TCM
On Easter Sunday, it seems reasonable to look at a recent paper about religious factors that might determine the usage of so-called alternative medicine (SCAM). This article examined the vitalistic/holistic foundation of SCAM.
The two Ukranian authors explain that, according to the principles of holistic medicine, health is associated with the harmonization of the elements and forces that constitute human nature on both the physical and spiritual levels of existence. Regarding the religious foundations of SCAM practices of Eastern origin, the systems such as yoga, Daoism, and Ayurveda perceive energy as an impersonal force that an individual can accumulate, balance, and influence through physical and spiritual exercises to achieve health, longevity, and personal self-improvement. These systems are vitalistic, as they recognize impersonal energy as the fundamental basis of existence. In contrast, the conceptual foundation of SCAM practices of Western origin differs fundamentally from Eastern approaches. These practices are not rooted in Christianity, despite having emerged in countries belonging to Christian civilization. This is because, in Christianity, the source of existence is God-Person, which significantly diminishes the ontological status of impersonal energy. As a result, Western SCAM practices have developed an instrumental approach to vitalistic methods, adapting many Eastern techniques to the Western cultural and anthropological context. Additionally, they are based on various personal quasi-scientific systems, such as Mesmer’s magnetism, Hahnemann’s homeopathy, Palmer’s chiropractic methods, and others. To an external observer, these methods may appear impressive. However, whether a physician chooses to incorporate them into their practice depends entirely
on their personal experience and convictions.
The authors concluced that “both Eastern and Western SCAM practices consider energy an important factor in health, and their holistic approach integrates work with the body, mind, and spirit. Regarding the religious foundation of Eastern SCAM practices, systems such as Yoga, Daoism, Ayurveda consider energy to be an impersonal force that individuals can accumulate, balance, and influence through physical and spiritual exercises to
achieve health, longevity, and personal self-improvement. These systems are vitalistic because they recognize energy as the fundamental basis of existence. In contrast, the conceptual foundation of Western SCAM practices is fundamentally different. These practices can not be rooted in Christianity, even though they originate from countries within Christian civilization. This is because, in Christianity, the source of existence is God-Person,
which diminishes the significance of energy. With some exceptions, Christianity lacks a holistic view of energy, and
human control over it is limited. As a result, Western SCAM practices have developed a more instrumental approach to vitalistic methods, including those borrowed from Eastern medicine. Furthermore, they rely on quasi-scientific systems developed by specific individuals, such as Mesmer’s magnetism, Hahnemann’s homeopathy, and Palmer’s chiropractic methods, and others.”
Convinced?
Me neither!
Happy Easter, nonetheless.
The fact that animal parts are used for so-called alternative medicine (SCAM) is well-known. The problem has so far been related mostly to China and TCM. A recent article reminds us of the fact that the abuse of animals for SCAM is also an African issue:
The use of animals for zootherapeutic purposes has been reported worldwide, and with the patronage of complementary and alternative medicines being on the ascendency, the trade and use of animal parts will only escalate. Many more of these animals used in traditional medicine will be pushed to extinction if policies for their sustainable use and conservation are not formulated. There have been studies across the world which assessed the trade and use of animals in traditional medicine including Ghana. However, all previous Ghanaian studies were conducted in a few specific cities. It therefore makes it imperative for a nationwide study which would provide more comprehensive information on the trade and use of animals in traditional medicine and its conservation implications. Using direct observation and semi-structured questionnaires, data were collected from 133 vendors of animal parts used in traditional medicines in 48 markets located across all 16 administrative regions of Ghana. Analysis of the data showed that the trade in wild animal parts for traditional medicine was more prevalent in the urban centres of Ghana. Overall, 75 identifiable animal species were traded on Ghanaian traditional medicine markets. Using their relative frequency of citation values, chameleons (Chamaeleo spp.; 0.81), lions (Panthera leo; 0.81) and the West African crocodile (Crocodylus suchus; 0.67) were the most commonly traded animals in Ghana. Majority of the vendors (59.1%) indicated that their clients use the animal parts for medicinal purposes mainly for skin diseases, epilepsy and fractures, while clients of 28.2% of the vendors use the animal parts for spiritual or mystical purposes, such as protection against spiritual attacks, spiritual healing and money rituals. Up to 54.2% of the animals were classified as Least Concern by IUCN, 14.7% were threatened, with 51.2% of CITES-listed ones experiencing a decreasing population trend. This study also found that 68.5% of the traded animal species are not listed on CITES, but among those listed, 69.6% are classified under Appendix II. Considering the level of representation of animals of conservation concerns, the harvesting and trade of animal parts for traditional medicine must be regulated. This call is even more urgent since 40.0% of the top ten traded animals are mammals; a class of animals with long gestation periods and are not prolific breeders.
The authors concluded that the trade of animal parts and products for traditional medicine in Ghana is widespread, especially in market centres in the urban area. These animals are used mainly for medicinal purposes, especially skin diseases, but their use for mystical purposes is also prevalent. Again, with the topmost traded animals being those in CITES Appendices I and II, means there is some laxity in the enforcement of laws that are to ensure sustainable use of animal resources. Although a majority of animals traded for traditional medicine may not be currently of conservation concern and not listed under CITES, policymakers and other stakeholders in Ghana and beyond would have to start working on ensuring the survival of the threatened ones and prevent the sliding of the non-threatened species into extinction so the biodiversity will be conserved for the use of the future generation.
All I want to add here is the fact that there is not a shred of evidence that animal parts in SCAM have any positive health effects. It is high time that this barbaric and useless trade stops!
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.
Tuina, or Tui Na is based on the notion that imbalances of the life-force, qi, can cause blockages or imbalances that lead to symptoms and illness. Tuina massage is similar to acupressure in that it targets specific acupoints. Practitioners use fingers to apply pressure to stimulate these points.
Some people suggest that Tuina might benefit diabetic peripheral neuropathy (DPN), but the evidence is inconclusive. This review evaluated its clinical efficacy and safety for DPN treatment.
Ten databases were searched, covering the period from their inception to February 21, 2024. Relevant data were extracted from studies meeting the inclusion criteria, and a meta-analysis was conducted using RevMan
5.3 software.
A total of 24 randomized controlled trials (RCTs) involving 1,989 participants were included. Patients in the experimental group received Tuina in addition to routine treatments and nursing of DPN. Patients in the control group received routine treatments and nursing of DPN, including health education, dietary guidance, blood sugar control, and oral vitamin B or mecobalamin.
The meta-analysis showed that, compared to various control therapies, Tuina demonstrated a higher overall clinical efficacy rate and improved Toronto Clinical Scoring System (TCSS) scores, indicating that Chinese Tuina may provide benefits beyond conventional treatment. Furthermore, improvements were observed in the motor and sensory nerve conduction velocities (MNCV and SNCV) of certain specific nerves, such as the common peroneal nerve, sural nerve, and ulnar nerve. Although the differences in MNCV and SNCV of the tibial and median nerves were not statistically significant, the overall improvement in clinical outcome supports the notion that Tuina is superior to conventional treatment.
The authors concluded that Chinese Tuina therapy is a safe and effective treatment option for DPN. It can alleviate clinical symptoms and improve the MNCV of the common peroneal nerve as well as the SNCV of the sural and ulnar nerves. Its efficacy in the tibial and median nerves remains unconfirmed, highlighting a need for future large-scale, high-quality RCTs.
There are several reasons why I cannot accept the conclusion that Tuina is effective for DPN, e.g:
- All the RCTs were of the notorious A+B vs B design that – as discussed ad nauseam on this blog – does not control for placebo effects and thus never generate negative results.
- None of the RCTs were single or double blind which means that expectation and therapist influence would have impacted on the findings.
- All of the studes originate from China; we have often discussed why such studies are notoriously unreliable. Funding for the review was supported by the National Key Research and Development Program of China and Jilin Provincial Natural Science Foundation Project.
- Most of the studies are published in journals and/or laguages that are not accessible to non-Chinese readers.
- None of these serious limitations are discussed by the review authors.
I REST MY CASE
Today is World Cancer Day. It is an international day observed every 4 February to raise awareness about cancer, encourage its prevention, and mobilise action to address the global cancer epidemic. Cancer and so-called alternative medicine (SCAM) are closely linked, for instance, through the fact that large proportions of desperate cancer patients use SCAM, many in the hope to cure their disease. I have therefore often tried to instill some rational thought into the debate by discussing the emerging, largely negative evidence on SCAM for cancer. Here are just a few recent examples:
- Homeopathy as a therapy for cancer? A new review from India
- Geopathic stress allegedly can cause health issues such as arthritis, multiple sclerosis and cancer – BUT, PLEASE, DON’T BELIEVE SUCH NONSENSE!
- Homeopathic Cancer Therapy? No, no and no!
- Medicinal Mushrooms for Cancer?
- Bioenergy therapies for cancer: implausible, ineffective, and an unethical waste of money
- Camel urine as a treatment for cancer patients?
- Homeopathy for cancer? Unsurprisingly, the evidence is not positive.
- When an undercover journalist tests alternative cancer healers
To mark the day, I had a look at what people post on ‘X’ about SCAM and cancer cure. Here are some of the more amazing assumptions, claims and comments that I found (warts and all):
- The Princess of Wales, Kate Middleton has been diagnosed with Cancer – there is a high probability she has Turbo Cancer, caused by COVID-19 mRNA Vaccines she took in 2021.
- Blue butterfly pea flowers (Clitoria ternatea) is one of the best CANCER KILLING and CANCER PROTECTIVE plants available to man.
- Dandelion root far more effective in fighting cancer cells than chemotherapy.
- In Kenya, research shows 76% of cancer patient who turn to traditional medicine instead of chemotherapy have drastically improved.
- I’ve just been diagnosed w cancer and will approach it with nutrition, suppl,and cont’d exercise… other alternative therapies as well. Been an RN for decades and have witnessed the horrors and pitfalls of modern medicine. Must b your own best advocate.
- I had a niece, a cousin and a friend die same week of the big C. was an eye-opener for me cause chemo did not help them at all….so looked at the alternative medicine….down in Mexico. but it was too late. cancer spread like wildfire.
- I pray to God that no one has to suffer through cancer but I agree with you 1000% alternative medicine as a matter fact we already know that there are three that can cure cancer. I ivermectin is one and I can’t remember the other two.
- Cancer has been proven to be eliminated with alternative medicine you denounce without a single study. I’m starting to think you hate the American people.
- Next time you or your loved one gets cancer, use “alternative medicine“.
- Most Doctors use drugs for treatment of symptoms because that’s how they are trained. No nutrition or alternative medicine is taught or encouraged. In cancer treat Drs are required to only recommend chemo because they could lose their license for alternative nedicine referrals.
- Spiritual causes of illness, including cancer, are often explored within alternative approaches to healing and holistic philosophies. Although traditional medicine does not recognize spiritual causes, many spiritual traditions and energetic practices.
- I pray that you look to alternative medicine, don’t listen to the current medical model as it is designed to keep people sick, western medicine does not heal. Chinese medicine does like others around the world. A primary cause of cancer is parasites. Western medicine doesn’t look.
- Chemotherapy is brutal, attacking both cancer and healthy cells. Alternative solutions do exist, but mainstream medicine often won’t offer them. Take control of your research, explore your options, and question everything.
- I cured my cancer symptoms using alternative medicine, including Ayurveda. Not drugs.
- I’m a double cancer survivor and I was in a clinical trial testing chemo in 2013-2014. Chemo is poison and big pharma. Alternative medicine is better. Changed must be made. I love that PresidentTtump has done this. And I can’t wait for RFKJr to lead HHS.
- Cancer kills you if you follow the advice of the medical establishment. There are many alternative cures for cancer and even more ways to prevent it in the first place. Do some research into naturopathic medicine if you truly want to be healthy.
- Maybe Trump should redirect that 500 billion to alternative medicine/supplement/ivermectin research that will eradicate cancer. And what is causing cancer. Don’t need a mRNA cancer vaccine. We already have the tools to stop cancer.
- Please get checked for parasites which is what cancer is. Try alternative medicine and see how that works – I bet it does.
- I have a friend who cured her own breast cancer with alternative methods. There are cures out there. Mainstream medicine just won’t recognize them.
- Everything is fake in medical field nowadays. Not only petition but also pathogen hypothesis medical academic papers about virus, cancer etc.. We need to build an alternative medicine field ASAP.
- …
- …
[I could have gone on almost for ever]
I had not expected to find much wisdom on ‘X’, but what I did find truly horrified me. For every sensible Tweet, there seem to be 10 imbecillic and dangerous ones. Imaging a desperate cancer patient reads these lies, misleading claims, nonsensical statements and conspiracy theories!
To set the record straight, let me state these two simple facts:
There is no SCAM that would change the natural history of any form of cancer.
What is more, there never ill be one! As soon as a treatment might look promising as a cancer cure, it will be investigated by mainstream scientists and – if it turns out to be helpful – integrated into conventional oncology. In other words, it will become evidence-based medicine.
You don’t believe me without evidence?
Ok, then please read my book on the subject.
PS
And yes, there are some SCAMs that might have a role in improving QoL, but that’s a different topic.
Kampo medicine is the Japanese form of traditional herbal medicine that is still very popular in Japan. The word Kampo means ‘Chinese style’ in Japanese. Kampo developed out of traditional Chinese herbal medicine after it was introduced into Japan in the 7th century. In the early 20th century, Kampo was further influenced by modern Western medicine and science. The Kampo system is a pragmatic and simplified version of Chinese herbal medicine. Kampo medicines are standardised and not individualised as in Chinese herbal medicine. They are based on the current symptoms of the patient, interpreted in the philosophy of Kampo. Kampo diagnostics consider hypofunction and hyperfunction, heat and cold, superficies and interior, and yin and yang.
Today, Kampō is fully integrated into the Japanese national health care system, and numerous Kampo preparations are registered in Japan and reimbursable from public funds. These standardised formulas contain mixtures of herbal ingredients. They are manufactured under proper quality control. The most commonly used plants include liquorice, ginger and Chinese peony root. Most Japanese doctors routinely prescribe Kampo medicines, and most patients combine Kampo with Western medicine. Since 2002, the teaching of Kampo has been included in Japanese curricula of medical and pharmacy education.
The efficacy of Kampo medicines is often less solidly documented than one would hope or expect. There is a remarkable shortage of high-quality clinical trials. One review concluded that “Kampo medicines potentially play some roles in preventing or ameliorating side effects of anticancer agents. Supportive care with Kampo medicines for patients with cancer might lead to physical, mental, and nutritional improvement.” As Kampo medicines contain pharmacologically active ingredients, they can also cause adverse effects and might interact with synthetic drugs. Yet, the risks of Kampo are currently woefully under-investigated.
This case of severe liver injury following the administration of the Kampo medicine ‘Saibokuto‘ attempted to identify the likely causative crude drug inducing liver injury through a systematic literature review.
A 29-year-old woman developed severe liver injury approximately two months after Saibokuto administration, necessitating steroid pulse therapy for recovery. A literature search was conducted. Using PubMed and the “Igaku Chuo Zasshi (ICHUSHI) database,” two individuals independently selected studies published between January 1997 and February 15, 2023. The search focused on studies involving human subjects, published in either English or Japanese, and specifically investigated Kampo medicines categorized as over-the-counter or prescription drugs suspected as causative agents of drug-induced liver injury (DILI). Studies on health supplements, discontinued Kampo medicines, and autoimmune hepatitis, were excluded. As it is ethically impossible to rechallenge drugs that cause liver injury, this review primarily relied on case report literature.
Through the review, 37 cases (men/women: 12/25, including present case) were analyzed, including 32 reports (36 cases) from 3,055 studies that met the inclusion criteria. Notably, 65.9% of cases were associated with Scutellariae radix, with onset occurring within 45 (1-730) days and recovery within 35 (7-184) days.
The authors concluded that their case study and literature review underscore a prevalent association between liver injury and Kampo medicines containing Scutellariae radix. Vigilant liver function monitoring, particularly within the first 2 months of administration, is recommended, especially for formulations containing Scutellariae radix.
Radix Scutellariae (scullcap) is the dried root of the medicinal plant Scutellariae baicalensis Georgi. It has a long history of application in traditional herbalism. Six flavones seem to be its major bioactive constituents. All six flavones are pharmacologically active.
Scullcap has been advocated to treat arthritis, lung problems, hay fever, seizures, HIV or AIDS, and hepatitis. Scullcap applied to the skin has been used to treat psoriasis, sores or swelling, and hemorrhoids. The evidence that it is effective for any condition is far from convincing. Adverse effects of scullcap are equally under-researched.
The paper discussed above is a poignant remeinder of the ‘appeal to tradition‘: not everything that has been used for centuries is safe. Only proper scientific investigations will determine the risk/benefit profile of a therapy.
This study evaluated the real-world impact of acupuncture on analgesics and healthcare resource utilization among breast cancer survivors.
The authors selected from a United States (US) commercial claims database (25% random sample of IQVIA PharMetrics® Plus for Academics) 18–63 years old malignant breast cancer survivors who were experiencing pain and were ≥ 1 year removed from cancer diagnosis. Using the difference-in-difference technique, annualized changes in analgesics [prevalence, rates of short-term (< 30-day supply) and long-term (≥ 30-day supply) prescription fills] and healthcare resource utilization (healthcare costs, hospitalizations, and emergency department visits) were compared between acupuncture-treated and non-treated patients.
Among 495 (3%) acupuncture-treated patients (median age: 55 years, stage 4: 12%, average 2.5 years post cancer diagnosis), most had commercial health insurance (92%) and experiencing musculoskeletal pain (98%). Twenty-seven percent were receiving antidepressants and 3% completed ≥ 2 long-term prescription fills of opioids. Prevalence of opioid usage reduced from 29 to 19% (P < 0.001) and NSAID usage reduced from 21 to 14% (P = 0.001) post-acupuncture. The relative prevalence of opioid and NSAID use decreased by 20% (P < 0.05) and 19% (P = 0.07), respectively, in the acupuncture-treated group compared to non-treated patients (n = 16,129). However, the reductions were not statistically significant after adjustment for confounding. Patients receiving acupuncture for pain (n = 264, 53%) were found with a relative decrease by 47% and 49% (both P < 0.05) in short-term opioid and NSAID fills compared to those treated for other conditions. High-utilization patients (≥ 10 acupuncture sessions, n = 178, 36%) were observed with a significant reduction in total healthcare costs (P < 0.001) unlike low-utilization patients.
The authors concluded that, although adjusted results did not show that patients receiving acupuncture had better outcomes than non-treated patients, exploratory analyses revealed that patients treated specifically for pain used fewer analgesics and those with high acupuncture utilization incurred lower healthcare costs. Further studies are required to examine acupuncture effectiveness in real-world settings.
Oh, dear!
Which institutions support such nonsense?
- School of Pharmacy & Pharmaceutical Sciences, University of California Irvine, 802 W Peltason Dr, Irvine, CA, 92697-4625, USA.
- School of Pharmacy, Chapman University, RK 94-206, 9401 Jeronimo Road, Irvine, CA, 92618, USA.
- College of Korean Medicine, Kyung Hee University, Seoul, South Korea.
- Integrative Medicine Program, Departments of Supportive Care Medicine and Medical Oncology, City of Hope Comprehensive Cancer Center, Duarte, CA, USA.
- School of Pharmacy, Chapman University, RK 94-206, 9401 Jeronimo Road, Irvine, CA, 92618, USA. [email protected].
- School of Pharmacy & Pharmaceutical Sciences, University of California Irvine, 802 W Peltason Dr, Irvine, CA, 92697-4625, USA. [email protected].
And which journal is not ashamed to publish it?
It’s the BMC Med!
The conclusion is, of course, quite wrong.
Please let me try to formulate one that comes closer to what the study actually shows:
This study failed to show that a ‘real world impact’ of acupuncture exists. Since the authors were dissatisfied with a negative result, subsequent data dredging was undertaken until some findings emerged that were in line with their expectations. Sadly, no responsible scienctist will take this paper seriously.
Two years ago, I reported about an acupuncture review that was, in my view, a fairly clear case of scientific misconduct. To remind you, here is my from 22/11/22 about it:
Acupuncture is emerging as a potential therapy for relieving pain, but the effectiveness of acupuncture for relieving low back and/or pelvic pain (LBPP) during pregnancy remains controversial. This meta-analysis aimed to investigate the effects of acupuncture on pain, functional status, and quality of life for women with LBPP pain during pregnancy.
The authors included all RCTs evaluating the effects of acupuncture on LBPP during pregnancy. Data extraction and study quality assessments were independently performed by three reviewers. The mean differences (MDs) with 95% CIs for pooled data were calculated. The primary outcomes were pain, functional status, and quality of life. The secondary outcomes were overall effects (a questionnaire at a post-treatment visit within a week after the last treatment to determine the number of people who received good or excellent help), analgesic consumption, Apgar scores >7 at 5 min, adverse events, gestational age at birth, induction of labor and mode of birth.
Ten studies, reporting on a total of 1040 women, were included. Overall, acupuncture
- relieved pain during pregnancy (MD=1.70, 95% CI: (0.95 to 2.45), p<0.00001, I2=90%),
- improved functional status (MD=12.44, 95% CI: (3.32 to 21.55), p=0.007, I2=94%),
- improved quality of life (MD=−8.89, 95% CI: (−11.90 to –5.88), p<0.00001, I2 = 57%).
There was a significant difference in overall effects (OR=0.13, 95% CI: (0.07 to 0.23), p<0.00001, I2 = 7%). However, there was no significant difference in analgesic consumption during the study period (OR=2.49, 95% CI: (0.08 to 80.25), p=0.61, I2=61%) and Apgar scores of newborns (OR=1.02, 95% CI: (0.37 to 2.83), p=0.97, I2 = 0%). Preterm birth from acupuncture during the study period was reported in two studies. Although preterm contractions were reported in two studies, all infants were in good health at birth. In terms of gestational age at birth, induction of labor, and mode of birth, only one study reported the gestational age at birth (mean gestation 40 weeks).
The authors concluded that acupuncture significantly improved pain, functional status and quality of life in women with LBPP during the pregnancy. Additionally, acupuncture had no observable severe adverse influences on the newborns. More large-scale and well-designed RCTs are still needed to further confirm these results.
What should we make of this paper?
In case you are in a hurry: NOT A LOT!
In case you need more, here are a few points:
- many trials were of poor quality;
- there was evidence of publication bias;
- there was considerable heterogeneity within the studies.
The most important issue is one studiously avoided in the paper: the treatment of the control groups. One has to dig deep into this paper to find that the control groups could be treated with “other treatments, no intervention, and placebo acupuncture”. Trials comparing acupuncture combined plus other treatments with other treatments were also considered to be eligible. In other words, the analyses included studies that compared acupuncture to no treatment at all as well as studies that followed the infamous ‘A+Bversus B’ design. Seven studies used no intervention or standard of care in the control group thus not controlling for placebo effects.
Nobody can thus be in the slightest surprised that the overall result of the meta-analysis was positive – false positive, that is! And the worst is that this glaring limitation was not discussed as a feature that prevents firm conclusions.
Dishonest researchers?
Biased reviewers?
Incompetent editors?
Truly unbelievable!!!
In consideration of these points, let me rephrase the conclusions:
The well-documented placebo (and other non-specific) effects of acupuncture improved pain, functional status and quality of life in women with LBPP during the pregnancy. Unsurprisingly, acupuncture had no observable severe adverse influences on the newborns. More large-scale and well-designed RCTs are not needed to further confirm these results.
PS
I find it exasperating to see that more and more (formerly) reputable journals are misleading us with such rubbish!!!
_________________________
Now – 2 years later! – the journal (BMJ-Open) has retracted the article and posted the following notice about the decision:
BMJ Open has retracted this article.1 After publication, multiple issues were raised with the journal concerning the design and reporting of the study. The editors and integrity team investigated the issues with the authors. There were fundamental flaws with the research, including the control group selection and data extraction, not amenable to correction.
I am delighted that this misleading paper is now officially discredited. Yet, I do have some concerns:
WHY DOES IT TAKE 2 YEARS TO IDENTIFY SOMETHING AS FRAUDULENT RUBBISH, WHEN IT TOOK ME ALL OF ~30 MINUTES?
Instead of just insisting on a triumphant ‘I TOLD YOU SO’, let me provide some constructive advice to reviewers and journal editors.
- Many journal editors are to lazy to find reviewers themselves and ask the submitting author to name a few. Having myself published in the BMJ Open (the journal that published the paper in question) I fear that this might have been the case in the present instance. This habit invites poor reviews, e.g. reviews from colleagues who owe a favour to the submitting authors. It does not promote objective reviews and should be abandonned.
- Papers on acupuncture originating from China (as the one in question) are very likely to be biased (or worse), as we have so often discussed on this blog. Editors should be extra careful with such submissions.
- Reviewers who have in the past overlooked obvious flaws in a paper should be banned from further reviewing in future.
- Editors should understand the reviewers’ comments only as guidelines and still have an obligation to check the actual submissions themselves. the responsibility for publishing an article lies with them alone.
- Editors who repeatedly make such mistakes should be dismissed.
I think that adhering to these suggestions might improve the quality of published research … and, by Jove, this would be badly needed in the realm of so-called alternative medicine!!!
In China, acupuncture has been employed as an adjunctive therapy for coronavirus disease 2019 (COVID-19). Press needle acupuncture is a special type of acupuncture that provides prolonged stimulation to acupuncture points. This study assessed the effectiveness of integrating press needles alongside pharmacologic treatment in patients with mild-to-moderate COVID-19.
Patients hospitalized with mild-to-moderate COVID-19 symptoms between December 2022 and January 2023 were included in the study. The enrolled patients were randomly assigned to receive:
- pharmacologic treatment alone (control group),
- or both pharmacologic treatment and press needle acupuncture (intervention group).
Patients were evaluated for clinical outcomes, including symptom scores, deterioration rates, fever durations, and nucleic acid test results. The patients’ complete blood count and C-reactive protein levels were also analyzed using venous blood samples both before and after treatment.
Both groups exhibited a reduction in clinical symptom scores, but symptoms regressed faster in the intervention group. Nucleic acid test negativity was achieved faster in the intervention group than in the control group. The intervention group also had a lower deterioration rate. Furthermore, the increase in the lymphocyte count and decrease in C-reactive protein levels following treatment were more pronounced in the intervention group than in the control group.
The authors concluded that this study suggests that utilizing press needle acupuncture as an adjunct to pharmacologic treatment can be effective in patients with mild-to-moderate COVID-19 symptoms.
To understand this study better, we need to comprehend the nature of the therapeutic ritual. This is how the authors describe it:
For each session, press needles were inserted into acupoints and kept in place for approximately 24 hours. Only 1 side of the body (left or right) was treated in each session. The following day, press needles were removed from 1 side of the body, and new press needles were placed on acupoints on the other side of the body. Press needle acupuncture was performed by a qualified physician who had completed comprehensive acupuncture training. By contrast, patients in the control group solely received daily pharmacologic treatment, such as Lianhua Qingwen granules, with ibuprofen added as needed for fever management. Study participants were instructed to notify researchers of the appearance of clinical symptoms, and they were prohibited from participating in other studies during the trial period.
So, neither the patients nor the therapists were blinded. To call such a study “single-blind” is a bit odd! And are we really supposed to assume that the verum therapy did not generate placebo effects?
What we have here, I fear, is a classic example of a study designed such that it cannot possibly produce a negative result. It followed the A+B versus B design and employed a treatment that is bound to generate a sizable placebo response. What is even worse, the authors do discuss the limitations of their study but ignore the ‘elefant in the room’: ” this study had several limitations. The sample size was modest, and basic randomization was used without stratification based on comorbidities, which could have introduced bias.”
What do we call a study that cannot possibly produce a negative result?
- A waste of resources?
- Fraud?
- Misleading?
- Naive?
- Unethical?
I leave the answer to you.
