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

bias

There are many patients in general practice with health complaints that cannot be medically explained. Some of these patients attribute their problems to dental amalgam.

This study examined the cost-effectiveness of the removal of amalgam fillings in patients with medically unexplained physical symptoms (MUPS) attributed to amalgam compared to usual care, based on a prospective cohort study in Norway.

Costs were determined using a micro-costing approach at the individual level. Health outcomes were documented at baseline and approximately two years later for both the intervention and the usual care using EQ-5D-5L. Quality-adjusted life year (QALY) was used as the main outcome measure. A decision analytical model was developed to estimate the incremental cost-effectiveness of the intervention. Both probabilistic and one-way sensitivity analyses were conducted to assess the impact of uncertainty on costs and effectiveness.

In patients who attributed health complaints to dental amalgam and fulfilled the inclusion and exclusion criteria, amalgam removal was associated with a modest increase in costs at the societal level as well as improved health outcomes. In the base-case analysis, the mean incremental cost per patient in the amalgam group was NOK 19 416 compared to the MUPS group, while the mean incremental QALY was 0.119 with a time horizon of two years. Thus, the incremental costs per QALY of the intervention were NOK 162 680, which is usually considered to be cost-effective in Norway. The estimated incremental cost per QALY decreased with increasing time horizons, and amalgam removal was found to be cost-saving over both 5 and 10 years.

The authors concluded that this study provides insight into the costs and health outcomes associated with the removal of amalgam restorations in patients who attribute health complaints to dental amalgam fillings, which are appropriate instruments to inform health care priorities.

The group sizes were 32 and 28 respectively. This study was thus almost laughably small and therefore cannot lead to firm conclusions of any type. In this contest, a recent systematic review might be relevant; it concluded as follows:

On the basis of the available RCTs, amalgam restorations, if compared with resin-based fillings, do not show an increased risk for systemic diseases. There is still insufficient evidence to exclude or demonstrate any direct influence on general health. The removal of old amalgam restorations and their substitution with more modern adhesive restorations should be performed only when clinically necessary and not just for material concerns. In order to better evaluate the safety of dental amalgam compared to other more modern restorative materials, further RCTs that consider important parameters such as long and uniform follow up periods, number of restorations per patient, and sample populations representative of chronic or degenerative diseases are needed.

Similarly, a review of the evidence might be informative:

Since more than 100 years amalgam is successfully used for the functional restoration of decayed teeth. During the early 1990s the use of amalgam has been discredited by a not very objective discussion about small amounts of quicksilver that can evaporate from the material. Recent studies and reviews, however, found little to no correlation between systemic or local diseases and amalgam restorations in man. Allergic reactions are extremely rare. Most quicksilver evaporates during placement and removal of amalgam restorations. Hence it is not recommended to make extensive rehabilitations with amalgam in pregnant or nursing women. To date, there is no dental material, which can fully substitute amalgam as a restorative material. According to present scientific evidence the use of amalgam is not a health hazard.

Furthermore, there is evidence that the removal of amalgam fillings is not such a good idea. One study, for instance, showed that the mercury released by the physical action of the drill, the replacement material and especially the final destination of the amalgam waste can increase contamination levels that can be a risk for human and environment health.

As dental amalgam removal does not seem risk-free, it is perhaps unwise to remove these fillings at all. Patients who are convinced that their amalgam fillings make them ill might simply benefit from assurance. After all, we also do not re-lay electric cables because some people feel they are the cause of their ill-health.

Today is WORLD ASTHMA DAY, a good opportunity perhaps to revisit a few of our own evaluations of so-called alternative medicine (SCAM) for asthma. Here are the abstracts of some of our systematic reviews on the subject:

YOGA

Objective: The objective of this systematic review was to assess the effectiveness of yoga as a treatment option for asthma.

Method: Seven databases were searched from their inception to October 2010. Randomized clinical trials (RCTs) and non-randomized clinical trials (NRCTs) were considered, if they investigated any type of yoga in patients with asthma. The selection of studies, data extraction, and validation were performed independently by two reviewers.

Results: Six RCTs and one NRCT met the inclusion criteria. Their methodological quality was mostly poor. Three RCTs and one NRCT suggested that yoga leads to a significantly greater reduction in spirometric measures, airway hyperresponsivity, dose of histamine needed to provoke a 20% reduction in forced expiratory volume in the first second, weekly number of asthma attacks, and need for drug treatment. Three RCTs showed no positive effects compared to various control interventions.

Conclusions: The belief that yoga alleviates asthma is not supported by sound evidence. Further, more rigorous trials are warranted.

SPINAL MANIPULATION

Some clinicians believe that spinal manipulation is an effective treatment for asthma. The aim of this systematic review was to critically evaluate the evidence for or against this claim. Four electronic databases were searched without language restrictions from their inceptions to September 2008. Bibliographies and departmental files were hand-searched. The methodological quality of all included studies was assessed with the Jadad score. Only randomised clinical trials of spinal manipulation as a treatment of asthma were included. Three studies met these criteria. All of them were of excellent methodological quality (Jadad score 5) and all used sham-manipulation as the control intervention. None of the studies showed that real manipulation was more effective than sham-manipulation in improving lung function or subjective symptoms. It is concluded that, according to the evidence of the most rigorous studies available to date, spinal manipulation is not an effective treatment for asthma.

ACUPUNCTURE

Contradictory results from randomised controlled trials of acupuncture in asthma suggest both a beneficial and detrimental effect. The authors conducted a formal systematic review and meta-analysis of all randomised clinical trials in the published literature that have compared acupuncture at real and placebo points in asthma patients. The authors searched for trials published in the period 1970-2000. Trials had to measure at least one of the following objective outcomes: peak expiratory flow rate, forced expiratory volume in one second (FEV1) and forced vital capacity. Estimates of the standarised mean difference, between acupuncture and placebo were computed for each trial and combined to estimate the overall effect. Hetereogeneity was investigated in terms of the characteristics of the individual studies. Twelve trials met the inclusion criteria but data from one could not be obtained. Individual patient data were available in only three. Standardised differences between means ranging from 0.071 to 0.133, in favour of acupuncture, were obtained. The overall effect was not conventionally significant and it corresponds to an approximate difference in FEV1 means of 1.7. After exploring hetereogenenity, it was found that studies where bronchoconstriction was induced during the experiment showed a conventionally significant effect. This meta-analysis did not find evidence of an effect of acupuncture in reducing asthma. However, the meta-analysis was limited by shortcomings of the individual trials, in terms of sample size, missing information, adjustment of baseline characteristics and a possible bias against acupuncture introduced by the use of placebo points that may not be completely inactive. There was a suggestion of preferential publication of trials in favour of acupuncture. There is an obvious need to conduct a full-scale randomised clinical trial addressing these limitations and the prognostic value of the aetiology of the disease.

RELAXATION THERAPIES

Background: Emotional stress can either precipitate or exacerbate both acute and chronic asthma. There is a large body of literature available on the use of relaxation techniques for the treatment of asthma symptoms. The aim of this systematic review was to determine if there is any evidence for or against the clinical efficacy of such interventions.

Methods: Four independent literature searches were performed on Medline, Cochrane Library, CISCOM, and Embase. Only randomised clinical trials (RCTs) were included. There were no restrictions on the language of publication. The data from trials that statistically compared the treatment group with that of the control were extracted in a standardised predefined manner and assessed critically by two independent reviewers.

Results: Fifteen trials were identified, of which nine compared the treatment group with the control group appropriately. Five RCTs tested progressive muscle relaxation or mental and muscular relaxation, two of which showed significant effects of therapy. One RCT investigating hypnotherapy, one of autogenic training, and two of biofeedback techniques revealed no therapeutic effects. Overall, the methodological quality of the studies was poor.

Conclusions: There is a lack of evidence for the efficacy of relaxation therapies in the management of asthma. This deficiency is due to the poor methodology of the studies as well as the inherent problems of conducting such trials. There is some evidence that muscular relaxation improves lung function of patients with asthma but no evidence for any other relaxation technique.

HERBAL MEDICINE

Background: Asthma is one of the most common chronic diseases in modern society and there is increasing evidence to suggest that its incidence and severity are increasing. There is a high prevalence of usage of complementary medicine for asthma. Herbal preparations have been cited as the third most popular complementary treatment modality by British asthma sufferers. This study was undertaken to determine if there is any evidence for the clinical efficacy of herbal preparations for the treatment of asthma symptoms.

Methods: Four independent literature searches were performed on Medline, Pubmed, Cochrane Library, and Embase. Only randomised clinical trials were included. There were no restrictions on the language of publication. The data were extracted in a standardised, predefined manner and assessed critically.

Results: Seventeen randomised clinical trials were found, six of which concerned the use of traditional Chinese herbal medicine and eight described traditional Indian medicine, of which five investigated Tylophora indica. Three other randomised trials tested a Japanese Kampo medicine, marihuana, and dried ivy leaf extract. Nine of the 17 trials reported a clinically relevant improvement in lung function and/or symptom scores.

Conclusions: No definitive evidence for any of the herbal preparations emerged. Considering the popularity of herbal medicine with asthma patients, there is urgent need for stringently designed clinically relevant randomised clinical trials for herbal preparations in the treatment of asthma.

BREATHING TECHNIQUES

Breathing techniques are used by a large proportion of asthma sufferers. This systematic review was aimed at determining whether or not these interventions are effective. Four independent literature searches identified six randomized controlled trials. The results of these studies are not uniform. Collectively the data imply that physiotherapeutic breathing techniques may have some potential in benefiting patients with asthma. The safety issue has so far not been addressed satisfactorily. It is concluded that too few studies have been carried out to warrant firm judgements. Further rigorous trials should be carried out in order to redress this situation.

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So, if you suffer from asthma, my advice is to stay away from SCAM. This might be easier said than done because SCAM practitioners are only too willing to lure asthma patients into their cult. In 2003, we have demonstrated this phenomenon by conducting a survey with chiropractors. Here is our short paper in full:

Classic chiropractic theory claims that vertebral subluxation blocks the flow of ‘‘innate intelligence’’ which, in turn, affects the health of asthma patients (1). Chiropractictors often use spinal manipulation (SM) to correct such malalignments and treat asthma (2). Several clinical trials of chiropractic SM exist, but the most rigorous ones are clearly negative (3,4). Chronic medication with corticosteroids can lead to osteoporosis, a condition, which is a contra-indication to chiropractic SM (5). Given this background, we aimed to determine whether chiropractors would advise an asthma patient on long-term corticosteroids (5 years) to try chiropractic as a treatment for this condition.

All 350 e-mail addresses listed at www.interadcom.com/chiro/html were randomised into two groups. A (deceptive) letter from a (fictitious) patient was sent to group A while group B was asked for advice on chiropractic treatment for asthma as part of a research project. Thus, groups A and B were asked the same question in di¡erent contexts: is chiropractic safe and e¡ective for an asthma patient on long-term steroids. After data collection, respondents from group A were informed that the e-mail had been part of a research project.

Of 97 e-mails in group A, we received 31 responses (response rate = 32% (95% CI, 0.23^ 0.41)). Seventy-four per cent (23 respondents) recommended visiting a chiropractor (95% CI, 0.59^ 0.89). Thirty-five per cent (11 respondents) mentioned minimal or no adverse effects of SM (95% CI, 0.18 ^ 0.52). Three chiropractors responded that some adverse e¡ects exist, e.g. risk of bone fracture, or stroke. Two respondents noted that other investigations (X-rays, spinal and neurological examination) were required before chiropractic treatment. Three respondents suggested additional treatments and one warned about a possible connection between asthma and the measles vaccine. Of 77 e-mails sent to group B, we received 16 responses (response rate = 21% (95% CI, 0.17^ 0.25)). Eleven respondents (69%) recommended visiting a chiropractor (95% CI, 0.46 ^ 0.91). Ten respondents mentioned minimal or no adverse effects of SM (95% CI, 0.39^ 0.87). Five chiropractors responded that adverse effects of SM exist (e.g. bone fracture). Five respondents suggested pre-testing the patient to check bone density, allergy, diet, exercise level, hydration and blood. Additional treatments were recommended by three respondents. The pooled results of groups A and B suggested that the majority of chiropractors recommend chiropractic treatment for asthma and the minority mention any adverse effects.

Our results demonstrate that chiropractic advice on asthma therapy is as readily available over the Internet as it is likely to be misleading. The majority of respondents from both groups (72%) recommended chiropractic treatment. This usually entails SM, a treatment modality which has been demonstrated to be ineffective in rigorous clinical trials (3,4,6). The advice may also be dangerous: the minority of the respondents of both groups (17%) caution of the risk of bone fracture. Our findings also suggest that, for the research question asked, a degree of deception is necessary. The response rate in group B was 12% lower than that of group A, and the answers received differed considerably between groups. In group A, 10% acknowledged the possibility of adverse e¡ects, this figure was 33% in group B. In conclusion, chiropractors readily provide advice regarding asthma treatment, which is often not evidence-based and has the potential to put patients at risk.

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As I stated above: if you suffer from asthma, my advice is to

stay away from SCAM.

There is a lack of data describing the state of naturopathic or complementary veterinary medicine in Germany. This survey maps the currently used treatment modalities, indications, existing qualifications, and information pathways. It records the advantages and disadvantages of these medicines as experienced by veterinarians. Demographic influences are investigated to describe the distributional impacts of using veterinary naturopathy and complementary medicine.

A standardized questionnaire was used for the cross-sectional survey. It was distributed throughout Germany in a written and digital format from September 2016 to January 2018. Because of the open nature of data collection, the return rate of questionnaires could not be calculated. To establish a feasible timeframe, active data collection stopped when the previously calculated limit of 1061 questionnaires was reached.

With the included incoming questionnaires of that day, a total of 1087 questionnaires were collected. Completely blank questionnaires and those where participants did not meet the inclusion criteria were not included, leaving 870 out of 1087 questionnaires to be evaluated. A literature review and the first test run of the questionnaire identified the following treatment modalities:

  • homeopathy,
  • phytotherapy,
  • traditional Chinese medicine (TCM),
  • biophysical treatments,
  • manual treatments,
  • Bach Flower Remedies,
  • neural therapy,
  • homotoxicology,
  • organotherapy,
  • hirudotherapy.

These were included in the questionnaire. Categorical items were processed using descriptive statistics in absolute and relative numbers based on the population of completed answers provided for each item. Multiple choices were possible.

Overall 85.4% of all the questionnaire participants used naturopathy and complementary medicine. The treatments most commonly used were:

  • complex homoeopathy (70.4%, n = 478),
  • phytotherapy (60.2%, n = 409),
  • classic homoeopathy (44.3%, n = 301),
  • biophysical treatments (40.1%, n = 272).

The most common indications were:

  • orthopedic (n = 1798),
  • geriatric (n = 1428),
  • metabolic diseases (n = 1124).

Over the last five years, owner demand for naturopathy and complementary treatments was rated as growing by 57.9% of respondents (n = 457 of total 789). Veterinarians most commonly used scientific journals and publications as sources for information about naturopathic and complementary contents (60.8%, n = 479 of total 788). These were followed by advanced training acknowledged by the ATF (Academy for Veterinary Continuing Education, an organisation that certifies independent veterinary continuing education in Germany) (48.6%, n = 383). The current information about naturopathy and complementary medicine was rated as adequate or nearly adequate by many (39.5%, n = 308) of the respondents.

The most commonly named advantages in using veterinary naturopathy and complementary medicine were:

  • expansion of treatment modalities (73.5%, n = 566 of total 770),
  • customer satisfaction (70.8%, n = 545),
  • lower side effects (63.2%, n = 487).

The ambiguity and unclear evidence of the mode of action and effectiveness (62.1%, n = 483) and high expectations of owners (50.5%, n = 393) were the disadvantages mentioned most frequently. Classic homoeopathy, in particular, has been named in this context (78.4%, n = 333 of total 425). Age, gender, and type of employment showed a statistically significant impact on the use of naturopathy and complementary medicine by veterinarians (p < 0.001). The university of final graduation showed a weaker but still statistically significant impact (p = 0.027). Users of veterinary naturopathy and complementary medicine tended to be older, female, self-employed and a higher percentage of them completed their studies at the University of Berlin. The working environment (rural or urban space) showed no statistical impact on the veterinary naturopathy or complementary medicine profession.

The authors concluded that this is the first study to provide German data on the actual use of naturopathy and complementary medicine in small animal science. Despite a potential bias due to voluntary participation, it shows a large number of applications for various indications. Homoeopathy was mentioned most frequently as the treatment option with the most potential disadvantages. However, it is also the most frequently used treatment option in this study. The presented study, despite its restrictions, supports the need for a discussion about evidence, official regulations, and the need for acknowledged qualifications because of the widespread application of veterinary naturopathy and complementary medicine. More data regarding the effectiveness and the mode of action is needed to enable veterinarians to provide evidence-based advice to pet owners.

I can only hope that the findings are seriously biased and not a true reflection of the real situation. The methodology used for recruiting participants (it is fair to assume that those vets who had no interest in SCAM did not bother to respond) strongly indicates that this might be the case. If, however, the findings were true, one would have to conclude that, for German vets, evidence-based healthcare is still an alien concept. The evidence that the preferred SCAMs are effective for the listed conditions is very weak or even negative. If the findings were true, one would need to wonder how much of veterinary SCAM use amounts to animal abuse.

WARNING: SATIRE

This is going to be a very short post. Yet, I am sure you agree that my ‘golden rules’ encapsulate the collective wisdom of so-called alternative medicine (SCAM):

  1. Conventional treatments are dangerous
  2. Conventional doctors are ignorant
  3. Natural remedies are by definition good
  4. Ancient wisdom knows best
  5. SCAM tackles the roots of all health problems
  6. Experience trumps evidence
  7. People vote with their feet (SCAM’s popularity and patients’ satisfaction prove SCAM’s effectiveness)
  8. Science is barking up the wrong tree (what we need is a paradigm shift)
  9. Even Nobel laureates and other VIPs support SCAM
  10. Only SCAM practitioners care about the whole individual (mind, body, and soul)
  11. Science is not yet sufficiently advanced to understand how SCAM works (the mode of action has not been discovered)
  12. SCAM even works for animals (and thus cannot be a placebo)
  13. There is reliable evidence to support SCAM
  14. If a study of SCAM happens to yield a negative result, it is false-negative (e.g. because SCAM was not correctly applied)
  15. SCAM is patient-centered
  16. Conventional medicine is money-orientated
  17. The establishment is forced to suppress SCAM because otherwise, they would go out of business
  18. SCAM is reliable, constant, and unwavering (whereas conventional medicine changes its views all the time)
  19. SCAM does not need a monitoring system for adverse effects because it is inherently safe
  20. SCAM treatments are individualized (they treat the patient and not just a diagnostic label like conventional medicine)
  21. SCAM could save us all a lot of money
  22. There is no health problem that SCAM cannot cure
  23. Practitioners of conventional medicine have misunderstood the deeper reasons why people fall ill and should learn from SCAM

QED

I am sure that I have forgotten several important rules. If you can think of any, please post them in the comments section.

The objective of this study was to compare chronic low back pain patients’ perspectives on the use of spinal manipulative therapy (SMT) compared to prescription drug therapy (PDT) with regard to health-related quality of life (HRQoL), patient beliefs, and satisfaction with treatment.

Four cohorts of Medicare beneficiaries were assembled according to previous treatment received as evidenced in claims data:

  1. The SMT group began long-term management with SMT but no prescribed drugs.
  2. The PDT group began long-term management with prescription drug therapy but no spinal manipulation.
  3. This group employed SMT for chronic back pain, followed by initiation of long-term management with PDT in the same year.
  4. This group used PDT for chronic back pain followed by initiation of long-term management with SMT in the same year.

A total of 1986 surveys were sent out and 195 participants completed the survey. The respondents were predominantly female and white, with a mean age of approx. 77-78 years. Outcome measures used were a 0-to-10 numeric rating scale to measure satisfaction, the Low Back Pain Treatment Beliefs Questionnaire to measure patient beliefs, and the 12-item Short-Form Health Survey to measure HRQoL.

Recipients of SMT were more likely to be very satisfied with their care (84%) than recipients of PDT (50%; P = .002). The SMT cohort self-reported significantly higher HRQoL compared to the PDT cohort; mean differences in physical and mental health scores on the 12-item Short Form Health Survey were 12.85 and 9.92, respectively. The SMT cohort had a lower degree of concern regarding chiropractic care for their back pain compared to the PDT cohort’s reported concern about PDT (P = .03).

The authors concluded that among older Medicare beneficiaries with chronic low back pain, long-term recipients of SMT had higher self-reported rates of HRQoL and greater satisfaction with their modality of care than long-term recipients of PDT. Participants who had longer-term management of care were more likely to have positive attitudes and beliefs toward the mode of care they received.

The main issue here is that the ‘study’ was a mere survey which by definition cannot establish cause and effect. The groups were different in many respects which rendered them not comparable. For instance, participants who received SMT had higher self-reported physical and mental health on average than those who received PDT. Differences also existed between the SMT and the PDT groups for agreement with the notion that “spinal manipulation for LBP makes a lot of sense”; 96% of the SMT group and 35% of the PDT group agreed with it. Compare this with another statement, “taking /having prescription drug therapy for LBP makes a lot of sense” and we find that only 13% of the SMT cohort agreed with, 95% of the PDT cohort agreed. Thus, a powerful bias exists toward the type of therapy that each person had chosen. Another determinant of the outcome is the fact that SMT means hands-on treatments with time, compassion, and empathy given to the patient, whereas PDT does not necessarily include such features. Add to these limitations the dismal response rate, recall bias, and numerous potential confounders and you have a survey that is hardly worth the paper it is printed on. In fact, it is little more than a marketing exercise for chiropractic.

In summary, the findings of this survey are influenced by a whole range of known and unknown factors other than the SMT. The authors are clever to avoid causal inferences in their conclusions. I doubt, however, that many chiropractors reading the paper think critically enough to do the same.

This study describes the use of so-called alternative medicine (SCAM) among older adults who report being hampered in daily activities due to musculoskeletal pain. The characteristics of older adults with debilitating musculoskeletal pain who report SCAM use is also examined. For this purpose, the cross-sectional European Social Survey Round 7 from 21 countries was employed. It examined participants aged 55 years and older, who reported musculoskeletal pain that hampered daily activities in the past 12 months.

Of the 4950 older adult participants, the majority (63.5%) were from the West of Europe, reported secondary education or less (78.2%), and reported at least one other health-related problem (74.6%). In total, 1657 (33.5%) reported using at least one SCAM treatment in the previous year.

The most commonly used SCAMs were:

  • manual body-based therapies (MBBTs) including massage therapy (17.9%),
  • osteopathy (7.0%),
  • homeopathy (6.5%)
  • herbal treatments (5.3%).

SCAM use was positively associated with:

  • younger age,
  • physiotherapy use,
  • female gender,
  • higher levels of education,
  • being in employment,
  • living in West Europe,
  • multiple health problems.

(Many years ago, I have summarized the most consistent determinants of SCAM use with the acronym ‘FAME‘ [female, affluent, middle-aged, educated])

The authors concluded that a third of older Europeans with musculoskeletal pain report SCAM use in the previous 12 months. Certain subgroups with higher rates of SCAM use could be identified. Clinicians should comprehensively and routinely assess SCAM use among older adults with musculoskeletal pain.

I often mutter about the plethora of SCAM surveys that report nothing meaningful. This one is better than most. Yet, much of what it shows has been demonstrated before.

I think what this survey confirms foremost is the fact that the popularity of a particular SCAM and the evidence that it is effective are two factors that are largely unrelated. In my view, this means that more, much more, needs to be done to inform the public responsibly. This would entail making it much clearer:

  • which forms of SCAM are effective for which condition or symptom,
  • which are not effective,
  • which are dangerous,
  • and which treatment (SCAM or conventional) has the best risk/benefit balance.

Such information could help prevent unnecessary suffering (the use of ineffective SCAMs must inevitably lead to fewer symptoms being optimally treated) as well as reduce the evidently huge waste of money spent on useless SCAMs.

This randomized, double-blind, placebo-controlled trial investigated whether homeopathic Hypericum leads to a reduction in postoperative pain and a decrease in pain medication compared with placebo. Inpatients undergoing lumbar sequestrectomy surgery were given the homeopathic treatment Hypericum C200 or a placebo in addition to usual pain management. The primary endpoint was pain relief measured with a visual analog scale. Secondary endpoints were the reduction of inpatient postoperative analgesic medication and change in sensory and affective pain perception.

The baseline characteristics were comparable between the two groups. Pain perception between baseline and day 3 did not significantly differ between the study arms. With respect to pain medication, total morphine equivalent doses did not differ significantly. However, a statistical trend and a moderate effect (d = 0.432) in the decrease of pain medication consumption in favor of the Hypericum group was observed.

The authors concluded that this is the first trial of homeopathy that evaluated the efficacy of Hypericum C200 after lumbar monosegmental spinal sequestrectomy. Although no significant differences between the groups could be shown, we found that patients who took potentiated Hypericum in addition to usual pain management showed lower consumption of analgesics. Further investigations, especially with regard to pain medication, should follow to better classify the described analgesic reduction.

I applaud the authors from the Institute of Integrative Medicine, Witten/Herdecke University, Herdecke, Germany (not an institution known for its objectivity in SCAM) to have published this negative study in a journal that is so clearly pro-SCAM that it very rarely contains anything in its pages that is not positive about SCAM. Yet, I am baffled by two things:

  1. The plant Hypericum is used in SCAM as a painkiller. According to the ‘like cures like’ axiom of homeopathy, it should thus INCREASE the pain of post-op patients.
  2. The researchers used a C 200 potency. I ask myself, how can anyone assume that such a dilution has any effect at all? C200 means that the plant tincture is diluted at a ratio of 1: 00000000000000000000 00000000000000000000 00000000000000000000 00000000000000000000 00000000000000000000 00000000000000000000 00000000000000000000 00000000000000000000 00000000000000000000 00000000000000000000 00000000000000000000 00000000000000000000 00000000000000000000 00000000000000000000 00000000000000000000 00000000000000000000 00000000000000000000 00000000000000000000 00000000000000000000 00000000000000000000. Less than one molecule of the plant per several universes!

To believe that such a dilution might work, one really needs to be a convinced disciple of Hahnemann. Yet, to disregard the ‘like cures like’ axiom, one needs to be what he called ‘a traitor’ to his true art of healing.

An article in PULSE entitled ‘ Revolutionising Chiropractic Care for Today’s Healthcare System’ deserves a comment, I think. Here I give you first the article followed by my comments. The references in square brackets refer to the latter and were inserted by me; otherwise, the article is unchanged.

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This Chiropractic Awareness Week (4th – 10th April), Catherine Quinn, President of the British Chiropractic Association (BCA), is exploring the opportunity and need for a more integrated healthcare eco-system, putting the spotlight on how chiropractors can help alleviate pressures and support improved patient outcomes.

Chiropractic treatment and its role within today’s health system often prompts questions and some debate – what treatments fit under chiropractic care? Is the profession evidence based? How can it support primary health services, with the blend of public and private practice in mind? This Chiropractic Awareness Week, I want to address these questions and share the British Chiropractic Association’s ambition for the future of the profession.

The role of chiropractic today

The need for effective and efficient musculoskeletal (MSK) treatment is clear – in the UK, an estimated 17.8 million people live with a MSK condition, equivalent to approximately 28.9% of the total population.1 Lower back and neck pain specifically are the greatest causes of years lost to disability in the UK, with chronic joint pain or osteoarthritis affecting more than 8.75 million people.2 In addition to this, musculoskeletal conditions also account for 30% of all GP appointments, placing immense pressure on a system which is already under stress.3 The impact of the COVID-19 pandemic is still being felt by these patients and their healthcare professionals alike. Patients with MSK conditions are still having their care impacted by issues such as having clinic appointments cancelled, difficulty in accessing face-to-face care and some unable to continue regular prescribed exercise.

With these numbers and issues in mind, there is a lot of opportunity to more closely integrate chiropractic within health and community services to help alleviate pressures on primary care [1]. This is something we’re really passionate about at the BCA. However, we recognise that there are varying perceptions of chiropractic care – not just from the public but across our health peers too. We want to address this, so every health discipline has a consistent understanding.

First and foremost, chiropractic is a registered primary healthcare profession [2] and a safe form of treatment [3], qualified individuals in this profession are working as fully regulated healthcare professionals with at least four years of Masters level training. In the UK, chiropractors are regulated by law and required to adhere to strict codes of practice [4], in exactly the same ways as dentists and doctors [5]. At the BCA we want to represent the highest quality chiropractic care, which is encapsulated by a patient centred approach, driven by evidence and science [6].

As a patient-first organisation [7], our primary goal is to equip our members to provide the best treatment possible for those who need our care [8]. We truly believe that working collaboratively with other primary care and NHS services is the way to reach this goal [9].

The benefits of collaborative healthcare

As chiropractors, we see huge potential in working more closely with primary care providers and recognise there’s mutual benefits for both parties [10]. Healthcare professionals can tap into chiropractors’ expertise in MSK conditions, leaning on them for support with patient caseloads. Equally, chiropractors can use the experience of working with other healthcare experts to grow as professionals.

At the BCA, our aim is to grow this collaborative approach, working closely with the wider health community to offer patients the best level of care that we can [11]. Looking at primary healthcare services in the UK, we understand the pressures that individual professionals, workforces, and organisations face [12]. We see the large patient rosters and longer waiting times and truly believe that chiropractors can alleviate some of those stresses by treating those with MSK concerns [13].

One way the industry is beginning to work in a more integrated way is through First Contact Practitioners (FCPs) [14]. These are healthcare professionals like chiropractors who provide the first point of contact to GP patients with MSK conditions [15]. We’ve already seen a lot of evidence showing that primary care services using FCPs have been able to improve quality of care [16]. Through this service MSK patients are also seeing much shorter wait times for treatment (as little as 2-3 days), so the benefits speak for themselves for both the patient and GP [17].

By working as part of an integrated care model, with chiropractors, GPs, physiotherapists and other medical professionals, we’re creating a system that provides patients with direct routes to the treatments that they need, with greater choice. Our role within this system is very much to contribute to the health of our country, support primary care workers and reinforce the incredible work of the NHS [18].

Overcoming integrated healthcare challenges

To continue to see the chiropractic sector develop over the coming years, it’s important for us to face some of the challenges currently impacting progress towards a more integrated healthcare service.

One example is that there is a level of uncertainty about where chiropractic sits in the public/private blend. This is something we’re ready to tackle head on by showing exactly how chiropractic care benefits different individuals, whether that’s through reducing pain, improving physical function or increasing mobility [19]. We also need to encourage more awareness amongst both chiropractors and other healthcare providers about how an integrated workforce could benefit medical professionals and patients alike [20]. For example, there’s only two FCP chiropractors to date, and that’s something we’re looking to change [14].

This is the start of a much bigger conversation and, at the BCA, we’ll continue to work on driving peer acceptance, trust and inclusion to demonstrate the value of our place within the healthcare industry [21]. We’re ready to support the wider health community and primary carers, alleviating some of the pressures already facing the NHS; we’re placed in the perfect position as we have the knowledge and experience to provide essential support [22]. My main takeaway from this year’s Chiropractic Awareness Week would be to simply start a conversation with us about how [23].

 

About the British Chiropractic Association:

The BCA is the largest and longest-standing association for chiropractors in the UK. As well as promoting international standards of education and exemplary conduct, the BCA supports chiropractors to progress and develop to fulfil their professional ambitions with honour and integrity, at every step [24]. This Chiropractic Awareness Week, the BCA is raising awareness about the rigour, relevance and evidence driving the profession and the association’s ambition for chiropractic to be more closely embedded within mainstream healthcare [25].

 

  1. https://bjgp.org/content/70/suppl_1/bjgp20X711497
  2. https://www.versusarthritis.org/about-arthritis/data-and-statistics/the-state-of-musculoskeletal-health/
  3. https://www.england.nhs.uk/elective-care-transformation/best-practice-solutions/musculoskeletal/#:~:text=Musculoskeletal%20(MSK)%20conditions%20account%20for,million%20people%20in%20the%20UK

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And here are my comments:

  1. Non sequitur = a conclusion or statement that does not logically follow from the previous argument or statement.
  2. A primary healthcare profession is a profession providing primary healthcare which, according to standard definitions, is the provision of health services, including diagnosis and treatment of a health condition, and support in managing long-term healthcare, including chronic conditions like diabetes. Thus chiropractors are not in that category.
  3. This is just wishful thinking. Chiropractic spinal manipulation is not safe!
  4. “Required to adhere to strict codes of practice”. Required yes, but how often do they not comply?
  5. This is not true.
  6. Chiropractic is very far from being “driven by evidence and science”.
  7. Platitude = a remark or statement, especially one with a moral content, that has been used too often to be interesting or thoughtful.
  8. Judging from past experience, the primary goal seems to be to protect chiropractors (see, for instance, here).
  9. Belief is for religion, in healthcare you need evidence. Have you looked at the referral rates of chiropractors to GPs, for instance?
  10. For chiropractors, the benefit is usually measured in £s.
  11. To offer the ” best level of care” you need research and evidence, not politically correct statements.
  12. Platitude = a remark or statement, especially one with a moral content, that has been used too often to be interesting or thoughtful.
  13. Belief is for religion, in healthcare you need evidence.
  14. First Contact Practitioners are “regulated, advanced and autonomous health CARE PROFESSIONALS who are trained to provide expert PATIENT assessment, diagnosis and first-line treatment, self-care advice and, if required, appropriate onward referral to other SERVICES.” I doubt that many chiropractors fulfill these criteria.
  15. Not quite; see above.
  16. “A lot of evidence”? Really? Where is it?
  17.  “The benefits speak for themselves” only if the treatments used are evidence-based.
  18. Platitude = a remark or statement, especially one with a moral content, that has been used too often to be interesting or thoughtful.
  19. Where is the evidence?
  20. Awareness is not needed as much as evidence?
  21. Platitude = a remark or statement, especially one with a moral content, that has been used too often to be interesting or thoughtful.
  22. Platitude = a remark or statement, especially one with a moral content, that has been used too often to be interesting or thoughtful.
  23. Fine, let’s start the conversation: where is your evidence?
  24. Judging from past experience honor and integrity seem rather thin on the ground (see, for instance here).

The article promised to ‘revolutionize chiropractic care and to answer questions like what treatments fit under chiropractic care? Is the profession evidence-based? Sadly, none of this emerged. Instead, we were offered politically correct platitudes, half-truths, and obscurations.

The revolution in chiropractic, it thus seems, is not in sight.

Today, several UK dailies report about a review of osteopathy just published in BMJ-online. The aim of this paper was to summarise the available clinical evidence on the efficacy and safety of osteopathic manipulative treatment (OMT) for different conditions. The authors conducted an overview of systematic reviews (SRs) and meta-analyses (MAs). SRs and MAs of randomised controlled trials evaluating the efficacy and safety of OMT for any condition were included.

The literature searches revealed nine SRs or MAs conducted between 2013 and 2020 with 55 primary trials involving 3740 participants. The SRs covered a wide range of conditions including

  • acute and chronic non-specific low back pain (NSLBP, four SRs),
  • chronic non-specific neck pain (CNSNP, one SR),
  • chronic non-cancer pain (CNCP, one SR),
  • paediatric (one SR),
  • neurological (primary headache, one SR),
  • irritable bowel syndrome (IBS, one SR).

Although with different effect sizes and quality of evidence, MAs reported that OMT is more effective than comparators in reducing pain and improving the functional status in acute/chronic NSLBP, CNSNP and CNCP. Due
to the small sample size, presence of conflicting results and high heterogeneity, questionable evidence existed on OMT efficacy for paediatric conditions, primary headaches and IBS. No adverse events were reported in most SRs. The methodological quality of the included SRs was rated low or critically low.

The authors concluded that based on the currently available SRs and MAs, promising evidence suggests the possible effectiveness of OMT for musculoskeletal disorders. Limited and inconclusive evidence occurs for paediatric conditions, primary headache and IBS. Further well-conducted SRs and MAs are needed to confirm and extend the efficacy and safety of OMT.

This paper raises several questions. Here a just the two that bothered me most:

  1. If the authors had truly wanted to evaluate the SAFETY of OMT (as they state in the abstract), they would have needed to look beyond SRs, MAs or RCTs. We know – and the authors of the overview confirm this – that clinical trials of so-called alternative medicine (SCAM) often fail to mention adverse effects. This means that, in order to obtain a more realistic picture, we need to look at case reports, case series and other observational studies. It also means that the positive message about safety generated here is most likely misleading.
  2. The authors (the lead author is an osteopath) might have noticed that most – if not all – of the positive SRs were published by osteopaths. Their assessments might thus have been less than objective. The authors did not include one of our SRs (because it fell outside their inclusion period). Yet, I do believe that it is one of the few reviews of OMT for musculoskeletal problems that was not done by osteopaths. Therefore, it is worth showing you its abstract here:

The objective of this systematic review was to assess the effectiveness of osteopathy as a treatment option for musculoskeletal pain. Six databases were searched from their inception to August 2010. Only randomized clinical trials (RCTs) were considered if they tested osteopathic manipulation/mobilization against any control intervention or no therapy in human with any musculoskeletal pain in any anatomical location, and if they assessed pain as an outcome measure. The selection of studies, data extraction, and validation were performed independently by two reviewers. Studies of chiropractic manipulations were excluded. Sixteen RCTs met the inclusion criteria. Their methodological quality ranged between 1 and 4 on the Jadad scale (max = 5). Five RCTs suggested that osteopathy compared to various control interventions leads to a significantly stronger reduction of musculoskeletal pain. Eleven RCTs indicated that osteopathy compared to controls generates no change in musculoskeletal pain. Collectively, these data fail to produce compelling evidence for the effectiveness of osteopathy as a treatment of musculoskeletal pain.

It was published 11 years ago. But I have so far not seen compelling evidence that would make me change our conclusion. As I state in the newspapers:

OSTEOPATHY SHOULD BE TAKEN WITH A SIZABLE PINCH OF SALT.

 

 

THE END?

No, it is the start of the ‘HOMEOPATHY AWARENESS WEEK 2022′!

But, running a quick search for new evidence, I came across an abstract that seems like signaling the end of homeopathy. Here it is in its full beauty:

Acne is estimated to affect 9.4% of the global population, making it the 8th most prevalent disease worldwide. Acne vulgaris (AV) is among the diseases that directly affect quality of life. This trial evaluated the efficacy of individualized homeopathic medicines (IHM) against placebo in AV.

Methods: In this double-blind, randomized, placebo-controlled trial conducted at the National Institute of Homoeopathy, India, 126 patients suffering from AV were randomized in a 1:1 ratio to receive either IHM (verum) in centesimal potencies or identical-looking placebo (control). The primary outcome measure was the Global Acne Grading System score; secondary outcomes were the Cardiff Acne Disability Index and Dermatology Life Quality Index questionnaires – all measured at baseline and 3 months after the intervention. Group differences and effect sizes (Cohen’s d) were calculated on the intention-to-treat sample.

Results: Overall, improvements were greater in the IHM group than placebo, with small to medium effect sizes after 3 months of intervention; however, the inter-group differences were statistically non-significant. Sulphur (17.5%), Natrum muriaticum (15.1%), Calcarea phosphorica (14.3%), Pulsatilla nigricans (10.3%), and Antimonium crudum (7.1%) were the most frequently prescribed medicines; Pulsatilla nigricansTuberculinum bovinum and Natrum muriaticum were the most effective of those used. No harms, unintended effects, homeopathic aggravations or any serious adverse events were reported from either group.

Conclusion: There was non-significant direction of effect favoring homeopathy against placebo in the treatment of AV. 

And why do I suggest that this signals the end of anything?

Two reasons:

  1. It is a negative study of homeopathy from India, and by Jove, there are not many of those (mind you, the authors did try their best to squeeze in a glimpse of positivity, but I shall ignore this for their benefit [I particularly liked the sentence: “Pulsatilla nigricans, Tuberculinum bovinum and Natrum muriaticum were the most effective of those used” which is remarkable considering that the inter-group results – the only ones that matter in a controlled trial –  were negative).
  2. It was published in the journal ‘HOMEOPATHY‘, the flagship publication of homeopathy.

I reckon that, if this journal (remember, its editor, the late Peter Fisher, fired me from the ed-board because of my criticism of the history of homeopathy) runs out of positive papers and starts publishing negative trials, it must be close to the end.

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