Artificial Intelligence's Role in Predicting Pain Relief: Published Results from the RELIEF Study

FLORHAM PARK, NJ / ACCESSWIRE / July 26, 2021 / Hisamitsu America, the marketers of Salonpas^®, announce today that Anesthesia & Research, an international, peer-reviewed scientific journal features the publication, in June 2021: 'Personalized Pain Therapy: Artificial Intelligence (AI) Utilized to Predict Patient Response to OTC Topical Analgesics," an exploratory pain management study based on data from the previously published RELIEF study.

"Topical analgesics have shown efficacy for patients experiencing mild and moderate pain," said Dr. Jeffrey Gudin, the Principal Investigator of the RELIEF study who is board certified in pain management, anesthesiology, addiction medicine and palliative care. Dr. Gudin serves as faculty at the University of Miami, Miller School of Medicine - Department of Anesthesiology, Perioperative Medicine and Pain Management. "However, due to high variability in patient demographics, clinical profile and analgesic response, identifying the most suitable treatment for pain patients is often challenging. Artificial intelligence and machine learning techniques have the potential and have shown promise in individualizing medical treatments. Our hypothesis was that applying machine learning with select data from clinical trials may enable clinicians to predict treatment response. This would prove invaluable in maximizing medication effectiveness while potentially minimizing the adverse effects associated with many analgesics."

Patients & Methodology:

Data was evaluated from 186 pain patients enrolled in the International Review Board (IRB)-approved RELIEF study after use of a topical pain-relieving analgesic patch for 14 days. A novel interpretable machine learning method was developed based on a multi-objective ensemble classification/regression technique. Data was expanded to increase predictive accuracy with pre-and-post-modeling techniques to raise interpretability. 85 features were identified that allowed calculation of data between testing and training groups.

Data from the RELIEF study was used to individualize the topical analgesics therapy by training and testing prediction models to evaluate which chronic pain patients would benefit from treatment with the Salonpas® Pain Relieving Patch, which contains methyl salicylate (10%), Menthol (6%) and Camphor (3.1%). Three different endpoints were examined in the study including the changes in total pain severity, total pain interference and total analgesic drugs used before and after the treatment from day 0 to day 14.

The RELIEF dataset was composed of data for 186 chronic pain patients. 89% of participants improved their total pain severity and total pain interference status and 42% reduced the total number of analgesic drugs used after the patch study treatment was employed.

"The machine learning model demonstrated that predictions of positive response could have been made prospectively for patients that had benefit from the topical pain-relieving patch," says Dr. Gudin. "Our results demonstrated that machine learning models were able to predict endpoints with high accuracy, suggesting that this predictive analytic methodology can be applied to separate and larger datasets and used retrospectively to analyze whether a certain treatment can be effective in a given population."

"Our mission is to provide people in pain with clinically proven topical analgesics and practitioners with the clinical proof they need to confidently recommend our products for their patients. This research suggests today's technology may provide the possibility for better patient outcomes for those in pain" said John Incledon, the President & CEO of Hisamitsu America Inc.

Based in Narragansett, Rhode Island, Clarity Science, LLC conducts scientifically rigorous and valid research that advances innovation in science and ultimately helps healthcare professionals provide improved patient care, leading to improved patient health worldwide.

Hisamitsu America provided a grant to Clarity Science to administer and conduct the IRB-approved study to collect data on patient outcomes for Quality of Life (QoL) components, pain relief scores and assessment of severity of pain and its impact on functioning, patient satisfaction, and an evaluation of differences, reported medical conditions and other prescribed or OTC oral medications commonly associated with pain.

About Hisamitsu America:

Hisamitsu America is the US division of Hisamitsu Pharmaceutical Co., Inc., founded in 1847, which has specialized in transdermal drug delivery system technology since the introduction of its Salonpas line of patches in 1934. The Salonpas^® product line, which gained early acceptance in Asia and is now registered in over 30 countries, has pioneered the development of transdermal patches to relieve pain. Since 2010, Salonpas has become one of the fastest growing OTC brands in the USA. Salonpas became the most popular pain relief brand on Facebook in 2020. For more information, https://us.hisamitsu/.

Media Contact: Nancy Thompson, Vorticom, Inc. 212.532.2208 (o), 917.371.4053 (m); nancyt@vorticom.com

SOURCE: Hisamitsu America

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