Monthly Archives: April 2019
Bleach can be a useful product – but not as a medicine taken by mouth or for injection.
A 39-year-old man with a fracture of the right acetabulum underwent open reduction and internal fixation with a plate under general anaesthesia. At closure, the surgeons injected 0.75% ropivacaine into the subcutaneous tissue of the incision wound for postoperative analgesia. Soon after injection, subcutaneous emphysema at the injection site and a sudden decrease in end-tidal CO2 tension with crude oscillatory ripples during the alveolar plateau phase were observed. Shortly thereafter, it was found that the surgeons had mistakenly injected hydrogen peroxide instead of ropivacaine. Fortunately, the patient recovered to normal status after 10 minutes. After the surgery, the patient was carefully observed for suspected pulmonary embolism and discharged without complications.
A team from Morocco reported the case of a massive embolism after hydrogen peroxide use in the cleaning of infected wound with osteosynthesis material left femoral done under spinal anaesthesia in a young girl of 17 years admitted after to the ICU intubated ventilated. She was placed under mechanical ventilation with vasoactive drugs for ten hours and then extubated without neurological sequelae.
Tunisian doctors reported 2 cases of embolic events with neurological signs. The first, during a pleural cleaning with hydrogen peroxide after cystectomy of a pulmonary hydatic cyst at the right upper lobe. The second case, after a pleural washing during the treatment of hepatitic hydatidosis complicated by a ruptured cyst in the thorax.
Canadian anaesthetists reported a case of suspected oxygen venous embolism during lumbar discectomy in the knee-prone position after use of H2O2. Immediately after irrigation of a discectomy wound with H2O2, a dramatic decrease of the PETCO2, blood pressure and oxygen saturation coincident with ST segment elevation occurred suggesting a coronary gas embolism. Symptomatic treatment was initiated immediately and the patient recovered without any sequelae.
Indian nephrologists reported a case of chlorine dioxide poisoning presenting with acute kidney injury.
A 1-year-old boy presented to the emergency department with vomiting and poor complexion after accidentally ingesting a ClO2-based household product. The patient had profound hypoxia that did not respond to oxygen therapy and required endotracheal intubation to maintain a normal oxygen level. Methemoglobinemia was suspected based on the gap between SpO2 and PaO2, and subsequently increased methemoglobin at 8.0% was detected. The patient was admitted to the paediatric intensive care unit for further management. After supportive treatment, he was discharged without any complications. He had no cognitive or motor dysfunction on follow up 3 months later.
The medical literature is littered with such case-reports. They give us a fairly good idea that the internal use of bleach is not a good idea. In fact, it has caused several deaths. Yet, this is precisely what some SCAM practitioners are advocating.
Now one of them is in court for manslaughter. “If I am such a clear and present danger and a murderer, I should be in jail by now,” said doctor Shortt, who despite a criminal investigation, is still treating patients in his office on the outskirts of Columbia, S.C. Shortt got his medical degree 13 years ago on the Caribbean island of Montserrat. Being a “longevity physician” didn’t seem to bother anyone until one of his patients wound up dead. Shortt gave her an infusion of hydrogen peroxide. Katherine Bibeau, a medical technologist and a mother of two, had been battling multiple sclerosis for two years, and was looking for any treatment that might keep her out of a wheelchair. According to her husband, doctor Shortt said hydrogen peroxide was just the thing. “He had said that there was other people who had been in wheelchairs, and had actually gone through treatment and were now walking again.” It didn’t worry the Bibeaus that Shortt wasn’t affiliated with any hospital or university – and that insurance didn’t cover most of his treatments. “He was a licensed medical doctor in Carolina,” says Bibeau. “So I put my faith in those credentials.” According to Shortt’s own records, the patient subsequently complained of “nausea,” “leg pain,” and later “bruises” with no clear cause. “She went Tuesday, she went Thursday. And by 11 o’clock on Sunday, she died,” says Mr Bibeau. Shortt never told him or his wife about any serious risks. “Even if it wasn’t effective, it should not have been harmful.”
Shortt has been putting hydrogen peroxide in several of his patients’ veins, because he believes it can effectively treat illnesses from AIDS to the common cold. “I think it’s an effective treatment for the flu,” says Shortt, who also believes that it’s effective for multiple sclerosis, Lyme disease, and “as adjunctive therapy” for heart disease. “Things that involve the immune system, viruses, bacteria, sometimes parasites.”
He’s not the only physician using this treatment. Intravenous hydrogen peroxide is a SCAM touted as a cure the medical establishment doesn’t want you to know about. There even is an association that claims to have trained hundreds of doctors how to administer it. The theory is that hydrogen peroxide releases extra oxygen inside the body, killing viruses and bacteria.
Natural News, for instance, tells us that cancer has a rival that destroys it like an M-60 leveling a field of enemy soldiers. It’s called “hydrogen peroxide,” and the “lame-stream,” mainstream media will tell you how “dangerous” it is at 35%, but they won’t tell you that you can drip a couple drops in a glass of water each day and end cancer. Yes, it’s true.
And hydrogen peroxide is not the only bleach that found its way into the realm of SCAM.
Perhaps even worse (if that is possible), the Genesis II Church of Health and Healing promote MMS as a miracle cure. It consists of chlorine dioxide, a powerful bleach that has been banned in several countries around the world for use as a medical treatment. The ‘Church’ claim that MMS cures 95% of all diseases in the world by making adults and children, including infants, drink industrial bleach. The group is inviting members to attend what they call their “effective alternative healing”.
The organizer of the event, Tom Merry, has publicized it by telling people that learning how to consume the bleach “could save your life, or the life of a loved one sent home to die”. The “church” is asking attendants of the meeting to “donate” $450 each, or $800 per couple, in exchange for receiving membership to the organization as well as packages of the bleach, which they call “sacraments”. The chemical is referred to as MMS, or “miracle mineral solution or supplement”, and participants are promised they will acquire “the knowledge to help heal many people of this world’s terrible diseases”.
Fiona O’Leary, a tireless and courageous campaigner for putting an end to a wide variety of mistreatments of children and adults, whose work helped to get MMS banned in Ireland, said she was horrified that the Genesis II Church, which she called a “bleach cult”, was hosting a public event in Washington.
In Fiona’s words: “ Its experimentation and abuse”. I do agree and might just add this: selling bleach for oral or intravenous application, while pretending it is an effective medicine, seems criminal as well.
Chiropractic spinal manipulative therapy (CSMT) for migraine?
There is no good evidence that it works!
On the contrary, there is good evidence that it does NOT work!
A recent and rigorous study (conducted by chiropractors!) tested the efficacy of chiropractic CSMT for migraine. It was designed as a three-armed, single-blinded, placebo -controlled RCT of 17 months duration including 104 migraineurs with at least one migraine attack per month. Active treatment consisted of CSMT (group 1) and the placebo was a sham push manoeuvre of the lateral edge of the scapula and/or the gluteal region (group 2). The control group continued their usual pharmacological management (group 3). The results show that migraine days were significantly reduced within all three groups from baseline to post-treatment. The effect continued in the CSMT and placebo groups at all follow-up time points (groups 1 and 2), whereas the control group (group 3) returned to baseline. The reduction in migraine days was not significantly different between the groups. Migraine duration and headache index were reduced significantly more in the CSMT than in group 3 towards the end of follow-up. Adverse events were few, mild and transient. Blinding was sustained throughout the RCT. The authors concluded that the effect of CSMT observed in our study is probably due to a placebo response.
One can understand that, for chiropractors, this finding is upsetting. After all, they earn a good part of their living by treating migraineurs. They don’t want to lose patients and, at the same time, they need to claim to practise evidence-based medicine.
What is the way out of this dilemma?
They only need to publish a review in which they dilute the irritatingly negative result of the above trial by including all previous low-quality trials with false-positive results and thus generate a new overall finding that alleges CSMT to be evidence-based.
This new systematic review of randomized clinical trials (RCTs) evaluated the evidence regarding spinal manipulation as an alternative or integrative therapy in reducing migraine pain and disability.
The searches identified 6 RCTs eligible for meta-analysis. Intervention duration ranged from 2 to 6 months; outcomes included measures of migraine days (primary outcome), migraine pain/intensity, and migraine disability. Methodological quality varied across the studies. The results showed that spinal manipulation reduced migraine days with an overall small effect size as well as migraine pain/intensity.
The authors concluded that spinal manipulation may be an effective therapeutic technique to reduce migraine days and pain/intensity. However, given the limitations to studies included in this meta-analysis, we consider these results to be preliminary. Methodologically rigorous, large-scale RCTs are warranted to better inform the evidence base for spinal manipulation as a treatment for migraine.
Bob’s your uncle!
Perhaps not perfect, but at least the chiropractic profession can now continue to claim they practice something akin to evidence-based medicine, while happily cashing in on selling their unproven treatments to migraineurs!
But that’s not very fair; research is not for promotion, research is for finding the truth; this white-wash is not in the best interest of patients! I hear you say.
Who cares about fairness, truth or conflicts of interest?
Christine Goertz, one of the review-authors, has received funding from the NCMIC Foundation and served as the Director of the Inter‐Institutional Network for Chiropractic Research (IINCR). Peter M. Wayne, another author, has received funding from the NCMIC Foundation and served as the co‐Director of the Inter‐Institutional Network for Chiropractic Research (IINCR)
And who the Dickens are the NCMIC and the IINCR?
At NCMIC, they believe that supporting the chiropractic profession, including chiropractic research programs and projects, is an important part of our heritage. They also offer business training and malpractice risk management seminars and resources to D.C.s as a complement to the education provided by the chiropractic colleges.
The IINCR is a collaborative effort between PCCR, Yale Center for Medical Informatics and the Osher Center for Integrative Medicine at Brigham and Women’s Hospital and Harvard Medical School. They aim at creating a chiropractic research portfolio that’s truly translational. Vice Chancellor for Research and Health Policy at Palmer College of Chiropractic Christine Goertz, DC, PhD (PCCR) is the network director. Peter Wayne, PhD (Osher Center for Integrative Medicine at Brigham and Women’s Hospital and Harvard Medical School) will join Anthony J. Lisi, DC (Yale Center for Medical Informatics and VA Connecticut Healthcare System) as a co-director. These investigators will form a robust foundation to advance chiropractic science, practice and policy. “Our collective efforts provide an unprecedented opportunity to conduct clinical and basic research that advances chiropractic research and evidence-based clinical practice, ultimately benefiting the patients we serve,” said Christine Goertz.
Really: benefiting the patients?
You could have fooled me!
Exactly 20 years ago, I published a review concluding that the generally high and possibly growing prevalence of complementary/alternative medicine use by children renders this topic an important candidate for rigorous investigation. Since then, many papers have emerged, and most of them are worrying in one way or another. Here is the latest one.
This Canadian survey assessed chiropractic (DC) and naturopathic doctors’ (ND) natural health product (NHP) recommendations for paediatric care. It was developed in collaboration with DC and ND educators, and delivered as an on-line national survey. NHP dose, form of delivery, and indications across paediatric age ranges (from newborn to 16 years) for each practitioner’s top five NHPs were assessed. Data were analysed using descriptive statistics, t-tests, and non-parametric tests.
Of the 421 respondents seeing one or more paediatric patients per week, 172 (41%, 107 DCs, 65 NDs) provided 440 NHP recommendations, categorized as:
- vitamins and minerals (89 practitioners, 127 recommendations),
- probiotics (110 practitioners, 110 recommendations),
- essential fatty acids (EFAs: 72 practitioners, 72 recommendations),
- homeopathics (56 practitioners, 66 recommendations),
- botanicals (29 practitioners, 31 recommendations),
- other NHPs (33 practitioners, 34 recommendations).
Indications for the NHP recommendations were tabulated for NHPs with 10 or more recommendations in any age category:
- 596 total indications for probiotics,
- 318 indications for essential fatty acids,
- 138 indications for vitamin D,
- 71 indications for multi-vitamins.
Good evidence regarding the efficacy, safety, and dosing for NHP use in children is scarce or even absent. Therefore, the finding that so many DCs and NDs recommend unproven NHPs for use in children is worrying, to say the least. It seems to indicate that, at least in Canada, DCs and NDs are peddling unproven, mostly useless and potentially harmful children.
In an earlier, similar survey the same group of researchers had disclosed that the majority of Canadian DCs and NDs seem to see infants, children, and youth for a variety of health conditions and issues, while, according to their own admission, not having adequate paediatric training.
Is this a Canadian phenomenon? If you think so, read this abstract:
This systematic review is aimed at estimating the prevalence of complementary and alternative medicine (CAM)-use by paediatric populations in the United Kingdom (UK).
AMED, CINAHL, COCHRANE, EMBASE and MEDLINE were searched for English language peer-reviewed surveys published between 01 January 2000 and September 2011. Additionally, relevant book chapters and our own departmental files were searched manually.
Eleven surveys were included with a total of 17,631 paediatric patients. The majority were of poor methodological quality. Due to significant heterogeneity of the data, a formal meta-analysis was deemed inappropriate. Ten surveys related to CAM in general, while one was specifically on homeopathy. Across all surveys on CAM in general, the average one-year prevalence rate was 34% and the average lifetime prevalence was 42%. In surveys with a sample size of more than 500, the prevalence rates were considerably lower than in surveys with the sample size of lower than 500. Herbal medicine was the most popular CAM modality, followed by homeopathy and aromatherapy.
Many paediatric patients in the UK seem to use CAM. Paediatricians should therefore have sufficient knowledge about CAM to issue responsible advice.
This means, I fear, that children are regularly treated by SCAM practitioners who are devoid of the medical competence to do so, and who prescribe or recommend treatments of unknown value, usually without the children needing them.
Why are regulators not more concerned about this obvious abuse?
The aim of this new systematic review was to evaluate the controlled trials of homeopathy in bronchial asthma. Relevant trials published between Jan 1, 1981, and Dec 31, 2016, were considered. Substantive research articles, conference proceedings, and master and doctoral theses were eligible. Methodology was assessed by Jadad’s scoring, internal validity by the Coch-rane tool, model validity by Mathie’s criteria, and quality of individualization by Saha’s criteria.
Sixteen trials were eligible. The majority were positive, especially those testing complex formulations. Methodological quality was diverse; 8 trials had “high” risk of bias. Model validity and individualization quality were compromised. Due to both qualitative and quantitative inadequacies, proofs supporting individualized homeopathy remained inconclusive. The trials were positive (evidence level A), but inconsistent, and suffered from methodological heterogeneity, “high” to “uncertain” risk of bias, incomplete study reporting, inadequacy of independent replications, and small sample sizes.
The authors of this review come from:
- the Department of Homeopathy, District Joint Hospital, Government of Bihar, Darbhanga, India;
- the Department of Organon of Medicine and Homoeopathic Philosophy, Sri Sai Nath Postgraduate Institute of Homoeopathy, Allahabad, India;
- the Homoeopathy University Jaipur, Jaipur, India;
- the Central Council of Homeopathy, Hooghly,
- the Central Council of Homeopathy, Howrah, India
They state that they have no conflicts of interest.
The review is puzzling on so many accounts that I had to read it several times to understand it. Here are just some of its many oddities:
- According to its authors, the review adhered to the PRISMA-P guideline; as a co-author of this guideline, I can confirm that this is incorrect.
- The authors claim to have included all ‘controlled trials (randomized, non-randomized, or observational) of any form of homeopathy in patients suffering from persistent and chronic bronchial asthma’. In fact, they also included uncontrolled studies (16 controlled trials and 12 uncontrolled observational studies, to be precise).
- The authors included papers published between Jan 1, 1981, and Dec 31, 2016. It is unacceptable, in my view, to limit a systematic review in this way. It also means that the review was seriously out of date already on the day it was published.
- The authors tell us that they applied no language restrictions. Yet they do not inform us how they handled papers in foreign languages.
- Studies of homeopathy as a stand alone therapy were included together with studies of homeopathy as an adjunct. Yet the authors fail to point out which studies belonged to which category.
- Several of the included studies are not of homeopathy but of isopathy.
- The authors fail to detail their results and instead refer to an ‘online results table’ which I cannot access even though I have the on-line paper.
- Instead, they report that 28 studies were included and ‘thus, the level of evidence was graded as A.’
- No direction of outcome was provided in the results section. All we do learn from the paper’s discussion section is that ‘the majority of the studies were positive, and the level of evidence could be graded as A (strong scientific evidence)’.
- Despite the high risk of bias in most of the included studies, the authors suggest a ‘definite role of homeopathy beyond placebo in the treatment of bronchial asthma’.
- The current Cochrane review (also authored by a pro-homeopathy team) concluded that there is not enough evidence to reliably assess the possible role of homeopathy in asthma. Yet the authors of this new review do not even attempt to explain the contradiction.
The purpose of this recently published survey was to obtain the demographic profile and educational background of chiropractors with paediatric patients on a multinational scale.
A multinational online cross-sectional demographic survey was conducted over a 15-day period in July 2010. The survey was electronically administered via chiropractic associations in 17 countries, using SurveyMonkey for data acquisition, transfer, and descriptive analysis.
The response rate was 10.1%, and 1498 responses were received from 17 countries on 6 continents. Of these, 90.4% accepted paediatric cases. The average practitioner was male (61.1%) and 41.4 years old, had 13.6 years in practice, and saw 107 patient visits per week. Regarding educational background, 63.4% had a bachelor’s degree or higher in addition to their chiropractic qualification, and 18.4% had a postgraduate certificate or higher in paediatric chiropractic.
The authors from the Anglo-European College of Chiropractic (AECC), Bournemouth University, United Kingdom, drew the following conclusion: this is the first study about chiropractors who treat children from the United Arab Emirates, Peru, Japan, South Africa, and Spain. Although the response rate was low, the results of this multinational survey suggest that pediatric chiropractic care may be a common component of usual chiropractic practice on a multinational level for these respondents.
A survey with a response rate of 10%?
An investigation published 9 years after it has been conducted?
Who at the AECC is responsible for controlling the quality of the research output?
Or is this paper perhaps an attempt to get the AECC into the ‘Guinness Book of Records’ for outstanding research incompetence?
But let’s just for a minute pretend that this paper is of acceptable quality. If the finding that ~90% of chiropractors tread kids is approximately correct, one has to be very concerned indeed.
I am not aware of any good evidence that chiropractic care is effective for paediatric conditions. On the contrary, it can do quite a bit of direct harm! To this, we sadly also have to add the indirect harm many chiropractors cause, for instance, by advising parents against vaccinating their kids.
This clearly begs the question: is it not time to stop these charlatans?
What do you think?
‘Mom’s Choice Awards’ have just honoured the homeopathic product ‘COLD CALM KIDS’. This remedy has the following ingredients:
- Allium cepa 3C HPUS
- Apis mellifica 15C HPUS
- Eupatorium perfoliatum 3C HPUS
- Gelsemium sempervirens 6C HPUS
- Kali bichromicum 6C HPUS
- Nux vomica 3C HPUS
- Phytolacca decandra 6C HPUS
- Pulsatilla 6C HPUS
3C = a dilution of 1:1000000
6C = a dilution of 1:1000000000000
15C = a dilution of 1:1000000000000000000000000000000
The ingredients are, according to this website, claimed to have the following effects:
- Allium cepa 3C HPUS – Relieves sneezing and runny nose
- Apis mellifica 15C HPUS – Relieves nasal congestion
- Eupatorium perfoliatum 3C HPUS – Relieves aches associated with colds
- Gelsemium sempervirens 6C HPUS – Relieves headaches associated with colds
- Kali bichromicum 6C HPUS – Relieves nasal discharge
- Nux vomica 3C HPUS – Relieves sneezing attacks
- Phytolacca decandra 6C HPUS – Relieves mild fever
- Pulsatilla 6C HPUS – Relieves colds with a loss of taste and smell
The formula could easily make Hahnemann turn in his grave! It goes against most of what he has been teaching. But I found these claims interesting nevertheless.
Are they true? To find out, I did some research. Here is what I found (in case anyone can find more evidence, I’d be most grateful to let me know):
- Allium cepa 3C HPUS – Relieves sneezing and runny nose NO GOOD EVIDENCE FOR THIS CLAIM
- Apis mellifica 15C HPUS – Relieves nasal congestion NO GOOD EVIDENCE FOR THIS CLAIM
- Eupatorium perfoliatum 3C HPUS – Relieves aches associated with colds NO GOOD EVIDENCE FOR THIS CLAIM
- Gelsemium sempervirens 6C HPUS – Relieves headaches associated with colds NO GOOD EVIDENCE FOR THIS CLAIM
- Kali bichromicum 6C HPUS – Relieves nasal discharge NO GOOD EVIDENCE FOR THIS CLAIM
- Nux vomica 3C HPUS – Relieves sneezing attacks NO GOOD EVIDENCE FOR THIS CLAIM
- Phytolacca decandra 6C HPUS – Relieves mild fever NO GOOD EVIDENCE FOR THIS CLAIM
- Pulsatilla 6C HPUS – Relieves colds with a loss of taste and smell NO GOOD EVIDENCE FOR THIS CLAIM
I am confused! If there is no good evidence, how come Boiron, the manufacturer of the product, is allowed to make these claims? And how come the product just was given an award?
The Mom’s Choice Awards® (MCA) evaluates products and services created for children, families and educators. The program is globally recognized for establishing the benchmark of excellence in family-friendly media, products and services. The organization is based in the United States and has reviewed thousands of items from more than 55 countries…
An esteemed panel of evaluators includes education, media and other experts as well as parents, children, librarians, performing artists, producers, medical and business professionals, authors, scientists and others.
MCA evaluators volunteer their time and are bound by a strict code of ethics which ensures expert and objective analysis free from any manufacturer association.
The evaluation process uses a proprietary methodology in which items are scored on a number of elements including production quality, design, educational value, entertainment value, originality, appeal and cost. Each item is judged on its own merit.
MCA evaluators are especially interested in items that help families grow emotionally, physically and spiritually; are morally sound and promote good will; and are inspirational and uplifting…
Now I am even more confused!
A benchmark of excellence?
A strict code of ethics?
I must have misunderstood something! Or perhaps the award was for achieving a maximum of 8 false claims for one single product!? Can someone please enlighten me?
Spinal manipulative therapy (SMT), especially hyperextension and rotation. have often been associated with cervical artery dissection (CAD), a tear in the internal carotid or the vertebral artery resulting in an intramural haematoma and/or an aneurysmal dilatation. But is the association causal? This question is often the subject of fierce discussions between chiropractors and the real doctors.
The lack of established causality relates to the chicken and egg discussion, i.e., whether the CAD symptoms lead the patient to seek cervical SMT or whether the cervical SMT provokes CAD along with the non-CAD presenting headache and/or neck complaint.
The aim of a new review was to provide an updated step-by-step risk-benefit assessment strategy regarding manual therapy and to provide tools for clinicians to exclude cervical artery dissection.
In light of the evidence provided, the reality, according to the review-authors, is:
- a) that there is no firm scientific basis for direct causality between cervical SMT and CAD;
- b) that the internal carotid artery (ICA) moves freely within the cervical pathway, while 74% of cervical SMTs are conducted in the lower cervical spine where the vertebral artery (VA) also moves freely;
- c) that active daily life consists of multiple cervical movements including rotations that do not trigger CAD, as is true for a range of physical activities;
- d) that a cervical manipulation and/or grade C cervical mobilization goes beyond the physiological limit but remains within the anatomical range, which theoretically means that the artery should not exceed failure strain.
These factors underscore the fact that no serious adverse event (AE) was reported in a large prospective national survey conducted in the UK that assessed all AEs in 28,807 chiropractic treatment consultations, which included 50,276 cervical spine manipulations.
The figure outlines a risk-benefit assessment strategy that should provide additional knowledge and improve the vigilance of all clinicians to enable them to exclude CAD, refer patients with suspected CAD to appropriate care, and consequently prevent CAD from progressing.
It has been argued that most patients present with at least two physical symptoms. The clinical characteristics and recommendations in the figure follow this assumption. This figure is intended to function as a knowledge base that should be implemented in preliminary screening and be part of good clinical practice. This knowledge base will likely contribute to sharpening the attention of the clinicians and alert them as to whether the presenting complaint, combined with a collection of warning signs listed in the figure, deviates from what he or she considers to be a usual musculoskeletal presentation.
Even though this is a seemingly thoughtful analysis, I think it omits at least two important points:
- The large prospective UK survey which included 50,276 cervical spine manipulations might be less convincing that it seems. It recorded about one order of magnitude less minor adverse effects of spinal manipulation than a multitude of previously published prospective surveys. The self-selected, relatively small group of participating chiropractors (32% of the total sample) were both experienced (67% been in practice for 5 or more years) and may not always have adhered to the protocol of the survey. Thus they may have employed their experience to intuitively select low-risk patients rather than including all consecutive cases, as the protocol prescribed. This hypothesis would ﬁrstly account for the unusually low rate of minor adverse effects, and secondly, it would explain why no serious complications occurred at all. Given that about 700 such complications are on record, the low incidence of serious adverse events could well be a gross underestimate.
- The effect of chiropractic spinal manipulative therapy is probably due to a placebo response. This means that it should probably not be done in the first place.
Whenever there are discussions about homeopathy (currently, they have reached fever-pitch both in France and in Germany), one subject is bound to emerge sooner or later: its cost. Some seemingly well-informed person will exclaim that USING MORE HOMEOPATHY WILL SAVE US ALL A LOT OF MONEY.
The statement is as predictable as it is wrong.
Of course, homeopathic remedies tend to cost, on average, less than conventional treatments. But that is beside the point. A car without an engine is also cheaper than one with an engine. Comparing the costs of items that are not comparable is nonsense.
What we need are proper analyses of cost-effectiveness. And these studies clearly fail to prove that homeopathy is a money-saver.
Even researchers who are well-known for their pro-homeopathy stance have published a systematic review of economic evaluations of homeopathy. They included 14 published assessments, and the more rigorous of these investigations did not show that homeopathy is cost-effective. The authors concluded that “although the identified evidence of the costs and potential benefits of homeopathy seemed promising, studies were highly heterogeneous and had several methodological weaknesses. It is therefore not possible to draw firm conclusions based on existing economic evaluations of homeopathy“.
Probably the most meaningful study in this area is an investigation by another pro-homeopathy research team. Here is its abstract:
This study aimed to provide a long-term cost comparison of patients using additional homeopathic treatment (homeopathy group) with patients using usual care (control group) over an observation period of 33 months.
Health claims data from a large statutory health insurance company were analysed from both the societal perspective (primary outcome) and from the statutory health insurance perspective (secondary outcome). To compare costs between patient groups, homeopathy and control patients were matched in a 1:1 ratio using propensity scores. Predictor variables for the propensity scores included health care costs and both medical and demographic variables. Health care costs were analysed using an analysis of covariance, adjusted for baseline costs, between groups both across diagnoses and for specific diagnoses over a period of 33 months. Specific diagnoses included depression, migraine, allergic rhinitis, asthma, atopic dermatitis, and headache.
Data from 21,939 patients in the homeopathy group (67.4% females) and 21,861 patients in the control group (67.2% females) were analysed. Health care costs over the 33 months were 12,414 EUR [95% CI 12,022-12,805] in the homeopathy group and 10,428 EUR [95% CI 10,036-10,820] in the control group (p<0.0001). The largest cost differences were attributed to productivity losses (homeopathy: EUR 6,289 [6,118-6,460]; control: EUR 5,498 [5,326-5,670], p<0.0001) and outpatient costs (homeopathy: EUR 1,794 [1,770-1,818]; control: EUR 1,438 [1,414-1,462], p<0.0001). Although the costs of the two groups converged over time, cost differences remained over the full 33 months. For all diagnoses, homeopathy patients generated higher costs than control patients.
The analysis showed that even when following-up over 33 months, there were still cost differences between groups, with higher costs in the homeopathy group.
A recent analysis confirms this situation. It concluded that patients who use homeopathy are more expensive to their health insurances than patients who do not use it. The German ‘Medical Tribune’ thus summarised the evidence correctly when stating that ‘Globuli are m0re expensive than conventional therapies’. This quote mirrors perfectly the situation in Switzerland which as been summarised as follows: ‘Globuli only cause unnecessary healthcare costs‘.
But homeopaths (perhaps understandably) seem reluctant to agree. They tend to come out with ever new arguments to defend the indefensible. They claim, for instance, that prescribing a homeopathic remedy to a patient would avoid giving her a conventional treatment that is not only more expensive but also has side-effects which would cause further expense to the system.
To some, this sounds perhaps reasonable (particularly, I fear, to some politicians), but it should not be reasonable argument for responsible healthcare professionals.
Because it could apply only to the practice of bad and unethical medicine: if a patient is ill and needs a medical treatment, she does certainly not need something that is ineffective, like homeopathy. If she is not ill and merely wants a placebo, she needs assurance, compassion, empathy, understanding and most certainly not an expensive and potentially harmful conventional therapy.
To employ the above analogy, if someone needs transport, she does not need a car without an engine!
So, whichever way we twist or turn it, the issue turns out to be quite simple:
WHITHOUT EFFECTIVENESS, THERE CAN BE NO COST-EFFECTIVENESS!
Fructus Psoraleae is the seed of Psoralea corylifolia Linn. It is the main ingredient of the herbal mixtures such as Qubaibabuqi, popular in China, India and other countries. It has been used for medicinal purposes for millennia. Thus many proponents would claim that it must be risk-free.
A recent case-report suggests that it might not be as safe as often assumed.
A 53-year-old woman was diagnosed with vitiligo in September 2017 and was treated with oral Qubaibabuqi tablets (15 tablets three times daily; Xinjiang Yinduolan Uyghur Pharmaceutical Company Limited, Urumqi, China), 10 mg of prednisone acetate tablets (Xinhua Pharmaceutical Company Limited, Zibo, China) once daily, and narrowband-ultraviolet B (NB-UVB) phototherapy (Sigma household narrowband-ultraviolet phototherapy instrument [SS-01B] pocket portable; Shanghai Sigma High Technology Co., Ltd. Shanghai, China) every other day. The prednisone acetate tablets were self-discontinued 3 months later; however, she continued to take Qubaibabuqi tablets orally and NB-UVB phototherapy was undertaken at home.
After approximately 7 months of treatment, the patient developed a severe, diffuse yellow staining of the skin and sclera in March 2018. On admission, she was diagnosed with acute cholestatic hepatitis associated with Fructus Psoraleae. Despite receiving active treatment, her condition rapidly deteriorated and she died 5 days later due to acute liver failure and multiple organ dysfunction. There are 6 further reported cases of liver injury associated with Fructus Psoraleae described in the English language literature. Cases of acute liver failure associated with the use of Fructus Psoraleae have not been previously described.
The authors of the case-report concluded that as a main ingredient in the Qubaibabuqi tablet formula, Fructus Psoraleae has potential hepatotoxicity. This potentially fatal adverse effect should be considered when physicians prescribe Qubaibabuqi tablets.
Psoralea corylifolia Linn (also known as Bu-gu-zh, Bu Ku Zi, Bol-gol-zhee, Boh-Gol-Zhee, Babchi, and Bakuchi) is a plant grown in China, India, Sri Lanka, Burma, and other countries, which is considered an important herbal medicine. It is used in TCM to tonify the kidneys, particularly kidney yang and essence. It is used for helping the healing of bone fractures, for lower back and knee pain, impotence, bed wetting, hair loss, and vitiligo. A recent review named it as one of the main herbs causing liver problems (other herbs included Polygonum multiflorum, Corydalis yanhusuo, and Rheum officinale).
Another review found that Psoralea corylifolia has cardiotonic, vasodilator, pigmentor, antitumor, antibacterial, cytotoxic, and anti-helminthic properties. About one hundred bioactive compounds have been isolated from seeds and fruits; the most important ones belong to coumarins, flavonoids, and meroterpenes groups. Psoralea corylifolia is part of many Ayurvedic and Chinese herbal mixtures.
Despite of the popularity of Psoralea corylifolia in the treatment of a very wide range of conditions, and despite the pharmacological studies into its potential therapeutic uses, there is an almost complete void as to clinical trials testing its clinical effectiveness.
The case-report is a poignant and tragic reminder of the often-neglected fact that neither a long history of usage nor popularity of a (herbal) treatment are reliable indicators for safety.
The aim of this systematic review was to determine the efficacy of conventional treatments plus acupuncture versus conventional treatments alone for asthma, using a meta-analysis of all published randomized clinical trials (RCTs).
The researchers included all RCTs in which adult and adolescent patients with asthma (age ≥12 years) were divided into conventional treatments plus acupuncture (A+B) and conventional treatments (B). Nine studies were included. The results showed that A+B could improve the symptom response rate and significantly decrease interleukin-6. However, indices of pulmonary function, including the forced expiratory volume in one second (FEV1) and FEV1/forced vital capacity (FVC) failed to be improved with A+B.
The authors concluded that conventional treatments plus acupuncture are associated with significant benefits for adult and adolescent patients with asthma. Therefore, we suggest the use of conventional treatments plus acupuncture for asthma patients.
I am thankful to the authors for confirming my finding that A+B must always be more/better than B alone (the 2nd sentence of their conclusion is, of course, utter nonsense, but I will leave this aside for today). Here is the short abstract of my 2008 article:
In this article, we test the hypothesis that randomized clinical trials of acupuncture for pain with certain design features (A + B versus B) are likely to generate false positive results. Based on electronic searches in six databases, 13 studies were found that met our inclusion criteria. They all suggested that acupuncture is effective (one only showing a positive trend, all others had significant results). We conclude that the ‘A + B versus B’ design is prone to false positive results and discuss the design features that might prevent or exacerbate this problem.
Even though our paper was on acupuncture for pain, it firmly established the principle that A+B is always more than B. Think of it in monetary terms: let’s say we both have $100; now someone gives me $10 more. Who has more cash? Not difficult, is it?
But why do SCAM-fans not get it?
Why do we see trial after trial and review after review ignoring this simple and obvious fact?
I suspect I know why: it is because the ‘A+B vs B’ study-design never generates a negative result!
But that’s cheating!
And isn’t cheating unethical?
My answer is YES!
(If you want to read a more detailed answer, please read our in-depth analysis here)