Date: May 16th, 2018

Reference: Beltaief K et al. Acupuncture versus titrated morphine in acute renal colic: a randomized controlled trial. J Pain Res. 2018

Guest Skeptic: Dr. Tony Seupaul  is the Chairman of the Department of Emergency Medicine, University of Arkansas. Dr. Cordell Cunningham is a PGY 2 in Emergency Medicine at University of Arkansas for Medical Sciences

Case: A 51-year-old man presents to the emergency department complaining of right flank pain radiating to his groin like his previous episodes of renal colic. He states the pain comes in “waves,” is associated with nausea but no vomiting. On exam, he is afebrile and appears very uncomfortable while grabbing his right flank. He has used ketorolac, acetaminophen and tamsulosin in the past. He really wants to avoid taking any opioids and is wondering if acupuncture could work?

Background: We have covered renal colic a number of times on the SGEM:

  • SGEM#4: Getting Un-Stoned (Renal Colic and Alpha Blockers)
  • SGEM#32: Stone Me (Fluids and Diuretics for Renal Colic)
  • SGEM#71: Like a Rolling Kidney Stone
  • SGEM#97: Hippy Hippy Shake – Ultrasound Vs. CT Scan for Diagnosing Renal Colic
  • SGEM#154: Here I Go Again, Kidney Stone
  • SGEM#202: Lidocaine for Renal Colic?

Here are the SGEM bottom lines on the management of renal colic from those previous episode:

Dr. Anthony Seupaul

Expulsive therapy is unnecessary for ureteric stones < 5mm.

There is some weak evidence that tamsulosin may help passage of larger stones (5 to 10 mm).

You don’t need to push fluids (oral/IV) or use diuretics to pass kidney stones.

Bedside emergency department ultrasound is safe and has several advantages over CT for the diagnosis of kidney stones.

Lidocaine cannot be recommended for the treatment of renal colic at this time.

We have also covered a couple of acupuncture papers on the SGEM.  Watch for a new episode coming up on battlefield ear acupuncture to treat low back pain in the emergency department.

  • SGEM#187: Pin Cushion – Acupuncture in the Emergency Department
  • SGEM#211: Pins and Needles – Acupuncture for Migraine Prophylaxis

The summary from those two critical reviews were:

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

The study on acupuncture to prevent the re-occurrence of migraine headaches in patients without aura does not provide any evidence of the efficacy.

The authors of the trial we are going to look at today say that acupuncture has been proven have efficacy treatingrenal colic pain.

  • Kaymar M et al. Comparison of the efficacy of diclofenac, acupuncture, and acetaminophen in the treatment of renal colic. Am J Emerg Med. 2015;33:749–753.
  • Lee YH et al. Acupuncture in the treatment of renal colic. J Urol. 1992;147:16–18.

These were two small non-blinded trials that limit their conclusions of acupuncture being a reasonable alternative.

Clinical Question: In adult patients presenting to the emergency department with renal colic, is acupuncture superior to morphine for pain control?

Reference: Beltaief K et al. Acupuncture versus titrated morphine in acute renal colic: a randomized controlled trial. J Pain Res. 2018

  • Population: Patients greater than 18 years old presenting to a Tunisian emergency department with clinical suspicion of uncomplicated renal colic and a pain score greater than 70 (out of 100) on visual analog scale (VAS).
    • Exclusion: Complicated renal colic (bilateral pain, fever, and/or decreased urine output), traumatic pain, on anticoagulants, skin afflictions, unable to assess VAS, analgesics in 6 hours prior, refusal of consent and pregnant women.
  • Intervention: 30 minutes of acupuncture seating needles until deqi (numbness and tingling) was achieved using the urinary bladder meridian points.
  • Comparison: Titrated morphine chloral hydrate using a bolus of 0.1 mg/kg every five minutes until pain score reached 50% of baseline.
  • Outcome:
    • Primary Outcome(s): Success was a composite outcome of durability and rapidity
      • Durability: Drop in the VAS of at least 50% from baseline at 30 minutes and lasting to 60 minutes.
      • Rapidity: Time to a drop in the VAS of at least 50% from baseline.
    • Adverse Events:
      • Intervention: Local rash/bleeding, itching, needle blockage, and fainting.
      • Control: Drowsiness, dizziness, nausea and vomiting, respiratory distress, and hypotension.

Authors’ Conclusions: “In ED patients with renal colic, acupuncture was associated with a much faster and deeper analgesic effect and a better tolerance profile in comparison with titrated IV morphine.”

Quality 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. Unsure
  4. The patients were analyzed in the groups to which they were randomized. Unsure
  5. The study patients were recruited consecutively (i.e. no selection bias). Yes
  6. The patients in both groups were similar with respect to prognostic factors. Unsure
  7. All participants (patients, clinicians, outcome assessors) were unaware of group allocation. No
  8. All groups were treated equally except for the intervention. Unsure
  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: They consecutively recruited 119 patients to be included in this trial. The mean age was in the low 40’s with about a 50/50 split between men and women.

No difference in success rate but a statistical difference in resolution time favoring acupuncture.

There were some problems with the result section of the paper.

  • Success: No difference between groups (87% acupuncture vs. 83% morphine p=0.6)
    • Durability: Drop in the VAS of at least 50% from baseline at 30 minutes and lasting to 60 minutes – No statistical difference difference
    • Rapidity: Time to a drop in the VAS of at least 50% from baseline (14.5 +/- 7.8 vs 28.2 +/- 12.4 minutes, P<0.001)
  • Adverse Events:
    • Less adverse events in the acupuncture group (3) vs. the morphine group (42)
    • No serious adverse events reported

1) Randomization and Concealment – It is so important to have concealed randomization. There is the potential that randomization might not have been concealed in this study. They used sealed envelopes but did not mention if the envelopes were opaque. This opens up the possibility of the envelopes being opened and re-sealed or looked through to breach randomization. It is much better to have an electronic randomization system to assign patients to study arms. 

However, even if the randomization process was concealed there was no blinding of the participants and the providers. This absolutely introduces bias into the study such as the placebo effect and expectations.

2) Baseline Characteristics and External Validity –They reported common baseline patient characteristics that were similar between groups. A key characteristic they did not report was whether or not the patient had used acupuncture before and what their thoughts were about this treatment modality. Because there is such a strong placebo effect in acupuncture studies this should have been investigated and controlled for in the trial. Fifteen of the 153 consecutive patients refused to participate in the study. Was that because they did not believe in acupuncture and did not want to get randomized into that group?

This trial was conducted in Tunisia. The acceptance of acupuncture in Tunisia may be different that than in North America. There may be cultural issues that minimize applicability to patients in North America who may be conditioned differently or inherently biased about the effects of acupuncture. A key component of the placebo effect working is a belief in the treatment. Would the same trial done in North America or a society that is more skeptical of acupuncture produce the same results?

3) Outcomes – Their outcome measures were a little confusing. What was the primary outcome? They say the main outcome was success, defined as having two components. This would make it a composite outcome. We know that composite outcomes can be easier to demonstrate significance because you are creating a bigger target. However, their results did not demonstrate a statistical difference between the two groups (87% acupuncture vs. 83% morphine).

When they separated the two groups out they did show significant differences in the VAS at 60 minutes and the mean time to resolution. We will discuss that a little bit more in the fourth and fifth nerdy point.

When it comes to adverse events, there were many more in the morphine group with the vast majority being dizziness, nausea and vomiting. There were no events that were considered serious and no patients seemed to drop out of the trial due to the reported adverse events. They could have asked the patients in the morphine group if theside effects of the treatment were bothersome.

4) Statistical vs. Clinical Significance – It is generally accepted in pain research that a 13mm change in the VAS is the minimal amount to be considered clinically significant (Gallagher et al AEM 2001).  Given that the study was un-blinded and may have unbalanced groups this could represent bias in addition to the random noise in any data set.

There are ways to explore the statistical vs. clinical significance issue. How about asking the patient if they were satisfied with pain reduction? What group would they prefer to have been assigned? If they were having another attack of renal colic would they like the same treatment? These questions could have teased out whether or not the differences observed were patient oriented outcomes.

5) Comparison Group – Was this a Strawman comparison? I’m not sure whether morphine chloral hydrate dosing is equivalent to morphine sulfate but 16.7 mg total seems like a larger dose than I would typically use in the emergency department for renal colic. They also started the acupuncture at time zero and continued for 30-minute session.  So, the placebo effect would have kicked in immediately and been maintained for at least the 30 minutes while the acupuncture was being administered. In contrast, the control group got intermittent contact with morphine being titrated every five minutes. Could that have delayed or shifted the effect of the control group to the right on the x-axis of time? Even looking at the x-axis it does not look correct. The time between 0-10 minutes looks the same distance as between 45-60 minutes? The slopes of the two lines look the same. It looks like if you shifted the morphine results to the left by 10 minutes would it would over-lap the acupuncture line?

The Achilles heel of the trial was a lack of a sham acupuncture group. It has been demonstrated previously that there is no difference between “true” acupuncture and sham acupuncture. One trial showed that just putting toothpicks into a patients back could achieve the same efficacy as real acupuncture for (Cherkin et al Arch Intern Med 2009) for back pain. Without a sham acupuncture group, it is not possible to minimize the placebo effect.

Comment on Authors’ Conclusion Compared to SGEM Conclusion: We disagree with the authors’ conclusions. It was a flawed study, it does not represent a place in the emergency department analgesic armamentarium and does not deserve to be further investigated due to a lack of biological plausibility.

SGEM Bottom Line: This trial does not support the claim that acupuncture works or is superior to morphine for adult patients presenting to the emergency department.

Dr. Cordell Cunningham

Case Resolution: You give 10mg IV ketorolac for the pain and 8mg IV of ondansetron for the nausea. He is re-assessed in 30 minutes without much relief. You discuss using sub-dissociated does of ketamine to minimize the amount of opioid. He agrees and ends up having his pain resolved.

Clinical Application: Acupuncture is based on meridians that have never been proven to exist. This seriously calls into question the biological plausibility of manipulating meridians to improve qi (chi). The Bayesian pre-test probability of acupuncture working is very low and would require a large effect size to demonstrate efficacy. This is another low-quality study that does not demonstrate acupuncture is useful for acute pain. It is wrong to use the serious opioid problem to justify a therapy which has not been proven to work.

What Do I Tell the Patient? It would be great if acupuncture had been shown to work in renal colic. Unfortunately, there is no good evidence to support it being effective. We will try get your pain down using medications proven to work and even have some new options available that can minimize opioids use.

Keener Kontest: Last weeks’ winner was a repeat winner. It was Dave Lemonick from Pittsburgh. He knew that of the over 100 lawsuits Dr. Kline has reviewed alleging negligence because of failure to diagnose pulmonary embolism in the emergency department, zero percent of the cases involve the failure of a decision rule.

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

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