Summary: One of the widely circulated studies, the OPAL study, demonstrated that opioids are of little use for low back and neck pain. However, many health experts have questioned the findings of this study. The study was done using oxycodone in moderate dosages along with naloxone (known to block the effects of opioids). Further, the study was done in moderate intensity pains. The strange choice of the drug and patients shows that the study cannot be generalized.
It is true that opioids have many side effects, and they are addictive. However, this is not always the case. Many patients have experienced significant pain relief and improved quality of life after opioid use.
However, in recent years, there has been much criticism regarding the widespread opioid use. This also resulted in many researchers carrying out clinical studies that did not find much benefit from opioids.
Since many individuals and regulatory bodies have already been critical of widespread opioid use, these studies were readily accepted as authoritative. However, some researchers are now raising questions about these studies. It appears that many such studies were faulty by design, or they have wrong conclusions.
Many Patients Hurt
One of the most popular studies has been the OPAL study, which was published in one of the most reputed journals, The Lancet. Thus, the study was widely quoted and discussed. It was quickly accepted as an authoritative source.
The study was done from Feb 2016 to March 2022, and 347 participants were divided into two groups. Out of them, about 300 participants finished this study. These participants were divided into two groups, with one receiving slow-releasing oxycodone (opioid) plus naloxone and the other group receiving a placebo.
The study did not find any differences in the pain scores in the patients after 6 weeks. Thus, those on oxycodone and those on placebo both reported similar kinds of pain relief. Hence, the authors of the study questioned opioid use. Moreover, the opioid group was more likely to experience side effects.
The study was done in patients with low back and neck pain. The authors of the study concluded that there are no reasons for using opioids in lower back and neck pain – two of the most common severe pain syndromes.
However, one of the letters written to the journal editors has raised concerns. It appears that the study had some major flaws. It used slow-releasing oxycodone with naloxone, a very uncommon choice of drug. Therefore, critics say that the findings of the study cannot be generalized in any way for other opioids.
Further, critics also questioned the choice of patients. Most of those who participated in the study did not have severe acute or early-onset pain. Most participants had low pain scores. Opioids, on the other hand, are more effective for those with acutely severe pains.
There are some other flaws in the study, like the use of a lower dose of oxycodone. Further, using naloxone along with oxycodone can block the effects of opioids, resulting in lesser pain relief.
Many health experts have also noted that OPAL study findings have also been submitted to the FDA, asking them not to conduct or approve studies regarding opioids. This will prevent approval of newer, more potent, and safer opioids, causing much harm to the patients.
Thus, many healthcare specialists and critics are saying that studies like OPAL are creating unjustified “opioid phobia.” This would ultimately harm the patients, as many of those living with severe pain might not be able to receive adequate opioid addiction treatment.
The authors of this letter criticizing the OPAL study say that it is regretful as such studies will make prescribing opioids more difficult. It will further promote policy changes. Ultimately, many of those living with painful conditions would suffer.
Source:
Jones, C. M. P., Day, R. O., Koes, B. W., Latimer, J., Maher, C. G., McLachlan, A. J., Billot, L., Shan, S., Lin, C.-W. C., McLachlan, H., Webb, M., Hamilton, M., Ahedi, H., Barber, A., Mak, W., Mathieson, S., Petrova, V., Bompoint, S., Shan, S., … Yang, S. C. (2023). Opioid analgesia for acute low back pain and neck pain (the OPAL trial): A randomised placebo-controlled trial. The Lancet, 402(10398), 304–312. https://doi.org/10.1016/S0140-6736(23)00404-X
Weisman, A., Eubanks, J. E., & Masharawi, Y. (2024). Opioids for back and neck pain: The OPAL trial. The Lancet, 403(10442), 2377–2378. https://doi.org/10.1016/S0140-6736(24)00483-5
