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

causation

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Really?

For dogs?

Yes, one (of many) website explains that dogs benefit from acupuncture in 5 different ways:

1. Pain management is one of the most common uses for acupuncture, often in conjunction with a more traditional treatment plan. Strong medical treatments like chemo, which can cause discomfort, are often paired with acupuncture to help make a pet more comfortable and able to fight the illness.

2. Musculoskeletal problems such as arthritis, hip dysplasia, or nerve injuries can respond to acupuncture. It is often employed during rehabilitation after an injury. Carefully monitoring a healing pet is important; without the feeling of pain, a dog can re-injure him or herself with over-activity.

3. Skin problems like allergic dermatitis, granulomas, or hot spots may respond well to acupuncture treatment because increased circulation can improve healing, while pain reduction will reduce a dog’s overgrooming or itching responses.

4. Gastrointestinal problems like nausea and diarrhea can be aided by the increased blood flow from acupuncture. It may also help normalize digestive activity by stimulating digestive secretions.

5. Respiratory problems like asthma and allergies can benefit from the immune-calming, anti-inflammatory capabilities of acupuncture.

But all of this is based on ‘experience’ (or probably more accurately, the wishful thinking of those who earn money by sticking needles into animals), not evidence!

So, what does the evidence tell us about acupuncture for dogs?

The answer is: next to nothing; there are almost no studies. And this is why this recent paper could be important.

This new study was aimed at quantifying changes in gastric and intestinal emptying times in the conscious dog following gastrointestinal acupoint stimulation.

In a randomised, blinded crossover study, six dogs were fed 30×1.5 mm barium-impregnated polyethylene spheres and underwent: (1) no acupuncture (Control); (2) stimulation of target points PC6 and ST36 (Target) and (3) stimulation of non-target points LU7 and BL55 (Sham). Abdominal radiographs were assessed immediately after feeding the spheres and every hour for 12 hours and their number in the stomach and large intestines was counted.

The number of barium-impregnated polyethylene spheres found distal to the stomach was less in the Target group compared to the Control and Sham groups between hours 2 and 4, but no differences between groups were seen for the remainder of the treatment period. The number of spheres found within the colon/rectum was less in the Target group compared to the Control and Sham groups between hours 4 and 6, and compared to the Sham group only at hour 7 but no differences between groups were seen after hour 8.

The authors concluded that acupuncture targeted at the gastrointestinal tract of dogs was associated briefly with slowed gastric emptying and gastrointestinal transit time. This foundational study lays the groundwork for additional studies of acupuncture effects associated with altered physiologic states.

There you have it: the proof has been presented that acupuncture works in dogs; and if it works in animals, it cannot be a placebo!

Hold on, not so quick!

This was a tiny study, and the effects are small, only temporary and of questionable relevance. It is possible (I’d say even likely) that the finding was entirely coincidental.

I think, I wait until we have more and better data.

The aim of this RCT was to investigate the effects of an osteopathic manipulative treatment (OMT) which includes a diaphragm intervention compared to the same OMT with a sham diaphragm intervention in chronic non-specific low back pain (NS-CLBP).

Participants (N=66) with a diagnosis of NS-CLBP lasting at least 3 months were randomized to receive either an OMT protocol including specific diaphragm techniques (n=33) or the same OMT protocol with a sham diaphragm intervention (n=33), conducted in 5 sessions provided during 4 weeks.

The primary outcomes were pain (evaluated with the Short-Form McGill Pain Questionnaire [SF-MPQ] and the visual analog scale [VAS]) and disability (assessed with the Roland-Morris Questionnaire [RMQ] and the Oswestry Disability Index [ODI]). Secondary outcomes were fear-avoidance beliefs, level of anxiety and depression, and pain catastrophization. All outcome measures were evaluated at baseline, at week 4, and at week 12.

A statistically significant reduction was observed in the experimental group compared to the sham group in all variables assessed at week 4 and at week 12. Moreover, improvements in pain and disability were clinically relevant.

The authors concluded that an OMT protocol that includes diaphragm techniques produces significant and clinically relevant improvements in pain and disability in patients with NS-CLBP compared to the same OMT protocol using sham diaphragm techniques.

This seems to be a rigorous study. The authors describe in detail their well-standardised interventions in the full text of their paper. This, of course, will be essential, if someone wants to repeat the trial.

I have but a few points to add:

  1. What I fail to understand is this: why the authors call the interventions osteopathic? The therapist was a physiotherapist and the techniques employed are, if I am not mistaken, as much physiotherapeutic as osteopathic.
  2. The findings of this trial are encouraging but almost seem a little too good to be true. They need, of course, to be independently replicated in a larger study.
  3. If that is done, I would suggest to check whether the blinding of the patient was successful. If not, there is a suspicion that the diaphragm technique works partly or mostly via a placebo effect.
  4. I would also try to make sure that the therapist cannot influence the results in any way, for instance, by verbal or non-verbal suggestions.
  5. Finally, I suggest to employ more than one therapist to increase generalisability.

Once all these hurdles are taken, we might indeed have made some significant progress in the manual therapy of NS-CLBP.

Do musculoskeletal conditions contribute to chronic non-musculoskeletal conditions? The authors of a new paper – inspired by chiropractic thinking, it seems – think so. Their meta-analysis was aimed to investigate whether the most common musculoskeletal conditions, namely neck or back pain or osteoarthritis of the knee or hip, contribute to the development of chronic disease.

The authors searched several electronic databases for cohort studies reporting adjusted estimates of the association between baseline neck or back pain or osteoarthritis of the knee or hip and subsequent diagnosis of a chronic disease (cardiovascular disease , cancer, diabetes, chronic respiratory disease or obesity).

There were 13 cohort studies following 3,086,612 people. In the primary meta-analysis of adjusted estimates, osteoarthritis (n= 8 studies) and back pain (n= 2) were the exposures and cardiovascular disease (n=8), cancer (n= 1) and diabetes (n= 1) were the outcomes. Pooled adjusted estimates from these 10 studies showed that people with a musculoskeletal condition have a 17% increase in the rate of developing a chronic disease compared to people without a musculoskeletal condition.

The authors concluded that musculoskeletal conditions may increase the risk of chronic disease. In particular, osteoarthritis appears to increase the risk of developing cardiovascular disease. Prevention and early

treatment of musculoskeletal conditions and targeting associated chronic disease risk factors in people with long

standing musculoskeletal conditions may play a role in preventing other chronic diseases. However, a greater

understanding about why musculoskeletal conditions may increase the risk of chronic disease is needed.

For the most part, this paper reads as if the authors are trying to establish a causal relationship between musculoskeletal problems and systemic diseases at all costs. Even their aim (to investigate whether the most common musculoskeletal conditions, namely neck or back pain or osteoarthritis of the knee or hip, contribute to the development of chronic disease) clearly points in that direction. And certainly, their conclusion that musculoskeletal conditions may increase the risk of chronic disease confirms this suspicion.

In their discussion, they do concede that causality is not proven: While our review question ultimately sought to assess a causal connection between common musculoskeletal conditions and chronic disease, we cannot draw strong conclusions  due  to  poor  adjustment,  the  analysis methods employed by the included studies, and a lack of studies investigating conditions other than OA and cardiovascular disease…We did not find studies that satisfied all of Bradford Hill’s suggested criteria for casual inference (e.g. none estimated dose–response effects) nor did we find studies that used contemporary causal inference methods for observational data (e.g. a structured identification approach for selection of confounding variables or assessment of the effects of unmeasured or residual confounders. As such, we are unable to infer a strong causal connection between musculoskeletal conditions and chronic diseases.

In all honesty, I would see this a little differently: If their review question ultimately sought to assess a causal connection between common musculoskeletal conditions and chronic disease, it was quite simply daft and unscientific. All they could ever hope is to establish associations. Whether these are causal or not is an entirely different issue which is not answerable on the basis of the data they searched for.

An example might make this clearer: people who have yellow stains on their 2nd and 3rd finger often get lung cancer. The yellow fingers are associated with cancer, yet the link is not causal. The association is due to the fact that smoking stains the fingers and causes cancer. What the authors of this new article seem to suggest is that, if we cut off the stained fingers of smokers, we might reduce the cancer risk. This is clearly silly to the extreme.

So, how might the association between musculoskeletal problems and systemic diseases come about? Of course, the authors might be correct and it might be causal. This would delight chiropractors because DD Palmer, their founding father, said that 95% of all diseases are caused by subluxation of the spine, the rest by subluxations of other joints. But there are several other and more likely explanations for this association. For instance,  many people with a systemic disease might have had subclinical problems for years. These problems would prevent them from pursuing a healthy life-style which, in turn, resulted is musculoskeletal problems. If this is so, musculoskeletal conditions would not increase the risk of chronic disease, but chronic diseases would lead to musculoskeletal problems.

Don’t get me wrong, I am not claiming that this reverse causality is the truth; I am simply saying that it is one of several possibilities that need to be considered. The fact that the authors failed to do so, is remarkable and suggests that they were bent on demonstrating what they put in their conclusion. And that, to me, is an unfailing sign of poor science.

Osteopathy is a form of manual therapy invented by the American Andrew Taylor Still (1828-1917). Today, US osteopaths (doctors of osteopathy or DOs) practise no or little manual therapy; they are fully recognised as medical doctors who can specialise in any medical field after their training which is almost identical with that of MDs. Outside the US, osteopaths practice almost exclusively manual treatments and are considered alternative practitioners. This post deals with the latter category of osteopaths.

Still defined his original osteopathy as a science which consists of such exact, exhaustive, and verifiable knowledge of the structure and function of the human mechanism, anatomical, physiological and psychological, including the chemistry and physics of its known elements, as has made discoverable certain organic laws and remedial resources, within the body itself, by which nature under the scientific treatment peculiar to osteopathic practice, apart from all ordinary methods of extraneous, artificial, or medicinal stimulation, and in harmonious accord with its own mechanical principles, molecular activities, and metabolic processes, may recover from displacements, disorganizations, derangements, and consequent disease, and regained its normal equilibrium of form and function in health and strength.

Based on such vague and largely nonsensical statements, traditional osteopaths feel entitled to offer treatments for most human diseases, conditions and symptoms. The studies they produce to back up their claims tend to be as poor as Still’s original assumptions were fantastic.

Here is an apt example:

The aim of this new study was to study the effect of osteopathic manipulation on pain relief and quality of life improvement in hospitalized oncology geriatric patients.

The researchers conducted a non-randomized controlled clinical trial with 23 cancer patients. They were allocated to two groups: the study group (OMT [osteopathic manipulative therapy] group, N = 12) underwent OMT in addition to physiotherapy (PT), while the control group (PT group, N = 12) underwent only PT. Included were postsurgical cancer patients, male and female, age ⩾65 years, with an oncology prognosis of 6 to 24 months and chronic pain for at least 3 months with an intensity score higher than 3, measured with the Numeric Rating Scale. Exclusion criteria were patients receiving chemotherapy or radiotherapy treatment at the time of the study, with mental disorders (Mini-Mental State Examination [MMSE] = 10-20), with infection, anticoagulation therapy, cardiopulmonary disease, or clinical instability post-surgery. Oncology patients were admitted for rehabilitation after cancer surgery. The main cancers were colorectal cancer, osteosarcoma, spinal metastasis from breast and prostatic cancer, and kidney cancer.

The OMT, based on osteopathic principles of body unit, structure-function relationship, and homeostasis, was designed for each patient on the basis of the results of the osteopathic examination. Diagnosis and treatment were founded on 5 models: biomechanics, neurologic, metabolic, respiratory-circulatory, and behaviour. The OMT protocol was administered by an osteopath with clinical experience of 10 years in one-on-one individual sessions. The techniques used were: dorsal and lumbar soft tissue, rib raising, back and abdominal myofascial release, cervical spine soft tissue, sub-occipital decompression, and sacroiliac myofascial release. Back and abdominal myofascial release techniques are used to improve back movement and internal abdominal pressure. Sub-occipital decompression involves traction at the base of the skull, which is considered to release restrictions around the vagus nerve, theoretically improving nerve function. Sacroiliac myofascial release is used to improve sacroiliac joint movement and to reduce ligament tension. Strain-counter-strain and muscle energy technique are used to diminish the presence of trigger points and their pain intensity. OMT was repeated once every week during 4 weeks for each group, for a total of 4 treatments. Each treatment lasted 45 minutes.

At enrolment (T0), the patients were evaluated for pain intensity and quality of life by an external examiner. All patients were re-evaluated every week (T1, T2, T3, and T4) for pain intensity, and at the end of the study treatment (T4) for quality of life.

The OMT added to physiotherapy produced a significant reduction in pain both at T2 and T4. The difference in quality of life improvements between T0 and T4 was not statistically significant. Pain improved in the PT group at T4. Between-group analysis of pain and quality of life did not show any significant difference between the two treatments.

The authors concluded that our study showed a significant improvement in pain relief and a nonsignificant improvement in quality of life in hospitalized geriatric oncology patients during osteopathic manipulative treatment.

GOOD GRIEF!

Where to begin?

Even if there had been a difference in outcome between the two groups, such a finding would not have shown an effect of OMT per se. More likely, it would have been due to the extra attention and the expectation in the OMT group (or caused by the lack of randomisation). The A+B vs B design used for this study  does not control for non-specific effects. Therefore it is incapable of establishing a causal relationship between the therapy and the outcome.

As it turns out, there were no inter-group differences. How can this be? I have often stated that A+B is always more than B alone. And this is surely true!

So, how can I explain this?

As far as I can see, there are two possibilities:

  1. The study was underpowered, and thus an existing difference was not picked up.
  2. The OMT had a detrimental effect on the outcome measures thus neutralising the positive effects of the extra attention and expectation.

And which possibility does apply in this case?

Nobody can know from these data.

Integrative Cancer Therapies, the journal that published this paper, states that it focuses on a new and growing movement in cancer treatment. The journal emphasizes scientific understanding of alternative and traditional medicine therapies, and the responsible integration of both with conventional health care. Integrative care includes therapeutic interventions in diet, lifestyle, exercise, stress care, and nutritional supplements, as well as experimental vaccines, chrono-chemotherapy, and other advanced treatments. I feel that the editors should rather focus more on the quality of the science they publish.

My conclusion from all this is the one I draw so depressingly often: fatally flawed science is not just useless, it is unethical, gives clinical research a bad name, hinders progress, and can be harmful to patients.

This systematic review included 18 studies assessing homeopathy in depression. Two double-blind placebo-controlled trials of homeopathic medicinal products (HMPs) for depression were assessed. The first trial (N = 91) with high risk of bias found HMPs were non-inferior to fluoxetine at 4 (p = 0.654) and 8 weeks (p = 0.965); whereas the second trial (N = 133), with low risk of bias, found HMPs was comparable to fluoxetine (p = 0.082) and superior to placebo (p < 0.005) at 6 weeks.

The remaining research had unclear/high risk of bias. A non-placebo-controlled RCT found standardised treatment by homeopaths comparable to fluvoxamine; a cohort study of patients receiving treatment provided by GPs practising homeopathy reported significantly lower consumption of psychotropic drugs and improved depression; and patient-reported outcomes showed at least moderate improvement in 10 of 12 uncontrolled studies. Fourteen trials provided safety data. All adverse events were mild or moderate, and transient. No evidence suggested treatment was unsafe.

The authors concluded that limited evidence from two placebo-controlled double-blinded trials suggests HMPs might be comparable to antidepressants and superior to placebo in depression, and patients treated by homeopaths report improvement in depression. Overall, the evidence gives a potentially promising risk benefit ratio. There is a need for additional high quality studies.

It is worth having a look at these two studies, I think.

The 1st (2011) study is from Brazil

Here is its abstract:

Homeopathy is a complementary and integrative medicine used in depression, The aim of this study is to investigate the non-inferiority and tolerability of individualized homeopathic medicines [Quinquagintamillesmial (Q-potencies)] in acute depression, using fluoxetine as active control. Ninety-one outpatients with moderate to severe depression were assigned to receive an individualized homeopathic medicine or fluoxetine 20 mg day−1 (up to 40 mg day−1) in a prospective, randomized, double-blind double-dummy 8-week, single-center trial. Primary efficacy measure was the analysis of the mean change in the Montgomery & Åsberg Depression Rating Scale (MADRS) depression scores, using a non-inferiority test with margin of 1.45. Secondary efficacy outcomes were response and remission rates. Tolerability was assessed with the side effect rating scale of the Scandinavian Society of Psychopharmacology. Mean MADRS scores differences were not significant at the 4th (P = .654) and 8th weeks (P = .965) of treatment. Non-inferiority of homeopathy was indicated because the upper limit of the confidence interval (CI) for mean difference in MADRS change was less than the non-inferiority margin: mean differences (homeopathy-fluoxetine) were −3.04 (95% CI −6.95, 0.86) and −2.4 (95% CI −6.05, 0.77) at 4th and 8th week, respectively. There were no significant differences between the percentages of response or remission rates in both groups. Tolerability: there were no significant differences between the side effects rates, although a higher percentage of patients treated with fluoxetine reported troublesome side effects and there was a trend toward greater treatment interruption for adverse effects in the fluoxetine group. This study illustrates the feasibility of randomized controlled double-blind trials of homeopathy in depression and indicates the non-inferiority of individualized homeopathic Q-potencies as compared to fluoxetine in acute treatment of outpatients with moderate to severe depression.

There are many important points to make about this trial:

  1. Contrary to what the reviewers claim, the trial had no placebo group.
  2. It was a double-dummy equivalence study comparing individualised homeopathy with the antidepressant fluoxetine.
  3. Fluoxetine might have been under-dosed (see below).
  4. Equivalence studies require large sample sizes, and with just 91 patients (only 55 of whom finished the study), this trial was underpowered which means the finding of equivalence is false positive.
  5. The authors noted that a higher percentage of troublesome adverse effects reported by patients receiving fluoxetine. This means that the trial was not double-blind; patients were able to tell by their side-effects which group they were in.
  6. The authors also state that more patients randomized to homeopathy than to fluoxetine were excluded due to worsening of their depressive symptoms. I think this confirms that homeopathy was ineffective.

The 2nd (2015) study is from Mexico

Here is its abstract:

Background: Perimenopausal period refers to the interval when women’s menstrual cycles become irregular and is characterized by an increased risk of depression. Use of homeopathy to treat depression is widespread but there is a lack of clinical trials about its efficacy in depression in peri- and postmenopausal women. The aim of this study was to assess efficacy and safety of individualized homeopathic treatment versus placebo and fluoxetine versus placebo in peri- and postmenopausal women with moderate to severe depression.

Methods/Design: A randomized, placebo-controlled, double-blind, double-dummy, superiority, three-arm trial with a 6 week follow-up study was conducted. The study was performed in a public research hospital in Mexico City in the outpatient service of homeopathy. One hundred thirty-three peri- and postmenopausal women diagnosed with major depression according to DSM-IV (moderate to severe intensity) were included. The outcomes were: change in the mean total score among groups on the 17-item Hamilton Rating Scale for Depression, Beck Depression Inventory and Greene Scale, after 6 weeks of treatment, response and remission rates, and safety. Efficacy data were analyzed in the intention-to-treat population (ANOVA with Bonferroni post-hoc test).

Results: After a 6-week treatment, homeopathic group was more effective than placebo by 5 points in Hamilton Scale. Response rate was 54.5% and remission rate, 15.9%. There was a significant difference among groups in response rate definition only, but not in remission rate. Fluoxetine-placebo difference was 3.2 points. No differences were observed among groups in the Beck Depression Inventory. Homeopathic group was superior to placebo in Greene Climacteric Scale (8.6 points). Fluoxetine was not different from placebo in Greene Climacteric Scale.

Conclusion: Homeopathy and fluoxetine are effective and safe antidepressants for climacteric women. Homeopathy and fluoxetine were significantly different from placebo in response definition only. Homeopathy, but not fluoxetine, improves menopausal symptoms scored by Greene Climacteric Scale.

And here are my critical remarks about this trial:

  1. The aim of a small study like this cannot be to assess or draw conclusions about the safety of the interventions used; for this purpose, we need sample sizes that are at least one dimension bigger.
  2. Fluoxetine might have been under-dosed (see below).
  3. The blinding of patients might have been jeopardized by patients experiencing the specific side-effects of fluoxetine. The authors reported adverse effects in all three groups. However, the characteristic and most common side-effects of fluoxetine (such as hives, itching, skin rash, restlessness, inability to sit still) were not included.

________________________________________________

Usual Adult Dose for Depression

Immediate-release oral formulations:
Initial dose: 20 mg orally once a day in the morning, increased after several weeks if sufficient clinical improvement is not observed
Maintenance dose: 20 to 60 mg orally per day
Maximum dose: 80 mg orally per day

Delayed release oral capsules:
Initial dose: 90 mg orally once a week, commenced 7 days after the last daily dose of immediate-release fluoxetine 20 mg formulations.

_________________________________________________

Considering all this, I feel that the conclusions of the above review are far too optimistic and not justified. In fact, I find them misleading, dangerous, unethical and depressing.

Central retinal artery occlusion, nystagmus, Wallenberg syndrome, ophthalmoplegia, Horner syndrome, loss of vision,  diplopia, and ptosis are all amongst the eye-related problems that have been associated with chiropractic upper spinal manipulations. Often the damage leaves a permanent deficit – happily, not in this instance.

US ophthalmologists published the case of a 59-year-old Caucasian female who presented with the acute, painless constant appearance of three spots in her vision immediately after a chiropractor performed cervical spinal manipulation using the high-velocity, low-amplitude technique. The patient described the spots as “tadpoles” that were constantly present in her vision. She noted the first spot while driving home immediately following a chiropractor neck adjustment, and became more aware that there were two additional spots the following day.

Slit lamp examination of the right eye demonstrated multiple unilateral pre-retinal haemorrhages with three present inferiorly along with a haemorrhage over the optic nerve and a shallow, incomplete posterior vitreous detachment. Optical Coherence Tomography (OCT) demonstrated the pre-retinal location of the haemorrhage.

These haemorrhages resolved within two months.

The specialists concluded that chiropractor neck manipulation has previously been reported leading to complications related to the carotid artery and arterial plaques. This presents the first case of multiple unilateral pre-retinal haemorrhages immediately following chiropractic neck manipulation. This suggests that chiropractor spinal adjustment can not only affect the carotid artery, but also could lead to pre-retinal haemorrhages.

In the discussion section of their paper, the authors stated: Upper spinal manipulation with the HVLA technique involves high velocity, low-amplitude thrusts on the cervical spine administered posteriorly. No other aetiology of the pre-retinal haemorrhages was found on work-up (no leukemic retinopathy, hypertension, diabetes, or retinal tear). The temporal association immediately while driving home from the chiropractic procedure makes other causes less likely, although we cannot exclude Valsalva retinopathy or progressive posterior vitreous detachment. Given the lack of any retinal vessel abnormalities or plaques along with the temporal association, we postulate that the chiropractor neck manipulation itself induced vitreo-retinal traction that likely led to pre-retinal haemorrhages which were self-limited. It is also possible that the HVLA technique could have mechanically assisted with induction of a posterior vitreous detachment.

If the authors are correct, one has to wonder: how often do such problems occur in patients who simply do not bother to report them, or doctors who do not correctly diagnose them?

By guest blogger Hans-Werner Bertelsen

Holistic ideas are booming, and they do not stop at dental medicine, where procedures and techniques that take an alleged ‘holistic’ approach are becoming more and more popular. Are these procedures and techniques effective, and do they offer a benefit over their conventional counterparts, or is it rather the providers of such procedures and techniques who benefit from a lack of knowledge and understanding in patients who seek out this so-called alternative dentistry? This paper will take a look at three topics—the concept of projections, material testing approaches, amalgam removal—that form the basis for many procedures and techniques in so-called alternative dentistry, to examine whether they offer a sound foundation for said procedures and techniques, or whether they are merely empty promises. Might they be nothing but marketing tricks?

The concept of projections suggests that conventional medicine does look closely enough at the human body, ignoring as of yet undiscovered energy lines and other mysterious linkages. Material testing approaches claim to detect harmful and allergenic components, the removal of which may be beneficial in case of systemic diseases, possibly even curing them. Beginning on July 1, 2018, the use of amalgam will be strongly restricted all throughout Europe. This easy-to-use material has received much attention for decades, as it contains a large proportion of mercury, which is known for its high neurotoxicity, and is, therefore, suspected of causing illness in the long term.

Normally, we think of projections as requiring a screen, onto which something then can be projected. Teeth, however, are also ideally suited as a dumping ground for the underlying causes of somatic and/or mental diseases, from where they can radiate out as so-called projections. Once these are identified as the true cause of disease, other potential causes such as age-related wear and tear, detrimental behaviors, or harmful eating habits can be readily ignored. This concept of projections may have particularly harmful and negative consequences in patients with tumors, as it may cause feelings of guilt, although in many cases no definite cause of tumor development can be discerned. Projected feelings of guilt, in turn, can be a negative influence on a person’s health.

The so-called “system of meridians” assigns relationship qualities to individual teeth, meaning that there are strict relationships of individual teeth to the body’s organs and individual entities. [1]

According to this system, an inflammation of the urinary bladder would be related to the number 1 teeth, the incisors. Rheumatism is linked to the number 8 teeth, the wisdom teeth. In between, there are the teeth of the ordinal numbers 2 to 7, distinguished by their locations on the left or right, in the upper or lower jaw, which offer a wealth of opportunities to assign a “guilty tooth” to clinically common physical complaints. However, this mysterious connection is postulated not only for teeth and major organs, but also for joints, vertebral levels, sensory organs, tonsils, and glands, with the relationships neatly organized in ten groups and subgroups. Multiplied by the number of teeth—eight per each of the four quadrants, 32 in total—these afford the “holistic dentist” 320 opportunities for projecting physical complaints ranging from asthma to zonulitis onto a tooth. Those who believe in this system of projections are not deterred by the fact that there is no scientific proof whatsoever for this odd thesis.

On the other hand, it is basic medical knowledge that pathogens may spread hematogenically and affect remote organs. Seeking adequate specialist counsel when dealing with rheumatic diseases, fevers of unclear etiology, or in conjunction with orthopedic joint surgeries, is, therefore, mandated by guidelines and an obvious standard in the practice of medicine. So-called alternative dentistry makes no particular mention of these general facts, but instead focuses on occult-seeming correlations in order to use a mysterious, almost conspiratorial idea of a disease to legitimize the often invasive treatment options it then recommends. Most patients will not realize that these interpretations often mistake synchronicity for causality. For example, most infections of the urinary bladder will resolve over time, regardless of whether any work was done on the upper incisors or not. However, if during the period of healing one of the incisors was treated by a dentist, it is easy enough to associate this treatment with the resolving bladder infection. From a psychological viewpoint, this constitutes a simple manipulation technique, applied to demonstrate the seemingly superior diagnostics of alternative dentistry: a simple, and easily recognized marketing strategy.

When asked what would happen to these doubtful projections in case of an autologous transplantation during which a tooth would move to another tooth’s original place in the jaw, three leading representatives of the so-called alternative dentistry answered in an evasive and even manipulative manner. [2]

There are reports of invasive therapies, conducted following dubious, often electromedical diagnostic procedures, that not only lead to high costs for the repair of the damage they caused, but also to a lasting mutilation of the patients’ jaws and dentitions. [3-6]

Another supposedly holistic school of thought that is similar to that of the system of meridians exists in some fields of dentistry regarding temporo-mandibular joint dysfunction (TMJD, TMD). These theories suggest that a disbalance in the interaction between jaw bones and masticatory muscles may be responsible for all kinds of diseases. [7]

According to the German self-appointed “TMJD Umbrella Organization” (CMD-Dachverband e. V.), TMJD is a “multifaceted disease.” The claim is that TMJD may not only cause back pain, vertigo, and tinnitus, but also sleep apnea, snoring, neck and shoulder pain, hip and knee pain, headaches, migraines, visual, mood swings, and even depression. However, there is no scientific evidence for any of these claims. [8,9]

Jens C. Türp of the University Center for Dental Medicine Basel’s Department of Oral Health & Medicine, Division Temporomandibular Disorders and Orofacial Pain, has called this standard diagnosis, offered by TMJD diagnosticians whenever a patient shows signs of nocturnal teeth grinding, “nonsense that makes your hair stand on end.”

“For a variety of general symptoms, it is claimed that they are caused by a TMJD: Tinnitus, ocular pressure, differences in the lengths of a person’s legs, back pain, hip pain, and knee pain, balance disorders, tingling in the fingers and many more. ‘A relationship [with TMJD] has never been proven for any of these symptoms’, says Türp. According to him, true TMJD causes problems with chewing and pain. Affected patients have difficulties opening their mouth wide or closing it fully. The “CMD-Arztsuche” (Find a TMJD Specialist) website recommends ‘a lasting correction of a person’s bite’ as treatment. This should be achieved with the help of ceramic inlays, dental crowns, and implants— all of which are expensive and unnecessary measures, in the opinion of Jens Türp. He treats his TMJD patients–almost always successfully, as he says–with occlusal splints, physiotherapy, and relaxation exercises.” (Translated from German [10])

In general, any patient should be advised, therefore, to seek a second opinion whenever confronted with a diagnosis requiring invasive treatments.

References:

1. Madsen, H. Studie zur Kieferorthopädie in der Alternativmedizin: Darstellung der Grundlagen und kritische Bewertung. Doctoral dissertation, Poliklinik für Kieferorthopädie der Universität Würzburg. Würzburg 1994

2. Schulte von Drach, M.C. Wenn Zähne fremdgehen. Süddeutsche Zeitung May 15, 2012.

3. Staehle, H.J. Der Patientin wurde das Gebiss verstümmelt. Zahnärztliche Mitteilungen 2000.

4. Dowideit, A. Wenn nach der “Störfeld-Messung” alle Backenzähne fehlen. Welt June 3, 2017.

5. Bertelsen, H.-W. Die Attraktvität “ganzheitlicher” Zahnmedizin – Teil 1: Bohren ohne Reue. skeptiker 2012, 4.

6. Bertelsen, H.-W. Die Attraktivität “ganzheitlicher” Zahnmedizin – Teil 2: Bohren ohne Reue. skeptiker 2013, 4.

7. CMD Dachverband e. V. Craniomandibuläre Dysfunktion – Ursachen & Symptome. http://www.cmd-dachverband.de/fuer-patienten/ursachen-symptome/ (May 11, 2018),

8. Wolf, T. Die richtige Hilfe bei Kieferbeschwerden. Spiegel Online July 7, 2014, 2014.

9. Türp, J.C.; Schindler, H.-J.; Antes, G. Temporomandibular disorders: Evaluation of the usefulness of a self-test questionnaire. Zeitschrift für Evidenz, Fortbildung und Qualität im Gesundheitswesen 2013, 107, 285-290.

10. Albrecht, B. Teure Tricks der Zahnärzte – so schützen Sie sich vor Überbehandlung. stern February 18, 2016.

 

Bacterial vaginosis is a common condition which is more than a triviality. It can have serious consequences including pelvic inflammatory disease, endometritis, postoperative vaginal cuff infections, preterm labor, premature rupture of membranes, and chorioamnionitis. Therefore, it is important to treat it adequately with antibiotics. But are there other options as well?

There are plenty of alternative or ‘natural’ treatments on offer. But do they work?

This trial was conducted on 127 women with bacterial vaginosis to compare a vaginal suppository of metronidazole with Forzejeh, a vaginal suppository of herbal Persian medicine combination of

  • Tribulus terrestris,
  • Myrtus commuis,
  • Foeniculum vulgare,
  • Tamarindus indica.

The patients (63 in metronidazole group and 64 in Forzejeh group) received the medications for 1 week. Their symptoms including the amount and odour of discharge and cervical pain were assessed using a questionnaire. Cervical inflammation and Amsel criteria (pH of vaginal discharge, whiff test, presence of clue cells and Gram staining) were investigated at the beginning of the study and 14 days after treatment.

The amount and odour of discharge, Amsel criteria, pelvic pain and cervical inflammation significantly decreased in Forzejeh and metronidazole groups (p = <.001). There was no statistically significant difference between the metronidazole and Fozejeh groups with respect to any of the clinical symptoms or the laboratory assessments.

The authors concluded that Forzejeh … has a therapeutic effect the same as metronidazole in bacterial vaginosis.

The plants in Fozejeh are assumed to have antimicrobial activities. Forzejeh has been used in folk medicine for many years but was only recently standardised. According to the authors, this study shows that the therapeutic effects of Forzejeh on bacterial vaginosis is similar to metronidazole.

Yet, I am far less convinced than these Iranian researchers. As this trial compared two active treatments, it was an equivalence study. As such, it requires a different statistical approach and a much larger sample size. The absence of a difference between the two groups is most likely due to the fact that the study was too small to show it.

If I am correct, the present investigation only demonstrates yet again that, with flawed study-designs, it is easy to produce false-positive results.

Kinesiology tape KT is fashionable, it seems. Gullible consumers proudly wear it as decorative ornaments to attract attention and show how very cool they are.

Am I too cynical?

Perhaps.

But does KT really do anything more?

A new trial might tell us.

The aim of this study was to investigate whether adding kinesiology tape (KT) to spinal manipulation (SM) can provide any extra effect in athletes with chronic non-specific low back pain (CNLBP).

Forty-two athletes (21males, 21females) with CNLBP were randomized into two groups of SM (n = 21) and SM plus KT (n = 21). Pain intensity, functional disability level and trunk flexor-extensor muscles endurance were assessed by Numerical Rating Scale (NRS), Oswestry pain and disability index (ODI), McQuade test, and unsupported trunk holding test, respectively. The tests were done before and immediately, one day, one week, and one month after the interventions and compared between the two groups.

After treatments, pain intensity and disability level decreased and endurance of trunk flexor-extensor muscles increased significantly in both groups. Repeated measures analysis, however, showed that there was no significant difference between the groups in any of the evaluations.

The authors, physiotherapists from Iran, concluded that the findings of the present study showed that adding KT to SM does not appear to have a significant extra effect on pain, disability and muscle endurance in athletes with CNLBP. However, more studies are needed to examine the therapeutic effects of KT in treating these patients.

Regular readers of my blog will be able to predict what I have to say about this study design: A+B versus B is not a meaningful test of anything. I used to claim that it cannot possibly produce a negative result – and yet, here it seems to have done exactly that!

How come?

The way I see it, there are two possibilities to explain this:

  • the KT has a mildly negative effect on CNLBP; thus the expected positive placebo-effect was neutralised to result in a null-effect overall;
  • the study was under-powered such that the true inter-group difference could not manifest itself.

I think the second possibility is more likely, but it does really not matter at all. Because the only lesson we can learn from this trial is this: inadequate study designs will  hardly ever generate anything worthwhile.

And this is, I think, a lesson that would be valuable for many researchers.

_______________________________________________________________________

Reference

2018 Apr;22(2):540-545. doi: 10.1016/j.jbmt.2017.07.008. Epub 2017 Jul 26.

Comparing spinal manipulation with and without Kinesio Taping® in the treatment of chronic low back pain.

 

I have often cautioned my readers about the ‘evidence’ supporting acupuncture (and other alternative therapies). Rightly so, I think. Here is yet another warning.

This systematic review assessed the clinical effectiveness of acupuncture in the treatment of postpartum depression (PPD). Nine trials involving 653 women were selected. A meta-analysis demonstrated that the acupuncture group had a significantly greater overall effective rate compared with the control group. Moreover, acupuncture significantly increased oestradiol levels compared with the control group. Regarding the HAMD and EPDS scores, no difference was found between the two groups. The Chinese authors concluded that acupuncture appears to be effective for postpartum depression with respect to certain outcomes. However, the evidence thus far is inconclusive. Further high-quality RCTs following standardised guidelines with a low risk of bias are needed to confirm the effectiveness of acupuncture for postpartum depression.

What a conclusion!

What a review!

What a journal!

What evidence!

Let’s start with the conclusion: if the authors feel that the evidence is ‘inconclusive’, why do they state that ‘acupuncture appears to be effective for postpartum depression‘. To me this does simply not make sense!

Such oddities are abundant in the review. The abstract does not mention the fact that all trials were from China (published in Chinese which means that people who cannot read Chinese are unable to check any of the reported findings), and their majority was of very poor quality – two good reasons to discard the lot without further ado and conclude that there is no reliable evidence at all.

The authors also tell us very little about the treatments used in the control groups. In the paper, they state that “the control group needed to have received a placebo or any type of herb, drug and psychological intervention”. But was acupuncture better than all or any of these treatments? I could not find sufficient data in the paper to answer this question.

Moreover, only three trials seem to have bothered to mention adverse effects. Thus the majority of the studies were in breach of research ethics. No mention is made of this in the discussion.

In the paper, the authors re-state that “this meta-analysis showed that the acupuncture group had a significantly greater overall effective rate compared with the control group. Moreover, acupuncture significantly increased oestradiol levels compared with the control group.” This is, I think, highly misleading (see above).

Finally, let’s have a quick look at the journal ‘Acupuncture in Medicine’ (AiM). Even though it is published by the BMJ group (the reason for this phenomenon can be found here: “AiM is owned by the British Medical Acupuncture Society and published by BMJ”; this means that all BMAS-members automatically receive the journal which thus is a resounding commercial success), it is little more than a cult-newsletter. The editorial board is full of acupuncture enthusiasts, and the journal hardly ever publishes anything that is remotely critical of the wonderous myths of acupuncture.

My conclusion considering all this is as follows: we ought to be very careful before accepting any ‘evidence’ that is currently being published about the benefits of acupuncture, even if it superficially looks ok. More often than not, it turns out to be profoundly misleading, utterly useless and potentially harmful pseudo-evidence.


Reference

Acupunct Med. 2018 Jun 15. pii: acupmed-2017-011530. doi: 10.1136/acupmed-2017-011530. [Epub ahead of print]

Effectiveness of acupuncture in postpartum depression: a systematic review and meta-analysis.

Li S, Zhong W, Peng W, Jiang G.

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