The three-year old Noah was diagnosed with acute lymphoblastic leukaemia, a blood cancer with a very good prognosis when treated (~85% of all children affected can be completely cured and expect to live a normal life). The child was admitted to hospital and, initially, chemotherapy was started. But the treatment was not finished, because the parents took their child home prematurely. The mother, a 22-year-old ‘holistic birth attendant’, had been against conventional treatments from the start. She nevertheless agreed to the first two rounds of chemotherapy — “because they can get a medical court order to force you to do it anyways for a child with his diagnosis”.
Noah’s parent treated their sons with a number of home remedies:
- colloidal silver,
- Reishi mushroom tea,
- Apricot seeds,
- and other forms of SCAM.
After the child had gone missing, the police issued an alert:
“On April 22, 2019 the parents failed to bring in the child to a medically necessary hospital procedure. The parents have further refused to follow up with the life saving medical care the child needs.”
In a matter of hours, the parents and their child were found. Noah was then taken from his parents and was “now being medically treated,” the sheriff’s office stated. The parents, meanwhile, were being investigated on suspicion of child neglect.
They insist that they were merely trying to give their son alternative medical care, accusing the police and medical officials of stripping them of the right to choose their own treatment plan for their son. Their supporters call the state’s decision to take custody of Noah a “medical kidnapping”. Medical kidnapping is defined as the State taking away children from their parents so that the children can receive medical or surgical care which the parents would otherwise not allow to be administered.
“We’re not trying to refuse any kind of treatment,” the parents told reporters. “They think we’re refusing treatment all around, putting him in danger, trying to kill him. But not at all. We’re trying to save him.” An organization fighting on behalf of the parents, the Florida Freedom Alliance, which also supports “vaccine freedom,” argues that the couple should be entitled to “medical freedom” and freedom from “medical kidnappings.”
Who is right and who is wrong?
Are medical kidnappings legal?
I am, of course, not sure about the legalities. But I am fairly certain about the evidence in the above case:
- Noah’s condition is treatable, and in all likelihood he would be cured, if treated according to current oncological standards. This view was also confirmed by the oncologist who is in charge of treating him in hospital.
- None of the treatments mentioned by the parents are effective. In fact, alternative cancer cures are a myth; they do not exist and they will never exist. Once a treatment shows promise, it would be scientifically investigated. And, if the results are positive, it would become mainstream quicker than I can climb a tree.
Ethically Noah’s case could not be clearer: the child’s life must be saved, whether with the support of his parents or not. However strongly parents might feel about their under-age kids’ care, they do not own their children and must not be allowed to cause them significant harm.
In 1995, Dabbs and Lauretti reviewed the risks of cervical manipulation and compared them to those of non-steroidal, anti-inflammatory drugs (NSAIDs). They concluded that the best evidence indicates that cervical manipulation for neck pain is much safer than the use of NSAIDs, by as much as a factor of several hundred times. This article must be amongst the most-quoted paper by chiropractors, and its conclusion has become somewhat of a chiropractic mantra which is being repeated ad nauseam. For instance, the American Chiropractic Association states that the risks associated with some of the most common treatments for musculoskeletal pain—over-the-counter or prescription nonsteroidal anti-inflammatory drugs (NSAIDS) and prescription painkillers—are significantly greater than those of chiropractic manipulation.
As far as I can see, no further comparative safety-analyses between cervical manipulation and NSAIDs have become available since this 1995 article. It would therefore be time, I think, to conduct new comparative safety and risk/benefit analyses aimed at updating our knowledge in this important area.
Meanwhile, I will attempt a quick assessment of the much-quoted paper by Dabbs and Lauretti with a view of checking how reliable its conclusions truly are.
The most obvious criticism of this article has already been mentioned: it is now 23 years old, and today we know much more about the risks and benefits of these two therapeutic approaches. This point alone should make responsible healthcare professionals think twice before promoting its conclusions.
Equally important is the fact that we still have no surveillance system to monitor the adverse events of spinal manipulation. Consequently, our data on this issue are woefully incomplete, and we have to rely mostly on case reports. Yet, most adverse events remain unpublished and under-reporting is therefore huge. We have shown that, in our UK survey, it amounted to exactly 100%.
To make matters worse, case reports were excluded from the analysis of Dabbs and Lauretti. In fact, they included only articles providing numerical estimates of risk (even reports that reported no adverse effects at all), the opinion of exerts, and a 1993 statistic from a malpractice insurer. None of these sources would lead to reliable incidence figures; they are thus no adequate basis for a comparative analysis.
In contrast, NSAIDs have long been subject to proper post-marketing surveillance systems generating realistic incidence figures of adverse effects which Dabbs and Lauretti were able to use. It is, however, important to note that the figures they did employ were not from patients using NSAIDs for neck pain. Instead they were from patients using NSAIDs for arthritis. Equally important is the fact that they refer to long-term use of NSAIDs, while cervical manipulation is rarely applied long-term. Therefore, the comparison of risks of these two approaches seems not valid.
Moreover, when comparing the risks between cervical manipulation and NSAIDs, Dabbs and Lauretti seemed to have used incidence per manipulation, while for NSAIDs the incidence figures were bases on events per patient using these drugs (the paper is not well-constructed and does not have a methods section; thus, it is often unclear what exactly the authors did investigate and how). Similarly, it remains unclear whether the NSAID-risk refers only to patients who had used the prescribed dose, or whether over-dosing (a phenomenon that surely is not uncommon with patients suffering from chronic arthritis pain) was included in the incidence figures.
It is worth mentioning that the article by Dabbs and Lauretti refers to neck pain only. Many chiropractors have in the past broadened its conclusions to mean that spinal manipulations or chiropractic care are safer than drugs. This is clearly not permissible without sound data to support such claims. As far as I can see, such data do not exist (if anyone knows of such evidence, I would be most thankful to let me see it).
To obtain a fair picture of the risks in a real life situation, one should perhaps also mention that chiropractors often fail to warn patients of the possibility of adverse effects. With NSAIDs, by contrast, patients have, at the very minimum, the drug information leaflets that do warn them of potential harm in full detail.
Finally, one could argue that the effectiveness and costs of the two therapies need careful consideration. The costs for most NSAIDs per day are certainly much lower than those for repeated sessions of manipulations. As to the effectiveness of the treatments, it is clear that NSAIDs do effectively alleviate pain, while the evidence seems far from being conclusively positive in the case of cervical manipulation.
In conclusion, the much-cited paper by Dabbs and Lauretti is out-dated, poor quality, and heavily biased. It provides no sound basis for an evidence-based judgement on the relative risks of cervical manipulation and NSAIDs. The notion that cervical manipulations are safer than NSAIDs is therefore not based on reliable data. Thus, it is misleading and irresponsible to repeat this claim.
The researcher who proves that highly diluted homeopathics work beyond placebo might be in for a Nobel Prize. The scientist who finds a cure for addictions probably also deserves one. The investigator who does both might get two Nobels. The question is, do these Brazilian homeopaths fulfil these criteria?
Their study investigated the effectiveness and tolerability of homeopathic Q-potencies of opium and E. coca in the integrative treatment of cocaine craving in a community-based psychosocial rehabilitation setting. A randomized, double-blind, placebo-controlled, parallel-group, eight-week pilot trial was performed at the Psychosocial Attention Center for Alcohol and Other Drugs (CAPS-AD), Sao Carlos/SP, Brazil. Eligible subjects included CAPS-AD patients between 18 and 65 years of age, with an International Classification of Diseases-10 diagnosis of cocaine dependence. The patients were randomly assigned to two treatment groups: psychosocial rehabilitation plus homeopathic Q-potencies of opium and E. coca (homeopathy group), and psychosocial rehabilitation plus indistinguishable placebo (placebo group). The main outcome measure was the percentage of cocaine-using days. Secondary measures were the Minnesota Cocaine Craving Scale and 12-Item Short-Form Health Survey scores. Adverse events were recorded in both groups.
The study population comprised 54 patients who attended at least one post-baseline assessment, out of the 104 subjects initially enrolled. The mean percentage of cocaine-using days in the homeopathy group was 18.1% compared to 29.8% in the placebo group (P < 0.01). Analysis of the Minnesota Cocaine Craving Scale scores showed no between-group differences in the intensity of cravings, but results significantly favored homeopathy over placebo in the proportion of weeks without craving episodes and the patients’ appraisal of treatment efficacy for reduction of cravings. Analysis of 12-Item Short-Form Health Survey scores found no significant differences. Few adverse events were reported: 0.57 adverse events/patient in the homeopathy group compared to 0.69 adverse events/patient in the placebo group.
The authors concluded that a psychosocial rehabilitation setting improved recruitment but was not sufficient to decrease dropout frequency among Brazilian cocaine treatment seekers. Psychosocial rehabilitation plus homeopathic Q-potencies of opium and E. coca were more effective than psychosocial rehabilitation alone in reducing cocaine cravings. Due to high dropout rate and risk of bias, further research is required to confirm our findings, with specific focus on strategies to increase patient retention.
I am glad that the authors mention the high dropout rate which clearly is a serious limitation of this fascinating trial. Had they analysed the data according to an intention to treat analysis – which, I think, would have been a better statistical approach – the results would almost certainly have been negative.
But there are other puzzling issues about this study:
- The authors say they used homeopathic remedies. I think, however, that this is not the case. Homeopathy is defined as a therapy that follows the ‘like cures like’ principle. If the remedy is based on the causative agent, as in the case of the present study, it follows a different principle (identical cures identical) and is not called homeopathy but isopathy (here an explanation from my book: “Isopathy is the use of potentised remedies which are derived from the causative agent of the disease that is being treated. It thus does not follow the supreme law of homeopathy; instead of ‘like cures like’, instead it postulates that identical cures identical. An example of isopathy is the use of potentised grass pollen to treat patients suffering from hay fever. Some of the methodologically best trials that generated a positive result were done using isopathy; they therefore did not test homeopathy and its principal assumption, the ‘like cures like’ theory. They are nevertheless regularly used by proponents of homeopathy to argue that homeopathy is effective”). This means that the above trial does, in fact, NOT test the defining principle of homeopathy.
- Moreover, I fail to understand why the authors called their trial a PILOT study. It does not explore the feasibility of a more definitive trial, but tests the effectiveness of the intervention. It is thus NOT a pilot study.
- I cannot help being suspicious of authors who, based on an extremely implausible, such as homeopathy, publish one paper after the next with positive or encouraging results.
- I am also puzzled by the fact that, in 2012 and 2013, the authors have published two previous studies along the same lines that produced encouraging results. Surely 6/5 years are a long enough period for INDEPENDENT replications to be carried out and published. And surely, a finding like this would have been replicated several times by now.
- I furthermore find it odd that the authors chose to publish their findings in the JOURNAL OF INTEGRATIVE MEDICINE. This is a 3rd class journal read only by those who promote alternative therapies. The notion that a treatment of addiction has finally be found should appear in journals like SCIENCE, NATURE, NEJM, etc.
- Considering the extremely low prior probability of their hypothesis, the authors should perhaps have not used the conventional 5% probability threshold, but one two dimensions lower.
- I have not found a statement regarding informed consent of the study participants.
So, are these Brazilian homeopaths likely to be on the next list of Nobel laureates?
I have my doubts.
What do you think?
Needle acupuncture in small children is controversial, not least because the evidence that it works is negative or weak, and because small children are unable to consent to the treatment. Yet it is recommended by some acupuncturists for infant colic. This, of course, begs the questions:
- Does the best evidence tell us that acupuncture is effective for infant colic?
- Are acupuncturists who recommend acupuncture for this condition responsible and ethical?
This systematic review and a blinding-test validation based on individual patient data from randomised controlled trials was aimed to assess its efficacy for treating infantile colic. Primary end-points were crying time at mid-treatment, at the end of treatment and at a 1-month follow-up. A 30-min mean difference (MD) in crying time between acupuncture and control was predefined as a clinically important difference. Pearson’s chi-squared test and the James and Bang indices were used to test the success of blinding of the outcome assessors [parents].
The investigators included three randomised controlled trials with data from 307 participants. Only one of the included trials obtained a successful blinding of the outcome assessors in both the acupuncture and control groups. The MD in crying time between acupuncture intervention and no acupuncture control was -24.9 min at mid-treatment, -11.4 min at the end of treatment and -11.8 min at the 4-week follow-up. The heterogeneity was negligible in all analyses. The statistically significant result at mid-treatment was lost when excluding the apparently unblinded study in a sensitivity analysis: MD -13.8 min. The registration of crying during treatment suggested more crying during acupuncture.
The authors concluded that percutaneous needle acupuncture treatments should not be recommended for infantile colic on a general basis.
The authors also provide this further comment: “Our blinding test validated IPD meta-analysis of minimal acupuncture treatments of infantile colic did not show clinically relevant effects in pain reduction as estimated by differences in crying time between needle acupuncture intervention and no acupuncture control. Analyses indicated that acupuncture treatment induced crying in many of the children. Caution should therefore be exercised in recommending potentially painful treatments with uncertain efficacy in infants. The studies are few, the analysis is made on small samples of individuals, and conclusions should be considered in this context. With this limitation in mind, our findings do not support the idea that percutaneous needle acupuncture should be recommended for treatment of infantile colic on a general basis.”
So, returning to the two questions that I listed above – what are the answers?
I think they must be:
The literature on malpractice in medicine is huge: more than 33 000 articles listed in Medline. By contrast, the literature on malpractice in alternative medicine hardly exists. An exception is this recent article. I therefore thought I share it with you and provide a few comments:
START OF QUOTE
According to the (US) National Practitioner Data Bank, between September 1, 1990 and January 29, 2012, a total of 5,796 chiropractic medical malpractice reports were filed. Lawsuits with the highest payouts in any medical field are related to misdiagnosis, failure to diagnose and delayed diagnosis of a severe medical condition.
Common reasons for chiropractic malpractice lawsuits:
Chiropractor causes stroke: Numerous cases have been documented in which a patient suffers a stroke after getting his or her neck manipulated, or adjusted. Especially forceful rotation of the neck from side to side can overextend an artery that runs along the spine, which can result in a blockage of blood flow to the brain. Strokes are among the most serious medical conditions caused by chiropractic treatment, and can result in temporary or permanent paralysis, and even death.
Herniated disc following adjustment: Although many patients seek the medical attention of a chiropractor after they have experienced a herniated disc, chiropractors can actually be the cause of the problem. Usually a herniated disc is caused by wear and tear, but a sudden heavy strain, increased pressure to the lower back or twisting motions can cause a sudden herniated disc. The stress that chiropractors exercise in their adjustments have been known to be the root cause of some herniated discs.
Sexual misconduct: The American Chiropractic Association has assembled a code of ethics “based upon the acknowledgement that the social contract dictates the profession’s responsibilities to the patient, the public and the profession.” Sexual misconduct is among the top ten reasons that patients file lawsuits against chiropractors. Often, chiropractic practices are unfamiliar to many new patients and can be misinterpreted as inappropriate even though they are absolutely normal, so it is important that patients familiarize themselves with common chiropractic methods of healing.
END OF QUOTE
In this context, a study of chiropractic from Canada might be interesting. It highlights the conclusions from Canadian courts: informed consent is an ongoing process that cannot be entirely delegated to office personnel… A further study showed that valid consent procedures are either poorly understood or selectively implemented by chiropractors. Arguably, not obtaining informed consent amounts to malpractice.
In our book, this is what we conclude about informed consent by alternative therapists in general: Genuine informed consent is unattainable for most CAM modalities. This presents a serious and intractable ethical problem for CAM practitioners. Attempts to square this circle by watering down or redeﬁning the criteria for informed consent are ethically indefensible. The concept of informed consent and its centrality in medical ethics therefore renders most CAM practice unacceptable. Conventional healthcare subscribes to the ethical principle ‘no consent, no treatment’: we are not aware of the existence of any good reasons to excuse CAM from this dictum.
I fear that, if we were to count the lack of informed consent by chiropractors (and other alternative practitioners) as malpractice, the numbers would be astronomical. Or, to put it differently, the often-cited relatively low malpractice rate in chiropractic is due to the omission of the vast majority of malpractice cases.
My previous post was about the question whether lay-homeopaths can practise homeopathy without breaking their code of ethics. The answer was NO, because they lack most of the skills needed to obtain informed consent.
What about doctor homeopaths?
Can they practice homeopathy ethically?
Doctors are, of course, also obliged to follow their ethical code, and that means they too must obtain informed consent from their patients before starting a therapy. This is, for instance, what the UK General Medical Council tells their members:
You must give patients the information they want or need about:
- the diagnosis and prognosis
- any uncertainties about the diagnosis or prognosis, including options for further investigations
- options for treating or managing the condition, including the option not to treat
- the purpose of any proposed investigation or treatment and what it will involve
- the potential benefits, risks and burdens, and the likelihood of success, for each option; this should include information, if available, about whether the benefits or risks are affected by which organisation or doctor is chosen to provide care
- whether a proposed investigation or treatment is part of a research programme or is an innovative treatment designed specifically for their benefit4
- the people who will be mainly responsible for and involved in their care, what their roles are, and to what extent students may be involved
- their right to refuse to take part in teaching or research
- their right to seek a second opinion
- any bills they will have to pay
- any conflicts of interest that you, or your organisation, may have
- any treatments that you believe have greater potential benefit for the patient than those you or your organisation can offer.
You should explore these matters with patients, listen to their concerns, ask for and respect their views, and encourage them to ask questions.
You should check whether patients have understood the information they have been given, and whether or not they would like more information before making a decision. You must make it clear that they can change their mind about a decision.
Following the 8 points from my previous post (I am trying to apply the same criteria to both types of homeopaths), a medical homeopath might tell her patient (whose stomach pain turns out to be caused, let’s assume, by a stomach ulcer) roughly this:
- The tests show that you are suffering from stomach ulcer.
- The natural history of this condition is usually benign, but it needs effective treatment; if not, the problem would become serious.
- Conventional medicine has several effective therapeutic options.
- I nevertheless propose to treat you with a homeopathic remedy.
- There is no good evidence that it will work beyond a placebo effect.
- The remedy is harmless, but not giving you an effective treatment might cause considerable harm.
- The cost of the consultation is £80, and the remedy will cost you around £15.
- I suggest you come again in a week or two; perhaps we need quite a few consultations altogether.
Again, as with the lay-homeopath from my previous post, any sensible patient would walk away without accepting the treatment. This means that our doctor homeopath can only practice homeopathy, if she does not inform her patient about points 5 and 6. In other words, doctors who practice homeopathy cannot obtain adequately informed consent. We have recently seen a real case of this happening and ending in the death of the patient.
Of course, the homeopath might send her patient to a specialist; or she might decide to administer a conventional therapy herself. Either way, she would not be practising homeopathy.
The dilemma is real, yet it is rarely considered. Here is a short passage from our book where we discuss the ethics of alternative medicine in full detail:
Genuine informed consent is unattainable for most CAM modalities. This presents a serious and intractable ethical problem for CAM practitioners. Attempts to square this circle by watering down or redeﬁning the criteria for informed consent are ethically indefensible. The concept of informed consent and its centrality in medical ethics therefore renders most CAM practice unacceptable. Conventional healthcare subscribes to the ethical principle ‘no consent, no treatment’; we are not aware of the existence of any good reasons to excuse CAM from this dictum.
As I said, the ethical practice of homeopathy is a practical impossibility.
Or do you think I got this wrong?
I am not a regular reader of the ‘HALTERNER ZEITUNG’, I have to admit; but this article from the paper came to me because of my interest in homeopathy. It tells a tragic story of a German women who paid dearly for consulting a homeopath.
Here is an excerpt – as it is in German, I will sum up the essence of the story below in English.
…Die traurige Geschichte beginnt im Jahr 2012. Die später verstorbene Frau aus Haltern lässt sich von ihrer Ärztin wegen Heiserkeit behandeln und bekommt homöopathische Mittel. Rund zehn Monate später wechselt die Seniorin den Arzt und muss umgehend ins Krankenhaus: Luftröhrenschnitt, Kehlkopf-Entfernung, Krebs. Die Frau verstirbt nach vierjähriger Leidenszeit.
Für Schwester und Tochter war das nicht nur ein Schock, sie machen der Ärztin nun auch schwere Vorwürfe. Aus ihrer Sicht hätte praktisch sofort eine Überweisung zu einem HNO-Arzt und damit eine schulmedizinische Behandlung erfolgen müssen.
Genau das habe die Patientin aber nicht gewollt, sagte die Ärztin. „Sie hat sich immer dagegen gewehrt.“ Angeblich soll das auch dokumentiert sein. Doch auch das ist umstritten. Die Hinterbliebenen werfen der Ärztin nämlich vor, die Unterlagen gefälscht zu haben.
150.000 Euro haben sie als Schmerzensgeld eingeklagt. Dafür sah die Medizinkammer zum jetzigen Zeitpunkt jedoch keine Grundlage. „Die Haftung ist vollkommen offen“, sagte Richter Norbert Schalla.
Man wolle die Leiden der Frau zwar nicht in Abrede stellen. Die Frage sei jedoch, inwieweit die Behandlung eines krankheitsbedingten Leidens tatsächlich verzögert worden sei. „Wir müssten erstens eine Pflichtverletzung und zweitens die Kausalität feststellen“, so Schalla. Beides sei aber außerordentlich schwierig, weil es außer der Ärztin keine Zeugen gebe.
Trotzdem hatten die Richter am Essener Landgericht am Ende eine „Goodwill-Zahlung“ vorgeschlagen, um einen möglicherweise jahrelangen Rechtsstreit zu verhindern. „Manchmal ist es besser, zu einem Abschluss zu kommen, damit man seinen inneren Frieden wiederfinden kann.“
Genau so hat es die Ärztin am Ende wohl auch gesehen. Ob die 10.000 Euro aber wirklich gezahlt werden, hängt allerdings noch von ihrer Haftpflicht-Versicherung ab. Die kann in den nächsten zwei Wochen noch ihr Veto einlegen.
Auch die Hinterbliebenen können die Einigung noch immer widerrufen. Sie müssen von dem Geld nämlich 94 Prozent der Prozesskosten tragen.
Here is my summary:
- An elderly woman with a sore throat consults her doctor who happens to be a homeopath.
- The doctor prescribes homeopathic remedies.
- The homeopathic treatment continues for months, evidently without success.
- 10 months later, the patient changes her doctor, and her new physician sends her straight away into hospital.
- There she is diagnosed with throat cancer.
- After 4 years of suffering, the woman dies.
- The patients relatives sue the homeopath for the relatively modest sum of 150 000 Euros.
- The homeopath claims that the old woman had refused to be referred to a specialist and that the case notes provide proof for that claim.
- The relatives suspect that the case notes have been altered retrospectively.
- The judge suggest a ‘good will’ payment of 10 000 Euro.
- The homeopath accepts, but it remains unclear whether the insurance agrees to pay this sum.
- The relatives have to pay 94% of the costs for the court proceedings.
Anyone who claims that homeopathy is harmless should remember this story. Similar (but hopefully less dramatic) things happen almost every time a homeopath treats a patient, we argue in our book. The practice of homeopathy is by and large medical neglect. Because homeopathy is employed mostly for minor, self-limiting conditions, the neglect usually remains invisible. However, as soon as homeopath venture to treat serious diseases, the neglect (the deliberate treatment of a disease with an ineffective therapy) becomes obvious.
We recently discussed the deplorable case of Larry Nassar and the fact that the ‘American Osteopathic Association’ stated that intravaginal manipulations are indeed an approved osteopathic treatment. At the time, I thought this was a shocking claim. So, imagine my surprise when I was alerted to a German trial of osteopathic intravaginal manipulations.
Here is the full and unaltered abstract of the study:
Introduction: 50 to 80% of pregnant women suffer from low back pain (LBP) or pelvic pain (Sabino und Grauer, 2008). There is evidence for the effectiveness of manual therapy like osteopathy, chiropractic and physiotherapy in pregnant women with LBP or pelvic pain (Liccardione et al., 2010). Anatomical, functional and neural connections support the relationship between intrapelvic dysfunctions and lumbar and pelvic pain (Kanakaris et al., 2011). Strain, pressure and stretch of visceral and parietal peritoneum, bladder, urethra, rectum and fascial tissue can result in pain and secondary in muscle spasm. Visceral mobility, especially of the uterus and rectum, can induce tension on the inferior hypogastric plexus, which may influence its function. Thus, stretching the broad ligament of the uterus and the intrapelvic fascia tissue during pregnancy can reinforce the influence of the inferior hypogastric plexus. Based on above facts an additional intravaginal treatment seems to be a considerable approach in the treatment of low back pain in pregnant women.
Objective: The purpose of this study was to compare the effect of osteopathic treatment including intravaginal techniques versus osteopathic treatment only in females with pregnancy-related low back pain.
Methods: Design: The study was performed as a randomized controlled trial. The participants were randomized by drawing lots, either into the intervention group including osteopathic and additional intravaginal treatment (IV) or a control group with osteopathic treatment only (OI). Setting: Medical practice in south of Germany.
Participants 46 patients were recruited between the 30th and 36th week of pregnancy suffering from low back pain.
Intervention Both groups received three treatments within a period of three weeks. Both groups were treated with visceral, mobilization, and myofascial techniques in the cervical, thoracic and lumbar spine, the pelvic and the abdominal region (American Osteopathic Association Guidelines, 2010). The IV group received an additional treatment with intravaginal techniques in supine position. This included myofascial techniques of the M. levator ani and the internal obturator muscles, the vaginal tissue, the pubovesical and uterosacral ligaments as well as the inferior hypogastric plexus.
Main outcome measures As primary outcome the back pain intensity was measured by Visual Analogue Scale (VAS). Secondary outcome was the disability index assessed by Oswestry-Low-Back-Pain-Disability-Index (ODI), and Pregnancy-Mobility-Index (PMI).
Results: 46 participants were randomly assigned into the intervention group (IV; n = 23; age: 29.0 ±4.8 years; height: 170.1 ±5.8 cm; weight: 64.2 ±10.3 kg; BMI: 21.9 ±2.6 kg/m2) and the control group (OI; n = 23; age: 32.0 ±3.9 years; height: 168.1 ±3.5 cm; weight: 62.3 ±7.9 kg; BMI: 22.1 ±3.2 kg/m2). Data from 42 patients were included in the final analyses (IV: n=20; OI: n=22), whereas four patients dropped out due to general pregnancy complications. Back pain intensity (VAS) changed significantly in both groups: in the intervention group (IV) from 59.8 ±14.8 to 19.6 ±8.4 (p<0.05) and in the control group (OI) from 57.4 ±11.3 to 24.7 ±12.8. The difference between groups of 7.5 (95%CI: -16.3 to 1.3) failed to demonstrate statistical significance (p=0.93). Pregnancy-Mobility-Index (PMI) changed significantly in both groups, too. IV group: from 33.4 ±8.9 to 29.6 ±6.6 (p<0.05), control group (OI): from 36.3 ±5.2 to 29.7 ±6.8. The difference between groups of 2.6 (95%CI: -5.9 to 0.6) was not statistically significant (p=0.109). Oswestry-Low-Back-Pain-Disability-Index (ODI) changed significantly in the intervention group (IV) from 15.1 ±7.8 to 9.2 ±3.6 (p<0.05) and also significantly in the control group (OI) from 13.8 ±4.9 to 9.2 ±3.0. Between-groups difference of 1.3 (95%CI: -1.5 to 4.1) was not statistically significant (p=0.357).
Conclusions: In this sample a series of osteopathic treatments showed significant effects in reducing pain and increasing the lumbar range of motion in pregnant women with low back pain. Both groups attained clinically significant improvement in functional disability, activity and quality of life. Furthermore, no benefit of additional intravaginal treatment was observed.
END OF QUOTE
My first thoughts after reading this were: how on earth did the investigators get this past an ethics committee? It cannot be ethical, in my view, to allow osteopaths (in Germany, they have no relevant training to speak of) to manipulate women intravaginally. How deluded must an osteopath be to plan and conduct such a trial? What were the patients told before giving informed consent? Surely not the truth!
My second thoughts were about the scientific validity of this study: the hypothesis which this trial claims to be testing is a far-fetched extrapolation, to put it mildly; in fact, it is not a hypothesis, it’s a very daft idea. The control-intervention is inadequate in that it cannot control for the (probably large) placebo effects of intravaginal manipulations. The observed outcomes are based on within-group comparisons and are therefore most likely unrelated to the treatments applied. The conclusion is as barmy as it gets; a proper conclusion should clearly and openly state that the results did not show any effects of the intravaginal manipulations.
In summary, this is a breathtakingly idiotic trial, and everyone involved in it (ethics committee, funding body, investigators, statistician, reviewers, journal editor) should be deeply ashamed and apologise to the poor women who were abused in a most deplorable fashion.
The RCC is a relatively new organisation. It is a registered charity claiming to promote “professional excellence, quality and safety in chiropractic… The organisation promotes and supports high standards of education, practice and research, enabling chiropractors to provide, and to be recognised for providing, high quality care for patients.”
I have to admit that I was not impressed by the creation of the RCC and lately have not followed what they are up to – not a lot, I assumed. But now they seem to plan a flurry of most laudable activities:
The Royal College of Chiropractors is developing a range of initiatives designed to help chiropractors actively engage with health promotion, with a particular focus on key areas of public health including physical activity, obesity and mental wellbeing.
Dr Mark Gurden, Chair of the RCC Health Policy Unit, commented:
“Chiropractors are well placed to participate in public health initiatives. Collectively, they have several million opportunities every year in the UK to support people in making positive changes to their general health and wellbeing, as well as helping them manage their musculoskeletal health of course.
Our recent AGM & Winter Conference highlighted the RCC’s intentions to encourage chiropractors to engage with a public health agenda and we are now embarking on a programme to:
- Help chiropractors recognise the importance of their public health role;
- Help chiropractors enhance their knowledge and skills in providing advice and support to patients in key areas of public health through provision of information, guidance and training;
- Help chiropractors measure and recognise the impact they can have in key areas of public health.
To take this work forward, we will be exploring the possibility of launching an RCC Public Health Promotion & Wellbeing Society with a view to establishing a new Specialist Faculty in due course.”
END OF QUOTE
A ‘Public Health Promotion & Wellbeing Society’. Great!
As this must be new ground for the RCC, let me list a few suggestions as to how they could make more meaningful contributions to public health:
- They could tell their members that immunisations are interventions that save millions of lives and are therefore in the interest of public health. Many chiropractors still have a very disturbed attitude towards immunisation: anti-vaccination attitudes still abound within the chiropractic profession. Despite a growing body of evidence about the safety and efficacy of vaccination, many chiropractors do not believe in vaccination, will not recommend it to their patients, and place emphasis on risk rather than benefit. In case you wonder where this odd behaviour comes from, you best look into the history of chiropractic. D. D. Palmer, the magnetic healer who ‘invented’ chiropractic about 120 years ago, left no doubt about his profound disgust for immunisation: “It is the very height of absurdity to strive to ‘protect’ any person from smallpox and other malady by inoculating them with a filthy animal poison… No one will ever pollute the blood of any member of my family unless he cares to walk over my dead body… ” (D. D. Palmer, 1910)
- They could tell their members that chiropractic for children is little else than a dangerous nonsense for the sake of making money. Not only is there ‘not a jot of evidence‘ that it is effective for paediatric conditions, it can also cause serious harm. I fear that this suggestion is unlikely to be well-received by the RCC; they even have something called a ‘Paediatrics Faculty’!
- They could tell their members that making bogus claims is not just naughty but hinders public health. Whenever I look on the Internet, I find more false than true claims made by chiropractors, RCC members or not.
- They could tell their members that informed consent is not an option but an ethical imperative. Actually, the RCC do say something about the issue: The BMJ has highlighted a recent UK Supreme Court ruling that effectively means a doctor can no longer decide what a patient needs to know about the risks of treatment when seeking consent. Doctors will now have to take reasonable care to ensure the patient is aware of any material risks involved in any recommended treatment, and of any reasonable alternative or variant treatments. Furthermore, what counts as material risk can no longer be based on a responsible body of medical opinion, but rather on the view of ‘a reasonable person in the patient’s position’. The BMJ article is available here. The RCC feels it is important for chiropractors to be aware of this development which is relevant to all healthcare professionals. That’s splendid! So, chiropractors are finally being instructed to obtain informed consent from all their patients before starting treatment. This means that patients must be told that spinal manipulation is associated with very serious risks, AND that, in addition, ~ 50% of all patients will suffer from mild to moderate side effects, AND that there are always less risky and more effective treatments available for any condition from other healthcare providers.
- The RCC could, for the benefit of public health, establish a compulsory register of adverse effects after spinal manipulations and make the data from it available to the public. At present such a register does not exist, and therefore its introduction would be a significant step in the right direction.
- The RCC could make it mandatory for all members to adhere to the above points and establish a mechanism of monitoring their behaviour to make sure that, for the sake of public health, they all do take these issues seriously.
I do realise that the RCC may not currently have the expertise and know-how to adopt my suggestions, as these issues are rather new to them. To support the RCC in their praiseworthy endeavours, I herewith offer to give one or more evidence-based lectures on these subjects (at a date and place of their choice) in an attempt to familiarise the RCC and its members with these important aspects of public health. I also realise that the RCC may not have the funds to pay professorial lecture fees. Therefore, in the interest of both progress and public health, I offer to give these lectures for free.
I can be contacted via this blog.
In 2017, Medline listed just over 1800 articles on ‘complementary alternative medicine’. If you find this number impressively high, consider that, for ‘surgery’ (a subject that has often been branded as less that active in conducting research), there were almost 18 000 Medline-listed papers.
So, the research activity in CAM is relatively small. Vis a vis the plethora of open questions, this inactivity is perhaps lamentable. What I find much more regrettable, however, is the near total lack of investigations into the ethical issues in CAM. In 2017, there were just 11 articles on Medline on ‘ethics and CAM’ (24393 articles on ‘ethics and surgery’).
One of the 11 papers that tackled the ethics directly and that was (in my opinion) one of the best is this article. Here is its concluding paragraph:
When we encounter patients who use or consider the use of complementary and/or alternative medicine, we should respect their autonomy while also fulfilling our obligations of beneficence and nonmaleficence. Physicians should become more knowledgeable about research on CAM therapies and approach discussions in an open, nonjudgmental manner to enhance patient trust. In situations where there is little risk of harm and the possibility of benefit, supporting a patient in their interest in complementary therapies can strengthen the patient-physician relationship. However, when a patient’s desire to utilize alternative therapies poses a health risk, physicians have the ethical obligation to skillfully counsel the patient toward those therapies that are medically appropriate.
I have had a long-lasting and keen interest in the ethics of CAM which resulted in the publication of many papers. Here is a selection:
For most of the time conducting this research, I felt that I was almost alone in realising the importance of this topic. And all this time, I was convinced that the subject needed more attention and recognition. Therefore, I teamed up with with the excellent ethicist Kevin Smith from the University of Dundee, and together we spent the best part of 2017 writing about it.
Our book is entitled ‘MORE HARM THAN GOOD? THE MORAL MAZE OF COMPLEMENTARY AND ALTERNATIVE MEDICINE’ and will be published shortly by Springer.
It is an attempt to highlight some of the most important topics in this broad and under-researched area. While working on it, I was continually struck by the fact that most of the issues we have been struggling with on this blog are, in the final analysis, ethical by nature.
My hope is that, in 2018, we will see many more high quality papers filling the almost total void of ethical perspectives on CAM. In my view, it is unquestionably an area that needs to be addressed with some urgency.