MD, PhD, MAE, FMedSci, FRSB, FRCP, FRCPEd.

Monthly Archives: July 2024

This study evaluated the effects of acupuncture and/or nicotine patches on smoking cessation. Eighty-eight participants were randomly allocated into four groups:

  • acupuncture combined with nicotine patch (ACNP),
  • acupuncture combined with sham nicotine patch (ACSNP),
  • sham acupuncture combined with nicotine patch (SACNP),
  • sham acupuncture combined with sham nicotine patch (SACSNP).

The primary outcome was self-reported smoking abstinence verified with expiratory Carbon Monoxide (CO) after 8 weeks of treatment. The modified Fagerstrom Test for Nicotine Dependence (FTND) score, Minnesota Nicotine Withdrawal Scale (MNWS), and the Brief Questionnaire of Smoking Urge (QSU-Brief) score were used as secondary indicators. SPSS 26.0 and Prism 9 software were used for statistical analyses.

Seventy-eight participants completed the study. There were no significant differences in patient characteristics at baseline across the four groups. At the end of treatment, there was a statistically significant difference (χ2 = 8.492, p = 0.037) in abstaining rates among the four groups favoring acupuncture combined with nicotine replacement patch. However, there were no significant differences in the reduction in the number of cigarettes smoked daily (p = 0.111), expiratory CO (p = 0.071), FTND score (p = 0.313), and MNWS score (p = 0.088) among the four groups. There was a statistically significant difference in QUS-Brief score changes among the four groups (p = 0.005). There was no statistically significant interaction between acupuncture and nicotine patch.

The authors concluded that acupuncture combined with nicotine replacement patch therapy was more effective for smoking cessation than acupuncture alone or nicotine replacement patch alone. No adverse reactions were found in the acupuncture treatment process.

Let’s look at this trial a little closer. The authors reveal that “the sham acupuncture targeted corresponding shoulder, eye, knee, and elbow acupoints on the auricle that are unrelated to smoking cessation”. Thus, the therapists were not ‘blind’ (the authers nevertheless call their study a double-blind trial which is confusing). This means that the acupuncturists (who had a vested interest in the trial generating positive results) had plenty of opportunity to influence the trial participants via verbal and non-verbal communication. In turn, this means that the observed positive outcome might be due to this influence rather than any postulated effect of acupuncture.

But there is a further caveat: the study originates from China. The researchers come from:

  • 1Hospital Infection-Control Department, Xi‘an Aerospace General Hospital, Xi’an, Shaanxi, China
  • 2School of Public Health, Center for Evidence-Based Medicine, Gansu University of Chinese Medicine, Lanzhou, Gansu, China
  • 3Department of Psychosomatic and Sleep Medicine, Gansu Gem Flower Hospital, Lanzhou, Gansu, China
  • 4Library, Gansu University of Chinese Medicine, Lanzhou, Gansu, China
  • 5School of Acupuncture and Tuina, Gansu University of Chinese Medicine, Lanzhou, Gansu, China
  • 6Department of Chinese Medicine, Health Center of Hekou Town, Lanzhou, Gansu, China

As we have discussed ad nauseam on this blog, Chinese researchers as good as never publish a negative study of acupuncture.

Enough reason not to take this study seriously?

Yes, I think so.

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.

Vaccine hesitancy has been defined as a continuum of attitudes, ranging from accepting vaccines with doubts to rejecting them. For good reasons, the topic has featured regularly on this blog, e.g.:

This new study aimed to explore the heterogeneity of a childhood-vaccine-hesitant group by using a person-oriented approach, i.e. latent profile analysis.

A non-representative cross-sectional sample of vaccine-hesitant Slovenians (N = 421, Mage = 35.21, 82.9% women) was used to identify differences based on their

  • reliance on personal research (“self” researching instead of relying on science),
  • over-confidence in knowledge,
  • endorsement of conspiracy theories,
  • complementary and alternative medicine,
  • trust in the healthcare system.

The analysis revealed three profiles of vaccine-hesitant individuals. The most hesitant profile—vaccine rejecting—expressed the greatest reliance on personal research, expressed the highest endorsement of conspiracy theories and complementary and alternative medicine, showed moderate overconfidence in their knowledge, and expressed the highest levels of distrust in the healthcare system. Furthermore, the researchers found differences in sociodemographic structure and noted that the identified profiles differed in their attitudes regarding MMR, HPV, and Seasonal Influenza vaccinations.

The authors concluded as follows: our findings not only further confirm the heterogeneous nature of vaccine-hesitant groups but also offer critical insights for public health interventions. By acknowledging the existence of distinct profiles within the vaccine-hesitant population, strategies can be tailored to address the nuanced beliefs and attitudes of these subgroups more effectively.

The authors suggest the following approaches:
  • Skeptics who already express a certain level of trust in healthcare, may be most receptive to messages from medical professionals. Given that skeptics are typically older, higher-educated men, interventions could focus on leveraging their existing trust in healthcare professionals and providing detailed, evidence-based information to address their specific concerns.
  • Self-directed researchers, who are characterized by high endorsement of CAM and conspiracy theories and moderate over-confidence, could benefit from interventions involving trusted community figures or CAM medicine experts who can bridge the gap between traditional and CAM perspectives. In addition, reaching out to younger women in this group through online platforms and providing credible information that counteracts misinformation could be effective.
  • Conventionalists, who have the highest trust in the healthcare system and tend to include more educated individuals with a left-leaning political orientation, may respond well to public health messages that emphasize the collective benefits of vaccination. Campaigns could focus on reinforcing their positive views on the efficacy, safety, and importance of vaccines while leveraging their trust in physicians and public health institutions.

The effectiveness of targeted interventions for each specific subgroup could then also be examined, employing insights from the present study. For instance, tailored communication strategies could be tested to determine which messages and messengers are the most effective in regard to changing attitudes and behaviors within each profile.

I better start this post with an appology: I am going to try and explain something that is rather obvious to rational thinkers. But recently, we had comments on this blog that made it clear to me that some of my readers are are far from rational. They have suggested that the real life test of a therapy like homeopathy is the survival rate of hospitals where this therapy is being used.

So why are the mortality rates in homeopathic hospitals lower that for normal hosptials?

Does that fact not prove the value of homeopathy?

No!

Why not?

Because with every comparison we need to make sure that we compare comparable things.

Patients who are admitted to homeopathic hospitals are very different from those in a normal hospital. To put it in a nutshell: THEY ARE FAR LESS SERIOUSLY ILL.

I should know that because I worked both in a homeopathic hospital and in several normal ones.

Most patients who chose to go to a homeopathic hospital are chronically unwell. Some do have a chronic illness but many others are not truly ill. Hardly anyone has a life-threatening disease.

During the months I worked in a homeopathic hospital, we only had to report one single fatality. I do remember many patients with asthma, allergies, neck pain, obseity, insomnia and similar conditions. During a comparable time period when I worked in a normal hospital of a similar size, we had dozens of fatalities.

I am sure that we all have sad experiences of a seriously ill relative or friend. Because her diesease is so serious she gets worse and worse. Eventually, home care does not suffice and she is admitted to hospital. We hope that there her life will be saved. Sadly, this is not always the case.

In other words, moribund patients are often rushed to hospital where many of them die. They are not rushed to a homeopathic hospital!

Or, to put it bluntly, the ‘real life test’ of measuring death rates of homeopathic (or naturopathic, integrative, etc.) hospitals and comparing them with the usually high mortality rates of normal hospitals is not just unreliable, it is meaningless rubbish.

As I stated above, all of this is entirely obvious – except, of course, for the deluded.

 

PS

There are comparisons between two or more hospitals that can provide useful information; they usually relate to specific conditions or interventions, e.g. hip replacement in hospital A versus hip replacement in hospital B.

 

Since it is a rare occurance these days – I retired more than a decade ago – that I publish something in the peer-reviewed literature, please allow me to make some brief comments of this review just published by Spanish researchers and myself. The aim of this systematic review with meta-analysis was to evaluate the clinical effectiveness of visceral osteopathy (VO) in musculoskeletal and non-musculoskeletal disorders.

Two independent reviewers searched in PubMed, Physiotherapy Evidence Database, Cochrane Library, Scopus, and Web of Science databases in November 2023 and extracted data for randomized controlled trials evaluating the clinical effectiveness of VO. The risk of bias and the certainty of evidence were assessed using the Risk-of-Bias tool 2 and the GRADE Profile, respectively. Meta-analyses were conducted using random effect models using RevMan 5.4. software.

Fifteen studies were included in the qualitative and seven in the quantitative synthesis. For musculoskeletal disorders, the qualitative and quantitative synthesis suggested that VO produces no statistically significant changes in any outcome variable for patients with low back pain, neck pain or urinary incontinence. For non-musculoskeletal conditions, the qualitative synthesis showed that VO was not effective for the treatment of irritable bowel syndrome, breast cancer, and very low weight preterm infants. Most of the studies were classified as high risk of bias and the certainty of evidence downgraded to low or very low.

We concluded that VO did not show any benefit in any musculoskeletal or non-musculoskeletal condition.

Yes, I agree: these findings are hardly surprising. Visceral osteopathy (or visceral manipulation) is an expansion of the general principles of osteopathy and involves the manual manipulation by a therapist of internal organs, blood vessels and nerves (the viscera) from outside the body. Visceral osteopathy was developed by the osteopath Jean-Piere Barral. He stated that through his clinical work with thousands of patients, he created this modality based on organ-specific fascial mobilization. And through work in a dissection lab, he was able to experiment with visceral manipulation techniques and see the internal effects of the manipulations.[1] According to its proponents, visceral manipulation is based on the specific placement of soft manual forces looking to encourage the normal mobility, tone and motion of the viscera and their connective tissues. These gentle manipulations may potentially improve the functioning of individual organs, the systems the organs function within, and the structural integrity of the entire body.[2]

Visceral osteopathy is being practised mostly by osteopaths and less commonly chiropractors and physiotherapists. It comprises of several different manual techniques firstly for diagnosing a health problem and secondly for treating it. Several studies have assessed the diagnostic reliability of the techniques involved. The totality of this evidence fails to show that they are sufficiently reliable to be od practical use.[3] Other studies have tested whether the therapeutic techniques used in visceral osteopathy are effective in curing disease or alleviating symptoms. The totality of this evidence fails to show that visceral osteopathy works for any condition.[4] The treatment itself seems to be safe, yet the risks of visceral osteopathy are nevertheless considerable: if a patient suffers from symptoms related to her inner organs, the therapist is likely to misdiagnose them and subsequently mistreat them. If the symptoms are due to a serious disease, this would amount to medical neglect and could, in extreme cases, cost the patient’s life.

[all references in brackets [] can be found in my recent book]

While the results of our review might be unsurprising, one thing about it did, after all, surprise me a great deal: the journal that published it, the ‘INTERNATIONAL JOURNAL OF OSTEOPATHIC MEDICINE‘. I even lost a bet for a bottle of wine with the lead author, because I said they would never accept it for publication!

Individuals with large followings can influence public opinions and behaviors, especially during a pandemic. In the early days of the COVID pandemic, US president Donald J Trump endorsed the use of unproven therapies. Subsequently, a death attributed to the wrongful ingestion of a chloroquine-containing compound occurred.

This paper investigated Donald J Trump’s speeches and Twitter posts, as well as Google searches and Amazon purchases, and television airtime for mentions of hydroxychloroquine, chloroquine, azithromycin, and remdesivir. Twitter sourcing was catalogued with Factba.se, and analytics data, both past and present, were analyzed with Tweet Binder to assess average analytics data on key metrics. Donald J Trump’s time spent discussing unverified treatments on the United States’ 5 largest TV stations was catalogued with the Global Database of Events, Language, and Tone, and his speech transcripts were obtained from White House briefings. Google searches and shopping trends were analyzed with Google Trends. Amazon purchases were assessed using Helium 10 software.

From March 1 to April 30, 2020, Donald J Trump made 11 tweets about unproven therapies and mentioned these therapies 65 times in White House briefings, especially touting hydroxychloroquine and chloroquine. These tweets had an impression reach of 300% above Donald J Trump’s average. Following these tweets, at least 2% of airtime on conservative networks for treatment modalities like azithromycin and continuous mentions of such treatments were observed on stations like Fox News. Google searches and purchases increased following his first press conference on March 19, 2020, and increased again following his tweets on March 21, 2020. The same is true for medications on Amazon, with purchases for medicine substitutes, such as hydroxychloroquine, increasing by 200%.

The authors concluded that individuals in positions of power can sway public purchasing, resulting in undesired effects when the individuals’ claims are unverified. Public health officials must work to dissuade the use of unproven treatments for COVID-19.

Trump is by no means the only politician who misled the public in matters of healthcare through ignorance, or stupidity, or both. Other recent examples that we previously discussed include, for instance:

Yes, Trump is not the only, but he is the most influential and might well be the most ignorant one:

For this reason alone – and there are many more – I hope he will not soon become merely a dark and scary chapter in the history of the US.

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!

The BBC has repeatedly misled the public on matters related to so-called alternative medicine (SCAM). Examples include:

Recently the BBC published an article about Ashwagandha. Here it is in its untouched beauty:

Ashwagandha is a herb (Withania somnifera) in the nightshade family, which also includes tomatoes and chilli peppers.  It has been used in traditional Indian medicine (Ayurveda) for thousands of years to make preparations for treating various ailments, from infectious diseases, like tuberculosis, to pain and inflammation, baldness and hiccups. In classic Ayurvedic texts, it’s also described as a ‘mental strength promoter’ (or ‘Balya’).

While lots of research has been done on ashwagandha, studies for specific conditions can be sparser. Perhaps the most recent assessment of its use for stress and anxiety comes from a 2022 review of studies by the Cochrane Collaboration, which is internationally recognised for its high-standard medical reviews. Although the Cochrane researchers were only able to find 12 studies on the subject, which together tested the herb on just 1,002 participants, their findings did suggest that ashwagandha can lower stress and anxiety. The researchers rated the ‘certainty’ of the evidence as ‘low’ and called for more detailed studies, though.

The benefits of ashwagandha are thought to be related to natural steroids called withanolides, but this group includes hundreds of compounds, with tens having been isolated from ashwagandha so far. As with any herbal remedy, the combination of compounds and the exact concoction you get depends on how and where the plant is grown, and how it’s prepared. This means that not all supplements based on the same plant are equal.

Remember, too, that herbal doesn’t mean risk-free. For some people, ashwagandha causes drowsiness and more serious side effects aren’t unknown. It’s best to treat it like a drug and not ‘just’ a herb.

The review cited in the article is this one:

Clinical trial studies revealed conflicting results on the effect of Ashwagandha extract on anxiety and stress. Therefore, we aimed to evaluate the effect of Ashwagandha supplementation on anxiety as well as stress. A systematic search was performed in PubMed/Medline, Scopus, and Google Scholar from inception until December 2021. We included randomized clinical trials (RCTs) that investigate the effect of Ashwagandha extract on anxiety and stress. The overall effect size was pooled by random-effects model and the standardized mean difference (SMD) and 95% confidence interval (CIs) for outcomes were applied. Overall, 12 eligible papers with a total sample size of 1,002 participants and age range between 25 and 48 years were included in the current systematic review and meta-analysis. We found that Ashwagandha supplementation significantly reduced anxiety (SMD: −1.55, 95% CI: −2.37, −0.74; p = .005; I2 = 93.8%) and stress level (SMD: −1.75; 95% CI: −2.29, −1.22; p = .005; I2 = 83.1%) compared to the placebo. Additionally, the non-linear dose–response analysis indicated a favorable effect of Ashwagandha supplementation on anxiety until 12,000 mg/d and stress at dose of 300–600 mg/d. Finally, we identified that the certainty of the evidence was low for both outcomes. The current systematic review and dose–response meta-analysis of RCTs revealed a beneficial effect in both stress and anxiety following Ashwagandha supplementation. However, further high-quality studies are needed to firmly establish the clinical efficacy of the plant.

This review is NOT a Cochrane Review; what is more (and more important), it seem rather uncritical.

The BBC article seems to down-play the safety issue related to Ashwagandha. As we have discussed on this blog, Ashwagandha is far from harmless. In fact, Ashwagandha has been shown to be a herb with a high risk of hepatobiliary toxicity as well as heart problems.

So, why does the BBC misinform the public?

Search me.

Manfred Lucha has been Baden-Württemberg’s Minister for Social Affairs, Health and Integration since 12 May 2016. He also is a staunch defender of homeopathy.

Lucha has repeatedly spoken out in favour of maintaining the reimbursement of costs for homeopathy by health insurance companies. He described anthroposophy and homeopathy as the essence of the Green Party. In August 2022, Lucha positioned himself against the Baden-Württemberg Medical Association on the subject of homeopathy. The Association had announced that additional training for doctors in homeopathy would be removed from the medical training catalogue. Health Minister Lucha stated that he still believed in the effectiveness of homeopathy and announced a legal review of the decision, as the Ministry of Health has legal supervision over the Medical Association. Lucha also criticised the plan by Federal Health Minister Karl Lauterbach to no longer allow homeopathic treatments to be paid for by health insurance companies. Finally, it seems safe to assume that Lucha is not amused about the new development about which I reported yesterday.

With so much outspoken engagement in the medical field, one would expect that Lucha has a solid background in evidence-based medicine and science. Yet, one would be mistaken.

After an apprenticeship as a chemical worker, Lucha completed secondary school and trained as a nurse at the Weißenau Psychiatric State Hospital. He went on to gain his university entrance qualification and studied social work. In 2005, he also completed a Master’s degree in ‘Management in Social and Health Care’. He then became the technical director of a community psychiatric centre in Friedrichshafen. Lucha is spokesman for the Bodensee district community psychiatric association and deputy federal chairman of the Federal Working Group of Community Psychiatric Associations.

Any education in evidence-based medicine?

No!

So, why does he feel he knows better than the experts?

I am not sure.

 

PS

Mr. Lucha, if you read these lines, please tell us.

To show my appreciation, I would then send you a copy of the German translation of my book on homeopathy.

The German medical profession is struggling to decide what stance it should take on homeopathy. The evidence is clear: homeopathy is a pure placebo therapy. But there are powerful lobby groups trying to prevent the general acceptance of this conclusion. Now, a further step towards progress has been taken.

After two years of heated debate, the Baden-Württemberg Medical Association, Germany, has decided that further training for doctors in homeopathy will be cancelled. In July 2022, the Assembly of Representatives had already voted in favour of removing homeopathy from the further training regulations in Baden-Württemberg. This move prompted fierce opposition on several levels; the Social Affairs Minister Manfred Lucha (Greens), for instance, called it the ‘absolutely the wrong signal’. Homeopathy is an important part of healthcare for many people, he had claimed.

The treatment of patients in Baden-Württemberg with homeopathy will neither be restricted nor prohibited by this step. Doctors who have already completed the further training programme or are still in the process of doing so will not be affected by the change.

The chamber’s evaluation had concluded that there is no scientific evidence showing that homeopathy is effective for any condition. The German Medical Association had arrived at the same verdict and, already in 2022, it had spoken out in favour of the abolition in 2022.

On this blog, we have regularly discussed the German homeopathy debate and its many twists and turns, e.g.:

I am fairly confident that, in the end, the evidence will prevail, the confusion will disappear, and an agreement with broad support will emerge also in Germany:

THE PLACE FOR HOMEOPATHY IS IN THE MEDICAL HISTORY BOOKS! 

 

 

 

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