Impact of integrative open dialogue about complementary alternative medicine. A phase II randomized controlled trial

Abstract Complementary alternative medicine (CAM) may reduce the symptom burden of side effects to antineoplastic treatment but also cause new side effects and non-adherence to conventional treatment. The aim of this randomized controlled study was to investigate the impact of integrative open dialogue about CAM (IOD-CAM) on cancer patients’ health and quality of life (QoL). Patients undergoing curative or palliative antineoplastic treatment were randomly assigned to standard care (SC) plus IOD-CAM or SC alone. A nurse specialist facilitated IOD-CAM in one or two sessions. The primary endpoint was the frequency of grade 3–4 adverse events (AE) eight weeks after enrollment. Secondary endpoints were frequency of grade 1–4 AE and patient reported QoL, psychological distress, perceived information, attitude towards and use of CAM 12 and 24 weeks after enrollment. Survival was analyzed post-hoc. Fifty-seven patients were randomized to IOD-CAM and 55 to SC. No significant difference in frequency of grade 3–4 AEs was shown between the two groups eight weeks after enrollment. The same applied to grade 1–4 AE and QoL, psychological distress, and perceived information 12 and 24 weeks after enrollment. However, a tendency towards better QoL, improved survival, and lower level of anxiety was found in the IOD-CAM group. IOD-CAM is not superior to SC in reducing frequency of AEs in patients undergoing oncology treatment. IOD-CAM does not compromise patient safety; it may reduce psychological stress, and improve QoL and overall survival. Further research on the effect of IOD-CAM on emotional well-being and overall survival is warranted.