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

Monthly Archives: June 2023

Psoriasis is a chronic inflammatory skin disorder, affecting the trunk and extensor surfaces of limbs and scalp predominantly. Its prevalence ranges between 0.1 and 11.4% and in India between 0.4 and 2.8%.  Psoriasis remains a frequently encountered condition in homeopathy practice, but there is a dearth of evidence supporting its use.

This 6-month, double-blind, randomized trial was conducted on 51 patients suffering from psoriasis at the National Institute of Homoeopathy, India. Patients were randomized to receive either individualized homeopathic medicines (IHMs; n = 25) in LM potencies or identical-looking placebos (n=26). Psoriasis area and severity index (PASI; primary), psoriasis disability index (PDI), and dermatological life quality index (DLQI; secondary) were measured at baseline, and every 2 months, up to 6 months. The intention-to-treat sample was analyzed using a two-way repeated measure analysis of variance.

Although intra-group changes were significant in both groups, improvements were significantly greater in the IHMs group than in the placebo group regarding the PASI scores after 6 months (F1, 49 = 10.448, P = 0.002). DLQI daily activity subscale scores also yielded similar significant results favoring IHMs against placebos after 6 months (F1, 49 = 5.480, P = 0.023). Improvement in PDI total (F1, 49 = 0.063, P = 0.803), DLQI total (F1, 49 = 1.371, P = 0.247), and all remaining subscales were higher in the IHMs group than placebos after 6 months, but non-significant statistically. Calcarea carbonica, Mercurius solubilis, Arsenicum album, and Petroleum were the most frequently prescribed medicines.

The authors concluded that IHMs exhibited better results than placebos in the treatment of psoriasis. Further research is warranted.

I am unable to access the full text of this paper [in case someone can, please send it to me for further scrutiny]. Judging from just the abstract, I see the following problems with this trial:

  • Psoriasis is a genetically determined condition, and I find it hard to believe that homeopathy can change its natural history.
  • The symptoms of psoriasis fluctuate and can be influenced by a range of factors, including stress.
  • We learn nothing about any concomitant interventions which are always necessary, e.g. creams, or compliance with them.
  • It is conceivable that patients in the verum group received inadvertent reassurance which, in turn, reduced stress and improved compliance with external treatments.
  • It is unclear whether patients were successfully blinded or whether inadvertent de-blinding occurred.

In any case, I would caution that this trial needs independent replications before we can take its findings seriously.

__________________________

Thanks to several readers, I now have the full text and can add the following points:

  • The authors report adverse events as follows: ” No adverse events were reported during the treatment period from either group that could be attributed causally to either IHMs or placebos. Some minor events unrelated to study medications, like common cold and injury occurring in both groups were treated with acute homeopathic medicines irrespective of allocated codes, and once those acute phases were over, the patients were returned to originally allocated groups again.” This is odd because homeopaths would expect aggravations in a high percentage of cases.
  • I am not sure that I understand the blinding procedure; it is described as follows: “Double-blinding method was adopted by masking the trial participants, investigators, outcome assessors, pharmacists, and data entry operators throughout the trial. Identical-looking vials were coded as either “1” or “2” and contained either medicines or placebos. The codes remained the same for all the randomized participants. Codes were assigned randomly and confidentially by another independent third party. Both medicines and placebos were repacked in identical glass bottles and labeled with code, name of medicine, and potency, and were dispensed according to the random number list. The vials were destined for each patient by the random number chart. The participants got the medicines dispensed personally at the hospital pharmacy. Codes were broken at the end of the trial after the dataset was frozen.”
  • The affiliations of the authors are interesting:1 Dept. of Materia Medica, National Institute of Homoeopathy, Ministry of AYUSH, Govt. of India, Block GE, Sector 3, Salt Lake, Kolkata 700106, West Bengal, India; affiliated to The West Bengal University of Health Sciences, Govt. of West Bengal, India
    2 Dept. of Repertory, National Institute of Homoeopathy, Ministry of AYUSH, Govt. of India, Block GE,
    Sector 3, Salt Lake, Kolkata 700106, West Bengal, India; affiliated to The West Bengal University of
    Health Sciences, Govt. of West Bengal, India 3 Dept. of Repertory, The Calcutta Homoeopathic Medical College and Hospital, Govt. of West Bengal, 265, 266, Acharya Prafulla Chandra Road, Kolkata 700009, West Bengal; affiliated to The West Bengal University of Health Sciences, Govt. of West Bengal, India
    4 East Bishnupur State Homoeopathic Dispensary, Chandi Daulatabad Block Primary Health Centre,
    Village and Post Office: Dakshin Gouripur, Police Station Bishnupur, South 24 Parganas 743503, West
    Bengal, under Department of Health & Family Welfare, Govt. of West Bengal, India 5 Dept. of Repertory, D. N. De Homoeopathic Medical College and Hospital, Govt. of West Bengal, 12, Gobinda Khatick Road, Tangra, Kolkata 700046, West Bengal; affiliated to The West Bengal University
    of Health Sciences, Govt. of West Bengal, India.

I think it is safe to repeat that independent replications would be essential.

This systematic review was aimed at determining if there has been a change in the reporting of adverse events associated with spinal manipulation in randomized clinical trials (RCTs) since 2016.

Databases were searched from March 2016 to May 2022: MEDLINE (Ovid), Embase, CINAHL, ICL, PEDro, and Cochrane Library. The following search terms and their derivatives were adapted for each platform: spinal manipulation; chiropractic; osteopathy; physiotherapy; naprapathy; medical manipulation and clinical trial.

Domains of interest (pertaining to adverse events) included: completeness and location of reporting; nomenclature and description; spinal location and practitioner delivering manipulation; methodological quality of the studies and details of the publishing journal. Frequencies and proportions of studies reporting on each of these domains were calculated. Univariable and multivariable logistic regression models were fitted to examine the effect of potential predictors on the likelihood of studies reporting on adverse events.

There were 5399 records identified by the electronic searches, of which 154 (2.9%) were included in the analysis. Of these, 94 (61.0%) reported adverse events with only 23.4% providing an explicit description of what constituted an adverse event. Reporting of adverse events in the abstract had increased (n=29, 30.9%) while reporting in the results section had decreased (n=83, 88.3%) over the past 6 years. Spinal manipulation was delivered to 7518 participants in the included studies. No serious adverse events were reported in any of these studies.

The authors concluded that, while the current level of reporting of adverse events associated with spinal manipulation in RCTs has increased since our 2016 publication on the same topic, the level remains low and inconsistent with established standards. As such, it is imperative for authors, journal editors and administrators of clinical trial registries to ensure there is more balanced reporting of both benefits and harms in RCTs involving spinal manipulation.

In fact, it is an ethical imperative to accurately report adverse effects. Not reporting adverse effects amounts to a violation of medical research ethics. Adverse effects of spinal manipulation occur in about 50% of all patients. This means that investigators reporting significantly lower figures are likely guilty of under-reporting. And under-reporting of adverse events is also a breach of ethical standards.

My conclusion thus is that the vast majority of trials of spinal manipulation are unethical and should be discarded.

This study investigated the potential benefits of auricular point acupressure on cerebrovascular function and stroke prevention among adults with a high risk of stroke.

A randomized controlled study was performed with 105 adults at high risk for stroke between March and July 2021. Participants were randomly allocated to receive either

  • auricular point acupressure with basic lifestyle interventions (n = 53) or
  • basic lifestyle interventions alone (n = 52) for 2 weeks.

The primary outcome was the kinematic and dynamic indices of cerebrovascular function, as well as the CVHP score at week 2, measured by the Doppler ultrasonography and pressure transducer on carotids.

Of the 105 patients, 86 finished the study. At week 2, the auricular point acupressure therapy with lifestyle intervention group had higher kinematic indices, cerebrovascular hemodynamic parameters score, and lower dynamic indices than the lifestyle intervention group.

The authors concluded that ccerebrovascular function and cerebrovascular hemodynamic parameters score were greater improved among the participants undergoing auricular point acupressure combined with lifestyle interventions than lifestyle interventions alone. Hence, the auricular point acupressure can assist the stroke prevention.

Acupuncture is a doubtful therapy.

Acupressure is even more questionable.

Ear acupressure is outright implausible.

The authors discuss that the physiological mechanism underlying the effect of APA therapy on cerebrovascular hemodynamic function is not fully understood at present. There may be two possible explanations.

  • First, a previous study has demonstrated that auricular acupuncture can directly increase mean blood flow velocity in the middle cerebral artery.
  • Second, cerebrovascular hemodynamic function is indirectly influenced by the effect of APA therapy on blood pressure.

I think there is a much simpler explanation: the observed effects are directly or indirectly due to placebo. As regular listeners of this blog know only too well by now, the A+B versus B study design cannot account for placebo effects. Sadly, the authors of this study hardly discuss this explanation – that’s why they had to publish their findings in just about the worst SCAM journal of them all: EBCAM.

Previous research revealed that cognitive abilities are negatively related to right-wing and prejudiced attitudes. No study has, however, investigated if emotional abilities also show such a relationship, although this can be expected based on both classic and recent literature. The aim of the present study was 2-fold:

(a) to investigate the relationship between emotional abilities and right-wing and prejudiced attitudes, and

(b) to pit the effects of emotional and cognitive abilities on these attitudes against each other.

Results from 2 adult samples (n = 409 and 574) in which abilities scores were collected in individual testing sessions, revealed that emotional abilities are significantly and negatively related to social-cultural and economic-hierarchical right-wing attitudes, as well as to blatant ethnic prejudice. These relationships were as strong as those found for cognitive abilities. For economic-hierarchical right-wing attitudes, emotional abilities were even the only significant correlate.

The authors concluded that the study of emotional abilities has the potential to significantly advance our understanding of right-wing and prejudiced attitudes.

__________

The researchers found that individuals with weaker emotional abilities — particularly emotional understanding and management — tended to score higher on a measure of right-wing authoritarianism and social dominance orientation. Right-wing authoritarianism is a personality trait that describes the tendency to submit to political authority and be hostile towards other groups, while social dominance orientation is a measure of a person’s preference for inequality among social groups.

The results of this study were univocal. People who endorse authority and strong leaders and who do not mind inequality — the two basic dimensions underlying right-wing political ideology — show lower levels of emotional abilities,” said Van Hiel, the lead author of the study. “Those with lower emotional and cognitive abilities were also more likely to agree with blatantly prejudiced statements such as “The White race is superior to all other races.”

Of course, the study only collected correlational data, preventing inferences of causality from being made. “Caution should be exercised in the interpretation of such results,” Van Hiel said. “One cannot discredit any ideology on the basis of such results as those presently obtained. Only in a distant future, we will be able to look back upon our times, and then we can maybe judge which ideologies were the best. Cognitively and emotionally smart people can make wrong decisions as well. The results have been obtained in one particular context. Would similar results be obtained in other contexts besides in a Western country with a long-standing stable democracy? Whether these tendencies are universal, or limited to particular contexts, is very intriguing.”

In the comments section, someone recently alerted us to a most remarkable article. I had a look at it and thought it would be a pity to let it pass without further comment. Here is the abstract:

There are many types of energy around us, including natural and artificial ones, the first of the ground energies due to the imbalance happened from the treatment of man with the ground (mines-the bases of huge buildings); the result of the Earth rotation, the result of geological faults, the flow of groundwater or energies resulting from other factors that result in radiations that harm organisms in general. Also we are continuously increasing the amount of carrier waves needed for the wireless technology of modern communication in the earth’s atmosphere every day. These electromagnetic waves are thousands of times stronger than the level used in the communication in our body cells. The problem is not the saturation of the earth’s atmosphere through quantity, but also a detrimental quality. Even people who avoid using high technology are not immune. No one is immune because these are carrier waves with penetrating properties. our immune systems are continuously trying to correct the distortion in the transfer of inner information in our body; very soon the threshold will be reached when a total collapse of our body defenses will take place. Balancing the activities of daily life, achieving harmony with our inner and outer environments, humanizing modern technology, integrating science and spirits, and discovering the unified scientific reality behind all religions is the work of some science such as Bio Geometry, Bio Design, Radiesthesia, …ext.

When one runs a blog on so-called alternative medicine (SCAM), it is almost inevitable to run into plenty of bullshit. Thus, over the years, I have gotten used to even the most compact versions of it. Yet, this paper – I do recommend you have a glance also at the full text – is truly outstanding.

In case there is someone amongst my readers who understands what the author wants to express, I would be most obliged to learn.

Numerous qualitative studies and a few quantitative studies have linked vaccine hesitancy or refusal with the belief in the efficacy of so-called alternative medicine (SCAM). Yet, large-scale data on this topic are scarce. In this study, the French researchers investigated the factors associated with the coverage rates of seven childhood vaccines or vaccine groups in the ninety-six metropolitan French departments. One of the factors investigated was the local interest in SCAM. In order to assess this interest, they built an Alternative Medicine Index based on departmental internet searches regarding SCAM—internet searches being a reliable indicator of the public’s actual interest in a given topic. They then conducted multiple regression analyses, which showed that this Index is a significant explanatory factor for the departmental variance in vaccination coverage rates, exceeding in importance the effect of other relevant local sociodemographic factors.

A further recent study from France adds to the picture. It presents the results of a survey conducted in July 2021 among a representative sample of the French mainland adult population (n = 3087). Using cluster analysis, the researchers identified five profiles of SCAM attitudes and found that even among the most pro-SCAM group, very few respondents disagreed with the idea that SCAM should only be used as a complement to conventional medicine. They then compared these SCAM attitudes to vaccine attitudes. Attitudes to SCAM had a distinct impact as well as a combined effect on attitudes to different vaccines and vaccines in general. They found that:

  • attitudes to SCAM provide a very limited explanation of vaccine hesitancy;
  • among the hesitant, pro-SCAM attitudes are often combined with other traits associated with vaccine hesitancy such as distrust of health agencies, radical political preferences, and low income.

Both SCAM endorsement and vaccine hesitancy are more prevalent among the socially disadvantaged. Drawing on these results, the researchers argue that, to better understand the relationship between SCAM and vaccine hesitancy, it is necessary to look at how both can reflect a lack of access and recourse to mainstream medicine and distrust of public institutions.

The fact that the enthusiasm for SCAM is associated with vaccine hesitancy has been discussed on this blog many times before, e.g.:

What seems fairly clear to me is that a cross-correlation exists: an attitude against modern medicine and the ‘scientific establishment’ determines both the enthusiasm for SCAM and the aversion to vaccination. What is, however, far from clear to me is what we could do about it.

Yes, better education seems important – and that’s precisely what I aim at achieving with this blog. Sadly, judging from some of the comments we receive, it does not seem crowned with much success.

Any other ideas?

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