This randomized controlled trial was aimed to investigate the effect of aromatherapy massage on anxiety, depression, and physiologic parameters in older patients with acute coronary syndrome. It was conducted on 90 older women with acute coronary syndrome. The participants were randomly assigned into the intervention and control groups. The intervention group received reflexology with lavender essential oil plus routine care and the control group only received routine care. Physiologic parameters, the levels of anxiety and depression in the hospital were evaluated using a checklist and the Hospital’s Anxiety and Depression Scale, respectively, before and immediately after the intervention.
Significant differences in the levels of anxiety and depression were reported between the groups after the intervention. The analysis of physiological parameters revealed a statistically significant reduction in systolic blood pressure, diastolic blood pressure, mean arterial pressure, and heart rate. However, no significant difference was observed in the respiratory rate.
The authors concluded that aromatherapy massage can be considered by clinical nurses an efficient therapy for alleviating psychological and physiological responses among older women suffering from acute coronary syndrome.
This trial does not show remotely what the authors think. It demonstrates that A+B is always more than B. We have discussed this phenomenon so often that I hesitate to mention it again. Any study with the ‘A+B versus B’ design can only produce a positive result. The danger that this result is false-positive is so high that it is best to forget about such investigations altogether.
Ethics committees should not accept such protocols.
Researchers should stop running such studies.
Reviewers should not pass them for publication.
Editors should not publish such trials.
THEY MISLEAD ALL OF US AND GIVE CLINICAL RESEARCH A BAD NAME.
George Vithoulkas * (GV) is one of today’s most influential lay-homeopaths, a real ‘super guru’. He has many bizarre ideas; one of the most peculiar one was recently outlined in his article entitled ‘An innovative proposal for scientific alternative medical journals’. Here are a few excerpts from it:
…the only evidence that homeopathy can present to the scientific world at this moment are these thousands of cured cases. It is a waste of time, money, and energy to attempt to demonstrate the effectiveness of homeopathy through double blind trials.
… the international “scientific” community, which has neither direct perception nor personal experience of the beneficial effects of homeopathy, is forced to repeat the same old mantra: “Where is the evidence? Show us the evidence!” … the successes of homeopathy have remained hidden in the offices of hardworking homeopaths – and thus go largely ignored by the world’s medical authorities, governments, and the whole international scientific community…
… simple questions that are usually asked by the “gnorant”, for example, “Can homeopathy cure cancer, multiple sclerosis, ulcerative colitis, etc.?” are invalid and cannot elicit a direct answer because the reality is that many such cases can be ameliorated significantly, and a number can be cured…
A journal could invite a selected number of good prescribers from all over the world as a start to this project and let them contribute to their honest experience and results, as well as their failures. The possibilities and limitations would soon be revealed…
I admit that an argument against accepting cases is that it is possible that false or unreliable information could be provided. This risk could be minimized by preselecting a well-known group of good prescribers, who could be asked to submit their cases, at least in the first phase of such a radical change in the policy of the journals…
This way, instead of rejecting important homeopathic case studies, in the name of a dry intellectualism and conservatism, homeopathy journals (including alternative and complementary journals) could become lively and interesting: initiating debates and discussions on real issues of therapeutics in medicine…
Our own “Evidence Based Medicine” lies in the multitude of chronic cases treated with homeopathy that we can present to the world and on the better quality of life that such cures offer.
END OF QUOTES
So, GV wants homeopathy to thrive by means of publishing lots of case reports of patients who benefitted from homeopathy. And he believes that this suggestion is ‘innovative’? It is not! Case reports were all the rage 150 years ago before medicine started to become a little more scientific. And today, there are several journals specialising in the publication of case-reports, hundreds of journals that like accepting them, as well as dozens of websites that do little else but publishing case reports of homeopathy.
But case reports essentially are anecdotes. Medicine finally managed to progress from its dark ages when we realised how unreliable case reports truly are. To state it yet again (especially for GV who seems to be a bit slow on the uptake): THE PLURAL OF ANECDOTE IS ANECDOTES, NOT EVIDENCE!
In the above article, GV claims that ‘it is a waste of time, money, and energy to attempt to demonstrate the effectiveness of homeopathy through double blind trials.’ That is most puzzling because, only a few years ago, he did publish this:
Alternative therapies in general, and homeopathy in particular, lack clear scientific evaluation of efficacy. Controlled clinical trials are urgently needed, especially for conditions that are not helped by conventional methods. The objective of this work was to assess the efficacy of homeopathic treatment in relieving symptoms associated with premenstrual syndrome (PMS). It was a randomised controlled double-blind clinical trial. Two months baseline assessment with post-intervention follow-up for 3 months was conducted at Hadassah Hospital outpatient gynaecology clinic in Jerusalem in Israel 1992-1994. The subjects were 20 women, aged 20-48, suffering from PMS. Homeopathic intervention was chosen individually for each patient, according to a model of symptom clusters. Recruited volunteers with PMS were treated randomly with one oral dose of a homeopathic medication or placebo. The main outcome measure was scores of a daily menstrual distress questionnaire (MDQ) before and after treatment. Psychological tests for suggestibility were used to examine the possible effects of suggestion. Mean MDQ scores fell from 0.44 to 0.13 (P<0.05) with active treatment, and from 0.38 to 0.34 with placebo (NS). (Between group P=0.057). Improvement >30% was observed in 90% of patients receiving active treatment and 37.5% receiving placebo (P=0.048). Homeopathic treatment was found to be effective in alleviating the symptoms of PMS in comparison to placebo. The use of symptom clusters in this trial may offer a novel approach that will facilitate clinical trials in homeopathy. Further research is in progress.
I find this intriguing, particularly because the ‘further research’ mentioned prominently in the conclusions never did surface! Perhaps its results turned out to be unfavourable to homeopathy? Perhaps this is why GV dislikes RCTs these days? Perhaps this is why he prefers case reports such as this one which he recently published:
START OF QUOTE
An 81-year-old female patient was admitted in July 2015 to the Cardiovascular Surgery Department of a hospital in Bucharest for an aortic valve replacement surgery.
The patient had a history of mild hypertension, insulin-dependent type 2 diabetes, coronary artery disease, congestive heart failure NYHA 2, severe aortic stenosis, moderate mitral regurgitation, mild pulmonary hypertension, bilateral carotid atheromatosis with a 50% stenosis of the left internal carotid artery, complete right mastectomy for breast cancer (at that moment in remission).
After a preoperative evaluation and preparation, the surgery was completed with the replacement of the aortic valve with a bioprosthesis (Medtronic Hancock II Ultra no. 23) and myocardial revascularization by using a double aortic-coronary bypass.
The post-operatory evolution was a good one in terms of the heart disease. However, the patient did not regain consciousness after the anaesthesia, maintaining a deep comatose state (GCS 7 points – E1V2M4).
A brain CT was performed the third day postoperatively, showing no recent ischemic or haemorrhagic cerebral lesions, moderate diffuse cerebral atrophy and carotid atheromatosis.
After the surgery, the patient was admitted to the Intensive Care Unit and was treated by using a multidisciplinary approach. The patient was treated with inotropic, antiarrhythmic, and diuretic drugs, insulin and antidiabetic drugs were used in order to keep the blood sugar levels under control. The patient was kept hydrated and the electrolytes balanced by using an i.v. line, prophylaxis for deep vein thrombosis, and pulmonary thromboembolism was performed by using low molecular weight heparin. Prophylaxis for bedsores was also performed by using a pressure relieve air mattress.
The patient went into acute respiratory distress, needing mechanical ventilation in order to maintain oxygenation.
Despite these complex and correctly performed therapeutic efforts, the patient did not regain consciousness and was still in a deep coma in the fourteenth day post-operatory (GCS 7 points – E1V2M4), without having a confirmed medical explanation.
At that point, the patient’s family requested a consult from a homeopathic specialist.
The homeopathic examination, which was performed in the fourteenth day postoperatively, revealed the following: old, comatose, tranquil patient, with pale and cold skin, with the need to uncover herself (the few movements that she made with her hands were to remove her blanket and clothes, as if she wanted more air – “thirst for air”), abdominal distension, and bloating.
The thorough evaluation of the patient and the analysis of her symptoms led us to the remedy most appropriate for this critical situation – Carbo Vegetabilis.
Homeopathic treatment was initiated the same day, by using Carbo Vegetabilis 200CH 7 granules twice a day, administered diluted in 20ml of water by using a nasogastric tube.
The patient’s evolution was spectacular. The next day after the initiation of the treatment (fifteenth day postoperatively) the patient was in a superficial coma (GCS 11 points – E2V4M5), and the following day she regained consciousness. Carbo Vegetabilis was administered in the same dose for a total of five days (including the nineteenth day postoperatively).
After these five days, the case was reassessed from a homeopathically point of view and the second evaluation revealed the following: severely dyspnoeic patient (even talking caused exhaustion) with pale skin, severe fatigue aggravated by the slightest movements, a weakness sensation located in the chest area, extreme lack of energy, the wish “to be left alone”.
Considering the state of general exhaustion the patient was in at that moment and her lack of energy, the homeopathic treatment was changed to a new remedy: Stanum metallicum 30CH 7 granules administered sublingually twice a day for a week.
After the administration of the second remedy, the patient’s general condition improved dramatically: she started eating, she was able to get up in a sitting position with only little help, her fatigue diminished significantly.
The patient was then transferred to a recovery clinic in Cluj-Napoca in order to continue the cardiovascular recovery treatment. During her three-week admission in the clinic, she followed an individualized cardiovascular recovery program, which led to her ability to walk short distances with minimal support and has was released from the hospital in September 2015.
The following weeks after release, the patient recovered almost entirely, both physically and mentally. She was able to retake her place in her family and in society in general.
END OF QUOTE
One has to be a homeopath (one who is ignorant of the ‘post hoc propter hoc fallacy’) to believe in a causal link between the intake of the homeopathic remedy and the recovery of this patient. Thankfully, comatose patients do re-gain consciousness all the time! Even without homeopathy! But GV seems to not know that. In the discussion of this paper, he even states this: “… even after a well-conducted therapy, this condition leads to the death of the patient.” Is it ethical to publish such falsehoods, I wonder?
As far as the case report goes, the homeopathic remedy might even have delayed the process – perhaps the patient would have re-gained consciousness quicker and more completely without it! My hypothesis (homeopathy cased harm) is exactly as strong and silly as the one (homeopathy cased benefit) of GV. Anecdotes will never be able to answer the question as to who is correct.
One has to be a homeopath (and a daft one at that) to believe that this sort of evidence will lead to the acceptance of homeopathy by the scientific community. No journal will take GV seriously. No editor can be that stupid!
Oooops! Hold on, I might be wrong here.
Dr Peter Fisher, editor of the journal ‘Homeopathy’ just published an editorial ( Fisher P, Homeopathy and intellectual honesty, Homeopathy (2017), see also my previous post) stating that, in future, ‘we will increase publication of well-documented case-reports’.
Did I just claim that no editor can be that stupid?
- I should declare a conflict of interest: when he got his ‘Right Livelihood Award’, GV sent me (and other prominent homeopathy-researchers) some of the prize money (I think it was around £ 1000) to support my research in homeopathy. I used it for exactly that purpose.
The nonsense that some naturopaths try to tell the public never ceases to amaze me. This article is a good example: a “naturopathic doctor” told a newspaper that “We do have a reputation associated with cancer, but we don’t treat cancer. We use highly intelligent computer software to find out what is wrong with the body at a scientific level, and we simply correct that, and the people who do that, they cure their own cancer.” As far as he is concerned, “The only hope for cancer is alternative medicine… When you look at the medical texts, the scientific literature, what is used, the chemotherapy and the radiation, they cannot cure cancer,” he said.
Through artificial intelligence, he said that he simply teaches people how to heal. Clients are hooked up to a computer that reads their body and gives a printout of what needs to be done to correct the abnormalities. “It looks at the abnormalities in the energetic pathways, abnormalities in nutritional status, and abnormalities in the toxic load of the body and how much it can carry. Once these things are identified and you actually put the patient on a path, they go out and heal themselves. I have nothing to do with it,” he said.
Before you discard this neuropath as an unimportant nutter, consider that this article is a mere example. There are thousands more.
This website, for instance, gives the impression of being much more official and trustworthy by adopting the name of CANCER TREATMENT CENTERS OF AMERICA. But the claims are just as irresponsible:
… natural therapies our naturopathic medicine team may recommend include:
- Herbal and botanical preparations, such as herbal extracts and teas
- Dietary supplements, such as vitamins, minerals and amino acids
- Homeopathic remedies, such as extremely low doses of plant extracts and minerals
- Physical therapy and exercise therapy, including massage and other gentle techniques used on deep muscles and joints for therapeutic purposes
- Hydrotherapy, which prescribes water-based approaches like hot and cold wraps, and other therapies
- Lifestyle counseling, such as exercise, sleep strategies, stress reduction techniques, as well as foods and nutritional supplements
- Acupuncture, to help with side effects like nausea and vomiting, dry mouth, hot flashes and insomnia
- Chiropractic care, which may include hands-on adjustment, massage, stretching, electronic muscle stimulation, traction, heat, ice and other techniques.
END OF QUOTE
And, would you believe it, there even is a NATUROPATHIC CANCER SOCIETY. They proudly claim that: Naturopathic medicine works best to eliminate:
END OF QUOTE
Vis a vis this plethora of irresponsible and dangerous promotion of quackery by naturopathic charlatans, I feel angry, sad and powerless. I know that my efforts to prevent cancer patients going to an early grave because of such despicable actions are bound to be of very limited success. But that does not mean that I will stop trying to tell the truth:
THERE IS NOT A JOT OF EVIDENCE THAT NATUROPATHY CAN CURE CANCER. SO, PLEASE DO NOT GO DOWN THIS ROUTE!
PS: …and no, I am not paid by BIG PHARMA or anyone else to say so.
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:
- 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.
- 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.
- 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.
- 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.
- 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.
Reiki has been on my mind repeatedly (see for instance here, here, here and here). It is one of those treatments that are too crazy for words and too implausible to mention. Yet a new paper firmly claims that it is more than a placebo.
This review evaluated clinical studies of Reiki to determine whether there is evidence for Reiki providing more than just a placebo effect. The available English-language literature of Reiki was reviewed, specifically for
- peer-reviewed clinical studies,
- studies with more than 20 participants in the Reiki treatment arm,
- studies controlling for a placebo effect.
Of the 13 suitable studies,
- 8 demonstrated Reiki being more effective than placebo,
- 4 found no difference but had questionable statistical resolving power,
- one provided clear evidence for not providing benefit.
The author concluded that these studies provide reasonably strong support for Reiki being more effective than placebo. From the information currently available, Reiki is a safe and gentle “complementary” therapy that activates the parasympathetic nervous system to heal body and mind. It has potential for broader use in management of chronic health conditions, and possibly in postoperative recovery. Research is needed to optimize the delivery of Reiki.
These are truly fantastic findings! Reiki is more than a placebo – would have thought so? Who would have predicted that something as implausible as Reiki would one day be shown to work?
Now let’s start re-writing the textbooks of physics and therapeutics and research how we can optimize the delivery of Reiki.
Hold on – not so quick! Here are a few reasons why we might be sceptical about the validity of this review:
- It was published in one of the worst journals of alternative medicine.
- The author claimed to include just clinical trials but ended up including non-clinical studies and animal studies.
- Four trials were not double-blind.
- There was no critical assessment of the studies methodological quality.
- The many flaws of the primary studies were not mentioned in this review.
- Papers not published in English were omitted.
- The author who declared no conflict of interest has this affiliation: “Australasian Usui Reiki Association, Oakleigh, Victoria, Australia”.
I think we can postpone the re-writing of textbooks for a little while yet.
The claims that are being made for the health benefits of Chinese herbal medicine are impressive. I am not sure that there is even a single human disease that is not alleged to be curable with the use of some Chinese herbal mixture. I find this worrying because some patients might actually believe such outrageous nonsense, particularly since Chinese researchers seem to bend over backwards to support them with science… or should I say pseudoscience?
This study was aimed at evaluating the association between mortality rate and early use of Chinese herbal products (CHPs) among patients with lung cancer. The researchers conducted a retrospective cohort study based on the National Health Insurance Research Database, Taiwan Cancer Registry, and Cause of Death Data. Patients with newly diagnosed lung cancer between 2002 and 2010 were classified as either the CHP (n = 422) or the non-CHP group (n = 2828) based on whether they used CHP within 3 months after first diagnosis of lung cancer. A Cox regression model was used to examine the hazard ratio (HR) of death for propensity score (PS) matching samples.
After PS matching, average survival time of the CHP group was significantly longer than that of the non-CHP group. The adjusted HR (0.82; 95% CI: 0.73-0.92) in the CHP group was lower than the non-CHP group. Stratified by clinical cancer stages, CHP group had longer survival time in the stage 3 subgroup. When the exposure period of CHP use was changed from 3 to 6 months, results remained similar.
The authors concluded that results indicated that patients with lung cancer who used CHP within 3 months after first diagnosis had a lower hazard of death than non-CHP users, especially for stage 3 lung cancer. Further experimental studies are needed to examine the causal relationship.
I would argue the direct opposite: further studies along these lines would be a waste of time!
I can name numerous reasons for this, for example:
- Investigating CHP as though it is one entity is nonsense. There are thousands of different CHPs; some are placebos; some are toxic; and a few might even have some health effects.
- The observed effect is almost certainly an artefact; the matching of the groups might have been sub-optimal; the CHP group differed systematically from the control group, for instance, by adhering to a healthier life-style; etc, etc.
All of this should be so obvious that it hardly deserves a mention. Why then do the authors not point it out prominently and clearly? Why did they ever embark on such a fatally flawed project? I cannot be sure, of course, … but perhaps one possible answer might be that the lead author is affiliated to a Department of Chinese Medicine?
The goal of this study was to assess clinical outcomes observed among adult patients who received acupuncture treatments at a United States Air Force medical center.
This retrospective chart review was performed at the Nellis Family Medicine Residency in the Mike O’Callaghan Military Medical Center at Nellis Air Force Base in Las Vegas, NV. The charts were from 172 consecutive patients who had at least 4 acupuncture treatments within 1 year. These patients were suffering from a wide range of symptoms, including pain, anxiety and sleep problems. The main outcome measures were prescriptions for opioid medications, muscle relaxants, benzodiazepines, and nonsteroidal anti-inflammatory drugs (NSAIDS) in the 60 days prior to the first acupuncture session and in the corresponding 60 days 1 year later; and Measure Yourself Medical Outcome Profile (MYMOP2) values for symptoms, ability to perform activities, and quality of life.
The most common 10 acupuncture treatments in descending order were: (1) the Auricular Trauma Protocol; (2) Battlefield Auricular Acupuncture; (3) Chinese scalp acupuncture, using the upper one-fifth of the sensory area and the Foot Motor Sensory Area; (4) the Koffman Cocktail; (5) lumbar percutaneous electrical nerve stimulation (PENS); (6) various auricular functional points; (7) Chinese scalp acupuncture, using the frontal triangle pattern; (8) cervical PENS; (9) the Great American Malady treatment; and (10) tendinomuscular meridian treatment with surface release.
The results show that opioid prescriptions decreased by 45%, muscle relaxants by 34%, NSAIDs by 42%, and benzodiazepines by 14%. MYMOP2 values decreased 3.50–3.11 (P < 0.002) for question 1, 4.18–3.46 (P < 0.00001) for question 3, and 2.73–2.43 (P < 0.006) for question 4.
The authors concluded that in this military patient population, the number of opioid prescriptions decreased and patients reported improved symptom control, ability to function, and sense of well-being after receiving courses of acupuncture by their primary care physicians.
The phraseology used by the authors is intriguing; they imply that the clinical outcomes were the result of the acupuncture treatment without actually stating it. This is perhaps most obvious in the title of the paper: Reduction in Pain Medication Prescriptions and Self-Reported Outcomes Associated with Acupuncture in a Military Patient Population. Association is not causation! But the implication of a cause effect relationship is clearly there. Once we realise who is behind this research we understand why: This study was funded by the ACUS Foundation as part of a Cooperative Research and Development Agreement with the 99th Medical Group, at Nellis Air Force Base.
The mission of Acus Foundation is to educate military physicians in the science and art of medical acupuncture, and to facilitate its integration into conventional military care… we are the most experienced team of physician teachers and practitioners of acupuncture in the United States. If they are so experienced, they surely also know that there are many explanations for the observed outcomes which are totally unrelated to acupuncture, e. g.:
- the natural history of the conditions that were being treated;
- the conventional therapies the soldiers received;
- the regression to the mean;
- social desirability;
- placebo effects.
In fact the results could even indicate that acupuncture caused a delay of clinical improvement; without a control group, we cannot know either way. All we can safely assume from this study is that it is yet another example of promotion masquerading as research.
A sizeable proportion of the general population is convinced that certain moon phases and moon signs may impact their health as well as the onset and clinical course of diseases. Those who believe in alternative medicine tend, I guess, to belong to this group. Here is a quote from one of the many websites making such claims: Understanding moon cycles and how they affect the body can be a key to better health. To understand how the moon influences your health the first step is to realize that your human body is made up of over 60% water, and the moon affects all water on the Earth. The moon controls the ebb and flow of the oceanic tides and it controls your human body in the same way.
There is, of course, no plausible reason for such claims and convictions, but this rarely stops the gullible. And anyway, it could be true – or couldn’t it?
This study investigated the perioperative and long-term outcome of living donor kidney transplantation (LDKT) dependent on moon phases and zodiac signs. Patient data were prospectively collected in a continuously updated kidney transplant database. Two hundred and seventy-eight consecutive patients who underwent LDKT between 1994 and December 2009 were selected for the study and retrospectively assigned to the four moon phases (new-moon, waxing-moon, full-moon, and waning-moon) and the corresponding zodiac sign (moon sign Libra), based on the date of transplantation. Pre-existing comorbidities, perioperative mortality, surgical outcome, and long-term survival data were analysed.
Of all LDKT procedures, 11.9; 39.9; 11.5; and 36.5% were performed during the new, waxing, full, and waning moon, respectively, and 6.2% during the moon sign Libra, which is believed to interfere with renal surgery. Survival rates at 1, 5, and 10 years after transplantation were 98.9, 92, and 88.7% (patient survival) and 97.4, 91.6, and 80.6% (graft survival) without any differences between all groups of lunar phases and moon signs. Overall perioperative complications and early graft loss occurred in 21.2 and 1.4%, without statistical difference (p > 0.05) between groups.
The authors concluded that moon phases and the moon sign Libra had no impact on early and long-term outcome measures following LDKT in our study. Thus, concerns of patients awaiting LDKT regarding the ideal time of surgery can be allayed, and surgery may be scheduled independently of the lunar phases.
The authors also concede that their study has some limitations. First, it is a retrospective analysis of a single transplant centre and the number of patients is not huge. In addition, due to the retrospective design of the study, no randomization of the patients was possible. However, a randomization of the patients would systematically ignore the patients preferences. Realization of such a randomized trial would therefore be challenging. As a consequence, we do not know in how many cases the transplant was scheduled according to the lunar phases on the explicit request of the patient. It would be interesting to know whether a strong desire of the patient and a corresponding fulfilment has any influence on the short- and long-term success of the surgery.
Nonsense, I hear the loonies shout: there are numerous studies confirming that the moon has a definite effect on our health!
How do you explain that?
I think there are at least two possible explanations:
- these studies were methodologically flawed and lack independent replications;
- it cannot be excluded that patients’ fear of the wrong moon-phase might exert a negative influence on their health, irrespective of any influence of the moon. In this case, the moon-phase itself would be irrelevant, but the fear would mimic a real phenomenon.
The claimed benefits of Shinrin-yoku are remarkable:
- Boosted immune system functioning, with an increase in the count of the body’s Natural Killer (NK) cells.
- Reduced blood pressure
- Reduced stress
- Improved mood
- Increased ability to focus, even in children with ADHD
- Accelerated recovery from surgery or illness
- Increased energy level
- Improved sleep
- Deeper and clearer intuition
- Increased flow of energy
- Increased capacity to communicate with the land and its species
- Increased flow of eros/life force
- Deepening of friendships
- Overall increase in sense of happiness
But is any of this really true?
The aim of this state-of-the-art review was to summarise empirical research conducted on the physiological and psychological effects of Shinrin-Yoku. Research published from 2007 to 2017 was considered. A total of 64 studies met the inclusion criteria. According to the authors, they show that health benefits associated with the immersion in nature continue to be currently researched. Longitudinal research, conducted worldwide, is needed to produce new evidence of the relationships associated with Shinrin-Yoku and clinical therapeutic effects. Nature therapy as a health-promotion method and potential universal health model is implicated for the reduction of reported modern-day “stress-state” and “technostress.”
A look at the primary studies reveals that they are usually small and of poor quality.
Perhaps a brand new review aimed more specifically at evaluating preventive or therapeutic effects of Shinrin-Yoku on blood pressure can tell us more. The authors considered all published, randomized, controlled trials, cohort studies, and comparative studies that evaluated the effects of the forest environment on changes in systolic blood pressure. Twenty trials involving 732 participants were reviewed. Systolic and diastolic blood pressure of patients submitted to the forest environment was significantly lower than that of controls. The authors concluded that this systematic review shows a significant effect of Shinrin-yoku on reduction of blood pressure.
I find this paper odd as well:
- it lacks important methodological detail;
- the authors included not just controlled clinical trials but all sorts of ‘studies’;
- there is no assessment of the methodological rigor of the primary trials (from what I could see, they were mostly too poor to draw any conclusions from them).
What does all of this mean?
I have no problems in assuming that relaxation in a forest is beneficial in many ways and a nice experience.
But why call this a therapy?
It is relaxation!
Why make so many unsubstantiated claims?
And why study it in such obviously flawed ways?
All this does, I fear, is giving science a bad name.
I recently came across this article; essentially it claims that, in 1918, chiropractic proved itself to be the method of choice for treating the flu!
Here is a short quote from it:
Chiropractors got fantastic results from influenza patients while those under medical care died like flies all around. Statistics reflect a most amazing, almost miraculous state of affairs. The medical profession was practically helpless with the flu victims but chiropractors seemed able to do no wrong.”
“In Davenport, Iowa, 50 medical doctors treated 4,953 cases, with 274 deaths. In the same city, 150 chiropractors including students and faculty of the Palmer School of Chiropractic, treated 1,635 cases with only one death.”
“In the state of Iowa, medical doctors treated 93,590 patients, with 6,116 deaths – a loss of one patient out of every 15. In the same state, excluding Davenport, 4,735 patients were treated by chiropractors with a loss of only 6 cases – a loss of one patient out of every 789.
“National figures show that 1,142 chiropractors treated 46,394 patients for influenza during 1918, with a loss of 54 patients – one out of every 886.”
“Reports show that in New York City, during the influenza epidemic of 1918, out of every 10,000 cases medically treated, 950 died; and in every 10,000 pneumonia cases medically treated 6,400 died. These figures are exact, for in that city these are reportable diseases.”
“In the same epidemic, under drugless methods, only 25 patients died of influenza out of every 10,000 cases; and only 100 patients died of pneumonia out of every 10,000 cases…”
“In the same epidemic reports show that chiropractors in Oklahoma treated 3,490 cases of influenza with only 7 deaths. But the best part of this is, in Oklahoma there is a clear record showing that chiropractors were called in 233 cases where medical doctors had cared for the patients, and finally gave them up as lost. The chiropractors saved all these lost cases but 25.”
END OF QUOTE
So what does that sort of ‘evidence’ really show?
Does it prove that chiropractic is effective against influenza?
Does it even suggest that chiropractic is effective against influenza?
I think it shows that some chiropractors (like many homeopaths) are deluded to a point where they are unable to differentiate pseudoscience from science, anecdote from evidence, cause from effect, etc.
In the case you need more explanations, let me re-phrase this section from a previous post:
In the typical epidemiological case/control study, one large group of patients [A] is retrospectively compared to another group [B]. By large, I mean with a sample size of thousands of patients. In our case, group A has been treated by chiropractors, while group B received the treatments available at the time. It is true that several of such reports seemed to suggest that chiropractic works. But this does by no means prove anything; the result might have been due to a range of circumstances, for instance:
- group A might have been less ill than group B,
- group A might have been richer and therefore better nourished,
- group A might have benefitted from better hygiene,
- group A might have received better care, e. g. hydration,
- group B might have received treatments that made the situation not better but worse.
Because these are RETROSPECTIVE studies, there is no way to account for these and many other factors that might have influenced the outcome. This means that epidemiological studies of this nature can generate interesting results which, in turn, need testing in properly controlled studies where these confounding factors are adequately controlled for. Without such tests, they are next to worthless.