require further research.
- Not ‘almost’ but ‘exactly’! But thanks for pointing it out.
- Wishful thinking and not true. Firstly, the author forgot about ‘homeopathic aggravations’ in which homeopaths so strongly believe. Secondly, I know of many non-homeopathic treatments that are free of adverse effects when done properly.
Altogether, I am as disappointed by this article as you must be: we were probably all hoping to hear about the discovery showing that homeopathy works splendidly in space – not least because we have known for a while that homeopaths seem to be from a different planet.
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.
