Altru Health System, Grand Forks, ND
Dr. Feldman reports no financial relationships relevant to this field of study.
- The authors of this multicenter Australian study sought to determine if acupuncture is at least as effective as conventional pharmacotherapy for acute pain relief in patients with low back pain, migraine, or ankle sprain in the emergency department (ED).
- They randomized 528 patients presenting with one of these complaints to receive either acupuncture alone, acupuncture plus pharmacotherapy, or pharmacotherapy alone.
- At one hour, acupuncture alone and acupuncture combined with medication were as effective in managing pain from acute ankle sprain and low back injury as pharmacotherapy alone. These modalities were not as effective as pharmacotherapy alone for migraine.
- None of the interventions were enough for full pain relief for the majority of participants at one hour post-admission. However, 48 hours after the ED visit, treatment satisfaction for the acupuncture and acupuncture plus pharmacotherapy groups increased from earlier measurements more than the pharmacotherapy group alone.
SYNOPSIS: In this study, researchers treated pain in the emergency department with acupuncture alone, acupuncture with conventional medication, or medication alone. They found acute efficacy was similar, although not optimal, for all modalities.
SOURCE: Cohen MM, Smit V, Andrianopoulos N, et al. Acupuncture for analgesia in the emergency department: A multicentre, randomised, equivalence and non-inferiority trial. Med J Aust 2017;206:494-499.
“Pain is whatever the experiencing person says it is, existing whenever he says it does.” Mary Margo McCaffery1
By nature, pain is a subjective and individual experience. It also is one of the most common presenting complaints in emergency departments (EDs) worldwide.2 The term oligoanalgesia, defined as undertreatment of pain, emerged in the medical literature in a landmark 1989 paper in which it was described as a major concern in acute settings.3 In subsequent years, efforts to measure and quantify, treat, contain, and manage pain rose to the forefront. The opioid crisis and cautions regarding dispensing narcotic pain medications have uncovered layers of complexity involved in the treatment of pain. Today, despite extensive knowledge and medical advances, pain continues to be treated less than adequately in most ED settings.4
Recognizing the challenges of treating acute pain in EDs and knowing that acupuncture is used to address pain in many outpatient settings, Cohen et al designed a study to determine if acupuncture alone or in combination with conventional medication was at least as effective as medication alone in addressing acute pain in the ED. The authors examined pain relief effectiveness for migraine, lower back pain, or ankle sprain within one hour after presentation to the ED.
Notably, this was both an equivalence and a noninferiority study. Equivalence studies are used most often to demonstrate that differences between the treatments are not large in either direction (more or less efficacious), while noninferiority studies are used more often to demonstrate that the intervention is not worse than standard treatment.5 In this study, equivalence was examined between acupuncture-only and pharmacotherapy-only arms; noninferiority was examined when comparing the combined treatment (medication plus acupuncture) with pharmacotherapy only and with acupuncture only. There was no placebo arm because of ethical constraints.
Pharmacotherapy was delivered via a protocol based on national guidelines and included first- and second-line agents. The protocol included the following as a first step for each diagnosis: nonsteroidal anti-inflammatory drugs (NSAIDs), including ibuprofen (400 mg), acetaminophen with or without codeine (500 to 1,000 mg paracetamol), or tramadol (50 to 100 mg). Specific interventions for each diagnosis included diazepam (5 mg) for lower back pain and metoclopramide for nausea associated with migraine. Rescue medication, including opiates for additional pain control, was administered to any participant at any time (regardless of group) if the provider deemed it necessary. Acupuncture was delivered in a standardized fashion with some individualization permitted. All acupuncturists were certified; four geographically diverse hospitals were selected for the study, so multiple acupuncturists were involved.
Pain was evaluated via a 10-point verbal numerical rating scale (VNRS), with a minimum score of 4 needed to qualify for the study. Pain scores were recorded hourly until discharge. Follow-up phone calls assessed pain up to 60 hours’ post discharge. Pain relief to a score of < 4 was considered clinically relevant, while dropping a score > 2 points was considered statistically significant. According to the authors, a difference of at least 1.5 VNRS units between groups was clinically significant and indicated nonequivalence.
The authors identified several secondary outcome measures, including level of functional impairment at 48 hours after discharge, use of rescue medication, adverse events, acceptability of treatment, and overall use of health resources.
Of 1,964 patients assessed, 528 eligible patients were randomized into one of the three treatment arms. Eligibility criteria included age (older than 18 years of age), ability and willingness to provide consent, and absence of acute major trauma or suspected infection.
Tables 1 and 2 review the number of participants for each diagnosis and each treatment arm. Treatment arms were randomized within each diagnosis. Note that treatment group percentages remained consistent throughout the study. For example, 31.4% of total patients presented with ankle pain and 31% of the total patients receiving any one of the three interventions presented with ankle pain. See Table 3 for select outcomes.
The acupuncture-only group received significantly more rescue medication. (See Table 4.) Satisfaction with treatment increased for all interventions from one hour to 48 hours after admission. Willingness to repeat the treatment increased from one hour to 48 hours after admission for the combined group and the acupuncture-only group. (See Table 4.) About 50% of participants in each treatment arm had an adverse event associated with the intervention. There was no statistical difference in this area among the treatment groups, and no further information was provided delineating the specific adverse events.
These results are best understood by looking closely at the context, setting, and goals of the study. The ethical constraints involved in randomizing treatment in the high-stakes, fast-moving ED setting presents barriers to design. Cohen et al explained that these barriers led to the use of equivalence and noninferiority parameters rather than a traditional randomized, controlled study. Yet, this design presents several challenges in interpretation. For example, did interaction with the acupuncturist influence pain relief? Would placebo medication combined with acupuncture have been as effective as conventional medication and acupuncture? It is important to know the answers to these questions before creating definitive treatment recommendations. Conclusions drawn from this study are limited to the parameters of equivalence and noninferiority.
Additionally, ethical concerns allowed the use of rescue medication at any point in the study at the discretion of the treating provider. A full 25% of the acupuncture-only group received rescue medication during the first hour after admission to the ED (compared with 19% of the overall group; P= 0.016.) It is not clear how quickly acupuncture or any of the studied interventions were administered during that first hour. The use of rescue medication essentially moves a significant portion of the group out of acupuncture-only and into the combined group, but presumably with a different algorithm or process than the members of the combined intervention group (who received medication on a predetermined schedule.) Clearly, pain management had to be achieved. However, it also is true that it is more difficult to control pain on a “prn” basis, and different providers will have varying biases and thresholds for intervention. These factors influenced the standardization of methodology in this study and lead to questions about the results.
Complicating matters further, Cohen et al chose to include three diagnoses and four settings. This allowed the study to gain strength from diversity of population as well as potential applicability to a variety of conditions. On the other hand, geographical diversity sacrificed control over specific providers. Given the subjective nature of pain, the specific ED provider and variations in the acupuncturist’s skill may play a role in the patients’ experience of pain; the extent or effect of this cannot be determined by this study.
Looking at three different diagnoses opened the study to more participants. Although it is true that equivalence studies are more powerful as the number of participants increases, the study is most credible when the diagnoses are looked at individually rather than grouped. Looking at individual diagnoses decreases the number of subjects and the power of the study to detect subtle but significant differences in results. Cohen et al acknowledged that the relatively low number of participants in the migraine group (91, or 17% of the total) may have affected results. A higher number of patients with migraine may have shifted the grouped results or may have narrowed the confidence limits within the migraine results. This is clearly an avenue for further exploration.
Although Cohen et al stated that satisfaction with treatment was a secondary goal of the study, these results are interesting and deserve a close look. Patients were contacted 48 hours after treatment and asked about their willingness to repeat the intervention. The percentage of participants who received acupuncture only or combined treatment and expressed a “definite yes” when asked about willingness to repeat increased from 47% at one-hour after ED admission to 61% 48 hours later for the acupuncture-only group and from 49% to 57% in the combined treatment group. When the pharmacotherapy-only participants were asked the same question, the “definite yes” response rate dropped from 57% at one-hour after admission to 52% 48 hours later. Although none of these results shows statistical significance, it is notable that willingness to repeat a treatment may change over time, the change may be toward more acceptance, and the shift may be influenced by a variety of factors. This is another area for future study and investigation.
Cohen et al noted that patients with an overall mean pain score of 6.7 one hour after ED admission reported that pain was not treated satisfactorily with any of the interventions. Additionally, they noted scores < 4 one-hour after admission (where < 4 is clinically relevant relief from pain) occurred in only 16% of the total group. Yet, 50% of participants felt comfortable enough one hour after admission to say they definitely would repeat the same treatment. This apparent contradiction may lead to questions if quantification of pain is enough to access patient satisfaction or even comfort. It may be that for some patients, remaining with a degree of pain was preferable to experiencing further intervention or medication.
This study suggests several promising areas for future research as well as clinical applicability in the interim. For example, the results of the largest diagnostic group (low back pain group; n = 270) are worth a second look. Acupuncture alone in an acute setting showed equivalence to conventional psychopharmacology, which can be useful to know when offering treatment to this population. Costs and availability of acupuncture in local EDs may be a temporary barrier that can be overcome with education, more studies, and continued efforts toward insurance reimbursement models.
This study reminds providers to be cognizant of the subjective nature of pain and especially to note that for some, patient satisfaction does not require complete pain control. In addition, although some of the methodologic shortcomings detract from the results, it is clear that many patients (at least in this population) are willing to consider acupuncture as a treatment for pain in the ED. More than 50% of these patients stated willingness to repeat this intervention. These findings alone are compelling and deserve a thought when considering pain control in acute settings.
- Pasero C. In memoriam: Margo McCaffery. Am J Nurs Available at: https://journals.lww.com/ajnonline/Fulltext/2018/03000/In_Memoriam___Margo_McCaffery.14.aspx. Accessed Sept. 10, 2018.
- Samcam I, Papa L. Acute pain management in the emergency department. Pain Management Milica Prostran, IntechOpen, doi: 10.5772/62861. Available at: https://www.intechopen.com/books/pain-management/acute-pain-management-in-the-emergency-department. Accessed Sept. 10, 2018
- Wilson JE, Pendleton JM. Oligoanesthesia in the emergency department. Am J Emerg Med 1989;7:620-623.
- Pollack CV Jr, Viscusi ER. Improving acute pain management in emergency room. Hosp Pract 2015;43:34-45.
- Walker E, Nowacki AS. Understanding equivalence and noninferiority testing. J Gen Intern Med 2011;26:192-196.