Category: Adverse events

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

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

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