study design
Cupping is a from of so-called alternative medicine (SCAM) that has featured already many times on this blog, e.g.:
- Wet cupping in the management of cervical spondylosis? No!
- The effectiveness of cupping therapy for low back pain
- Cupping: “the propagation of ancient, scientifically unsound techniques that may cause more harm than benefit”
- Cupping therapy for non-specific chronic low back pain
- Cupping for Olympic swimmers. Or: why breaking your shoulder is not necessarily good for writing a successful book
- Wet cupping and dry humour
- Cupping for athletes: rubbish trials, rubbish review, rubbish journal
- The future of cupping: it’s bright, profitable and vacuous
Now a new and interesting paper has been published on the subject
This review aimed to investigate the effectiveness of cupping therapy on low back pain (LBP). Medline, Embase, Scopus and WANFANG databases were searched for relevant cupping RCTs on low back pain articles up to 2023. A complementary search was manually made on 27 September for update screening. Full-text English and Chinese articles on all ethnic adults with LBP of cupping management were included in this study. Studies looking at acute low back pain only were excluded. Two independent reviewers screened and extracted data, with any disagreement resolved through consensus by a third reviewer. The methodological quality of the included studies was evaluated independently by two reviewers using an adapted tool. Change-from-baseline outcomes were treated as continuous variables and calculated according to the Cochrane Handbook. Data were extracted and pooled into the meta-analysis by Review Manager software (version 5.4, Nordic Cochrane Centre).
Eleven trials involving 921 participants were included (6 on dry and 5 on wet cupping). Five studies were assessed as being at low risk of bias, and six studies were of acceptable quality. High-quality evidence demonstrated cupping significantly improves pain at 2-8 weeks endpoint intervention (d=1.09, 95% CI: [0.35-1.83], p = 0.004). There was no continuous pain improvement observed at one month (d=0.11, 95% CI: [-1.02-1.23], p = 0.85) and 3-6 months (d=0.39, 95% CI: [-0.09-0.87], p = 0.11). Dry cupping did not improve pain (d=1.06, 95% CI: [-0.34, 2.45], p = 0.14) compared with wet cupping (d=1.5, 95% CI: [0.39-2.6], p = 0.008) at the endpoint intervention. There was no evidence indicating the association between pain reduction and different types of cupping (p = 0.2). Moderate- to low-quality evidence showed that cupping did not reduce chronic low back pain (d=0.74, 95% CI: [-0.67-2.15], p = 0.30) and non-specific chronic low back pain (d=0.27, 95% CI: [-1.69-2.24], p = 0.78) at the endpoint intervention. Cupping on acupoints showed a significant improvement in pain (d=1.29, 95% CI: [0.63-1.94], p < 0.01) compared with the lower back area (d=0.35, 95% CI: [-0.29-0.99], p = 0.29). A potential association between pain reduction and different cupping locations (p = 0.05) was found. Meta-analysis showed a significant effect on pain improvement compared to medication therapy (n = 8; d=1.8 [95% CI: 1.22 – 2.39], p < 0.001) and usual care (n = 5; d=1.07 [95% CI: 0.21- 1.93], p = 0.01). Two studies demonstrated that cupping significantly mediated sensory and emotional pain immediately, after 24 h, and 2 weeks post-intervention (d= 5.49, 95% CI [4.13-6.84], p < 0.001). Moderate evidence suggested that cupping improved disability at the 1-6 months follow-up (d=0.67, 95% CI: [0.06-1.28], p = 0.03). There was no immediate effect observed at the 2-8 weeks endpoint (d=0.40, 95% CI: [-0.51-1.30], p = 0.39). A high degree of heterogeneity was noted in the subgroup analysis (I2 >50%).
The authors concluded that high- to moderate-quality evidence indicates that cupping significantly improves pain and disability. The effectiveness of cupping for LBP varies based on treatment durations, cupping types, treatment locations, and LBP classifications. Cupping demonstrated a superior and sustained effect on pain reduction compared with medication and usual care. The notable heterogeneity among studies raises concerns about the certainty of these findings. Further research should be designed with a standardized cupping manipulation that specifies treatment sessions, frequency, cupping types, and treatment locations. The actual therapeutic effects of cupping could be confirmed by using objective pain assessments. Studies with at least six- to twelve-month follow-ups are needed to investigate the long-term efficacy of cupping in managing LBP.
A crucial point here is that only 3 of the included studies were ‘patient-blind’, i.e. tried to control for placebo effects by using a sham procedure:
- The first of these used leaking vaccum cups that failed to create sucction. This would therefore not have resulted in the typical circular hematoma. In other words, patients were easily de-blinded.
- The second trial compared two different wet cupping techniques which involved different procedures. This would have been easily identifiable by the patients. In other words, patients were easily de-blinded.
- The third (which showed no effectiveness of cupping) supposedly patient-blind study used a similar method as the first. In other words, patients were easily de-blinded.
In addition, we ought to remember that in no study was it possible to blind the therapists. Thus there is a danger of verbal or non-verbal communications impacting on the outcomes.
In my view, it follows that the effectiveness of cupping is far lass certain than the authors of this paper try to make us believe.
This study analyzed the effect of a protocol based on the Mat Pilates method in an intervention group compared to a usual care control group, on quality of life, fatigue and body image of head and neck cancer survivors.
The study was designed as a randomized clinical trial with 30 survivors, allocated into an intervention group and a control group.
- The intervention group underwent a 12-week Mat Pilates, twice a week, one hour long.
- The control group attended two lectures and received weekly follow-up throughout the study period.
Data collection took place through individual face-to-face interviews, focusing on assessing the outcomes: quality of life (FACT-H&N); fatigue (FACT-F) and body image (BIS).
The Mat Pilates group showed significant improvements compared to the control group in both intra-group and inter-group analyses across the variables:
- quality of life (in total score (p = 0.007)/(p = 0.003),
- family well-being (p = 0.001)/(p = 0.008),
- functional well-being (p = 0.001)/(p = 0.001)),
- body image in the total score (p = 0.001)/(p = 0.001),
- subscales: body image (p = 0.046)/(p = 0.010),
- body care (p = 0.026)/(p = 0.010),
- body touch (p = 0.013)/(p = 0.022),
- fatigue (p = 0.006)/(p = 0.003).
The authors concluded that, based on these findings, future research could delve deeper into understanding the long-term effects of Mat Pilates interventions on quality of life, body image, and fatigue levels among survivors of head and neck cancer.
These conclusions are prudently cautious. The reason for this caution probably is the fact that the findings tell us far less than the results might imply.
The naive reader would think they show the effectiveness of pilates excercises. This, however, would be erroneous. The positive results are to be expected, if only due to the extra attention given to the verum patients or the disappointment of the control group for not receiveing it.
If we truly want to evaluate the specific effects of a treatment like pilates, we need to design a different type of study. Nobody doubts that group excercise can improve plenty of subjective parameters. The question, I think, is whether pilates is better in achieving this aim than other forms of excercise. Thus we might need an equivalence study comparing two or more forms of excercise. Such studies are more difficult to plan and conduct. Yet, without them, I fear that we will not be able to determine the value of specific forms of excercise.
This study aimed to determine the effects of Reiki on pain and biochemical parameters in patients undergoing bone marrow transplantation. This investigation was designed as a “single-blind, repeated measures, randomized prospective controlled study”. It was conducted between August 2022 and April 2023 with patients who underwent autologous bone marrow transplantation (BMT).
- In the Reiki group (n = 21), Reiki therapy was applied directly to the energy centers for 30 min on the 0th and 1st day of BMT, and from a distance for 30 min on the 2nd day.
- No intervention was performed on the control group (n = 21).
Data were collected using the Personal Information Form, Visual Analog Scale (VAS), and biochemical parameters. Pain and biochemical parameters were evaluated on days 0, 1, 2, and 10 before the Reiki application.
There were no statistically significant differences in pain scores between the groups before the intervention (p > .005). The Reiki group showed a significant improvement in the mean VAS score compared with the control group on days 1 and 2 (p = .002; p < .001, respectively). The measurement of procalcitonin showed a decrease in the Reiki group and an increase in the control group (p = .026, p = .001, p < .001, respectively). Although the Reiki group had better absolute neutrophil, thrombocyte, and C-reactive protein values than the control group, no significant difference was observed between the groups (p > .05).
The authors concluded that Reiki is effective for pain control and enhancing the immune system response.
For the following reasons, I beg to differ:
- The patients of the verum group were fully aware of receiving the therapy; thus they were expecting/hoping to benefit from it.
- The patients of the control group received no therapy; thus they were disappointed which may have influenced thie VAS ratings.
- The procalcitonin levels are of doubtful relevance; they changed only within the group which, in a controlled clinical trial that is supposed to compare groups is meaningless and most likely a chance finding.
- The only people who could have been blinded in this ‘single blind’ study were the evaluators of the results (even though the authors state that “patients were blinded to the group assignments”) which is meaningless if patients and therapists are not blinded.
Because of all this, I feel that the conclusions should be re-written:
Reiki is known to cause a placebo effect which most likely caused the observed outcomes.
This study aimed at examining the feasibility issues of comparing individualized homeopathic medicines (IHMs) with identical-looking placebos for treating knee osteoarthritis (OA).
Forty eligible patients participated in this double-blind, randomized (1:1), placebo-controlled feasibility trial in the outpatient clinics of a homeopathic hospital in West Bengal, India. Either IHMs or identical-looking placebos were administered, along with mutually agreed-upon concomitant care guidelines. The Knee Injury and Osteoarthritis Outcome Score (KOOS) was the primary outcome measure, along with derived Western Ontario and McMaster Universities Arthritis Index (WOMAC) scores from KOOS. The EQ-5D-5L questionnaire and Visual Analog Scale (VAS) were the secondary outcomes. All were measured at baseline and after 2 months. Group differences and effect sizes (Cohen’s d) were estimated using an intention-to-treat approach. p-Values less than 0.05 (two-tailed) were considered statistically significant.
Enrolment/screening and trial retention rates were 43% and 85% respectively. Recruitment was difficult owing to the coronavirus disease 2019 (COVID-19) lockdown. Group differences were statistically significant, favoring IHMs against placebos in all the KOOS sub-scales: symptoms (p < 0.001), pain (p = 0.002), activities of daily living (p < 0.001), sports or recreation (p = 0.016), and quality of life (p = 0.002). Derived WOMAC scores from KOOS favored IHMs against placebos: stiffness (p < 0.001) and pain (p < 0.001). The EQ-5D-5L questionnaire score (p < 0.001) and EQ-5D-5L VAS scores (p < 0.001) also yielded significant results, favoring IHMs over placebos. All the effect sizes ranged from moderate to large. Sulphur was the most frequently prescribed homeopathic medication. Neither group reported any harm or serious adverse events.
The authors concluded that, although recruitment was sub-optimal due to prevailing COVID-19 conditions during the trial, the action of IHMs was found to be superior to that of placebos in the treatment of knee OA. Larger and more definitive studies, with independent replications, are warranted in order to substantiate the findings.
Sorry, but I don’t understand this: the authors stated multiple times that this was a feasibility study (which tests feasibility and not effectiveness), and then they promptly report effectiveness data for which the trial was grossly under-powered (i.e. too small). Why are they doing such nonsense? Perhaps their affiliations provide a hint?
- 1Department of Materia Medica, D. N. De Homoeopathic Medical College and Hospital, Kolkata; affiliated to The West Bengal University of Health Sciences, Kolkata, West Bengal, India.
- 2Department of Repertory, D.N. De Homoeopathic Medical College and Hospital, Kolkata, West Bengal, India.
- 3Department of Organon of Medicine and Homoeopathic Philosophy, D.N. De Homoeopathic Medical College and Hospital, Kolkata, West Bengal, India.
- 4Department of Practice of Medicine, D.N. De Homoeopathic Medical College and Hospital, Kolkata, West Bengal, India.
- 5Department of Surgery, D.N. De Homoeopathic Medical College and Hospital, Kolkata, West Bengal, India.
- 6Department of Homoeopathy, East Bishnupur State Homoeopathic Dispensary, Chandi Daulatabad Block Primary Health Centre, West Bengal, India.
- 7Department of Community Medicine, D.N. De Homoeopathic Medical College and Hospital, Kolkata, West Bengal, India.
I do symathise with the pressures of reporting positive findings, if your salary comes from homeopathic institutions. Yet, I cannot help but pointing out:
THESE FINDINGS ARE INVALID AND FALSE-POSITIVE!
This study aimed to explore women with breast cancer (WBC) lived experiences on the use of So-Called Alternative Medicine (SCAM) for breast cancer management. In-depth interviews guided by semi-structured questions were conducted with 21 WBC recruited using convenience sampling. The thematic analysis generated four main themes:
- Access, affordability and support for medical treatment.
- Beliefs in SCAM treatment.
- Feeling the potential benefits of SCAM.
- Acknowledging the negative aspects of SCAM.
The outcomes from using SCAM based on the lived experiences of WBC indicated that some SCAM treatments could improve quality of life. However, some fraudulent SCAM obtained from unprofessional SCAM providers could cause harmful effects, delay medical cancer treatment, and increase breast cancer treatment costs.
The authors concluded that there is an urgent need to enhance the awareness of appropriate treatment, including evidence-based SCAM, for WBC. Improved understanding in the use of SCAM as a part of quality breast cancer care services could contribute to increasing the quality of life and survival rates of women with breast cancer.
This is a very strange paper, in my view. If we disregard the fact that a small interview study cannot possibly yield reliable outcomes, we essentially have two results:
- Some SCAM treatments could improve quality of life and survival.
- Some fraudulent SCAM obtained from unprofessional SCAM providers could cause harm.
So, which SCAM is good and which bad?
By definition, such an investigation cannot answer this crucial question.
If you do nevertheless want answers, I recommend you read my evidence-based assessments summarised in a recent book. For those who don’t want to wait, here is the answer in a nutshell:
- A few SCAMs are indeed proven to inprove the quality of life of cancer patients.
- No SCAM has been shown to improve survival.
- Almost all SCAMs have the potential to harm cancer patients.
My conclusion:
“Lived experiences” may sound interesting, but scientific evidence is the only reliable guide.
Osteoarthritis of the knee (OAK) is a chronic degenerative musculoskeletal disorder that strongly affects the elderly population and decreases their quality of life. Pain, stiffness, and restricted knee movements are the major characteristic features of OAK. There are no studies available on the effect of the liver 7 (LR 7) acupuncture point on pain and range of motion. This study therefore tested the effectiveness of the LR 7 acupuncture point on pain and range of motion in chronic OAK patients.
Thirty-five subjects aged between 40 and 65 years were recruited from Government Yoga and Naturopathy Medical College, Chennai. Participants were included in the study after they fulfilled the eligibility criteria. The duration of acupuncture was 20 minutes (5 days/week) for 2 weeks. Baseline and post-intervention assessments were performed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and the degree of knee flexion and extension was measured using a goniometer.
Pre- and post-trial outcomes were compared using paired t-tests. LR 7 acupuncture reduced the WOMAC score from 49 to 30 (p < 0.001), indicating that pain was alleviated. Treatment increased the range of knee flexion from 110 to 115 degrees and reduced knee extension (p < 0.01) from 16 to 9 degrees (p < 0.001). These findings indicate that acupuncture treatment improved the range of knee movement.
The authors concluded that the present study showed that 10 sessions of LR 7 acupuncture for people with OAK significantly reduced pain and increased range of motion. We conclude that LR 7 acupuncture is an adjuvant therapy for alleviating pain and managing OAK.
On several levels, this is a shocking paper:
- There already are many controlled clinical trials of acupuncture for OAK; thus there is no reason whatsoever to conduct and publish a trial that is methodolagically inferior to this body of evidence.
- The conclusions are incorrect; as the study had no control group, it is impossible to establish causaality between the treatment and the outcome. The pain reduction might have been caused by phenomena that are unrelated to acupuncture, e.g. placebo effect, regression towards the mean, social desirability.
- The authors state that they are “grateful to principal and faculities of government of yoga and naturopathy medical college and hospital for their support”. This means that they were misguided by a governmental medical college and hospital in planning and running a study that is a waste of resources and thus arguably unethical.
Research of this nature is dangerous:
- It undermines the trust people put in science.
- It makes a laughing stock of more serious attempts to test the value of acupuncture.
- It misuses the cooperation of patients who give their time and good will to advance our knowledge.
- It wasts precious resources.
- It is an incentive for others to do similarly nonsensical pseudo-science.
- It misleads patients and carers into believing in quackery.
The only valid conclusion that can be drawn from this paper is, I think, this:
The people involed in planning, conducting, supporting and publishing this study have little understanding of clinical research and should receive adequate education and training before they are allowed to continue.
Acute encephalitis syndrome is a health burden to a populous country like India. It is characterized by a sudden onset of fever, altered sensorium with or without seizures, irritability, abnormal behaviour, or unconsciousness. This study aims to augment further evidence on the effects of add-on homeopathic treatment in reducing mortality and morbidity in children.
This comparative retrospective study included children hospitalized with acute encephalitis syndrome between July 2016 to December 2016. The researchers compared the parameters of children for whom decisions on Glasgow Outcome scale and Liverpool outcome score aided by add-on homeopathy against those of children from the same year when the add-on homeopathy was not used. All the children were on conventional supportive care and treatment tailored to each child. We also counted the days until the resumption of oral feeding and the length of hospital stay.
Ordinal regression analysis on analyses on 622 children (IH +CSC=329; IMP only=293) was done. Odds of a shift towards increased recovery were superior in the homeopathy-added group than in the IMP group without adjustment (crude OR 2·30, 95% CI 1·66 to 3·20; p=0·0001) and with adjustment (adjusted OR 3.38, 95% CI 2·38 to 4.81; p=0·0001). There was 14.8% less mortality and 17.4% more recovery in the add-on homeopathy group compared to CSC alone. Individualized homeopathic remedies commonly used were: Belladonna (n =238), Stramonium (n =17), Opium (n = 14), Sulphur (n=11) and Hyoscyamus niger (n = 7).
The authors concluded that this retrospective cohort study advocates for add-on homoeopathy in children suffering acute encephalitis which can produce notable improvements in terms of mortality and morbidity. Further studies in different settings are warranted.
If responsible physicians come across such an unexpected and implausible finding, instead of publishing it unchecked, they must properly test the hypothesis in a rigorous trial. As it stands, the results are meaningless and might even do untold harm, if some doctors drew the conclusion that homeopathy saves lives in acute encephalitis.
The most likely explanation for the reported outcomes is that there was considerable selection bias in recruiting patients to this study. The less severely ill patients might thus have ended up in the homeopathy group. The plausibility for the outcomes being due to the homeopathic treatment is virtually zero.
So, why did the authors of this paper publish such utterly unreliable findings and did not even include a hint of critical thinking? I think their affiliations might go some way in answering this question:
- Ramesh Prasad, Clinical Trial Unit Homoeopathy,BRD Medical College and Hospital, GorakhpurAlok Upadhyay, Clinical Trial Unit Homoeopathy (Viral encephalitis) BRD Medical College and Hospital, Gorakhpur
- Vinod Kumar Maurya, Clinical Trial Unit Homoeopathy (Viral encephalitis) BRD Medical College and Hospital, Gorakhpur
- Preeti Verma, Clinical Trial Unit Homoeopathy (Viral encephalitis) Medical College and Hospital, Gorakhpur
- Shashi Arya, Clinical Trial Unit Homoeopathy (Viral encephalitis) Medical College and Hospital, Gorakhpur
- Supriya Singh, Central Council for Research in Homoeopathy
- Purnima Shukla, Clinical Trial Unit Homoeopathy (Viral encephalitis) BRD Medical College and Hospital, Gorakhpur
- AK Gupta, Clinical Trial Unit Homoeopathy (Viral encephalitis) BRD Medical College and Hospital, Gorakhpur
- Arvind Kumar, Central Council for Research in Homoeopathy
- Praveen Oberai, Central Council for Research in Homoeopathy
- Raj K Manchanda, Central Council for Research in Homoeopathy, New Delhi
And why did they take all of 8 years to publish this nonsense?
Search me!
You might remember that I recently reported of TWO studies sponsored by the ‘Carstens Stiftung’ and wonder whether the second is any better that the first. Here is its published outline: Multimodal online programme and biosignal analysis:
Here, too, the basic principles of a plant-based wholefood diet, Kneipp hydrotherapy, naturopathic self-help strategies and elements of holistic therapy and mind-body medicine are taught – but online. ‘The study represents a prototype for the optimal use of modern digital tools in naturopathic care situations and could serve as a best-practice model for online therapy approaches,’ says Dr Michael Jeitler, Deputy Research Coordinator at the Charité University Outpatient Clinic for Naturopathy at Immanuel Hospital Berlin. There is an urgent need for this, as it is known that only one sixth of the population in Germany is reached with appropriate lifestyle interventions taught in a practical manner.
The hypothesis: The physical resilience of patients with post-COVID syndrome improves more with a combination of naturopathic therapy in an online setting and routine care than with routine care alone. A total of 120 subjects will be included in the two-arm randomised controlled trial.
Group 1 will receive online training lasting 120 minutes once a week over a period of 2 months. In addition, there will be a recommendation to consolidate what has been learnt in daily 30-minute exercises at home. An online diary will also be kept. The observation period per patient is 12 months.
Group 2 will initially be placed on a waiting list.
A highlight of the project is a physiological sub-study focusing on the establishment and validation of a biosignal characterisation of post-COVID syndrome and in particular the prominent symptoms of fatigue. To this end, heart rate, blood pressure, respiratory rate, pulse, electrodermal activity and brain activity are measured simultaneously in patients with fatigue. ‘This approach should make it possible to objectively quantify the clinical symptom changes of fatigue, which have been difficult to objectify up to now,’ says Jeitler. ‘We hope to gain a better understanding of fatigue itself and its role in post-COVID syndrome. Ideally, this will improve diagnosis in the future.’
There will also be an embedded qualitative sub-study. After two months, both some of the test subjects and the GPs treating them will be interviewed individually about their perceptions and experiences in order to better adapt the naturopathic interventions to the needs and requirements of the patients in the long term.
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What is in my view particularly noteworthy is the fact that both studies pretend (like proper science) to test a hypothesis. This is, of course, not true. A true test of a hypothesis would be open to either its confirmation or its rejection. However, with the present study we have a situation where only a confirmation is on the cards. This discloses one thing very clearly: we are dealing here not with proper science, but with proper pseudoscience.
This study follows (just as the first trial) a ‘A+B versus B’ design and thus has the same major flaws as the first trial sponsored by the ‘Carstens Stiftung’. The reason for using this study design seems all too obvious: it will always generate a positive outcome. There is, of course, a prize: the study is unable to show that the intervention has any effects other than placebo. The Carstens Stiftung is happy to pay this price; their main interest seems to be not to answer meaningful research questions but to generate findings that lend themselves to promoting so-called alternative medicine (SCAM).
The Carl and Veronica Carstens Foundation is providing EUR 600,000 for 2 research projects to identify effective so-called alternative medicine (SCAM) therapies for post-COVID syndrome. The one that I will focus on here is headed by a member of my ALTERNATIVE MEDICINE HALL OF FAME, Prof Dr Gustav Dobos, Essen University Hospital.
The project is entitled: Multimodal group programme based on Kneipp
It is being described as follows:
A team of researchers led by Prof Gustav Dobos and Dr Heidemarie Haller, in cooperation with Prof Mark Stettner and Prof Christoph Kleinschnitz from the Department of Neurology at Essen University Hospital, will conduct a single-blind, randomised controlled study with two arms. A total of 86 subjects with post-COVID syndrome will be included and randomly divided into two groups.
Group 1 will undergo a 10-week group programme based on the Kneipp therapy pillars. The subjects will meet once a week, so there will be two sessions for each Kneipp pillar. These will include an educational and a practical part with the aim of developing their own strategies for coping with illness and actively integrating these into their everyday lives.
- Plant-based wholefoods and medicinal teas will be used to strengthen convalescence.
- Mindful exercise sessions in nature should help to utilise the effect of daylight and vitamin D on the immune system.
- In the area of hydrotherapy, water treatments, dry brushing, wraps and compresses will be used.
- There will be medical advice on herbal medicine options for individual symptoms such as sleep disorders, digestive problems, pain, coughs, anxiety or circles of thought.
The aim is to facilitate a balance of lifestyle in professional, family and social areas by means of organisational therapy. Relaxation and meditation techniques, for example, are taught for this purpose. In order to consolidate what they have learnt, participants in group 1 also receive a self-help book and homework.
Group 2 is the control group and is initially placed on a waiting list. In both groups, standard therapy is (additionally) permitted at any time. A symptom and therapy diary will also be kept in both groups.
The primary aim is to test whether the group programme as an add-on to standard therapy can improve self-help skills and alleviate the burden of post-COVID symptoms more than standard therapy alone. Parameters of quality of life, cardiovascular and pulmonary performance and the so-called flourishing of the test subjects as motivated personalities are also recorded at 4 points in time before, during and up to 16 weeks after the end of the intervention phase.
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And why do I call this study ‘nonsensical’?
Mainly because the results of the trial are known before even the first patient was recruited!
How come?
Because, as we have previously discussed here at nauseam, A+B will always be more than B alone. Kneipp therapy plus usual care will have more effects than usual care alone, even if Kneipp therapy generates nothing but placebo effects. This is particularly true, of course, for subjective outcome measures.
So, the conclusion of the trial, once it is published, will state something like this:
Our study has shown that the multimodal group programme based on Kneipp is effective in reducing the symptoms of post-COVID.
And what is wrong with that?
Plenty!
It means that money and effort will be wasted, that science will be undermined, and that we will be potentially misled about the effectiveness of mixed bag of treatments called ‘Kneipp therapy’. Perhaps it is effective (beyond placebo), but perhaps it’s not – this study will not tell us either way.
Cancer often causes reduced resilience, quality of life (QoL) and poorer overall well-being. To mitigate these problems, so-called alternative medicine (SCAM) is often advocated for patients with cancer. This study aimed to evaluate the long-term effects of an interdisciplinary integrative oncology group-based program (IO-GP) on the resilience and use of SCAM in patients with cancer.
This was a prospective, observational, single-center study. Resilience (RS-13), SCAM usage (I-CAM-G), QoL (SF-12) and health-related lifestyle factor (nutrition, smoking, alcohol consumption and physical exercise) data were collected for 70 patients who participated in a 10-week IO-GP between January 2019 and June 2022 due to cancer. The IO-GP was offered at the setting of a university hospital and was open to adult patients with cancer. It contained elements from mind-body medicine and positive psychology, as well as recommendations on healthy diet, exercise and SCAM approaches. Patients who completed the IO-GP at least 12months prior (1-4.5years ago) were included in this study. Statistical analysis included descriptive analysis and parametric and nonparametric tests to identify significant differences (P<.05).
Resilience increased significantly ≥12months after participation in the IO-GP (n=44, P=.006, F=8.274) and had a medium effect size (r=.410). The time since the IO-GP was completed (“12-24months,” “24-36months,” and “>36months”) showed no statistically significant interaction with changes in resilience (P=.226, F=1.544). The most frequently used SCAM modalities within the past 12months were vitamins/minerals (85.7%), relaxation techniques (54.3%), herbs and plant medicine (41.1%), yoga (41.4%) and meditation (41.4%). The IO-GP was the most common source informing study participants about relaxation techniques (n=24, 64.9%), meditation (n=21, 72.4%) and taking vitamin D (n=16, 40.0%). Significantly greater levels of resilience were found in those practicing meditation (P=.010, d=−.642) or visualization (P=.003, d=−.805) compared to non-practitioners.
The authors concluded that IO-GPs have the potential to empower patients with cancer to continue using SCAM practices—especially from mind-body medicine—even 1 to 4.5 years after completing the program. Additionally, resilience levels increased. These findings provide notable insight into the long-term effects of integrative oncology interventions on resilience and the use of SCAM, especially in patients with breast cancer.
Really?
“Long-term effects of integrative oncology interventions”?
I am sorry, but I see no effects here at all. All I do see are correlations.
For all we know, the outcomes might have even been better if no SCAMs had been offered.
For all we know, the main reason for the observed changes is simply the passage of time.
CORRELATION IS NOT CAUSATION!
There is, of course, little wrong with conductiong studies of this nature – even though they are never really informative, in my view – but there is much wrong when the bias of the authors kicks in and they imply (in the title and throughout the text of their paper) that their interventions were the cause of the observed outcome. This does not provide “notable insight”, it merely misleads some people who are less able to think critically.
WISHFUL THINKING IS NOT SCIENCE!
Sadly, this simple lesson seems to be ever so hard to comprehend by SCAM researchers. One does not need to look far to find hundreds of SCAM studies that are plagued by the same or similar biases. As a result, SCAM research is gradually becoming the laughing stock of real scientists.
