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Date: September 7th, 2017

Reference: Cohen et al. Acupuncture for analgesia in the emergency department: a multicentre, randomised, equivalence and non-inferiority trial. MJA 2017

Guest Skeptic: Dr. Alfred Sacchetti is a full time practicing Emergency Physician, who is also the Chief of Emergency Medicine at Our Lady of Lourdes Medical Center in Camden, New Jersey, USA, an Assistant Clinical Professor of Emergency Medicine and an Active Researcher.   In addition, Dr. Sacchetti is one of the few individuals to have lectured on the same panel with Dr. Milne and survived with his sanity and reputation intact.

Case: A 41-year-old man presents to the emergency department with an acute onset of back pain. He was putting some groceries into the car and felt something pull in his lower back.  He has no “red flags” on your history and physical examination. He is worried about taking pain pills and wants to know if acupuncture would work?

Background: One of the most common reasons to visit an emergency department is for pain. Unfortunately, pain is often poorly controlled. Inadequate pain control is called oligoanalgesia and has been recognized as a problem for years (Wilson et al).

Low back pain is an extremely common presentation to US Emergency Departments representing 2.4% or 2.7 million visits annually. The vast majority of presentations are benign in etiology but can be time consuming and frustrating for both patients and physicians.

Many different treatment modalities have been tried to treat low back pain with limited success.

Opioids are very effective at reducing pain. However, they come with many side effects and concerns about addiction and diversion.

ACEP has some guidelines with the American Pain Society from 2007 on the use of opioids. They state opioids should be reserved for severe, disabling pain that is not controlled or not likely to be controlled with NSAIDs or acetaminophen. This will be a challenge, considering the limited effectiveness of NSAIDs and acetaminophen.

In the face of what is being called the opioid epidemic, acupuncture has been suggested as a possible treatment modality.

Acupuncture is part of Traditional Chinese Medicine that has been around for thousands of years. It is based on the idea that the body has a life force flowing through meridians that is called chi/Qi. Disease and illness are result of chi/qi being blocked. Acupuncture is a method of placing needles into the skin to unblock the flow of chi/qi through the meridians to restore balance to the body.

There has been a great deal of research done on acupuncture to treat a variety of conditions. No convincing/high-quality evidence has been published demonstrating its efficacy. Placebo control studies using sham acupuncture have demonstrated it does not matter where you put the needles and suggests a strong placebo component.

Clinical Question: Can acupuncture provide pain relief equivalent to pharmacologic treatment in the emergency department?

 Reference: Cohen et al. Acupuncture for analgesia in the emergency department: a multicentre, randomised, equivalence and non-inferiority trial. MJA 2017

  • Population: Patients presenting to one of four emergency departments, at least 18 years old with low back pain, migraine or ankle sprain when an acupuncturist was present.
    • Exclusions: If the treating physician felt it was inappropriate to include the patient due to signs of illness or had a temperature above 37.7 C, major trauma, used anticoagulation medication or had a mechanical heart valve,skin infections precluding the use of certain acupuncture points, refused or unable to consent, used any form of analgesia one hour prior to presenting to the emergency department or presented to an emergency department for the same condition more than four times in the previous three months. 

  • Intervention: Acupuncture or acupuncture + pharmacotherapy
  • Comparison: Pharmacotherapy
  • Outcome:
    • Primary: Reduction in Verbal Numerical Rating Scale (VNRS) at one hour. Clinical significance is VNRS less than 4 and statistical significance is a VNRS decrease of more than 2.
    • Secondary: Functionality at 48 hours, adverse events, use of rescue medication, acceptability of treatment and health resource use.

Authors’ Conclusions: “The effectiveness of acupuncture in providing acute analgesia for patients with back pain and ankle sprain was comparable with that of pharmacotherapy. Acupuncture is a safe and acceptable form of analgesia, but none of the examined therapies provided optimal acute analgesia. More effective options are needed.”

checklistQuality Checklist for Randomized Clinical Trials:

  1. The study population included or focused on those in the emergency department. Yes
  2. The patients were adequately randomized. Yes
  3. The randomization process was concealed. Yes
  4. The patients were analyzed in the groups to which they were randomized. Yes
  5. The study patients were recruited consecutively (i.e. no selection bias). Unsure
  6. The patients in both groups were similar with respect to prognostic factors. Yes
  7. All participants (patients, clinicians, outcome assessors) were unaware of group allocation. No. This was a single blinded study with the participants and acupuncturists not being blinded to the intervention but outcome assessors were blinded to treatment allocation and acupuncturists to pharmacotherapy use.
  8. All groups were treated equally except for the intervention. No. Pharmacologic therapy was at discretion of the treating physician.
  9. Follow-up was complete (i.e. at least 80% for both groups). Yes
  10. All patient-important outcomes were considered. Yes
  11. The treatment effect was large enough and precise enough to be clinically significant. No

Key Results: There were 528 patients included in this study with a mean age of 41 years and about 50/50 male/female split. Just over half had low back pain with 17% having a migraine and 31% with an ankle sprain.

Primary Outcome: No difference in clinical or statistical relevant reduction of pain at one hour between groups.

 All three groups had terrible reduction in pain (acupuncture only, acupuncture-pharmacotherapy combo or pharmacotherapy alone). Less than 20% had a clinical reduction (<4) and less than 40% had a statistical reduction of pain (>2 point drop).

Results Acupuncture

  • Secondary Outcomes(acupuncture vs. pharmacotherapy):
    • Rescue Medication – 25% vs. 15%
    • Adverse Events – 51% vs. 54%
    • Functionality at 48 hours, acceptability of treatment and health resource use (see manuscript)

Screen Shot 2015-04-25 at 3.11.12 PMThere were a number of concerns we had with this study. Instead of my usual five issues I have expanded it so Al and I both get to discuss five issues.

Dr. Michael Ben-Meir

Dr. Michael Ben-Meir

I did reach out to the lead author Dr. Marc Cohen who put me in touch with one of his co-authors Dr. Michael Ben-Meir. Michael is a full time emergency physician, Director of his Emergency Department and researcher. He was away and we could only record his segment after Al and I recorded the episode. However, Michael has been added in post-production to respond to each of our concerns. You can hear his responses listening to the episode on iTunes.

  1. Blinding: One of the major issues with this study design was lack of blinding. It was only a single blinded study. The patients knew they were getting acupuncture. Acupuncture is a very hands on intervention that can introduce a strong placebo effect. This placebo effect would bias the study in favor of acupuncture.
  2. Control Group: The lack of a sham control group to minimize the placebo effect is another major problem with this study. It would have been a much stronger study if there was a sham acupuncture group. A previous study using tooth picks as sham acupuncture showed no difference between real acupuncture and sham acupuncture.
  3. Straw Man: Another problem with this study design was a straw man comparison. Comparing multiple non-effective therapies provides little to no valuable information to clinicians. The primary outcome of pain at one hour showed no difference between groups with less than 40% getting a pain reduction of 2 points or more. About 85% of patients still had a pain rating above 4 on the VNRS in all groups.
  4. Opioid Sparing: The use of rescue medication was 10% higher in the acupuncture only group. Rescue medicine for all three groups was morphine 2.5mg IV bolus. This is not exactly opioid sparing if more opioids are needed in the acupuncture only group. However, the dose of morphine was also a straw man rescue dose with 0.05-0.1mg/kg IV being a more reasonable dose.
  5. Consecutive Patients: We are unsure if these were consecutive patients presenting to the emergency department. Patients were included only when an acupuncturist was present. We are not sure if the acupuncturist worked night, weekends and holidays? Patients presenting at different days of the week and times of days could represent a different population.
  6. Selection Bias: They excluded patients if the treating physician felt inclusion was inappropriate because of the signs of illness, or if the patient had one of a number of other exclusions that were listed in the PICO. This could have introduced selection bias.
  7. Delay in Publication: This trial was conducted in 2010-11 but was published only in 2017. What was the reason for the delay?
  8. Disease Entities Chosen: They chose to look at low back pain, migraines and ankle sprains. There can be considerable variability in subjective perception of pain and degree of pain with these types of medical condition.
  9. Length of Stay (LOS): The use of acupuncture did not increase ED LOS. However, it would take the ED physician additional time to perform acupuncture. What about all the other patients in the ED? Time spent doing acupuncture would delay the ED physician from managing other patients. This could impact the ED LOS for the other patients. If someone else is doing the acupuncture their could be delays in them coming to the ED to provide the service.
  10. Safety: They claim that acupuncture is safe. Only 355 patients received acupuncture. This study is too small to detect a rare complication and there have been reports of serious complications with acupuncture treatment including death.

Comment on Authors’ Conclusion Compared to SGEM Conclusion: We agree with the authors that more options are needed for patients with pain presenting to the emergency department. However, we disagree with the authors that acupuncture is effective. This unblinded, pragmatic non-inferiority trial only provides more evidence that acupuncture has a placebo effect. In addition, there is not enough evidence to claim safety.  

SGEM Bottom Line: There is no high-quality evidence that acupuncture works for patients presenting to the emergency department with back pain, ankle sprains or migraines.

Case Resolution: You offer him acetaminophen to treat his back pain but set his expectations. He is encouraged to keep active and told the benefit observed with acupuncture is most likely a placebo effect. If he develops any red flag signs or symptoms he should return to the emergency department.

Dr, Alfred Sacchetti

Dr, Alfred Sacchetti

Clinical Application: There is still no high-quality evidence that acupuncture is effective for any medical condition.

What Do I Tell the Patient? There are no great treatments for back pain. A short course of opioids can work, but can have serious problems (side effects and risk of addition).

Keener Kontest: Last weeks’ winner was Roberto Cosentini from Italy. He knew that knew Joseph Priestley is credited with discovering oxygen.

Listen to this weeks’ episode to hear the keener question.  If you think you know the answer then send an email to TheSGEM@gmail.com with “keener” in the subject line. The first correct answer will receive a cool skeptical prize.

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Remember to be skeptical of anything you learn, even if you heard it on the Skeptics’ Guide to Emergency Medicine.

 BEEM 2017-18