methodology
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.
Mushrooms are somewhat neglected in medical research, I often feel. This systematic review focused on clinical studies testing the effectiveness of mushrooms in cancer care. A total of 39 met the authors’ inclusion criteria. The studies included 12 different mushroom preparations. Some of the findings were encouraging:
- A survival benefit was reported using Huaier granules (Trametes robiniophila Murr) in 2 hepatocellular carcinoma studies and 1 breast cancer study.
- A survival benefit was also found in 4 gastric cancer studies using polysaccharide-K (polysaccharide-Kureha; PSK) as an adjuvant therapy.
- Eleven studies reported a positive immunological response.
- Quality-of-life (QoL) improvement and/or reduced symptom burden was reported in 14 studies using various mushroom supplements.
- Most studies reported adverse effects of grade 2 or lower, mainly nausea, vomiting, diarrhea, and muscle pain.
The authors caution that limitations included small sample size and not using randomized controlled trial design. Many of the reviewed studies were observational. Most showed favorable effects of mushroom supplements in reducing the toxicity of chemotherapy, improving QoL, favorable cytokine response, and possibly better clinical outcomes.
The authors concluded that the evidence is inconclusive to recommend the routine use of mushrooms for cancer patients. More trials are needed to explore mushroom use during and after cancer treatment.
The use of mushrooms for medicinal purposes has a long history in many cultures. Some mushrooms are known to be highly poisonous, some have hallucinogenic effects, and some are assumed to have pharmacological effects that have therapeutic potential. Some mushrooms possess pharmacologic properties such as anti-tumour, immunomodulating, antioxidant, cardiovascular, anti-hypercholesterolemic, anti-viral, anti-bacterial, anti-parasitic, anti-fungal, detoxification, hepatoprotective, and anti-diabetic effects.
Many modern medicines were derived from fungi. The best-known example is penicillin; others include several cancer drugs, statins and immunosuppressants. In Traditional Chinese Medicine, numerous herbal mixtures contain mushrooms; examples are reishi, maitake and shiitake which are all assumed to have anti-cancer properties.
As the review authors point out, there is a paucity of clinical trials testing the effectiveness of mushrooms, and the existing studies tend to be of poor quality. At present, most of our knowledge comes from traditional use or test-tube studies. The adverse effects depend on the specific mushroom in question and, can in some instances, be serious.
Considering the potential and the complexity of mycomedicine, I find it surprising to not see much more research into this subject.
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?
According to chiropractic belief, vertebral subluxation (VS) is a clinical entity defined as a misalignment of the spine affecting biomechanical and neurological function. The identification and correction of VS is the primary focus of the chiropractic profession. The purpose of this study was to estimate VS prevalence using a sample of individuals presenting for chiropractic care and explore the preventative public health implications of VS through the promotion of overall health and function.
A brief review of the literature was conducted to support an operational definition for VS that incorporated neurologic and kinesiologic exam components. A retrospective, quantitative analysis of a multi-clinic dataset was then performed using this operational definition.
The operational definition used in this study included:
- (1) inflammation of the C2 (second cervical vertebra) DRG,
- (2) leg length inequality,
- (3) tautness of the erector spinae muscles,
- (4) upper extremity muscle weakness,
- (5) Fakuda Step test,
- radiographic analysis based on the (6) frontal atlas cranium line and (7) horizontal atlas cranium line.
Descriptive statistics on patient demographic data included age, gender, and past health history characteristics. In addition to calculating estimates of the overall prevalence of VS, age- and gender-stratified estimates in the different clinics were calculated to allow for potential variations.
A total of 1,851 patient records from seven chiropractic clinics in four states were obtained. The mean age of patients was 43.48 (SD = 16.8, range = 18-91 years). There were more females (n = 927, 64.6%) than males who presented for chiropractic care. Patients reported various reasons for seeking chiropractic care, including, spinal or extremity pain, numbness, or tingling; headaches; ear, nose, and throat-related issues; or visceral issues. Mental health concerns, neurocognitive issues, and concerns about general health were also noted as reasons for care. The overall prevalence of VS was 78.55% (95% CI = 76.68-80.42). Female and male prevalence of VS was 77.17% and 80.15%, respectively; notably, all per-clinic, age, or gender-stratified prevalences were ≥50%.
The authors concluded that the results of this study suggest a high rate of prevalence of VS in a sample of individuals who sought chiropractic care. Concerns about general health and wellness were represented in the sample and suggest chiropractic may serve a primary prevention function in the absence of disease or injury. Further investigation into the epidemiology of VS and its role in health promotion and prevention is recommended.
This is one of the most hilarious pieces of ‘research’ that I have recently encountered. The strategy is siarmingly simple:
- invent a ficticious pathology (VS) that will earn you plently of money;
- develop criteria that allow you to diagnose this pathology in the maximum amount of consumers;
- show gullible consumers that they are afflicted by this pathology;
- use scare mongering tactics to convince consumers that the pathology needs treating;
- offer a treatment that, after a series of expensive sessions, will address the pathology;
- cash in regularly while this goes on;
- when the consumer has paid enough, declare that your fabulous treatment has done the trick and the consumer is again healthy.
The strategy is well known amongst practitioners of so-called alternative medicine (SCAM), e.g.:
- Traditional acupuncturists diagnose a ficticious imbalance of yin and yang only to normalise it with numerous acupuncture sessions.
- Naturopaths diagnose ficticious intoxications and treat it with various detox measures.
- Iridologists diagnose ficticious abnormalities of the iris that allegedly indicate organ disstress and treat it with whatever SCAM they can offer.
As they say:
No disease can be more surely, effectively, and profitably treated than a condition that the unsuspecting customer did not have in the first place!
PS
Sadly, such behavior exists in convertional medicine occasionally too, but SCAM relies almost entirely on it.
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.
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.
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.
We have discussed the homeopathic obscession with bovine mastitis before. For instance, we have looked at this systematic review which did exactly that. Its authors are highly respected and come from institutions that are not likely to promote bogus claims:
- Département de Sciences Cliniques, Faculté de Médecine Vétérinaire, Université de Montréal, Canada
- Département de Sciences Cliniques, Faculté de Médecine Vétérinaire, Université de Montréal, Canada
- Canadian Bovine Mastitis and Milk Quality Research Network, Canada
- Canadian Bovine Mastitis and Milk Quality Research Network, Canada
- Sherbrooke Research and Development Centre, Agriculture and Agri-Food Canada
- Canadian Bovine Mastitis and Milk Quality Research Network, Canada
- Département de Pathologie et Microbiologie, Faculté de Médecine Vétérinaire, Université de Montreal, Canada.
A total of 2,451 manuscripts were first identified and 39 manuscripts corresponding to 41 studies were included. Among these, 22 were clinical trials, 18 were experimental studies, and one was an observational study. The treatments evaluated were conventional anti-inflammatory drugs (n = 14), oxytocin with or without frequent milk out (n = 5), biologics (n = 9), homeopathy (n = 5), botanicals (n = 4), probiotics (n = 2), and other alternative products (n = 2). All trials had at least one unclear or high risk of bias. Most trials (n = 13) did not observe significant differences in clinical or bacteriological cure rates in comparison with negative or positive controls. Few studies evaluated the effect of treatment on milk yield. In general, the power of the different studies was very low, thus precluding conclusions on non-inferiority or non-superiority of the treatments investigated. No evidence-based recommendations could be given for the use of an alternative or non-antimicrobial conventional treatment for clinical mastitis. The authors concluded that homeopathic treatments are not efficient for management of clinical mastitis.
Did this finally stop homeopaths from claiming that their placebos work for mastitis?
I would not count on it!
Will it stop homeopaths to conduct trials of the subject?
No!
Recently a new study has emerged. Its aim was to assess the potential of a novel homeopathic complex medicine in managing bovine mastitis. Twenty-four lactating Holstein cows with mastitis were divided into two groups: the homeopathic complex group received a homeopathic complex daily for 60 days at a dose of 20 g/d; the placebo group received the calcium carbonate vehicle without homeopathic medicines at the same dose and repetition. The main outcome measure was somatic cell count (SCC; cells/mL), with additional outcome measures including milk production (kg/d), milk constituents (percentage of protein, fat, lactose and total milk solids), and serum levels of cortisol, glucose, ammonia and lactic acid. All outcomes were measured at the beginning of the study and after 30 and 60 days. Milk samples were also collected from all animals at the beginning of the study, confirming a high (>0.2) MAR index for isolated bacterial cultures.
Assessment of SCC showed a statistically significant difference favoring the homeopathic complex versus placebo group at day 60. A reduction in serum cortisol levels and an increase in fat, lactose and total milk solids in animals treated with the homeopathic complex at day 60 were also seen. Other outcome measures did not show statistically significant inter-group differences.
The authors from the Paranaense University-Praça Mascarenhas de Moraes, Umuarama, Paraná, Brazil, concluded that the results of this non-randomized, open-label, placebo-controlled trial suggest the potential for a novel homeopathic complex medicine in management of multiple antibiotic-resistant bovine mastitis, thus offering dairy farmers an additional option to antibiotics and making dairy products safer for consumer health and milk production more sustainable.
Here are just some of the most obvious points of concern:
- The trial was supported by the manufacturer of the homeopathic product, yet the authors declare no conflicts of interest.
- The exact nature of the product remains unknown to anyone like me who tried to obtain the information by searching the websites of the manufacturer, etc.
- The trial was non-ramdomized and open label, i.e. wide open to bias, yet the authors do not shy away from drawing firm conclusions.
- There is no plausible rationale for homeopathy in this (or any other) indication.
- Homeopathy for animals contradicts the gospel of Hahnemann, its inventor.
- Overwhelmingly, the evidence fails to show that homeopathy is effective for bovine mastitis.
I do understand that manufacturers smell a lucrative market, but I still think that, for serious veterianarians, scientists, journal editors, etc., the subject should be closed.
