Updated Edition!
In these pre-Xmas days, many homes will smell of cinnamon. It’s certainly a wonderful spice for creating an atmosphere. But ther are also other uses for ciannamon.
Current treatments for overactive bladder (OAB) have limited efficacy, low persistence and a high rate of adverse events commonly leading to treatment cessation in clinical practice. Clinicians in Asia commonly use traditional Chinese medicine as an alternative for OAB treatment despite it having uncertain efficacy and safety. To evaluate the efficacy and safety of cinnamon patch (CP) treatment for alleviating symptoms of OAB, this double-blind randomized, placebo-controlled trial was conducted.
The 6-week study was conducted in an outpatient setting; 66 subjects diagnosed as having OAB were enrolled and treated with a placebo (n=33) or CP (n=33). The OAB symptom score (OABSS) was selected as the primary end point, and a patient perception of bladder condition (PPBC), an urgency severity scale (USS), and post-voiding residual urine (PVR) volume were selected as secondary end points.
In total, 66 participants (40 women and 26 men), 60 years of age, were included in the intention-to-treat analyses. Baseline characteristics were comparable between the CP and placebo groups. Treatment with a CP showed statistically significant differences in reductions in OABSS scores, PPBC scores, and USS scores.
The authors concluded that compared to a placebo, treatment with CP might be considered an effective and safe complementary therapy for OAB. Further studies employing a positive control, different dosage forms, larger sample sizes, and longer treatment periods are warranted.
Cinnamon (Cinnamomum zeylanicum and Cinnamon cassia)belongs to the Lauraceae family. It contains manganese, iron, dietary fiber, and calcium as well as cinnamaldehyde, cinnamic acid, cinnamate, and numerous other components such as polyphenols and antioxidant, anti-inflammatory, antidiabetic, antimicrobial, anticancer effects. Several reports have dealt with the numerous properties of cinnamon in the forms of bark, essential oils, bark powder, and phenolic compounds, and each of these properties can play a key role in human health.
The new study is interesting and prompts me to ponder:
- Do the pharmacologically active ingredients of cinnamon pass the skin barrier in sufficient amounts to have any effect at all? Or perhaps it was the scent? In which case, this would have been a study of aromatherapy.
- Considering the typical scent of cinnamon, I find it hard to imagine that this study was truly double blind.
- Cinnamon is alleged to have antimicrobial, antiviral, antifungal, antioxidant, antitumor, antihypertensive, antilipemic, antidiabetic, gastroprotective, and immunomodulatory effects. I do wonder which, if any, of these are responsible for the observed clinical results of this trial.
- Cinnamon is known to sometimes lead to allergic reactions. I wonder whether this could be a problem when it is applied in patches.
So, for the time being, I think, I prefere cinnamon, the spice, to cinnamon, the medicine.
In so-called alternative medicine (SCAM), we have numerous diets that are either promoted for specific conditions or that are popular in a more general sense. Meat-free forms of nutrition can perhaps not be characterised as SCAM, but they are certainly popular with consumers as well as practitioners of SCAM. It is often said that meat-free diets are healthy, but few entusiasts like to consider that it might be associated with health risks.
This study tested whether vegetarianism and veganism are risk factors for bone factures in a prospective cohort with a large proportion of non-meat eaters.
In EPIC-Oxford, dietary information was collected at baseline (1993–2001) and at follow-up (≈ 2010). Participants were categorised into four diet groups at both time points (with 29,380 meat eaters, 8037 fish eaters, 15,499 vegetarians, and 1982 vegans at baseline in analyses of total fractures). Outcomes were identified through linkage to hospital records or death certificates until mid-2016. The risks were calculated of total (n = 3941) and site-specific fractures (arm, n = 566; wrist, n = 889; hip, n = 945; leg, n = 366; ankle, n = 520; other main sites, i.e. clavicle, rib, and vertebra, n = 467) by diet group over an average of 17.6 years of follow-up.
Compared with meat eaters and after adjustment for socio-economic factors, lifestyle confounders, and body mass index (BMI), the risks of hip fracture were higher in
- fish eaters (hazard ratio 1.26; 95% CI 1.02–1.54),
- vegetarians (1.25; 1.04–1.50),
- vegans (2.31; 1.66–3.22).
This was equivalent to rate differences of 2.9 (0.6–5.7), 2.9 (0.9–5.2), and 14.9 (7.9–24.5) more cases for every 1000 people over 10 years, respectively. The vegans also had higher risks of total (1.43; 1.20–1.70), leg (2.05; 1.23–3.41), and other main site fractures (1.59; 1.02–2.50) than meat eaters. Overall, the significant associations appeared to be stronger without adjustment for BMI and were slightly attenuated but remained significant with additional adjustment for dietary calcium and/or total protein. No significant differences were observed in risks of wrist or ankle fractures by diet group with or without BMI adjustment, nor for arm fractures after BMI adjustment.
The authors concluded that non-meat eaters, especially vegans, had higher risks of either total or some site-specific fractures, particularly hip fractures. This is the first prospective study of diet group with both total and multiple specific fracture sites in vegetarians and vegans, and the findings suggest that bone health in vegans requires further research.
The effect is by no means large, and I doubt that it will persuade many non-meat eaters to change their diet. However, perhaps the study can serve as a reminder that people who avoid meat might some lack essential nutrients and that they should therefore consider making sure that no deficiencies can develop.
Recent comments on this blog prompted me to look into a very strange therapeutic and diagnostic device used by some practitioners of so-called alternative medicine (SCAM):
The OBERON provides the most unique tool for scanning the various organs and systems of the physical body without having to make a medical or surgical intrusion. Developed by Russian scientists since the early 1990’s, the OBERON is the most revolutionary computer programmed invention available in the world today for analyzing and treating all the body’s organs and functions.
This device scans each organ or tissue on a cellular level. It compares the measurements to a database of thousands of referenced conditions and their diagnosis. OBERON uses a special emitter to modulate the carrier frequency for the cell communication and it uses special sensor trigger readers built into headphones to read the cells own signals.
OBERON finds out how stressed an organ is, and if there are any diseases developing, how much the cells are influenced by a specific disease, and which micro organisms and bacteria are in the area at the time of the scan.
BENEFITS OF THE OBERON:
Rebalances the body so that it can start to heal itself!
Makes intrusive and embarrassing examinations a THING OF THE PAST!!!!
Quick examination (in seconds) with immediate results
Replaces dozens of traditional diagnostic methods.
Finds weaknesses in the skeleton, organs, blood, tissue, etc.
There are no side effects, unpleasantness or injury after treatment
Bio-resonance META-therapy
A print out of the report on findings can be taken at the end of the session…
The method is based on an analysis of the brain stems electromagnetic waves which contain the complete information of the entire organism. This information is read by a sensor. A frequency transmitter aimed at the projection area of the brain stem stimulates this electromagnetic radiation.
Meta- Therapy repairs the organism using a diversity of modulated electromagnetic waves. This treatment stimulates the body’s own functions so that they solve the problem and it stimulates the immune defense and is a very good supplement or alternative to traditional treatment. The patient can follow on the screen how the organ progressively gets better, and afterwards one can take a new measurement showing the improvement…
________________________________________
Sounds fantastic?
Yes, indeed – fantastic as in fantasy!
Almost as much relation to reality as OBERON, king of the fairies in medieval literature.
The modern OBERON device is being used by infamous proponents of integrated medicine like Dr Julian Kenyon who already made an appearance on this blog. On his website, Kenyon published a paper in which he provides details about the OBERON. To a lay person, the sciency text might look like science; however, this impression would be false. The ‘study’ Kenyon mentioned is not on Medline. In fact, Dr Kenyon (former associate of the late George Lewith) has merely 4 Medline-listed papers:
- Physiological and psychological explanations for the mechanism of acupuncture as a treatment for chronic pain. Soc Sci Med. 1984;19(12):1367-78. doi: 10.1016/0277-9536(84)90026-1.PMID: 6085191 Review.
- Is electrodermal testing as effective as skin prick tests for diagnosing allergies? A double blind, randomised block design study. BMJ. 2001 Jan 20;322(7279):131-4. doi: 10.1136/bmj.322.7279.131.PMID: 11159567 Free PMC article. Clinical Trial.
- Randomised double-blind trial on the immediate effects of naloxone on classical Chinese acupuncture therapy for chronic pain. Acupunct Electrother Res. 1983;8(1):17-24. doi: 10.3727/036012983816715064.PMID: 6135300 Clinical Trial.
- Food sensitivity, a search for underlying causes. Case study of 12 patients. Kenyon JN.Acupunct Electrother Res. 1986;11(1):1-13. doi: 10.3727/036012986816359238.PMID: 2872775
And what about other researchers? Aren’t there ANY decent studies of the OBERON?
Not as far as I can see (if anyone does know of peer-reviewed research, please let me know).
So, what is the conclusion?
My conclusion is this:
There is no evidence that the OBERON does anything useful other than putting money in the bank accounts of those charlatans who use or manufacture it.
And what does that make Kenyon and all the other SCAM practitioners using the OBERON or similar devices?
I leave it to you to decide.
The Center for Science in the Public Interest*** (CSPI) announced its agreement with Boiron to improve the labeling on the homeopathic products manufactured by Boiron and sold under the Boiron or other private label brands. The agreement covers the labeling for over 50 homeopathic products.
On Boiron’s Oscillococcinum and two similar products, Boiron will substantially increase the prominence of the words “Homeopathic Medicine” on the front of the box and the disclaimer on the back of the box that says the product’s uses have not been evaluated by the Food and Drug Administration (FDA). These changes will make it easier for consumers to identify that the products are homeopathic products, and are not FDA approved over-the-counter medicines.
For all of the other homeopathic products manufactured by Boiron, consumers will receive much more information on the packages. In addition to increasing the prominence of the words “Homeopathic Medicine,” a new disclaimer in large and contrasting font will be added to the back of the package (endorsed by the American Association of Homeopathic Pharmacists) stating: “Claims based on traditional homeopathic practice, not accepted medical evidence, and not FDA evaluated.”…
“The labeling changes that Boiron has agreed to on all the products covered by the agreement will help consumers more clearly identify that these are homeopathic products and are not FDA approved over-the-counter medicines that have been scientifically proven to be safe and effective,” said CSPI litigation director Lisa Mankofsky. “In addition, the vast majority of the covered homeopathic products will bear a disclaimer clarifying that they are based on traditional homeopathic practice, not accepted medical evidence, and not FDA evaluated. We think that consumers will find this labeling change important when choosing a remedy. We encourage other manufacturers to similarly make their labels more transparent and clear for consumers.”
Bravo!
Clearly a step into the right direction!
But it’s a small step only. It is a long way short of what Dylan Evans suggestied in his book ‘Placebo‘, first published in 2004:
Warning: this product is a placebo. It will work only if you believe in homeopathy, and only for certain conditions such as pain and depression. Even then, it is not likely to be as powerful as orthodox drugs. You may get fewer side-effects from this treatment than from a drug, but you will probably also get less benefit.
***The Center for Science in the Public Interest is perhaps the oldest independent, science-based consumer advocacy organization with an impressive record of accomplishments and a clear and ambitious agenda for improving the food system to support healthy eating.
There is some encouraging evidence regarding the positive influence of vitamin D on COVID-19. But is it convincing? Is it causal? As always, it is worth looking at the totality of the reliable evidence.
In this systematic review and meta-analysis, the researchers analyze the association between vitamin D deficiency and COVID-19 severity. They conducted an analysis of the prevalence of vitamin D deficiency and insufficiency in people with the disease. Five online databases—Embase, PubMed, Scopus, Web of Science, ScienceDirect and pre-print Medrevix were searched. The inclusion criteria were observational studies measuring serum vitamin D in adult and elderly subjects with COVID-19. The main outcome was the prevalence of vitamin D deficiency in severe cases of COVID-19.
The researchers identified 1542 articles and 27 met their inclusion criteria. The results show that
- vitamin D deficiency was not associated with a higher chance of infection by COVID-19,
- severe cases of COVID-19 present 64% more vitamin D deficiency compared with mild cases,
- vitamin D concentration insufficiency increased hospitalization and mortality rates,
- There was a positive association between vitamin D deficiency and the severity of the disease.
The authors concluded that the results of the meta-analysis confirm the high prevalence of vitamin D deficiency in people with COVID-19, especially the elderly. We should add that vitamin D deficiency was not associated with COVID-19 infection. However, we observed a positive association between vitamin D deficiency and the severity of the disease. From this perspective, evaluating blood vitamin D levels could be considered in the clinical practice of health professionals. Moreover, vitamin D supplementation could be considered in patients with vitamin D deficiency and insufficiency, if they have COVID-19. However, there is no support for supplementation among groups with normal blood vitamin D values with the aim of prevention, prophylaxis or reducing the severity of the disease.
These are interesting findings, no doubt. They relate to associations, as the authors repeatedly stress in the text of the paper. They do not, however, signify cause and effect relationships. The principal outcome of this research should be a hypothesis that subsequently needs testing in clinical trials.
So, why on earth did the authors chose that seriously misleading title of their paper? It clearly implies a causal effect; and this can only be verified by conducting clinical trials. One such study has been published (as discussed here) and it concluded that administration of calcifediol may improve the clinical outcome of subjects requiring hospitalization for COVID-19.
My conclusion: it seems well worth conducting more and more rigorous clinical trials.
Despite reported widespread use of dietary supplements by cancer patients, few empirical data with regard to their safety or efficacy exist. Because of concerns that antioxidants could reduce the cytotoxicity of chemotherapy, a prospective study was carried out to evaluate associations between supplement use and breast cancer outcomes.
Patients with breast cancer randomly assigned to an intergroup metronomic trial of cyclophosphamide, doxorubicin, and paclitaxel were queried on their use of supplements at registration and during treatment (n =1,134). Cancer recurrence and survival were indexed at 6 months after enrollment.
There were indications that use of any antioxidant supplement (vitamins A, C, and E; carotenoids; coenzyme Q10) both before and during treatment was associated with an increased hazard of recurrence and, to a lesser extent, death. Relationships with individual antioxidants were weaker perhaps because of small numbers. For non-antioxidants, vitamin B12 use both before and during chemotherapy was significantly associated with poorer disease-free survival and overall survival. Use of iron during chemotherapy was significantly associated with recurrence as was use both before and during treatment. Results were similar for overall survival. Multivitamin use was not associated with survival outcomes.
The authors concluded that associations between survival outcomes and use of antioxidant and other dietary supplements both before and during chemotherapy are consistent with recommendations for caution among patients when considering the use of supplements, other than a multivitamin, during chemotherapy.
These data are interesting but, for a range of reasons, not compelling. There might have been several important confounding factors distorting the findings. Even though clinical and life-style variables were statistically adjusted for in this study, it might still be possible that supplement users and non-users were not comparable in impotant prognostic variables. Simply put, sicker patients might be more likely to use supplements and would then have worse outcomes not because of the supplements but their disease severity.
Moreover, it seems important to note that other research showed the opposite effects. For instance, a study prospectively examined the associations between antioxidant use after breast cancer (BC) diagnosis and BC outcomes in 2264 women. The cohort included women who were diagnosed with early stage, primary BC from 1997 to 2000 who enrolled, on average, 2 years postdiagnosis. Baseline data were collected on antioxidant supplement use since diagnosis and other factors. BC recurrence and mortality were ascertained, and hazard ratios (HRs) and 95% confidence intervals (CIs) were estimated.
Antioxidant supplement use after diagnosis was reported by 81% of women. Among antioxidant users, frequent use of vitamin C and vitamin E was associated with a decreased risk of BC recurrence. Vitamin E use was associated with a decreased risk of all-cause mortality. Conversely, frequent use of combination carotenoids was associated with increased risk of death from BC and all-cause mortality.
The authors concluded that frequent use of vitamin C and vitamin E in the period after BC diagnosis was associated with a decreased likelihood of recurrence, whereas frequent use of combination carotenoids was associated with increased mortality. The effects of antioxidant supplement use after diagnosis likely differ by type of antioxidant.
Yet another study provided limited support for the hypothesis that antioxidant supplements may reduce the risk of breast cancer recurrence or breast cancer-related mortality.
Confused?
Me too!
What is needed, it seems, is a systematic review of all these contradicting studies. A 2009 review is available of the associations between antioxidant supplement use during breast cancer treatment and patient outcomes.
Inclusion criteria were: two or more subjects; clinical trial or observational study design; use of antioxidant supplements (vitamin C, vitamin E, antioxidant combinations, multivitamins, glutamine, glutathione, melatonin, or soy isoflavones) during chemotherapy, radiation therapy, and/or hormonal therapy for breast cancer as exposures; treatment toxicities, tumor response, recurrence, or survival as outcomes.
A total of 22 articles met the criteria. Their findings did not support any conclusions regarding the effects of individual antioxidant supplements during conventional breast cancer treatment on toxicities, tumor response, recurrence, or survival. A few studies suggested that antioxidant supplements might decrease side effects associated with treatment, including vitamin E for hot flashes due to hormonal therapy and glutamine for oral mucositis during chemotherapy. Underpowered trials suggest that melatonin may enhance tumor response during treatment.
The authors concluded that the evidence is currently insufficient to inform clinician and patient guidelines on the use of antioxidant supplements during breast cancer treatment. Thus, well designed clinical trials and observational studies are needed to determine the short- and long-term effects of such agents.
Still confused?
Me too!
Antioxidants seem to have evolved as parts of elaborate networks in which each substance plays slightly different roles. This means that each antioxidant has a different spectrum of actions. And this means that it is probably not very constructive to lump them all together and excect to see uniform effects. What we would need to create more clarity is a series of RCTs on single antioxidants. But who is going to fund them? We might be waiting a long time for more clarity. Meanwhile, consuming a healthy and well-balanced diet might be the best advice for cancer patients and everyone else.
Out of the blue I received an email infroming me that Wellness consultancy and online health boutique Conscious Spaces is marking the Black Friday sale season with 12% off its hugely popular Qi tech EMF protection devices. Shop Black EMFriday at consciousspaces.com/collections/black-emfriday…
I must be a sucker for such stuff, so I had to have a look.
Most impressive!
The ‘Qi-Max Cell™ 5G / WIFI / EMF Protection For Home & Business’ for instance is for sale at £4,399.00 Sale Price (normally it costs £600 more!!!).
Naturally, I was fascinated and had to know more. Luckily, the email told me all I needed to know:
What are EMFs?
EMFs, or electromagnetic fields, are invisible fields of energy, or radiation waves. There are many different types of electromagnetic fields in the world around us. They come from both natural sources (like sunlight) and man-made sources (like mobile phones). Over the last century, exposure to man-made EMFs has been steadily increasing in line with the growing demand for electricity and the more recent explosion of wireless technology, including smart phones, laptops and tablets.
Where’s the harm?
Exposure to EMFs of the kind emitted by mobile technologies has been found to be harmful to health by a growing number independent, non-industry funded scientists and doctors. With thousands of papers, the extent of scientific research into the health impacts of EMF radiation exposure is too vast to list, but a cohesive body of evidence exists surrounding the damage caused to DNA, cells, organ systems, fertility, brain function, liver and memory.
How do Qi tech devices work?
WaveGuard’s Qi technology provides a sanctuary from EMFs by creating a protective shield of negatively charged electrons. These devices come in a variety of sizes to provide different size torus fields of protection, from the Qi-Me, for personal protection on the go, through to the Qi-Max, providing a protective field with a 50m radius.
The Qi-Me device uses the same technology as the larger Qi-Shield device which has been scientifically proven to provide EMF Protection tested using a double-blind study at the BION Institute. Priced at £399 (£350 during Black Friday), it provides a 1m radius (2m diameter) of EMF protection and is available in Walnut, Maple, Olive and Yew.
The Qi-Shield provides an EMF protection field of 2.5m radius (5m diameter). Perfect for your office, bedroom, vehicle or air travel, it is priced at £899 (£790 during Black Friday) and is available in walnut.
The Qi-Home provides the relief of being protected from harmful and damaging EMFs while at home, with an EMF protection field of 7.5m radius (15m diameter). It is priced at £2750 (£2,420 during Black Friday) it is available in Swiss pine, oak and beech.
The Qi-Max Cell is the largest and most powerful EMF protection device, creating an EMF protection field of 50m radius (100m diameter). Available in Swiss pine, it is priced at £4999 (£4,399 during Black Friday).
Tara Williams, founder of Conscious Spaces, says: ‘The calming effect I felt when I first held a Qi-Shield in a high EMF environment was a revelation. My heart rate is usually up in those sorts of settings, but this had an immediate positive effect. I now carry this or the Qi-Me with me wherever I go and have noticed a real improvement in my EHS (electromagnetic hypersensitivity) symptoms.’
________________________________________
As I said, I am most impressed by the ‘Qi-Max Cell’ (it creates an EMF protection field of 50m radius (100m diameter) in width and 35m radius (70m diameter) in height, protecting your family, workplace and business against mobile phone radiation, WiFi, electrical frequencies, electro-magnetic frequencies) and, of course by the prospect of saving £600!
But seriously! Would it not be illuminating to get such a device and take it apart to see what technology it actually contains? Or does one of my readers already know?
In its homeland, Germany, homeopathy had a free ride for many decades. Only in the last 5 years or so, has a vocal opposition emerged of people who argue that disproven treatments should not be paid for by the public purse. Most political parties have been clever enough to pick up on the changed attitude of the German people and have thus joined more or less openly into the growing criticism of homeopathy. One noteable exception has been the German Green Party who have a long tradition of being in favour of all things alternative. Now this seems to have finally changed.
The ‘Frankfurter Allgemeine Zeitung’ (FAZ) just reported that the German Green Party no longer backs homeopathy. After many years of supporting homeopathy and other so-called alternative medicines (SCAMs) and after years of agonising about it, the party has now decided to side with reason, science and evidence. Last Sunday, on their annual party conference, the Greens have voted to back a statement according to which the German health insurers should only reemburse treatments which are “medically reasonable and justifiable and which are supported by evidence of efficacy that is scientifically proven”. Even though they did not mention it in the text, it is understood that the they meant foremost homeopathy.
The Greens rejected a suggestion to go even further and would have stated that a treatment should not be covered, if “its efficacy has not been scientifically proven to be better than a placebo.” They also did not agree to an application by the homeopathy lobby to state that would have allowed the reembursement of homeopathy.
For those of my readers who read German, here is the short article from the FAZ.
Die Grünen haben in ihrem langwierigen Streit um die Homöopathie eine Lösung gefunden. Der Parteitag billigte am Sonntag eine Formulierung, derzufolge nur noch Leistungen von den gesetzlichen Krankenkassen übernommen werden sollten, „die medizinisch sinnvoll und gerechtfertigt sind und deren Wirksamkeit wissenschaftlich erwiesen ist“. Damit gehen die Grünen auf Distanz zu Homöopathie als Kassenleistung – auch wenn die umstrittene Heilmethode in dem Text nicht ausdrücklich genannt wird.
Eine noch weitergehende Formulierung, derzufolge Leistungen, deren Wirksamkeit über den Placeboeffekt hinaus nicht wissenschaftlich bewiesen sei, explizit als Kassenleistung ausgeschlossen werden sollten, fand aber keine Mehrheit.
What is the ‘DRX9000 decompression system’? It is a table attached to Space Age-looking controls that allegedly stretches the disks of the vertebrae, allowing protrusions to be pulled back into place and thus taking pressure off nerve roots. The website of Excite Medical informs us that the DRX9000® has been cleared by the FDA to treat patients suffering with incapacitating lower back pain and sciatica caused by herniated discs, degenerative discs, and posterior facet syndrome.
This sounds almost as though it is evidence based, doesn’t it?
But is it?
My Medline search resulted in three papers about the device (if anyone knows of more, please let me know):
- Background: This study‘s goal was a retrospective chart audit of 100 outpatients with discogenic low back pain (LBP) lasting more than 12 weeks treated with a 2-month course of motorized spinal decompression via the DRX9000 (Axiom Worldwide, Tampa, FL, U.S.A.).Methods: Patients at a convenience sample of four clinics received 30-minute DRX9000 sessions daily for the first 2 weeks tapering to 1 session/week. Treatment protocol included lumbar stretching, myofascial release, or heat prior to treatment, with ice and/or muscle stimulation afterwards. Primary outcome was verbal numerical pain intensity rating (NRS) 0 to 10 before and after the 8-week treatment.Results: Of the 100 initial subjects, three withdrew their protected health information, and three were excluded because their LBP duration was less than 12 weeks. The remaining 94 subjects (63% female, 95% white, age = 55 (SD 16) year, 52% employed, 41% retired, LBP median duration of 260 weeks) had diagnoses of herniated disc (73% of patients), degenerative disc disease (68%), or both (27%). Mean NRS equaled 6.05 (SD 2.3) at presentation and decreased significantly to 0.89 (SD 1.15) at end of 8-week treatment (P < 0.0001). Analgesic use also appeared to decrease (charts with data = 20) and Activities of Daily Living improved (charts with data = 38). Follow-up (mean 31 weeks) on 29/94 patients reported mean 83% LBP improvement, NRS of 1.7 (SD 1.15), and satisfaction of 8.55/10 (median 9).Conclusions: This retrospective chart audit provides preliminary data that chronic LBP may improve with DRX9000 spinal decompression. Randomized double-blind trials are needed to measure the efficacy of such systems.
- Background: Because previous studies have suggested that motorized non-surgical spinal decompression can reduce chronic low back pain (LBP) due to disc degeneration (discogenic low back pain) and disc herniation, it has accordingly been hypothesized that the reduction of pressure on affected discs will facilitate their regeneration. The goal of this study was to determine if changes in LBP, as measured on a verbal rating scale, before and after a 6-week treatment period with non-surgical spinal decompression, correlate with changes in lumbar disc height, as measured on computed tomography (CT) scans.Methods: A retrospective cohort study of adults with chronic LBP attributed to disc herniation and/or discogenic LBP who underwent a 6-week treatment protocol of motorized non-surgical spinal decompression via the DRX9000 with CT scans before and after treatment. The main outcomes were changes in pain as measured on a verbal rating scale from 0 to 10 during a flexion-extension range of motion evaluation and changes in disc height as measured on CT scans. Paired t-test or linear regression was used as appropriate with p < 0.05 considered to be statistically significant.Results: We identified 30 patients with lumbar disc herniation with an average age of 65 years, body mass index of 29 kg/m2, 21 females and 9 males, and an average duration of LBP of 12.5 weeks. During treatment, low back pain decreased from 6.2 (SD 2.2) to 1.6 (2.3, p < 0.001) and disc height increased from 7.5 (1.7) mm to 8.8 (1.7) mm (p < 0.001). Increase in disc height and reduction in pain were significantly correlated (r = 0.36, p = 0.044).Conclusions: Non-surgical spinal decompression was associated with a reduction in pain and an increase in disc height. The correlation of these variables suggests that pain reduction may be mediated, at least in part, through a restoration of disc height. A randomized controlled trial is needed to confirm these promising results.
- Objectives: This study aims to compare the efficiency of conventional motorized traction (CMT) with non-surgical spinal decompression (NSD) using the DRX9000™ device in patients with low back pain associated with lumbar disc herniation (LDH).Patients and methods: Between March 2009 and September 2009, a total of 48 patients (29 females, 19 males; mean age 43.1±9.8 years; range, 18 to 65 years) were randomized into two groups. The first group (n=24) underwent CMT and the second group (n=24) underwent NSD for a total of 20 sessions over six weeks. The patients were evaluated before and after the treatment. Pain was assessed using the Visual Analog Scale (VAS), functional status using the Oswestry Disability Index (ODI), quality of life using the Short Form-36 (SF-36), state of depression mood using the Beck Depression Inventory (BDI), and the global assessment of the illness using the Patient’s Global Assessment of Response to Therapy (PGART) and Investigator’s Global Assessment of Response to Therapy (IGART) scales. Results: There was no significant difference in the evaluation outcomes before the treatment between the groups. However, a statistically significant decline was found in the VAS, ODI, and BDI scores after the treatment in both groups (all p<0.001). Except for two subgroups, no significant changes were observed in the SF-36 form. Assessment of “marked improvement” was globally most frequently reported one in both groups. No significant difference was observed in the evaluation outcomes after treatment between the groups. Conclusion: Our study results show that both CMT and NSD are effective methods in pain management and functional status and depressive mood improvement in patients with LDH, and NSD is not superior to CMT in terms of pain, functionality, depression and quality of life.
Studies one and two are retrospective and thus useless for establishing cause and effect. Study 3 is an RCT, but as an equivalence study it is desperately underpowered. Most likely, it merely demonstrates that both of the tested treatments are ineffective.
In other words, there seems to be no good evidence that the DRX9000 works for low back pain (LBP). This can hardly come as a surprise to anyone who has kept up with the evidence. What is more, traction can also cause significant harm. The current Cochrane review concludes that traction, either alone or in combination with other treatments, has little or no impact on pain intensity, functional status, global improvement and return to work among people with LBP.
Yet, the claims for the device are grandiose. According to a recent article in NBCnews (from which I take the liberty of citing passages below), the company behind the DRX9000, Excite Medical, claims that nearly 9 out of 10 patients who qualify for treatment on the DRX9000 will get relief. Excite Medical also says that 2,400 of its systems are in use in 45 nations and shows it off at trade shows everywhere from Las Vegas to Dusseldorf, Germany, and Dubai, United Arab Emirates. Chiropractors across the United States buy the machines from Excite Medical, often using the same claims as the manufacturers — sometimes even going beyond them.
But a FairWarning investigation — based on review of lawsuits, scientific studies, government documents, chiropractic websites and interviews with experts — found that the claims of success for spinal decompression stretch the truth, enticing patients to pay thousands of dollars for a treatment that has never been proven in scientifically rigorous studies to live up to its stupendous billing.
Despite a spate of state regulatory actions in the 2000s against Axiom Worldwide, the original manufacturer of the DRX9000, and chiropractors for making unproven claims, they still permeate the internet. And federal and state regulators who can sanction false claims now show little evidence that they are interested in reining them in…
“This non-surgical spinal decompression system … is scientifically Proven By Mayo Clinic, Duke University, Stanford, and Johns Hopkins University School of Medicine!” according to the website for GO Chiropractic in Illinois, which offers treatment with the DRX9000. Jamie Stephens, one of the chiropractors who runs Go Chiropractic, said in an email, “We have seen nothing but outstanding results from this technology,” and referred further questions to Excite Medical, which he said provided his advertising materials…
Excite Medical says [the treatment] typically runs about $3,500 for a full course of sessions on the DRX9000…
Chiropractors who paid as much as $125,000 for the device also got a package of suggested promotional materials, including the claim the DRX9000 was used in a scientific study that showed an 86 percent success rate. Many of the chiropractors took out newspaper ads that included the claims.
In later lawsuits, chiropractors complained that they were duped by Axiom. One, James Spiering in Texas, described being flown, plane fare and hotel paid, to Axiom headquarters in Florida, where he was told he would recover his investment in four months and clear $1.7 million in five years. Spiering said he was shown videos full of “fraudulent” claims. The parties settled out of court in 2010 for an undisclosed amount.
Regulators across the U.S. also had started to take notice of the DRX9000’s claims of extraordinary success. Over the course of three years or so, the Oregon attorney general, the Florida attorney general and a group of 11 California district attorneys all filed suits against Axiom or a former chiropractor who created some of its marketing. The suits ended in penalties — $1.125 million in the California case — and Axiom agreed to only make claims based on reliable scientific evidence, according to news stories and settlement documents.
_______________________________
What does that tell us?
I think it suggests that:
- LBP patients will try any rubbish that promises help.
- Chiropractors and other back pain quacks often could not care less about the evidence.
- Money is the driving force behind most back pain quackery.
Many experts doubt that acupuncture generates the many positive health effects that are being claimed by enthusiasts. Yet, few consider that acupuncture might not be merely useless but could even make things worse. Here is a trial that seems to suggest exactly that.
This study evaluated whether combining two so-called alternative medicines (SCAMs), acupuncture and massage, reduce postoperative stress, pain, anxiety, muscle tension, and fatigue more than massage alone.
Patients undergoing autologous tissue breast reconstruction were randomly assigned to one of two postoperative SCAMs for three consecutive days. All participants were observed for up to 3 months. Forty-two participants were recruited from January 29, 2016 to July 11, 2018. Twenty-one participants were randomly assigned to massage alone and 21 to massage and acupuncture. Stress, anxiety, relaxation, nausea, fatigue, pain, and mood (score 0-10) were measured at enrollment before surgery and postoperative days 1, 2, and 3 before and after the intervention. Patient satisfaction was evaluated.
Stress decreased from baseline for both Massage-Only Group and Massage+Acupuncture Group after each treatment intervention. Change in stress score from baseline decreased significantly more in the Massage-Only Group at pretreatment and posttreatment. After adjustment for baseline values, change in fatigue, anxiety, relaxation, nausea, pain, and mood scores did not differ between groups. When patients were asked whether they would recommend the study, 100% (19/19) of Massage-Only Group and 94% (17/18) of Massage+Acupuncture Group responded yes.
The authors concluded tha no additive beneficial effects were observed with addition of acupuncture to massage for pain, anxiety, relaxation, nausea, fatigue, and mood. Combined massage and acupuncture was not as effective in reducing stress as massage alone, although both groups had significant stress reduction. These findings indicate a need for larger studies to explore these therapies further.
I recently went to the supermarket to find out whether combining two bank notes (£10 + £5) can buy more goods than one £10 note alone. What I found was interesting: the former did indeed purchase more than the latter. Because I am a scientist, I did not stop there; I went to a total of 10 shops and my initial finding was confirmed each time: A+B results in more than A alone.
It stands to reason that the same thing happens with clinical trials. We even tested this hypothesis in a systematic review entitled ‘A trial design that generates only ”positive” results‘. Here is our abstract:
In this article, we test the hypothesis that randomized clinical trials of acupuncture for pain with certain design features (A + B versus B) are likely to generate false positive results. Based on electronic searches in six databases, 13 studies were found that met our inclusion criteria. They all suggested that acupuncture is effective (one only showing a positive trend, all others had significant results). We conclude that the ‘A + B versus B’ design is prone to false positive results and discuss the design features that might prevent or exacerbate this problem.
But why is this not so with the above-mentioned study?
Why is, in this instance, A even more that A+B?
There are, of course, several possible answers. To use my supermarket example again, the most obvious one is that B is not a £5 note but a negative amount, a dept note, in other words: A + B can only be less than A alone, if B is a minus number. In the context of the clinical trail, this means acupuncture must have caused a negative effect.
But is that possible? Evidently yes! Many patients don’t like needles and experience stress at the idea of a therapist sticking one into their body. Thus acupuncture would cause stress, and stress would have a negative effect on all the other parameters quantified in the study (pain, anxiety, muscle tension, and fatigue).
My conclusion: in certain situations, acupuncture is more than just useless; it makes things worse.
