patient choice
The German Heilpraktiker (HP), a non-medically trained practitioner of so-called alternative medicine (SCAM), has repeatedly been the subject of my posts. In a nutshell: the profession was created by the Nazis and was originally destined to disappear within one generation. But this did not happen, and today there are ~100 000 HPs who are allowed to treat almost any condition without mandatory training or experience. Many HP schools exist but you can also become an HP without formal training.
Now a report has been published by undercover journalists investigating these HP schools in Germany. Here I have summarized a few crucial passages for you (if you read German, I strongly recommend reading the original article):
There are more than 150 HP schools in Germany. On average, training costs several thousand euros. There is no uniform and state regulation for the training. The curricula are mostly created by the schools themselves.
In addition to medical and psychological content, the schools often offer seminars that are not based on scientific knowledge. The curricula sometimes include courses such as astrology, homeopathy, or so-called quantum healing. HP organizations give indeed training guidelines. However, these are not met by about 83% of the schools.
The students were isolated at the HP school from their environment and urged to break off contact with their families. “Without us you are nothing. That came so often and I then, unfortunately, believed in it, because I was alone. If I had had no one else from school, then I would really have been completely alone,” explains a former student in an interview. “During that time, I also thought for the first time: Are we in some kind of cult here?
The school’s principal rejects the cult accusation: “We have been confronted with the allegation that we are a cult for some time and have always dealt with it very openly because we are not a cult. The principal also denies other accusations made by former students, saying that the allegations of suggestion, coercion, compulsion, or sweeping statements are simply false. He said he would be happy to face them “in a personal conversation outside the public eye to answer their questions.”
In order to get to the bottom of the treatment methods, the reporter also had herself treated by the principal of the school in an undercover self-experiment. In the first session, she determined that the reporter’s sciatica had been passed on to her by her mother, which is why she should sever her ties with her. In the second session, she recommended that she no longer visit her cancer-stricken grandfather. When the principal learned that the ill grandpa was of the zodiac sign Cancer, she concluded, “Cancer gets cancer.” The cancer, she said, was due to the fact that he had done nothing for his soul. And further, the patient runs the risk of adopting the grandfather’s cancer symptoms when she visits him.
The Hamburg health authority, which is listed as a “supervisory authority” on the school’s homepage, explains in response to an inquiry that no official supervision exists for HP schools. To obtain permission for opening a school, no training is necessary. Neither possible training courses nor institutions offering such training courses are regulated by the state.
The journalist also asked the Federal Health Ministry whether it sees the need for action and legal control. The Ministry’s response was evasive: “If necessary,” the HP law should be reformed in the future.
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This is shocking news for many Germans who believe that HPs are well-trained healthcare professionals. However, those who have read my recently published book cannot be surprised. Poor training is only one of a myriad of deficits of HPs. It is time that the government realizes that the current is unacceptable and endangers public health. It is time, in other words, that the government does something about the HP profession.
According to a German court ruling, the homeopathic remedy Meditonsin for colds may no longer be advertised with certain statements. The Higher Regional Court in Hamm, Germany made it clear that it shares the opinion of the Regional Court in Dortmund, which had sentenced the marketing company to desist from making statements such as “rapid and reliable reduction of the intensity of the typical cold symptoms”. Such statements falsely generate the impression that therapeutic success can be expected with certainty. The court made it clear that the company’s appeal against the previous ruling was unlikely to be successful. The company subsequently withdrew its appeal today – and the judgment is now legally binding.
The lawsuit filed by a consumer organization was thus successful. It had criticized several statements as unfair and inadmissible advertising. The Dortmund court shared this view in September 2022 – and according to the spokesman, the Higher Regional Court in Hamm now followed the argumentation of the lower court.
The statements that
- “good efficacy and tolerability were once again impressively confirmed by a pharmacy-based observational study”,
- and “all cold complaints showed a clear improvement in the course of the disease”,
were deemed to be misleading advertising. They must therefore be omitted, the ruling stated.
Meditonsin is currently being advertised as follows:
For support of the immune system at the first signs of a cold to help the body build up the defense against pathogens effectively.
In addition, conditions are made more difficult for the intruders – through an effective medicine: the well-known Meditonsin® supports your defenses and naturally fights the onset of inflammation of the ears, nose and throat with pure homeopathic ingredients.
If applied early and correctly, Meditonsin® helps to ensure that the typical unpleasant symptoms have no chance to develop. Because Meditonsin® is particularly well tolerated and protects the organism, it is for both adults and children alike – a family medicine in the best sense.
Meditonsin contains two homeopathic ingredients in the D5 and one in the D8 dilution. To the best of my knowledge, there is no sound evidence that the remedy is effective for anything.
Low back pain is the leading cause of years lived with disability globally, but most interventions have only short-lasting, small to moderate effects. Cognitive functional therapy (CFT) is an individualized approach that targets unhelpful pain-related cognitions, emotions, and behaviors that contribute to pain and disability. Movement sensor biofeedback might enhance treatment effects.
This study aimed to compare the effectiveness and economic efficiency of CFT, delivered with or without movement sensor biofeedback, with usual care for patients with chronic, disabling low back pain.
RESTORE was a randomized, three-arm, parallel-group, phase 3 trial, done in 20 primary care physiotherapy clinics in Australia. The researchers recruited adults (aged ≥18 years) with low back pain lasting more than 3 months with at least moderate pain-related physical activity limitation. Exclusion criteria were serious spinal pathology (eg, fracture, infection, or cancer), any medical condition that prevented being physically active, being pregnant or having given birth within the previous 3 months, inadequate English literacy for the study’s questionnaires and instructions, a skin allergy to hypoallergenic tape adhesives, surgery scheduled within 3 months, or an unwillingness to travel to trial sites. Participants were randomly assigned (1:1:1) via a centralized adaptive schedule to
- usual care,
- CFT only,
- CFT plus biofeedback.
The primary clinical outcome was activity limitation at 13 weeks, self-reported by participants using the 24-point Roland Morris Disability Questionnaire. The primary economic outcome was quality-adjusted life-years (QALYs). Participants in both interventions received up to seven treatment sessions over 12 weeks plus a booster session at 26 weeks. Physiotherapists and patients were not masked.
Between Oct 23, 2018, and Aug 3, 2020, the researchers assessed 1011 patients for eligibility. After excluding 519 (51·3%) ineligible patients, they randomly assigned 492 (48·7%) participants; 164 (33%) to CFT only, 163 (33%) to CFT plus biofeedback, and 165 (34%) to usual care. Both interventions were more effective than usual care (CFT only mean difference –4·6 [95% CI –5·9 to –3·4] and CFT plus biofeedback mean difference –4·6 [–5·8 to –3·3]) for activity limitation at 13 weeks (primary endpoint). Effect sizes were similar at 52 weeks. Both interventions were also more effective than usual care for QALYs, and much less costly in terms of societal costs (direct and indirect costs and productivity losses; –AU$5276 [–10 529 to –24) and –8211 (–12 923 to –3500).
The authors concluded that CFT can produce large and sustained improvements for people with chronic disabling low back pain at considerably lower societal cost than that of usual care.
This is a well-designed and well-reported study. It shows that CFT is better than usual care. The effect sizes are not huge and seem similar to many other treatments for chronic LBP, including the numerous so-called alternative medicine (SCAM) options that are available.
Faced with a situation where we have virtually dozens of therapies of similar effectiveness, what should we recommend to patients? I think this question is best and most ethically answered by accounting for two other important determinants of usefulness:
- risk
- cost.
CFT is both low in risk and cost. So is therapeutic exercise. We would therefore need a direct comparison of the two to decide which is the optimal approach.
Until we have such a study, patients might just opt for one or both of them. What seems clear, meanwhile, is this: SCAM does not offer the best solution to chronic LBP. In particular, chiropractic, osteopathy, or acupuncture – which are neither low-cost nor risk-free – are, contrary to what some try so very hard to convince us of, sensible options.
It is not only practitioners of so-called alternative medicine (SCAM) who can be fraudulent charlatans. The study of medicine does not protect you from joining in. Here is an impressive case in point:
It has been reported that a former doctor convicted of fraudulently submitting nearly $120 million in claims related to the 1-800-GET-THIN Lap-Band surgery business has been sentenced to seven years in federal prison.
Julian Omidi, 58, of West Hollywood was sentenced Monday by U.S. District Court Judge Dolly M. Gee. The judge also imposed a five-year probation period on Surgery Center Management LLC, an Omidi-controlled Beverly Hills-based company. In the coming weeks, Gee is expected to hold a separate hearing to decide on restitution and forfeiture in the case, along with setting a fine for the Beverly Hills company.
“Mr. Omidi made millions at the expense of the multiple victim companies he defrauded, and he violated his oath to ‘do no harm’ by callously misleading patients about the need for a sleep study and subsequent weight loss surgery,” said Donald Alway, the assistant director in charge of the FBI’s Los Angeles field office.
Omidi controlled several entities in the GET-THIN network. Prosecutors say Omidi incentivized employees to ensure patients underwent sleep studies and then falsified the results to show that patients had obstructive sleep apnea to help them qualify for insurance coverage for the weight loss surgery. Those results were then filed with insurance companies to pre-approve the Lap-Band weight-loss surgeries. The 1-800-GET-THIN business received approximately $41 million for those procedures, according to prosecutors. While not all patients were approved to receive the surgery, prosecutors say GET-THIN would bill the patient roughly $15,000 for each sleep study, totaling $27 million in payments from insurance providers.
Omidi and his Beverly Hills-based company, Surgery Center Management, were found guilty of 28 counts of wire fraud, three counts of mail fraud, and one count of conspiracy to commit money laundering. Omidi was also found guilty of two counts of making false statements relating to healthcare matters, one count of aggravated identity theft, and two counts of money laundering after a 48-day trial in downtown Los Angeles.
“As found by the jury, the defendant Julian Omidi deliberately and repeatedly acted with an eye towards business and profits, rather than in the interest of GET-THIN’s medical patients, by inducing patients to undergo medical treatment premised on fraud rather than medical necessity, including surgeries that carry significant risks and life-long health impacts,” said U.S. Atty. Martin Estrada. A series of Los Angeles Times columns from 2010 to 2014 detailed how five patients died after they received Lap-Band surgeries at clinics affiliated with 1-800-GET-THIN. During a 2009 inspection, the Department of Health and Human Services found unsanitary conditions, inoperative scrub sinks, one-time-only equipment being reused, and several other deficiencies. The inspector shut down the clinic for a day, but further action was not taken at the time.
Omidi’s medical license was revoked in 2009, and he was arrested. In 2014, federal agencies seized more than $110 million from the 1-800-GET-THIN network in securities and funds.
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This is a spectacular case, of course. Yet, I fail to see how it differs in principle from the many instances we see on a daily basis in the realm of SCAM. Let me give you just a few examples:
- A chiropractor diagnoses subluxation and subsequently treats his patient with a series of spinal manipulations.
- A naturopath uses iridology to diagnose a weakness of the liver and subsequently treats it with herbal remedies.
- An acupuncturist diagnoses a blockage of chi and follows it up with a series of acupuncture sessions.
- A Heilpraktiker employs bioresonance to diagnose an intoxication which he then treats with a detox program.
The strategy is always the same:
- Charlatans use bogus diagnostic methods.
- They make bogus diagnoses with them.
- They then start expensive and often dangerous treatments.
- They make good money by defrauding the system.
Could someone please explain what the difference in principle is between the case of the fraudulent surgeon and the average SCAM practitioner?
Imagine you have caught a cold. You think it is not necessary to see a doctor, but you want to take something that helps your body to get better. What is your choice of remedy? There are many options provided by conventional medicine as well as by so-called alternative medicine (SCAM).
Many people opt for SCAM to address health issues or prevent diseases. Yet, the evidence for SCAMs is either lacking or controversial due to methodological weaknesses. Thus, practitioners and patients primarily rely on subjective references rather than credible evidence from systematic research.
This study investigated whether cognitive and personality factors explain the differences in belief in SCAM and homeopathy. The researchers investigated the robustness of 21 predictors when examined together to obtain insights into some key determinants of such beliefs in a sample of 599 participants (60% female, 18-81 years). A combination of predictors explained 20% of the variance in SCAM belief. These predictors were:
- ontological confusions,
- spiritual epistemology,
- agreeableness,
- death anxiety,
- gender.
Approximately 21% of the variance in belief in homeopathy was explained by the following predictors:
- ontological confusions,
- illusory pattern perception,
- need for cognitive closure,
- need for cognition,
- honesty-humility,
- death anxiety,
- gender,
- age.
The authors concluded that some of the predictors from previous research replicated whereas others did not. Demographics and certain cognitive variables seem to be key determinants associated with beliefs in SCAM and homeopathy. Those individual differences and cognitive biases might result in a different perception of the world. However, variables related to abilities did not predict the beliefs. Thus, they might not be a result of inability but rather of ignorance.
Previous studies have shown that SCAM believers tend to believe in paranormal phenomena and conspiracies. I think that, in the discussion sections of this blog, we have ample evidence for this to be true. Paranormal beliefs are usually built on a magical worldview without reasoned review, which is shared by SCAM proponents. Such beliefs advocate emotional criteria for truth instead of data and logical considerations. Another belief, namely spirituality, is closely related to paranormal beliefs and religiosity and also associated with being a SCAM user. Lindeman found that SCAM belief could be best explained by intuitive reasoning, paranormal beliefs, and ontological confusions, defined as category mistakes in which properties of living and lifeless entities are mixed.
The authors point out that their results do not replicate previous findings that showed predictive value of certain cognitive variables such as cognitive style. An explanation could be that rather inattention to accuracy than the inability to consider empirical evidence fosters the beliefs. People might simply not be aware of the absence of evidence. Another possibility is that people are aware of the absence of evidence but are reluctant to engage with it. Practitioners and patients often claim “whatever works is good” or “the main thing is that it works”. Thus, it is ignorance rather than a lack of capacity to appropriately process the evidence.
The authors of this study are well aware of the limitations of their research:
“As with most cross-sectional studies using questionnaires, our results are based on self-reports. Additionally, single items were used for measuring belief strength. Even if multi-item measures often have advantages, single items can be advantageous in terms of practical benefits, e.g., adapting to subjects’ limited attention and time resources. There are several single item measures successfully used to measure diverse concepts including attitudes. Also, the variance on those items in our sample shows that participants were able to reflect their beliefs and rank them on the scale provided. Another limitation is that the findings are based on regression analyses, which do not provide insight into causality. Thus, the relationship remains correlational. Even if our sample was broader than in many other psychological studies—it was slightly unbalanced, especially in comparison to the German population. It over-represented educated individuals which may lead to an inadequate variation of the cognitive variables if we consider the relationship between cognition and education. However, education and the cognitive variables are only weakly correlated. Thus, it can be assumed that the unbalanced sample did not affect the distribution of cognitive variables to a great extent.”
I came across an article entitled “Consent for Paediatric Chiropractic Treatment (Ages 0-16)“. Naturally, it interested me. Here is the full paper; I have only inserted a few numbers in square brackets which refer to my comments below:
By law, all Chiropractors are required to inform you of the risks and benefits of chiropractic spinal manipulation and the other types of care we provide. Chiropractors use manual therapy alongside taking a thorough history, and doing a neurological, orthopaedic and chiropractic examination to both diagnose and to treat spinal, cranial and extremity dysfunction. This may include taking joints to the end range of function, palpating soft tissues (including inside the mouth and the abdomen), mobilisation, soft tissue therapy and very gentle manipulation [1]. Our Chiropractors have been educated to perform highly specific types of bony or soft tissue manipulation and we strive to follow a system of evidence-based care [2]. At the core of our belief system is “Do No Harm”. We recognise that infants and children are not tiny adults. The force of an adjustment used in a child is at least less than half of what we might use with a fully grown adult. Studies by Hawk et al (2016) and Marchand (2013) agreed that Chiropractors use 15 – 35 x less force in the under 3-month age group when compared to medical practitioners doing manipulation (Koch, 2002) [3]. We also use less force in all other paediatrics groups, especially when compared to adults (Marchand, 2013). In addition to using lower force, depth, amplitude and speed in our chiropractic adjustments [4], we utilise different techniques. We expect all children under the age of 16 years to be accompanied by a responsible adult during appointments unless prior permission to treat without a consenting adult e.g., over the age of 14 has been discussed with the treating chiropractor.
Risks
- Research into chiropractic care for children in the past 70 years has shown it to have a low risk of adverse effects (Miller, 2019) [5]. These effects tend to be mild and of short duration e.g., muscular or ligament irritation. Vorhra et al (2007) found the risk of severe of adverse effects (e.g. fracture, quadriplegia, paraplegia, and death) is very, very rare and was more likely to occur in individuals where there is already serious underlying pathology and missed diagnosis by other medical profession [6]. These particular cases occurred more than 25 years ago and is practically unheard of now since research and evidence-based care has become the norm [7].
- The most common side effect in infants following chiropractic treatment includes fussiness or irritability for the first 24 hours, and sleeping longer than usual or more soundly. (Miller and Benfield, 2008) [8]
- In older children, especially if presenting with pain e.g., in the neck or lower back, the greatest risk is that this pain may increase during examination due to increasing the length of involved muscles or ligaments [9]. Similarly, the child may also experience pain, stiffness or irritability after treatment (Miller & Benfield, 2008) [10]. Occasionally children may experience a headache.[11] We find that children experience side effects much less often than adults.[12]
Benefits
- Your child might get better with chiropractic care. [13] If they don’t, we will refer you on [14].
- Low risk of side effects and very rare risk of serious adverse effects [15].
- Drug-free health care. We are not against medication, but we do not prescribe [16].
- Compared with a medical practitioner, manual therapy carried out by a chiropractor is 20 x less likely to result in injury (Koch et al 2002, Miller 2009).[17]
- Children do not often require long courses of treatment (>3 weeks) unless complicating factors are present.[18]
- Studies have shown that parents have a high satisfaction rate with Chiropractic care [19].
- Physical therapies are much less likely to interfere with biomedical treatments. (McCann & Newell 2006) [20]
- You will have a better understanding of diagnosis of any complain and we will let you know what you can do to help.[21]
We invite you to have open discussions and communication with your treating chiropractor at all times. Should you need any further clarification please just ask.
References
- Hawk, C. Shneider, M.J., Vallone, S and Hewitt, E.G. (2016) – Best practises recommendations for chiropractic care of children: A consensus update. JMPT, 39 (3), 158-168.
- Marchand, A. (2013) – A Proposed model with possible implications for safety and technique adaptations for chiropractic spinal manipulative therapy for infants and children. JMPT, 5, 1-14
- Koch L. E., Koch, H, Graumann-Brunnt, S. Stolle, D. Ramirez, J.M., & Saternus, K.S. (2002) – Heart rate changes in response to mild mechanical irritation of the high cervical cord region in infants. Forensic Science International, 128, 168-176
- Miller J (2019) – Evidence-Based Chiropractic Care for Infants: Rational, Therapies and Outcomes. Chapter 11: Safety of Chiropractic care for Infants p111. Praeclarus Press
- Vohra, S. Johnston, B.C. Cramer, K, Humphreys, K. (2007) – Adverse events associated with paediatric spinal manipulation: A Systematic Review. Pediatrics, 119 (1) e275-283
- Miller, J and Benfield (2008) – Adverse effects of spinal manipulative therapy in children younger than 3 years: a retrospective study in a chiropractic teaching clinic. JMPT Jul-Aug;31(6):419-23.
- McCann, L.J. & Newell, S.J. (2006). Survey of paediatric complementary and alternative medicine in health and chronic disease. Archives of Diseases of Childhood, 91, 173-174
- Corso, M., Cancelliere, C. , Mior., Taylor-Vaise, A. Côté, P. (2020) – The safety of spinal manipulative therapy in children under 10 years: a rapid review. Chiropractic Manual therapy 25: 12
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- “taking joints to the end range of function” (range of motion, more likely) is arguably not “very gently”;
- “we strive to follow a system of evidence-based care”; I do not think that this is possible because pediatric chiropractic care is hardy evidence-based;
- as a generalizable statement, this seems to be not true;
- ” lower force, depth, amplitude and speed”; I am not sure that there is good evidence for that;
- research has foremost shown that there might be significant under-reporting;
- to blame the medical profession for diagnoses missed by chiropractors seems odd;
- possibly because of under-reporting;
- possibly because of under-reporting;
- possibly because of under-reporting;
- possibly because of under-reporting;
- possibly because of under-reporting;
- your impressions are not evidence;
- your child might get even better without chiropractic care;
- referral rates of chiropractors tend to be low;
- possibly because of under-reporting;
- chiropractors have no prescription rights but some lobby hard for it;
- irrelevant if we consider the intervention useless and thus obsolete;
- any evidence for this statement?;
- satisfaction rates are no substitute for real evidence;
- that does not mean they are effective, safe, or value for money;
- this is perhaps the strangest statement of them all – do chiropractors think they are the optimal diagnosticians for all complaints?
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According to its title, the paper was supposed to deal with consent for chiropractic pediatric care. It almost totally avoided the subject and certainly did not list the information chiropractors must give to parents before commencing treatment.
Considering the arguments that the article did provide has brought me to the conclusion that chiropractors who treat children are out of touch with reality and seem in danger of committing child abuse.
Social prescribing (SP) has been mentioned here several times before. It seems important to so-called alternative medicine (SCAM), as some enthusiasts – not least King Charles – are trying to use it as a means to smuggle nonsensical treatments into routine healthcare.
SP is supposed to enable healthcare professionals to link patients with non-medical interventions available in the community to address underlying socioeconomic and behavioural determinants. The question, of course, is whether it has any relevant benefits.
This systematic review included all randomised controlled trials of SP among community-dwelling adults recruited from primary care or community setting, investigating any chronic disease risk factors defined by the WHO (behavioural factors: smoking, physical inactivity, unhealthy diet and excessive alcohol consumption; metabolic factors: raised blood pressure, overweight/obesity, hyperlipidaemia and hyperglycaemia). Random effect meta-analyses were performed at two time points: completion of intervention and follow-up after trial.
The researchers identified 9 reports from 8 trials totalling 4621 participants. All studies evaluated SP exercise interventions which were highly heterogeneous regarding the content, duration, frequency and length of follow-up. The majority of studies had some concerns about the risk of bias. A meta-analysis revealed that SP likely increased physical activity (completion: mean difference (MD) 21 min/week, 95% CI 3 to 39, I2=0%; follow-up ≤12 months: MD 19 min/week, 95% CI 8 to 29, I2=0%). However, SP may not improve markers of adiposity, blood pressure, glucose and serum lipid. There were no eligible studies that primarily target unhealthy diet, smoking or excessive alcohol-drinking behaviours.
The authors concluded that SP exercise interventions probably increased physical activity slightly; however, no benefits were observed for metabolic factors. Determining whether SP is effective in modifying the determinants of chronic diseases and promotes sustainable healthy behaviours is limited by the current evidence of quantification and uncertainty, warranting further rigorous studies.
Great! Regular exercise improves physical fitness.
But do we need SP for this?
Don’t get me wrong, I have nothing against connecting patients with social networks to improve their health and quality of life. I do, however, object if SP is used to smuggle unproven or disproven SCAMs into EBM. In addition, I ask myself whether we really need the new profession of a ‘link worker’ to facilitate SP. I remember being taught that a good doctor should look after his/her patients holistically, and surely that includes mentioning and facilitating social networks for those who need them.
I, therefore, fear that SP is taking something valuable out of the hands of doctors. And the irony is that SP is favoured by those who are all too quick to turn around and say: LOOK AT HOW FRIGHTFULLY REDUCTIONIST AND HEARTLESS DOCTORS HAVE BECOME. WE NEED MORE HOLISM IN MEDICINE AND THAT CAN ONLY BE PROVIDED BY SCAM PRACTITIONERS!
In Germany, so-called alternative medicine (SCAM) is used by about 6o% of the population. The type and extent of in-patient complementary care are, however, largely unknown.
The objective of this study was, therefore, to conduct a survey on SCAM procedures in Bavarian acute care hospitals by screening the websites of all respective facilities in order to cover a broad range of SCAMs.
In 2020, an independent and comprehensive website screening of all 389 Bavarian acute hospitals, including all departments, was conducted by two independent raters. SCAMs offered were analyzed in total as well as separately by specialty.
Among all 389 Bavarian acute care hospitals, 82% offered at least one and 66% at least three different SCAMs on their website. Relaxation techniques (52%), acupuncture (44%), massage (41%), movement-, art-, and music therapy (33%, 30%, and 28%), meditative movement therapies like yoga (30%), and aromatherapy (29%) were offered most frequently. Separated by specialty, SCAMs were most common in psychiatry/psychosomatics (relaxation techniques 69%, movement and art therapy 60% each) at 87%, and in gynecology/obstetrics (most common acupuncture 64%, homeopathy 60%, and aromatherapy 41%) at 72%.
The stated areas of application of SCAM included:
- use as a stand-alone therapy (65%; n=254),
- for prevention (7%; n=27),
- as support for conventional therapy (7%; n=27)
- as preparation before drug therapy or surgery (5%; n=18).
The authors concluded that the vast majority of Bavarian acute care hospitals also seem to conduct complementary medicine procedures in therapy, especially for psychological indications and in obstetrics and gynaecology, according to the hospital websites. How often these procedures are used in inpatient or outpatient settings as well as evidence on effectiveness of the applied procedures should be investigated in further studies.
In my view, this article invites several points of criticism.
Something that irritates me regularly is the fact that much of SCAM research takes years to be published. If a given research project is important, it would seem unethical to sit on it for so long. If it is not important, it is unethical to conduct it in the first place. In the above case, we are dealing with a survey of SCAM use, and we know that SCAM use is strongly influenced by fashion which means it changes fast and frequently. I would therefore argue that data that are now three years old are of limited interest.
Another point is the lack of a definition or range of treatments included. The authors state they looked for whatever form of SCAM the websites mentioned (herbal medicine is popular in Germany, yet absent in this survey; this suggests that the survey method has created a blind spot). Yet, they include as SCAM things like massage (which in Germany is entirely mainstream), physiotherapeutic exercise (Bewegungstherapie), and biofeedback all of which are arguably conventional treatments. This means that the true prevalence figures of SCAM use are not nearly as high as they pretend.
My main criticism would be that the authors abstain from any comments about the evidence for the SCAMs they monitored. They stated that this was beyond the scope of the project. As the research was supported by the Bavarian government, it would nevertheless have been essential, in my view, to dedicate a few words about the fact that many of the SCAMs and their uses are not evidence-based.
Essentially, this survey is in the tradition of hundreds of previous SCAM prevalence surveys that show a high degree of popularity of SCAM and thus imply that
IF SCAM IS SO VERY POPULAR, IT MUST BE GOOD;
AND IF IT’S GOOD, WE MUST HAVE MORE OF IT.
PS
It is often said that SCAM researchers are relatively free of financial conflicts of interest. Let me show you the complete list of conflicts declared by the authors of this survey.
- JL: received funding for this project from the Bavarian State Ministry of Health and Care; Further research support: Steigerwald Arzneimittelwerke GmbH, Falk Foundation; TechLab, Dr. Willmar Schwabe; Repha GmbH biologic drugs; Lecture fees: Falk Foundation, Repha GmbH biologic drugs; Celgene GmbH; Dr. Willmar Schwabe; Medice Arzneimittel, Galapagos Biopharma; consultant/expert: Medizinverlage Stuttgart; Steigerwald Arzneimittelwerke GmbH; Repha GmbH; Ferring Arzneimittel GmbH; Dr. Willmar Schwabe
- TK: received funding for this project from the Bavarian State Ministry of Health and Care, beyond that there are no other conflicts of interest
- CL: Lecture fees: Celgene GmbH, Roche GmbH, Novartis Pharma GmbH, BMS GmbH & Co. KGaA, Mundipharma GmbH Co. KG, Merck KGaA.
Low back pain (LBP) affects almost all of us at some stage. It is so common that it has become one of the most important indications for most forms of so-called alternative medicine (SCAM). In the discussions about the value (or otherwise) of SCAMs for LBP, we sometimes forget that there are many conventional medical options to treat LBP. It is therefore highly relevant to ask how effective they are. This overview aimed to summarise the evidence from Cochrane Reviews of the efficacy, effectiveness, and safety of systemic pharmacological interventions for adults with non‐specific LBP.
The Cochrane Database of Systematic Reviews was searched from inception to 3 June 2021, to identify reviews of randomised controlled trials (RCTs) that investigated systemic pharmacological interventions for adults with non‐specific LBP. Two authors independently assessed eligibility, extracted data, and assessed the quality of the reviews and certainty of the evidence using the AMSTAR 2 and GRADE tools. The review focused on placebo comparisons and the main outcomes were pain intensity, function, and safety.
Seven Cochrane Reviews that included 103 studies (22,238 participants) were included. There was high confidence in the findings of five reviews, moderate confidence in one, and low confidence in the findings of another. The reviews reported data on six medicines or medicine classes: paracetamol, non‐steroidal anti‐inflammatory drugs (NSAIDs), muscle relaxants, benzodiazepines, opioids, and antidepressants. Three reviews included participants with acute or sub‐acute LBP and five reviews included participants with chronic LBP.
Acute LBP
Paracetamol
There was high‐certainty evidence for no evidence of difference between paracetamol and placebo for reducing pain intensity (MD 0.49 on a 0 to 100 scale (higher scores indicate worse pain), 95% CI ‐1.99 to 2.97), reducing disability (MD 0.05 on a 0 to 24 scale (higher scores indicate worse disability), 95% CI ‐0.50 to 0.60), and increasing the risk of adverse events (RR 1.07, 95% CI 0.86 to 1.33).
NSAIDs
There was moderate‐certainty evidence for a small between‐group difference favouring NSAIDs compared to placebo at reducing pain intensity (MD ‐7.29 on a 0 to 100 scale (higher scores indicate worse pain), 95% CI ‐10.98 to ‐3.61), high‐certainty evidence for a small between‐group difference for reducing disability (MD ‐2.02 on a 0‐24 scale (higher scores indicate worse disability), 95% CI ‐2.89 to ‐1.15), and very low‐certainty evidence for no evidence of an increased risk of adverse events (RR 0.86, 95% CI 0. 63 to 1.18).
Muscle relaxants and benzodiazepines
There was moderate‐certainty evidence for a small between‐group difference favouring muscle relaxants compared to placebo for a higher chance of pain relief (RR 0.58, 95% CI 0.45 to 0.76), and higher chance of improving physical function (RR 0.55, 95% CI 0.40 to 0.77), and increased risk of adverse events (RR 1.50, 95% CI 1. 14 to 1.98).
Opioids
None of the included Cochrane Reviews aimed to identify evidence for acute LBP.
Antidepressants
No evidence was identified by the included reviews for acute LBP.
Chronic LBP
Paracetamol
No evidence was identified by the included reviews for chronic LBP.
NSAIDs
There was low‐certainty evidence for a small between‐group difference favouring NSAIDs compared to placebo for reducing pain intensity (MD ‐6.97 on a 0 to 100 scale (higher scores indicate worse pain), 95% CI ‐10.74 to ‐3.19), reducing disability (MD ‐0.85 on a 0‐24 scale (higher scores indicate worse disability), 95% CI ‐1.30 to ‐0.40), and no evidence of an increased risk of adverse events (RR 1.04, 95% CI ‐0.92 to 1.17), all at intermediate‐term follow‐up (> 3 months and ≤ 12 months postintervention).
Muscle relaxants and benzodiazepines
There was low‐certainty evidence for a small between‐group difference favouring benzodiazepines compared to placebo for a higher chance of pain relief (RR 0.71, 95% CI 0.54 to 0.93), and low‐certainty evidence for no evidence of difference between muscle relaxants and placebo in the risk of adverse events (RR 1.02, 95% CI 0.67 to 1.57).
Opioids
There was high‐certainty evidence for a small between‐group difference favouring tapentadol compared to placebo at reducing pain intensity (MD ‐8.00 on a 0 to 100 scale (higher scores indicate worse pain), 95% CI ‐1.22 to ‐0.38), moderate‐certainty evidence for a small between‐group difference favouring strong opioids for reducing pain intensity (SMD ‐0.43, 95% CI ‐0.52 to ‐0.33), low‐certainty evidence for a medium between‐group difference favouring tramadol for reducing pain intensity (SMD ‐0.55, 95% CI ‐0.66 to ‐0.44) and very low‐certainty evidence for a small between‐group difference favouring buprenorphine for reducing pain intensity (SMD ‐0.41, 95% CI ‐0.57 to ‐0.26).
There was moderate‐certainty evidence for a small between‐group difference favouring strong opioids compared to placebo for reducing disability (SMD ‐0.26, 95% CI ‐0.37 to ‐0.15), moderate‐certainty evidence for a small between‐group difference favouring tramadol for reducing disability (SMD ‐0.18, 95% CI ‐0.29 to ‐0.07), and low‐certainty evidence for a small between‐group difference favouring buprenorphine for reducing disability (SMD ‐0.14, 95% CI ‐0.53 to ‐0.25).
There was low‐certainty evidence for a small between‐group difference for an increased risk of adverse events for opioids (all types) compared to placebo; nausea (RD 0.10, 95% CI 0.07 to 0.14), headaches (RD 0.03, 95% CI 0.01 to 0.05), constipation (RD 0.07, 95% CI 0.04 to 0.11), and dizziness (RD 0.08, 95% CI 0.05 to 0.11).
Antidepressants
There was low‐certainty evidence for no evidence of difference for antidepressants (all types) compared to placebo for reducing pain intensity (SMD ‐0.04, 95% CI ‐0.25 to 0.17) and reducing disability (SMD ‐0.06, 95% CI ‐0.40 to 0.29).
The authors concluded as follows: we found no high‐ or moderate‐certainty evidence that any investigated pharmacological intervention provided a large or medium effect on pain intensity for acute or chronic LBP compared to placebo. For acute LBP, we found moderate‐certainty evidence that NSAIDs and muscle relaxants may provide a small effect on pain, and high‐certainty evidence for no evidence of difference between paracetamol and placebo. For safety, we found very low‐ and high‐certainty evidence for no evidence of difference with NSAIDs and paracetamol compared to placebo for the risk of adverse events, and moderate‐certainty evidence that muscle relaxants may increase the risk of adverse events. For chronic LBP, we found low‐certainty evidence that NSAIDs and very low‐ to high‐certainty evidence that opioids may provide a small effect on pain. For safety, we found low‐certainty evidence for no evidence of difference between NSAIDs and placebo for the risk of adverse events, and low‐certainty evidence that opioids may increase the risk of adverse events.
This is an important overview, in my opinion. It confirms what I and others have been stating for decades: WE CURRENTLY HAVE NO IDEAL SOLUTION TO LBP.
This is regrettable but true. It begs the question of what one should recommend to LBP sufferers. Here too, I have to repeat myself: (apart from staying as active as possible) the optimal therapy is the one that has the most favourable risk/benefit profile (and does not cost a fortune). And this option is not drugs, chiropractic, osteopathy, acupuncture, or any other SCAM – it is (physio)therapeutic exercise which is cheap, safe, and (mildly) effective.
During the coronavirus disease 2019 pandemic, Ayurvedic herbal supplements and homeopathic remedies were promoted as immune boosters (IBs) and disease-preventive agents. This happened in most parts of the world but nowhere more intensely than in India.
The present study examined the clinical outcomes among patients with chronic liver disease who presented with complications of portal hypertension or liver dysfunction temporally associated with the use of IBs in the absence of other competing causes. This Indian single-center retrospective observational cohort study included patients with chronic liver disease admitted for the evaluation and management of jaundice, ascites, or hepatic encephalopathy temporally associated with the consumption of IBs and followed up for 180 days. Chemical analysis was performed on the retrieved IBs.
From April 2020 to May 2021, 1022 patients with cirrhosis were screened, and 178 (19.8%) were found to have consumed complementary and alternative medicines. Nineteen patients with cirrhosis (10.7%), jaundice, ascites, hepatic encephalopathy, or their combination related to IBs use were included. The patients were predominantly male (89.5%). At admission, 14 (73.75%) patients had jaundice, 9 (47.4%) had ascites, 2 (10.5%) presented with acute kidney injury, and 1 (5.3%) had overt encephalopathy. Eight patients (42.1%) died at the end of the follow-up period. Hepatic necrosis and portal-based neutrophilic inflammation were the predominant features of liver biopsies.
Ten samples of IBs, including locally made ashwagandha powder, giloy juice, Indian gooseberry extracts, pure giloy tablets, multiherbal immune-boosting powder, other multiherbal tablets, and the homeopathic remedy, Arsenicum album 30C, were retrieved from our study patients. Samples were analyzed for potential hepatotoxic prescription drugs, known hepatotoxic adulterants, pesticides, and insecticides, which were not present in any of the samples. Detectable levels of arsenic (40%), lead (60%), and mercury (60%) were found in the samples analyzed. A host of other plant-derived compounds, industrial solvents, chemicals, and anticoagulants was identified using GC–MS/MS. These include glycosides, terpenoids, phytosteroids, and sterols, such as sitosterol, lupeol, trilinolein, hydroxy menthol, methoxyphenol, butyl alcohol, and coumaran derivatives.
The authors concluded that Ayurvedic and Homeopathic supplements sold as IBs potentially cause the worsening of preexisting liver disease. Responsible dissemination of scientifically validated, evidence-based medical health information from regulatory bodies and media may help ameliorate this modifiable liver health burden.
The authors comment that Ayurvedic herbal supplements and homeopathic remedies sold as IBs, potentially induce idiosyncratic liver injury in patients with preexisting liver disease. Using such untested advertised products can lead to the worsening of CLD in the form of liver failure or portal hypertension events, which are associated with a high risk of mortality compared to those with severe AH-related liver decompensation in the absence of timely liver transplantation. Severe mixed portal inflammation and varying levels of hepatic necrosis are common findings on liver histopathology in IB-related liver injury. Health regulatory authorities and print and visual media must ensure the dissemination of responsible and factual scientific evidence-based information on herbal and homeopathic “immune boosters” and health supplements to the public, specifically to the at-risk patient population.
