MD, PhD, MAE, FMedSci, FRSB, FRCP, FRCPEd.

acupuncture

Motor aphasia is common among patients with stroke. Acupuncture is recommended by TCM enthusiasts as a so-called alternative medicine (SCAM) for poststroke aphasia, but its efficacy remains uncertain.

JAMA just published a study that investigated the effects of acupuncture on language function, neurological function, and quality of life in patients with poststroke motor aphasia.
The study was designed as a multicenter, sham-controlled, randomized clinical trial. It was conducted in 3 tertiary hospitals in China from October 21, 2019, to November 13, 2021. Adult patients with poststroke motor aphasia were enrolled. Data analysis was performed from February to April 2023.

Eligible participants were randomly allocated (1:1) to manual acupuncture (MA) or sham acupuncture (SA) groups. Both groups underwent language training and conventional treatments.
The primary outcomes were the aphasia quotient (AQ) of the Western Aphasia Battery (WAB) and scores on the Chinese Functional Communication Profile (CFCP) at 6 weeks. Secondary outcomes included WAB subitems, Boston Diagnostic Aphasia Examination, National Institutes of Health Stroke Scale, Stroke-Specific Quality of Life Scale, Stroke and Aphasia Quality of Life Scale–39, and Health Scale of Traditional Chinese Medicine scores at 6 weeks and 6 months after onset. All statistical analyses were performed according to the intention-to-treat principle.

Among 252 randomized patients (198 men [78.6%]; mean [SD] age, 60.7 [7.5] years), 231 were included in the modified intention-to-treat analysis (115 in the MA group and 116 in the SA group). Compared with the SA group, the MA group had significant increases in AQ (difference, 7.99 points; 95% CI, 3.42-12.55 points; P = .001) and CFCP (difference, 23.51 points; 95% CI, 11.10-35.93 points; P < .001) scores at week 6 and showed significant improvements in AQ (difference, 10.34; 95% CI, 5.75-14.93; P < .001) and CFCP (difference, 27.43; 95% CI, 14.75-40.10; P < .001) scores at the end of follow-up.

The authors concluded that in this randomized clinical trial, patients with poststroke motor
aphasia who received 6 weeks of MA compared with those who received SA demonstrated
statistically significant improvements in language function, quality of life, and neurological
impairment from week 6 of treatment to the end of follow-up at 6 months after onset.

I was asked by the SCIENCE MEDIC CENTRE to provide a short comment. This is what I stated:

Superficially, this looks like a rigorous trial. We should remember, however, that several groups, including mine, have shown that very nearly all Chinese acupuncture studies report positive results. This suggests that the reliability of these trials is less than encouraging. Moreover, the authors state that real acupuncture induced ‘de chi’, while sham acupuncture did not. This shows that the patients were not blinded and the outcomes might easily be due to a placebo response.

Here, I’d like to add two further points:

The aim of this study was to investigate whether there is a difference in outcome between participants with high compared to low pain self-efficacy (PSE) receiving manual therapy, acupuncture, and electrotherapy.

Participants were stratified into high or low baseline (i) PSE, (ii) shoulder pain and disability index (SPADI), and (iii) did or did not receive the treatment. Whether the effect of treatment differs for people with high compared to low PSE was assessed using the 95% confidence interval of the difference of difference (DoD) at a 5% significance level (p < 0.05).

Treatment was labelled using 3 categories, 2 of which were subcategories of the first

  • “Any passive treatment” – any form of manual therapy and/or acupuncture and/or electrotherapy.
  • “Any manual therapy” – shoulder or spine joint mobilisations, deep transverse frictions, capsular stretches, trigger point therapy, muscle facilitation, or other techniques listed by the treating physiotherapist.
  • “Spinal/shoulder joint mobilisation” – for example, Maitland, Kaltenborn or Mulligan techniques.

To be categorised, treatment must have been delivered by the physiotherapist at least once and may have been delivered in conjunction with other treatments.

Six-month SPADI scores were consistently lower (less pain and disability) for those who did not receive passive treatments compared to those who did (statistically significant less pain and disability in 7 of 24 models). However, DoD was statistically insignificant.

The authors concluded that PSE did not moderate the relationship between treatment and outcome. However, participants who received passive treatment experienced equal or more pain and disability at 6 months compared to those who did not. Results are subject to confounding by indication but do indicate the need for further appropriately designed research.

This analysis suggests that manual therapy, electrotherapy, or acupuncture in addition to advice and exercise offered no improvement in pain or disability at six months, irrespective of PSE. Some patients who receive these treatments experienced more pain and disability at six months compared to those who do not.

I am not aware of compelling evidence that either of these treatments, all of which are often recommended, are effective for shoulder pain, and the results of this new study certainly do not suggest they are. However, as the design of the study was not primarily for this research question, these findings are, of course, merely tentative and need to be investigated further.

Diabetic peripheral neuropathy (DPN) is a common complication of diabetes mellitus and can lead to serious complications. Therapeutic strategies for pain control are available but there are few approaches that influence neurological deficits such as numbness.

This study investigated the effectiveness of acupuncture on improving neurological deficits in patients suffering from type 2 DPN.

The acupuncture in DPN (ACUDPN) study was a two-armed, randomized, controlled, parallel group, open, multicenter clinical trial. Patients were randomized in a 1:1 ratio into two groups: The acupuncture group received 12 acupuncture treatments over 8 wk, and the control group was on a waiting list during the first 16 wk, before it received the same treatment as the other group. Both groups received routine care.

Outcome parameters were evaluated after 8, 16 and 24 wk. They included:

  • neurological scores, such as an 11-point numeric rating scale (NRS) for hypesthesia,
  • neuropathic pain symptom inventory (NPSI),
  • neuropathy deficit score (NDS),
  • neuropathy symptom score (NSS);
  • nerve conduction studies (NCS) as assessed with a handheld point-of-care device.

Sixty-two participants were included. The NRS for numbness showed a difference of 2.3 (P < 0.001) in favor of the acupuncture group, the effect persisted until week 16 with a difference of 2.2 (P < 0.001) between groups and 1.8 points at week 24 compared to baseline. The NPSI was improved in the acupuncture group by 12.6 points (P < 0.001) at week 8, the NSS score at week 8 with a difference of 1.3 (P < 0.001); the NDS and the TNSc score improved for the acupuncture group in week 8, with a difference of 2.0 points (P < 0.001) compared to the control group. Effects were persistent in week 16 with a difference of 1.8 points (P < 0.05). The NCS showed no meaningful changes. In both groups only minor side effects were reported.

The authors concluded that acupuncture may be beneficial in type 2 diabetic DPN and seems to lead to a reduction in neurological deficits. No serious adverse events were recorded and the adherence to treatment was high. Confirmatory randomized sham-controlled clinical studies with adequate patient numbers are needed to confirm the results.

That “acupuncture may be beneficial” has been known before and presumably was the starting point of the present study. So, why conduct an open, under-powered trial with non-blind assessors and without defining a primary outcome measure?

Could the motivation be to add yet another false-positive study to the literature of acupuncture?

False-positive, you ask?

Yes, let me explain by having a look at the outcome measures:

  • NRS = a subjective endpoint.
  • NPSI = a subjective endpoint.
  • NDS = a subjective endpoint.
  • NSS = a subjective endpoint.
  • NCS = the only objective endpoint.

And what is remarkable about that?

  • Subjective endpoints are likely to respond to placebo effects.
  • Objective endpoints are not likely to respond to placebo effects.

In other words, what the authors of this study have, in fact, confirmed with their study is this:

acupuncture is a theatrical placebo!

As regulars on this blog know, I am very sceptical about the plethora of nonsensical surveys published in the realm of so-called alternative medicine (SCAM) and thus rarely refer to them here. Today, however, I will make an exception. This international online-survey assessed the demographical data, clinical practice, and sources of information used by SCAM practitioners in Austria, Germany, United States of America, Australia, and New Zealand.

In total, 404 respondents completed the survey, of which 254 (62.9%) treated cancer patients. Most practitioners were acupuncturists and herbalists (57.1%), had (16.8 ± 9.9) years of clinical experience and see a median of 2 (1, 4) cancer patients per week. Breast cancer (61.8%) is the most common cancer type seen in SCAM clinics. Adjunctive SCAM treatments are frequently concurrent with the patient’s cancer specific treatment (39.9%), which is also reflected by the main goal of a SCAM treatment to alleviate side effects (52.4%). However, only 28.0% of the respondents are in contact with the treating oncologist. According to the respondents, pain is most effectively treated using acupuncture, while herbal medicine is best for cancer-related fatigue. SCAM practitioners mostly use certified courses (33.1%) or online databases (28.3%) but often believe that experts are more reliable to inform their practice (37.0%) than research publications (32.7%).

The authors concluded that acupuncturists and herbalists commonly treat cancer patients. Most practitioners use SCAM as an adjunct to biomedicine as supportive care and use it largely in accordance with current oncological guidelines.

You would think that the combined expertise of these institutions are capable of producing a decent survey:

  • Palliative Care Unit, Division of Oncology, Department of Internal Medicine, Medical University of Graz, 8036 Graz, Austria
  • Northern College of Acupuncture, York YO1 6LJ, United Kingdom
  • School of Health and Society, Faculty of Education, Health and Wellbeing, University of Wolverhampton, Wolverhampton WV1 1LY, United Kingdom
  • National Institute of Complementary Medicine Health Research Institute, Western Sydney University, Penrith NSW 2751, Australia
  • Translational Health Research Institute, Western Sydney University, Penrith NSW 2751, Australia
  • Medical Research Institute of New Zealand, Wellington 6021, New Zealand
  • Translational Oncology, University Hospital of Augsburg, 86156 Augsburg, Germany

Well, you would have been mistaken! This surely is one of the worst investigations I have seen for a while. Here are just three reasons why:

  • The researchers designed an anonymous self-completion questionnaire collecting data about the participating practitioners’ demographics and clinical practice of integrative oncology. Someone should tell them that one ought to validate questionnairs before using them and that validated questionnairs exist. Unvalidated questionnairs cannot tell us much of value.
  • The researchers  invited SCAM practitioners in Austria, Germany, USA, Australia, and New Zealand to participate in this study. Invitations were distributed through social media and emails between October 2022 and December 2022 by professional organizations. Someone should tell them that research needs to be reproducible and surveys need to cover a representative population – both criteria that are not met here.
  • The survey participants had to hold a valid license to perform acupuncture, herbal medicine, or both. That excludes all other SCAM practitioners.

Despite these serious flaws, the survey shows two findings that might be worth mentioning:

  • only 28.0% of the SCAM practitioners were in contact with the treating oncologist;
  • SCAM practitioners believe that “experts” are more reliable to inform their practice than research publications.

For me, these two points alone would be sufficient reason to run a mile!

As promised, here is my translation of the article published yesterday in ‘Le Figaro’ arguing in favour of integrating so-called alternative medicine (SCAM) into the French healthcare system [the numbers in square brackets were inserted by me and refer to my comments listed at the bottom].

So-called unconventional healthcare practices (osteopathy, naturopathy, acupuncture, homeopathy and hypnosis, according to the Ministry of Health) are a cause for concern for the health authorities and Miviludes, which in June 2023 set up a committee to support the supervision of unconventional healthcare practices, with the task of informing consumers, patients and professionals about their benefits and risks, both in the community and in hospitals. At the time, various reports, surveys and press articles highlighted the risks associated with NHPs, without pointing to their potential benefits [1] in many indications, provided they are properly supervised. There was panic about the “booming” use of these practices, the “explosion” of aberrations, and the “boost effect” of the pandemic [2].

But what are the real figures? Apart from osteopathy, we lack reliable data in France to confirm a sharp increase in the use of these practices [3]. In Switzerland, where it has been decided to integrate them into university hospitals and to regulate the status of practitioners who are not health professionals, the use of NHPs has increased very slightly [4]. With regard to health-related sectarian aberrations, referrals to Miviludes have been stable since 2017 (around 1,000 per year), but it should be pointed out that they are a poor indicator of the “risk” associated with NHPs (unlike reports). The obvious contrast between the figures and the press reports raises questions [5]. Are we witnessing a drift in communication about the risks of ‘alternative’ therapies? [6] Is this distortion of reality [7] necessary in order to justify altering the informed information and freedom of therapeutic choice of patients, which are ethical and democratic imperatives [8]?

It is the inappropriate use of certain NHPs that constitutes a risk, more than the NHPs themselves! [9] Patients who hope to cure their cancer with acupuncture alone and refuse anti-cancer treatments are clearly using it in a dangerous alternative way [10]. However, acupuncture used to relieve nausea caused by chemotherapy, as a complement to the latter, is recommended by the French Association for Supportive Care [11]. The press is full of the dangers of alternative uses, but they are rare: less than 5% of patients treated for cancer according to a European study [12]. This is still too many. Supervision would reduce this risk even further [13].

Talking about risky use is therefore more relevant than listing “illusory therapies”, vaguely defined as “not scientifically validated” and which are by their very nature “risky” [14]. What’s more, it suggests that conventional treatments are always validated and risk-free [15]. But this is not true! In France, iatrogenic drug use is estimated to cause over 200,000 hospital admissions and 10,000 deaths a year [16]. Yes, some self-medication with phytotherapy or aromatherapy does carry risks… just like any self-medication with conventional medicines [17]. Yes, acupuncture can cause deep organ damage, but these accidents occur in fewer than 5 out of every 100,000 patients [18]. Yes, cervical manipulations by osteopaths can cause serious or even fatal injuries, but these exceptional situations are caused by practitioners who do not comply with the decree governing their practice.[19] Yes, patients can be swindled by charlatans, but there are also therapeutic and financial abuses in conventional medicine, such as those reported in dental and ophthalmology centres. [20]

Are patients really that naive? No. 56% are aware that “natural” remedies can have harmful side-effects, and 70% know that there is a risk of sectarian aberrations or of patients being taken in by a sect [21]. In view of the strong demand from patients, we believe that guaranteeing safe access to certain NHPs is an integral part of their supervision, based on regulation of the training and status of practitioners who are not health professionals, transparent communication, appropriate research, the development of hospital services and outpatient networks of so-called “integrative” medicine combining conventional practices and NHPs, structured care pathways with qualified professionals, precise indications and a safe context for treatment.[22] This pragmatic approach to reducing risky drug use [17] has demonstrated its effectiveness in addictionology [23]. It should inspire decision-makers in the use of NHPs”.

  1. Reports about things going wrong usually do not include benefits. For instance, for a report about rail strikes it would be silly to include a paragraph on the benefits of rail transport. Moreover, it is possible that the benefits were not well documented or even non-existent.
  2. No, there was no panic but some well-deserved criticism and concern.
  3. Would it not be the task of practitioners to provide reliable data of their growth or decline?
  4. The situation in Switzerland is often depicted by enthusiasts as speaking in favour of SCAM; however, the reality is very different.
  5. Even if reports were exaggerated, the fact is that the SCAM community does as good as nothing to prevent abuse.
  6. For decades, these therapies were depicted as gentle and harmless (medicines douces!). As they can cause harm, it is high time that there is a shift in reporting and consumers are informed responsibly.
  7. What seems a ‘distortion of reality’ to enthusiasts might merely be a shift to responsible reporting akin to that in conventional medicine where emerging risks are taken seriously.
  8. Are you saying that informing consumers about risks is not an ethical imperative? I’d argue it is an imperative that outweighs all others.
  9. What if both the inappropriate and the appropriate use involve risks?
  10.  Sadly, there are practitioners who advocate this type of usage.
  11. The recommendation might be outdated; current evidence is far less certain that this treatment might be effective (“the certainty of evidence was generally low or very low“)
  12. The dangers depend on a range of factors, not least the nature of the therapy; in case of spinal manipulation, for instance, about 50% of all patients suffer adverse effects which can be severe, even fatal.
  13. Do you have any evidence showing that supervision would reduce this risk, or is this statement based on wishful thinking?
  14. As my previous comments demonstrate, this statement is erroneous.
  15. No, it does not.
  16. Even if this figure is correct, we need to look at the risk/benefit balance. How many lives were saved by conventional medicine?
  17. Again: please look at the risk/benefit balance.
  18. How can you be confident about these figures in the absence of any post-marketing surveillance system? The answer is, you cannot!
  19. No, they occur even with well-trained practitioners who comply with all the rules and regulations that exist – spoiler: there hardly are any rules and regulations!
  20. Correct! But this is a fallacious argument that has nothing to do with SCAM. Please read up about the ‘tu quoque’ and the strawman’ fallacies.
  21. If true, that is good news. Yet, it is impossible to deny that thousands of websites try to convince the consumer that SCAM is gentle and safe.
  22. Strong demand is not a substitute for reliable evidence. In any case, you stated above that demand is not increasing, didn’t you?
  23. Effectiveness in addictionology? Do you have any evidence for this or is that statement also based on wishful thinking?

My conclusion after analysing this article in detail is that it is poorly argued, based on misunderstandings, errors, and wishful thinking. It cannot possibly convince rational thinkers that SCAM should be integrated into conventional healthcare.

PS

The list of signatories can be found in the original paper.

The purpose of this systematic review was to assess the effectiveness and safety of conservative interventions compared with other interventions, placebo/sham interventions, or no intervention on disability, pain, function, quality of life, and psychological impact in adults with cervical radiculopathy (CR), a painful condition caused by the compression or irritation of the nerves that supply the shoulders, arms and hands.

A multidisciplinary team autors searched MEDLINE, CENTRAL, CINAHL, Embase, and PsycINFO from inception to June 15, 2022 to identify studies that were:

  1. randomized trials,
  2. had at least one conservative treatment arm,
  3. diagnosed participants with CR through confirmatory clinical examination and/or diagnostic tests.

Studies were appraised using the Cochrane Risk of Bias 2 tool and the quality of the evidence was rated using the Grades of Recommendations, Assessment, Development, and Evaluation approach.

Of the 2561 records identified, 59 trials met the inclusion criteria (n = 4108 participants). Due to clinical and statistical heterogeneity, the findings were synthesized narratively.

There is very-low certainty evidence supporting the use of:

  • acupuncture,
  • prednisolone,
  • cervical manipulation,
  • low-level laser therapy

for pain and disability in the immediate to short-term, and

  • thoracic manipulation,
  • low-level laser therapy

for improvements in cervical range of motion in the immediate term.

There is low to very-low certainty evidence for multimodal interventions, providing inconclusive evidence for pain, disability, and range of motion.

There is inconclusive evidence for pain reduction after conservative management compared with surgery, rated as very-low certainty.

The authors concluded that there is a lack of high-quality evidence, limiting our ability to make any meaningful conclusions. As the number of people with CR is expected to increase, there is an urgent need for future research to help address these gaps.

I agree!

Yet, to patients suffering from CR, this is hardly constructive advice. What should they do vis a vis such disappointing evidence?

They might speak to a orthopedic surgeon; but often there is no indication for an operation. What then?

Patients are bound to try some of the conservative options – but which one?

  • Acupuncture?
  • Prednisolone?
  • Cervical manipulation,?
  • Low-level laser therapy?

My advice is this: be patient – the vast majority of cases resolves spontaneously regardless of therapy – and, if you are desperate, try any of them except cervical manipulation which is burdened with the risk of serious complications and often makes things worse.

According to chiropractic belief, vertebral subluxation (VS) is a clinical entity defined as a misalignment of the spine affecting biomechanical and neurological function. The identification and correction of VS is the primary focus of the chiropractic profession. The purpose of this study was to estimate VS prevalence using a sample of individuals presenting for chiropractic care and explore the preventative public health implications of VS through the promotion of overall health and function.

A brief review of the literature was conducted to support an operational definition for VS that incorporated neurologic and kinesiologic exam components. A retrospective, quantitative analysis of a multi-clinic dataset was then performed using this operational definition.

The operational definition used in this study included:

  • (1) inflammation of the C2 (second cervical vertebra) DRG,
  • (2) leg length inequality,
  • (3) tautness of the erector spinae muscles,
  • (4) upper extremity muscle weakness,
  • (5) Fakuda Step test,
  • radiographic analysis based on the (6) frontal atlas cranium line and (7) horizontal atlas cranium line.

Descriptive statistics on patient demographic data included age, gender, and past health history characteristics. In addition to calculating estimates of the overall prevalence of VS, age- and gender-stratified estimates in the different clinics were calculated to allow for potential variations.

A total of 1,851 patient records from seven chiropractic clinics in four states were obtained. The mean age of patients was 43.48 (SD = 16.8, range = 18-91 years). There were more females (n = 927, 64.6%) than males who presented for chiropractic care. Patients reported various reasons for seeking chiropractic care, including, spinal or extremity pain, numbness, or tingling; headaches; ear, nose, and throat-related issues; or visceral issues. Mental health concerns, neurocognitive issues, and concerns about general health were also noted as reasons for care. The overall prevalence of VS was 78.55% (95% CI = 76.68-80.42). Female and male prevalence of VS was 77.17% and 80.15%, respectively; notably, all per-clinic, age, or gender-stratified prevalences were ≥50%.

The authors concluded that the results of this study suggest a high rate of prevalence of VS in a sample of individuals who sought chiropractic care. Concerns about general health and wellness were represented in the sample and suggest chiropractic may serve a primary prevention function in the absence of disease or injury. Further investigation into the epidemiology of VS and its role in health promotion and prevention is recommended.

This is one of the most hilarious pieces of ‘research’ that I have recently encountered. The strategy is siarmingly simple:

  • invent a ficticious pathology (VS) that will earn you plently of money;
  • develop criteria that allow you to diagnose this pathology in the maximum amount of consumers;
  • show gullible consumers that they are afflicted by this pathology;
  • use scare mongering tactics to convince consumers that the pathology needs treating;
  • offer a treatment that, after a series of expensive sessions, will address the pathology;
  • cash in regularly while this goes on;
  • when the consumer has paid enough, declare that your fabulous treatment has done the trick and the consumer is again healthy.

The strategy is well known amongst practitioners of so-called alternative medicine (SCAM), e.g.:

  • Traditional acupuncturists diagnose a ficticious imbalance of yin and yang only to normalise it with numerous acupuncture sessions.
  • Naturopaths diagnose ficticious intoxications and treat it with various detox measures.
  • Iridologists diagnose ficticious abnormalities of the iris that allegedly indicate organ disstress and treat it with whatever SCAM they can offer.

As they say:

No disease can be more surely, effectively, and profitably treated than a condition that the unsuspecting customer did not have in the first place!

 

PS

Sadly, such behavior exists in convertional medicine occasionally too, but SCAM relies almost entirely on it.

NICE helps practitioners and commissioners get the best care to patients, fast, while ensuring value for the taxpayer. Internationally, NICE has a reputation for being reliable and trustworthy. But is that also true for its recommendations regarding the use of acupuncture? NICE currently recommends that patients consider acupuncture as a treatment option for the following conditions:

Confusingly, on a different site, NICE also recommends acupuncture for retinal migraine, a very specific type of migraine that affect normally just one eye with symptoms such as vision loss lasting up to one hour, a blind spot in the vision, headache, blurred vision and seeing flashing lights, zigzag patterns or coloured spots or lines, as well as feeling nauseous or being sick.

I think this perplexing situation merits a look at the evidence. Here I quote the conclusions of recent, good quality, and (where possible) independent reviews:

So, what do we make of this? I think that, on the basis of the evidence:

  • a positive recommendation for all types of chromic pain is not warranted;
  • a positive recommendation for the treatment of TTH is questionable;
  • a positive recommendation for migraine is questionable;
  • a positive recommendation for prostatitis is questionable;
  • a positive recommendation for hiccups is not warranted;
  • a positive recommendation for retinal migraine is not warranted.

But why did NICE issue positive recommendations despite weak or even non-existent evidence?

SEARCH ME!

 

 

.

This review evaluated the magnitude of the placebo response of sham acupuncture in trials of acupuncture for nonspecific LBP, and assessed whether different types of sham acupuncture are associated with different responses. Four databases including PubMed, EMBASE, MEDLINE, and the Cochrane Library were searched through April 15, 2023, and randomized controlled trials (RCTs) were included if they randomized patients with LBP to receive acupuncture or sham acupuncture intervention. The main outcomes included the placebo response in pain intensity, back-specific function and quality of life. Placebo response was defined as the change in these outcome measures from baseline to the end of treatment. Random-effects models were used to synthesize the results, standardized mean differences (SMDs, Hedges’g) were applied to estimate the effect size.

A total of 18 RCTs with 3,321 patients were included. Sham acupuncture showed a noteworthy pooled placebo response in pain intensity in patients with LBP [SMD −1.43, 95% confidence interval (CI) −1.95 to −0.91, I2=89%]. A significant placebo response was also shown in back-specific functional status (SMD −0.49, 95% CI −0.70 to −0.29, I2=73%), but not in quality of life (SMD 0.34, 95% CI −0.20 to 0.88, I2=84%). Trials in which the sham acupuncture penetrated the skin or performed with regular needles had a significantly higher placebo response in pain intensity reduction, but other factors such as the location of sham acupuncture did not have a significant impact on the placebo response.

The authors concluded that sham acupuncture is associated with a large placebo response in pain intensity among patients with LBP. Researchers should also be aware that the types of sham acupuncture applied may potentially impact the evaluation of the efficacy of acupuncture. Nonetheless, considering the nature of placebo response, the effect of other contextual factors cannot be ruled out in this study.

As the authors stated in their conclusion: the effect of other contextual factors cannot be ruled out. I would go much further and say that the outcomes noted here are mostly due to effects other than placebo. Obvious candidates are:

  • regression towards the mean;
  • natural history of the condition;
  • success of patient blinding;
  • social desirability.

To define the placebo effect in acupuncture trials as the change in the outcome measures from baseline to the end of treatment – as the authors of the review do – is not just naive, it is plainly wrong. I would not be surprised, if different sham acupuncture treatments have different effects. To me this would be an expected, plausible finding. But such differences just cannot be estimated in the way the authors suggest. For that, we would need an RCT in which patients are randomized to be treated in the same setting with a range of different types of sham acupuncture. The results of such a study might be revealing but I doubt that many ethics committees would be happy to grant their approval for it.

In the absence of such data, the best we can do is to design trials such that the verum is tested against a credible placebo which, for patients, is indistinguishable from the verum, while demonstrating that blinding is successful.

This case report aims to describe the effects of craniosacral therapy and acupuncture in a patient with chronic migraine.
A 33-year-old man with chronic migraine was treated with 20 sessions of craniosacral therapy and acupuncture for 8 weeks. The number of migraine and headache days were monitored every month. The pain intensity of headache was measured on the visual analog scale (VAS). Korean Headache Impact Test-6 (HIT-6) and Migraine Specific Quality of Life (MSQoL) were also used.
The number of headache days per month reduced from 28 to 7 after 8 weeks of treatment and to 3 after 3 months of treatment. The pain intensity of headache based on VAS reduced from 7.5 to 3 after 8 weeks and further to < 1 after 3 months of treatment. Furthermore, the patient’s HIT-6 and MSQoL scores improved during the treatment period, which was maintained or further improved at the 3 month follow-up. No side effects were observed during or after the treatment.
The authors concluded that this case indicates that craniosacral therapy and acupuncture could be effective treatments for chronic
migraine. Further studies are required to validate the efficacy of craniosacral therapy for chronic migraine.

So, was the treatment period 8 weeks long or was it 3 months?

No, I am not discussing this article merely for making a fairly petty point. The reason I mention it is diffteren. I think it is time to discuss the relevance of case reports.

What is the purpose of a case report in medicine/healthcare. Here is the abstract of an article entitled “The Importance of Writing and Publishing Case Reports During Medical Training“:

Case reports are valuable resources of unusual information that may lead to new research and advances in clinical practice. Many journals and medical databases recognize the time-honored importance of case reports as a valuable source of new ideas and information in clinical medicine. There are published editorials available on the continued importance of open-access case reports in our modern information-flowing world. Writing case reports is an academic duty with an artistic element.

An article in the BMJ is, I think, more informative:

It is common practice in medicine that when we come across an interesting case with an unusual presentation or a surprise twist, we must tell the rest of the medical world. This is how we continue our lifelong learning and aid faster diagnosis and treatment for patients.

It usually falls to the junior to write up the case, so here are a few simple tips to get you started.

First steps

Begin by sitting down with your medical team to discuss the interesting aspects of the case and the learning points to highlight. Ideally, a registrar or middle grade will mentor you and give you guidance. Another junior doctor or medical student may also be keen to be involved. Allocate jobs to split the workload, set a deadline and work timeframe, and discuss the order in which the authors will be listed. All listed authors should contribute substantially, with the person doing most of the work put first and the guarantor (usually the most senior team member) at the end.

Getting consent

Gain permission and written consent to write up the case from the patient or parents, if your patient is a child, and keep a copy because you will need it later for submission to journals.

Information gathering

Gather all the information from the medical notes and the hospital’s electronic systems, including copies of blood results and imaging, as medical notes often disappear when the patient is discharged and are notoriously difficult to find again. Remember to anonymise the data according to your local hospital policy.

Writing up

Write up the case emphasising the interesting points of the presentation, investigations leading to diagnosis, and management of the disease/pathology. Get input on the case from all members of the team, highlighting their involvement. Also include the prognosis of the patient, if known, as the reader will want to know the outcome.

Coming up with a title

Discuss a title with your supervisor and other members of the team, as this provides the focus for your article. The title should be concise and interesting but should also enable people to find it in medical literature search engines. Also think about how you will present your case study—for example, a poster presentation or scientific paper—and consider potential journals or conferences, as you may need to write in a particular style or format.

Background research

Research the disease/pathology that is the focus of your article and write a background paragraph or two, highlighting the relevance of your case report in relation to this. If you are struggling, seek the opinion of a specialist who may know of relevant articles or texts. Another good resource is your hospital library, where staff are often more than happy to help with literature searches.

How your case is different

Move on to explore how the case presented differently to the admitting team. Alternatively, if your report is focused on management, explore the difficulties the team came across and alternative options for treatment.

Conclusion

Finish by explaining why your case report adds to the medical literature and highlight any learning points.

Writing an abstract

The abstract should be no longer than 100-200 words and should highlight all your key points concisely. This can be harder than writing the full article and needs special care as it will be used to judge whether your case is accepted for presentation or publication.

What next

Discuss with your supervisor or team about options for presenting or publishing your case report. At the very least, you should present your article locally within a departmental or team meeting or at a hospital grand round. Well done!

Both papers agree that case reports can be important. They may provide valuable resources of unusual information that may lead to new research and advances in clinical practice and should offer an interesting case with an unusual presentation or a surprise twist.

I agree!

But perhaps it is more constructive to consider what a case report cannot do.

It cannot provide evidence about the effectiveness of a therapy. To publish something like:

  • I had a patient with the common condition xy;
  • I treated her with therapy yz;
  • this was followed by patient feeling better;

is totally bonkers – even more so if the outcome was subjective and the therapy consisted of more than one intervention, as in the article above. We have no means of telling whether it was treatment A, or treatment B, or a placebo effect, or the regression towards the mean, or the natural history of the condition that caused the outcome. The authors might just as well just have reported:

WE RECENTLY TREATED A PATIENT WHO GOT BETTER

full stop.

Sadly – and this is the reason why I spend some time on this subject – this sort of thing happens very often in the realm of SCAM.

Case reports are particularly valuable if they enable and stimulate others to do more research on a defined and under-researched issue (e.g. an adverse effect of a therapy). Case reports like the one above do not do this. They are a waste of space and tend to be abused as some sort of indication that the treatments in question might be valuable.

 

Subscribe via email

Enter your email address to receive notifications of new blog posts by email.

Recent Comments

Note that comments can be edited for up to five minutes after they are first submitted but you must tick the box: “Save my name, email, and website in this browser for the next time I comment.”

The most recent comments from all posts can be seen here.

Archives
Categories