ABSTRACT
Purpose: This study evaluates if the addition of a curcumin formulation with a polyvinylpyrrolidone-hydrophilic carrier (CHC; Diabec®, Alfa Intes, Italy) to intravitreal injections of dexamethasone (DEX-IVT) can affect the morphological retinal characteristics, extending the steroid re-treatment period in patients with diabetic macular edema (DME). Methods: A randomized controlled clinical trial was carried out in DME patients, randomly assigned to receive DEX-IVT or DEX-IVT and a CHC. The evaluation of the mean difference of central retinal thickness (CRT) was the primary aim. Secondary aims were the evaluations of best-corrected visual acuity, differences in the predetermined retinal layer thickness, the number/time of re-treatment, and the assessment of safety. Results: A total of 73 DME patients were included (35 in the control group and 38 in the combined therapy group). In both the control and combined therapy groups, the mean CRT change from T0 to the 6 months' evaluation was significant (p = 0.00). The mean CRT result was significantly different at month 4 (p = 0.01) between the control and combined therapy groups, with a greater reduction in the combined therapy group, in particular, in patients with ≤10 years of diabetes. A trend of CRT reduction in the combined therapy group has been observed also considering patients with subfoveal neuroretinal detachment. In addition, we observed that the reduction of inner retinal layer thickness was greater in the combination group, in comparison with controls. Conclusion: The combination of a CHC to DEX-IVT is a promising therapeutic option in case of DME, in particular, for patients with early-stage diabetes and with an inflammatory phenotype. Further studies will be necessary to confirm these findings.
ABSTRACT
OBJECTIVES: To explore the impact of a Mindfulness-Based Stress Reduction (MBSR) intervention for people with metastatic cancer integrated in Early Palliative Care (EPC). DESIGN: Mixed-method study. SETTINGS/LOCATION: EPC Service integrated with Oncology Unit, Carpi General Hospital, Italy from January to October 2017. The MBSR intervention took place inside the hospital. SUBJECTS: Study participation was offered to 25 consecutive people referred to the EPC service. INCLUSION CRITERIA: people with metastatic cancer between 18 and 75 years old; informed consent. EXCLUSION CRITERIA: Performance Status <60% according to Karnofsky scale; active psychiatric disorder. 20 patients were included in the study. INTERVENTION: The adapted program consists of 8 meetings for 2.5 h once a week, a 4.5 h session between the 6th and 7th weeks and 0.5 h home practice daily. The following mindfulness practices were included during the training: formal sitting meditation, body scan, light yoga, walking meditation, and Aikido exercises. Participants were provided with materials for home practice. A qualified MBSR instructor conducted the program. Sessions were attended by a clinical psychologist and a physician trained in meditation, together with the palliative nurse as facilitators. OUTCOME MEASURES: Feasibility and acceptability were assessed on 16 participants. In addition, pre-post measures of cancer pain and mood state were collected. Semi-structured, in-depth interviews were conducted on a subset of 8 participants at the end of the study and analysed using the Interpretative-Phenomenological approach. RESULTS: MBSR attendance to meetings and adherence to home practice were 75%. MBSR intervention helped participants to develop an accepting attitude in respect to metastatic cancer disease helping them to face anxiety and cancer pain. MBSR improves self-regulation of mood state engendering feelings of compassion MBSR program supports participants in questioning and reconnecting with their values and spiritual beliefs. CONCLUSIONS: A Mindfulness intervention integrated into EPC setting is feasible, well accepted and could help metastatic cancer patients to control cancer pain together with an opportunity of emotional and spiritual relief.