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

children

1 2 3 9

Reiki is a form of energy healing popularised by the Japanese Mikao Usui (1865-1926). ‘Rei’ means universal spirit (sometimes thought of as a supreme being), and ‘ki’ is the assumed universal life energy. Reiki is broadly based on some of the obsolete concepts of Traditional Chinese Medicine. Reiki practitioners believe that they can transfer ‘healing energy’ to a patient which, in turn, stimulates the self-healing properties of the body. They assume that the therapeutic effects of this technique are obtained from a ‘universal life energy’ that provides strength, harmony, and balance to the body and mind.

This study (entitled ‘ The Power of Reiki’) was conducted to pilot testing the feasibility and efficacy of Reiki to provide pain relief among pediatric patients undergoing hematopoietic stem cell transplantation (HSCT). Paediatric patients undergoing HSCT during the inpatient phase in the Stem Cell Transplantation Unit were eligible to participate. Short and medium effects were assessed investigating the increase or decrease of patient’s pain during three specific time periods (“delta”) of the day: morning of the Reiki session versus assessment before Reiki session (within subjects control period), assessment before Reiki session versus assessment after Reiki session (within subjects experimental period) and assessment after Reiki session versus morning the day after Reiki session (within subject follow-up period). The effect of 88 Reiki therapy sessions in nine patients was analysed following a short, medium, and long-term perspective. Repeated-measures analysis of variance revealed a significant difference among the three periods: a decrease of the pain occurred in the experimental period in short and medium term, while in the follow-up period, the pain level remained stable.

The authors concluded that this study demonstrates the feasibility of using Reiki therapy in pediatric cancer patients undergoing HSCT. Furthermore, these findings evidence that trained pediatric oncology nurses can insert Reiki into their clinical practice as a valid instrument for diminishing suffering from cancer in childhood.

This is an unusual conclusion in that it is strictly speaking correct. What is wrong, however, that the abstract reports findings related to the alleged effectiveness of Reiki. A feasibility study is not designed for that purpose. I therefore suggest to ignore all allusions to therapeutic effects.

This, I think, begs the question as to why it is necessary or productive to study Reiki in clinical trials.

  • The treatment is not plausible.
  • There have been many trials already.
  • The ones that are sufficiently rigorous fail to show that it has any effects beyond placebo.
  • The medical literature is already highly polluted with Reiki studies reporting false-positive results.
  • This can only confuse researchers who attempt to conduct reviews on the subject.
  • Reiki studies discredit clinical research.
  • They are a waste of valuable resources.
  • Arguably, they are even unethical.

If you ask me, it is high time to stop researching such implausible nonsense.

 

Bleach can be a useful product – but not as a medicine taken by mouth or for injection.

A 39-year-old man with a fracture of the right acetabulum underwent open reduction and internal fixation with a plate under general anaesthesia. At closure, the surgeons injected 0.75% ropivacaine into the subcutaneous tissue of the incision wound for postoperative analgesia. Soon after injection, subcutaneous emphysema at the injection site and a sudden decrease in end-tidal CO2 tension with crude oscillatory ripples during the alveolar plateau phase were observed. Shortly thereafter, it was found that the surgeons had mistakenly injected hydrogen peroxide instead of ropivacaine. Fortunately, the patient recovered to normal status after 10 minutes. After the surgery, the patient was carefully observed for suspected pulmonary embolism and discharged without complications.

A team from Morocco reported the case of a massive embolism after hydrogen peroxide use in the cleaning of infected wound with osteosynthesis material left femoral done under spinal anaesthesia in a young girl of 17 years admitted after to the ICU intubated ventilated. She was placed under mechanical ventilation with vasoactive drugs for ten hours and then extubated without neurological sequelae.

Tunisian doctors reported 2 cases of embolic events with neurological signs. The first, during a pleural cleaning with hydrogen peroxide after cystectomy of a pulmonary hydatic cyst at the right upper lobe. The second case, after a pleural washing during the treatment of hepatitic hydatidosis complicated by a ruptured cyst in the thorax.

Canadian anaesthetists reported a case of suspected oxygen venous embolism during lumbar discectomy in the knee-prone position after use of H2O2. Immediately after irrigation of a discectomy wound with H2O2, a dramatic decrease of the PETCO2, blood pressure and oxygen saturation coincident with ST segment elevation occurred suggesting a coronary gas embolism. Symptomatic treatment was initiated immediately and the patient recovered without any sequelae.

Indian nephrologists reported a case of chlorine dioxide poisoning presenting with acute kidney injury.

A 1-year-old boy presented to the emergency department with vomiting and poor complexion after accidentally ingesting a ClO2-based household product. The patient had profound hypoxia that did not respond to oxygen therapy and required endotracheal intubation to maintain a normal oxygen level. Methemoglobinemia was suspected based on the gap between SpO2 and PaO2, and subsequently increased methemoglobin at 8.0% was detected. The patient was admitted to the paediatric intensive care unit for further management. After supportive treatment, he was discharged without any complications. He had no cognitive or motor dysfunction on follow up 3 months later.

The medical literature is littered with such case-reports. They give us a fairly good idea that the internal use of bleach is not a good idea. In fact, it has caused several deaths. Yet, this is precisely what some SCAM practitioners are advocating.

Now one of them is in court for manslaughter. “If I am such a clear and present danger and a murderer, I should be in jail by now,” said doctor Shortt, who despite a criminal investigation, is still treating patients in his office on the outskirts of Columbia, S.C. Shortt got his medical degree 13 years ago on the Caribbean island of Montserrat. Being a “longevity physician” didn’t seem to bother anyone until one of his patients wound up dead. Shortt gave her an infusion of hydrogen peroxide. Katherine Bibeau, a medical technologist and a mother of two, had been battling multiple sclerosis for two years, and was looking for any treatment that might keep her out of a wheelchair. According to her husband, doctor Shortt said hydrogen peroxide was just the thing. “He had said that there was other people who had been in wheelchairs, and had actually gone through treatment and were now walking again.” It didn’t worry the Bibeaus that Shortt wasn’t affiliated with any hospital or university – and that insurance didn’t cover most of his treatments. “He was a licensed medical doctor in Carolina,” says Bibeau. “So I put my faith in those credentials.” According to Shortt’s own records, the patient subsequently complained of “nausea,” “leg pain,” and later “bruises” with no clear cause. “She went Tuesday, she went Thursday. And by 11 o’clock on Sunday, she died,” says Mr Bibeau. Shortt never told him or his wife about any serious risks. “Even if it wasn’t effective, it should not have been harmful.”

Shortt has been putting hydrogen peroxide in several of his patients’ veins, because he believes it can effectively treat illnesses from AIDS to the common cold. “I think it’s an effective treatment for the flu,” says Shortt, who also believes that it’s effective for multiple sclerosis, Lyme disease, and “as adjunctive therapy” for heart disease. “Things that involve the immune system, viruses, bacteria, sometimes parasites.”

He’s not the only physician using this treatment. Intravenous hydrogen peroxide is a SCAM touted as a cure the medical establishment doesn’t want you to know about. There even is an association that claims to have trained hundreds of doctors how to administer it. The theory is that hydrogen peroxide releases extra oxygen inside the body, killing viruses and bacteria.

Natural News, for instance, tells us that cancer has a rival that destroys it like an M-60 leveling a field of enemy soldiers. It’s called “hydrogen peroxide,” and the “lame-stream,” mainstream media will tell you how “dangerous” it is at 35%, but they won’t tell you that you can drip a couple drops in a glass of water each day and end cancer. Yes, it’s true.

And hydrogen peroxide is not the only bleach that found its way into the realm of SCAM.

Perhaps even worse (if that is possible), the Genesis II Church of Health and Healing promote MMS as a miracle cure. It consists of chlorine dioxide, a powerful bleach that has been banned in several countries around the world for use as a medical treatment. The ‘Church’ claim that MMS cures 95% of all diseases in the world by making adults and children, including infants, drink industrial bleach. The group is inviting members to attend what they call their “effective alternative healing”.

The organizer of the event, Tom Merry, has publicized it by telling people that learning how to consume the bleach “could save your life, or the life of a loved one sent home to die”. The “church” is asking attendants of the meeting to “donate” $450 each, or $800 per couple, in exchange for receiving membership to the organization as well as packages of the bleach, which they call “sacraments”. The chemical is referred to as MMS, or “miracle mineral solution or supplement”, and participants are promised they will acquire “the knowledge to help heal many people of this world’s terrible diseases”.

Fiona O’Leary, a tireless and courageous campaigner for putting an end to a wide variety of mistreatments of children and adults, whose work helped to get MMS banned in Ireland, said she was horrified that the Genesis II Church, which she called a “bleach cult”, was hosting a public event in Washington.

In Fiona’s words: “ Its experimentation and abuse”. I do agree and might just add this: selling bleach for oral or intravenous application, while pretending it is an effective medicine, seems criminal as well.

Exactly 20 years ago, I published a review concluding that the generally high and possibly growing prevalence of complementary/alternative medicine use by children renders this topic an important candidate for rigorous investigation. Since then, many papers have emerged, and most of them are worrying in one way or another. Here is the latest one.

This Canadian survey assessed chiropractic (DC) and naturopathic doctors’ (ND) natural health product (NHP) recommendations for paediatric care. It was developed in collaboration with DC and ND educators, and delivered as an on-line national survey. NHP dose, form of delivery, and indications across paediatric age ranges (from newborn to 16 years) for each practitioner’s top five NHPs were assessed. Data were analysed using descriptive statistics, t-tests, and non-parametric tests.

Of the 421 respondents seeing one or more paediatric patients per week, 172 (41%, 107 DCs, 65 NDs) provided 440 NHP recommendations, categorized as:

  • vitamins and minerals (89 practitioners, 127 recommendations),
  • probiotics (110 practitioners, 110 recommendations),
  • essential fatty acids (EFAs: 72 practitioners, 72 recommendations),
  • homeopathics (56 practitioners, 66 recommendations),
  • botanicals (29 practitioners, 31 recommendations),
  • other NHPs (33 practitioners, 34 recommendations).

Indications for the NHP recommendations were tabulated for NHPs with 10 or more recommendations in any age category:

  • 596 total indications for probiotics,
  • 318 indications for essential fatty acids,
  • 138 indications for vitamin D,
  • 71 indications for multi-vitamins.

Good evidence regarding the efficacy, safety, and dosing for NHP use in children is scarce or even absent. Therefore, the finding that so many DCs and NDs recommend unproven NHPs for use in children is worrying, to say the least. It seems to indicate that, at least in Canada, DCs and NDs are peddling unproven, mostly useless  and potentially harmful children.

In an earlier, similar survey the same group of researchers had disclosed that the majority of Canadian DCs and NDs seem to see infants, children, and youth for a variety of health conditions and issues, while, according to their own admission, not having adequate paediatric training.

Is this a Canadian phenomenon? If you think so, read this abstract:

AIM:

This systematic review is aimed at estimating the prevalence of complementary and alternative medicine (CAM)-use by paediatric populations in the United Kingdom (UK).

METHOD:

AMED, CINAHL, COCHRANE, EMBASE and MEDLINE were searched for English language peer-reviewed surveys published between 01 January 2000 and September 2011. Additionally, relevant book chapters and our own departmental files were searched manually.

RESULTS:

Eleven surveys were included with a total of 17,631 paediatric patients. The majority were of poor methodological quality. Due to significant heterogeneity of the data, a formal meta-analysis was deemed inappropriate. Ten surveys related to CAM in general, while one was specifically on homeopathy. Across all surveys on CAM in general, the average one-year prevalence rate was 34% and the average lifetime prevalence was 42%. In surveys with a sample size of more than 500, the prevalence rates were considerably lower than in surveys with the sample size of lower than 500. Herbal medicine was the most popular CAM modality, followed by homeopathy and aromatherapy.

CONCLUSIONS:

Many paediatric patients in the UK seem to use CAM. Paediatricians should therefore have sufficient knowledge about CAM to issue responsible advice.

This means, I fear, that children are regularly treated by SCAM practitioners who are devoid of the medical competence to do so, and  who prescribe or recommend treatments of unknown value, usually without the children needing them.

Why are regulators not more concerned about this obvious abuse?

The purpose of this recently published survey was to obtain the demographic profile and educational background of chiropractors with paediatric patients on a multinational scale.

A multinational online cross-sectional demographic survey was conducted over a 15-day period in July 2010. The survey was electronically administered via chiropractic associations in 17 countries, using SurveyMonkey for data acquisition, transfer, and descriptive analysis.

The response rate was 10.1%, and 1498 responses were received from 17 countries on 6 continents. Of these, 90.4% accepted paediatric cases. The average practitioner was male (61.1%) and 41.4 years old, had 13.6 years in practice, and saw 107 patient visits per week. Regarding educational background, 63.4% had a bachelor’s degree or higher in addition to their chiropractic qualification, and 18.4% had a postgraduate certificate or higher in paediatric chiropractic.

The authors from the Anglo-European College of Chiropractic (AECC), Bournemouth University, United Kingdom, drew the following conclusion: this is the first study about chiropractors who treat children from the United Arab Emirates, Peru, Japan, South Africa, and Spain. Although the response rate was low, the results of this multinational survey suggest that pediatric chiropractic care may be a common component of usual chiropractic practice on a multinational level for these respondents.

A survey with a response rate of 10%?

An investigation published 9 years after it has been conducted?

Who at the AECC is responsible for controlling the quality of the research output?

Or is this paper perhaps an attempt to get the AECC into the ‘Guinness Book of Records’ for outstanding research incompetence?

But let’s just for a minute pretend that this paper is of acceptable quality. If the finding that ~90% of chiropractors tread kids is approximately correct, one has to be very concerned indeed.

I am not aware of any good evidence that chiropractic care is effective for paediatric conditions. On the contrary, it can do quite a bit of direct harm! To this, we sadly also have to add the indirect harm many chiropractors cause, for instance, by advising parents against vaccinating their kids.

This clearly begs the question: is it not time to stop these charlatans?

What do you think?

‘Mom’s Choice Awards’ have just honoured the homeopathic product ‘COLD CALM KIDS’. This remedy has the following ingredients:

  • Allium cepa 3C HPUS
  • Apis mellifica 15C HPUS
  • Eupatorium perfoliatum 3C HPUS
  • Gelsemium sempervirens 6C HPUS
  • Kali bichromicum 6C HPUS
  • Nux vomica 3C HPUS
  • Phytolacca decandra 6C HPUS
  • Pulsatilla 6C HPUS

3C = a dilution of 1:1000000

6C = a dilution of 1:1000000000000

15C = a dilution of 1:1000000000000000000000000000000

The ingredients are, according to this website, claimed to have the following effects:

  • Allium cepa 3C HPUS – Relieves sneezing and runny nose
  • Apis mellifica 15C HPUS – Relieves nasal congestion
  • Eupatorium perfoliatum 3C HPUS – Relieves aches associated with colds
  • Gelsemium sempervirens 6C HPUS – Relieves headaches associated with colds
  • Kali bichromicum 6C HPUS – Relieves nasal discharge
  • Nux vomica 3C HPUS – Relieves sneezing attacks
  • Phytolacca decandra 6C HPUS – Relieves mild fever
  • Pulsatilla 6C HPUS – Relieves colds with a loss of taste and smell

The formula could easily make Hahnemann turn in his grave! It goes against most of what he has been teaching. But I found these claims interesting nevertheless.

Are they true? To find out, I did some research. Here is what I found (in case anyone can find more evidence, I’d be most grateful to let me know):

  • Allium cepa 3C HPUS – Relieves sneezing and runny nose NO GOOD EVIDENCE FOR THIS CLAIM
  • Apis mellifica 15C HPUS – Relieves nasal congestion NO GOOD EVIDENCE FOR THIS CLAIM
  • Eupatorium perfoliatum 3C HPUS – Relieves aches associated with colds NO GOOD EVIDENCE FOR THIS CLAIM
  • Gelsemium sempervirens 6C HPUS – Relieves headaches associated with colds NO GOOD EVIDENCE FOR THIS CLAIM
  • Kali bichromicum 6C HPUS – Relieves nasal discharge NO GOOD EVIDENCE FOR THIS CLAIM
  • Nux vomica 3C HPUS – Relieves sneezing attacks NO GOOD EVIDENCE FOR THIS CLAIM
  • Phytolacca decandra 6C HPUS – Relieves mild fever NO GOOD EVIDENCE FOR THIS CLAIM
  • Pulsatilla 6C HPUS – Relieves colds with a loss of taste and smell NO GOOD EVIDENCE FOR THIS CLAIM

I am confused! If there is no good evidence, how come Boiron, the manufacturer of the product, is allowed to make these claims? And how come the product just was given an award?

The Mom’s Choice Awards® (MCA) evaluates products and services created for children, families and educators. The program is globally recognized for establishing the benchmark of excellence in family-friendly media, products and services. The organization is based in the United States and has reviewed thousands of items from more than 55 countries…

An esteemed panel of evaluators includes education, media and other experts as well as parents, children, librarians, performing artists, producers, medical and business professionals, authors, scientists and others.

MCA evaluators volunteer their time and are bound by a strict code of ethics which ensures expert and objective analysis free from any manufacturer association.

The evaluation process uses a proprietary methodology in which items are scored on a number of elements including production quality, design, educational value, entertainment value, originality, appeal and cost. Each item is judged on its own merit.

MCA evaluators are especially interested in items that help families grow emotionally, physically and spiritually; are morally sound and promote good will; and are inspirational and uplifting…

Now I am even more confused!

A benchmark of excellence?

A strict code of ethics?

Morally sound?

I must have misunderstood something! Or perhaps the award was for achieving a maximum of 8 false claims for one single product!? Can someone please enlighten me?

Here is the abstract of a paper that makes even the most senior assessor of quackery shudder:

Objective:

The purpose of this report is to describe the manipulation under anesthesia (MUA) treatment of 6 infants with newborn torticollis with a segmental dysfunction at C1/C2.

Clinical Features:

Six infants aged 4 1/2 to 15 months previously diagnosed with newborn torticollis were referred to a doctor of chiropractic owing to a failure to respond adequately to previous conservative therapies. Common physical findings were limited range of motion of the upper cervical spine. Radiographs demonstrated rotational malpositions and translation of atlas on axis in all 6 infants, and 1 had a subluxation of the C1/C2 articulation.

Interventions and Outcome:

Selection was based on complexity and variety of different clinical cases qualifying for MUA. Treatment consisted of 1 mobilization and was performed in the operating room of a children’s hospital by a certified chiropractic physician with the author assisting. Along with the chiropractor and his assistant, a children’s anesthesiologist, 1 to 2 operating nurses, a children’s radiologist, and in 1 case a pediatric surgeon were present. Before the mobilization, plain radiographs of the cervico-occipital area were taken. Three infants needed further investigation by a pediatric computed tomography scan of the area because of asymmetric bony conditions on the plain radiographs. Follow-up consultations at 2, 3, 5, or 6 weeks were done. Patient records were analyzed for restriction at baseline before MUA compared with after MUA treatment for active rotation, passive rotation, and passive rotation in full flexion of the upper cervical spine. All 3 measurements showed significant differences. The long-term outcome data was collected via phone calls to the parents at 6 to 72 months. The initial clinical improvements were maintained.

Conclusion:

These 6 infants with arthrogenic newborn torticollis, who did not respond to previous conservative treatment methods, responded to MUA.

___________________________________________________________________

After reading the full text, I see many very serious problems and questions with this paper; here are 14 of the most obvious ones.

1. A congenital torticollis (that’s essentially what these kids were suffering from) has a good prognosis and does not require such invasive treatments. There is thus no plausible reason to conduct a case series of this nature.

2. A retrospective case series does not allow conclusions about therapeutic effectiveness, yet in the article the author does just that.

3. The same applies to her conclusions about the safety of the interventions.

4. It is unclear how the 6 cases were selected; it seems possible or even likely that they are, in fact, 6 cases of many more treated over a long period of time.

5. If so, this paper is hardly a ‘retrospective case series’; at best it could be called a ‘best case series’.

6. The X-rays or CT scans are unnecessary and potentially harmful.

7. The anaesthesia is potentially very harmful and unjustifiable.

8. The outcome measure is unreliable, particularly if performed by the chiropractor who has a vested interest in generating a positive result.

9. The follow-up by telephone is inadequate.

10. The range of the follow-up period (6-72 months) is unacceptable.

11. The exact way in which informed consent was obtained is unclear. In particular, we would need to know whether the parents were fully informed about the futility of the treatment and its considerable risks.

12. The chiropractor who administered the treatments is not named. Why not?

13. Similarly, it is unclear why the other healthcare professionals involved in these treatments are not named as co-authors of the paper.

14. It is unclear whether ethical approval was obtained for these treatments.

The author seems inexperienced in publishing scientific articles; the present one is poorly written and badly constructed. A Medline research reveals that she has only one other publication to her name. So, perhaps one should not be too harsh in judging her. But what about her supervisors, the journal, its reviewers, its editor and the author’s institution? The author comes from the Department of Chiropractic Medicine, Medical Faculty University, Zurich, Switzerland. On their website, they state:

The Faculty of Medicine of the University of Zurich is committed to high quality teaching and continuing research-based education of students in health care professions. Excellent and internationally recognised scientists and clinically outstanding physicians are at the Faculty of Medicine devoted to patients and public health, to teaching, to the support of young researchers and to academic medicine. The interaction between research and teaching, and their connection to clinical practice play a central role for us…

The Faculty of Medicine of the University of Zurich promotes innovative research in the basic fields of medicine, in the clinical application of knowledge, in personalised medicine, in health care, and in the translational connection between all these research areas. In addition, it encourages the cooperation between primary care and specialised health care.

It seems that, with the above paper, the UZH must have made an exception. In my view, it is a clear case of scientific misconduct and child abuse.

The present trial evaluated the efficacy of homeopathic medicines of Melissa officinalis (MO), Phytolacca decandra (PD), and the combination of both in the treatment of possible sleep bruxism (SB) in children (grinding teeth during sleep).

Patients (n = 52) (6.62 ± 1.79 years old) were selected based on the parents report of SB. The study comprised a crossover design that included 4 phases of 30-day treatments (Placebo; MO 12c; PD 12c; and MO 12c + PD 12c), with a wash-out period of 15 days between treatments.

At baseline and after each phase, the Visual Analogic Scale (VAS) was used as the primary outcome measure to evaluate the influence of treatments on the reduction of SB. The following additional outcome measures were used: a children’s sleep diary with parent’s/guardian’s perceptions of their children’s sleep quality, the trait of anxiety scale (TAS) to identify changes in children’s anxiety profile, and side effects reports. Data were analyzed by ANOVA with repeated measures followed by Post Hoc LSD test.

Significant reduction of SB was observed in VAS after the use of Placebo (-1.72 ± 0.29), MO (-2.36 ± 0.36), PD (-1.44 ± 0.28) and MO + PD (-2.21 ± 0.30) compared to baseline (4.91 ± 1.87). MO showed better results compared to PD (p = 0.018) and Placebo (p = 0.050), and similar result compared to MO+PD (p = 0.724). The sleep diary results and TAS results were not influenced by any of the treatments. No side effects were observed after treatments.

The authors concluded that MO showed promising results in the treatment of possible sleep bruxism in children, while the association of PD did not improve MO results.

Even if one fully subscribed to the principles of homeopathy, this trial raises several questions:

  1. Why was it submitted and then published in the journal ‘Phytotherapy’. All the remedies were given as C12 potencies. This has nothing to do with phytomedicine.
  2. Why was a cross-over design chosen? According to homeopathic theory, a homeopathic treatment has fundamental, long-term effects which last much longer than the wash-out periods between treatment phases. This effectively rules out such a design as a means of testing homeopathy.
  3. MO is used in phytomedicine to induce sleep and reduce anxiety. According to the homeopathic ‘like cures like’ assumption, this would mean it ought to be used homeopathically to treat sleepiness or for keeping patients awake or for making them anxious. How can it be used for sleep bruxism?

Considering all this, I ask myself: should we trust this study and its findings?

What do you think?

An impressive 17% of US chiropractic patients are 17 years of age or younger. This figure increases to 39% among US chiropractors who have specialized in paediatrics. Data for other countries can be assumed to be similar. But is chiropractic effective for children? All previous reviews concluded that there is a paucity of evidence for the effectiveness of manual therapy for conditions within paediatric populations.

This systematic review is an attempt to shed more light on the issue by evaluating the use of manual therapy for clinical conditions in the paediatric population, assessing the methodological quality of the studies found, and synthesizing findings based on health condition.

Of the 3563 articles identified through various literature searches, 165 full articles were screened, and 50 studies (32 RCTs and 18 observational studies) met the inclusion criteria. Only 18 studies were judged to be of high quality. Conditions evaluated were:

  • attention deficit hyperactivity disorder (ADHD),
  • autism,
  • asthma,
  • cerebral palsy,
  • clubfoot,
  • constipation,
  • cranial asymmetry,
  • cuboid syndrome,
  • headache,
  • infantile colic,
  • low back pain,
  • obstructive apnoea,
  • otitis media,
  • paediatric dysfunctional voiding,
  • paediatric nocturnal enuresis,
  • postural asymmetry,
  • preterm infants,
  • pulled elbow,
  • suboptimal infant breastfeeding,
  • scoliosis,
  • suboptimal infant breastfeeding,
  • temporomandibular dysfunction,
  • torticollis,
  • upper cervical dysfunction.

Musculoskeletal conditions, including low back pain and headache, were evaluated in seven studies. Only 20 studies reported adverse events.

The authors concluded that fifty studies investigated the clinical effects of manual therapies for a wide variety of pediatric conditions. Moderate-positive overall assessment was found for 3 conditions: low back pain, pulled elbow, and premature infants. Inconclusive unfavorable outcomes were found for 2 conditions: scoliosis (OMT) and torticollis (MT). All other condition’s overall assessments were either inconclusive favorable or unclear. Adverse events were uncommonly reported. More robust clinical trials in this area of healthcare are needed.

There are many things that I find remarkable about this review:

  • The list of indications for which studies have been published confirms the notion that manual therapists – especially chiropractors – regard their approach as a panacea.
  • A systematic review evaluating the effectiveness of a therapy that includes observational studies without a control group is, in my view, highly suspect.
  • Many of the RCTs included in the review are meaningless; for instance, if a trial compares the effectiveness of two different manual therapies none of which has been shown to work, it cannot generate a meaningful result.
  • Again, we find that the majority of trialists fail to report adverse effects. This is unethical to a degree that I lose faith in such studies altogether.
  • Only three conditions are, according to the authors, based on evidence. This is hardly enough to sustain an entire speciality of paediatric chiropractors.

Allow me to have a closer look at these three conditions.

  1. Low back pain: the verdict ‘moderate positive’ is based on two RCTs and two observational studies. The latter are irrelevant for evaluating the effectiveness of a therapy. One of the two RCTs should have been excluded because the age of the patients exceeded the age range named by the authors as an inclusion criterion. This leaves us with one single ‘medium quality’ RCT that included a mere 35 patients. In my view, it would be foolish to base a positive verdict on such evidence.
  2. Pulled elbow: here the verdict is based on one RCT that compared two different approaches of unknown value. In my view, it would be foolish to base a positive verdict on such evidence.
  3. Preterm: Here we have 4 RCTs; one was a mere pilot study of craniosacral therapy following the infamous A+B vs B design. The other three RCTs were all from the same Italian research group; their findings have never been independently replicated. In my view, it would be foolish to base a positive verdict on such evidence.

So, what can be concluded from this?

I would say that there is no good evidence for chiropractic, osteopathic or other manual treatments for children suffering from any condition.

And why do the authors of this new review arrive at such dramatically different conclusion? I am not sure. Could it perhaps have something to do with their affiliations?

  • Palmer College of Chiropractic,
  • Canadian Memorial Chiropractic College,
  • Performance Chiropractic.

What do you think?

I stared my Exeter post in October 1993. It took the best part of a year to set up a research team, find rooms etc. So, our research began in earnest only mid 1994. From the very outset, it was clear to me that investigating the risks of so-called alternative medicine (SCAM) should be our priority. The reason, I felt, was simple: SCAM was being used a million times every day; therefore it was an ethical imperative to check whether these treatments were as really safe as most people seemed to believe.

In the course of this line of investigation, we did discover many surprises (and lost many friends). One of the very first revelation was that homeopathy might not be harmless. Our initial results on this topic were published in this 1995 article. In view of the still ongoing debate about homeopathy, I’d like to re-publish the short paper here:

Homoeopathic remedies are believed by doctors and patients to be almost totally safe. Is homoeopathic advice safe, for example on the subject of immunization? In order to answer this question, a questionnaire survey was undertaken in 1995 of all 45 homoeopaths listed in the Exeter ‘yellow pages’ business directory. A total of 23 replies (51%) were received, 10 from medically qualified and 13 from non-medically qualified homoeopaths.

The homoeopaths were asked to suggest which conditions they perceived as being most responsive to homoeopathy. The three most frequently cited conditions were allergies (suggested by 10 respondents), gynaecological problems (seven) and bowel problems (five).

They were then asked to estimate the proportion of patients that were referred to them by orthodox doctors and the proportion that they referred to orthodox doctors. The mean estimated percentages were 1 % and 8%, respectively. The 23 respondents estimated that they spent a mean of 73 minutes on the first consultation.

The homoeopaths were asked whether they used or recommended orthodox immunization for children and whether they only used and recommended homoeopathic immunization. Seven of the 10 homoeopaths who were medically qualified recommended orthodox immunization but none of the 13 non-medically qualified homoeopaths did. One non-medically qualified homoeopath only used and recommended homoeopathic immunization.

Homoeopaths have been reported as being against orthodox immunization’ and advocating homoeopathic immunization for which no evidence of effectiveness exists. As yet there has been no attempt in the United Kingdom to monitor homoeopaths’ attitudes in this respect. The above findings imply that there may be a problem. The British homoeopathic doctors’ organization (the Faculty of Homoeopathy) has distanced itself from the polemic of other homoeopaths against orthodox immunization, and editorials in the British Homoeopathic Journal call the abandonment of mass immunization ‘criminally irresponsible’ and ‘most unfortunate, in that it will be seen by most people as irresponsible and poorly based’.’

Homoeopathic remedies may be safe, but do all homoeopaths merit this attribute?

This tiny and seemingly insignificant piece of research triggered debate and research (my group must have published well over 100 papers in the years that followed) that continue to the present day. The debate has spread to many other countries and now involves numerous forms of SCAM other than just homeopathy. It relates to many complex issues such as the competence of SCAM practitioners, their ethical standards, education, regulation, trustworthiness and the risk of neglect.

Looking back, it feels odd that, at least for me, all this started with such a humble investigation almost a quarter of a century ago. Looking towards the future, I predict that we have so far merely seen the tip of the iceberg. The investigation of the risks of SCAM has finally started in earnest and will, I am sure, continue thus leading to a better protection of patients and consumers from charlatans and their bogus claims.

An article referring to comments Prof David Colquhoun and I recently made in THE TIMES about acupuncture for children caught my attention. In it, Rebecca Avern, an acupuncturist specialising in paediatrics and heading the clinical programme at the College of Integrated Chinese Medicine, makes a several statements which deserve a comment. Here is her article in full, followed by my short comments.

START OF QUOTE

Just before Christmas an article appeared in the Times with the headline ‘Professors raise alarm over rise of acupuncture for children’. There has been little or nothing in the mainstream press relating to paediatric acupuncture. So, in a sense, and in the spirit of ‘all press is good press’, this felt like progress. The article quoted myself and Julian Scott, and mentioned several childhood conditions for which children seek treatment. It also mentioned some of the reasons that parents choose acupuncture for their children.

However, it included some negative quotes from our old friends Ernst and Colquhoun. The first was Ernst stating that he was ‘not aware of any sound evidence showing that acupuncture is effective for any childhood conditions’. Colquhoun went further to state that there simply is not ‘the slightest bit of evidence to suggest that acupuncture helps anything in children’. Whilst they may not be aware of it, good evidence does exist, albeit for a limited number of conditions. For example, a 2016 meta-analysis and systematic review of the use of acupuncture for post-operative nausea and vomiting (PONV) concluded that children who received acupuncture had a significantly lower risk of PONV than those in the control group or those who received conventional drug therapy.[i]

Ernst went on to mention the hypothetical risk of puncturing a child’s internal organs but he failed to provide evidence of any actual harm. A 2011 systematic review analysing decades of acupuncture in children aged 0 to 17 years prompted investigators to conclude that acupuncture can be characterised as ‘safe’ for children.[ii]

Ernst also mentioned what he perceived is a far greater risk. He expressed concern that children would miss out on ‘effective’ treatment because they are having acupuncture. In my experience running a paediatric acupuncture clinic in Oxford, this is not the case. Children almost invariably come already having received a diagnosis from either their GP or a paediatric specialist. They are seeking treatment, such as in the case of bedwetting or chronic fatigue syndrome, because orthodox medicine is unable to effectively treat or even manage their condition. Alternatively, their condition is being managed by medication which may be causing side effects.

When it comes to their children, even those parents who may have reservations about orthodox medicine, tend to ensure their child has received all the appropriate exploratory tests. I have yet to meet a parent who will not ensure that their child, who has a serious condition, has the necessary medication, which in some cases may save their lives, such as salbutamol (usually marketed as Ventolin) for asthma or an EpiPen for anaphylactic reactions. If a child comes to the clinic where this turns out not to be the case, thankfully all BAcC members have training in a level of conventional medical sciences which enables them to spot ‘red flags’. This means that they will inform the parent that their child needs orthodox treatment either instead of or alongside acupuncture.

The article ended with a final comment from Colquhoun who believes that ‘sticking pins in babies is a rather unpleasant form of health fraud’. It is hard not to take exception to the phrase ‘sticking pins in’, whereas what we actually do is gently and precisely insert fine, sterile acupuncture needles. The needles used to treat babies and children are usually approximately 0.16mm in breadth. The average number of needles used per treatment is between two and six, and the needles are not retained. A ‘treatment’ may include not only needling, but also diet and lifestyle advice, massage, moxa, and parental education. Most babies and children find an acupuncture treatment perfectly acceptable, as the video below illustrates.

The views of Colquhoun and Ernst also beg the question of how acupuncture compares in terms of safety and proven efficacy with orthodox medical treatments given to children. Many medications given to children are so called ‘off-label’ because it is challenging to get ethical approval for randomised controlled trials in children. This means that children are prescribed medicines that are not authorised in terms of age, weight, indications, or routes of administration. A 2015 study noted that prescribers and caregivers ‘must be aware of the risk of potential serious ADRs (adverse drug reactions)’ when prescribing off-label medicines to children.[iii]

There are several reasons for the rise in paediatric acupuncture to which the article referred. Most of the time, children get better when they have acupuncture. Secondly, parents see that the treatment is gentle and well tolerated by their children. Unburdened by chronic illness, a child can enjoy a carefree childhood, and they can regain a sense of themselves as healthy. A weight is lifted off the entire family when a child returns to health. It is my belief that parents, and children, vote with their feet and that, despite people such as Ernst and Colquhoun wishing it were otherwise, more and more children will receive the benefits of acupuncture.

[i] Shin HC et al, The effect of acupuncture on post-operative nausea and vomiting after pediatric tonsillectomy: A meta-analysis and systematic review. Accessed January 2019 from: https://www.ncbi.nlm.nih.gov/pubmed/26864736

[ii] Franklin R, Few Serious Adverse Events in Pediatric Needle Acupuncture. Accessed January 2019from: https://www.medscape.com/viewarticle/753934?src=trendmd_pilot

[iii] Aagaard L (2015) Off-Label and Unlicensed Prescribing of Medicines in Paediatric Populations: Occurrence and Safety Aspects. Basic and Clinical Pharmacology and Toxicology. Accessed January 2019 from: https://onlinelibrary.wiley.com/doi/pdf/10.1111/bcpt.12445

END OF QUOTE

  1. GOOD EVIDENCE: The systematic review cited by Mrs Avern was based mostly on poor-quality trials. It even included cohort studies without a control group. To name it as an example of good evidence, merely discloses an ignorance about what good evidence means.
  2. SAFETY: The article Mrs Avern referred to is a systematic review of reports on adverse events (AEs) of acupuncture in children. A total of 279 AEs were found.  Of these, 25 were serious (12 cases of thumb deformity, 5 infections, and 1 case each of cardiac rupture, pneumothorax, nerve impairment, subarachnoid haemorrhage, intestinal obstruction, haemoptysis, reversible coma, and overnight hospitalization), 1 was moderate (infection), and 253 were mild. The mild AEs included pain, bruising, bleeding, and worsening of symptoms. Considering that there is no reporting system of such AEs, this list of AEs is, I think, concerning and justifies my concerns over the safety of acupuncture in children. The risks are certainly not ‘hypothetical’, as Mrs Avern claimed, and to call it thus seems to be in conflict with the highest standard of professional care (see below). Because the acupuncture community has still not established an effective AE-surveillance system, nobody can tell whether such events are frequent or rare. We all hope they are infrequent, but hope is a poor substitute for evidence.
  3. COMPARISON TO OTHER TREATMENTS: Mrs Avern seems to think that acupuncture has a better risk/benefit profile than conventional medicine. Having failed to show that acupuncture is effective and having demonstrated that it causes severe adverse effects, this assumption seems nothing but wishful thinking on her part.
  4. EXPERIENCE: Mrs Avern finishes her article by telling us that ‘children get better when they have acupuncture’. She seems to be oblivious to the fact that sick children usually get better no matter what. Perhaps the kids she treats would have improved even faster without her needles?

In conclusion, I do not doubt the good intentions of Mrs Avern for one minute; I just wished she were able to develop a minimum of critical thinking capacity. More importantly, I am concerned about the BRITISH ACUPUNCTURE COUNCIL, the organisation that published Mrs Avern’s article. On their website, they state: The British Acupuncture Council is committed to ensuring all patients receive the highest standard of professional care during their acupuncture treatment. Our Code of Professional Conduct governs ethical and professional behaviour, while the Code of Safe Practice sets benchmark standards for best practice in acupuncture. All BAcC members are bound by these codes. Who are they trying to fool?, I ask myself.

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