pain
Removing the chest tube in cardiac patients after surgery is one of the worst experiences of hospitalization in the intensive care units. Various pharmacological and non-pharmacological methods are available to control pain in these patients. This study aimed to investigate the combined effect of reflexology massage and respiratory relaxation on pain following chest tube removal in cardiac surgery patients of Shahid Beheshti Hospital in Shiraz, Iran, in 2023.
The study was a double-blind randomized clinical trial performed on 140 patients who underwent heart surgery and had a chest tube in Shiraz, Iran. The samples were randomly divided into four groups:
1- control group,
2- respiratory relaxation group,
3- foot reflex massage group,
4- a combination of respiratory relaxation and reflexology massage.
To collect data, two demographic questionnaires, and a visual analog scale were used.
The participants of the 4 groups were not meaningfully different in terms of age, BMI, duration of surgical operation, gender, job, education, place of residency, number of chest tubes, history of operation (P = 0.99, 0.31, 0.06, 0.81, 0.97, 0.96, 0.17, 0.10, 0.89 respectively).
The mean scores of pain intensity during chest tube removal, and 15 min after chest tube removal were not statistically different among the 4 groups. However, just after chest tube removal, the mean scores of pain intensity differed meaningfully among four groups (P = 0.008).
The authors concluded that the results showed that reflexology massage and respiratory relaxation both reduce pain immediately after chest tube removal in heart surgery patients. Also, the combination of these two techniques was more effective in reducing patients’ average pain.
Double blind?
Really?
How did they do that?
Here is their description:
“For the blinding purpose of the study, a nurse who worked at the ICU had to record the pain intensity and the data, so the possible researcher bias did not impact the results. Also, the patients knew the concept of the study but did not know that there were whether in single relaxation groups or mixed methods groups and did not know that other patients had different methods used for them. Also, the pain intensity data for the control group was routinely checked by the nurses, and along with the fact that they had no information that some of the patients were in the intervention groups and received complementary and alternative therapies, therefore, their data were also considered blinded. Therefore, the study could have their initial aim to use the double-blinded design.”
Double blind usually means that the therapist and the patient were masked as to the group alloca. Blinding the nurse is fine, but the therapists were not blind and could therefore have influenced the patients via verbal and non-verbal communications.
According to the authors, patients did not know whether they were “in single relaxation groups or mixed methods groups”. I think that cannot be true. Even if it were, what about the control group? Surely every patient knows whether or not he/she receives a reflexology massage!
It follows, I think, that the study was NOT double-blind, not even single-blind!
Does that matter?
Yes!
Firstly, I don’t want to be misled in this way.
Secondly, as blinding did not happern, the findings can be explaind by the effects of patient expectation and might therefore NOT be the result of the therapies. In other words, the conclusions drawn by the authors are not warranted.
Do Chiropractors Break Necks? This is an interesting question. “Dr.” Greg Malakoff (Chiropractor/Neurologist, Board Certified) provided the following answer (never mind that he seems to mean ‘do chiros cause strokes?’):
… The total disinformation that seems to be republished monthly on the news concerning chiropractors and strokes is based on a study performed in the 1950’s, that has been totally discredited. However, students these days are rather lazy and every time a meta analysis is performed on this old study it reaches all the news stations because their main sponsors are drug companies and they don’t want you having the opportunity to get well without their products. A meta analysis is simply someone reading the old study, and writing a book report on it.
If they were to actually study what has been discovered since the 1950’s, which is a tremendous amount of valid scientific research, not one done on a cadaver and deliberately making false conclusions, they would discover a few things, that I feel you should know.
The typical stroke victim if they survive has stroke posture, which consists of the arm being flexed and a lower leg extended. That would be a whole lot of brain damage, but we don’t see the entire motor strip damaged on brain scans. We typically see just a small area with an infarct. That area is the internal capsule. Picture a vase with all it’s stems entering into the narrow portion of it. All the neurons in the brain that leave it from different areas of the motor cortex with long nerves that go to innervate the muscles that you want to move are exiting through this narrow opening called the internal capsule.
Why is that important to know if you ever want a chance at being healthy? The arteries in the back of your neck, called the vertebral arteries do not go there, they do not go to the internal capsule where we see the stroke damage. That part of the brain is being fed by the carotid arteries that are in the front of your neck. That means the chiropractor is not the problem, we are not affecting those arteries. Case closed.
However, there is a type of more severe stroke related to the back of the neck arteries called vertebral artery dissection. These arteries feed the brain stem and the vital centers in there. The vital centers are what keep you breathing and your heart beating. That means, that I have never been sued by a victim of this because they are going to be dead before they get off of the table. That doesn’t happen, well it hasn’t happened to me or just about any other chiropractor. People can get this type of artery damage, but it is proven to be practically impossible to tear those arteries by a chiropractic adjustment. It would require hundreds of pounds of force to tear those arteries with a chiropractic adjustment. So unless your chiropractor is the size of a Polar Bear, there is a good chance you are remaining sick or in pain for no reason at all.
I know, what about that playboy model who died from the chiropractor that she went to? The incompetent medical examiner said that was the cause, but apparently he and all the media don’t read well. She had fallen and hurt the arteries in her neck a month earlier. The E.R. didn’t bother to do an ultrasound Doppler study of her arteries and if they had, they might have realized that she was injured more severely. Instead, she sought help for her neck pain a month later from a chiropractor. Most chiropractors do not have ultrasound Doppler equipment in their office. Neither do most urgent medical care centers. In this case, the adjustment aggravated the severe insult that she had sustained a month earlier. Perhaps he is guilty of taking for granted that the E.R. had done it’s job properly. She should never have been released from the E.R.
While it was all over the news everyday, every hour of every day for weeks, just how often does something like this occur? You are more likely to get blown up out of the sky by a terrorist, and as you are falling to earth still in your seat, get struck by lightning and shot and stabbed by terrorists that have parachuted out of another plane to make sure they had finished their job. However, they too get struck by lightning and you fall to the ground safely where you are now eaten by a land shark.
With that in mind, millions of people are suffering daily for decades because they are afraid of a chiropractic adjustment. This is the safest and most powerful form of treatment known to modern medical science. The number 3 leading cause of death in America is from medicine. Compare that to the one woman that died from a chiropractor in Canada. The case is kind of famous because that was the case that had Chiropractic outlawed in a province. The patient was obese, smoked, was diabetic, and took birth control pills. She had died of a stroke a month after going to the chiropractor. She was the perfect storm of walking disease and as I stated earlier, if the chiropractor was to have caused the stroke, she was not walking out of his office.
There are millions of dollars to be made off of your medical misery. You being sick helps fuel our economy. However, if you want the opportunity to be healthy it can’t be achieved with a lifestyle of drugs. Chiropractors have been labeled back pain doctors, but we are really brain doctors. Our treatment affects your brain and your brain is responsible for creating good health. If you are a drug company, then you would want people to be sick and miserable enough to buy your product. If you are sick and tired of being sick and tired your best chance of not staying that way is to visit a chiropractor. Don’t let all the disinformation keep you miserable and unhealthy.
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I find Malakoff’s answer relevant nnot least because it demonstrates a few points that are important:
- Some chiros call themselves doctors and manage to fool consumers in assuming that they are medically competent.
- Some even call themselves neurologists, it seems.
- They are the exact opposite of competent.
- They understand neither science, nor medicine, nor the methodologies used.
- They have misunderstood so much about [patho)physiology that it’s frightening to think they treat ill people.
- Despite all this they love to use pseudo-scientific language.
- They use it to impress and to white-wash their quackery and the chiropractic profession.
- They have an unrealistic view about the value of chiropractic.
- They are in denial about the risks of spinal manipulation.
- They are consumed by conspiracy theories without even attempting to provide evidence in their support.
We had to deal with Hongchi Xiao several times before:
- Slapping therapy? No thanks!
- China Power and Influence
- Slapping therapy: therapist arrested and charged with manslaughter by gross negligence
Slapping therapy is based on the notion that slapping patients at certain points of their body has positive therapeutic effects. Hongchi Xiao, a Chinese-born investment banker, popularised this SCAM which, he claims, is based on the principles of Traditional Chinese Medicine. It is also known as ‘Paida’—in Chinese, this means ‘to slap your body’. The therapy involves slapping the body surface with a view of stimulating the flow of ‘chi’, the vital energy postulated in Traditional Chinese Medicine. Slapping therapists believe that this ritual restores health and eliminates toxins. They also claim that the bruises which patients tend to develop after the treatment are the visible signs of toxins coming to the surface. Hongchi Xiao advocates slapping as “self-healing method” that should be continued until the skin starts looking bruised. He and his follows conduct workshops and sell books teaching the public which advocate slapping therapy as a panacea, a cure-all. The assumptions of slapping therapy fly in the face of science and are thus not plausible. There is not a single clinical trial testing whether slapping therapy is effective. It must therefore be categorised as unproven.
Now it has been reported that Hongchi Xiao has been sentenced to 10 years in prison for the death of a 71-year-old diabetic woman who stopped taking insulin during one of his workshops.
Hongchi Xiao, 61, was convicted of manslaughter by gross negligence for failing to get medical help for Danielle Carr-Gomm as she howled in pain and frothed at the mouth during the fourth day of a workshop in October 2016. The Californian healer promoted paida lajin therapy which entails getting patients to slap themselves repeatedly to release “poisonous waste” from the body. The technique has its roots in Chinese medicine and has no scientific basis and patients often end up with bruises, bleeding — or worse.
Xiao had extradited from Australia, where he had been convicted of manslaughter after a 6-year-old boy died when his parents withdrew his insulin medication after attending one of his workshops in Sydney. “I consider you dangerous even though you do not share the characteristics of most other dangerous offenders,” Justice Robert Bright said during sentencing at Winchester Crown Court. “You knew from late in the afternoon of day one of the fact that Danielle Carr-Gomm had stopped taking her insulin. Furthermore, you made it clear to her you supported this.” Bright added Xiao only made a “token effort” to get Carr-Gomm to take her insulin once it was too late and had shown no sign of remorse as he even continued to promote paida lajin in prison.
Carr-Gomm was diagnosed with type 1 diabetes in 1999 and was desperate to find a cure that didn’t involve injecting herself with needles, her son, Matthew, said. She sought out alternative treatments and had attended a previous workshop by Xiao in Bulgaria a few months before her death in which she also became seriously ill after ceasing her medication. However, she recorded a video testimonial, calling Xiao a “messenger sent by God” who was “starting a revolution to put the power back in the hands of the people to cure themselves and to change the whole system of healthcare.”
Xiao had congratulated Carr-Gomm when she told other participants at the English retreat that she had stopped taking her insulin. By day three, Carr-Gomm was “vomiting, tired and weak, and by the evening she was howling in pain and unable to respond to questions,” prosecutor Duncan Atkinson said.
A chef who wanted to call an ambulance said she deferred to those with holistic healing experience. “Those who had received and accepted the defendant’s teachings misinterpreted Mrs. Carr-Gomm’s condition as a healing crisis,” Atkinson said.
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A healing crisis?
A crisis of collective stupidity, I’d say!
The ‘Healy’ has featured on this blog before and is thus known to my regulars: The ‘Healy’: deep cellular healing with quantum bollocks. Now the ‘Healy’ has won an award … albeit a negative one: the Austrian Skeptiks necative prize ‘GOLDENES BRETT VORM KOPF’ (Golden Plank before the Head)
Other nomineed for the award were:
- The broadcaster AUF1 TV, which has been categorised as right-wing extremist.
- The Austrian Veterinary Association known to support homeopathy for animals.
At yesterday’s gala in the Vienna City Hall, it was announced that the ‘Healy’ is the proud winner.
A total of 160 nominations were received by the Vienna Sceptics (Gesellschaft für kritisches Denken, GkD), which awards the prize on behalf of the Gesellschaft zur Wissenschaftlichen Untersuchung von Parawissenschaften (GWUP). On the basis of all these nominations, a ‘shortlist’ of three was subsequently agreed upon by the jury.
The organisers explained in their press release that the ‘Healy’ is advertised as a medical device for the treatment of pain, including chronic pain and migraines, as well as for the supportive treatment of mental illnesses such as depression and anxiety with a lot of pseudo-scientific phraseology.
A ‘quantum sensor’ allegedly measures the ideal ‘frequency’ of the user and causes a ‘bioenergetic field harmonisation’. However, the ‘quantum sensor’ turns out to be nothing more than a simple infrared diode, available for 20 cents. By contrast, consumers are asked to pay up to 4,500 Euros for the ‘Healy’!
Several research platforms, medical information portals and consumer centres have come to damning conclusions about the device. There is talk of ‘bioresonance scams’, ‘dubious frequency therapy’ for which there is a lack of scientific evidence and an ‘esoteric scam’. In addition to the considerable commercial interest and widespread use, the jury said that the manufacturer’s way of dealing with critics was also decisive for the win.
Having recently favoured the Austrian Veterinary Association (AVA) to win the award, I am in two minds. On the one hand, I am disappointed that the AVA did not make it. On the other hand, having reported about the ‘Healy’s extraordinary quantum bollocks some time ago, I am delighted that a worthy winner has been found and crowned.
This update of a systematic review evaluated the effectiveness of spinal manipulations as a treatment for migraine headaches.
Amed, Embase, MEDLINE, CINAHL, Mantis, Index to Chiropractic Literature, and Cochrane Central were searched from inception to September 2023. Randomized clinical trials (RCTs) investigating spinal manipulations (performed by various healthcare professionals including physiotherapists, osteopaths, and chiropractors) for treating migraine headaches in human subjects were considered. Other types of manipulative therapy, i.e., cranial, visceral, and soft tissue were excluded. The Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach was used to evaluate the certainty of evidence.
Three more RCTs were published since our first review; amounting to a total of 6 studies with 645 migraineurs meeting the inclusion criteria. Meta-analysis of six trials showed that, compared with various controls (placebo, drug therapy, usual care), SMT (with or without usual care) has no superior effect on migraine intensity/severity measured with a range of instruments (standardized mean difference [SMD] − 0.22, 95% confidence intervals [CI] − 0.65 to 0.21, very low certainty evidence), migraine duration (SMD − 0.10; 95% CI − 0.33 to 0.12, 4 trials, low certainty evidence), or emotional quality of life (SMD − 14.47; 95% CI − 31.59 to 2.66, 2 trials, low certainty evidence) at post-intervention. A meta-analysis of two trials showed that compared with various controls, SMT (with or without usual care) increased the risk of adverse effects (risk ratio [RR] 2.06; 95% CI 1.24 to 3.41, numbers needed to harm = 6; very low certainty evidence). The main reasons for downgrading the evidence were study limitations (studies judged to be at an unclear or high risk of bias), inconsistency (for pain intensity/severity), imprecision (small sizes and wide confidence intervals around effect estimates) and indirectness (methodological and clinical heterogeneity of populations, interventions, and comparators).
We cocluded that the effectiveness of SMT for the treatment of migraines remains unproven. Future, larger, more rigorous, and independently conducted studies might reduce the existing uncertainties.
The only people who might be surprised by these conclusions are chiropractors who continue to advertise and use SMT to treat migraines. Here are a few texts by chiropractors (many including impressive imagery) that I copied from ‘X’ just now (within less that 5 minutes) to back up this last statement:
- So many people are suffering with Dizziness and migraines and do not know what to do. Upper Cervical Care is excellent at realigning the upper neck to restore proper blood flow and nerve function to get you feeling better!
- Headache & Migraine Relief! Occipital Lift Chiropractic Adjustment
- Are migraines affecting your quality of life? Discover effective chiropractic migraine relief at…
- Neck Pain, Migraine & Headache Relief Chiropractic Cracks
- Migraine Miracle: Watch How Chiropractic Magic Erases Shoulder Pain! Y-Strap Adjustments Unveiled
- Tired of letting migraines control your life? By addressing underlying issues and promoting spinal health, chiropractors can help reduce the frequency and severity of migraines. Ready to experience the benefits of chiropractic for migraine relief?
- Did you know these conditions can be treated by a chiropractor? Subluxation, Back Pain, Chronic Pain, Herniated Disc, Migraine Headaches, Neck Pain, Sciatica, and Sports Injuries.
- When a migraine comes on, there is not much you can do to stop it except wait it out. However, here are some holistic and non-invasive tips and tricks to prevent onset. Check out that last one! In addition to the other tips, chiropractic care may prevent migraines in your future!
Evidence-based chiropractic?
MY FOOT!
If you live in the UK, you could not possibly escape the discussion about the ‘Assisted Dying Bill’ which passed yesterday’s vote in the House of Commons (MPs have voted by 330 to 275 in favour of legalising voluntary assisted suicide). Once the bill passed all the further parliamentary hurdles – which might take several years – it will allow terminally ill adults who are
- expected to die within six months,
- of sound mind and capable of managing their own affairs
to seek help from specialised doctors to end their own life.
After listening to many debates about the bill, I still I have serious concerns about it. Here are just a few:
- Palliative care in the UK is often very poor. It was argued that the bill will be an incentive to improve it. But what, if this is wishful thinking? What if palliative care deteriorates to a point where it becomes an incentive to suicide? What if the bill should even turn out to be a reason for not directing maximum efforts towards improving palliative care?
- How sure can we be that an individual patient is going to die within the next six months? Lawmakers might believe that predicting the time someone has left to live is a more or less exact science. Doctors (should) know that it is not.
- How certain can we be that a patient is of sound mind and capable of managing their own affairs? By definition, we are dealing with very ill patients whose mind might be clouded, for example, by the effects of drugs or pain or both. Lawmakers might think that it is clear-cut to establish whether an individual patient is compos mentis, but doctors know that this is often not the case.
- In many religions, suicide is a sin. I am not a religious person, but many of the MPs who voted for the bill are or pretend to be. Passing a law that enables members of the public to commit what in the eyes of many lawmakers must be a deadly sin seems problematic.
In summary, I feel the ‘Assisted Dying Bill’ is a mistake for today; it might even be a very grave mistake for a future time, if we have a government that is irresponsible, neglects palliative care even more than we do today and views the bill as an opportunity to reduce our expenditure on pensions.
Dry needling (DN) is a treatment used by various healthcare practitioners, including physical therapists, physicians, and chiropractors. It involves the use of either solid filiform needles or hollow-core hypodermic needles for therapy of muscle pain, including pain related to myofascial pain syndrome. DN is mainly used to treat myofascial trigger points, but it is also used to target connective tissue, neural ailments, and muscular ailments. There is conflicting evidence regarding the effectiveness of DN for any condition.
Orofacial pain (OFP) typically has a musculoskeletal, dental, neural, or sinogenic origin. Our systematic review was aimed at evaluating the evidence base for the effectiveness of DN for OFP.
We searched Medline, Cochrane Central, and Web of Science (from their respective inceptions to February 2024) for RCTs evaluating the effectiveness of DN in patients with OFP. Studies with patients suffering from cervicogenic or tension type headaches as well as observational studies were excluded. Primary outcomes were pain intensity and severity; secondary outcomes were disability, quality of life, and adverse effects (AEs). The review adhered to the methods described by in the Cochrane Handbook.
Twenty-four RCTs with a total of 1,318 patients suffering from OFP could be included. Most had an unclear or high risk of bias, and the quality of the evidence ranged from very low to low for all comparisons and outcomes. A meta-analysis suggested that, compared with usual care alone, DN + usual care had no effect on pain intensity (visual analogue scale) (standardized mean difference = −1.89, 95% confidence intervals −5.81 to 2.02, very low certainty evidence) at follow-ups of up to 6 weeks. Only 6 RCTs (25%) mentioned AEs, and none of them reported that AEs had occurred. The remaining 18 (75%) studies failed to report AEs.
We concluded that DN cannot be considered as an effective treatment option for OFP. This is due to the uncertainties of the available evidence. We believe that larger, rigorous, and better reported trials with more homogeneous comparators might potentially reduce the current uncertainties. Such trials should strictly adhere to the classifications provided by the International Headache Society and published in the International Classification of Orofacial Pain.
Yet again, I need to stress that the vast majority od RCTs failed to mention AEs. When will the last (pseudo-) researcher have learnt that the non-reporting of AEs is a violation of research ethics?
It has been reported that the Dresden Higher Regional Court (OLG) examined the extent to which a doctor must inform his patient, if he/she uses so-called alternative medine (SCAM) that deviates from conventional medicine. To be precise, the case was about a detoxification therapy with so-called chelating agents. A patient had received ‘holistic treatment’ for symptoms of exhaustion with sleep disorders, headaches, concentration problems and general restlessness and became worse and worse during the course of the therapy. Eventually, he sued for compensation for pain and suffering and damages.
Initially, the patient had been treated conservatively with iron supplements. After carrying out ‘provocation test’, the doctor diagnosed a heavy metal load, which he treated with ‘elimination therapy’ in the form of an i.v. “detox therapy” (2-3-dimercaptopropane-1-sulfonate (DMPS)). The patient subsequently became increasingly unwell, leading to hospitalisation and treatment for severe thrombocytopenia with moderate liver damage.
The expert opinion obtained in the first-instance of the ensuing legal proceedings considered the cause of the patient’s complaints to be the administration of an inadmissibly excessive amount of alpha-lipoic acid during ‘detoxification therapy’. It became clear that the doctor had not properly informed the patient about this therapy and its risks.
The court considered that the basic information required under German law had not been provided. This basic information gives the patient a general idea of the severity of the procedure and the impact of the associated burdens on their lifestyle. The obligation to provide information also applies to practitioners who use SCAM. A doctor who offers SCAM must therefore clearly inform the patient that they are deviating from a conventional approach. He/she must also explain why he/she is doing this and what advantages and disadvantages the patient can expect as a result.
Detoxification therapy is indisputably such a SCAM, the costs of which are not covered by the health insurance companies. The patient must therefore not only be informed of the risks and the danger of failure of the procedure, but must also be informed that the planned therapy is not standard medical practice and that the effectiveness of the therapy is unproven.
The patient must be able to weigh up whether they want to take the risks of treatment with regard to the prospects of success in view of their state of health before the procedure. Such information was not provided in the present case. For this reason, the Regional Court awarded damages for pain and suffering amounting to EUR 15,000 for the damage to health suffered.
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On this blog, we have often discussed the problems of informed consent. Informed consent, I have previously stated, must usually include full information on:
- the diagnosis
- its natural history
- the most effective treatment options available
- the proposed therapy
- its effectiveness
- its risks
- its cost
- a rough treatment plan
Only when this information has been transmitted to and understood by the patient can informed consent be considered complete. I do understand why many SCAM practitioners do not like informed consent – it could stop many from practising: they are frequently unable to provide the required information. Yet, ALL clinicians have a moral, ethical and legal duty to obtain informed consent BEFORE starting a therapy. It is reassuring that the German court agrees.
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!!!
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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!!!
