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

clinical trial

1 2 3 34

The UK Reiki Federation (UKRF) is an independent organisation of individuals who have been attuned to Reiki, with the objective of providing support and guidance to Reiki professionals and to the public, with particular reference to education and training, and the public practice of Reiki. Some of their members give of their time each week to send Reiki healing to anyone who makes a request from anywhere in the world.

Each week the volunteers receive a list of those people/animals/events that have requested healing and they all collectively send positive Reiki healing to everyone on the list.

The UKRF claim that Reiki distant healing (RDH) has now been scientifically proven by Lynne McTaggart in these articles http://www.shareguide.com/McTaggart.html and https://lynnemctaggart.com/the-intention-experiment/ that healing is magnified when many healers are involved, so we are contributing an amazing vibration of positivity into our world and doing so much good, with so little effort. Imagine how brilliant it would be if even more members decided they too wanted to support other people, with minimum effort. It’s so simple just to place your hands on the list and send Reiki to everyone on it. It can be so quick if time is an issue for you and yet so powerful.

A group of UKRF members send Reiki to each other at specific times of the week. They state that we have a list of members’ names and allocated time slots in the week when we can send and receive Reiki energy to each other. The intention is to send Reiki for all the different time slots and then sit down and receive the energy whenever it is convenient for us to do so. Those members who have given me feedback all say they can feel the energy flowing during these times.

I urge you to look up the two ‘scientific proofs’ by McTaggart – I promise, you will not regret the effort. For those who might like to see real evidence for or against RDH, I ran a quick Medline search. Somewhat to my surprise, I did find a rigorous study RDH. Here is its abstract:

In this randomised, double-blinded study, women who underwent an elective C-section were allocated to either usual care (control, n=40) or three distant reiki sessions in addition to usual care (n=40). Pain was assessed using a visual analogue scale (VAS). The primary endpoint was the Area Under the VAS-Time Curve (AUC) for days 1-3. Secondary measures included: the proportion of women who required opioid medications and dose consumed, rate of healing and vital signs.

AUC for pain was not significantly different in the distant reiki and control groups (mean ± SD; 212.1 ± 104.7 vs 223.1 ± 117.8; p=0.96). There were no significant differences in opioid consumption or rate of healing; however, the distant reiki group had a significantly lower heart rate (74.3 ± 8.1 bpm vs 79.8 ± 7.9 bpm, p=0.003) and blood pressure (106.4 ± 9.7 mmHg vs 111.9 ± 11.0 mmHg, p=0.02) post surgery.

CONCLUSION: Distant reiki had no significant effect on pain following an elective C-section.

_______________________________________________________________

This begs at least three questions, in my view:

  1. Which evidence should I trust, that of McTaggart or that from what seems to be the only RCT on RDH?
  2. The UK Reiki Foundation state on their website: As the largest Reiki-only professional organisation in the UK and Europe we are setting the highest standard for Reiki. Is the promotion of the McTaggart ‘proof’ combined with the omission from the UKRF site of the only trial of RDH truly in accordance with the highest standards?
  3. Is a professional organisation that does such things really professional?

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.

 

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 aim of this new systematic review was to evaluate the controlled trials of homeopathy in bronchial asthma. Relevant trials published between Jan 1, 1981, and Dec 31, 2016, were considered. Substantive research articles, conference proceedings, and master and doctoral theses were eligible. Methodology was assessed by Jadad’s scoring, internal validity by the Coch-rane tool, model validity by Mathie’s criteria, and quality of individualization by Saha’s criteria.

Sixteen trials were eligible. The majority were positive, especially those testing complex formulations. Methodological quality was diverse; 8 trials had “high” risk of bias. Model validity and individualization quality were compromised. Due to both qualitative and quantitative inadequacies, proofs supporting individualized homeopathy remained inconclusive. The trials were positive (evidence level A), but inconsistent, and suffered from methodological heterogeneity, “high” to “uncertain” risk of bias, incomplete study reporting, inadequacy of independent replications, and small sample sizes.

The authors of this review come from:

  • the Department of Homeopathy, District Joint Hospital, Government of Bihar, Darbhanga, India;
  • the Department of Organon of Medicine and Homoeopathic Philosophy, Sri Sai Nath Postgraduate Institute of Homoeopathy, Allahabad, India;
  • the Homoeopathy University Jaipur, Jaipur, India;
  • the Central Council of Homeopathy, Hooghly,
  • the Central Council of Homeopathy, Howrah, India

They state that they have no conflicts of interest.

The review is puzzling on so many accounts that I had to read it several times to understand it. Here are just some of its many oddities:

  • According to its authors, the review adhered to the PRISMA-P guideline; as a co-author of this guideline, I can confirm that this is incorrect.
  • The authors claim to have included all ‘controlled trials (randomized, non-randomized, or observational) of any form of homeopathy in patients suffering from persistent and chronic bronchial asthma’. In fact, they also included uncontrolled studies (16 controlled trials and 12 uncontrolled observational studies, to be precise).
  • The authors included papers published between Jan 1, 1981, and Dec 31, 2016. It is unacceptable, in my view, to limit a systematic review in this way. It also means that the review was seriously out of date already on the day it was published.
  • The authors tell us that they applied no language restrictions. Yet they do not inform us how they handled papers in foreign languages.
  • Studies of homeopathy as a stand alone therapy were included together with studies of homeopathy as an adjunct. Yet the authors fail to point out which studies belonged to which category.
  • Several of the included studies are not of homeopathy but of isopathy.
  • The authors fail to detail their results and instead refer to an ‘online results table’ which I cannot access even though I have the on-line paper.
  • Instead, they report that 28 studies were included and ‘thus, the level of evidence was graded as A.’
  • No direction of outcome was provided in the results section. All we do learn from the paper’s discussion section is that ‘the majority of the studies were positive, and the level of evidence could be graded as A (strong scientific evidence)’.
  • Despite the high risk of bias in most of the included studies, the authors suggest a ‘definite role of homeopathy beyond placebo in the treatment of bronchial asthma’.
  • The current Cochrane review (also authored by a pro-homeopathy team) concluded that there is not enough evidence to reliably assess the possible role of homeopathy in asthma. Yet the authors of this new review do not even attempt to explain the contradiction.

Confusion?

Incompetence?

Scientific misconduct?

Fraud?

YOU DECIDE!

The aim of this systematic review was to determine the efficacy of conventional treatments plus acupuncture versus conventional treatments alone for asthma, using a meta-analysis of all published randomized clinical trials (RCTs).

The researchers included all RCTs in which adult and adolescent patients with asthma (age ≥12 years) were divided into conventional treatments plus acupuncture (A+B) and conventional treatments (B). Nine studies were included. The results showed that A+B could improve the symptom response rate and significantly decrease interleukin-6. However, indices of pulmonary function, including the forced expiratory volume in one second (FEV1) and FEV1/forced vital capacity (FVC) failed to be improved with A+B.

The authors concluded that conventional treatments plus acupuncture are associated with significant benefits for adult and adolescent patients with asthma. Therefore, we suggest the use of conventional treatments plus acupuncture for asthma patients.

I am thankful to the authors for confirming my finding that A+B must always be more/better than B alone (the 2nd sentence of their conclusion is, of course, utter nonsense, but I will leave this aside for today). Here is the short abstract of my 2008 article:

In this article, we test the hypothesis that randomized clinical trials of acupuncture for pain with certain design features (A + B versus B) are likely to generate false positive results. Based on electronic searches in six databases, 13 studies were found that met our inclusion criteria. They all suggested that acupuncture is effective (one only showing a positive trend, all others had significant results). We conclude that the ‘A + B versus B’ design is prone to false positive results and discuss the design features that might prevent or exacerbate this problem.

Even though our paper was on acupuncture for pain, it firmly established the principle that A+B is always more than B. Think of it in monetary terms: let’s say we both have $100; now someone gives me $10 more. Who has more cash? Not difficult, is it?

But why do SCAM-fans not get it?

Why do we see trial after trial and review after review ignoring this simple and obvious fact?

I suspect I know why: it is because the ‘A+B vs B’ study-design never generates a negative result!

But that’s cheating!

And isn’t cheating unethical?

My answer is YES!

(If you want to read a more detailed answer, please read our in-depth analysis here)

 

 

There is much propaganda for homeopathic vaccinations or homeoprophylaxis (as homeopaths like to call it, in order to give it a veneer of respectability), and on this blog we have discussed it repeatedly. The concept is unproven and dangerous. Yet it is being promoted relentlessly. Currently, I get > 12 million websites when I google ‘homeopathic vaccination’, and there are hundreds of dangerously misleading books and newspaper articles on the subject.

One study that I therefore always wanted to conduct was a trial comparing homeopathic ‘vaccines’ to placebo in terms of immunological response in human volunteers. Somehow, I never managed to get it going. Thus, I was delighted when, a few weeks ago, I received an article for peer-review (I hope I am allowed to disclose this fact here); it was almost exactly the trial I had dreamt of doing one day: the first ever study to test whether there is an antibody response to homeopathic vaccines. Now I am even more delighted to see that it has been published.

Its aim was to compare the antibody response of homeopathic and conventional vaccines and placebo in young adults. The authors hypothesized that there would be no significant difference between homeopathic vaccines and placebo, while there would be a significant increase in antibodies in those received conventional vaccines.

A placebo-controlled, double-blind RCT was conducted where 150 university students who had received childhood vaccinations were assigned to diphtheria, pertussis, tetanus, mumps, measles homeopathic vaccine, placebo, or conventional diphtheria, pertussis, tetanus (Tdap) and mumps, measles, rubella (MMR) vaccines. The primary outcome was a ≥ two-fold increase in antibodies from baseline following vaccination as measured by ELISA. Participants, investigators, study coordinator, data blood drawers, laboratory technician, and data analyst were blinded.

None of the participants in either the homeopathic vaccine or the placebo group showed a ≥ two-fold response to any of the antigens. In contrast, of those vaccinated with Tdap, 68% (33/48) had a ≥ two-fold response to diphtheria, 83% (40/48) to pertussis toxoid, 88% (42/48) to tetanus, and 35% (17/48) of those vaccinated with MMR had a response to measles or mumps antigens (p < 0.001 for each comparison of conventional vaccine to homeopathic vaccine or to placebo). There was a significant increase in geometric mean titres of antibody from baseline for conventional vaccine antigens (p < 0.001 for each), but none for the response to homeopathic antigens or placebo.

The authors concluded that homeopathic vaccines do not evoke antibody responses and produce a response that is similar to placebo. In contrast, conventional vaccines provide a robust antibody response in the majority of those vaccinated.

I think this is in every respect an excellent trial. It should once and for all get rid of what is arguably the homeopathy-cult’s most dangerous idea, namely that highly diluted homeopathic remedies can protect humans against infectious diseases. On this blog, I once called it ‘a danger for both the public and the individual who might believe in it … promoting HP is unethical, irresponsible and possibly even criminal.’

I said it ‘should’ get rid of this nonsense, but will it?

As homeopaths have, for now 200 years, showed themselves utterly impervious to evidence, I for one am not holding my breath. Yet, thanks to this excellent study, we can, when confronted with the notion of homeopathic vaccinations, henceforth point out that it is not just totally implausible but that, in addition, it has also been experimentally shown to be false.

My thanks to the Canadian investigators!

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?

I am being told to educate myself and rethink the subject of NAPRAPATHY by the US naprapath Dr Charles Greer. Even though he is not very polite, he just might have a point:

Edzard, enough foolish so-called scientific, educated assesments from a trained Allopathic Physician. When asked, everything that involves Alternative Medicine in your eyesight is quackery. Fortunately, every Medically trained Allopathic Physician does not have your points of view. I have partnered with Orthopaedic Surgeons, Medical Pain Specialists, General practitioners, Thoracic Surgeons, Forensic Pathologists and Others during the course, whom appreciate the Services that Naprapaths provide. Many of my current patients are Medical Physicians. Educate yourself. Visit a Naprapath to learn first hand. I expect your outlook will certainly change.

I have to say, I am not normally bowled over by anyone who calls me an ‘allopath’ (does Greer not know that Hahnemann coined this term to denigrate his opponents? Is he perhaps also in favour of homeopathy?). But, never mind, perhaps I was indeed too harsh on naprapathy in my previous post on this subject.

So, let’s try again.

Just to remind you, naprapathy was developed by the chiropractor Oakley Smith who had graduated under D D Palmer in 1899. Smith was a former Iowa medical student who also had investigated Andrew Still’s osteopathy in Kirksville, before going to Palmer in Davenport. Eventually, Smith came to reject Palmer’s concept of vertebral subluxation and developed his own concept of “the connective tissue doctrine” or naprapathy.

Dr Geer published a short article explaining the nature of naprapathy:

Naprapathy- A scientific, Evidence based, integrative, Alternative form of Pain management and nutritional assessment that involves evaluation and treatment of Connective tissue abnormalities manifested in the entire human structure. This form of Therapeutic Regimen is unique specifically to the Naprapathic Profession. Doctors of Naprapathy, pronounced ( nuh-prop-a-thee) also referred to as Naprapaths or Neuromyologists, focus on the study of connective tissue and the negative factors affecting normal tissue. These factors may begin from external sources and latently produce cellular changes that in turn manifest themselves into structural impairments, such as irregular nerve function and muscular contractures, pulling its’ bony attachments out of proper alignment producing nerve irritability and impaired lymphatic drainage. These abnormalities will certainly produce a pain response as well as swelling and tissue congestion. Naprapaths, using their hands, are trained to evaluate tissue tension findings and formulate a very specific treatment regimen which produces positive results as may be evidenced in the patients we serve. Naprapaths also rely on information obtained from observation, hands on physical examination, soft tissue Palpatory assessment, orthopedic evaluation, neurological assessment linked with specific bony directional findings, blood and urinalysis laboratory findings, diet/ Nutritional assessment, Radiology test findings, and other pertinent clinical data whose information is scrutinized and developed into a individualized and specific treatment plan. The diagnostic findings and results produced reveal consistent facts and are totally irrefutable. The deductions that formulated these concepts of theory of Naprapathic Medicine are rationally believable, and have never suffered scientific contradiction. Discover Naprapathic Medicine, it works.

What interests me most here is that naprapathy is evidence-based. Did I perhaps miss something? As I cannot totally exclude this possibility, I did another Medline search. I found several trials:

1st study (2007)

Four hundred and nine patients with pain and disability in the back or neck lasting for at least 2 weeks, recruited at 2 large public companies in Sweden in 2005, were included in this randomized controlled trial. The 2 interventions were naprapathy, including spinal manipulation/mobilization, massage, and stretching (Index Group) and support and advice to stay active and how to cope with pain, according to the best scientific evidence available, provided by a physician (Control Group). Pain, disability, and perceived recovery were measured by questionnaires at baseline and after 3, 7, and 12 weeks.

RESULTS:

At 7-week and 12-week follow-ups, statistically significant differences between the groups were found in all outcomes favoring the Index Group. At 12-week follow-up, a higher proportion in the naprapathy group had improved regarding pain [risk difference (RD)=27%, 95% confidence interval (CI): 17-37], disability (RD=18%, 95% CI: 7-28), and perceived recovery (RD=44%, 95% CI: 35-53). Separate analysis of neck pain and back pain patients showed similar results.

DISCUSSION:

This trial suggests that combined manual therapy, like naprapathy, might be an alternative to consider for back and neck pain patients.

2nd study (2010)

Subjects with non-specific pain/disability in the back and/or neck lasting for at least two weeks (n = 409), recruited at public companies in Sweden, were included in this pragmatic randomized controlled trial. The two interventions compared were naprapathic manual therapy such as spinal manipulation/mobilization, massage and stretching, (Index Group), and advice to stay active and on how to cope with pain, provided by a physician (Control Group). Pain intensity, disability and health status were measured by questionnaires.

RESULTS:

89% completed the 26-week follow-up and 85% the 52-week follow-up. A higher proportion in the Index Group had a clinically important decrease in pain (risk difference (RD) = 21%, 95% CI: 10-30) and disability (RD = 11%, 95% CI: 4-22) at 26-week, as well as at 52-week follow-ups (pain: RD = 17%, 95% CI: 7-27 and disability: RD = 17%, 95% CI: 5-28). The differences between the groups in pain and disability considered over one year were statistically significant favoring naprapathy (p < or = 0.005). There were also significant differences in improvement in bodily pain and social function (subscales of SF-36 health status) favoring the Index Group.

CONCLUSIONS:

Combined manual therapy, like naprapathy, is effective in the short and in the long term, and might be considered for patients with non-specific back and/or neck pain.

3rd study (2016)

Participants were recruited among patients, ages 18-65, seeking care at the educational clinic of Naprapathögskolan – the Scandinavian College of Naprapathic Manual Medicine in Stockholm. The patients (n = 1057) were randomized to one of three treatment arms a) manual therapy (i.e. spinal manipulation, spinal mobilization, stretching and massage), b) manual therapy excluding spinal manipulation and c) manual therapy excluding stretching. The primary outcomes were minimal clinically important improvement in pain intensity and pain related disability. Treatments were provided by naprapath students in the seventh semester of eight total semesters. Generalized estimating equations and logistic regression were used to examine the association between the treatments and the outcomes.

RESULTS:

At 12 weeks follow-up, 64% had a minimal clinically important improvement in pain intensity and 42% in pain related disability. The corresponding chances to be improved at the 52 weeks follow-up were 58% and 40% respectively. No systematic differences in effect when excluding spinal manipulation and stretching respectively from the treatment were found over 1 year follow-up, concerning minimal clinically important improvement in pain intensity (p = 0.41) and pain related disability (p = 0.85) and perceived recovery (p = 0.98). Neither were there disparities in effect when male and female patients were analyzed separately.

CONCLUSION:

The effect of manual therapy for male and female patients seeking care for neck and/or back pain at an educational clinic is similar regardless if spinal manipulation or if stretching is excluded from the treatment option.

_________________________________________________________________

I don’t know about you, but I don’t call this ‘evidence-based’ – especially as all the three trials come from the same research group (no, not Greer; he seems to have not published at all on naprapathy). Dr Greer does clearly not agree with my assessment; on his website, he advertises treating the following conditions:

Anxiety
Back Disorders
Back Pain
Cervical Radiculopathy
Cervical Spondylolisthesis
Cervical Sprain
Cervicogenic Headache
Chronic Headache
Chronic Neck Pain
Cluster Headache
Cough Headache
Depressive Disorders
Fibromyalgia
Headache
Hip Arthritis
Hip Injury
Hip Muscle Strain
Hip Pain
Hip Sprain
Joint Clicking
Joint Pain
Joint Stiffness
Joint Swelling
Knee Injuries
Knee Ligament Injuries
Knee Sprain
Knee Tendinitis
Lower Back Injuries
Lumbar Herniated Disc
Lumbar Radiculopathy
Lumbar Spinal Stenosis
Lumbar Sprain
Muscle Diseases
Musculoskeletal Pain
Neck Pain
Sciatica (Not Due to Disc Displacement)
Sciatica (Not Due to Disc Displacement)
Shoulder Disorders
Shoulder Injuries
Shoulder Pain
Sports Injuries
Sports Injuries of the Knee
Stress
Tendonitis
Tennis Elbow (Lateral Epicondylitis)
Thoracic Disc Disorders
Thoracic Outlet Syndrome
Toe Injuries

Odd, I’d say! Did all this change my mind about naprapathy? Not really.

But nobody – except perhaps Dr Greer – can say I did not try.

And what light does this throw on Dr Greer and his professionalism? Since he seems to be already quite mad at me, I better let you answer this question.

Dengue is a viral infection spread by mosquitoes; it is common in many parts of the world. The symptoms include fever, headache, muscle/joint pain and a red rash. The infection is usually mild and lasts about a week. In rare cases it can be more serious and even life threatening. There’s no specific treatment – except for homeopathy; at least this is what many homeopaths want us to believe.

This article reports the clinical outcomes of integrative homeopathic care in a hospital setting during a severe outbreak of dengue in New Delhi, India, during the period September to December 2015.

Based on preference, 138 patients received a homeopathic medicine along with usual care (H+UC), and 145 patients received usual care (UC) alone. Assessment of thrombocytopenia (platelet count < 100,000/mm3) was the main outcome measure. Kaplan-Meier analysis enabled comparison of the time taken to reach a platelet count of 100,000/mm3.

The results show a statistically significantly greater rise in platelet count on day 1 of follow-up in the H+UC group compared with UC alone. This trend persisted until day 5. The time taken to reach a platelet count of 100,000/mm3 was nearly 2 days earlier in the H+UC group compared with UC alone.

The authors concluded that these results suggest a positive role of adjuvant homeopathy in thrombocytopenia due to dengue. Randomized controlled trials may be conducted to obtain more insight into the comparative effectiveness of this integrative approach.

The design of the study is not able to control for placebo effects. Therefore, the question raised by this study is the following: can an objective parameter like the platelet count be influenced by placebo? The answer is clearly YES.

Why do researchers go to the trouble of conducting such a trial, while omitting both randomisation as well as placebo control? Without such design features the study lacks rigour and its results become meaningless? Why can researchers of Dengue fever run a trial without reporting symptomatic improvements?  Could the answer to these questions perhaps be found in the fact that the authors are affiliated to the ‘Central Council for Research in Homoeopathy, New Delhi?

One could argue that this trial – yet another one published in the journal ‘Homeopathy’ – is a waste of resources and patients’ co-operation. Therefore, one might even argue, such a study might be seen as unethical. In any case, I would argue that this study is irrelevant nonsense that should have never seen the light of day.

 

Power Point therapy (PPT) is not what you might think it is; it is not related to a presentation using power point. Power According to the authors of the so far only study of PPT, it is based on the theories of classic acupuncture, neuromuscular reflexology, and systems theoretical approaches like biocybernetics. It has been developed after four decades of experience by Mr. Gerhard Egger, an Austrian therapist. Hundreds of massage and physiotherapists in Europe were trained to use it, and apply it currently in their practice. The treatment can be easily learned. It is taught by professional PPT therapists to students and patients for self-application in weekend courses, followed by advanced courses for specialists.

The core hypothesis of the PPT system is that various pain syndromes have its origin, among others, in a functional pelvic obliquity. This in turn leads to a static imbalance in the posture of the body. This may result in mechanical strain and possible spinal nerve irritation that may radiate and thus affect dermatomes, myotomes, enterotomes, sclerotomes, and neurotomes of one or more vertebra segments. Therefore, treating reflex zones for the pelvis would reduce and possibly resolve the functional obliquity, improve the statics, and thus cure the pain through improved function. In addition, reflex therapy might be beneficial also in patients with unknown causes of back pain. PPT uses blunt needle tips to apply pressure to specific reflex points on the nose, hand, and feet. PPT has been used for more than 10 years in treating patients with musculoskeletal problems, especially lower back pain.

Sounds more than a little weird?

Yes, I agree.

Perhaps we need some real evidence.

The aim of this RCT was to compare 10 units of PPT of 10 min each, with 10 units of standard physiotherapy of 30 min each. Outcomes were functional scores (Roland Morris Disability, Oswestry, McGill Pain Questionnaire, Linton-Halldén – primary outcome) and health-related quality of life (SF-36), as well as blinded assessments by clinicians (secondary outcome).

Eighty patients consented and were randomized, 41 to PPT, 39 to physiotherapy. Measurements were taken at baseline, after the first and after the last treatment (approximately 5 weeks after enrolment). Multivariate linear models of covariance showed significant effects of time and group and for the quality of life variables also a significant interaction of time by group. Clinician-documented variables showed significant differences at follow-up.

The authors concluded that both physiotherapy and PPT improve subacute low back pain significantly. PPT is likely more effective and should be studied further.

I was tempted to say ‘there is nothing fundamentally wrong with this study’. But then I hesitated and, on second thought, found a few things that do concern me:

  • The theory on which PPT is based is not plausible (to put it mildly).
  • It would have been easy to conduct a placebo-controlled trial of PPT. The authors justify their odd study design stating this: This was the very first randomized controlled trial of PPT. Therefore, the study has to be considered a pilot. For a pivotal study, a clearly defined primary outcome would have been essential. This was not possible, as no previous experience was able to suggest which outcome would be the best. In my view, this is utter nonsense. Defining the primary outcome of a back pain study is not rocket science; there are plenty of validated measures of pain.
  • The study was funded by the Foundation of Natural Sciences and Technical Research in Vaduz, Liechtenstein. I cannot find such an organisation on the Internet.
  • The senior author of this study is Prof H Walach who won the prestigious award for pseudoscientist of the year 2012.
  • Walach provides no less than three affiliations, including the ‘Change Health Science Institute, Berlin, Germany’. I cannot find such an organisation on the Internet.
  • The trial was published in a less than prestigious SCAM journal, ‘Forschende Komplementarmedizin‘ – its editor in-chief: Harald Walach.

So, in view of these concerns, I think PPT might not be nearly as promising as this study implies. Personally, I will wait for an independent replication of Walach’s findings.

1 2 3 34
Recent Comments

Note that comments can be edited for up to five minutes after they are first submitted but you must tick the box: “Save my name, email, and website in this browser for the next time I comment.”

The most recent comments from all posts can be seen here.

Categories