Monthly Archives: September 2024
‘ARS TECHNICA’ recently reported that the maker of a homeopathic nasal spray is refusing to recall its product after the Food and Drug Administration (FDA) found evidence of dangerous microbial contamination.
On 18 September 2024, the FDA therefore warned consumers to immediately stop using ‘SnoreStop nasal spray‘—made by Green Pharmaceuticals—because it may contain microbes that, when sprayed directly into nasal cavities, can cause life-threatening infections:
FDA is warning consumers and health care professionals not to use SnoreStop Nasal Spray, distributed by Green Pharmaceuticals Inc., Camarillo, Calif., because it may have microbial contamination. SnoreStop Nasal Spray was previously sold on the company’s website and other sites.
The use of microbially contaminated nasal spray can potentially lead to infection, which can be life threatening in certain patient populations, such as immune-compromised individuals. This unapproved product is marketed for children beginning at age 5 and adults with unproven claims that it opens air passages and relieves congestion.
Consumers who use SnoreStop should contact their health care professional with questions.
FDA recommended Green Pharmaceuticals recall their SnoreStop Nasal Spray product on Aug. 13 and Sept. 12, 2024. The agency reiterated its recall recommendation multiple times during this time. To date, the company has not taken action to recall this potentially dangerous product from the market.
FDA inspected Green Pharmaceuticals facility in April 2024 and uncovered laboratory test results that reported significant microbial contamination in SnoreStop Nasal Spray lot number 2460. FDA investigators found evidence that some products in this lot had been repackaged and distributed to customers for use as single units and in kits.
Following FDA’s inspection, on Aug. 8, 2024, Green Pharmaceutical destroyed the remaining SnoreStop Nasal Spray from lot 2460 and other products the company had on-hand. Green Pharmaceuticals subsequently stopped selling nasal spray products on their website. However, the agency is concerned that consumers may have purchased contaminated SnoreStop.
Previously, FDA issued a warning letter to Green Pharmaceuticals on Dec. 16, 2022, for distributing unapproved drugs and lack of quality controls over the products they sell. Additionally, the company voluntarily recalled one lot of SnoreStop NasoSpray on June 9, 2022, after FDA testing found the product contained microbial contamination identified as Providencia rettgeri. SnoreStop NasoSpray was renamed as SnoreStop Nasal Spray following this recall.
FDA encourages health care professionals and patients to report adverse events or quality problems experienced with the use of any medication to FDA’s MedWatch Adverse Event Reporting program:
- Complete and submit the report online; or
- Download and complete the form, then submit it via fax at 1-800-FDA-0178
‘ARS TECHNICA’ reported that, instead of discarding the batch, the FDA inspectors found evidence that Green Pharmaceuticals had repackaged some of the contaminated lot and distributed it as single spray bottles or as part of a starter kit.
This isn’t new territory for the company. In 2022, Green Pharmaceuticals got warnings from the FDA and issued a recall due to microbial contamination in its SnoreStop nasal spray. In June 2022, the FDA held a conference with the company over findings of bacteria and fungi in the spray. Some of the results suggested high levels of microbial contamination. “The individual sample results varied between 420 and up to 6,200 colony forming units (CFU)/mL for total aerobic microbial count… and between 30 and up to 3,800 CFU/mL for total yeast and mold counts,” the FDA reported in a December 2022 warning letter sent after the fact.
The FDA noted finding the specific bacterial pathogen Providencia rettgeri, an opportunistic germ that can lurk in health care settings. It’s most often linked to urinary tract infections, but it can also cause pneumonia, brain and spinal cord infections, heart infections, and wound and bloodstream infections in vulnerable people, according to a 2018 review.
“The high bioburden in conjunction with the route of administration with this drug product poses a high risk of harm to vulnerable patients, including children,” the FDA wrote in its warning letter. Green Pharmaceuticals recalled SnoreStop in June 2022, after its meeting with the FDA.
Aside from the gross microbial contamination, the FDA also noted in its letter that SnoreStop appears to be an unapproved new drug, illegally claiming to treat a disease without FDA approval. SnoreStop is said to contain dilutions of: nux vomica (a natural source of strychnine), belladonna (deadly nightshade), Ephedra vulgaris (a source of the drug ephedrine), hydrastis canadensis (a toxic herb), Kali Bichromicum (potassium dichromate, which is considered toxic and carcinogenic), Teucrium marum (similar to catnip), and Histaminum hydrochloricum (Histamine dihydrochloride).
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There is, of course, no evidence that any of these ingredients – in any dilution or potency – can make people stop snoring.
I have mentioned the infamous paper by Frass et al several times:
- Homeopathy’s most prominent researcher, Prof Michael Frass, has been found guilty of “data falsification, fabrication and manipulation”
- Michael Frass’ research into homeopathy for cancer: “numerous breaches of scientific integrity”
- An update on the dubious cancer study by Prof Michael Frass et al
- A thorough analysis of Prof M. Frass’ recent homeopathy trial casts serious doubts on its reliability
Now the journal THE ONCLOLOGIST that published the study (previously been deemed fraudulent by an independent agency) has finally reacted – not by a retraction but by a ‘correction’. Here is what RETRACTION WATCH just published about it:
A paper that claimed to show a homeopathic intervention improved quality of life and survival for people with advanced lung cancer has received an extensive correction two years after a research integrity watchdog asked the journal to retract the article over concerns about manipulated data, Retraction Watch has learned.
The two scientists who sounded the alarm on the paper are not satisfied with the correction, they told us.
The article, “Homeopathic Treatment as an Add‐On Therapy May Improve Quality of Life and Prolong Survival in Patients with Non‐Small Cell Lung Cancer: A Prospective, Randomized, Placebo‐Controlled, Double‐Blind, Three‐Arm, Multicenter Study,” appeared in The Oncologist in November 2020. Michael Frass, the lead author of the paper, is a homeopathic practitioner who was working at the Medical University of Vienna, at the time the work was published.
The paper has been cited 18 times, according to Clarivate’s Web of Science, and was included in a German medical organization’s guideline about complementary treatment for cancer patients. Many homeopathy organizations posted about the study on X as evidence of the approach’s benefit, helping propel the article to the top 5% of all research articles for which Altmetric, a publication data company, has tracked online attention.
Norbert Aust, a retired mechanical engineer who started the Homeopathy Information Network in Germany, and Viktor Weisshäupl, a retired anesthesiologist now working on the Initiative for Scientific Medicine in Austria. The pair undertook an analysis of the study protocols and data posted to ClinicalTrials.gov.
They found several differences between the initial registration posted in January 2012, a protocol dated January 2011 but uploaded in July 2019, and the published paper. These differences included the number of participants, study arms, exclusion criteria, follow-up time, and cancer types included in the study. Aust and Weisshäupl also noted the study protocol said the software the authors used to analyze their data was a version not yet available in 2011.
“In conclusion, it seems likely that the substantial modifications of crucial study parameters that occurred after the study had been started and results had become available biased the results in favor of homeopathy,” Aust and Weisshäupl wrote in a description of their findings on Edzard Ernst’s blog in June 2021.
According to another article Aust and Weisshäupl published in Skeptical Inquirer in 2023, the pair reported their findings to the Medical University Vienna, which referred the matter to the Austrian Agency for Scientific Integrity.
In a report dated September 2022 and obtained by Retraction Watch, the Austrian watchdog said its investigation “found numerous manipulations,” and asked The Oncologist’s editor in chief Susan Bates to retract the article.
Among the findings:
- “The presentation of the study as double-blind placebo controlled is untrue.”
- “Substantial” changes to the study protocol while it was running, including to the primary endpoint, that were not mentioned in the publication, “suggestive of data manipulation.”
- “Many patients were excluded post-hoc, which is suggestive of data manipulation.”
- “Fully implausible” survival data, “compatible with selective deletion of records.”
- “The patients in the homeopathy group report a quality of life that is much higher than that of the general population known from other surveys. For patients with stage four non-small cell lung cancer this is highly implausible.”
The Oncologist published an expression of concern in October 2022 citing “credible information from the Austrian Agency for Research Integrity about potential data falsification and data manipulation in this article.”
“While The Oncologist editorial team investigates and communicates with the corresponding author, the editors are publishing this Expression of Concern to alert readers that, pending the outcome and review of a full investigation, the research results presented may not be reliable,” the notice stated.
On Tuesday, the journal published an extensive correction to the article, stating:
Additional details not included in the original publication have since been provided by the authors and reviewed by the editors to clarify these concerns. These omissions do not affect the results of this study.
Frass told us he and his team were “pleased that after a profound and thorough investigation by The Oncologist it has now been proven that the paper is correct. The Commission’s allegations are unsubstantiated and completely unfounded.” He provided a diagram he and a friend made which he said showed “all allegations could be refuted adequately.”
Along with the correction, the journal published an editorial by Bates and another editor describing how The Oncologist published the paper in a section dedicated to the results of clinical trials that might not otherwise be posted. It concluded:
The Oncologist and its CTR section hope that—by turning to the laboratory to determine whether any fraction of a homeopathic remedy holds a thread of promise—science identifies what is in these mixtures and that, in turn, potential anticancer compounds are then developed through conventional pathways.
We reached out to Bates for comment, and received the following response from a spokesperson for Oxford University Press, the journal’s publisher:
In 2022 The Oncologist received a letter about “Homeopathic Treatment as an Add-On Therapy May Improve Quality of Life and Prolong Survival in Patients with Non-Small Cell Lung Cancer: A Prospective, Randomized, Placebo-Controlled, Double-Blind, Three-Arm, Multicenter Study” from the Commission for Research Integrity of the Austrian Agency for Research Integrity (OeAWI) and the journal issued an expression of concern. The journal has since conducted a thorough investigation and based on guidelines from the Committee on Publication Ethics (COPE), determined that a correction is the appropriate response to the concerns raised. The accompanying editorial provides further context. The correction and editorial are the journal’s full response.
The correction doesn’t address the issues Aust, Weisshäupl, and the Austrian Agency for Scientific Integrity found with the study, Aust told us.
“They explain some trifles,” he said, “but the elephant in the room is not mentioned.” He also wondered why a letter to the editor he and Weisshäupl submitted in 2021 had not been published.
The editorial’s question of whether some components in the homeopathic intervention could be therapeutic “is completely irrelevant,” Aust said.
“If some results are obtained by data manipulation and falsification, then it is pointless to argue if there might have been some effect by the preparations that were administered,” he said. “The data are not valid and it is wrong, unethical and might cause harm for patients if they stay published like solid outcomes of some rigorous trial.”
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Because a group of experts including myself is working on our own response to this affair, I will, for now, abstain from any further comment and hope that my readers find the above article by RETRACTION WATCH enlightening.
Cupping is a from of so-called alternative medicine (SCAM) that has featured already many times on this blog, e.g.:
- Wet cupping in the management of cervical spondylosis? No!
- The effectiveness of cupping therapy for low back pain
- Cupping: “the propagation of ancient, scientifically unsound techniques that may cause more harm than benefit”
- Cupping therapy for non-specific chronic low back pain
- Cupping for Olympic swimmers. Or: why breaking your shoulder is not necessarily good for writing a successful book
- Wet cupping and dry humour
- Cupping for athletes: rubbish trials, rubbish review, rubbish journal
- The future of cupping: it’s bright, profitable and vacuous
Now a new and interesting paper has been published on the subject
This review aimed to investigate the effectiveness of cupping therapy on low back pain (LBP). Medline, Embase, Scopus and WANFANG databases were searched for relevant cupping RCTs on low back pain articles up to 2023. A complementary search was manually made on 27 September for update screening. Full-text English and Chinese articles on all ethnic adults with LBP of cupping management were included in this study. Studies looking at acute low back pain only were excluded. Two independent reviewers screened and extracted data, with any disagreement resolved through consensus by a third reviewer. The methodological quality of the included studies was evaluated independently by two reviewers using an adapted tool. Change-from-baseline outcomes were treated as continuous variables and calculated according to the Cochrane Handbook. Data were extracted and pooled into the meta-analysis by Review Manager software (version 5.4, Nordic Cochrane Centre).
Eleven trials involving 921 participants were included (6 on dry and 5 on wet cupping). Five studies were assessed as being at low risk of bias, and six studies were of acceptable quality. High-quality evidence demonstrated cupping significantly improves pain at 2-8 weeks endpoint intervention (d=1.09, 95% CI: [0.35-1.83], p = 0.004). There was no continuous pain improvement observed at one month (d=0.11, 95% CI: [-1.02-1.23], p = 0.85) and 3-6 months (d=0.39, 95% CI: [-0.09-0.87], p = 0.11). Dry cupping did not improve pain (d=1.06, 95% CI: [-0.34, 2.45], p = 0.14) compared with wet cupping (d=1.5, 95% CI: [0.39-2.6], p = 0.008) at the endpoint intervention. There was no evidence indicating the association between pain reduction and different types of cupping (p = 0.2). Moderate- to low-quality evidence showed that cupping did not reduce chronic low back pain (d=0.74, 95% CI: [-0.67-2.15], p = 0.30) and non-specific chronic low back pain (d=0.27, 95% CI: [-1.69-2.24], p = 0.78) at the endpoint intervention. Cupping on acupoints showed a significant improvement in pain (d=1.29, 95% CI: [0.63-1.94], p < 0.01) compared with the lower back area (d=0.35, 95% CI: [-0.29-0.99], p = 0.29). A potential association between pain reduction and different cupping locations (p = 0.05) was found. Meta-analysis showed a significant effect on pain improvement compared to medication therapy (n = 8; d=1.8 [95% CI: 1.22 – 2.39], p < 0.001) and usual care (n = 5; d=1.07 [95% CI: 0.21- 1.93], p = 0.01). Two studies demonstrated that cupping significantly mediated sensory and emotional pain immediately, after 24 h, and 2 weeks post-intervention (d= 5.49, 95% CI [4.13-6.84], p < 0.001). Moderate evidence suggested that cupping improved disability at the 1-6 months follow-up (d=0.67, 95% CI: [0.06-1.28], p = 0.03). There was no immediate effect observed at the 2-8 weeks endpoint (d=0.40, 95% CI: [-0.51-1.30], p = 0.39). A high degree of heterogeneity was noted in the subgroup analysis (I2 >50%).
The authors concluded that high- to moderate-quality evidence indicates that cupping significantly improves pain and disability. The effectiveness of cupping for LBP varies based on treatment durations, cupping types, treatment locations, and LBP classifications. Cupping demonstrated a superior and sustained effect on pain reduction compared with medication and usual care. The notable heterogeneity among studies raises concerns about the certainty of these findings. Further research should be designed with a standardized cupping manipulation that specifies treatment sessions, frequency, cupping types, and treatment locations. The actual therapeutic effects of cupping could be confirmed by using objective pain assessments. Studies with at least six- to twelve-month follow-ups are needed to investigate the long-term efficacy of cupping in managing LBP.
A crucial point here is that only 3 of the included studies were ‘patient-blind’, i.e. tried to control for placebo effects by using a sham procedure:
- The first of these used leaking vaccum cups that failed to create sucction. This would therefore not have resulted in the typical circular hematoma. In other words, patients were easily de-blinded.
- The second trial compared two different wet cupping techniques which involved different procedures. This would have been easily identifiable by the patients. In other words, patients were easily de-blinded.
- The third (which showed no effectiveness of cupping) supposedly patient-blind study used a similar method as the first. In other words, patients were easily de-blinded.
In addition, we ought to remember that in no study was it possible to blind the therapists. Thus there is a danger of verbal or non-verbal communications impacting on the outcomes.
In my view, it follows that the effectiveness of cupping is far lass certain than the authors of this paper try to make us believe.
Having recently come across the strange and scary story of the Nazi’s experiments on Caladium Seguinum, I did some research to find out about the current medicinal uses of this plant. Perhaps unsurprisingly, it is today mostly advocated as a homeopathic remedy. In particular, it is highly recommended for erectile dysfunction (ED) and premature ejaculation. Here are some extracts from a particularly ‘impressive’ article on this topic:
… [Caladium Seguinum] … is particularly suited for treating premature ejaculation and erectile dysfunction, since these two problems cause widespread testicular swelling. The genital swelling is often associated with pruritus and internal inflammation that can be effectively treated with caladium.
The use of Caladium Seguinum is more common among men who are diagnosed with typical symptoms, along with an established case of either premature ejaculation or erectile dysfunction. Prescription of caladium is more common among men who suffer from genitals lacking vitality, wherein the penis doesn’t enter a state of arousal in a normal manner.
It has been noted that emotional and stress-linked problems are often the cause of underlying, undiagnosable causes of sexual problems among men. Similarly, ED and premature ejaculation are more commonly associated with men who are mentally exhausted or suffering from a mental trauma. In such cases, the use of caladium is applicable.
In cases wherein male impotency is linked to lifestyle habits like smoking, caladium is often prescribed. Further, premature ejaculation and erectile dysfunction in men who also complain of motion sickness are more likely to be treated with caladium. Caladium is very helpful if the premature ejaculation or erectile dysfunction has resulted in visible inflammation of the penile region, particularly redness of the glans.
Men who are suffering from ED along with symptoms like cold sweats and thickening of the scrotum skin are ideal candidates for caladium treatment. Men presenting disturbed respiratory functions, often described as an asthma-like condition, along with having erectile dysfunction are better candidates for caladium treatment.
Some of the other symptoms that contribute towards premature ejaculation and erectile dysfunction and are usually treated with caladium or caladium-enriched homeopathic mixtures include:
- Propensity towards unintentional penile erection
- Painful erection
- Testicular discomfort associated with gonorrhea
- Itching or surface eruptions on scrotal sac
- Disturbed sleep patterns
- Nighttime discharge from penis
Advantages of Caladium Seguinum
The biggest advantage of using homeopathic remedies for male infertility problems like erectile dysfunction is their overall safety. None of the homeopathic medications, including caladium, are known to induce any serious side-effects. However, the use of Caladium without medical supervision of a homeopathic specialist is highly inadvisable. Caladium Seguinum is retailed in various potencies and gauging the required potency is rather difficult.
For instance, Caladium Seguinum is commonly retailed with potency grading between 6X and 30X. Here, determining the appropriate potency largely depends upon understanding the associated symptoms and past medical history. In some cases, Caladium of lower potency is better suited since it is prescribed in combination with other homeopathic medications for better results.
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I think I know the question you were about to ask:
IS THERE ANY EVIDENCE FOR THESE CLAIMS?
The short answer is NO!
- The article itself does not provide any.
- My Medline search did not identify any.
- Further searches were equally unsuccessful.
In fact, there is no homeopathic remedy that has been shown to be effective for the named conditions.
What is more, there is no homeopathic remedy that has been shown to be effective for ANY condition.
This begs the question as to what we should call the many claims to the contrary:
- Wishful thinking?
- Naive mistakes?
- Commercials?
- Fraud?
You decide.
This study analyzed the effect of a protocol based on the Mat Pilates method in an intervention group compared to a usual care control group, on quality of life, fatigue and body image of head and neck cancer survivors.
The study was designed as a randomized clinical trial with 30 survivors, allocated into an intervention group and a control group.
- The intervention group underwent a 12-week Mat Pilates, twice a week, one hour long.
- The control group attended two lectures and received weekly follow-up throughout the study period.
Data collection took place through individual face-to-face interviews, focusing on assessing the outcomes: quality of life (FACT-H&N); fatigue (FACT-F) and body image (BIS).
The Mat Pilates group showed significant improvements compared to the control group in both intra-group and inter-group analyses across the variables:
- quality of life (in total score (p = 0.007)/(p = 0.003),
- family well-being (p = 0.001)/(p = 0.008),
- functional well-being (p = 0.001)/(p = 0.001)),
- body image in the total score (p = 0.001)/(p = 0.001),
- subscales: body image (p = 0.046)/(p = 0.010),
- body care (p = 0.026)/(p = 0.010),
- body touch (p = 0.013)/(p = 0.022),
- fatigue (p = 0.006)/(p = 0.003).
The authors concluded that, based on these findings, future research could delve deeper into understanding the long-term effects of Mat Pilates interventions on quality of life, body image, and fatigue levels among survivors of head and neck cancer.
These conclusions are prudently cautious. The reason for this caution probably is the fact that the findings tell us far less than the results might imply.
The naive reader would think they show the effectiveness of pilates excercises. This, however, would be erroneous. The positive results are to be expected, if only due to the extra attention given to the verum patients or the disappointment of the control group for not receiveing it.
If we truly want to evaluate the specific effects of a treatment like pilates, we need to design a different type of study. Nobody doubts that group excercise can improve plenty of subjective parameters. The question, I think, is whether pilates is better in achieving this aim than other forms of excercise. Thus we might need an equivalence study comparing two or more forms of excercise. Such studies are more difficult to plan and conduct. Yet, without them, I fear that we will not be able to determine the value of specific forms of excercise.
Soon after taking power in 1933, the Nazis introduced a program of involuntary sterilisation of those German citizens who they considered unworthy of reproduction. These were predominantly, but not exclusively, people afflicted with heridetary diseases. The declared aim was to sanitize the German gene pool. Involuntary sterilisation was legalized through the ‘law for the prevention of genetically diseased offspring’ (Gesetz zur Verhuetung erbkranken Nachwuchs) as early as July 14, 1933. The law provided that handicapped individuals were to be identified, examined by a jury of experts who had to write an experts’ report, and subsequently sterilized.
In order to implement the law, a large number of new health authorities had to be established. By 1935, approximately 220 hereditary health courts and 30 higher hereditary health courts had thus been set up. Each court relied on the expertise of two physicians and one district judge. Throughout Germany, doctors were required to register with these courts every known case of hereditary illness. This included patients suffering from genetic blindness and deafness, manic depression, schizophrenia, epilepsy, congenital feeble-mindedness, Huntington’s chorea, and alcoholism. The doctors who carried out the sterilisations were paid 10 Reichsmark per case for their services.
The most common methods of sterilization were vasectomy for men and ligation of ovarian tubes for women. Around 6 000 patients, mostly women, died as a result of these operations. Because such methods sterilisations required a lengthy post-operative recovery time, the Nazis started looking for more economical methods of sterilisation. New options were thus tested on camp prisoners at Auschwitz and at Ravensbrück. For instance, experimental drugs were tried, carbon dioxide was injected and X-rays were administered. Another option that was considered was herbal medicine.
In October 1941, Adolf Pokorny, an Austrian dermatologist, wrote to Himmler. ‘Driven by the idea that the enemy must not only be defeated, but destroyed’, he suggested carrying out sterilisation experiments with the South American plant Caladium seguinum. Pokorny drew Himmler’s attention to a publication by Madaus, which suggested that the sap of the hogweed caused permanent sterility in animals:
‘If it were possible … to produce a drug that produces undetected sterilisation in humans in a relatively short time, we would have an effective weapon at our disposal. The very idea that the three million Bolsheviks currently in German captivity could be sterilised so that they would be available as workers, but excluded from reproduction, opens up far-reaching prospects.’
In order not to jeopardise the research in this regard, Pokorny recommended that plant cultivation be started soon and that Madaus be prohibited from publishing further papers on this subject so that the ‘enemy’ would not be made aware of these plans. Himmler who was easily impressed by quacks of all types instructed Oswald Pohl and Ernst-Robert Grawitz to follow up Pokorny’s tips and contact Madaus so that he could check ‘the possibility of experiments on criminals who would have to be sterilised in and of themselves’.
In the spring of 1942, the SS contacted the Madaus company. Gerhard Madaus, the company’s boss, had died shortly beforehand and his successor pledged to maintain secrecy about the effects of the plant. A chemist from IG Farben asserted that sterilisation might be possible. In October 1942, the SS placed an order for extracts to be used in human experiments. Ultimately, however, no such trials took place. There were several reasons for this:
- the plant did not thrive in the European climate,
- the Madaus company did not have enough glasshouses for growing the plant,
- attempts to synthesise the plant’s ingredients failed.
After the war, Himmler committed suicide, Oswald was sentenced to death and executed, Grawitz killed himself and his family, and Pokorny was put on trial in the famous ‘Nuremberg Doctors Tribunal‘. He defended himself by arguing that he had all along been aware of the ineffectiveness of Caladium seguinum and that he had wanted to dissuade Himmler from using tried and tested methods of sterilisation with his proposal. The court did not accept his argument, but nevertheless acquitted him:
‘We are not impressed by the defence which the accused has put forward, and it is difficult to believe that he was guided by the noble motives which he states when he wrote the letter. Rather, we are inclined to believe that Pokorny wrote the letter for entirely different and more personal reasons. […] In Pokorny’s case, the prosecution has not succeeded in proving his guilt. As outrageous and base as the suggestions in this letter are, there is not the slightest evidence that any steps were ever taken to apply them through human experimentation. We therefore declare that the accused must be acquitted, not because of, but in spite of the defence he has put forward.’
Porkorny was thus released from prison; his fate thereafter is not known.
This study aimed to determine the effects of Reiki on pain and biochemical parameters in patients undergoing bone marrow transplantation. This investigation was designed as a “single-blind, repeated measures, randomized prospective controlled study”. It was conducted between August 2022 and April 2023 with patients who underwent autologous bone marrow transplantation (BMT).
- In the Reiki group (n = 21), Reiki therapy was applied directly to the energy centers for 30 min on the 0th and 1st day of BMT, and from a distance for 30 min on the 2nd day.
- No intervention was performed on the control group (n = 21).
Data were collected using the Personal Information Form, Visual Analog Scale (VAS), and biochemical parameters. Pain and biochemical parameters were evaluated on days 0, 1, 2, and 10 before the Reiki application.
There were no statistically significant differences in pain scores between the groups before the intervention (p > .005). The Reiki group showed a significant improvement in the mean VAS score compared with the control group on days 1 and 2 (p = .002; p < .001, respectively). The measurement of procalcitonin showed a decrease in the Reiki group and an increase in the control group (p = .026, p = .001, p < .001, respectively). Although the Reiki group had better absolute neutrophil, thrombocyte, and C-reactive protein values than the control group, no significant difference was observed between the groups (p > .05).
The authors concluded that Reiki is effective for pain control and enhancing the immune system response.
For the following reasons, I beg to differ:
- The patients of the verum group were fully aware of receiving the therapy; thus they were expecting/hoping to benefit from it.
- The patients of the control group received no therapy; thus they were disappointed which may have influenced thie VAS ratings.
- The procalcitonin levels are of doubtful relevance; they changed only within the group which, in a controlled clinical trial that is supposed to compare groups is meaningless and most likely a chance finding.
- The only people who could have been blinded in this ‘single blind’ study were the evaluators of the results (even though the authors state that “patients were blinded to the group assignments”) which is meaningless if patients and therapists are not blinded.
Because of all this, I feel that the conclusions should be re-written:
Reiki is known to cause a placebo effect which most likely caused the observed outcomes.
“Is Chiropractic Worth the Taxpayer’s Expense?” is the interesting question asked in this article by Ikenna Idika Ogbu from the Department of Neurosurgery, University Hospitals of North Midlands, UK and Chandrasekaran Kaliaperumal from the Department of Clinical Neurosciences, Royal Infirmary of Edinburgh, UK. Here is the abstract:
Chiropractic remains a service provided outside the NHS in the United Kingdom and the argument for inclusion has been ongoing since the 90’s. There are significant patient-reported benefits from chiropractic backed by evidence in specific use-cases as cervicogenic headaches and there are significant potential cost-savings from the inclusion of chiropractic as an NHS service. The evidence, however, does not particularly favour the use case of chiropractic, especially in the context of Low Back Pain (LBP) and the benefits of chiropractic are unclear. Considering the potential cost-savings for the NHS and the society, there should be consideration for its inclusion. However, the evidence will need to be clearer to argue for inclusion of chiropractic in the NHS spectrum of services, especially for spinal services.
So, the authors confirm that, even for back pain, “the benefits of chiropractic are unclear”, and in the next sentence they advocate “consideration for its inclusion.”
Does that make sense?
No!
Let’s be clear: the least expensive way to proceed in the short term is usually to do nothing. No treatment is invariably less expensive than treatment! Yet, this logic obviously does not account for the two most important factors in this equation: risk and benefit.
- Not treating a condition can cause prolonged, needless suffering.
- Not treating a condition can cause significant follow-up costs.
- Treating it can cause adverse effects and additional suffering.
- Adverse effects can cause significant follow-up costs.
- Treating the condition effectively will result in less suffering.
- Treating the condition effectively will result in less follow-up costs.
It follows that we should treat health problems:
- effectively,
- with few risks of side-effects,
- as cheaply as possible.
It also follows that costs are by no means the only factor in this complex equation. Cost-effectiveness without effectiveness is not possible. Moreover, cost-effectiveness withoout an acceptable degree of safety is unlikely.
In the case of chiropractic, we have hardly reliable proof of effectiveness or safety. And this means that, before we can consider chiropractic to be paid for from public money, we first need solid evidence for its safey and efficacy – each for the relevant health problem to be treated. Once we have reliable data about all this – AND ONLY THEN – might we consider including chiropractic into the public healthcare budget.
In other words, the above cited paper is naive and ill-informed to the extreme.
Many patients seek Chinese herbal medicines (CHM) from traditional Chinese medicine (TCM) clinics. This study aimed to estimate the risk of major adverse cardiovascular events (MACEs) in adults diagnosed with obesity, with or without CHM.
Patients with obesity aged 18 to 50 years were identified using diagnostic codes from Taiwan’s National Health Insurance Research Database between 2008 and 2018. The researchers randomized 67,655 patients with or without CHM using propensity score matching. All patients were followed up from the start of the study until MACEs, death, or the end of 2018. A Cox proportional regression model was used to evaluate the hazard ratios of MACEs in the CHM and non-CHM cohorts.
During a median follow-up of 4.2 years, the CHM group had a higher incidence of MACEs than the non-CHM control cohort (9.35 versus 8.27 per 1,000 person-years). The CHM group had a 1.13-fold higher risk of MACEs compared with the non-CHM control (adjusted hazard ratio [aHR] = 1.13; 95% confidence interval [CI]: 1.07–1.19; p <0.001), especially in ischemic stroke (aHR = 1.18; 95% CI: 1.07–1.31; p <0.01), arrhythmia (aHR = 1.26; 95% CI: 1.14–1.38; p <0.001), and young adults aged 18 to 29 years (aHR = 1.22; 95%
CI: 1.05–1.43; p <0.001).
The authors concluded that, although certain CHMs offer cardiovascular benefits, young and middle-aged obese adults receiving CHM exhibit a higher risk of MACEs than those not receiving CHM. Therefore, TCM practitioners should be cautious when prescribing medications to young patients with obesity, considering their potential cardiovascular risks.
I am not sure why the authors concluded that “certain CHMs offer cardiovascular benefits”; their data do not support this statement and I am not aware of any such evidence either. The more valid result of this study is that the use of CHMs is a risk factor for cardiovascular health in obese people. I fear that this might also be true for non-obese individuals and could also apply to non-cardiovascular areas of health.
Just like any other form of herbal therapy, CHMs can contain toxic ingredients and might interact with prescribed medications. Unlike most other forms of herbal treatments CHMs are known to be often contaminated (e.g. with heaviy metals) and/or adulterated (e.g. with illegal amounts of synthetic drugs). as they typically contain a multitude of herbs, the risk of interactions is also increased. Our 2013 review shoed that “herbal medicinal products (HMPs) were adulterated or contaminated with dust, pollens, insects, rodents, parasites, microbes, fungi, mould, toxins, pesticides, toxic heavy metals and/or prescription drugs. The most severe adverse effects caused by these adulterations were agranulocytosis, meningitis, multi-organ failure, perinatal stroke, arsenic, lead or mercury poisoning, malignancies or carcinomas, hepatic encephalopathy, hepatorenal syndrome, nephrotoxicity, rhabdomyolysis, metabolic acidosis, renal or liver failure, cerebral edema, coma, intracerebral haemorrhage, and death. Adulteration and contamination of HMPs were most commonly noted for traditional Indian and Chinese remedies, respectively.”
My advice has therefore long been very clear and outspoken:
CHMs are best avoided!
This study aimed at examining the feasibility issues of comparing individualized homeopathic medicines (IHMs) with identical-looking placebos for treating knee osteoarthritis (OA).
Forty eligible patients participated in this double-blind, randomized (1:1), placebo-controlled feasibility trial in the outpatient clinics of a homeopathic hospital in West Bengal, India. Either IHMs or identical-looking placebos were administered, along with mutually agreed-upon concomitant care guidelines. The Knee Injury and Osteoarthritis Outcome Score (KOOS) was the primary outcome measure, along with derived Western Ontario and McMaster Universities Arthritis Index (WOMAC) scores from KOOS. The EQ-5D-5L questionnaire and Visual Analog Scale (VAS) were the secondary outcomes. All were measured at baseline and after 2 months. Group differences and effect sizes (Cohen’s d) were estimated using an intention-to-treat approach. p-Values less than 0.05 (two-tailed) were considered statistically significant.
Enrolment/screening and trial retention rates were 43% and 85% respectively. Recruitment was difficult owing to the coronavirus disease 2019 (COVID-19) lockdown. Group differences were statistically significant, favoring IHMs against placebos in all the KOOS sub-scales: symptoms (p < 0.001), pain (p = 0.002), activities of daily living (p < 0.001), sports or recreation (p = 0.016), and quality of life (p = 0.002). Derived WOMAC scores from KOOS favored IHMs against placebos: stiffness (p < 0.001) and pain (p < 0.001). The EQ-5D-5L questionnaire score (p < 0.001) and EQ-5D-5L VAS scores (p < 0.001) also yielded significant results, favoring IHMs over placebos. All the effect sizes ranged from moderate to large. Sulphur was the most frequently prescribed homeopathic medication. Neither group reported any harm or serious adverse events.
The authors concluded that, although recruitment was sub-optimal due to prevailing COVID-19 conditions during the trial, the action of IHMs was found to be superior to that of placebos in the treatment of knee OA. Larger and more definitive studies, with independent replications, are warranted in order to substantiate the findings.
Sorry, but I don’t understand this: the authors stated multiple times that this was a feasibility study (which tests feasibility and not effectiveness), and then they promptly report effectiveness data for which the trial was grossly under-powered (i.e. too small). Why are they doing such nonsense? Perhaps their affiliations provide a hint?
- 1Department of Materia Medica, D. N. De Homoeopathic Medical College and Hospital, Kolkata; affiliated to The West Bengal University of Health Sciences, Kolkata, West Bengal, India.
- 2Department of Repertory, D.N. De Homoeopathic Medical College and Hospital, Kolkata, West Bengal, India.
- 3Department of Organon of Medicine and Homoeopathic Philosophy, D.N. De Homoeopathic Medical College and Hospital, Kolkata, West Bengal, India.
- 4Department of Practice of Medicine, D.N. De Homoeopathic Medical College and Hospital, Kolkata, West Bengal, India.
- 5Department of Surgery, D.N. De Homoeopathic Medical College and Hospital, Kolkata, West Bengal, India.
- 6Department of Homoeopathy, East Bishnupur State Homoeopathic Dispensary, Chandi Daulatabad Block Primary Health Centre, West Bengal, India.
- 7Department of Community Medicine, D.N. De Homoeopathic Medical College and Hospital, Kolkata, West Bengal, India.
I do symathise with the pressures of reporting positive findings, if your salary comes from homeopathic institutions. Yet, I cannot help but pointing out:
THESE FINDINGS ARE INVALID AND FALSE-POSITIVE!
