evidence
Postoperative gastrointestinal dysfunction (PGD) is one of the most common complications among patients who have undergone thoracic surgery. Acupuncture has long been used in traditional Chinese medicine to treat gastrointestinal diseases and has shown benefit as an alternative therapy for the management of digestive ailments. This study aimed to explore the therapeutic effectiveness of acupuncture as a means to aid postoperative recovery of gastrointestinal function in patients undergoing thoracoscopic surgery.
In total, 112 patients aged 18-70 years undergoing thoracoscopic surgery between 15 June 2022 and 30 August 2022 were randomized into two groups.
- Patients in the acupuncture group (AG) first received acupuncture treatment 4 h after surgery, and treatment was repeated at 24 and 48 h.
- Patients in the control group (CG) did not receive any acupuncture treatment.
Both groups received the same anesthetic protocol. Ultrasound-guided thoracic paravertebral block (TPVB) was performed in the paravertebral spaces between T4 and T5 with administration of 20 mL of 0.33% ropivacaine. All patients received patient-controlled intravenous analgesia (PCIA) after surgery.
Median time to first flatus [interquartile range] in the AG was significantly less than in the CG (23.25 [18.13, 29.75] vs 30.75 [24.13, 45.38] h, p < 0.001). Time to first fluid intake after surgery was significantly less in the AG, as compared with the CG (4 [3, 7] vs 6.5 [4.13, 10.75] h, p = 0.003). Static pain, measured by visual analog scale (VAS) score, was significantly different on the third day after surgery (p = 0.018). Dynamic pain VAS scores were lower in the AG versus CG on the first three postoperative days (p = 0.014, 0.003 and 0.041, respectively).
The authors concluded that addition of acupuncture appeared to improve recovery of postoperative gastrointestinal function and alleviate posteoperative pain in patients undergoing thoracoscopic surgery. Acupuncture may represent a feasible strategy for the prevention of PGD occurrence.
Yes, I agree, acupuncture appeared to have an effect.
But did it?
I doubt it!
- It could have been the expectation of an acupuncture benefit – the placeno effect – that did the trick.
- It could have been the extra attention of the acupuncturist.
- It could have been the gentle persuasion of the acupuncturist.
- It could have been all manner of influences.
We will never know!
And because we cannot know, we should design studies better such that
- they lead to a conclusive result,
- they are not a waste of precious resources,
- they cannot mislead us into thinking that acupuncture is more than a theatrical placebo.
Whenever a journalist wants to discuss the subject of acupuncture with me, he or she will inevitably ask one question:
DOES ACUPUNCTURE WORK?
It seems a legitimate, obvious and simple question, particularly during ‘Acupuncture Awareness Week‘, and I have heard it hundreds of times. Why then do I hesitate to answer it?
Journalists – like most of us – would like a straight answer, like YES or NO. But straight answers are in short supply, particularly when we are talking about acupuncture.
Let me explain.
Acupuncture is part of ‘Traditional Chinese Medicine’ (TCM). It is said to re-balance the life forces that determine our health. As such it is seen as a panacea, a treatment for all ills. Therefore, the question, does it work?, ought to be more specific: does it work for pain, obesity, fatigue, hair-loss, addiction, anxiety, ADHA, depression, asthma, old age, etc.etc. As we are dealing with virtually thousands of ills, the question, does it work?, quickly explodes into thousands of more specific questions.
But that’s not all!
The question, does acupuncture work?, assumes that we are talking about one therapy. Yet, there are dozens of different acupuncture traditions and sites:
- body acupuncture,
- ear acupuncture,
- tongue acupuncture,
- scalp acupuncture,
- etc., etc.
Then there are dozens of different ways to stimulate acupuncture points:
- needle acupuncture,
- electroacupuncture,
- acupressure,
- moxibustion,
- ultrasound acupuncture,
- laser acupuncture,
- etc., etc.
And then there are, of course, different acupuncture ‘philosophies’ or cultures:
- TCM,
- ‘Western’ acupuncture,
- Korean acupuncture,
- Japanese acupuncture,
- etc., etc.
If we multiply these different options, we surely arrive at thousands of different variations of acupuncture being used for thousands of different conditions.
But this is still not all!
To answer the question, does it work?, we today have easily around 10 000 clinical trials. One might therefore think that, despite the mentioned complexity, we might find several conclusive answers for the more specific questions. But there are very significant obstacles that are in our way:
- most acupuncture trials are of lousy quality;
- most were conducted by lousy researchers who merely aim at showing that acupuncture works rather that testing whether it is effective;
- most originate from China and are published in Chinese which means that most of us cannot access them;
- they get nevertheless included in many of the systematic reviews that are currently being published without non-Chinese speakers ever being able to scrutinise them;
- TCM is a hugely important export article for China which means that political influence is abundant;
- several investigators have noted that virtually 100% of Chinese acupuncture trials report positive results regardless of the condition that is being targeted;
- it has been reported that about 80% of studies emerging from China are fabricated.
Now, I think you understand why I hesitate every time a journalist asks me:
DOES ACUPUNCTURE WORK?
Most journalists do not have the patience to listen to all the complexity this question evokes. Many do not have the intellectual capacity to comprehend an exhaustive reply. But all want to hear a simple and conclusive answer.
So, what do I say in this situation?
Usually, I respond that the answer would depend on who one asks. An acupuncturist is likely to say: YES, OF COURSE, IT DOES! An less biased expert might reply:
IT’S COMPLEX, BUT THE MOST RELIABLE EVIDENCE IS FAR FROM CONVINCING.
The aim of this study was to establish an international consensus regarding the use of spinal manipulation and mobilisation among infants, children, and adolescents among expert international physiotherapists. Twenty-six international expert physiotherapists in manual therapy and paediatrics voluntarily participated in a 3-Round Delphi survey to reach a consensus via direct electronic mail solicitation using Qualtrics®. Consensus was defined a-priori as ≥75% agreement on all items with the same ranking of agreement or disagreement. Round 1 identified impairments and conditions where spinal mobilisation and manipulation might be utilised. In Rounds 2 and 3, panelists agreed or disagreed using a 4-point Likert scale.
Eleven physiotherapists from seven countries representing five continents completed all three Delphi rounds. Consensus regarding spinal mobilisation or manipulation included:
● Manipulation is not recommended: (1) for infants across all conditions, impairments, and
spinal levels; and (2) for children and adolescents across most conditions and spinal levels.
● Manipulation may be recommended for adolescents to treat spinal region-specific joint
hypomobility (thoracic, lumbar), and pain (thoracic).
● Mobilisation may be recommended for children and adolescents with hypomobility, joint
pain, muscle/myofascial pain, or stiffness at all spinal levels.
The authors of this paper concluded that consensus revealed spinal manipulation should not be performed on infants regardless of condition, impairment, or spinal level. Additionally, the panel agreed that manipulation may be recommended only for adolescents to treat joint pain and joint hypomobility (limited to thoracic and/or lumbar levels). Spinal mobilisation may be recommended for joint hypomobility, joint pain, muscle/myofascial pain, and muscle/myofascial stiffness at all spinal levels among children and adolescents.
Various forms of spinal manipulations are the hallmark therapy of chiropractors. Almost 100% of their patients recieve these interventions. So, what will our friends, the chiros, say about the consensus? Might it be this:
- Physiotherapists are not the experts on spinal manipulation.
- Only chiropractors can do them properly.
- And when WE do them, they are very good*!
(* for our income)
This study aims to assess the feasibility of a pragmatic prospective study aiming to report the immediate and delayed (48-hours post-treatment) AEs associated with manual therapies in children aged 5 or younger and to report preliminary data on AEs frequency.
Between July 2021 and March 2022, chiropractors were recruited through purposive sampling and via a dedicated Facebook group for Quebec chiropractors interested in pediatrics. Legal guardians of patients aged 5 or younger were invited to fill out an online information and consent form. AEs were collected using the SafetyNET reporting system, which had been previously translated by the research team. Immediate AEs were collected through a questionnaire filled out by the legal guardian immediately after the treatment, while delayed AEs were collected through a questionnaire sent by email to the legal guardian 48 h after the treatment. Feasibility was assessed qualitatively through feedback from chiropractors and quantitatively through recruitment data.
Overall, a total of 28 chiropractors expressed interest following the Facebook publication, and 5 participated. An additional two chiropractors were enrolled through purposive sampling. In total, 80 legal guardians consented to their child’s participation, and data from 73 children were included for the analysis of AEs. At least one AE was reported in 30% of children (22/73), and AEs were mainly observed immediately following the treatment (16/22). The most common AEs were irritability/crying (11 children) or fatigue/tiredness (11 children). Feasibility analysis demonstrated that regular communication between the research team and clinicians, as well as targeting clinicians who showed great interest in pediatrics, were key factors for successful research.
The authors concluded that their results suggest that it is feasible to conduct a prospective pragmatic study evaluating AEs associated with manual therapies in private practices. Direct communication with the clinicians, a strategic clinicians’ recruitment plan, and the resulting administrative burden should be considered in future studies. A larger study is required to confirm the frequency of AEs reported in the current study.
It is hardly surprising that such a study is ‘feasible’. I could have told the authors that and saved them the trouble of doing the study. What is surprising, in my view, that chiropractors, after ~120 years of existence of the profession, ask whether it is feasible.
I suggest to do the definitive study on a much larger sample, extend the observation period, and recruit a representative rather than self-selected sample of chiros … or – much better – forget about the study and establich a functioning post-marketing surveillance system.
These days, it has become a rare event – I am speaking of me publishing a paper in the peer-reviewed medical literature. But it has just happened: Spanish researchers and I published a meta-analysis on the effectiveness of craniosacral therapy. Here is its abstract:
The aim of this study was to evaluate the clinical effectiveness of craniosacral therapy (CST) in the management of any conditions. Two independent reviewers searched the PubMed, Physiotherapy Evidence Database, Cochrane Library, Web of Science, and Osteopathic Medicine Digital Library databases in August 2023, and extracted data from randomized controlled trials (RCT) evaluating the clinical effectiveness of CST. The PEDro scale and Cochrane Risk of Bias 2 tool were used to assess the potential risk of bias in the included studies. The certainty of the evidence of each outcome variable was determined using GRADEpro. Quantitative synthesis was carried out with RevMan 5.4 software using random effect models.
Fifteen RCTs were included in the qualitative and seven in the quantitative synthesis. For musculoskeletal disorders, the qualitative and quantitative synthesis suggested that CST produces no statistically significant or clinically relevant changes in pain and/or disability/impact in patients with headache disorders, neck pain, low back pain, pelvic girdle pain, or fibromyalgia. For non-musculoskeletal disorders, the qualitative and quantitative synthesis showed that CST was not effective for managing infant colic, preterm infants, cerebral palsy, or visual function deficits.
We concluded that the qualitative and quantitative synthesis of the evidence suggest that CST produces no benefits in any of the musculoskeletal or non-musculoskeletal conditions assessed. Two RCTs suggested statistically significant benefits of CST in children. However, both studies are seriously flawed, and their findings are thus likely to be false positive.
So, CST is not really an effective option for any condition.
Not a big surprise! After all, the assumptions on which CST is based fly in the face of science.
Since CST is nonetheless being used by many healthcare professionals, it is, I feel, important to state and re-state that CST is an implausible intervention that is not supported by clinical evidence. Hopefully then, one day, these practitioners will remember that their ethical obligation is to treat their patients not according to their beliefs but according to the best available evidence. And, hopefully, our modest paper will have helped rendering healthcare a little less irrational and somewhat more effective.
An article about chiropractic caught my attention. Let me show you its final section which, I think, is relevant to what we often discuss on this blog:
If chiropractic treatment is unscientific, then why do I feel better? Because lots of things alleviate pain. Massage, analgesia and heat – but also a provider who listens, empathises and bothers to examine a patient. Then there is the placebo effect. For centuries, doctors have recognised that different interventions with unclear pathways result in clinical improvement. Among the benefits patients attributed to placebo 100 years ago: “I sleep better; my appetite is improved; my breathing is better; I can walk further without pain in my chest; my nerves are steadier.” Nothing has changed. Pain is a universal assignment; no one has a monopoly on its relief.
The chiropractic industry owes its existence to a ghost. Its founder, David Palmer, wrote in his memoir The Chiropractor that the principles of spinal manipulation were passed on to him during a séance by a doctor who had been dead for half a century. Before this, Palmer was a “magnetic healer”.
Today, chiropractors preside over a multibillion-dollar regulated industry that draws patients for various reasons. Some can’t find or afford a doctor, feel dismissed, or worse, mistreated. Others mistrust the medical establishment and big pharma. Still others want natural healing. But none of these reasons justifies conflating a chiropractor with a doctor. The conflation feels especially hazardous in an environment of health illiteracy, where the mere title of doctor confers upon its bearer strong legitimacy.
Chiropractors don’t have the same training as doctors. They cannot issue prescriptions or order advanced imaging. They do not undergo lifelong peer review or open themselves to monthly morbidity audits.
I know that doctors could do with a dose of humility, but I can’t find any evidence (or the need) for the assertion on one website that chiropractors are “academic overachievers”. Or the ambit claim that most health professionals have no idea how complicated the brain is, but chiropractors do.
Forget doctors, patients deserve more respect.
My friend’s back feels better for now. When it flares, I wonder if she will seek my advice – and I am prepared to hear no. Everyone is entitled to see a chiropractor. But no patient should visit a chiropractor thinking that they are seeing a doctor.
______________________
I would put it more bluntly:
- chiropractors are poorly trained; in particular, they do not learn to question their own, often ridiculous beliefs;
- they are poorly regulated; in the UK, the GCC seems to protect the chiros rather than the public;
- chiropractors regularly disregard essential rules of medical ethics, e.g. informed consent;
- many try to mislead us by pretending they are physicians;
- their hallmark intervention, spinal manipulation, can cause considerable harm;
- it generates hardly any demonstrable benefit for any condition;
- chiropractors also cause considerable harm, e.g. by interfering with real medicine, e.g. vaccinations;
- thus, in general, chiropractors do more harm than good;
- yes, everyone is entitled to see a chiropractor, but before they do, reliable information should be mandatory.
A recent article about ayurvedic medicine caught my eye. Here are a few excerpts:
Imagine if there were a magic pill to ward off COVID-19. Or if you could cure diabetes with vegetable juices and herbal pills instead of controlling it with insulin medication. Or if yoga and breathing exercises were all you need to do to get rid of asthma. These are all claims made by Patanjali Ayurved, one of India’s biggest manufacturers of traditional ayurvedic products…
Many scientists have expressed concerns over the lack of research into the safety and efficacy of ayurvedic products… Nonetheless, Ayurveda enjoys widespread acceptance among Indians. And under India’s Hindu-nationalist government that took power in 2014, ayurveda and other alternative systems of medicine have received unprecedented government support. India’s ministry of alternative medicine gets nearly $500 million a year. The government also promotes ayurveda through its international trade and diplomatic channels. All this set Patanjali’s fortunes soaring.
But now the Supreme Court of India has temporarily banned Patanjali – named after a Hindu mystic best known for his writings on yoga – from advertising some of its products… “The entire country has been taken for a ride,” Ahsanuddin Amanullah, one of the two judges conducting the court hearing, told the lawyer representing the government… The Indian Medical Association had brought the case to court in August 2022, claiming that Patanjali and its brand ambassador Baba Ramdev made a series of false claims against evidence-backed modern medicine and its practitioners, and spread misinformation about COVID-19 vaccines. Their petition also referred to instances where Ramdev lambasted modern medicine as a “stupid and bankrupt science” at a yoga session. The trigger was a series of Patanjali advertisements in Indian newspapers in July 2022 claiming that ayurvedic products could cure chronic conditions like diabetes, high blood pressure, heart diseases and autoimmune conditions. The Indian Medical Association’s petition alleged that such claims were in violation of India’s Drugs and Magic Remedies (Objectionable Advertisements) Act.
…The company’s public face – yoga guru Baba Ramdev – is a vocal supporter of India’s ruling party, the BJP, and Prime Minister Narendra Modi. Modi even inaugurated Patanjali’s ayurvedic research facility in 2017… Some scientists have accused their government of promoting these alternative medicines at the expense of modern medicine, partly as a way to glorify India’s culture and history. “One of the political ideas of this government is to glorify the Hindu tradition,” says Dhrubajyoti Mukherjee, president of the Breakthrough Science Society, an organization that promotes scientific thinking. “But in the name of our glorious past, the government is propagating obscure, unscientific ideas.”
… A few months after the outbreak of the COVID-19 pandemic in 2020, India’s health minister at the time, Harsh Vardhan participated in the company’s launch of pills, where Ramdev, the yoga guru, claimed the pills showed “100 percent favorable results” during clinical trials on patients. Despite experts flagging the lack of evidence, the company said it sold 2.5 million kits in six months, consisting of the tablets to ward off COVID-19 and bottled oils that would allegedly boost immunity. And the company is making an enormous amount of money: Its income was over $1.3 billion in the financial year 2021-22, with profits of $74 million before taxes.
Addressing the overall impact of misinformation about ayurvedic treatments, Dr. Jayesh Lele, vice president of the Indian Medical Association, says “Our worry is people are being misguided. We have got people who’ve left our treatment saying their kidneys will be able to function properly [using ayurvedic medicines] and ended up with renal failure. The same happened with patients suffering from hepatitis, who’ve got the wrong medicine and ended up with further problems. And if you say every day that modern medicine is bad, that is not acceptable.”
_______________
The sad thing, in my view, is that (as discussed previously) ayurvedic medicine has not just taken India for a ride:
- King Charles’ “Ayurvedic Centre of Excellence” turns out to be an embarrassing failure
- Dr Michael Dixon seems to support homeopathy as a treatment for cancer
- PRINCE CHARLES: the ‘immense value’ of alternative diagnostic methods
- Will the UK ‘ROYAL COLLEGE OF GENERAL PRACTITIONERS’ soon become a ‘ROYAL COLLEGE OF QUACKERY’?
And perhaps even more disappointing is the notion that, while in India they take action in order to prevent harm, I can see no such developments in the UK.
The origin of coronavirus 2 (SARS-CoV-2) has been the subject of intense speculation and several conspiracy theories, not least amongst the enthusiasts of so-called alternative medicine. Now Australian scientists have attempted to identify the origin of the coronavirus 2 (SARS-CoV-2). As this is undoubtedly a most sensitive subject, let me show you the unadulterated abstract of their paper:
The origin of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is contentious. Most studies have focused on a zoonotic origin, but definitive evidence such as an intermediary animal host is lacking. We used an established risk analysis tool for differentiating natural and unnatural epidemics, the modified Grunow–Finke assessment tool (mGFT) to study the origin of SARS-COV-2. The mGFT scores 11 criteria to provide a likelihood of natural or unnatural origin. Using published literature and publicly available sources of information, we applied the mGFT to the origin of SARS-CoV-2. The mGFT scored 41/60 points (68%), with high inter-rater reliability (100%), indicating a greater likelihood of an unnatural than natural origin of SARS-CoV-2. This risk assessment cannot prove the origin of SARS-CoV-2 but shows that the possibility of a laboratory origin cannot be easily dismissed.
The somewhat clumsy wording harbours explosive potential. It is more likely that the pandemic was started by a laboratory accident than by a zoonosis. In this case, it would be man-made rather than natural. The authors of the paper do, however, caution that their analysis does not prove the origin of the coronavirus. They merely speak of likelihoods. Moreover, it seems important to stress that there is no scientific evidence that Sars-CoV-2 was deliberately developed as a biological warfare agent.
Will this paper put an end to speculation and conspiracy?
I doubt it!
Looking at some ancient papers of mine, I came across a short BMJ paper from 1994. Here is a passage from it:
… A standard letter (on departmental letterhead) was written (in German) to all 189 firms that we identified as marketing herbal drugs in Germany. It asked (among other questions) for reprints of articles reporting controlled clinical trials on the company’s product(s).
Only 19 replies had reached us six weeks later. Four of these included at least one reprint. Twelve respondents regretted not knowing of clinical trials on their drug(s). In three cases we had written to a wrong address (one
instance) or to a firm which did not market phytomedicines (two instances).
These data, though far from conclusive, do not give the impression that research is in proportion to either prevalence or financial tumover of herbal remedies…
I wonder what the results would be, if we repeated this little excercise today, 30 years afteer the original investigation. I fear that the findings would be much the same or perhaps even worse. I also suspect that they would be similar regardless of the country we chose. Those who sell herbal remedies have very little incentive to do expensive clinical trials to test whether the products they earn their money with actually work. They may be doing well without it and ask themselves, why spend money on research that might not show what we hope and could easily turn out to jeopardize our financial success?
But the problem is by no means confined to herbal manufacturers (who would arguably have an important share to initiate and sponsor research). Even though fundamental questions remain unanswered, research into herbal medicine is scarce across the board.
To see whether this statement is true, I did a very quick Medline search. It showed that, in 2023, just over 13 000 papers on herbal medicine emerged. Of those, just 460 were listed as clinical trials. The latter figure is almost certainly considerably smaller than the true amount because Medline is over-generous in classifying papers as clinical trials. I thus estimate that only around 200 clinical trials of herbal medicine are conducted each year. Considering that we are dealing with thousands of herbs and ten thousands of herbal products, this figure is an embarrassment for the sector – which, as we have seen just days ago, is doing extremely well in finacial terms.
Dry needling is a therapy that is akin to acupuncture and trigger point therapy. It is claimed to be safe – but is this true?
Researchers from Ghent presented a series of 4 women aged 28 to 35 who were seen at the emergency department (ED) with post-dry needling pneumothorax between September 2022 and December 2023. None of the patients had any relevant medical history. All had been treated for a painful left shoulder, trapezius muscle or neck region in outpatient physiotherapist practices. At least three different physiotherapists were involved.
One patient presented to the ER on the same day as the dry needling procedure, the others presented the day after. All mentioned thoracic pain and dyspnoea. Clinical examination in all of these patients was unremarkable, as were their vital signs. Diagnosis was confirmed with ultrasound (US) and chest X-ray (CXR) in all patients. The latter exam showed left-sided apical pleural detachment with a median of 3.65 cm in expiration.
Two patients were managed conservatively. One patient (initial pneumothorax 2.5 cm) was discharged. The US two days later displayed a normally expanded lung. One patient with an initial apical size of 2.8 cm was admitted with 2 litres of oxygen through a nasal canula and discharged from the hospital the next day after US had shown no increase in size. Her control CXR 4 days later showed only minimal pleural detachment measuring 6 mm. The two other patients were treated with US guided needle aspiration. One patient with detachment initially being 4.5 cm showed decreased size of the pneumothorax immediately after aspiration. She was admitted to the respiratory medicine ward and discharged the next day. Control US and CXR after 1 week showed no more signs of pneumothorax. In the other patient, with detachment initially being 5.5 cm, needle aspiration resulted in complete deployment on US immediately after the procedure, but control CXR showed a totally collapsed lung 3 hours later. A small bore chest drain was placed but persistent air leakage was seen. Several trials of clamping the drain resulted in recurrent collapsing of the lung. After CT-scan had shown no structural deformities of the lung, suction was gradually reduced and the drain was successfully removed on the sixth day after placement. The patient was then discharged home. Control CXR 3 weeks later was normal.
The authors concluded that post-dry needling pneumothorax is, contrary to numbers cited in literature, not extremely rare. With rising popularity of the technique we expect complications to occur more often. Patients and referring doctors should be aware of this. In their informed consent practitioners should mention pneumothorax as a considerable risk of dry needling procedures in the neck, shoulder or chest region.
The crucial question, in my view, is this: do the risks of dry-needling out weigh the risks of this form of therapy? Let’s have a look at some of the recent evidence that we discussed on this blog:
- Spinal Manipulation and Electrical Dry Needling for Subacromial Pain Syndrome: A Nonsensical Trial
- Dry needling is useless for rehabilitation after shoulder surgery
- High velocity, low amplitude techniques are not superior to no treatment in the management of tension-type headache
- Which treatments are best for acute and subacute mechanical non-specific low back pain? A systematic review with network meta-analysis
- Acupuncture for chronic pain: the new NICE guideline
- Acupuncture for the Relief of Chronic Pain? A new, thorough synthesis fails to produce strong evidence that acupuncture works
The evidence is clearly mixed and unconvincing. I am not sure whether it is strong enough to afford a positive risk/benefit balance. In other words: dry needling is a therapy that might best be avoided.
