MD, PhD, FMedSci, FRSB, FRCP, FRCPEd

case report

1 2 3 6

According to its authors, the objective of this paper was “to demonstrate the need for using both alternative and conventional treatments to improve clinical outcomes in the treatment of schizoaffective disorder”.

Instead of doing anything remotely like this, the authors present two case histories:

  • a 23-y-old female (case 1)
  • and a 34-y-old female (case 2).

Both patients had been diagnosed with schizoaffective disorder of the bipolar type. Individualized homeopathic treatment was initiated for both patients, who were also on conventional medications. A Likert scale was used to evaluate the intensity of each patient’s symptoms at each follow-up, based on self-reporting.

During the course of treatment, both patients’ symptoms normalized, and they regained their ability to hold jobs, attend school (at the age of 23/34 ???), and maintain healthy relationships with their families and partners while requiring fewer pharmaceutical interventions.

The authors concluded that these two cases …  illustrate the value of individualized homeopathic prescriptions with proper case management in the successful treatment of that disorder. Future large-scale, double-blind, placebo-controlled studies should investigate individualized homeopathic treatments for mental health concerns, because the diseases cause great economic and social burden.

The article was published in Altern Ther Health Med.by Grise DE, Peyman T, and Langland J who seem to be from the ‘Southwest College of Naturopathic Medicine, Tempe, Arizona’. Two of the authors have recently published similarly odd case reports:

  1. This case report demonstrates a successful approach to managing patients with type 2 diabetes mellitus (DM2). Botanical herbs (including Gymnema sylvestre) and nutrients (including alpha lipoic acid and chromium) were used alongside metformin to help improve insulin sensitization; however, the greatest emphasis of treatment for this patient centered on a low-carbohydrate, whole-foods diet and regular exercise that shifted the focus to the patient’s role in controlling their disease. Research on DM2 often focuses on improving drug efficacy while diet and lifestyle are generally overlooked as both a preventive and curative tool. During the 7 months of treatment, the patient’s hemoglobin A1c and fasting glucose significantly decreased to within normal ranges and both cholesterol and liver enzyme markers normalized. A significant body of evidence already exists advocating for disease management using various diets, including Mediterranean, low-carb, and low-fat vegan diets; however, no clear dietary standards have been established. This study supports the use of naturopathic medicine as well as dietary and lifestyle changes to develop the most efficacious approach for the treatment of DM2.
  2. This case report illustrates the improvement of an acupuncture-treated patient who incurred a severe traumatic brain injury (TBI) from a snowboarding accident. Over 4 years, the patient progressed from initially not being able to walk, having difficulty with speech, and suffering from poor eyesight to where he has now regained significant motor function, speech, and vision and has returned to snowboarding. A core acupuncture protocol plus specific points added to address the patient’s ongoing concerns was used. This case adds to the medical literature by demonstrating the potential role of acupuncture in TBI treatment.
  3. The current case study intended to evaluate the benefits of an alternative, multifaceted approach-including botanical and homeopathic therapies in conjunction with a low-FODMAP diet-in the treatment of small intestinal bacterial overgrowth (SIBO) and its associated symptoms. Design • The research team performed a case study. Setting • The study was conducted at SCNM Medical Center (Tempe, AZ, USA). Participant • The participant was a female patient at the SCNM Medical Center with chronic, daily, severe abdominal bloating and pain that particularly worsened after meals and by the end of the day. The patient also had a significant history of chronic constipation that had begun approximately 10 y prior to her experiencing the daily abdominal pain. Intervention • Based on a lactulose breath test for hydrogen and methane, the research team diagnosed the patient with a case of mild SIBO. The treatment approach was multifaceted, involving a low-FODMAP diet, antimicrobial botanical therapy, and homeopathic medicine. Results • The patient’s abdominal pain and bloating resolved with the treatment of the SIBO, although her underlying constipation, which was likely associated with other factors, remained. Conclusions • This case study supports an alternative, multifaceted approach to the treatment of SIBO and commonly associated symptoms.
  4. The study intended to examine the benefits of treating plantar warts with a topical, botanical blend that has had clinical success treating herpes simplex virus cold sores. Methods • A synergistic botanical blend was applied topically. Setting • The case report was completed at the Southwest College of Naturopathic Medicine (Tempe, Arizona, USA). Participant • The participant was a 24-y-old male soccer player, 177.8 cm tall, and weighing 69 kg with previously diagnosed, viral mosaic warts. Intervention • The patient used a pumice stone during bathing for the first week to remove dead tissue and ensure sufficient contact and entry of the botanical gel into infected tissue. After drying the area, the patient applied the botanical gel blend 1 to 2 times daily postshower, spreading it evenly across the surface of the entire lesion. The patient discontinued the exfoliation technique after the first week. Results • Within the first week of treatment, the patient noted changes to the infected area of the hallux epidermal tissue. The combination of exfoliation and application of the gel caused marked, visible differences in presentation by the fifth day of treatment. At 1-mo postintervention, or day 90, the epidermal tissue was asymptomatic and devoid of petechiae, malformations, or visible infection. Conclusions • The results of the current case study directly contrast with the drawbacks of commonly accepted, first-line interventions in the treatment of viral plantar warts and, in many respects, demonstrate better efficacy and fewer side effects than the standard of care. The positive results also highlight the necessity for additional study in the fields of sports medicine and podiatry to further establish the botanical blend when treating viral plantar in athletes, an overall at-risk population for the condition.
  5. This study intended to examine the benefits of treatment of a pediatric patient with natural supplements and an elimination diet for IgG food allergies. Design • The research team reported a case study. Setting • The study was conducted at Southwest Naturopathic Medical Center (Tempe, AZ, USA). Participant • The participant was a 10-y-old Caucasian female who had diagnoses of allergic rhinitis and reactive bronchospasm, the second of which was exacerbated by allergens such as wheat, perfumes, and seasonal flora. Intervention • Following testing for IgE- and IgG-reactive foods, the patient was treated with natural supplements to reduce her allergic responses and was instructed to make dietary changes to eliminate the IgG-reactive foods. Outcome Measures • The patient’s symptom severity was tracked starting 1 mo after her initial visit to Southwest Naturopathic Medical Center. The severity was based on the patient’s subjective reports about her congestion to her mother and on her mother’s observations of the effect of symptoms on her attention and school performance. The bronchospasm severity was based on the frequency of a sensation of wheezing and chest tightness, the frequency of inhaler use, and the occurrence of any exacerbation of symptoms with acute respiratory illness Results • After 1 mo, in which the patient used the natural supplements, she experienced a 90% improvement in coughing; a 70% improvement in nasal congestion; less chest tightness; and no need for use of loratadine, diphenhydramine, or albuterol. At the 8-mo follow-up visit, her nasal congestion was reported to be entirely gone. Conclusions • The case demonstrates the effectiveness of natural supplements and a diet eliminating IgG-reactive foods in the treatment and management of pediatric allergic rhinitis and reactive bronchospasm.

These articles are all quite similarly ridiculous, but the first one reporting two patients who felt better after taking individualised homeopathic remedies (together with conventional medicines) is, I think, the ‘best’. I suggest the authors continue their high-flying careers by publishing a series of further case reports on similar themes:

  • How the crowing of the cock in the morning causes the sun to rise.
  • The danger of WW 3 causes Americans to elect an idiot as president.
  • Increase of CO2 emissions due to global warming.
  • Immunisation neglect caused by measles outbreaks.
  • Brexit vote due to economic downturn.
  • Excessive alcohol consumption caused by hangover.
  • Why does lying in bed cause tiredness?

Please feel free to suggest more ‘post hoc propter hoc’ research themes for our aspiring team of naturopathic pseudo-scientists to be published in Altern Ther Health Med.

 

 

 

We all know Epsom salt, don’t we? This paper provides an interesting history of it: The purgative effect of the waters of Epsom, in southern England, was first discovered in the early seventeenth century. Epsom subsequently developed as one of the great English spas where high society flocked to take the medicinal waters. The extraction of the Epsom Salts from the spa waters and their chemical analysis, the essential feature of which was magnesium sulphate, were first successfully carried out by Doctor Nehemiah Grew, distinguished as a physician, botanist and an early Fellow of the Royal Society. His attempt to patent the production and sale of the Epsom Salts precipitated a dispute with two unscrupulous apothecaries, the Moult brothers. This controversy must be set against the backcloth of the long-standing struggle over the monopoly of dispensing of medicines between the Royal College of Physicians and the Worshipful Society of Apothecaries of London.

Epsom salt has the reputation of being very safe. But unfortunately, even something as seemingly harmless as Epsom salt can become dangerous in the hand of people who have little understanding of physiology and medicine. Indian doctors have just published a paper in (‘BMJ Case Reports’) with the details of a 38-year-old non-alcoholic, non-diabetic man suffering from gallstones. The patient was prescribed three tablespoons of Epsom salt to be taken with lukewarm water for 15 days for ‘stone dissolution’ by a ‘naturopathy practitioner’. He subsequently developed loss of appetite and darkening of urine from the 12th day of treatment and jaundice from the second day after treatment completion. The patient denied fevers, skin rash, joint pains, myalgia, abdominal pain, abdominal distension and cholestatic symptoms.

Examination revealed a deeply icteric patient oriented to time, place and person without an enlarged liver or stigmata of chronic liver disease. Liver function tests were abnormal, and a  liver biopsy revealed sub-massive necrosis with dense portal-based fibrosis, mixed portal inflammation, extensive peri-venular canalicular and hepatocellular cholestasis with macro-vesicular steatosis and peri-sinusoidal fibrosis (suggestive of steato-hepatitis) without evidence of granulomas, inclusion bodies or vascular changes suggestive of acute drug-induced liver injury.

After discontinuation of Epsom salt and adequate hydration, the patient had an uneventful recovery with normalisation of liver function tests after 38 days.  The Roussel Uclaf Causality Assessment score was strongly suggestive of Epsom salt-induced liver injury.

I was invited to provide a comment and stated that, in my view, this case reminds us:

1) that naturopaths prescribe a lot of nonsense,

2) that not everything which is promoted as natural is safe,

3) that treatments which apparently have ‘stood the test of time’ can still be rubbish, and

4) that even a relatively harmless remedy can become life-threatening, if one takes it at a high dose for a prolonged period of time.

Naturopaths have advocated Epsom salt for gall-bladder problems since centuries, yet there is no good evidence that it works. It is time that alternative practitioners abide by the rules of evidence-based medicine.

A quick Medline search reveals that there is only one further report of a serious adverse effect after Epsom salt intake: a case of fatal hypermagnesemia caused by an Epsom salt enema. A 7-year-old male presented with cardiac arrest and was found to have a serum magnesium level of 41.2 mg/dL (33.9 mEq/L) after having received an Epsom salt enema earlier that day. The medical history of Epsom salt, the common causes and symptoms of hypermagnesemia, and the treatment of hypermagnesemia are reviewed. The easy availability of magnesium, the subtle initial symptoms of hypermagnesemia, and the need for education about the toxicity of magnesium should be of interest to physicians.

… and to alternative practitioners, I hasten to add.

How often have we heard that chiropractic has moved on and has given up the concept of subluxation/malalignment? For sure there is no evidence for such nonsense, and it would be high time to give it up!  But, as has been argued here and elsewhere, if chiros give it up, what is there left? What then would differentiate them from physios ? The answer is not a lot.

In any case, chiros have by no means given up subluxation. One can argue this point ad nauseam; yet, most chiros remain in denial.

For this post, I have chosen a different approach to make my point. I simply went on twitter and had a look what messages chiros tweet. The impression I got is that the majority of chiros are totally immersed in subluxation. To provide some proof, I have copied a few images – if chiros do not listen to words, perhaps they understand pictures, I thought.

So, here we go – enjoy!

[please click to see them full size]

 

On this blog, we have often discussed the risks of spinal manipulation. As I see it, the information we have at present suggests that

  • mild to moderate adverse effects are extremely frequent and occur in about half of all patients;
  • serious adverse effects are being reported regularly;
  • the occur usually with chiropractic manipulations of the neck (which are not of proven efficacy for any condition) and often relate to vascular accidents;
  • the consequences can be permanent neurological deficits and even deaths;
  • under-reporting of such cases might be considerable and therefore precise incidence figures are not available;
  • there is no system to accurately monitor the risks;
  • chiropractors are in denial of these problems.

Considering the seriousness of these issues, it is important to do more rigorous research. Therefore, any new paper published on this subject is welcome. A recent article might shed new light on the topic.

The objective of this systematic review was to identify characteristics of 1) patients, 2) practitioners, 3) treatment process and 4) adverse events (AE) occurring after cervical spinal manipulation (CSM) or cervical mobilization. A systematic searches were performed in 6 electronic databases up to December 2014. Of the initial 1043 articles thus located, 144 were included, containing 227 cases. 117 cases described male patients with a mean age of 45 and a mean age of 39 for females. Most patients were treated by chiropractors (66%). Manipulation was reported in 95% of the cases, and neck pain was the most frequent indication for the treatment. Cervical arterial dissection (CAD) was reported in 57%  of the cases and 45.8% had immediate onset symptoms. The overall distribution of gender for CAD was 55% for female. Patient characteristics were described poorly. No clear patient profile, related to the risk of AE after CSM, could be extracted, except that women seemed more at risk for CAD. The authors of this review concluded that there seems to be under-reporting of cases. Further research should focus on a more uniform and complete registration of AE using standardized terminology.

This article provides little new information; but it does confirm what I have been saying since many years: NECK MANIPULATIONS ARE ASSOCIATED WITH SERIOUS RISKS AND SHOULD THEREFORE BE AVOIDED.

The current volume of the ‘Allgemeinen Homöopathischen Zeitung’ contains all the abstracts of the ‘Homeopathic World Congress 2017’ which will be hosted in Leipzig, 14-17 July this year by the ‘Deutschen Zentralvereins Homöopathischer Ärzte’ under the patronage of the German Health Secretary, Annette Widmann-Mauz. As not many readers of this blog are likely to be regular readers of this important journal, I have copied six of the more amusing abstracts below:

A male patient with bilateral solid renal mass was investigated and given an individualized homeopathic remedy. Antimonium crudum in 50000 potency was selected after proper case taking and evaluation. Investigations were done before and after treatment. Follow ups took place monthly. Results The patient had symptomatic relief from pain in flanks, acute retention and hematuria. The ultrasonography suggests a reduction in size of both lesions over a period of two years. A small number of lymph nodes of the para-aortic group are still visible. There is a normal level of urea and creatinine, no anemia or hypertention. The patient is surviving since 2014. Conclusion In the present day when malignancies are treated with surgeries, chemo and radiotherapies, homeopathy has a significant role to play as seen in the above case. This case with bilateral solid renal mass, probably a renal cell carcinoma, received an individualized homeopathic remedy-treatment compliant with the totality of symptoms, and permitted the patient to live longer without anemia, hypertension, anorexia or weight loss. The quality of life was maintained without the side effects of surgery, radiotherapy and chemotherapy. Acute retentions, which he used to suffer also remained absent, thereafter. The result of this case suggests to take up further studies on individualized homeopathic treatment in malignant diseases.

Urinary tract infections (UTI) are often a complaint in the homeopathic practice, mainly as uncomplicated infections in the form of a one time event. Some patients, however, have a tendency to develop recurrent or complicated urinary tract infections. Methods It is shown on the basis of case documentation that UTI should be treated homeopathic, variably. The issue of prophylaxis will be discussed. Results If there is a tendency to complicated UTI, chronic treatment after case taking of the symptom-totality of the affected must take place during a free interval. In contrast, the chronically recurring and flaming up of UTI, as well as the uniquely occurring of uncomplicated UTI, are handled as an acute illness. The treatment is based on the striking, characteristic symptoms of the infected. Conclusion The homeopathic treatment of UTI in the acute case of uncomplicated forms is usually very successful, The chronic treatment of complicated UTI shows certain difficulties. A safe homeopathic prophylaxis, in terms of conventional medicine, is problematical.

The homeopathic clinic of the Municipal Public Servant Hospital of São Paulo (HSPM – Brazil) has among patient records some cases of thyroid gland diseases (hypothyroidism or hyperthyroidism), which were treated whith the systemic homeopathic method of Carillo. This study evaluates patients with diseases of thyroid gland, analyzing improvements using a Iodium-like equalizer, adjacent to the systemic medication. The reviewed 21 cases using Iodium equalizer for the disease, adjacent to the systemic medication, in the homeopathic clinic of the HSPM, from 2000 to 2013. In four cases, it was possible to reduce the dose of allopathic medicine and finally terminate it due to normalization of the thyroid gland function. There was one case of hyperthyroidism and it was possible to terminate the use of methimazole. There were four cases, in which the function of the thyroid gland was normalized without the associated use of hormone. In three cases it was possible to reduce the dose of hormone. There were nine cases, in which it was not possible to reduce the dose of the hormone. In cases where there was an improvement applying homeopathic treatment, TSH and free T4 returned to the normal reference value. In cases that were not effective, TSH and free T4 had not normalized. Therefore, the effectiveness of Iodium depends on the ability and stability of the gland thyroid to increase or decrease hormone production, in addition to the treatment of a chronic disease, that affects the thyroid gland.

Cystitis composes infections in the urinary system, especially bladder and urethra. It has multiple causes, but the most common is infection due to microorganisms such as E. coli, streptococcus, staphylococcus etc. If the system is attacked by pathogenetic agents, the defense must include more powerful noxious agents which can fight and destroy the attacking organisms, here is the role of nosodes. Nosodes are the potentised remedies made up from dangerous noxious materials. The use of nosodes in cystitis is based on the aphorism 26– Therapeutic Law of Nature: A weaker one is always distinguished by the stronger one! Colibacillinum, streptococcinum, staphylococcinum, lyssinum, medorrhinum, psorinum and tuberculinum are useful in handling cystitis relating to the organism involved [as found in urine test] and symptom similarity. Method An observational prospective study on a group of 30 people proves the immediate, stronger defensive action of nosodes. Result Amazing! Nosodes given in low potency provided instant relief to patients. Repetition of the same, over several months offered immunity for further attacks of cystitis, as Hering had already testified nosodes have prophylactic action. Conclusion According to law of similia – as per the pathology, as per the defense! By inducing a strong artificial disease, homeopathy can eliminate the natural disease from the body. Usually nosodes are used as intercurrent drugs which play the role of catalysts, on the journey to recovery, but they are also very effective in cystitis as an acute remedy. Acute cystitis is a very troublesome state for the patients, to cure it homeopathy has an arsenal of nosodes.

In 1991, no antiretroviral therapy (ART) treatment was available. The Central Council for Research in Homeopathy had established a clinical research unit at Mumbai for undertaking investigations in HIV/AIDS. So far 2502 cases have been enrolled for homeopathic treatment and three studies have been published since then. In this paper we will highlight the impact of long term homeopathic management of cases, which have been followed up for more than 15 years. Method The HIV positive cases enrolled in different studies are continuously being managed in this unit and even after study conclusion. All the cases are being treated solely with individualised homeopathy. The cases are assessed clinically (body weight, opportunistic infections, etc.) as well as in respect to CD4 counts and CD4/CD8 ratio. Results The CD4 count was maintained in all patients, except in one case. Three patients had the CD4 level in the range of 500–1200, four in the range of 300–500, one had a 272 CD4 count. There has been a decline of CD4/ CD8 ratio since baseline, but the patients have maintained their body weights and remained free from major HIV related illnesses and opportunistic infections. The frequently indicated remedies were pulsatilla pratensis, lycopodium clavatum, nux vomica,tuberculinum bovinum, natrum muriaticum, rhus toxicodendron, medorrhinum, arsenicum album, mercurius solubilis, thuja occidentalis, nitic acid, sulphur, bryonia alba and hepar sulph. Conclusion In the emergent scenario of drug resistance and adverse reactions of ART in HIV infections, there may be a possibility of employing homeopathy as an adjuvant therapy to existing standard ART treatment. Further studies are desirable.

In the last 20 years we have treated in the Clinica St. Croce many patients with cancer. We often deal with palliative states and we aim at pain relief and improvement of life-quality, and if possible a prolongation of life. Is this possible by prescribing a homeopathic therapy? Methodology The exact application and the knowledge of the responses to the Q-potencies often give indications for the correct choice of remedy. Acute conditions of pain often need a more frequent repetition of the C-potencies needed for pain relief. Results Even with severe pain or in so-called final stages homeopathy can offer great assistance. On the basis of case reports from Clinica St. Croce, the procedure for the homeopathic treatment of cancer, and the treatment of pain and final states will be illustrated and clarified. In addition, some clinically proven homeopathic remedies will be presented for the optimal palliation in the treatment of end-states and accompanying the dying. Conclusions With the precise application and knowledge of the responses to the Q- and C-potencies, the homeopathic doctor is given a wonderful helper to treat even the most serious palliative states and can accomplish, sometimes, a miraculous healing.

MY BRIEF COMMENT

These abstracts are truly hilarious and show how totally unaware some homeopaths are of the scientific method. I say ‘some’, but perhaps it is most or even all? How can a scientific committee reviewing these abstracts let them pass and allow the material to be presented at the ‘World Congress’? How can a Health Secretary accept the patronage of such a farce?

These abstracts are therefore not just hilarious but also truly depressing. If we had needed proof that homeopathy has no place in real healthcare of today, these abstracts would go a long way in providing it. To realise that politicians, physicians, patients, consumers, journalists etc. take such infantile nonsense seriously is not just depressing but at the same time worrying, I find.

The website of ‘HOMEOPATHY 360’ has just published a new post offering a handy instruction for killing patients suffering from acute appendicitis. If you do not believe me – I don’t blame you, I too found it hard to believe – read this short excerpt advocating homeopathy for this life-threatening condition (for readers without a medical background: if acute appendicitis is not treated promptly, the inflamed appendix might burst, spilling faecal material into the abdominal cavity, resulting in a life-threatening peritonitis):

The post is entitled “A Cure of Acute Appendicitis Using Frequent Homeopathic Doses in Solution

Here is the abstract:

“Placing centesimal potencies in solution and prescribing them frequently for acute conditions is not widely practiced. It can be superior to dry doses in many cases, where a persistent mild medicinal action is preferred to a strong aggravation. By prescribing dissolved doses of Arnica Montana 1m, a case of acute appendicitis was cured quickly. This suggests that centesimal potencies given frequently in solution may be more efficacious, prompt and gentle than treatment with dry doses.”

Fascinating, isn’t it?

Here are more details demonstrating that the author has done his homework:

“When treating a patient with acute medical condi­tion, in certain cases we fail to cure. Even though our case taking, evaluation, analysis, remedy and potency selection seem correct. What is the cause? In the Organon 5th edition (1833) Dr. Hahnemann introduced olfaction and dissolved centesimal remedies as a new method of administering doses. Around the year 1840 Hahnemann began to introduce LM potencies into his practice. From 1840 to 1843 he used both centesimal and LM potencies side by side in medicinal solutions. By these methods he hoped to avoid unwanted aggravations and provide rapid cure.

In some acute cases the aggravation can be discouragingly pro­longed and often cannot be discerned from the patient’s own disease. Many times we change the original prescrip­tion which could very well have been the simillimum. In acute diseases, a dry dose will many times produce an un­necessary aggravation because of the patient’s increased susceptibility. I have much experience now with what I call a “watery dose.” To prepare it, one or two globules of size 10 are diluted in 15ml. of distilled water in which 5 drops of alcohol added with 20 to 30 succussions. From this solution 10 drops are added to another 15 ml of water, and from this solution 5 to 10 drops dose repeated according to the severity of the disease. In such diluted solutions the correct number of drops must be precise. Every time be­fore taking the dose the solution is succussed 5 to 10 times. The same solution can be used for several days or weeks. Hahnemann recommended using carefully measured and dosed solutions with sensitive patients. Many times I have used this method with great success. It is not necessary to take 4 oz. to 8 oz. of water, Just fifteen ml. of distilled water is sufficient. This technique of dosing is also known as a split dose because it uses one or two pills in a solution that is then split over several days or weeks.

The results using this type of dosing can be very dif­ferent from dry doses. There is continuous amelioration of the complaints without aggravation. This comes closer to the ideal of strengthening the weakened vital force than is seen when we simply produce a similar stronger artificial disease in the patient.”

The author also provides a detailed case history of a patient who survived this treatment (of course, without mentioning that acute appendicitis can, in rare cases, have a spontaneous recovery).

MY ADVICE:

I would not recommend Arnica or any other homeopathic remedy for routine use in acute appendicitis (or any other condition) – unless, of course, you want to kill a maximum number of your patients suffering from this medical/surgical emergency.

The new guidelines by the American College of Physicians entitled ‘Noninvasive Treatments for Acute, Subacute, and Chronic Low Back Pain: A Clinical Practice Guideline From the American College of Physicians’ have already been the subject of the previous post. Today, I want to have a closer look at a small section of these guidelines which, I think, is crucial. It is entitled ‘HARMS OF NONPHARMACOLOGIC THERAPIES’. I have taken the liberty of copying it below:

“Evidence on adverse events from the included RCTs and systematic reviews was limited, and the quality of evidence for all available harms data is low. Harms were poorly reported (if they were reported at all) for most of the interventions.

Low-quality evidence showed no reported harms or serious adverse events associated with tai chi, psychological interventions, multidisciplinary rehabilitation, ultrasound, acupuncture, lumbar support, or traction (9,95,150,170–174). Low-quality evidence showed that when harms were reported for exercise, they were often related to muscle soreness and increased pain, and no serious harms were reported. All reported harms associated with yoga were mild to moderate (119). Low-quality evidence showed that none of the RCTs reported any serious adverse events with massage, although 2 RCTs reported soreness during or after massage therapy (175,176). Adverse events associated with spinal manipulation included muscle soreness or transient increases in pain (134). There were few adverse events reported and no clear differences between MCE and controls. Transcutaneous electrical nerve stimulation was associated with an increased risk for skin site reaction but not serious adverse events (177). Two RCTs (178,179) showed an increased risk for skin flushing with heat compared with no heat or placebo, and no serious adverse events were reported. There were no data on cold therapy. Evidence was insufficient to determine harms of electrical muscle stimulation, LLLT, percutaneous electrical nerve stimulation, interferential therapy, short-wave diathermy, and taping.”

The first thing that strikes me is the brevity of the section. Surely, guidelines of this nature must include a full discussion of the risks of the treatments in question!

The second thing that is noteworthy is the fact that the authors confirm the fact I have been banging on about for years: clinical trials of alternative therapies far too often fail to mention adverse effects.  I have often pointed out that the failure to report adverse effects in clinical trials is an unacceptable violation of medical ethics. By contrast, the guideline authors seem not to feel strongly about this omission.

The third thing that is noteworthy is that the guidelines evaluate the harms of the treatments purely on the basis of the adverse effects reported in the clinical trials and systematic reviews included in their efficacy assessments. This is nonsensical for at least two reasons:

  1. The guideline authors themselves are aware that the trials very often fail to mention adverse effects.
  2. For any assessment of harm, one has to go far beyond the evidence of clinical trials, because trials tend to be too small to pick up rare adverse effects, and because they are always conducted under optimally controlled conditions where adverse effects are less likely to occur than in real life.

Together, these features of the assessment of harms explain why the guideline authors arrive at conclusions which are oddly misguided; I would even feel that they resemble a white-wash. Here are two of the most overt misjudgements:

  • no harms associated with acupuncture,
  • only trivial harm associated with spinal manipulations.

The best evidence we have today shows that acupuncture leads to mild adverse effects in about 10% of all cases and is also associated with very severe complications (e.g. pneumothorax, cardiac tamponade, infections, deaths) in an unknown number of patients. More details can be found for instance here, here, here and here.

And the best evidence available shows that spinal manipulation leads to moderately severe adverse effects in ~50% of all cases. In addition, we know of hundreds of cases of very severe complications resulting in stroke, permanent neurological deficits or deaths. More details can be found for instance here, here, here and here.

In the introduction, I stated that this small section of the guidelines is crucial.

Why?

The reason is simple: any responsible therapeutic decision has to be based not just on the efficacy of the treatment in question but on its risk/benefit balance. The evidence shows that the risks of some alternative therapies can be considerable, a fact that is almost totally neglected in the guidelines. Therefore, the recommendations of the new guidelines by the American College of Physicians entitled ‘Noninvasive Treatments for Acute, Subacute, and Chronic Low Back Pain: A Clinical Practice Guideline From the American College of Physicians’ are in several aspects not entirely correct and need to be reconsidered.

On this blog, we have had (mostly unproductive) discussions with homeopath so often that sometimes they sound like a broken disk. I don’t want to add to this kerfuffle; what I hope to do today is to summarise  a certain line of argument which, from the homeopaths’ point of view, seems entirely logical. I do this in the form of a fictitious conversation between a scientist (S) and a classical homeopath (H). My aim is to make the reader understand homeopaths better so that, future debates might be better informed.

HERE WE GO:

S: I have studied the evidence from studies of homeopathy in some detail, and I have to tell you, it fails to show that homeopathy works.

H: This is not true! We have plenty of evidence to prove that patients get better after seeing a homeopath.

S: Yes, but this is not because of the remedy; it is due to non-specific effect like the empathetic consultation with a homeopath. If one controls for these factors in adequately designed trials, the result usually is negative.

I will re-phrase my claim: the evidence fails to show that highly diluted homeopathic remedies are more effective than placebos.

H: I disagree, there are positive studies as well.

S: Let’s not cherry pick. We must always consider the totality of the reliable evidence. We now have a meta-analysis published by homeopaths that demonstrates the ineffectiveness of homeopathy quite clearly.

H: This is because homeopathy was not used correctly in the primary trials. Homeopathy must be individualised for each unique patient; no two cases are alike! Remember: homeopathy is based on the principle that like cures like!!!

S: Are you saying that all other forms of using homeopathy are wrong?

H: They are certainly not adhering to what Hahnemann told us to do; therefore you cannot take their ineffectiveness as proof that homeopathy does not work.

S: This means that much, if not most of homeopathy as it is used today is to be condemned as fake.

H: I would not go that far, but it is definitely not the real thing; it does not obey the law of similars.

S: Let’s leave this to one side for the moment. If you insist on individualised homeopathy, I must tell you that this approach can also be tested in clinical trials.

H: I know; and there is a meta-analysis which proves that it is effective.

S: Not quite; it concluded that medicines prescribed in individualised homeopathy may have small, specific treatment effects. Findings are consistent with sub-group data available in a previous ‘global’ systematic review. The low or unclear overall quality of the evidence prompts caution in interpreting the findings. New high-quality RCT research is necessary to enable more decisive interpretation.

If you call this a proof of efficacy, I would have to disagree with you. The effect was tiny and at least two of the best studies relevant to the subject were left out. If anything, this paper is yet another proof that homeopathy is useless!

H: You simply don’t understand homeopathy enough to say that. I tried to tell you that the remedy must be carefully chosen to fit each unique patient. This is a very difficult task, and sometimes it is not successful – mainly because the homeopaths employed in clinical trials are not skilled enough to find it. This means that, in these studies, we will always have a certain failure rate which, in turn, is responsible for the small average effect size.

S: But these studies are always conducted by experienced homeopaths, and only the very best, most experienced homeopaths were chosen to cooperate in them. Your argument that the trials are negative because of the ineffectiveness of the homeopaths – rather than the ineffectiveness of homeopathy – is therefore nonsense.

H: This is what you say because you don’t understand homeopathy!

S: No, it is what you say because you don’t understand science. How else would you prove that your hypothesis is correct?

H: Simple! Just look at individual cases from the primary studies within this meta-analysis . You will see that there are always patients who did improve. These cases are the proof we need. The method of the RCT is only good for defining average effects; this is not what we should be looking at, and it is certainly not what homeopaths are interested in.

S: Are you saying that the method of the RCT is wrong?

H: It is not always wrong. Some RCTs of homeopathy are positive and do very clearly prove that homeopathy works. These are obviously the studies where homeopathy has been applied correctly. We have to make a meta-analysis of such trials, and you will see that the result turns out to be positive.

S: So, you claim that all the positive studies have used the correct method, while all the negative ones have used homeopathy incorrectly.

H: If you insist to put it like that, yes.

S: I see, you define a trial to have used homeopathy correctly by its result. Essentially you accept science only if it generates the outcome you like.

H: Yes, that sounds odd to you – because you don’t understand enough of homeopathy.

S: No, what you seem to insist on is nothing short of double standards. Or would you accept a drug company claiming: some patients did feel better after taking our new drug, and this is proof that it works?

H: You see, not understanding homeopathy leads to serious errors.

S: I give up.

Traditional and folk remedies have been repeatedly been reported to contain toxic amounts of lead. I discussed this problem before; see here, here, and here. Recently, two further papers were published which are relevant in this context.

In the first article, Indian researchers presented a large series of patients with lead poisoning due to intake of Ayurvedic medicines, all of whom presented with unexplained abdominal pain.

In a retrospective, observational case series from a tertiary care center in India, the charts of patients who underwent blood lead level (BLL) testing as a part of workup for unexplained abdominal pain between 2005 and 2013 were reviewed. The patients with lead intoxication (BLLs >25 μg/dl) were identified and demographics, history, possible risk factors, clinical presentation and investigations were reviewed. Treatment details, duration, time to symptomatic recovery, laboratory follow-up and adverse events during therapy were recorded.

BLLs were tested in 786 patients with unexplained abdominal pain, and high levels were identified in 75 (9.5%) patients of which a majority (73 patients, 9.3%) had history of Ayurvedic medication intake and only two had occupational exposure. Five randomly chosen Ayurvedic medications were analyzed and lead levels were impermissibly high (14-34,950 ppm) in all of them. Besides pain in abdomen, other presenting complaints were constipation, hypertension, neurological symptoms and acute kidney injury. Anemia and abnormal liver biochemical tests were observed in all the 73 patients. Discontinuing the Ayurvedic medicines and chelation with d-penicillamine led to improvement in symptoms and reduction in BLLs in all patients within 3-4 months.

The authors of this paper concluded that the patients presenting with severe recurrent abdominal pain, anemia and history of use of Ayurvedic medicines should be evaluated for lead toxicity. Early diagnosis in such cases can prevent unnecessary investigations and interventions, and permits early commencement of the treatment.

The second article German researchers analysed 20 such ‘natural health products’ (NHPs) from patients with intoxication symptoms. Their findings revealed alarming high concentrations of mercury and/or lead (the first one in “therapeutic” doses). 82 % of the studied NHPs contained lead concentrations above the EU limit for dietary supplements. 62 % of the samples exceeded the limit values for mercury. Elevated blood lead and mercury levels in patients along with clinical intoxication symptoms corroborate the causal assumption of intoxication (s).

The authors concluded that, for NHPs there is evidence on a distinct toxicological risk with alarming low awareness for a possible intoxication which prevents potentially life-saving diagnostic steps in affected cases. In many cases patients do not communicate the events to their physicians or the local health authority so that case reports (e.g. the BfR-DocCentre) are missing. Thus, there is an urgent need to raise awareness and to initiate more suitable monitory systems (e.g. National Monitoring of Poisonings) and control practice protecting the public.

The authors of the 2nd paper also reported a detailed case report:

Patient, male, 31 with BMI slightly below normal, non-smoker, was referred to the neurological department of the university clinic with severe peripheral poly neuropathy and sensory motor symptoms with neuropathic pain. The patient was in good general state of health until approximately 3 weeks before hospital admission; he spent his holiday in Himalaya region and came back with headaches and fatigue. He was taking pain medication without any relieve; his routine blood values were normal. He claimed to take no further medications. Since poly neuropathy and fatigue could be caused by pesticides or other poisoning, i.e. heavy metals, we have been consulted for taking a detailed exposure history. While in the clinic, 3 different NHPs were found in form of globules, (a, b, c for morning, lunch time and evening respectively), which he imported from his trip to Asia and ingested 3 times a day against stress. We have analyzed these 3 NHPs and found: 45 μg/g, 53,000 μg/g and 28 μg/g lead (for morning, midday and evening globules, respectively) and additionally 15.72 μg/g mercury in the “evening globules”. Since, his blood metal levels were: 340 μg/L Pb and 15 μg/L Hg a diagnosis of heavy metal intoxication was made. Slowly occurring clinical recovery after starting chelation therapy corroborated with the causal assumption proposed. He was released for further consultancy to his family physician. The administrated treatment and the improvement of his status corroborate lead and mercury intoxication.

The researchers finish their paper with this stark warning: In many countries, even in Germany, no comprehensive nutria vigilance- or poisoning monitoring system exists, from which the application of natural health products and the consequent intoxication can be estimated. There is also an urgent need for comprehensive scientifically evaluated studies based on efficient national monitoring to protect the consumer from heavy metal intoxications. There are no comparable surveillance systems like the US ABLES program for lead- and no surveillance systems for mercury exposures allowing any comparisons. Exposure to lead and mercury from environmental sources remains an overlooked and serious public health risk.

We have discussed the risks of (chiropractic) spinal manipulation more often than I care to remember. The reason for this is simple: it is an important subject; making sure that as many consumers know about it will save lives, I am sure. Therefore, any new paper on the subject is likely to be reported on this blog.

Objective of this review was to identify characteristics of 1) patients, 2) practitioners, 3) treatment process and 4) adverse events (AE) occurring after cervical spinal manipulation (CSM) or cervical mobilization. Systematic searches were performed in 6 electronic databases. Of the initial 1043 studies, 144 studies were included.

They reported 227 cases. 117 cases described male patients with a mean age of 45 (SD 12) and a mean age of 39 (SD 11) for females. Most patients were treated by chiropractors (66%) followed by non-clinicians (5%), osteopaths (5%), physiotherapists (3%) and other medical professions. Manipulation was reported in 95% of the cases (mobilisations only in 1.7%), and neck pain was the most frequent indication.

Cervical arterial dissection (CAD) was reported in 57% of the cases and 46% had immediate onset symptoms; in 2% onset of symptoms took for more than two weeks. Other complications were disc rupture, spinal cord swelling and thrombus. The most frequently reported symptoms included disturbance of voluntary control of movement, pain, paresis and visual disturbances.

In most of the reports, patient characteristics were described poorly. No clear patient profile, related to the risk of AE after CSM, could be extracted. However, women seem more at risk for CAD.

The authors concluded that there seems to be under-reporting of cases. Further research should focus on a more uniform and complete registration of AE using standardized terminology.

I do not want to repeat what I have stated in previous posts on this subject. So,let me just ask this simple question: IF THERE WERE A DRUG MARKTED FOR NECK PAIN BUT NOT SUPPORTED BY GOOD EVIDENCE FOR EFFICACY, DO YOU THINK IT WOULD BE ON THE MARKET AFTER 227 CASES OF SEVERE ADVERSE EFFECTS HAD BEEN DESCRIBED?

I think the answer is NO!

If we then consider the huge degree of under-reporting in this area which might bring the true figure up by one or even two dimensions, we must ask: WHY IS CERVICAL MANIPULATION STILL USED?

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