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

quality of life

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If you live in the UK, you could not possibly escape the discussion about the ‘Assisted Dying Bill’ which passed yesterday’s vote in the House of Commons (MPs have voted by 330 to 275 in favour of legalising voluntary assisted suicide). Once the bill passed all the further parliamentary hurdles – which might take several years – it will allow terminally ill adults who are

  • expected to die within six months,
  • of sound mind and capable of managing their own affairs

to seek help from specialised doctors to end their own life.

After listening to many debates about the bill, I still I have serious concerns about it. Here are just a few:

  1. Palliative care in the UK is often very poor. It was argued that the bill will be an incentive to improve it. But what, if this is wishful thinking? What if palliative care deteriorates to a point where it becomes an incentive to suicide? What if the bill should even turn out to be a reason for not directing maximum efforts towards improving palliative care?
  2. How sure can we be that an individual patient is going to die within the next six months? Lawmakers might believe that predicting the time someone has left to live is a more or less exact science. Doctors (should) know that it is not.
  3. How certain can we be that a patient is of sound mind and capable of managing their own affairs? By definition, we are dealing with very ill patients whose mind might be clouded, for example, by the effects of drugs or pain or both. Lawmakers might think that it is clear-cut to establish whether an individual patient is compos mentis, but doctors know that this is often not the case.
  4. In many religions, suicide is a sin. I am not a religious person, but many of the MPs who voted for the bill are or pretend to be. Passing a law that enables members of the public to commit what in the eyes of many lawmakers must be a deadly sin seems problematic.

In summary, I feel the ‘Assisted Dying Bill’ is a mistake for today; it might even be a very grave mistake for a future time, if we have a government that is irresponsible, neglects palliative care even more than we do today and views the bill as an opportunity to reduce our expenditure on pensions.

A journalist from the DAILY MAIL alerted me to the fact that yet another celebrity having decided to sell dietary supplements, interviewed me on the subject, and eventually published an article about it. One would not have thought that the Beckhams are short of money – so, why did David Beckham turn into a snake-oil salesman? I am far from being able to answer this question. What I now do know is that, via his firm ‘IM8’, he has started marketing two supplements (one of his slogans is ‘Built by Science, Trusted by Beckham’):

Daily Ultimate Essentials: All-in-One Supplement

This is a ‘multi-everything’ supplement. The only truly remarkable thing about it is its price tag. There are hundreds of similar products on the market. Almost all of them are much cheaper, and none is helpful for anyone who is healthy and consumes a balanced diet, as far as I can see.

Daily Ultimate Longevity: Healthy Aging

The implication here seems to be not a trivial one; the name clearly implies that we live longer, if we regularly bought this supplement. Not onlly that, we would also be healthier! I can see no evidence for either of these claims, yet a simple calculation tells me that we would be considerably poorer, if we fell for this advertising gimmick.

On the website, we learn a bit more:

At IM8, our commitment to science goes beyond innovation—it’s the foundation of everything we do. A world-class team of experts from space science, medicine, and academia has united with one goal: to revolutionize wellness. We’ve pioneered CRT8™ (Cell Rejuvenation Technology 8), designed to enhance cellular rejuvenation and push the limits of what’s possible in health.

Each of our products undergoes rigorous third-party testing and clinical trials, ensuring purity, efficacy, and results you can trust. With IM8, you’re getting scientifically driven core nutrition for optimal health and longevity.

___________________

I feel embarrassed for the ‘world-class team of experts from space science, medicine, and academia’ who give their good name to this hyped up nonsense. Moreover, I ask myself whether David Beckham’s new attempt to increase his wealth might be a case for the Advertising Standards Authority (ASA).

 

“As a medical doctor having taken care of thousands of patients in my life, I strive to ensure the health safety and superior wellbeing of my patients. I continue to encourage, educate and inform not only my patients, but the public to stay strong and healthy any time, not just during a pandemic. Our body is our temple and what we put in it and what we don’t affects the way we feel, think and function. Essential vitamins and minerals are key component to daily functioning but thats not always possible in this day and age with our busy hectic lifestyles, so after years of educating my patients, now I made it a little easier to get all the nutrition you need to live strong and stay healthy.”

These are the words from an advertisement for “Immune System Support for your Active Life” sold by Dr. Janette Nesheiwat who was just nominated as Donald Trump’s next SURGEON GENERAL. Amongst other items, she sells 60 capsules of ‘B+C BOOST Plus D3 & Zinc‘ for US$26.99.

Her website describes the new US Surgeon General as follows:

Dr. Janette Nesheiwat is a top Family and Emergency Medicine doctor. She brings a refreshingly no-nonsense attitude to the latest medical news, breaking down everything you need to know to keep you- and your family- healthy at all times.

Whether caring for her patients in the ER, serving on the front lines of disaster relief with the Red Cross, or sharing need-to-know info with TV audiences, Dr. Nesheiwat’s mission is not only to save lives—but to change them, by giving real people the treatment and the expertise they need.

Her sincere and straightforward approach is a product of her background. She was one of five kids raised by a widowed mother, and also completed US Army ROTC Advanced Officer Training in Ft. Lewis, Washington prior to becoming a Family and Emergency Physician. She has led medical relief missions around the globe and today she is a medical news correspondent and the Medical Director at CityMD.

I was always telling my patients who were unwell drink some tea, take some vitamin b12 and vitamin C. I found myself repeating my all natural regimen to my patients over and over “take some B12 and C to Boost” your immune system. Thats how I came up with BC Boost. Although I am a doctor, I am not quick to prescribe drugs unless I feel necessary as we want to put into our body the most natural wholesome ingredients.

Vitamin B12 is a cofactor in DNA synthesis. It helps maintain healthy blood cells and nerve function as well as prevent anemia which causes fatigue, a common complaint in those who are sick, tired, run down. Vitamin C is needed for development of collagen and a strong immune system as well as body repair and growth.

Yes, you are quite right, Dr. Nesheiwat might have forgotten one or two not-so-unimportant details:

  1. If you eat a healthy diet, you don’t need vitamins.
  2. If you do need vitamins, you can buy them cheaper elsewhere.
  3. These vitamins do not boost your immune system.
  4. Boosting the immune system could actually do a lot of harm to the many people suffering from auto-immune diseases.

But never mind, we can nevertheless be confident that Dr. Nesheiwat will bring great joy to the US supplement industry. I am less confident, however, that she did public health a great service when, in her role as a regular ‘Fox News’ commentator, she warned that wearing face masks during the pandemic exposed consumers to toxic substances linked to seizures and cancer.

Dr. Janette spreading misinformation about vaccines, masks, and COVID on FOX News.

Dry needling (DN) is a treatment used by various healthcare practitioners, including physical therapists, physicians, and chiropractors. It involves the use of either solid filiform needles or hollow-core hypodermic needles for therapy of muscle pain, including pain related to myofascial pain syndrome. DN is mainly used to treat myofascial trigger points, but it is also used to target connective tissue, neural ailments, and muscular ailments. There is conflicting evidence regarding the effectiveness of DN for any condition.

Orofacial pain (OFP) typically has a musculoskeletal, dental, neural, or sinogenic origin. Our systematic review was aimed at evaluating the evidence base for the effectiveness of DN for OFP.

We searched Medline, Cochrane Central, and Web of Science (from their respective inceptions to February 2024) for RCTs evaluating the effectiveness of DN in patients with OFP. Studies with patients suffering from cervicogenic or tension type headaches as well as observational studies were excluded. Primary outcomes were pain intensity and severity; secondary outcomes were disability, quality of life, and adverse effects (AEs). The review adhered to the methods described by in the Cochrane Handbook.

Twenty-four RCTs with a total of 1,318 patients suffering from OFP could be included. Most had an unclear or high risk of bias, and the quality of the evidence ranged from very low to low for all comparisons and outcomes. A meta-analysis suggested that, compared with usual care alone, DN + usual care had no effect on pain intensity (visual analogue scale) (standardized mean difference = −1.89, 95% confidence intervals −5.81 to 2.02, very low certainty evidence) at follow-ups of up to 6 weeks. Only 6 RCTs (25%) mentioned AEs, and none of them reported that AEs had occurred. The remaining 18 (75%) studies failed to report AEs.

We concluded that DN cannot be considered as an effective treatment option for OFP. This is due to the uncertainties of the available evidence. We believe that larger, rigorous, and better reported trials with more homogeneous comparators might potentially reduce the current uncertainties. Such trials should strictly adhere to the classifications provided by the International Headache Society and published in the International Classification of Orofacial Pain. 

Yet again, I need to stress that the vast majority od RCTs failed to mention AEs. When will the last (pseudo-) researcher have learnt that the non-reporting of AEs is a violation of research ethics?

The objective of the present double-blind, randomized, placebo-controlled, feasibility trial was to identify the effects of individualized homeopathic medicinal products (IHMPs) against placebos in post-COVID-19 conditions. Sixty participants with post-COVID-19 conditions were randomised into either:

  • group verum (n = 30; IHMPs plus concomitant care),
  • group control (n = 30; placebos plus concomitant care).

Feasibility issues; primary—post-COVID-19 symptoms checklist; secondary—Measure Yourself Medical Outcomes Profile version 2 (MYMOP-2); all of them were measured at baseline, and monthly intervals, up to 3 months. The intention-to-treat sample was analyzed; group differences were reported using descriptive statistics: means, 95% confidence intervals (CIs), and between group effect sizes (Cohen’s d).

Feasibility concerns showed promise; recruitment, retention, and attrition rates were 34.2%, 95%, and 5%, respectively. Group differences in both primary and secondary outcomes favored IHMPs against placebos: symptoms checklist score mean difference after 3 months: −4.2, 95% CI −4.9 to −3.4, d = 2.854 and MYMOP-2 mean difference after 3 months: −2.2, 95% CI −2.8 to −1.7, d = 2.082, respectively. Natrum muriaticum (11.7%), Pulsatilla nigricans (10%), Rhus toxicodendron (8.3%), and Calcarea carbonica (8.3%) were the most frequently prescribed remedies.

The authors concluded that IHMPs produced better results than placebos in reducing symptoms checklist scores and MYMOP-2 scores in the treatment of post-COVID-19 conditions. Definitive trials are warranted to confirm the findings.

A feasibility study (the authors employ this term repeatedly) has – as I have often pointed out – the purpose of testing whether a trial disign, set-up, etc. is FEASIBLE. It is not meant to report other outcome data.

Why?

Mainly because such studies are far too underpowered for generating reliable results!

This means that the present findings can be ignored. They are most likely caused by chance.

Why are they published anyway, and why could the authors find a journal that goes along with such nonsense?

Are they too stupid or are they biased or both?

The nature of the journal might provide a hint for answering these questions (J Integr Complement Med), and so does the list of authors and their affiliations:

  • 1Department of Organon of Medicine and Homoeopathic Philosophy, D. N. De Homoeopathic Medical College and Hospital, Govt. of West Bengal, Kolkata, India.
  • 2Department of Pathology and Microbiology, D. N. De Homoeopathic Medical College & Hospital, Govt. of West Bengal, Kolkata, India.
  • 3Department of Practice of Medicine, D. N. De Homoeopathic Medical College and Hospital, Govt. of West Bengal, Kolkata, India.
  • 4Department of Homeopathy, East Bishnupur State Homoeopathic Dispensary, Chandi Daulatabad Block Primary Health Centre, Department of Health & Family Welfare, Govt. of West, Kolkata, India.
  • 5Department of Repertory, D. N. De Homoeopathic Medical College and Hospital, Govt. of West Bengal, Kolkata, India.
  • 6Department of Community Medicine, D. N. De Homoeopathic Medical College and Hospital, Govt. of West Bengal, Kolkata, India.

I rest my case.

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:

  1. Access, affordability and support for medical treatment.
  2. Beliefs in SCAM treatment.
  3. Feeling the potential benefits of SCAM.
  4. 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:

  1. Some SCAM treatments could improve quality of life and survival.
  2. 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.

 

Chemotherapy-induced nausea and vomiting (CINV) is a common adverse event in cancer patients and can negatively affect their quality of life (QoL). This randomized phase II cross-over trial aimed to evaluate the clinical efficacy of an electric massage chair (EMC) for the treatment of CINV. It was conducted on solid cancer patients who received moderate (MEC) to high emetogenic chemotherapy (HEC). The participants were randomly assigned to receive their first chemotherapy either on a standard bed (Group A) or in an EMC (Group B) during the infusion. The patients were then crossed over to the next cycle. CINV and QoL questionnaires were collected from the participants.

A total of 59 patients completed the trial protocol and were included in the analysis, with 29 and 30 patients in Groups A and B, respectively. The mean INVR (Index of Nausea, Vomiting, and Retching) score in the 2nd day of the first cycle was higher in Group B (3.63 ± 5.35) than Group A (2.76 ± 4.78), but the difference was not statistically significant (p = 0.5367). The complete response rate showed little difference between the groups. Among the high-emetic risk subgroups, patients who received HEC (p = 0.04595), younger patients (p = 0.0108), and non-colorectal cancer patients (p = 0.0495) presented significantly lower CINV scores when EMC was applied.

The authors concluded that there was no significant difference in INVR scores between standard care and EMC. Applying EMC at the first chemotherapy infusion may help preserve QoL and reduce CINV in high-risk patients.

Receiving chemotherapy for the first time is a very frightening event. In my view, everything should be done by the care team to make it less scary and as agreeable as possible. Patients might chose whether they prefere to lie down or sit, whether they have their own room or are treated in the company of others, with or without music, etc., etc. If an EMC is available, they should be able to try it and decide whether it suits them or not. If it does, I would not care a hoot whether EMC is a proven intervention or not, wether it is placebo or not, etc.

The main thing here is to make patients comfortable – and that, in my view, hardly needs a clinical trial.

The American Society of Clinical Oncology (ASCO) and the Society for Integrative Oncology have collaborated to develop guidelines for the application of integrative approaches in the management of:

  • anxiety,
  • depression,
  • fatigue,
  • use of cannabinoids and cannabis in patients with cancer.

These guidelines provide evidence-based recommendations to improve outcomes and quality of life by enhancing conventional cancer treatment with integrative modalities.

All studies that informed the guideline recommendations were reviewed by an Expert Panel which was made up of a patient advocate, an ASCO methodologist, oncology providers, and integrative medicine experts. Panel members reviewed each trial for quality of evidence, determined a grade quality assessment label, and concluded strength of recommendations.

The findings show:

  • Strong recommendations for management of cancer fatigue during treatment were given to both in-person or web-based mindfulness-based stress reduction, mindfulness-based cognitive therapy, and tai chi or qigong.
  • Strong recommendations for management of cancer fatigue after cancer treatment were given to mindfulness-based programs.
  • Clinicians should recommend against using cannabis or cannabinoids as a cancer-directed treatment unless within the context of a clinical trial.
  • The recommended modalities for managing anxiety included Mindfulness-Based Interventions (MBIs), yoga, hypnosis, relaxation therapies, music therapy, reflexology, acupuncture, tai chi, and lavender essential oils.
  • The strongest recommendation in the guideline is that MBIs should be offered to people with cancer, both during active treatment and post-treatment, to address depression.

The authors concluded that the evidence for integrative interventions in cancer care is growing, with research now supporting benefits of integrative interventions across the cancer care continuum.

I am sorry, but I find these guidelines of poor quality and totally inadequate for the purpose of providing responsible guidance to cancer patients and carers. Here are some of my reasons:

  • I know that this is a petty point, particularly for me as a non-native English speaker, but what on earth is an INTEGRATIVE THERAPY? I know integrative care or integrative medicine, but what could possibly be integrative with a therapy?
  • I can vouch for the fact that the assertion “all studies that informed the guideline recommendations were reviewed” is NOT  true. The authors seem to have selected the studies they wanted. Crucially, they do not reveal their selection criteria. I have the impression that they selected positive studies and omitted those that were negative.
  • The panel of experts conducting the research should be mentioned; one can put together a panel to show just about anything simply by choosing the right individuals.
  • The authors claim that they assessed the quality of the evidence, yet they fail to tell us what it was. I know that many of the trials are of low quality and their results therefore less than reliable. And guidance based on poor-quality studies is misguidance.
  • The guidelines say nothing about the risks of the various treatments. In my view, this would be essential for any decent guideline. I know that some of the mentioned therapies are not free of adverse effects.
  • They also say nothing about the absolute and relative effect sizes of the treatments they recommend. Such information would ne necessary for making informed decisions about the optimal therapeutic choices.
  • The entire guideline is bar any critical thinking.

Overall, these guidelines provide more an exercise in promotion of dubious therapies than a reliable guide for cancer patients and their carers. The ASCO and the Society for Integrative Oncology should be ashamed to have given their names to such a poor-quality document.

Astrology is a subject that regularly crops up in the realm of so-called alternative medicine (SCAM). Thus we have dealt with it on several occasions, e.g.:

Many SCAM proponents evidently believe that astrology works.

The question is, does astrology have any value at all in healthcare?

Several recent papers go some way in answering it.

The first paper evaluated the existing research base on correlates of belief in astrology and fortune-telling. the researchers conducted a scoping review to synthesize the available literature base on belief in astrology and to review the evidence for “fortune-telling addiction” using Arksey and O’Malley’s methodological framework. Databases of PubMed, ProQuest, EBSCO, and SCOPUS were searched for relevant studies published in peer-reviewed journals.

The search findings revealed the association of belief in astrology with cognitive, personality, and psychological factors such as thinking style, self-concept verification, and stress. Case studies on “fortune-telling addiction” have conceptualized it as a possible behavioral addiction and have reported symptoms such as distress, cravings, and salience.

The second study examined the relationship between Western zodiac signs and subjective well-being in a nationally representative American sample from the General Social Survey (N = 12,791). Well-being was measured across eight components:

  • general unhappiness,
  • depressive symptoms,
  • psychological distress,
  • work dissatisfaction,
  • financial dissatisfaction,
  • perceived dullness of one’s life,
  • self-rated health,
  • unhappiness with marriage.

Parametric and nonparametric analyses consistently revealed no robust associations between zodiac signs and any of the well-being variables, regardless of whether demographic factors were controlled for. The effect sizes were negligible, accounting for 0.3% or less of the variance in well-being, demonstrating that zodiac signs lack predictive power for well-being outcomes. An additional analysis revealed that astrological signs were no more predictive of than random numbers. Thus, a randomly generated number between 1 and 12 is statistically as predictive of one’s well-being as one’s zodiac sign.

The authors concluded that these findings challenge popular astrological claims about the influence of zodiac signs on well-being and quality of life.

The third paper reports a retrospective, single-center cohort study of 2545 adult patients with confirmed COVID-19 infection presenting to the emergency room over a 14-month period (September 2020 to November 2021). COVID-19 infectivity was determined based on polymerase chain reaction (PCR) testing. Western and Chinese Zodiac signs were designated using date of birth. Both Zodiac signs were evaluated for risk of infection and death.

Mortality rates across the zodiac and astrology signs showed no statistical difference using the 12-sample test for equality of proportions. Coincidentally, the mean age for the deceased was 74.5 years, and it was 53.9 years for those alive, resulting in a difference of 20.6 years. A two-sample t-test confirms that the observed difference of 20.6 years of age between the two groups is statistically significant with a p-value <0.05. The coefficient of the predictor age is statistically significant. The odds ratio estimate of age is 1.06, with the corresponding 95% confidence interval (CI) being (1.048, 1.073). This means that the odds of dying increase by 6% for every additional year.

The authors concluded that there was no statistical significance between Western and Chinese Zodiac signs and mortality or infections. 

So, does astrology have any value in healthcare?

The answer is as simple as it is unsurprising:

No!

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