8. Group Paper

Comparing Alternative Methods to Opioids for Chronic Pain

By: Salma Ahmed, Shamira Bernal, Zhuolin Chen, Stephanie Torres, Mayra A Palencia 

Abstract

Over the last 2 decades the use of opioid prescription medication has increased dangerously. Combined with lack of education, misinformation and the ease of a simple prescription, opioid misuse has reached the point of crisis. What this means for society is increased mortality amongst the populations of users and increased costs for the U.S in relation to healthcare and legal fees such as incarceration. In 2017 an estimated 47,600 people died from an overdose involving opioids and approximately $78.5 billion a year is what the U.S is spending in costs related to opioid use. This paper intends to address one of the sources of opioid prescriptions and compare alternative methods that could potentially decrease usage. Chronic non cancer pain is a major source of the opioids being prescribed today. Two separate studies will be reviewed and evaluated on the success and potential use as an alternative or adjunct to opioid-like medication. Medical cannabis programs were implemented in the first study that will be discussed  in New Mexico with the purpose of finding if MCPs in chronic pain patients would decrease opioid prescriptions. A final total of 37 patients with chronic back pain were involved in the study that enrolled in an MCP and 29 patients for the comparison group that also had chronic pain but did not enroll in an MCP. Records were retrieved from both groups for a 21 month period spanning from 3 months pre-enrollment through 18 months post enrollment. Ultimately results proved that MCP patients significantly reduced their daily opioid prescription dosage, and even ceased to fill their opioid prescription altogether. The second study that is discussed was designed to determine if a short course of acupuncture will improve long term outcomes in patients with chronic lower back pain. In this study a total of 241 patients with non specific lower back pain were recruited to participate in which 160 received acupuncture therapy and 81 did not. Of those patients who received acupuncture therapy they were asked to evaluate their pain at 12 and 24 months and although the statistical significance of this study wasn’t strong, participants did report feeling an improvement in their pain at 24 months which yields the possibility of its use as an alternative or adjunct therapy that we are searching for. 

INTRODUCTION

Chronic non-cancer related pain has become a growing medical issue in adults, as of 2016 an estimated 19% of adults suffer from persistent pain ( Penney., Ritenbaugh., Debar., Elder & Deyo., 2016., p.1). The rise in chronic pain patients have led to the increased use of prescription opioids in the U.S over the last 2 decades. There are several causes for the escalation of prescribed opioids for example, aggressive marketing from pharmaceutical companies and misleading information regarding abuse and addiction potential (Meir 2019). Physicians as well as the patients were led to believe that opioids were safer than they actually were. In addition, some argue that it is easier to prescribe opioids for pain than any other alternative forms of care or medicine, it is accepted as a standard treatment for chronic pain and pressure on physicians to avoid undertreatment of pain all play a role in the rise of prescription opioids (Penney., et al, 2016, p.1). A combination of fear and lack of effort to source alternatives has led to the current opioid crisis and in turn motivated research for better alternatives for chronic pain management. The studies that will be discussed expand on specific alternatives, medical marijuana and acupuncture, to opioids in the treatment of chronic pain. These studies were important and worthy of conducting due to the rise in opioid use and dangerous adverse effects that could potentially be avoided with other forms of treatment. As of 2017 opioid related drug overdoses were the leading cause of preventable deaths in the U.S killing approximately 91 Americans everyday (Vigil., Stith., Adams & Reeve., 2017, p.2). Additionally, the National Institute on Drug Abuse reported the opioid epidemic is costing the U.S approximately $78.5 billion a year in health care, lost productivity, addiction treatment and more ( Vallet., 2019, p.1).  In Vigil’s study on the associations between medical cannabis and prescription opioid use a unique factor was the use of Medical Cannabis Programs (MCPs) . MCPs are self managed by patients once enrolled and they are in direct conflict with the United States federal law which makes it difficult for researchers to measure efficacy. In this study surveys were used along with data from opioid prescriptions filled over an average of 20 months in order to maneuver around federal law. The hypothesis guiding Vigil’s study is that the implementation of MCPs in chronic pain patients will decrease opioid prescriptions which in turn lower opioid related mortality rates and improve quality of life as well as other factors. The specific purposes of this study were to show the correlation of patients with chronic pain prior to enrollment in MCPs and opioid prescription patterns after enrollment along with patients who declined enrollment altogether. Vigil and his colleagues were seeking patterns that could potentially be a positive shift for chronic pain patients with the use of MCPs. In Thomas’ acupuncture study one of the unique factors was the prior expectations and beliefs of patients that were documented and compared. Before randomization expectations of improvement in condition had a positive treatment effect in both groups (Thomas., MacPherson.,Thorpe., Brazier., Fitter., Campbell., Roman., Walters., Nicholl., 2006). The hypothesis guiding this study was to determine if a short course of acupuncture will improve long term outcomes in patients with chronic lower back pain for the purpose of creating  a sufficient and safe alternative to traditional pain treatments. 

               METHODS

Associations between medical cannabis and prescription opioid use in chronic pain patients: a preliminary cohort study:  

Study 1: 

This study was approved by the Institutional Review Board at the University of New Mexico. This experiment was conducted using a historical, cohort research design, then measured the effect of enrollment in the New Mexico MCP (medical cannabis program) on opioid prescription patterns in response to patient reports of changes in pain reduction and improved quality of life among enrollees. New Mexico permits medical cannabis use only for patients with certain debilitating medical conditions. All patients in this study had a diagnosis of “severe chronic pain” which was validated yearly by two independent physicians.(Vigil., Smith., Adams., & Reeve., 2017, p 3) Also patients had to have a physician’s referral to be able to enroll in the MCP.

This study was designed by thirty seven opioid using patients that were diagnosed with severe chronic pain. The opioid using patients had a mean age of 54 years old and 54% of the patients were male and diagnosed with 86% chronic back pain enrolled in the MCP between 04/01/2010 and 10/03/2015 were compared to 29 patients that were not enrolled had a mean age of 60 years and 69% of them were male with 100% chronic back pain. Prescription Monitoring Program opioids were used for over a 21 month period to measure the absence of opioid prescriptions activity , and to measure reduction. MCP patients reported benefits as well as the side effects of using cannabis were collected. The independent variable in this study would be the administration of cannabis treatment. The dependent variable, which is being measured, is the intensity of back pain. 

Patients were able to self-manage the potency, frequency and the particular type of cannabis that they wanted to use such as the strain of whole dried food, edible or extract which took place of pharmaceutical medication. Patients enrolling in the MCP did not have direct medical supervision for their cannabis treatment they also were not given instructions for changing their opioid prescription usage, whether it was to reduce or increase.

The MCP patients that participated in this study were recruited to complete a survey which was in regards to their experience with the MCP to renew there MCP license. 

A comparison group was created which consisted of patients from the same rehabilitation clinic that met the original criteria necessary to enroll but declined the invitation to participate in the MCP. For these patients no cannabis was used which was made sure by random urine analysis that were conducted every six months during the observation period. This comparison group consisted of 53 non-enrolled patients whose records of their prescribed medications were retrieved over the 21 month period. 

The initial pool which consisted of 146 MCP and 53 non-MCP patients , sample only patients were included filling two opioid prescriptions during the three months before they were enrolled in MPC. 87 MCP patients as well as 15 patients in the comparison group did not fill opioid prescriptions at all within those 3 months prior which were then excluded from the analysis. Also, 18 MCP patients along with 9 comparison group patients filled only one opioid prescription during those 3 months prior which also lead to them being excluded from the analysis. There was one patient who was diagnosed with rheumatoid arthritis who was also excluded from the MCP group due to the fact that they had an inflammatory rather than musculoskeletal disorder. Another 3 MCP patients were also dropped as outliers due to them receiving maximum doses of over 200 mg IV morphine. 

The final sample resulted in 37 MCP patients who suffered through chronic musculoskeletal and predominantly back pain disorders and 29 comparison group patients.  A logistic regression model was used to estimate the effect of MCP participation on the cessation of prescribed opioids also observed if the patients decreased or reduced their average prescribed dosages between the first three months which are pre-enrollment for the MCP  and the last three months of the study. A least squares approach was used to observe the effect of patients participation in the MCP on the percentage change in opioid prescription. That same approach was also used to analyze the monthly change in the daily dosage of IV morphine within the MCP participation. 

Study 2: 

In an open randomized controlled trial, Thomas et al. recruited 241 study patients aged 18-65 with non-specific low back pain of 4-52 weeks’ duration who were assessed by their general practitioner as suitable for primary care management. The independent variable in this RCT is the administration of traditional acupuncture. These study subjects are randomized to receive either individualized traditional acupuncture treatments from one of six qualified acupuncturists (160 patients) or usual care only (81 patients). The experimental group received acupuncture care of up to 10 individualized treatment sessions over three months from acupuncturists who were registered with the British Acupuncture Council using disposable needles. The control group received National Health Service treatment according to their general practitioner’s assessment of need. Usual care includes exercise classes, manual therapy, psychological support and surgery. 

To measure the dependent variable, the intensity of low back pain, the researchers took various outcome measures. The primary outcome was the bodily pain dimension of the SF-36 at 12 and 24 months, scored on a 0 to 100 (no pain) scale, which assesses pain experienced in the past four weeks and has been validated for use in primary care and in patients with back pain. After three months, the protocol was amended to include economic data and additional clinical end point at 24 months. In addition, the secondary outcomes were scores on the Oswestry pain disability index, the McGill present pain index, and the seven remaining dimensions of the SF-36 health status questionnaire. Each secondary outcome was measured at baseline and at 3, 12, and 24 months.

Randomization was completed through a computer-generated, blocked randomization sequence provided by the study statistician. The study subjects received their treatment assignment by telephone. Treatment allocation was transparent to both participants and researchers in the open RCT, but analysis of the primary outcome was completed by another statistician who was blind to treatment assignment.  

Data analysis was achieved using statistical analysis software. Using SPSS version 11.5 and Stata version 8, covariance for outcomes at 12 and 24 months was analyzed with baseline SF-36 pain scores as a covariate. Sensitivity analysis was carried out using a complex regression model comprised of baseline covariates observed to affect outcomes at three months. Exploratory analysis was conducted through the analysis of covariance to study the interaction between the analgesic effect of acupuncture and patients’ expectations of pain alleviation and belief in acupuncture’s effectiveness. 

RESULTS 

Study 1:

  In“Associations between medical cannabis and prescription opioid use in chronic pain patients: A preliminary cohort study” by Jacob M. Vigil et al. Their research showed that MCP (medical Cannabis Program) had a significant reduction in the daily opioid prescription dosage, and even ceased to fill their opioid prescription altogether. MCP patients reduced their dosage by 47 percentage points. There was a significant reduction in ceased opioid prescriptions (p <0.001, reduction of 15%), reduction in prescribed daily opioid dosages ( p=0.001, 31% reduction), and a reduction in percentage point change in prescribed daily opioid dosage ( p=0.013),  Meanwhile, the comparison group increased their dosage by 10 percentage points.

MCP patients appeared to have started with higher doses than the comparison group, but as time progresses from 1-17 months there was a significant decrease in opioid dosage (p= 0.015). In the first 4-6 months of the study there was no significance in the time reduction in prescribed daily opioid dosages amount MCP participants, but after the 9th month, there was a  decrease of dosage from months 10-12 by 9.67 mg, (p=0.016), months 13-15 by 8.88 mg (p=0.025), months 16-18 by 10.15 (p=0.013), and months 9-21 by 11.43 (p=0.006) The comparison group on the other hand stayed flat or may have also increased slightly. The average MCP patient was prescribed 11.43 mg fewer of morphine per day than their pre-enrollment period.

         Regarding pre-to post-enrollment participants, they were given as survey to measure their pain, quality of life, and side effects of using cannabis one-year post- MCP enrollment, and their enrollment, the respondents reported that there was a reduction in pain that was statistically significant in  Pain reduction from Cannabis usage (p=<0.001). Participants also did not report serious side effects from cannabis use. The effects of medical Cannabis on quality of life, special interactions, activity levels and concentration, showed no patient reported negative or extremely negative effects on quality of life, or social life. Only 3 participants did not report “good” or “great benefit” on activity level, and the majority of the participants reported an improvement in concentration prior to enrollment of MCP. 

Study 2:

 In “Randomized controlled trial of a short course of traditional acupuncture compared with usual care for persistent non-specific low back pain” by K J Thomas et al, their results showed that there was a decrease in pain when participants had acupuncture done in a span of 24 months, and there was a statistically significant difference found between the groups that had acupuncture and no acupuncture. The participants that were in the acupuncture group had better scores in the Oswestry Pain Disability Index and the McGill Present Pain Intensity Measure. The Oswestry Pain Disability Index is a questionnaire used to assess acute lower back pain in patients and is widely used by physical therapists. (Fairbanks, 2008). The McGill Present Pain Intensity Measure is a self report questionnaire in which patients rank their pain from 0-5, 0 being no pain and 5 being severe pain, and is the most frequently used questionnaire to assess pain. (Melzack 2005). Thomas’s participants showed acupuncture treatment group felt much better after treatment, at 24 months of treatment (p=0.04) and they also stated that it helped with their back problem (p=0.07). Even though the statistical significance of this study wasn’t strong, it still showed that patients responded well to acupuncture to help manage back pain. 

                                                                 DISCUSSION 

Author’s main conclusion was that although their current study was limited, the results portray a significant reduction or cessation of opioid use after patients were enrolled in Medical Cannabis programs. Moreover, author stated how they were able to create new sources in order to develop the theory of using cannabis in order to treat patients with chronic pain. Thus, one potential factor that concerned them was how patients were legally allowed to self-manage the amount of cannabis they consumed. Nevertheless, studies showed how some  MCP enrollees were able to reduce their opioid prescription dosages and how others were able to end their need of opioid prescription after 18 months of being admitted. Furthermore, studies displayed how patient’s chronic pain reduced and felt as though their quality of life improved. However, the author explained that while the side effects of utilizing cannabis appears to be non-serious(e.g. Dizziness and confusion), it is recommended for adult patients to use Cannabis sativa ; as it is safer for long term use and does not increased risk of mortality in patients. Some limitations were found in their study, for example, not being able to randomly select a specific group of patients, rather patients were self-selected and had the choice to refuse treatment without being advised of the benefits. Another limitation was not having full access to the data that was conducted during the treatment, as only patients who renewed their MCP licenses results were shown in the database. Also, the author explains how they were unable to conduct studies on whether patients were already trying to reduce their opioid treatment before they were enrolled in the clinic.Therefore, future investigations should target rate of changes of medication use while controlling current social environment as their study was limited due to certain laws they had to follow in order to conduct the experiment. Also, include additional data of how medical cannabis can serve as an alternative method to treat patients with chronic pain rather than utilizing opioids; so, the U.S Congress could consider implementing cannabis as a tool to treat the current opioid epidemic. Acupuncture was also found to treat non-specific low back pain for long term treatment. Author’s main conclusion was that weak evidence was found on patients that underwent a short-term treatment for low back pain, however, patients that underwent 24 months treatment found some benefits as they were satisfied with the acupuncture treatment and reduced their consumption of painkiller medicine. Moreover, some limitations that affected their data was an effect of clustering by practitioner, since the clustering analysis displayed little difference of patients that were treated for 12 months versus patients that were treated for 24 months.  Author added that even though utilizing acupuncture was beneficial , other components that strengthen the therapy was the special care patients received from acupuncturists like massage, advice on diet and exercise; as patient reported a relaxing experience from the treatment. Further studies should include more evidence for long-term effects, as patients tend to seek help only when they are in pain , once the pain is “relief” patients stop going to therapy; which is a huge mistake as the pain will come back.

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