Clinical trials examine effectiveness and efficacy of integrative medicine

Photo Cred: Pexels/Rodnae Productions

By Linda Childers

At University Hospitals (UH) Connor Whole Health in Cleveland, Ohio, Jeffery Dusek, PhD, director of research, is leading a multi-center study of acupuncture being used in the emergency department (ED) to manage pain and reduce exposure to opioid medications.

The study, funded by a $2 million grant from the National Center for Complementary and Integrative Health of the National Institutes of Health (NIH), is one of many clinical trials taking place across the country examining integrative medicine modalities that complement conventional clinical practice.

“We’ve seen patients in the ED readily accept a referral for adjunctive acupuncture and report less pain after acupuncture,” said Dusek who hopes the clinical trial will provide critical evidence to support the inclusion of acupuncture in EDs across the country.

While opioids are traditionally prescribed for pain, Dusek said they aren’t always necessary or clinically appropriate.

“Pain accounts for 78 percent of patient visits to the ED and opioids are often prescribed despite risks of addiction and adverse effects,” Dusek said. “Many physicians are tired of narcoticizing patients and are seeking non-pharmacologic options for pain.”

By partnering with the BraveNet Practice-Based Research Network, Dusek’s clinical trial is looking specifically at how acupuncture can help patients presenting in the ED with acute non-emergent musculoskeletal, back, pelvic, noncardiac chest, abdominal, flank, or head pain.

Dusek said he and his colleagues at University Hospitals (UH) Connor Whole Health have also examined how music therapy can improve the quality of life for adults with sickle cell disease (SCD). In an April 2022 paper published in the Journal of Pain Research, Dusek and his colleagues examined how a six-session music therapy session could improve self-efficacy, quality of life, and coping skills in adults with SCD.

“SCD is an incredibly painful disease and our research showed that music therapy effectively provided SCD patients with relaxation, pain reduction, and improved quality of life,” Dusek said. “While we plan to do more research to determine the efficacy of music therapy for SCD, the initial results were very promising.”

Many other researchers are looking at the role that music therapy plays in pain control. One study, published in the journal, Frontiers in Neurology, found that when paired with music therapy, ibuprofen reduced pain responses in the inflammation pain model by 93 percent as compared to the drug alone.

Dusek said University Hospitals (UH) Connor Whole Health has music therapists that conduct rounds with the medical team and provide music therapy plans tailored to each patient’s individual needs.

“They can provide live soothing music and imagery to soothe patients in managing their pain, by playing a guitar or other instrument at the bedside,” Dusek said. “They also work with our pediatric and cancer patients to help them cope with the pain and stress of a serious illness and being hospitalized.”

An enthusiastic response to integrative medicine clinical trials

While traditional clinical trials often face obstacles such as low enrollment, Brent Bauer, MD, director of the Mayo Clinic Integrative Medicine and Health program in Rochester, Minnesota, said the opposite is true of integrative medicine clinical trials.

“We have patients referred to our clinical trials by physicians and nurses and we often have employees here at the Mayo Clinic volunteer as participants,” Bauer said. “Our clinical trials have looked at topics such as animal-assisted therapy for hospitalized patients, aromatherapy for stress, anxiety, and depression for hospital staff during the COVID-19 pandemic, and more.”

Bauer said integrative medicine clinical trials offer both providers and patients trusted results that practitioners can incorporate into their practice. Because many clinical trials have become decentralized, going beyond traditional brick and mortar facilities, Bauer said researchers are now able to offer integrative medicine clinical trials to a broader base of patients.

Decentralized clinical trials use technology such as telemedicine to deliver consent and education to patients, while also utilizing remote monitoring, direct-to-patient distribution of investigational medicines, and use of local labs and image centers. For these clinical trials, Bauer said patient participants are needed from across the country.

Since clinical trials play a critical role in discovering new treatments and improving health outcomes, integrative medicine practitioners are encouraged to refer any clients they believe might benefit from participating in research. A full list of integrative medicine clinical trials can be found at clinicaltrials.gov or on the NIH website.

“Our clinical trials have looked at mindfulness-based meditation with fibromyalgia patients, massage, and music therapy on quality of life for hospice patients, acupuncture for COVID related olfactory loss, and more,” he said. “The results allow practitioners to expand their medical toolkit and offer patients new modalities.”