clinical trial
When Harald Walach et al first published it, I did report about their paper entitled “Treatment effects in pharmacological clinical randomized controlled trials are mainly due to placebo”. The objective of their analysis was to determine what contributes to the size of the placebo effect in clinical drug trials by meta-regressions of randomized placebo-controlled clinical trials.
Walach and his co-authors concluded that the high correlation of r= .73 between placebo improvement and treatment improvement rates is genuine and not explainable by study or disease characteristics. We conclude from our data that the placebo-effect is the major driver of treatment effects in clinical trials that alone explains 69% of the variance. This leaves only limited space for effects due to pharmacological substances. Context effects are more important than pharmacological ones in the conditions studied by us.
At the time, I called this SLOPPY SCIENCE and explained:
- The authors lumped together trials of various drugs as though they are a homogeneous entity in terms of effectiveness beyond placebo (which, of course, they are not).
- The placebo response is the measured improvement of a patient in a clinical trial after receiving a sham treatment. Yet, the authors claim “the placebo response in clinical trials has four components: regression to the mean (RTM), measurement artefacts, natural tendency (NT) of the disease, and the genuine placebo effect”. This is nonsense, and I even fear that the authors know it.
- The paper’s ‘highlight’ claims that contextual factors like expectations and doctor-patient interactions drive healing. Yet, these phenomena are seperate from the placebo-effect and were not the subject of this investigation.
- Correlation is not causation.
Now RETRACTION WATCH have published interesting news about Walach’s article:
… Stephen Rhodes, a researcher at University Hospitals Cleveland Medical Center in Ohio, criticized the study in a letter to the editor in February, citing a “number of errors that lead to some sweeping conclusions.” In the letter, Rhodes wrote those leaps “reflect a misunderstanding of what a ‘treatment effect’ is,” noting that in a placebo-controlled trial, the measure can’t be “due to placebo.”
We asked Gideon Meyerowitz-Katz, a sleuth and research fellow at the University of Wollongong in Australia, to take a look at the paper. Meyerowitz-Katz called the work “bizarre” and told us the results seem to indicate “simply being in a clinical trial is the main component of healing.” The studies included in the analysis had “very low average treatment effects,” meaning they didn’t show a huge benefit for the interventions tested. The clinical trials included had another issue: one was retracted in 2018 after journal editors realized all its participants had been enrolled and randomized on the same day. “I do not think that a meta-analysis which includes work retracted nearly a decade ago can be relied on as evidence,” Meyerowitz-Katz said. When he attempted to replicate the methods, Meyerowitz-Katz wasn’t able to do so. The researchers claimed to have taken one of the formulas from a previous paper; however, the referenced paper used a regression model, and the formula was not listed, he said. Meyerowitz-Katz also pointed out a potential undisclosed conflict of interest. Walach runs the Change Health Science Institute, which promotes “homeopathy and various COVID-19 conspiracy theories,” he said.
Walach, in response to Meyerowitz-Katz’s comments, called the term “conspiracy theory” “an analytically void terminology, because it is dependent on the political mainstream view, which is in turn dependent on political power.” He did not respond to any of Meyerowitz-Katz’s critiques of the paper.
Meyerowitz-Katz touched on many of the same issues Rhodes had raised in his letter. Rhodes questioned if the results really suggest there is “limited space for effects due to pharmacological substances,” quoting from the original paper. He also wrote by weighing clinical trials by study size rather than standard deviation, the researchers are “throwing information away.”
The researchers responded to Rhodes in their own letter to the editor, conceding they should have used “treatment response” rather than “treatment effect” in the title “to avoid confusion.” The authors also argued they had demonstrated “whenever a treatment is very effective, so is the improvement in the placebo group and vice versa.”
Retraction Watch sent questions to the Journal of Clinical Epidemiology, including the above critiques of the paper. Andrea Tricco, the co-editor-in-chief of the publication, told us the journal was investigating the concerns and was “treating this as a matter of highest urgency.” Stefan Schmidt, the corresponding author of the paper, told us his group has been asked to give “a detailed reply within 30 days.”
PS
I think it is only fair to add this note by RETRACTION WATCH:
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This cross-sectional meta-epidemiological study investigated the patient-reported acupuncture-related adverse events (A-AEs) in acupuncture randomised controlled trials (RCTs). All RCTs were included that used acupuncture as the intervention group to obtain the efficacy and/or safety of acupuncture therapy and that based the acupuncture therapy on Traditional Medicine theory.
The researchers assessed
- (1) the general characteristics of acupuncture RCTs;
- (2) the general characteristics of PROs;
- (3) the reporting scores of PROs by the Extension of Consolidated Standards of Reporting Trials of Patient-Reported Outcomes (CONSORT PRO Extension);
- (4) the general characteristic of A-AEs; (5) the incidence of A-AEs.
They included 476 RCTs; 296 (62.2%) used PROs as study outcomes, 272 (57.1%) reported safety outcomes. The Visual Analogue Scale (149, 23.7%) and the Pittsburgh Sleep Quality Index (42, 6.7%) were the most common PROs reported. The reporting of PROs was incomplete, with sufficiently reporting scores ranging from 2.7% to 97.6% across the CONSORT PRO Extension.
164 studies reported A-AEs, of which 141 reported specific details. The OR for the incidence of AEs in the acupuncture group compared to the control group was 1.434 (95% CI 1.148 to 1.793). The researchers identified 1277 reports of A-AEs, predominantly tissue injury (eg, haematoma, bleeding), irritation (eg, pain, post-acupuncture discomfort), with no reports of serious A-AEs. The reporting of A-AEs lacked details on the acquisition methods (15.5%), occurrence time (5.5%), A-AEs’ treatment (18.1%) and A-AEs’ recovery (19.7%). Studies that reported funding, registry information, acupuncturist qualifications and non-significant primary outcomes were associated with the A-AEs’ reporting, and the difference was statistically significant (p≤0.05).
The authors concluded that their study found that the reporting of PROs and A-AEs was insufficient in acupuncture RCTs. Future studies should clarify the clinical significance of using PROs as outcomes and report AEs comprehensively to provide patients with sufficient information on the benefits and harms of acupuncture treatments.
If you have followed my blog for any length of time, you will have seen numerous studies that show how poor the reporting of AEs is in trials of acupuncture and other forms of so-called alternative medicine (SCAM). This is not just regrettable, it is unethical, dangerous and amounts to scientific misconduct.
Based on such flawed evidence SCAM promoters claim that their treatments are quite safe. But because of the very inadequate reporting this assumption might well be wrong. Thus consumers are systematically being misled into making wrong, and in a worst case scenaario fatal, therapeutic decisions.
Imagine what scandal it would generate, if we found that studies of pharmaceuticals were systematically hiding AEs by simply not monitoring and reporting them!
Yes, this was the (rather sensationalist) headline of a recent article in the Daily Mail that I allegedly wrote. Its unusual genesis might interest some of you.
I was contacted by a journalist who asked for a telephone interview on the subject of chiropractic as well as my recent book. I agreed under the condition that we do this not over the phone but in writing via email. So, he sent me his questions and I supplied the responses; here they are:
· What’s the absolute worst case scenario of seeing a chiropractor?
The worst that can happen is that you die. Certain manipulations that chiropractors regularly do can injure an artery that supplies part of the brain. This would then result in a stroke; and a stroke can of course be fatal. This is what happened, for example, to the American model Katie May. She had pinched a nerve in her neck on a photoshoot and consulted a chiropractor who manipulated her neck. This caused a tear to an artery in her upper spine. The result was a massive stroke of which she died a few days later.
· How did you first become interested in the topic?
I learned hands on spinal manipulation as a junior doctor. Later, as the head of the department of Physical Medicine and Rehabilitation at the University of Vienna, we used such techniques routinely. In 1993, I became chair of Complementary Medicine in Exeter, and my task was to scientifically investigate alternative therapies such as chiropractic. Recently, I decided to summarize all our research in a book.
· What did you learn from your research?
In essence, our investigations found that almost all the claims that chiropractors make are unsubstantiated. Their manipulations are not nearly as effective as they claim. More worryingly, they are also not free of risks. About 50% of patients who see a chiropractor suffer from side effects after spinal manipulation. These are usually not severe and disappear after 2 or 3 days. But, in addition, very serious complications like stroke, death, bone fractures, paralysis can also occur. Chiropractors say that these are rare, and I hope they are right, but the truth is that nobody knows because there is no system of monitoring such events. We once asked British neurologists to report cases of neurological complications occurring within 24 hours of cervical spine manipulation over a 12-month period. This unearthed a total of 35 cases. Particularly striking was the fact that none of these cases had previously been reported anywhere. So, the underreporting was exactly 100%. This tells me that, when chiropractors claim there are just a few such incidents, in truth there might be a few hundred or even thousand.
· Is there an especially shocking finding?
What I find particularly unnerving is the way chiropractors regularly disregard medical ethics. Take the issue of informed consent, for example. It means that we all have to fully inform patients about the treatment we plan to give. In the case of chiropractic spinal manipulation, it would need to include that the therapy is of doubtful effectiveness, that other options are more likely to help, and that the treatment carries very frequent minor as well as probably rare major risks. I do understand why chiropractors do often not provide this information – it would chase away most patients and thus impact of their income. At the same time, I feel that chiropractors should not be allowed to violate fundamental principles of medical ethics. This is not in the interest of patients!!!
· Why do you think patients are so keen on chiropractors?
I am not sure that they really are so keen; some are but the vast majority are not. Our own research suggests that, depending on the country, between 7 and 33% of the population see chiropractors. This means that between 93 and 67% have enough sense to avoid chiropractors.
· But what does the evidence actually show about the efficacy of chiropractic?
As it happens our most recent summary has just been published. It concluded that “it is uncertain if chiropractic spinal manipulation is more effective than sham, control, or deep friction massage interventions for patients with headaches” [Is chiropractic spinal manipulation effective for the treatment of cervicogenic, tension-type, or migraine headaches? A systematic review – ScienceDirect]. For other conditions the evidence tends to be even less convincing. The only exception might be chronic low back pain, according to another recent summary [Analgesic effects of non-surgical and non-interventional treatments for low back pain: a systematic review and meta-analysis of placebo-controlled randomised trials | BMJ Evidence-Based Medicine]. But here too, I would argue that other treatments are safer and cheaper.
· Are some chiropractors worse than others?
The profession is divided into 2 groups, the ‘straights’ and the ‘mixers’. The former believe in all the nonsense their founding father, DD Palmer, proclaimed 120 years ago, including that spinal manipulation is the only treatment for virtually all our ailments, and that vaccinations must be avoided at all cost. The mixers have realized that Palmer was a charlatan of the worst kind, focus on musculoskeletal conditions and use treatments borrowed from physiotherapy. Needless to say that the mixers might be bad, but the straights are even worse.
· What can patients do to keep safe?
Avoid chiropractors, go to a library and read my book.
· If you have backpain or joint pain what can you do instead?
There is lots people can do but advice has to be individualized. By far the best is to prevent back pain from happening. Here advice might include more exercise, loosing weight, changing your mattress, avoiding certain things like heavy lifting, etc. If you are acutely suffering, see a physio or a doctor, keep moving and be aware that over 90% of back pain disappears within a few days regardless of what you do.
________________________
I had insisted that I see his edits before this gets published, and a little while later I received the edited version. To my big surprise, the journalist had transformed the interview into an article allegedly authored by me. I told him that I was uncomfortable with this solution, and we agreed that he would make it clear that the article was merely based on an interview with me. I then revised the article in question and the result was the mentioned article published still naming me as its author but with a footnote: “As told in an interview with Ethan Ennals”
Never a dull day when you research so-called alternative medicine!
Dr. Stephan Baumgartner, Deputy Director of the “Institute of Complementary and Integrative Medicine” in Bern, Switzerland, and Dr. Alexander Tournier, Research Associate at the same institution are well known defenders of homeopathy. They just published a paper entitled SCIENTIFIC EVIDENCE ON HOMEOPATHY. Needless to say that such an article is relevant for my blog and attracted my interest.
In their abstract, they claim that “the most recent meta-analyses of RCTs across all indications concluded that there is evidence for specific effects of homeopathic remedies superior to placebo when prescribed by a qualified homeopath. Furthermore, there are several meta-analyses on specific indications (e.g. allergic complaints, childhood diarrhoea) which provide evidence for specific effects of homeopathic preparations superior to placebo.”
As I have published several such papers, I had a look at which of them – if any – they quoted. It turns out they only cited the one entitled “Homeopathy for postoperative ileus? A meta-analysis“. Here is its abstract:
Homeopathic remedies are advocated for the treatment of postoperative ileus, yet data from clinical trials are inconclusive. We therefore performed meta-analyses of existing clinical trials to determine whether homeopathic treatment has any greater effect than placebo administration on the restoration of intestinal peristalsis in patients after abdominal or gynecologic surgery. We conducted systematic literature searches to identify relevant clinical trials. Meta-analyses were conducted using RevMan software. Separate meta-analyses were conducted for any homeopathic treatment versus placebo; homeopathic remedies of < 12C potency versus placebo; homeopathic remedies of > or = 12C potency versus placebo. A “sensitivity analysis” was performed to test the effect of excluding studies of low methodologic quality. Our endpoint was time to first flatus. Meta-analyses indicated a statistically significant (p < 0.05) weighted mean difference (WMD) in favor of homeopathy (compared with placebo) on the time to first flatus. Meta-analyses of the three studies that compared homeopathic remedies > or = 12C versus placebo showed no significant difference (p > 0.05). Meta-analyses of studies comparing homeopathic remedies < 12C with placebo indicated a statistically significant (p < 0.05) WMD in favor of homeopathy on the time to first flatus. Excluding methodologically weak trials did not substantially change any of the results. There is evidence that homeopathic treatment can reduce the duration of ileus after abdominal or gynecologic surgery. However, several caveats preclude a definitive judgment. These results should form the basis of a randomized controlled trial to resolve the issue.
And here is the paragraph from the article by Baumgartner and Tournier citing our paper:
Barnes et al. (1997) performed a systematic review and meta-analysis of controlled clinical
trials investigating the effects of a homeopathic treatment of postoperative ileus. Meta
analysis yielded a statistically significant (p < 0.05) weighted mean difference (WMD) in favour
of homeopathy (compared with placebo) on the time to first flatus. The exclusion of
methodologically weak trials did not substantially alter the results. The authors concluded
that “our analyses suggest that homeopathic treatment administered immediately after
abdominal surgery may reduce the time to first flatus when compared with placebo
administration”.
(The bits that I have put in bold print are the ones that appear in this paragraph.)
Are you puzzled?
Me too!
What they also forgot to mention is the fact that, in our paper, we explained that the partly positive outcome was produced by several small and flawed trials. They were the reason why eventulally a large and rigorous study was conducted. Its results showed homeopathy to be no better than placebo. Yet, in the meta-analysis this study was not large enough to out-weigh the rigorous trial (this is a well-known weakness of meta-analyses and requires carefull attention when interpreting the findings).
It seems important to note that after the rigorous trial, no further studies of homeopathy for post-operative ileus have emerged. The reason, it seems, is that this trial was conclusive and thus put the notion to rest that homeopathy might work for this highly prevalent condition.
Finally, as I merely looked at one single aspect, I wonder whether there are further misrepresentations in the Baumgartner/Tournier paper.
Here is my question to my readers: does the behavior of Baumgartner and Tournier amount to
- honest error,
- sloppiness,
- wishful thinking,
- dishonesty,
- fraud,
- scientific misconduct?
PLEASE, DO LET ME KNOW WHAT YOU THINK
Homeopathy is harmless – except when it kills you!
Death by homeopathy has been a theme that occurred with depressing regularity on my blog, e.g.:
- Death by homeopathy
- Another death by homeopathy
- Death by homeopathy?
- The case of a boy tortured to death with homeopathy
- Homeopathy is the death of the patient suffering from gangrene
Now, there is yet another sad fatality that must be added to the list. This case report presents a 61-year-old woman with metastatic breast cancer who opted for homeopathic treatments instead of standard oncological care. She presented to the Emergency Department with bilateral necrotic breasts, lymphedema, and widespread metastatic disease. Imaging revealed extensive lytic and sclerotic lesions, as well as pulmonary emboli. Laboratory results showed leukocytosis, lactic acidosis, and hypercalcemia of malignancy.
During hospitalization, patient was managed with anticoagulation and broad-spectrum antibiotics. Despite disease progression, patient declined systemic oncological treatments, leading to a complicated disease trajectory marked by frailty, sarcopenia, and functional quadriplegia, ultimately, a palliative care approach was initiated, and she was discharged to hospice and died.
This case highlights the complex challenges in managing advanced cancer when patients choose alternative therapies over evidence-based treatments. The role of homeopathy in cancer care is controversial, as it lacks robust clinical evidence for managing malignancies, especially metastatic disease.
Although respecting patient autonomy is essential, this case underscores the need for healthcare providers to ensure patients are fully informed about the limitations of alternative therapies. While homeopathy may offer emotional comfort, it is not a substitute for effective cancer treatments. Earlier intervention with conventional oncology might have altered the disease course and improved outcomes. The eventual transition to hospice care focused on maintaining the quality of life and dignity at the end-of-life, emphasizing the importance of integrating palliative care early in the management of advanced cancer to enhance patient and family satisfaction.
Even though such awful stories are far from rare, reports of this nature rarely get published. Clinicians are simply too busy to write up case histories that show merely what sadly must be expected, if a patient refuses effective therapy for a serious condition and prefers to use homeopathy as an “alternative”. Yet, the rather obvious truth is that homeopathy is no alternative. I have pointed it out many times before: if a treatment does not work, it is dangerously misleading to call it alternative medicine – one of the reasons why I nowadays prefer the term so-called alternative medicine (SCAM).
But what about homeopathy as an adjunctive cancer therapy?
In 2011, Walach et al published a prospective observational study with cancer patients in two differently treated cohorts: one cohort with patients under complementary homeopathic treatment (HG; n = 259), and one cohort with conventionally treated cancer patients (CG; n = 380). The authors observed an improvement of quality of life as well as a tendency of fatigue symptoms to decrease in cancer patients under complementary homeopathic treatment.
Walach and other equally deluded defenders of homeopathy (such as Wurster or Frass) tend to interpret these findings as being caused by homeopathy. Yet, this does not seem to be the case, as they regularly forget about the possibility of other, more plausible explanations for their results (e.g. placebo or selection bias). I am not aware of a rigorous trial showing that adjunctive homeopathy has specific effects when used by cancer patients (if a reader knows more, please let me know; I am always keen to learn).
So, is there a role for homeopathy in the fight against cancer?
My short answer:
No!
This “randomized controlled clinical trial” (has anyone ever seen a randomized trial without a control group? – No, therefore, the correct term is “ramdomized clinical trial (RCT)”) aimed to compare the effectiveness of wet cupping therapy (WCT) and Acupuncture in treating migraine patients. It was conducted between 01.03.2022 and 01.10.2023 in a Traditional and Complementary Medicine Center of a tertiary hospital. Patients diagnosed with migraine were included in the study and randomized into three groups.
- The WCT group received wet cupping 3 times, once a month.
- The acupuncture group received 10 sessions of acupuncture once a week.
- The waiting list group served as the control group.
VAS and MIDAS scales were used for all groups at the beginning and the end of the treatment, and the results were compared.
Initially, 168 patients were enrolled. However, there were some dropouts throughout the study period. In the acupuncture group, 11 patients did not attend subsequent sessions, with one dropout occurring due to adverse effects. In the wet cupping (WCT) group, three patients discontinued their participation following the initial treatment. Ultimately, a total of 153 patients were included.
The findings show that all three groups were similar regarding age and sex. Migraine Disability Assessment Scale (MIDAS) and Visual Analogue Scale (VAS) pain scores decreased significantly in both treatment groups after the applications, while they remained similar for the same period in the control group. Additionally, the post-treatment values of MIDAS and VAS in both the WCT and acupuncture groups were significantly lower compared to controls, while they were similar when compared in between.
The authors concluded that both of these applications were found to be similarly effective in improving disability status and pain intensity in patients with migraine.
I beg to differ!
Apart from all other flaws of this trial, it did not control for placebo effects. Both WCT and acupuncture are invasive treatments that are bound to cause sizeable placebo responses. The waiting list control might account for the natural history of the disease and for regression towards the mean, but it is not a method for allowing for placebo effects. In view of this fundamental limitation of the study, its conclusions should be re-written as follows:
Both of these applications were similarly effective in producing sizeable placebo effects which in turn improved disability status and pain intensity in patients with migraine.
For migraine patients, this means that neither of these therapies are likely to be the best available option.
Recently, several papers reported about PP353 as a new ‘wonder drug’ for chronic low back pain (cLBP). The reason is that Persica Pharmaceuticals Limited (Persica) announced positive results of a randomised, double-blind, placebo-controlled clinical trial assessing the safety and efficacy of PP353 as a treatment for patients with chronic low back pain (cLBP). PP353 is a specifically formulated combination of linezolid, iohexol and a thermosensitive gel that is injected into the degenerate lumbar disc, delivering prolonged exposure of a high concentration at the site of infection. A 2-dose regime (dosed 4 days apart) is said to eliminate the infection, thus addressing the underlying cause of cLBP which is claimed to be an infection.
Intradiscal administration of 3 mL of PP353 has been reported to be well-tolerated and based on the pharmacokinetics following a single injection, a two-dose regimen of PP353 (150 mg linezolid) on Day 1 and Day 5 ± 1 was selected to explore safety, tolerability, pharmacokinetics, and efficacy in Part B of the Persica 002 study.
The abovementioned efficacy trial enrolled 44 patients who had suffered from cLBP for more than 6 months (mean duration of 5.5 years) and had not been helped by existing non-surgical treatments. They were randomized to receive either PP353 or placebo injected into intervertebral discs. The results of the study demonstrated statistically significant and clinically meaningful results in patients with cLBP. Compared to placebo, the verum led to a 30% reduction of pain after 12 months. The placebo group did not achieve clinically meaningful change from baseline. The PP353 group also reported statistically significant and clinically meaningful reductions in disability with a within-group reduction of 9.4-points (63%) and a between-group reduction of 3.9-points (39%) from placebo in the Full Analysis Set of subjects at 12 months.
The manufacturer claims to provide an alternative, non-opioid, treatment for cLBP patients by replacing the 100-day high-dose oral antibiotics course to treat cLBP with an injectable antibiotic formulation that will achieve high local concentration and adequate duration of exposure in the spine to effect the sterilisation of the infected disc.
Local administration of antibiotic has the potential to elicit a faster response because an effective drug concentration in the infected tissue is immediately achieved. It also significantly reduces the amount of drug required, reducing the likelihood of systemic side effects, especially those associated with perturbation of the gut microbiome.
Intradiscal administration of therapeutics to treat cLBP is an established but mostly ineffective route. Persica believes that an effective treatment must address the underlying cause of disease – the infection. An effective antibacterial therapeutic should reduce the inflammatory stimuli in the intervertebral space and adjacent bone and allow repair over time, leading to a reduction in pain.
During the development of PP353, Persica tested several generic antibiotics in vitro and in vivo to find an antibiotic with the required properties: active against the bacteria identified in disc and herniated tissue samples, little to no resistance in clinical isolates, and the ability to be formulated to provide a depot to extend the duration of exposure.
To enable administration of the antibiotic, Persica developed a unique formulation which delivers the antibiotics to the site of infection and ensures that it remains within the infected area.
_______________________
Sounds good?
Yes, perhaps even a little too good to be true!
Here are some of my concerns:
- The manufacturer has, as far as I can see, not published the findings in a peer-reviewed journal and thus wants us to believe the findings without scrutinizing the methodology.
- Even if they eventually do publish the study in full, and even if it turns out to be rigorous, one would still want independent preplications.
- There is an undenialble and very substantial financial interest in the matter (anyone who comes out with an effective and safe pill against cLBP, will quickly make billions!), and one might therefore wonder how objective the manufacturer can be about the merits of PP353.
- The assumption that many cases of cLBP are caused by a disc infection is a well-known theory, but it remains largely unproven.
- As we dicuseed only recently, antibiotics have not been shown to be effective for cLBP.
Clearly, we have to wait and see – but my advice is to take PP353 with a healthy pinch of salt.
The aim of this recent review was to investigate the efficacy of non-surgical and non-interventional treatments for adults with low back pain compared with placebo. It included all randomised controlled trials evaluating non-surgical and non-interventional treatments compared with placebo or sham in adults (≥18 years) suffering from non-specific low back pain.
Random effects meta-analysis was used to estimate pooled effects and corresponding 95% confidence intervals on outcome pain intensity (0 to 100 scale) at first assessment post-treatment for each treatment type and by duration of low back pain—(sub)acute (<12 weeks) and chronic (≥12 weeks). Certainty of the evidence was assessed using the Grading of Recommendations Assessment (GRADE) approach.
A total of 301 trials (377 comparisons) provided data on 56 different treatments or treatment combinations. One treatment for acute low back pain: (non-steroidal anti-inflammatory drugs (NSAIDs)), and five treatments for chronic low back pain:
- exercise,
- spinal manipulative therapy,
- taping,
- antidepressants,
- transient receptor potential vanilloid 1 (TRPV1) agonists)
were found to be efficacious. However, effect sizes were small and of moderate certainty. Three treatments for acute low back pain (exercise, glucocorticoid injections, paracetamol), and two treatments for chronic low back pain (antibiotics, anaesthetics) were not efficacious and are unlikely to be suitable treatment options; moderate certainty evidence. Evidence is inconclusive for remaining treatments due to small samples, imprecision, or low and very low certainty evidence.
The authors concluded that the current evidence shows that one in 10 non-surgical and non-interventional treatments for low back pain are efficacious, providing only small analgesic effects beyond placebo. The efficacy for the majority of treatments is uncertain due to the limited number of randomised participants and poor study quality. Further high-quality, placebo-controlled trials are warranted to address the remaining uncertainty in treatment efficacy along with greater consideration for placebo-control design of non-surgical and non-interventional treatments.
This is an important analysis, not least because of the fact that the research received no specific grant from any funding agency in the public, commercial, or not-for-profit sectors. The methodology is sound and the results thus seem reliable.
The findings are in keeping with what we have been discussing at nauseam here: no treatment works really well for back pain. For acute symptoms no so-called alternative medicine (SCAM) at all is efficacious. For chronic pain, spinal manipulation therapy (SMT) have small effects. As SMT is neither cheap nor free of risks, excercise is much preferable.
Considering that most SCAMs are heavily promoted for low back pain (e.g. acupuncture, Alexander technique, cupping, Gua Sha, herbal medicine, homeopathy, massage, mind-body therapies, reflexology, Reiki, yoga), this verdict is sobering indeed!
Qi-gong is a branch of Traditional Chinese Medicine that employs meditation, exercise, deep breathing and other techniques with a view of strengthening the assumed life force ‘qi’ and thus improving health and prolong life. Qi-gong has ancient roots in China and has recently also become popular in other countries. There are several distinct forms of qi-gong which can be categorized into two main groups, internal qi-gong and external qi-gong. Internal qi-gong refers to a physical and mental training method for the cultivation of oneself to achieve optimal health in both mind and body. Internal qi-gong is not dissimilar to tai chi but it also employs the coordination of different breathing patterns and meditation. External qi-gong refers to a treatment where qi-gong practitioners direct their qi-energy to the patient with the intention to clear qi-blockages or balance the flow of qi within that patient. According to Taoist and Buddhist beliefs, qi-gong allows access to higher realms of awareness.
The assumptions of qi-gong are not scientifically plausible. But this does not stop enthusiasts to submit it to clinical trials.
A quasi-experimental pretest-posttest study was conducted with 231 adolescent girls aged 13-17 years suffering from premenstrual syndrome (PMS). Participants underwent a 4-week Qi Gong therapy program, with five 45-minute sessions weekly. Data were collected using a demographic questionnaire and Modified PMS Scale, analysing pre- and post-intervention symptoms through descriptive statistics, paired t-tests and chi-square tests.
The intervention significantly reduced PMS severity, with mild PMS cases increasing from 48 (20.78%) to 166 (71.86%) post-intervention. Paired t-tests revealed a highly significant mean difference in PMS scores (T = 12.251, p < 0.001).
The authors concluded that Qi Gong therapy offers a holistic, non-invasive approach for managing PMS by addressing both physiological and emotional dimensions to the condition. Its ability to balance hormones, alleviate stress and improve overall quality of life makes it a valuable addition to PMS care.
This study originated from the Department of Obstetrics and Gynecological Nursing, Nootan college of Nursing, Sankalchand Patel university, Visnagar, Gujarat, India; the Department of Pediatric Nursing of the same institution and the Department of Psychiatric Nursing of the same institution. One would have hoped that its authors know better than to draw such conclusions from such a study. Here are some points of concern:
- There is no reason why the treatment should be holistic.
- The study did not have a control group; causal inferences are thus not waarranted.
- The study did not produce any evidence to show that the treatment addressed either physiological or emotional dimensions.
- The study did not produce any evidence to show that the treatment did anything to hormones.
- The study did not produce any evidence to show that the treatment alleviated stress.
- The study did not produce any evidence to show that the treatment improved quality of life.
- I see no resason why the treatment should be promoted as a valuable addition to PMS care.
- The PMS severity changed after the treatment and not necessarily because of it.
- The true reasons it changed might be multifold, e.g.: placebo, regression towards the mean, social desirability.
- Misleading the public by drawing far-reaching conclusions has the potential to do untold harm.
I have said it often, and it saddens me to have to say it again:
If the quality of research into so-called alternative medicine (SCAM) does not improve dramatically, nobody can blame the public to not take SCAM seriously any more.
- pain,
- anxiety,
- fatigue,
- feelings (eg, happy, calm)
on 0- to 10-point numeric rating scales. Data were analyzed with Wilcoxon signed rank tests.
- What on earth is a ‘mixed-method, feasibility, pilot study’? A hallmark of pseudo-researchers seems to be that they think they can invent their own terminology.
- There is no objective, validated outcome measure.
- The conclusion that ‘Reiki is feasible‘ has been known and does not need to be tested any longer.
- The conclusion that ‘Reiki improved positive emotions and feelings and decreased negative measures’ is false. As there was no control group, these improvements might have been caused by a whole lot of other things than Reiki – for instance, the extra attention, placebo effects, regression towards the mean or social desirability.
- The conclusion that ‘implementing Reiki in clinical practice should be further explored to improve mental health and well-being’ is therefore not based on the data provided. In fact, as Reiki is an implausible esoteric nonsense, it is a promotion of wasting resources on utter BS.
Does it matter?
Why not let pseudo-scientists do what they do best: PSEUDO-SCIENCE?
I think it matters because:
- Respectable institutions like the Mayo Clinic should not allow its reputation being destroyed by quackery.
- The public should not be misled by charlatans.
- Patients suffering from mental health problems deserve better.
- Resources should not be wasted on pseudo-research.
- ‘Academic journals like ‘Glob Adv Integr Med Health’ have a responsibility for what they publish.
- ‘The ‘Academic Consortium for Integrative Medicine & Health‘ that seems to be behind this particular journal claim to be “the world’s most comprehensive community for advancing the practice of whole health, with leading expertise in research, clinical care, and education. By consolidating the top institutions in the integrative medicine space, all working in unison with a common goal, the Academic Consortium is the premier organizational home for champions of whole health. Together with over 86 highly esteemed member institutions from the U.S., Australia, Brazil, Canada and Mexico, our collective vision is to transform the healthcare system by promoting integrative medicine and health for all.” In view of the above, such statements are a mockery of the truth.
