experience
- complement conventional and supportive care,
- be complemented with other supportive therapies,
- substitute for supportive drugs,
- replace other supportive therapies,
- not be suitable to replace all supportive therapies,
- be the only supportive option available in some situations.
Approximately 30% of children diagnosed with attention-deficit/hyperactivity disorder (ADHD), the most prevalent mental health disorder in children worldwide, do not respond to conventional pharmaceutical treatments. Previous studies of homeopathic treatment for ADHD have been inconclusive. The objectives of this randomized double-blind placebo-controlled clinical trial were to determine if there
- (a) is an overall effect of homeopathic treatment (homeopathic medicines plus consultation) in the treatment of ADHD;
- (b) are any specific effects the homeopathic consultation alone in the treatment of ADHD;
- (c) are any specific effects of homeopathic medicines in the treatment of ADHD.
Children aged 6-16 years diagnosed with ADHD were randomized to one of three arms:
- Arm 1 (Remedy and Consultation);
- Arm 2 (Placebo and Consultation);
- Arm 3 (Usual Care).
The primary outcome was the change of CGI-P T score between baseline and 28 weeks.
There was an improvement in ADHD symptoms as measured by the Conner 3 Global Index-Parent T-score in the two groups (Arms 1 and 2) that received consultations with a homeopathic practitioner when compared with the usual care control group (Arm 3). Parents of the children in the study who received homeopathic consultations (Arms 1 and 2) also reported greater coping efficacy compared with those receiving usual care (Arm 3). There was no difference in adverse events among the three study arms.
The authors concluded that, in this study, homeopathic consultations provided over 8 months with the use of homeopathic remedy was associated with a decrease in ADHD symptoms in children aging 6-16 years when compared with usual treatment alone. Children treated with homeopathic consultations and placebo experienced a similar decrease in ADHD symptoms; however, this finding did not reach statistical significance when correcting for multiple comparisons. Homeopathic remedies in and of themselves were not associated with any change in ADHD symptoms.
This is an interesting study. It – yet again! – confirms that the effects observed after homeopathic treatments are not due to the remedie but are caused by the interaction with the homeopath. To put it more clearly:
HOMEOPATHIC REMEDIES HAVE NO SPECIFIC EFFECTS; ANY BENEFITS ARE DUE TO THE EFFECTS OF THE THERAPEUTIC ENCOUNTER AND OTHER NON-SPECIFIC EFFECTS.
‘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).
__________________
There is, of course, no evidence that any of these ingredients – in any dilution or potency – can make people stop snoring.
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.
This study aimed to explore women with breast cancer (WBC) lived experiences on the use of So-Called Alternative Medicine (SCAM) for breast cancer management. In-depth interviews guided by semi-structured questions were conducted with 21 WBC recruited using convenience sampling. The thematic analysis generated four main themes:
- Access, affordability and support for medical treatment.
- Beliefs in SCAM treatment.
- Feeling the potential benefits of SCAM.
- Acknowledging the negative aspects of SCAM.
The outcomes from using SCAM based on the lived experiences of WBC indicated that some SCAM treatments could improve quality of life. However, some fraudulent SCAM obtained from unprofessional SCAM providers could cause harmful effects, delay medical cancer treatment, and increase breast cancer treatment costs.
The authors concluded that there is an urgent need to enhance the awareness of appropriate treatment, including evidence-based SCAM, for WBC. Improved understanding in the use of SCAM as a part of quality breast cancer care services could contribute to increasing the quality of life and survival rates of women with breast cancer.
This is a very strange paper, in my view. If we disregard the fact that a small interview study cannot possibly yield reliable outcomes, we essentially have two results:
- Some SCAM treatments could improve quality of life and survival.
- Some fraudulent SCAM obtained from unprofessional SCAM providers could cause harm.
So, which SCAM is good and which bad?
By definition, such an investigation cannot answer this crucial question.
If you do nevertheless want answers, I recommend you read my evidence-based assessments summarised in a recent book. For those who don’t want to wait, here is the answer in a nutshell:
- A few SCAMs are indeed proven to inprove the quality of life of cancer patients.
- No SCAM has been shown to improve survival.
- Almost all SCAMs have the potential to harm cancer patients.
My conclusion:
“Lived experiences” may sound interesting, but scientific evidence is the only reliable guide.
Available data suggest that general practitioners (GPs) in Germany use so-called alternative medicine (SCAM) modalities more frequently than GPs in many other countries. German researchers investigated the country differences perceived by GPs who have worked in Germany and in one of four other European countries with regard to the role of SCAM in primary care.
A qualitative study was conducted using semi-structured interviews with 12 GPs who had worked both in Germany and Italy, the Netherlands, Norway or the United Kingdom (UK; n = 3 for each of the four countries). Participants were asked how they perceived and experienced country differences regarding health system, relevance of SCAM modalities, the role of evidence-based medicine (EBM) and science, and how they handle so-called indeterminate situations. For the analysis, we followed a thematic analysis approach according to Braun and Clarke with focus on themes that cover SCAM.
Participants unanimously reported that they perceived SCAM to be more relevant in general practice in Germany compared to the other countries. The researchers identified four overarching themes in relation to the perceived reasons for these differences.
- Physicians with experiences in countries with a strong EBM and science orientation (Netherlands, Norway and the UK) considered the deeply ingrained view in national healthcare systems and GP communities that SCAM modalities are not evidence-based as the main reason for the lower use of SCAM by GPs.
- Extensive training of communication skills was cited as a reason that reduced the need for SCAM in the Netherlands, Norway and the UK.
- Differences in patient expectations and demands were perceived as a factor contributing to greater utilisation of SCAM by German GPs compared to the other countries.
- Country-specific reimbursement mechanisms were considered as a factor influencing the role of SCAM in general practice.
The authors concluded that their study results point to major differences between countries with regard to the role of SCAM in GP care. Differences in basic attitudes in the discipline of general practice, patient expectations and system conditions appear to play an important role here.
The authors comment that a remarkable finding is the very consistent narrative with regard to the Netherlands, Norway and the United Kingdom that a stronger scientific and EBM orientation is seen as the main reason for the lower utilisation of SCAM by GPs compared to Germany. I agree that this is an important and, as far as I can see, new aspect. It concurrs with my personal impression that many German doctors feel that EBM is some sort of ‘KOCHBUCH MEDIZIN’ [cookbook medicine] that limits their freedom of prescribing based on intuition and experience. This, I have always felt, is a profound misunderstanding of what EBM is about.
- There is no question that cancer patients deserve measures that improve their QoL.
- There is also no question that essential oils contain active ingredients.
- Yet, it is doubtful that they reach the blood stream in sufficient concentrations to have meaningful health effects.
- Much more likely is the notion that not the oils but the massage during a typical aromatherapy is the effective element of the treatment.
- In addition, we have to think of the placebo effect [which is difficult to control for in clinical trials of aromatherapy].
So, should we use aromatherapy for cancer patients?
If it makes a patient feel better, I would use it. But there are many patients who dislike to be touched/massaged; in such cases, I would not advocate it. In addition, I would try to find out whether there are other measures that are more effective for improving the QoL (e.g. an emapthetic conversation, a cup of tea, a kind gesture, a visit from a friend) of my patient.
In any case, I would not think of aromatherapy as a THERAPY. It is more pamering and TLC than a real therapy that interfers with the disease process; it has more to do with wellness that with cure. And I would certainly caution of the many specific claims made for aromaatherapy by its enthusiasts; they are usually not supported by sound evidence, they may distract from truly effective therapies, and they have nothing to do with any pharmacological effects that the essential oils may or may not have.
The aim of this study was to assess the effectiveness of different forms of walking in reducing symptoms of depression and anxiety. A systematic review and meta-analysis of randomized controlled trials (RCTs) was conducted assessing the effects of walking on depressive and anxiety symptoms. MEDLINE, Cochrane Central Register of Controlled Trials (CENTRAL), Embase, PsycINFO, Allied and Complementary Medicine Database (AMED), CINAHL, and Web of Science were searched on April 5, 2022. Two authors independently screened the studies and extracted the data. Random-effects meta-analysis was used to synthesize the data. Results were summarized as standardized mean differences (SMDs) with 95% CIs in forest plots. The risk of bias was assessed by using the Cochrane Risk of Bias tool.
This review included 75 RCTs with 8636 participants; 68 studies reported depressive symptoms, 39 reported anxiety symptoms, and 32 reported both as the outcomes. One study reported the results for adolescents and was not included in the meta-analysis. The pooled results for adults indicated that walking could significantly reduce depressive symptoms (RCTs: n=44; SMD −0.591, 95% CI −0.778 to −0.403; I2=84.8%; τ2=0.3008; P<.001) and anxiety symptoms (RCTs: n=26; SMD −0.446, 95% CI −0.628 to −0.265; I2=81.1%; τ2=0.1530; P<.001) when compared with the inactive controls. Walking could significantly reduce depressive or anxiety symptoms in most subgroups, including different walking frequency, duration, location (indoor or outdoor), and format (group or individual) subgroups (all P values were <.05). Adult participants who were depressed (RCTs: n=5; SMD −1.863, 95% CI −2.764 to −0.962; I2=86.4%; τ2=0.8929) and those who were not depressed (RCTs: n=39; SMD −0.442, 95% CI −0.604 to −0.280; I2=77.5%; τ2=0.1742) could benefit from walking effects on their depressive symptoms, and participants who were depressed could benefit more (P=.002). In addition, there was no significant difference between walking and active controls in reducing depressive symptoms (RCTs: n=17; SMD −0.126, 95% CI −0.343 to 0.092; I2=58%; τ2=0.1058; P=.26) and anxiety symptoms (14 RCTs, SMD −0.053, 95% CI −0.311 to 0.206, I2=67.7%, τ2=0.1421; P=.69).
The authors concluded that various forms of walking can be effective in reducing symptoms of depression and anxiety, and the effects of walking are comparable to active controls. Walking can be adopted as an evidence-based intervention for reducing depression and anxiety. More evidence on the effect of low-intensity walking is needed in the future.
Clinical trials of walking are encounter considerable methodological difficulties: there is no adequate placebo, for instance. Thus, such studies are often conducted against no treatment or against ‘active control’ which means that the control group receives a therapy of known effectiveness.
The former comparison is not very meaningful because it does not allow us to tell whether the effects are truly caused by walking or by some non-specific effect. The latter comparison is more rigorous but also not perfect because the patients cannot be blinded.
This means we have to accept a degree of uncertainty in estimating the benefit of walking. As walking is not expensive, not hazardous, and has many other health benefits, this caveat seems truly minor. In other words, the findings reported here are encouraging and should be accepted in clinical practice.
Yet, there is still one ‘hair in the soup’: depressed people find it often very hard to motivate themselves to do activities such as walking. Thus, compliance with this treatment might often be less than satisfactory. It might be worth researching how this obstacle can be best overcome.
This retrospective audit aimed to assess the clinical effectiveness of telehealth interventions in an out-patient, individualized homeopathy clinical setting for 305 individuals with symptoms of positive or probable COVID-19
by a team of professional homeopaths working together in the United States during spring and summer of
2020.
The audit lasted from March to August 2020. It examined the merits of the initiative considering accessibility, effectiveness, safety, efficiency, and appropriateness of the care model.
Positive intervention outcomes were found in every measure:
- individual remedy prescriptions (83.4% positive),
- final outcomes of interventions (76.2% positive),
- degree of recovery following homeopathic interventions (74.4%).
Additionally, ease of access for a range of users, a high level of safety of the interventions, and efficiency of care and team resources indicated consistently positive outcomes.
The authors concluded that, given the significant strain on conventional healthcare systems during the early stages of the pandemic, the complementary medicine interventions studied here offer important considerations for meeting the demands for COVID-19 acute care with agile and adaptive complementary medicine models.
If one were to look for ridiculously poor studies in the realm of homeopathy, one would be spoilt for choice. Amongst the many such papers, this one would achieve a very high ranking. The investigation is nonsensical in:
- concept,
- design,
- endpoints,
- write-up,
- conclusion.
The paper prompts me to ask a few questions (and some answers):
Whoever had the notion that an audit can “assess the clinical effectiveness” of a therapy?
Do the authors even know what an audit is?
What institutions are behind such embarrassingly poor work? They are:
- ‘HOHM Foundation’, New York,
- the ‘Academy of Homeopathy Education,
- HOHM Foundation, Philadelphia.
Which journal publishes such rubbish?
It’s INTEGRATIVE MEDICINE REPORTS, a publication that claims to be a “high-quality open access journal”.
And who sponsors such idiocy?
This study was funded by donations to HOHM Partners and to Homeopathy Help Network by clients and community members.
Say no more!
This review was aimed at quantifying the proportion attributable to contextual effects of physical therapy interventions for musculoskeletal pain. Randomized placebo-controlled trials evaluating the effect of physical therapy interventions on musculoskeletal pain.
Risk of bias was evaluated using the Cochrane risk-of-bias tool for randomized trials (ROB 2.0). The proportion of physical therapy interventions effect that is explained by contextual effects was calculated, and a quantitative summary of the data from the studies was conducted using the random-effects inverse-variance model (Hartung-Knapp-Sidik-Jonkman method).
Sixty-eight studies were included in the systematic review (total number of participants: n=5,238), and 54 placebo-controlled trials informed our meta-analysis (participants: n=3,793). Physical therapy interventions included:
- soft tissue techniques,
- mobilization,
- manipulation,
- taping,
- exercise therapy,
- dry needling.
Placebo interventions included manual, non-manual interventions, or both.
The results show the following:
- The type of treatment with the largest proportion not attributable to the specific effects (PCE) for pain intensity assessed immediately after the intervention was mobilization, which represented 87% of the overall treatment effect (PCE = 0.87, 95% CI: 0.54, 1.19).
- For soft tissue techniques, the PCE was 81% of the overall treatment effect (PCE = 0.81, 95% CI: 0.64, 0.97).
- For dry needling, the PCE was 75% (PCE = 0.75, 95% CI: 0.36, 1.15).
- For manipulation techniques the PCE was 74% (PCE = 0.74, 95% CI: 0.33, 1.14).
- For taping the PCE was 69% of the overall treatment effect (PCE = 0.69, 95% CI: 0.48, 0.89).
- The smallest proportion not attributable to the specific intervention itself for pain intensity was exercise therapy accounting for 46% of the overall treatment effect (PCE = 0.46, 95% CI: 0.41, 0.52).
The authors concluded that the outcomes of physical therapy interventions for musculoskeletal pain were significantly influenced by contextual effects. Boosting contextual effects consciously to enhance therapeutic outcomes represents an ethical opportunity that could benefit patients.
This sounds as though most of the treatments in question rely mainly on placebo effects. But what about conventional therapies? The authors point out that the PCEs of general medicine and surgery in pain-related conditions are also large. In particular, the overall proportion not attributable to the specific effects of general medicine interventions is high (PCE = 65%), with higher values observed in semi-objective and objective outcomes (PCE = 78 and 94%, respectively) than in subjective outcomes (PCE = 50%).
What does that mean for healthcare routine?
As placebo and other context effects are unreliable, usually short-lived, and not normally affecting the cause of the problem (but merely the symptoms), I would say that those treatments with a very high PCE are of limited value, paticularly if they are also expensive or burdened with risks. Of the treatments studied here, I would – based on the current analysis – avoid the following therapies for pain management:
- mobilization,
- soft tissue techniques,
- dry needling,
- manipulation,
- taping.
By and large, these are also the conclusions drawn from various other strands of evidence that we have repeatedly discussed in previous posts.
