bias
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.
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!
.
The British doctor and outspoken anti-vaxer Aseem Malhotra has featured several times on this blog, e.g.:
- UK Cardiologist Dr. Aseem Malhotra receives a well-deserved award
- Dr Aseem Malhotra and Dr Steven James: candour and complacency
Now, there has been a potentially important new development in his story. The Good Law Project recently announced the following:
During the pandemic, we depended on doctors telling us how we could protect ourselves and our loved ones. We trusted their advice would be based on the most reliable and up-to-date research.
But when the British cardiologist Dr Aseem Malhotra went on television, or posted to his hundreds of thousands of followers on social media, he repeatedly claimed the vaccine was ineffective and posed a greater threat than Covid, causing “horrific unprecedented harms including sudden cardiac death” – suggestions refuted by medical experts and branded false by factcheckers.
The General Medical Council is responsible for regulating doctors in the UK and investigating those whose conduct falls short of the required standards. Despite the clear risk to public health of vaccine misinformation, it has so far refused to launch an investigation into Malhotra’s public pronouncements, originally saying that they “don’t consider that the comments or posts made by the doctor call his fitness to practice into question…” and subsequently upholding that decision after a number of doctors challenged it.
Good Law Project is supporting a doctor who is taking the regulator to the High Court over their failure to investigate whether Malhotra has breached standards. The judicial review has now been given permission to proceed by the High Court, which held that it raises an “issue of general public importance” as to how the GMC exercises its functions.
According to the claimant, Dr Matt Kneale, medical professionals “should not be using their professional status to promote harmful misinformation”.
“When doctors repeatedly say things that are incorrect, misleading and put people’s health at risk – for example by encouraging them to refuse a vaccine – the GMC must hold them to account,” Kneale said.
For the Good Law Project Executive Director, Jo Maugham, the regulator’s failure to investigate doctors spreading misinformation forms part of a wider pattern.
“What we have learned from both the pandemic inquiry and the calamitous economic consequences of Brexit,” Maugham explained, “is quite how serious are the consequences of deciding, as Michael Gove did, that we have ‘had enough of experts’.”
The council may prefer to avoid becoming embroiled in a controversy over free speech, he continued, but “its primary obligation is to protect the public – and it’s really hard to see how its stance delivers on that objective.”
Dr Malhotra is far from the only proponent of vaccine misinformation in the UK. Open Democracy revealed that anti-lockdown MPs, including Tufton Street’s Steve Baker, took large donations from a secretive group called The Recovery Alliance, which has been linked with a fake grassroots organisation that campaigned against the vaccine.
We’re working to stop misinformation from going unchallenged, and to make sure that regulators like the General Medical Council hold dangerous doctors who make unfounded claims accountable.
By helping to fund this case, you’ll be fighting for trust in the medical profession and to make sure public safety is doctors’ first priority. Any support you can give will help us make positive change.
____________________
The ‘Good Law Project’?
Who are they?
Good Law Project is a not for profit campaign organisation that uses the law for a better world. We know that the law, in the right hands, can be a fair and decent force for good. It is a practical tool for positive change and can make amazing things happen. We are proud to be primarily funded by members of the public, which keeps us fiercely independent. We want to inspire hope in difficult times by showing that you can make a difference, with the backing of good law. Our mission is to use the law to hold power to account, protect the environment, and ensure no one is left behind. You can learn more about our organisation and achievements in 2022-23 in our annual report.
You might even decide to support this splendid organization!
I hope you do.
Congratulations to Joseph Prahlow, MD, who is the winner of the Excellence in Homeopathy Award! Here are the conclusions of his winning essay. Special thanks to Hermeet Singh and Boiron for their prize donation.
Despite the many obstacles and challenges which face homeopathy in the 21st century, the homeopathic community should be emboldened and encouraged by the fact that there are also many opportunities for the advancement of homeopathy as an alternative choice in health care.
Proclaim the Truth: Homeopathy Actually Works
Notwithstanding the challenges involved (especially for a student) in arriving at the correct simillimum for a case, let alone the appropriate follow-up and case management, the truth of the matter is that homeopathy does, in fact, work! Those of us who have been the beneficiaries of homeopathic care, or who have seen the benefits in others, know with no doubt whatsoever that homeopathy represents a truly amazing form of alternative medicine that is able to successfully treat patients having a wide range of health concerns, including some very ill individuals. And it’s not just based on “experience” or “perception,” although such evidence should not be discounted. Numerous studies show the effectiveness of homeopathy.6-9 The fact that homeopathy actually works represents one of the biggest and most important opportunities for homeopathy. The corresponding challenge relates to “getting the word out” into the general community as well as the medical community. Instead of homeopathy being the “last resort,” it should increasingly become the “first choice” amongst patients. Only by “spreading the word” of its success can this become a reality.
What intrigued me here was the evidence that an award-winning homeopath believes might justify the claim that
“Numerous studies show the effectiveness of homeopathy”
6. Mathie RT, Lloyd SM, Legg LA, et al. Randomised placebo-controlled trials of individualized homeopathic treatment: systematic review and meta-analysis. Syst Rev. 2014 Dec 6;3:142. doi: 10.1186/2046-4053-3-142.
As we have discussed previously that meta-analysis is phoney and created a false-positive result by omitting at least two negative studies.
7. Taylor JA, Jacobs J. Homeopathic ear drops as an adjunct in reducing antibiotic usage in children with otitis media. Glob Pediatr Health 2014 Nov 21;1:2333794X14559395. doi: 10.1177/2333794X14559395.
This study had the notorious A+B versus B design and thus was unable to test for specific effects of homeopathy. Moreover, the lead author, Dr Jennifer Jacobs, was a paid consultant to Standard Homeopathic Company.
8. Sorrentino L, Piraneo S, Riggio E, et al. Is there a role for homeopathy in breast cancer surgery? A first randomized clinical trial on treatment with Arnica montana to reduce post-operative seroma and bleeding in patients undergoing total mastectomy. J Intercult Ethnopharmacol 2017 Jan 3;6(1):1-8. doi: 10.5455/jice.20161229055245.
This study showed no significant result in the intention to treat analysis. The positive conclusion seems to be based on data dredging only.
9. Frass M, Lechleitner P, Grundling C, et al. Homeopathic treatment as an add-on therapy may improve quality of life and prolong survival in patients with non-small cell lung cancer: a randomized, placebo-controlled, double-blind, three-arm, multic0-e1955enter study. Oncologist 2020 Dec 25(12):e1930-e1955. doi: 10.1002/onco.13548.
This study is since months under investigation for fraud. The reasons for this have been discussed previously.
Perhaps the award winning author should chance the crucial sentence into something like:
Numerous studies have shown how homeopaths try to mislead the public?
In any case, please do not let this stop you from reading the full paper by the award-winning author. I promise you that it will create much hilarity.
What does homeopathy offer our modern ailing world?
NOTHING!
According to Healthcare.gov, a primary care provider in the US is “a physician (MD or DO), nurse practitioner, clinical nurse specialist or physician assistant, as allowed under state law, who provides, coordinates or helps a patient access a range of healthcare services.” A growing movement exists to expand who can act as a primary care privider (PCP). Chiropractors have been a part of this expansion, but is that wise? This is the question recently asked by Katie Suleta of THE AMERICAN COUNCIL ON SCIENCE AND HEALTH In it, she explains that:
- chiropractors would like to act as PCPs,
- chiropractors are not trained in pharmacology,
- chiropractors receive some training in supplements,
- chiropractors wish to avoid pumping the body full of “synthetic” hormones and substances.
Subsequently, she adresses the chiropractic profession’s stance on vaccines.
First, look at similar professional organizations to establish a reasonable expectation. The American Medical Association has firmly taken a stance on vaccines and provides resources for physicians to help communicate with patients. There is no question about where they stand on the topic, whether it be vaccines in general or COVID-19 vaccines specifically. Ditto the American Osteopathic Association and American Association of Colleges of Osteopathic Medicine. There is a contingent of vaccine-hesitant MDs and DOs. There is also an anti-vax contingent of MDs and DOs. The vaccine hesitant can be considered misguided and cautious, while anti-vaxxers often have more misinformation and an underlying political agenda. The two groups pose a threat but are, thankfully, the minority. They’re also clearly acting against the recommendations of their professional organizations.
Let’s now turn to the American Chiropractic Association (ACA). Unlike the American Medical Association or American Osteopathic Association, they seem to take no stance on vaccines. None. Zip. Zilch. As of this writing, if you go to the ACA website and search for “vaccines,” zero results are returned. Venturing over to the ACA-CDID, there is a category under their “News and Articles” section for ‘Vaccines.’ This seems promising! However, when you click on it, it returns one article on influenza vaccines from Fox News from 2017. It’s not an original article. It’s not a perspective piece. No recommendations are to be found—nothing even on the COVID-19 vaccines. Basically, there is effectively nothing on ACA-CDID’s website either. We’re oh for two.
The last one we’ll try is DABCI University. No, it’s not a professional organization, but it does train DCs. The words ‘university’ and ‘internist’ are involved, so they must talk about vaccines…right? Wrong again. While there is a lot of content available only to paying members and students, the sections of their website that are publicly available are noticeably short on vaccine information. There is a section dedicated to articles, currently including five whole articles, and not a single one talked about vaccines. One report addresses the pharmacokinetics of coffee enemas, but none talks about one of the most fundamental tools PCPs have to help prevent illness.
Why It’s Important
Chiropractic was defined by DD. Palmer, its founder, as “a science of healing without drugs.” It relies on spinal manipulation. In traditional chiropractic, there is no room for medications at all. A rift has developed within the profession, and some chiropractors, those seeking that internal medicine certification, “try to avoid pumping the body with synthetic hormones and other prescriptions.”
During the COVID-19 pandemic, several prominent chiropractors publicly pushed anti-vaccine views. To highlight just a few prominent examples: Vax Con ’21, Mile Hi Chiro, and Ben Tapper. Vax Con ’21 was organized and orchestrated by the Chiropractic Society of Wisconsin. It featured Judy Mikovits, of Plandemic fame, as a speaker and touted her book with a forward written by Robert F. Kennedy Jr. It offered continuing education units (CEUs) to DCs to attend this anti-vaccine conference that peddled misinformation about COVID-19 vaccines and other prevention measures. Healthcare providers are often required to complete a certain number of continuing education units to maintain licensure, ensuring that they stay current and sharp as healthcare evolves or, in this case, devolves.
This conference was not unique in this either. Mile Hi Chiro was just held in Denver in September of this year, had several questionable speakers (including RFK and Ben Tapper of Disinformation Dozen fame), and offered continuing education. If professional conferences offer continuing education units for attendees and push vaccine misinformation, that should concern everyone. Especially if the profession in question wants to act as PCPs.
Despite training in a system that believes “the body has an innate intelligence, and the power to heal itself if it is functioning properly, and that chiropractic care can help it do that,” without medications, but frequently with supplements, roughly 58% of Oregon’s chiropractors were vaccinated against COVID-19. That said, their training and inclination, along with the silence of their professional organizations and the chiropractic conferences featuring anti-vaccine sentiment, make them a profession that, at the very least, doesn’t consider vaccinations or medications viable health alternatives. We’re now talking about an entire profession that wants to be PCPs.
Irrespective of your belief about the efficacy of COVID-19 vaccination, the germ theory of disease remains unchallenged. Anyone unwilling to work to treat and prevent infectious diseases within their community with the most effective means at our disposal should not be allowed to dispense medical advice. Chiropractors lack the basic training that a PCP should have. I’ve said it before and I’ll say it again: I want healthcare accessible for everyone. But, if you’re looking for a PCP, consider going to an MD, DO, NP, or PA – they come fully equipped for your primary care needs.
Regular readers of this blog will be aware that I have discussed the thorny issue of chiros and vaccinations many times before, e.g.:
- Chiropractic and Public Health
- The International Chiropractors Association’s Statement on Vaccination
- The General Chiropractic Council’s ‘Registrant Survey 2020’ has just been published
- Far too many chiropractors believe that vaccinations do not have a positive effect on public health
- Vaccination: chiropractors “espouse views which aren’t evidence based”
- Patients consulting chiropractors, homeopaths, or naturopaths are less likely to agree to the flu jab
- “The uncensored truth” about COVID-19 vaccines” … as told by some chiro loons
- Beliefs and behaviors of US chiropractors
- Media attention forces (some) chiropractors to get their act together
- Ever wondered why so many chiropractors are profoundly anti-vax?
I agree with Katie Suleta that the issue is important and thank her for raising it. I also agree with her conclusion that, if you’re looking for a PCP, consider going to an MD, DO, NP, or PA – they come fully equipped for your primary care needs.
Do not consult chiropractors.
The concept that the outcomes of spinal manipulation therapy (SMT) – the hallmark intervention of chiropractors which they use on practically every patient – are optimized when the treatment is aimed at a clinically relevant joint is commonly assumed and central to teaching and clinical use of chiropractic. But is the assumption true?
This systematic review investigated whether clinical effects are superior when this is the case compared to SMT applied elsewhere. Eligible study designs were randomized controlled trials that investigated the effect of SMT applied to candidate versus non-candidate sites for spinal pain.
The authors obtained studies from four different databases. Risk of bias was assessed using an adjusted Cochrane risk of bias tool, adding four items for study quality. Between-group differences were extracted for any reported outcome or, when not reported, calculated from the within-group changes. Outcomes were compared for SMT applied at a ‘relevant’ site to SMT applied elsewhere. The authors prioritized methodologically robust studies when interpreting results.
Ten studies were included. They reported 33 between-group differences; five compared treatments within the same spinal region and five at different spinal regions.
None of the nine studies with low or moderate risk of bias reported statistically significant between-group differences for any outcome. The tenth study reported a small effect on pain (1.2/10, 95%CI – 1.9 to – 0.5) but had a high risk of bias. None of the nine articles of low or moderate risk of bias and acceptable quality reported that “clinically-relevant” SMT has a superior outcome on any outcome compared to “not clinically-relevant” SMT. This finding contrasts with ideas held in educational programs and clinical practice that emphasize the importance of joint-specific application of SMT.
The authors concluded that the current evidence does not support that SMT applied at a supposedly “clinically relevant” candidate site is superior to SMT applied at a supposedly “not clinically relevant” site for individuals with spinal pain.
I came across this study when I searched for the published work of Prof Stephen Perle, a chiropractor and professor at the School of Chiropractic, College of Health Sciences, University of Bridgeport, US, who recently started trolling me on this blog. Against my expectation, I find his study interesting and worthwhile.
His data quite clearly show that the effects of SMT are non-specific and mainly due to a placebo response. That in itself is not hugely remarkable and has been suspected to some time, e.g.:
- Chiropractic manipulation for migraine is a placebo therapy
- Chiropractic treatments are placebos
- Chiropractic spinal manipulation = placebo!
- Manual therapy (mainly chiropractic and osteopathy) does not have clinically relevant effects on back pain compared with sham treatment
- Manual therapies for back pain: not better than a placebo
- Is spinal manipulation a placebo therapy?
What is remarkable, however, is the fact that Perle and his co-authors offer all sorts of other explanation for their findings without even seriously considering what is stareing in their faces:
SPINAL MANIPULATIONS ARE PLACEBOS
CHIROPRACTIC IS A PLACEBO THERAPY
This might be almost acceptable, if chiropractic would not also be burdened with significant risks (as we have discussed ad nauseam on this blog) – another fact of which chiros like Perle are in denial.
What does all that mean for patients?
The practical implication is fairly straight forward: the risk/benefit balance of chiropractic is negative. And this surely means the only responsible advice to patients is this:
NEVER CONSULT A CHIRO!
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.
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.
Much of the discussions on this blog are directly or indirectly related to the subject of research integrity. Research integrity refers to the ethical and professional standards that researchers must adhere to while conducting research. It involves conducting research in a way that allows others to have confidence and trust in the methods and findings of the research. Research integrity includes honesty, rigour, transparency, open communication, care and respect for all participants, and accountability. According to the ‘Concordat To Support Research Integrity‘, the core elements of research integrity are:
- Honesty in all aspects of research, including in the presentation of research goals, intentions and findings; in reporting on research methods and procedures; in gathering data; in using and acknowledging the work of other researchers; and in conveying valid interpretations and making justifiable claims based on research findings.
- Rigour, in line with prevailing disciplinary norms and standards, and in performing research and using appropriate methods; in adhering to an agreed protocol where appropriate; in drawing interpretations and conclusions from the research; and in communicating the results.
- Transparency and open communication in declaring potential competing interests in the reporting of research data collection methods; in the analysis and interpretation of data; in making research findings widely available, which includes publishing or otherwise sharing negative or null results to recognise their value as part of the research process; and in presenting the work to other researchers and to the public.
- Care and respect for all participants in research, and for the subjects, users and beneficiaries of research, including humans, animals, the environment and cultural objects. Those engaged with research must also show care and respect for the integrity of the research record.
- Accountability of funders, employers and researchers to collectively create a research environment in which individuals and organisations are empowered and enabled to own the research process. Those engaged with research must also ensure that individuals and organisations are held to account when behaviour falls short of the standards set by this concordat.
These points apply to all types and aspects of research and to all individuals involved in it. Obviously, they apply also to research of so-called alternative medicine (SCAM). I will therefore briefly discuss each point in respect of SCAM research.
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Honesty in research is an important ethical prerequisite. In SCAM, we regularly see that the honesty seems to be in short supply. There are many ways in which lack of honesty shows itself. For me, the most impressive one is when SCAM researchers disclose – as they often do – that their aim is to demostrate that their assumptions/theories/hypotheses are correct. In such cases, they abuse the tools of science which are not for confirming hypotheses but for testing, i.e. trying to falsifying them. This blog offers plenty of examples for this phenomenon (e.g. here or here)
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The lack of rigor in much of SCAM research is legend and has become a constant theme on this blog. How often have we seen useless and unnecessary observational studies or pilot studies on subjects where controlled trials already exist? How often have we lamented over misinterpretation of a study’s findings? How often have we reported research that was ill-conceived from the outset, unable to answer any meaningful research question? My all time favourite examples of drawing a wrong conclusions are from the area of homeopathy, e.g. here and here.
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Much of SCAM research is being conducted by SCAM enthusiasts who have no qualitification or experience in research or science. Inevitably, this must lead to bias. Just think of the fact that some countries, e.g. China, or some SCAM journals, or some SCAM researchers (e.g. THE ALTERNATIVE MEDICINE HALL OF FAME) publish as good as no negative findings
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Lack of respect for research subjects has many guises. For instance, if clinical trials are being conducted of treatments that are utterly implausible. This, in my view, constitutes an abuse of the willingness of volunteers to make a contribution to research. Another example is the incessant flow of untrustworthy research by SCAM enthusiasts which eventually can only erode the public’s trust in research and is bound to render the essential cooperation of researchers and volunteers more and more problematic.
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When I think of accountability, I think yet again of the men and women in my ALTERNATIVE MEDICINE HALL OF FAME. As any of its members ever been held accountable for misleading the public through their pseudo-research? Sadly, the answer, as far as I know, is NO.
