BOSTON — A novel "blended therapy" may help pain patients who are taking high doses of opioids to reduce their intake to safer levels without reducing efficacy or causing withdrawal symptoms, preliminary research suggests.
In a small study, participants received blended therapy consisting of hydroxyzine pamoate and codeine plus ondansetron, gabapentin, and docusate.
"There were no side effects, no withdrawal, and a decrease in pain," Dennis J. Bonner, MD, St. Mary Medical Center and Bonner Pain Management, Levittown, Pennsylvania, told Medscape Medical News.
The study was presented here at the Academy of Integrative Pain Management (AIPM) Inaugural Global Pain Clinician Summit 2018.
In the wake of the opioid epidemic, the Center for Disease Control and Prevention issued a guideline suggesting that clinicians reduce a patient's morphine milligram equivalent (MME) to below 90.
Clinicians are now looking for ways to reduce the amount of opioids their pain patients are taking to this recommended level, said Bonner.
"That means either serious withdrawal, serious weaning, where patients get sick, or they can switch them over to this blended therapy," he explained.
The patented combination includes a maximal dose of codeine and other medications that boost pain relief or block adverse effects.
The blended therapy, which is compounded and delivered in capsule form, consists of the following:
Codeine phosphate 120 mg;
Hydroxyzine pamoate 100 mg (hydroxyzine pamoate is an antihistamine used as a sedative to treat anxiety and as an anesthetic);
Ondansetron 4 mg to treat nausea and vomiting;
Gabapentin 300 mg to prevent seizures; and
Docusate 100 mg to treat or prevent constipation.
Bonner noted that his aunt, who was a pharmacist, used hydroxyzine in the 1960s to treat patients who could not afford more expensive pain-relieving therapies.
"We're using an old technology that's been forgotten about and reintroducing it in a different way," he said.
When used with other therapies, hydroxyzine can enhance the effect of opioid drugs. The combination "decreases the narcotic load but increases the efficacy of the narcotic, so patients get the pain relief and don't get the withdrawal," Bonner reported.
The study included 20 of Bonner's patients. The patients ranged in age from the mid-twenties to the mid-fifties; there were about an equal number of men and women.
All of the participants had had chronic pain for years. The primary source of pain included failed surgeries, workplace accidents, and serious automobile accidents.
Many of these patients were receiving up to 350 MMEs, which is "a very high dose of narcotic," said Bonner. Some were taking morphine or oxycontin or were using extended-release transdermal fentanyl patches.
While the patients were still taking their normal opioid dose, they were asked to rate pain levels on a 10-point scale. They were then switched to the blended therapy. After 2 days, they were again asked to report pain levels.
For some patients, the need for high doses of opioids "dropped immediately," from 360 MMEs to 54 MMEs, "which is low and under the recommended safety numbers," noted Bonner.
Bringing a patient's "very dangerous" dose of narcotic to such a low level decreases the risk for overdose and death, he added.
A statistical analysis in which pain scores during initial opioid use were compared to those after introduction of the blended therapy showed a significant difference. For some patients, the pain score was cut in half or even by two thirds. One patient's score decreased from 6 to less than 2.
In the days after the switch to the blended formulation, "none of the patients had serious withdrawal," Bonner reported.
Asked if this combination avoided some side effects but introduced others, he said "all medications have side effects."
Bonner now plans to increase the number of patients in the study. "We will have another 10 patients to include very soon," he said.
Commenting on the findings for Medscape Medical News, Clayton Jackson, MD, president of the AIPM and clinical assistant professor of family medicine and psychiatry, University of Tennessee College of Medicine, Memphis, said he found the study interesting.
"The idea that in combining different drugs, patients may be able to reduce their opioid equivalent but still have adequate pain relief is fascinating," he said.
Jackson cautioned that patients metabolize codeine differently, so not all patients would benefit from this combination approach.
"But certainly, in this small sample size of patients, it was found to be effective," he said.
Dr Bonner is the creator of the combination pain formula and has a financial interest in T Baxter Inc. Dr Jackson is a consultant for Otsuka Pharmaceuticals and Aspire Healthcare.
Academy of Integrative Pain Management (AIPM) Inaugural Global Pain Clinician Summit 2018. Abstract 1, presented November 9, 2018.
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Cite this: Novel 'Blended Therapy' May Help Cut High-Dose Opioid Use - Medscape - Nov 19, 2018.