Category: Clinical practice

e-19th century

Papers from the early 19th century

Inspired by Cloquet, Sarlandière, Pelletan, Carraro, and Pouillet, on Acupuncture. Edinburgh Med Surg J 1827;27:190–200.

On the 25th October 2018 three rather unusual papers appeared on my PubMed search.[1–3] They were remarkable because they were nearly two centuries late! So I guess there is an ongoing process of digitising journal archives, and it happens that the word ‘acupuncture’ or ‘acupuncturation’ appeared in the titles of these old papers. I often use the search term ‘acup*’, where the asterisk is a wild card – meaning it can stand for any letter or combination of letters. Generally, that means I will get ‘acupuncture’ or ‘acupressure’… I never expected, in the modern era to get ‘acupuncturation’!

I was very pleased to find that the full text of these papers was hosted on PubMed Central (PMC), although they are reasonably big files since they are page images. The oldest of the three was published in 1827, and it is this paper to which the following extracts and comments are attributed.

The Edinburgh Medical and Surgical Journal was published in Edinburgh from 1805 to 1855, and was described as: …exhibiting a concise view of the latest and most important discoveries in medicine, surgery, and pharmacy.

EMSJ 1805

It was clearly a quite prestigious and conservative journal, as the opening paragraph of the earliest paper reveals:[1]

Those of our readers who have perused the essay of Mr Churchill on acupuncture and his papers in the London Medical Repository, and who are aware that investigations have been lately made on the same subject in various parts of the Continent, may be surprised that hitherto no notice has been taken of it in this Journal. Our reason has been, that the first accounts given of the virtues of the new remedy were so marvellous, and therefore seemed to savour so much of quackery, that, coming, as they did, from persons not of the highest authority, we could not but follow the general example, and decline giving implicit credit to their assertions.

The same paragraph goes on to describe the editors’ change of heart – dare I say u‑turn on the matter:

But these assertions have been re-echoed from almost every quarter of Europe; observations have been made on the subject at many continental schools of eminence; the several accounts given by unconnected writers agree very remarkably in every essential particular; the alleged facts have at length been put to the test of a full and minute train of experiments by one of the most scientific of the Parisian physicians, in a great public hospital, and under the eyes of its pupils; the results of these experiments, as published by his hospital assistants, harmonize exactly with the statements made by those who introduced the remedy into Europe; and under such circumstances we cannot any longer delay presenting a summary of the interesting information which has been accumulated in its favour.

So how about that then?

The acuphiles jump for joy…
(my neologism – ‘acupuncture lovers’) 

But wait:

It must be confessed, however, that after all we cannot approach this singular topic without hesitation.

What now? I love the use of the term ‘singular’ here, meaning remarkable, which has fallen out of common use. It is the word I have noticed jumping out with great regularity from the text of Conan Doyle’s Sherlock Holmes, as reanimated by the wonderfully expressive voice of Stephen Fry.

It is true, that, in the hands of M. Cloquet, the remedial virtues of acupuncture have passed triumphantly through an ordeal, to which no remedy, whose claims were false, could be submitted without detection. But, at the same time, the utmost ingenuity of its favourers has been unable to discover, in a long course of minute inquires, any rational way of accounting for its effects; and, what is perhaps of more consequence, they have been unable to detect any physiological change or phenomenon co-ordinate with its operation. There is in short a total want of every sort of evidence in its favour as a remedy, except that most treacherous kind, the evidence of succession; and consequently, a philosophical mind, especially considering the diseases in which the greatest success has been obtained, will naturally feel inclined to attribute the cures which have been accomplished to the influence of the imagination, and to sentence acupuncture to banishment from regular practice, as being nothing else than a variety of animal magnetism.

…a total want of every sort of evidence in its favour as a remedy, except that most treacherous kind, the evidence of succession!

Could it be:

…nothing else than a variety of animal magnetism!

Well the piece goes on to say that the journal is not the place to discuss evidence, and proceeds to describe the experiences of the fellows who have written about the technique. It is interesting to note the common opinion of where the technique works best, or should I say, where it doesn’t!

It is applied to all manner of maladies; but those in which it is accounted most applicable and is in reality most successful, are evidently such as do not belong to the active inflammatory disorders.

The paper describes the fine needles used, the fact that they simply do not hurt at all to insert, and that they are often retained for only 5 to 6 minutes; but a chap called Cloquet describes having left them in for over an hour.

Sewing needles could be used apparently, but only after passing a thread through the eye so that the needle did not get lost inside the body. Longer needles are also described – three inches in length and one fortieth of an inch in diameter (the latter is just over 0.6mm, so not too fat).

Louis Berlioz, the father of the famous composer, is credited as having first written about its use in the contemporary practice of the time as a ‘memoire to the Parisian Society of Medicine’. Berlioz is also credited as being the first to use electrical stimulation of needles in the form of galvanism.

Rather alarming is the description of how there is no damage to tissues or organs, including the heart and lungs, followed immediately by a description of a fatality that seems to have resulted from the terror caused by the accidental disappearance of needles into the abdomen.

In regard to the accidents arising from acupuncture, it is only necessary to add, that in a few cases the operation has been followed by a tendency to fainting, and that in one instance, which occurred at the Hotel-Dieu of Paris, the accidental disappearance of the needles in the skin of the belly was followed by such extreme and uncontrollable terror, that the patient expired soon after.

After a long description of the effects observed in patients, this paper finishes with some conjecture over the mechanism. They include the possibility that it ‘operates through the mind’, but my favourite idea of theirs is that it acts by:

…rectifying an aberration of the nervous fluid.

References

  1. Cloquet, Sarlandière, Pelletan, Carraro, and Pouillet, on Acupuncture. Edinburgh Med Surg J 1827;27:190–200.http://www.ncbi.nlm.nih.gov/pubmed/30330050 (accessed 25 Oct2018).
  2. Renton J. Observations on Acupuncture. Edinburgh Med Surg J 1830;34:100–7.http://www.ncbi.nlm.nih.gov/pubmed/30330219 (accessed 25 Oct2018).
  3. Banks JT. Observations on Acupuncturation. Edinburgh Med Surg J 1831;35:323–8.http://www.ncbi.nlm.nih.gov/pubmed/30329900 (accessed 25 Oct2018).

Declaration of interests MC

Another fatality

Inspired by Jian et al. Medicine 2018

pubcrawlerLast Saturday (3rd November 5, 2018) I was lecturing on the BMAS Foundation Course, and during the morning coffee break I received one of my regular email alerts from PubCrawler – an Irish website that searches (or crawls) PubMed (the US National Library of Medicine) leaving you free to go to the pub! It was somewhat ironic that I was about to give the Safety Brief for the course, when I received notification of this fatal case report – a death from bilateral tension pneumothorax in Shanghai, China.[1]

Reports of deaths from acupuncture are very rare, but there may be a degree of under-reporting, as can be inferred to some degree by this case. The last fatality reported was a curious one, possibly related to strong needling around the vagus nerve in the neck,[2] and prior to that there had been no reports for 10 years.[3]

…why emphasize this risk of which we should all be very aware?

So this is another report of pneumothorax – why emphasize this risk of which we should all be very aware? Well it was fatal, and most are not, but the remarkable features of this case relate to the postmortem diagnosis and the wonderful images provided by the authors.

A 52 year old man of apparently normal constitution received acupuncture and cupping treatment at an ‘illegal’ Chinese medicine clinic some 30 hours before being admitted to hospital with severe dyspnoea. He had been treated with 0.25x75mm needles to a variety of points on the dorsal and low back, some of which were clearly over the lung fields. It is not clear how deep the needles were inserted, but 30mm needles are long enough to reach the lung in some of the points used, so there is no question that the lungs were within easy reach of 75mm needles.

…there is no question that the lungs were within easy reach of 75mm needles.

It was not clear that he had acupuncture, so the early suspicion was of airway blockage. The patient collapsed 30 minutes after admission and cardiopulmonary resuscitation was attempted for an hour, although tension pneumothorax was clearly not suspected.

The body was frozen after death and then thawed before being subject to postmortem computed tomography (PMCT), some 207 hours after death. The CT images demonstrate dramatic collapse and compression of both lungs as well as severe compression in the upper mediastinum. The trachea appears to be only mildly deviated because of bilateral tension, so this important sign in unilateral tension pneumothorax would not have been apparent on resuscitation.

Jian 2018 Fig 1.png
PMCT findings in (A) the lung window, (B) the mediastinal window. Both lungs were collapsed and the density of both lungs was significantly elevated. Mediastinal compression and compression of heart and major vessels were also detected.
Jian 2018 Fig 2.png
Screen images of 3D reconstructions of lungs. Views in the coronal (A), axial (B) and sagittal (C) planes showed the collapsed lungs (purple) and gas in the pleural space (blue). 3D reconstructions (D) showed the collapsed lungs (red) and gas in pleural space (translucent).

Full body PMCT was a new concept to me, and in this case it was highly instructive. It lead the forensic examiners to perform a pneumothorax test – making a small opening into each side of the chest underwater to look for formation of bubbles. I spent a whole summer in the pathology department in Leeds, and assisted at many post mortems, but I had not seen nor heard of this test before, so clearly it is not routinely performed.

Jian 2018 Fig 4
Results of bilateral pneumothorax test.

This is a very well described and wonderfully illustrated forensic case report, but most importantly it is a reminder to all of us who needle over the thorax to be vigilant in our techniques. The BMAS has published guidelines on safe needling over the thorax.

References

  1. Jian J, Shao Y, Wan L, et al. Autopsy diagnosis of acupuncture-induced bilateral tension pneumothorax using whole-body postmortem computed tomography: A case report. Medicine (Baltimore) 2018;97:e13059. doi:10.1097/MD.0000000000013059
  2. Watanabe M, Unuma K, Fujii Y, et al. An autopsy case of vagus nerve stimulation following acupuncture. Leg Med (Tokyo) 2015;17:120–2. doi:10.1016/j.legalmed.2014.11.001
  3. Chang S-A, Kim Y-J, Sohn D-W, et al. Aortoduodenal fistula complicated by acupuncture. Int J Cardiol 2005;104:241–2. doi:10.1016/j.ijcard.2004.12.035

Declaration of interests MC

The one-needle wonder

A clinical vignette by Jens Foell (JF), edited by Mike Cummings (MC)

Jens leaves
Jens Foell

Bian Que is a prominent figure in the history of medicine. Allegedly he possessed x ray eyes and amazing healing properties. Legend says that he could cure people with one needle (eg getting an unconscious person back into action by needling Baihui – GV20). Performing the one-needle-wonder is every acupuncturist’s dream.

Bian Que
Woodcut portrait of Bian Que from the Wellcome Collection

On an ordinary evening in a minor injury unit in rural North Wales I came close to living this dream. A ‘doctor advice’ callback appeared on the screen: a paramedic visited a 76 year old woman who had called emergency services because she experienced acute intense left sided shoulder/arm pain. Nothing had helped. She could not drive a car, because she could not move the steering wheel. The ambulance crew had checked her vital signs. They were all in normal range. They performed an ECG, which did not show any signs of cardiac disease. They did not know what to do next, because the shoulder was just as painful as before despite the regular pain medication she had taken plus the intravenous paracetamol she has been given. They were stuck, and so was the patient. The patient had COPD, high blood pressure, hypothyroidism and carpal tunnel syndrome as long-term conditions. I recommended that she should be seen face to face in the unit.

When she arrived with her daughter she was clearly not well. The daughter was doing the talking for her. The patient was holding her breath and grimaced in pain. She described the pain as dull and throbbing and unbearable. I re-examined chest and neck; the cervical foraminal closure maneuver did not reproduce her pain, she could move her shoulder blade and I could passively move her arm in all directions. In the next step I carefully palpated her shoulder muscles. The muscles of the posterior armpit were quite tender to touch and finally I found a taut band with an active trigger point in what must have been the teres major muscle. Pressing on the painful spot reproduced the patient’s pain and palpating across the fibres of the muscle with a pincer grip elicited a twitch response.

Is unscheduled care the right place to perform acupuncture? Is dry needling or injection of trigger points with local anaesthetic standard practice in out of hours care? Certainly not. But what would be the alternative? The alternative would consist of escalating the drug regime in a frail elderly person with COPD by introducing stronger opioids or gabapentinoids or giving more nonsteroidal drugs with the added risk of injuries to kidney and stomach.

I explained the working diagnosis and the possible management options to the patient. She insisted that none of her medication had worked so far and going on like this is not an option. So I decided to offer acupuncture/dry needling. I used my purple middle-of-the-road standard needle, kept my controlling pincer grip on site and moved the needle around in the muscle bulk I held between my fingers. After removing the needle I asked the patient to relax her armpit muscles. I moved her arm around in several directions and gently stretched the muscle, followed by asking her again to relax the arm.

With an expression of astonishment she said she could move her arm again and that the pain has diminished substantially. She said it is still there, but bearable. I arranged with her that she should obtain a chest x ray film to make sure this was not the secondary feature of a potential primary malignancy (years of smoking!) and that I would contact her later to see how she was getting on after this non-pharmacological intervention for severe acute pain.

A week later I phoned the contact number to evaluate the intervention. It turned out the contact number belonged to the paramedic. The paramedic said that he had seen her in the village and that “acupuncture worked very well”. Eventually I obtained her home number and phoned her personally. She told me that indeed the intense shoulder pain had gone, that the chest x ray film was unremarkable and that she was getting physiotherapy for her carpal tunnel syndrome.

In retrospect I would not claim that this one-needle-intervention could be classified as a ‘wonder’ cure, but it certainly saved her from escalating the drug ladder or a hospital referral.

Generalising from this case there are several points to consider: acute myofascial pain can frequently be encountered in urgent-care-settings, but dry needling/acupuncture is not routinely part of the therapeutic culture in these settings. There is in my view an unmet need. Rather than in chronic pain settings skillful treatment of myofascial trigger points, identified by reproducing the patient’s pain pattern, can make a meaningful and immediate difference and keep the drug burden at bay.

Declaration of interests JF

Declaration of interests MC

Needle Migration in the neck

Comments by Michael Meinen (MM) and Mike Cummings (MC)

This blog was first published on 24th August 2018 on https://blogs.bmj.com/aim/

Case report

El-Wahsh S, Efendy J & Sheridan M. Migration of self-introduced acupuncture needle into the brainstem. J Neurosci Rural Pract 2018; 9(3): 434 – 436.

JNRP-9-434-g001
Lateral cervical spine x ray film showing the 0.25x30mm needle within the muscle layer

Presentation

An elderly man presented to an emergency department after an acupuncture needle (which he had inserted himself) had broken off in the attempt to withdraw it.[1] Exploration of the neck was unsuccessful, and the patient required a CT scan to locate the needle (ultrasound failed to locate it); four days after initial presentation, it had migrated cranially through the foramen magnum and pierced the dura mater with the tip resting in the brainstem. It had to be removed by open surgery, followed by a patch repair of the dura mater. The tip of the needle was angulated. The patient made a good recovery and was free of symptoms at follow-up after a month.

Discussion

Accidental perforations of anatomical structures are well documented as complications of acupuncture.[2] Indeed there are several cases of penetration of the brainstem with acupuncture needles.[3–7] This presentation highlights a few safety issues, and suggests an approach to dealing with such incidents in future..

The location of the needle suggests insertion in the midline at GV16 (Fengfu), which the patient must have performed by touch alone, at a slight upward angle. When patients are taught self-acupuncture, the danger of deep insertion should be discussed in detail, and perhaps self-needling without the ability to see what is being done should be discouraged in potentially dangerous areas such as this. At this point it is salient to remind readers of the BMAS needling policy in the neck.

Above C2 – angle the needle tip towards the palpable occipital bone.
Perpendicular insertion should be avoided.

Below C2 – angle the needle tip towards the cervical articular pillar
(the pars interarticularis and facet joints usually between C3 and C5).

On presentation, the needle (0.25x30mm) was 8mm below the surface of the skin, embedded in the muscles of the neck. The patient had been unsuccessful in his attempt to retrieve the needle. Ultrasound scanning failed to show the needle, and an initial surgical attempt to remove the needle in the emergency department was unsuccessful. The authors felt that manipulations by the patient and doctors had contributed to the needle migration. This suggests that, should a needle break and disappear into the patient’s soft tissue, that neither patient or practitioner should attempt to remove it, but that the patient should be referred, or self-refer, immediately to an emergency department. Again, this needs to be discussed when instructing a patient in self-acupuncture.

It seems that this location is particularly vulnerable to needle migration because of the thickness of muscle and the lack of resistance to needle progression when the tip reaches the spinal canal or brainstem. It seems sensible for the patient to relax the postural muscles of the neck by lying down with the head supported without any pressure on the needle site, while specialist investigation with x ray films and CT is awaited.

References

  1. El-Wahsh S, Efendy J, Sheridan M. Migration of Self-Introduced Acupuncture Needle into the Brainstem. J Neurosci Rural Pract 2018;9:434–6. doi:10.4103/jnrp.jnrp_480_17
  2. White A. A cumulative review of the range and incidence of significant adverse events associated with acupuncture. Acupunct Med 2004;22:122–33. doi:10.1136/aim.22.3.122
  3. Anderson DW, Datta M. The self-pith. AJNR Am J Neuroradiol 2007;28:714–5.
  4. Choo DC, Yue G. Acute intracranial hemorrhage caused by acupuncture. Headache 2000;40:397–8.
  5. Zhu Y, Xue Z, Xie D, et al. Medulla oblongata hemorrhage after acupuncture: A case report and review of literature. Interdiscip Neurosurg 2018;11:1–3. doi:10.1016/j.inat.2017.09.013
  6. He W, Zhao X, Li Y, et al. Adverse events following acupuncture: a systematic review of the Chinese literature for the years 1956-2010. J Altern Complement Med 2012;18:892–901. doi:10.1089/acm.2011.0825
  7. Miyamoto S, Ide T, Takemura N. Risks and causes of cervical cord and medulla oblongata injuries due to acupuncture. World Neurosurg 2010;73:735–41.pm:20934166

Declaration of interests MM

Declaration of interests MC

EA for stress urinary incontinence

– perhaps via direct pudendal nerve stimulation

This blog was first published on 4th December 2017 on https://blogs.bmj.com/aim/

blue clean clear dew
Photo by Pixabay on Pexels.com

Earlier in 2017 this paper popped up in JAMA.[1] It was from the same group that had published a huge multicentre trial of electroacupuncture (EA) for chronic severe functional constipation,[2] which was featured in a previous blog. This was a large sham controlled trial (n=504) although not as big as the previous one on constipation (n=1075).

EA can influence symptoms in overactive bladder

We have known for some time that EA can influence symptoms in overactive bladder, albeit under another name.[3] These are mainly urge symptoms, and a similar mechanism that reduces pain perception might be postulated to explain the results. Urinary stress incontinence (SUI) seems entirely different, and so the results of this trial were rather unexpected (by me at least).

I revisited the paper to examine the intervention in more detail and consider the anatomy involved. The active EA intervention involved just two points on each side (I love the simplicity!) – BL33 and BL35. 75mm needles were employed, and inserted 50 to 60mm. At BL33 the angulation (oblique inferiomedial) aimed to have the needle tip entering the S3 foramina. At BL35 (just lateral to the coccyx) the needle was angled superiolateral. In terms of safety, the structure to be avoided in this area is the rectum, and a paper in Acupuncture in Medicine studied the position of needle tips relative to the rectum when inserted into sacral foramina,[4] but not BL35. Needles inserted into S4 got close to the rectum (4-8mm), but there was a bigger margin in S2 and S3 (19-29.5mm). At BL35, a sufficient lateral angulation would avoid getting close to the rectum, but this angulation would be critical.

joi170065f1
Figure 1 from Lui et al JAMA 2017[1]

In terms of physiological effects the needle placement at the S3 foramina would certainly stimulate the dorsal ramus of S3, and possibly the ventral ramus, depending on depth. A superiolateral angulation at BL35 might approach the pudendal nerve as it passes over the sacrospinous ligament, lateral to the sacrum at about the level of S4 (sacral hiatus). Direct stimulation of the pudendal nerve has been described in a small case series of patients with spinal stenosis refractory to less invasive EA,[5] and nerve stimulation was confirmed by perineal sensation. The study in JAMA on SUI does not mention perineal sensation but just mentions mild shivering of the skin around the points, presumably secondary to muscle contraction. EA at 50Hz was applied at a current of 1-5mA. If either needle tip was close to motor fibres, the relevant muscle would have contracted quite strongly for the entire period of stimulation (30 minutes). The authors do not report such effects, but they do discuss the possibility of S3 and pudendal nerve stimulation. If direct electrical nerve stimulation occurred, the effect may have been in some part attributed to pelvic floor muscle contraction induced by motor nerve stimulation. With this in mind it is interesting to note that the effect observed after 18 sessions of acupuncture over 6 weeks was similar to 12 weeks of a pelvic floor exercise programme.

18 sessions of acupuncture over 6 weeks was similar to 12 weeks of a pelvic floor exercise programme

I should note that the sham technique involved no skin penetration and no electrical output, so if there was direct motor nerve stimulation in the active group, there would have been quite a considerable difference in terms of the physiological stimulation applied between the groups.

References

  1. Liu Z, Liu Y, Xu H, et al. Effect of Electroacupuncture on Urinary Leakage Among Women With Stress Urinary Incontinence: A Randomized Clinical Trial. JAMA 2017;317:2493–501. doi:10.1001/jama.2017.7220
  2. Liu Z, Yan S, Wu J, et al. Acupuncture for Chronic Severe Functional Constipation: A Randomized Trial. Ann Intern Med 2016;165:761–9. doi:10.7326/M15-3118
  3. Peters KM, Carrico DJ, Perez-Marrero R a, et al. Randomized Trial of Percutaneous Tibial Nerve Stimulation Versus Sham Efficacy in the Treatment of Overactive Bladder Syndrome: Results From the SUmiT Trial. J Urol 2010;183:1438–43. doi:10.1016/j.juro.2009.12.036
  4. Katayama Y, Kamibeppu T, Nishii R, et al. CT evaluation of acupuncture needles inserted into sacral foramina. Acupunct Med 2016;34:20–6. doi:10.1136/acupmed-2015-010775
  5. Inoue M, Hojo T, Nakajima M, et al. Pudendal nerve electroacupuncture for lumbar spinal canal stenosis – a case series. Acupunct Med 2008;26:140–4.pm:18818559

Declaration of interests MC

EA for chronic severe functional constipation

– it seems to work after an intensive course…

This blog was first published on 28th November 2017 on https://blogs.bmj.com/aim/

adult attic bathroom bathtub
Photo by Pixabay on Pexels.com

About a year ago I was surprised to see a sham controlled RCT of electroacupuncture (EA) published in Annals of Internal Medicine.[1] I was surprised for several reasons: I review for Annals, and I had not seen the paper for review; it was on chronic severe functional constipation – a subject with few previous RCTs of acupuncture; it was positive; it was the biggest 2 arm RCT in the acupuncture literature to date (n=1075).

The treatment was relatively straightforward – EA to the rectus abdominis muscle bilaterally (ST25—SP14) and manual stimulation of a point in tibialis anterior bilaterally (ST37). The sham control involved shallow needling of points close by, but not on the meridians, avoidance of typical needling sensation (de qi) and sham EA (ie no electrical stimulus, but the power indicator and sound as if it were real EA). The frequency used varied from 10 to 50Hz and the intensity was between 0.1 and 1mA. The frequency covers the best range for autonomic modulation (as judged by visceral blood flow), but the intensity was varied from sub-threshold (in terms of nerve stimulation you generally need 0.3 to 0.5mA for the lowest electrical threshold nerves to respond) to a rather gentle stimulus of 1mA. In my experience, many patients do not perceive sensation until around 1.5mA when needle tips are placed into muscle.

Twenty-eight EA sessions were provided over 8 weeks

Twenty-eight EA sessions were provided over 8 weeks – 5 sessions per week for the first 2 weeks, and 3 sessions per week for the next 5 weeks. So it was quite an intense course of treatment. There was no comment about rotation of needling sites – with such an intense treatment regime it is common to alternate similar protocols so that needle sites do not get sore.

The primary outcome was based on a stool diary and was the number of complete spontaneous bowel movements (CSBM) per week. EA performed significantly better than sham at 8 weeks and the effect was maintained at 12 weeks follow-up.

Lui-Fig-CSBM-2016-1024x660
Figure 2 from Lui et al Ann Int Med 2016[1]

Blinding appears to have been maintained at 4 and 8 weeks from a random sample of 140 participants. At 8 weeks about 90% from each group guessed that they had received the real EA.

The size of the effect appears to be clinically relevant, with a change from baseline in CSBM of greater than 1 per week,[2] although the group average does not exceed 3 per week so most participants in the active group would still be considered to have constipation.

Of interest is a follow-up paper published recently that examines factors associated with the response to acupuncture in this trial. It found that age was inversely related to response to acupuncture (ie younger patients did better), and comorbidities reduced the likelihood of response.[3]

References

  1. Liu Z, Yan S, Wu J, et al. Acupuncture for Chronic Severe Functional Constipation: A Randomized Trial. Ann Intern Med 2016;165:761–9. doi:10.7326/M15-3118
  2. Johanson JF, Wald A, Tougas G, et al. Effect of tegaserod in chronic constipation: a randomized, double-blind, controlled trial. Clin Gastroenterol Hepatol 2004;2:796–805. doi:10.1016/S1542-3565(04)00356-8
  3. Yang X, Liu Y, Liu B, et al. Factors related to acupuncture response in patients with chronic severe functional constipation: Secondary analysis of a randomized controlled trial. PLoS One 2017;12:e0187723. doi:10.1371/journal.pone.0187723

Declaration of interests MC

Burning nerves with needles in back pain – stop the burning, just use the needles!

This blog was first published on 27th July 2017 on https://blogs.bmj.com/aim/

I subsequently attended the Spanish Pain Society conference (#SEDPalma2018) and there was a whole session devoted to this paper and why it did not apply to the way these specialists used the technique :-/.

Mint-1024x379

This piece has also been stimulated by a publication in JAMA, this time evaluating the use of denervation of joints in spinal pain.[1] It is a set of three large (n=251, n=228, n=202), probably definitive, pragmatic trials that evaluate the use of radiofrequency denervation (RFD) as an addition to a 3 month standardised exercise programme. The design is such that the intervention was given the greatest possible opportunity to demonstrate an effect, that is both the specific effect of the intervention plus the context in which it is provided. This is rather similar to the Acupuncture in Routine Care (ARC) trials performed as part of the German Modellvorhaben Akupunktur;[2] all of which were markedly positive for acupuncture.

…at no time point did the addition of RFD reach clinical significance for the primary outcome

The results seem clear – at no time point did the difference been intervention and control reach clinical significance in terms of pain intensity (the primary outcome); and in only one of 18 time points across the three trials did the difference reach statistical significance (the 3 week outcome in the sacroiliac joint trial). The measure used for clinical significance here was 2 points on a 0-10 scale of pain, or 20mm on a 100mm visual analogue scale, but at no point did RFD achieve the lower level of 1 point set by NICE in NG59.[3]

The data from NG59 comparing acupuncture with no acupuncture controls (the closest equivalent comparison to the current trials of RFD) gave a pooled result at less than 4 months of more than 60% greater than the best outcome recorded in these trials of RFD. A result that was both statistically significant and clinically relevant by the standards used in NG59, although it would not have reached the standard set in these trials.

So what is RFD, and why am I drawing attention to this? RFD is a method of burning nerves, and the idea is that by denervating a pain source in the spine you might achieve sustained pain relief in chronic back pain. The typical targets are facet joints, sacroiliac joints and intervertebral joints. The radiofrequency term is unnecessarily confusing since the method uses electrical pulses at about 5000Hz rather than electromagnetic radiation in the radiowave spectrum. The latter stretches roughly from 3×103Hz to 3×109Hz equating respectively to wavelengths from 100km to 1mm, but that’s enough physics for now. Basically the high frequency electrical pulses cause a heating effect at the tip of the RFD probe and it typically reaches 80 degrees C, which coagulates the tissues at the tip.

Isn’t burning nerves a bit of an archaic technique? Yes it is, and in principle modern pain medicine tends to try to avoid neurolytic treatments. Damaging nerves can cause neuropathic pain in some individuals, and the nerves can grow back anyway.

Why was it recommended in NG59? This decision was controversial because the guideline development group (GDG) for NG59 recommended RFD based on quite limited data from very small trials, and the current Cochrane review clearly concluded that the evidence was insufficient to recommend it.[4] The decision to recommend RFD and recommend against acupuncture was also controversial because of potential conflicts of interests of interventionists on the GDG and how these were addressed.[5]

In reviewing the data on RFD used by NG59, I discovered that there was quite disproportionate weighting given to one particular trial despite it only having 20 patients per group (Tekin 2007 [6]). The reason for this is the meta-analytic software favours trials with low standard errors.

K16.1-RFD-1024x626
K.16.1 from Appendices K-Q of NG59

Anyway, I thought I would take a closer look at this paper, and discovered that the control group dropped from 6.8 to 4.3 on a 0 to 10 pain score from pre- to post-procedure. The slightly funny thing about this was that the control procedure involved exactly the same intervention as was used to determine eligibility for the trial – a diagnostic medial branch block ie a local anaesthetic block to the nerve that would then be coagulated or burnt in the active (CRF) group. In order to get in the trial the patients had to have a reduction in pain score of 50% or more, yet the control group who went on to have the same procedure again only dropped by about 37% (see Table 2 from Tekin 2007 below).

Tekin-2007-Table-2-1024x366
Table 2 from Tekin 2007

Well it all just goes to show that small trials are unreliable, but what should we do now? We should ask the centre that conducted the guideline (the National Guideline Centre hosted by the RCP) to perform an urgent review on the grounds of safety. As it stands NG59 has all but stopped NHS acupuncture for back pain and is likely to result in a vast increase in the use of RFD, which now we see doesn’t actually do anything worthwhile for patients, but may boost the Maserati-purchasing power of certain interventionists.

References

  1. Juch JNS, Maas ET, Ostelo RWJG, et al. Effect of Radiofrequency Denervation on Pain Intensity Among Patients With Chronic Low Back Pain: The Mint Randomized Clinical Trials. JAMA 2017;318:68–81. doi:10.1001/jama.2017.7918
  2. Cummings M. Modellvorhaben Akupunktur–a summary of the ART, ARC and GERAC trials. Acupunct Med 2009;27:26–30. doi:10.1136/aim.2008.000281
  3. NICE guideline on low back pain and sciatica in over 16s: assessment and management. https://www.nice.org.uk/guidance/ng59. 2016.
  4. Maas ET, Ostelo RWJG, Niemisto L, et al. Radiofrequency denervation for chronic low back pain. Cochrane database Syst Rev 2015: CD008572. doi:10.1002/14651858.CD008572.pub2
  5. Cummings M. NG59 used different levels of evidence for conventional interventions compared with those for acupuncture and may not have adequately addressed personal financial COIs of the GDG chair. BMJ. 2017;356. http://www.bmj.com/content/356/bmj.i6748/rr-6
  6. Tekin I, Mirzai H, Ok G, et al. A comparison of conventional and pulsed radiofrequency denervation in the treatment of chronic facet joint pain. Clin J Pain;23:524–9. doi:10.1097/AJP.0b013e318074c99c

Declaration of interests MC

Why not needles for OA – no steroid, just the needles!

This blog was first published on 30th May 2017 on https://blogs.bmj.com/aim/

OA-knee-JAMA-2017

This piece has been stimulated by a recent publication in JAMA evaluating the use of regular intra-articular corticosteroid injections for symptom management and cartilage volume in osteoarthritis (OA) of the knee.[1] Previous research had suggested that the inflammatory process in the knee was associated with both pain and progression of cartilage loss, however, this trial clearly demonstrated a greater loss of cartilage after two years of 3 monthly intra-articular triamcinolone injections compared with the same frequency of saline injections.

It seems pretty clear then that we should avoid long-term use of intra-articular steroid within the knee and probably other synovial joints.

Previous research, also published in JAMA, indicates that steroid can also have a negative impact in the long term on lateral epicondylalgia.[2] Furthermore, a systematic review of the effects of local corticosteroid on tendon clearly concluded that the impact was negative both in vitro and in vivo.[3]

In shoulder pain it does not seem to matter whether or not the steroid is injected into the presumed target based on imaging, or whether it is injected into the buttock.[4] Moreover, given the anatomical vulnerability of the human supraspinatus tendon and its propensity for self destruction with age,[5] combined with the known negative effects of steroid on tendon, it looks as though we should avoid steroid in the shoulder too.

So what do we do if we do not inject steroid into our peripheral sources of musculoskeletal pain? We can try injecting other things I guess. Diclofenac, botulinum toxin or maybe normal saline – the latter seems to do very well when used as a control procedure in trials, in terms of the change from baseline. Having been brought up to accept steroid injection as a standard conventional procedure, it was a major surprise to find that needles alone (dry needling or local acupuncture) in tender muscle appeared to be highly effective.[6] Having got over this surprise I was guided through the process of my first systematic review to find that virtually none of the trials of needling and injection therapies in myofascial trigger point pain demonstrated superiority for any individual technique.[7] Indeed, saline injection (the intended control procedure) proved superior in most outcomes of one particularly good quality trial.[8]

Despite saline injection being no less effective in terms of pain relief than an ‘active’ comparator, and being associated with clinically meaningful changes from baseline in trials, we do not use it in practice. Well it has not been tested in a double blind randomised controlled trial… but what would we use in the control group of such a trial? Perhaps the needle without an injection. Then we have the challenge of blinding the practitioner, and we are getting closer to the dilemma of acupuncture research.

Acupuncture needles are less traumatic than hypodermic needles and push in fewer bugs from the skin…

…and there is no reason for them to go inside the joint

Acupuncture needles are less traumatic than hypodermic needles, and carry no risk related to the injected substance. They also carry less from the outside of the organism (skin flora and contaminants) into the internal environment because they lack the hollow bore of a needle for injection. In general we avoid needling into joint spaces with acupuncture needles despite the reduced theoretical risk of carrying in bugs from the outside. The best quality evidence for acupuncture in chronic pain related to osteoarthritis demonstrates and effect size (standardised mean difference) of 0.26 over sham acupuncture (minimal needling in the biggest trials) and an effect size of 0.57 over no acupuncture controls (waiting list, usual care, or guideline-based conventional care).[9] For comparison, topical non-steroidal anti-inflammatory drugs have an effect size of 0.4 over placebo and oral preparations range from 0.29 to 0.44.[10] So 0.57 looks pretty good if you don’t mind buying a bit of the relatively safe context of acupuncture, or if you prefer something more potent you might go for oral opiates which come in at 0.78… but we all know the path from there on, and it does not look so rosey.

Well I would go for the needles, probably with a little umph added from electrical impulses as Jorge Vas did in 2004,[11] with an effect size of 1.21 (this was an outlier in the Vickers IPDM,[9] but the only trial to use electroacupuncture (EA) to muscles around the knee compared with non-penetrating sham EA).

References

  1. McAlindon TE, LaValley MP, Harvey WF, et al. Effect of Intra-articular Triamcinolone vs Saline on Knee Cartilage Volume and Pain in Patients With Knee Osteoarthritis: A Randomized Clinical Trial. JAMA 2017;317:1967–75. doi:10.1001/jama.2017.5283
  2. Coombes BK, Bisset L, Brooks P, et al. Effect of corticosteroid injection, physiotherapy, or both on clinical outcomes in patients with unilateral lateral epicondylalgia: a randomized controlled trial. JAMA 2013;309:461–9. doi:10.1001/jama.2013.129
  3. Dean BJF, Lostis E, Oakley T, et al. The risks and benefits of glucocorticoid treatment for tendinopathy: a systematic review of the effects of local glucocorticoid on tendon. Semin Arthritis Rheum 2014;43:570–6. doi:10.1016/j.semarthrit.2013.08.006
  4. Ekeberg OM, Bautz-Holter E, Tveitå EK, et al. Subacromial ultrasound guided or systemic steroid injection for rotator cuff disease: randomised double blind study. BMJ 2009;338:a3112. doi:10.1136/bmj.a3112
  5. Vincent K, Leboeuf-Yde C, Gagey O. Are degenerative rotator cuff disorders a cause of shoulder pain? Comparison of prevalence of degenerative rotator cuff disease to prevalence of nontraumatic shoulder pain through three systematic and critical reviews. J shoulder Elb Surg 2017;26:766–73. doi:10.1016/j.jse.2016.09.060
  6. Cummings TM. A computerised audit of acupuncture in two populations: civilian and forces. Acupunct Med 1996;14:37–9. doi:10.1136/aim.14.1.37
  7. Cummings TM, White AR. Needling therapies in the management of myofascial trigger point pain: a systematic review. Arch Phys Med Rehabil 2001;82:986–92. doi:10.1053/apmr.2001.24023
  8. Frost FA, Jessen B, Siggaard-Andersen J. A control, double-blind comparison of mepivacaine injection versus saline injection for myofascial pain. Lancet 1980;1:499–500.pm:0006102230
  9. Vickers AJ, Cronin AM, Maschino AC, et al. Acupuncture for chronic pain: individual patient data meta-analysis. Arch Intern Med 2012;172:1444–53. doi:10.1001/archinternmed.2012.3654
  10. Birch S, Lee MS, Robinson N, et al. The U.K. NICE 2014 Guidelines for Osteoarthritis of the Knee: Lessons Learned in a Narrative Review Addressing Inadvertent Limitations and Bias. J Altern Complement Med 2017;23:242–6. doi:10.1089/acm.2016.0385
  11. Vas J, Mendez C, Perea-Milla E, et al. Acupuncture as a complementary therapy to the pharmacological treatment of osteoarthritis of the knee: randomised controlled trial. BMJ 2004;329:1216.pm:15494348

Declaration of interests MC

TENS and acupuncture appear cost-effective in knee osteoarthritis

knee-pain

This blog was first published on 9th March 2017 on https://blogs.bmj.com/aim/

journal.pone_.0172749.g003-1024x507
Figure 3 from Woods B et al PLoS One 2017[1]

This figure may seem familiar to some who follow big data in the acupuncture field. It comes from another big project at the Centre for Health Economics, University of York.[1] It is effectively a repeat of their first large network meta-analysis (NMA) that included acupuncture and sham acupuncture in knee osteoarthritis (OA),[2] but this time replacing pain outcomes with health-related quality of life in the form of the EQ-5D aka Euroqol.

There are also overlaps with Saramago et al from 2016,[3] which I wrote about on this blog under the title Quality sham. This paper by Woods et al narrows the view from chronic pain to OA knee alone and extends the analysis to a full cost comparison of non-pharmacological interventions.

This is a thorough piece of work from a well-recognised centre. Whilst data for some interventions was limited, the data for acupuncture and muscle strengthening exercise for example appears fairly reliable; that is, the confidence intervals are tight and the point estimate consistent in both analyses illustrated in the figure above. In total the NMA included 88 RCTs (randomised controlled trials) and 7507 patients.

I suppose the major limitation of this analysis is that there was only data available to calculate outcomes at 8 weeks ie after a course of treatment rather than in the long term. Woods et al cover this aspect in their discussion and put forward an argument for positive commissioning decisions rather than waiting for more evidence.

In terms of EQ-5D outcomes, acupuncture appears to do well, but costs of performing a course of treatment must also be taken into account. When this is done, TENS is the most cost effective intervention, coming in at £2690 per QALY (quality adjusted life year) versus usual care. When only trials with a low risk of selection bias were considered the effect size of TENS dropped and it then came in at £6142 per QALY versus usual care. In this analysis acupuncture then became cost effective at £13 502 versus TENS.

I should note that when all non-pharmacological interventions are considered TENS and acupuncture are the two most cost effective. In the latest clinical guideline from NICE on osteoarthritis (CG177)[4] TENS is recommended, but acupuncture is not.

…when all non-pharmacological interventions are considered TENS and acupuncture are the two most cost effective, but NICE only recommends TENS

References

  1. Woods B, Manca A, Weatherly H, et al. Cost-effectiveness of adjunct non-pharmacological interventions for osteoarthritis of the knee. PLoS One 2017;12:e0172749. doi:10.1371/journal.pone.0172749
  2. Corbett MS, Rice SJC, Madurasinghe V, et al. Acupuncture and other physical treatments for the relief of pain due to osteoarthritis of the knee: network meta-analysis. Osteoarthritis Cartilage 2013;21:1290–8. doi:10.1016/j.joca.2013.05.007
  3. Saramago P, Woods B, Weatherly H, et al. Methods for network meta-analysis of continuous outcomes using individual patient data: a case study in acupuncture for chronic pain. BMC Med Res Methodol 2016;16:131. doi:10.1186/s12874-016-0224-1
  4. NICE guideline update on osteoarthritis: the care and management of osteoarthritis in adults. http://guidance.nice.org.uk/CG177. 2014.

Declaration of interests MC

Precision needling in myofascial pain

This blog was first published on 9th February 2017 on https://blogs.bmj.com/aim/

Inspired by Wang et al Acupunct Med 2017 [1]

acupmed-2009-December-27-4-148-F1.large_-1024x845
Image taken from Cummings M Acupunct Med 2009 [2]

I got interested in swapping my hypodermic needles for filiform ones some 25 years ago, and was encouraged by my early success treating myofascial pain in a military population.[3] I became more and more expert at identifying these targets we call trigger points, touching them briskly with the tip of my fine filiform needle, and seeing them twitch with almost immediate relief of pain and tightness in the muscle. The twitch seemed to go along with immediate results, but it could be elusive, and other colleagues claimed similar success with less 3 dimensional accuracy – superficial needling or simply needling an acupuncture point nearby. As I have followed the clinical research in acupuncture I became less and less convinced that my accuracy, and the accuracy I tried to teach would be validated since there was so little difference between even real and sham needling.

I became less and less convinced that precision of trigger point needling would be validated

My early research was a review of all both wet and dry needling in myofascial pain.[4] There was a strong suggestion that when injecting trigger points (wet needling), the substance in the syringe did not seem to matter, but all groups appeared to improve dramatically. At the time there were not many trials using filiform needles.

Now we have a selection of trials that can be combined in meta-analysis, and the tentative conclusion is that targeting trigger points seems to have some specific effect over sham, but that targeting acupuncture points is not clearly superior to sham.[1]

acupmed-2016-011176-F3.large_-862x1024
Figure 3 from Wang et al Acupunct Med 2017 [1]

It is always worth having a careful look at Forest plots – so easy to miss the wood for the trees, so to speak, or even overlook some very strange trees! There are some issues to note here. The results of one trial (1.1.4 Tekin 2013) got included twice, albeit at different time points – they probably should have just decided on using one time point. Then there is a noticeable outlier in the lower plot (1.1.5 Chou 2009) – the effect size of this trial was huge in comparison to all the others. Under these circumstances it is always worth doing a sensitivity analysis excluding outliers. In this case it led me to check the original paper, and whilst the authors of this review classified it under acupuncture point treatment rather than trigger point treatment, the paper seems to suggest it used a trigger point needling technique to obtain multiple local twitch responses (LTRs) from remote trigger points that happened to be also at acupuncture point sites – in this case LI11 & TE5. Tricky to know how to classify this one then, but wait, there is another paper that used remote needling of a trigger point and measured an effect on upper trapezius myofascial pain (1.1.4 Tsai 2010). Maybe we should exclude that one as well in sensitivity analysis? Well I would have done all that for you, but given the small total number of total participants and the risk of bias, any conclusions would be unlikely to rise beyond a tentative suggestion.

So there you have it, perhaps the first meta-analysis of filiform needling in myofascial pain that points towards more accurate targeting of trigger points – but we have a long way to go!

References

  1. Wang R, Li X, Zhou S, et al. Manual acupuncture for myofascial pain syndrome: a systematic review and meta-analysis. Acupunct Med 2017. doi:10.1136/acupmed-2016-011176
  2. Cummings M. Myofascial trigger points: does recent research gives new insights into the pathophysiology? Acupunct Med 2009;27:148–9. doi:10.1136/aim.2009.001289
  3. Cummings TM. A computerised audit of acupuncture in two populations: civilian and forces. Acupunct Med 1996;14:37–9. doi:10.1136/aim.14.1.37
  4. Cummings TM, White AR. Needling therapies in the management of myofascial trigger point pain: a systematic review. Arch Phys Med Rehabil 2001;82:986–92. doi:10.1053/apmr.2001.24023

Declaration of interests MC