Alessandro Casarella

Background/Objectives: Fibromyalgia (FM) is diagnosed using symptom-based criteria, and clinician-assigned labels may diverge from standardized classification frameworks. FM may also coexist with musculoskeletal and other pain-related conditions. We determined the proportion of patients in a combined referral-based cohort who fulfilled the 2019 ACTTION-American Pain Society Pain Taxonomy (AAPT) criteria after retrospective record-based adjudication and described documented concomitant musculoskeletal or pain-related diagnoses and symptom burden according to AAPT status. Methods: This retrospective, single-center cross-sectional pilot study included consecutive adult outpatients evaluated in a tertiary pain unit between January and April 2026 after referral for suspected FM or with a previous clinician-assigned FM diagnosis. AAPT classification was reconstructed from available longitudinal clinical documentation; the historical look-back varied by record availability and extended approximately 8–10 years in some patients. Results: Among 76 patients (96.1% female), 28 fulfilled the AAPT criteria (36.8%; 95% CI, 26.9–48.1). At least one documented concomitant musculoskeletal or pain-related diagnosis was recorded in 25/28 AAPT MET patients (89.3%; 95% CI, 72.8–96.3) and 26/48 AAPT NOT MET patients (54.2%), corresponding to a crude, unadjusted OR of 7.05 (95% CI, 1.87–26.54; p = 0.002). This association may partly reflect criterion-related overlap and differential diagnostic ascertainment. Exploratory analyses suggested greater symptom and affective burden in the AAPT MET group, whereas NRS pain intensity did not differ. Conclusions: Approximately one-third of this combined referral-based cohort fulfilled the AAPT criteria on retrospective adjudication. Documented concomitant musculoskeletal or pain-related diagnoses were common, but the observed association with AAPT status should not be interpreted as independent or causal. Standardized classification and multidimensional clinical pain phenotyping provide complementary information in chronic widespread pain.

Background/Objectives: Fibromyalgia (FM) is diagnosed using symptom-based criteria, and clinician-assigned labels may diverge from standardized classification frameworks. FM may also coexist with other pain-generating musculoskeletal disorders. We determined the proportion of patients referred for suspected or previously diagnosed FM who fulfilled the 2019 ACTTION-American Pain Society Pain Taxonomy (AAPT) criteria after specialist record-based adjudication and compared documented concomitant pain-related diagnoses and symptom severity according to AAPT status. Methods: This retrospective, single-center cross-sectional pilot study included consecutive adult outpatients evaluated in a tertiary pain unit for suspected or previously diagnosed FM. Routinely collected clinical records were reviewed to determine fulfilment of the AAPT 2019 criteria, identify documented concomitant pain-related diagnoses, and assess symptom severity using FIQR, Zung SAS/SDS, DN4, and NRS measures. Results: Among 76 patients (96.1% female), 28 fulfilled the AAPT criteria (36.8%; 95% CI, 26.9–48.1). Of these, 25 (89.3%; 95% CI, 72.8–96.3) had at least one documented concomitant pain-related diagnosis, compared with 26/48 (54.2%) patients who did not fulfil the criteria (OR, 7.05; 95% CI, 1.87–26.54; p = 0.002). Exploratory analyses showed higher FIQR, SAS, SDS, and DN4 scores in the AAPT MET group, whereas NRS pain intensity did not differ significantly. Conclusions: Approximately one-third of patients in this referral-based cohort fulfilled the AAPT criteria, and concomitant pain-related diagnoses were common. Because the retrospective adjudication, small single-center sample, and potential definitional and detection biases limit causal interpretation, these findings should be considered hypothesis-generating. They suggest that criteria-based classification and clinical assessment provide complementary information when evaluating chronic widespread pain.

Pain in children remains frequently underrecognized and undertreated despite significant advances in pediatric analgesia. The pharmacologic management of pediatric pain is challenging due to developmental differences in pharmacokinetics and pharmacodynamics, variability in drug metabolism, age-dependent responses, and the limited availability of high-quality pediatric clinical trials. This narrative review summarizes current evidence regarding the pharmacologic management of nociceptive, neuropathic, and nociplastic pain in children, integrating developmental pharmacology, efficacy data, safety considerations, and limitations of available evidence. A mechanism-based classification of pain provides a useful framework for therapeutic decision-making; however, clinical conditions often involve overlapping mechanisms requiring individualized and multidisciplinary approaches. Evidence supporting pharmacological interventions varies considerably according to pain type. Acetaminophen and NSAIDs remain the most used agents for nociceptive pain, while opioids retain a role in selected cases of moderate-to-severe pain under careful monitoring. Management of neuropathic and nociplastic pain remains particularly challenging due to limited pediatric trials, frequent off-label prescribing, and reliance on extrapolation from adult populations. Future research should focus on age-specific randomized controlled trials, pharmacokinetic and pharmacogenomic variability, long-term safety outcomes, and integration of pharmacologic treatments within multimodal pain management strategies.

Pain in children remains frequently underrecognized and undertreated despite significant advances in pediatric analgesia. The pharmacologic management of pediatric pain is challenging due to developmental differences in pharmacokinetics and pharmacodynamics, variability in drug metabolism, age-dependent responses, and the limited availability of high-quality pediatric clinical trials. This narrative review summarizes current evidence regarding the pharmacologic management of nociceptive, neuropathic, and nociplastic pain in children, integrating developmental pharmacology, efficacy data, safety considerations, and limitations of available evidence. A mechanism-based classification of pain provides a useful framework for therapeutic decision-making; however, clinical conditions often involve overlapping mechanisms requiring individualized and multidisciplinary approaches. Evidence supporting pharmacological interventions varies considerably according to pain type. Acetaminophen and NSAIDs remain the most commonly used agents for nociceptive pain, while opioids retain a role in selected cases of moderate-to-severe pain under careful monitoring. Management of neuropathic and nociplastic pain remains particularly challenging due to limited pediatric trials, frequent off-label prescribing, and reliance on extrapolation from adult populations. Future research should focus on age-specific randomized controlled trials, pharmacokinetic and pharmacogenomic variability, long-term safety outcomes, and integration of pharmacologic treatments within multimodal pain management strategies.

Background and objectives: Fibromyalgia (FM) is diagnosed using symptom-based criteria, and clinician-assigned labels frequently diverge from them. FM also coexists with pain-generating musculoskeletal disorders. We determined how many patients referred or labeled as having FM fulfilled the 2019 ACTTION-American Pain Society Pain Taxonomy (AAPT) criteria after specialist assessment and compared concomitant pain-related diagnoses and symptom severity by AAPT status. Methods: Single-center cross-sectional pilot study of consecutive adult outpatients attending a pain unit for suspected or previously diagnosed FM. Clinical records were reviewed to determine fulfilment of the AAPT 2019 criteria, identify documented concomitant pain-related diagnoses, and assess symptom severity (FIQR, Zung SAS/SDS, DN4, NRS). Results: Among 76 patients (96.1% female), 28 fulfilled the AAPT criteria (36.8%; 95% CI, 26.9–48.1%). Of these, 25 (89.3%; 95% CI, 72.8–96.3%) had at least one documented concomitant pain-related diagnosis, versus 54.2% of those not fulfilling the criteria (OR, 7.05; 95% CI, 1.87–26.54; p = 0.002). AAPT MET patients had higher FIQR, SAS, SDS and DN4 scores, whereas NRS did not differ significantly. Conclusion: Approximately one-third of patients with an FM label fulfilled the AAPT criteria, and most of those who did also had a concomitant pain-related diagnosis. Comprehensive assessment for coexisting pain generators remains necessary.

Introduction: Type 2 diabetes mellitus (T2DM) is a common disease burdened with significant morbidity and mortality. Despite the substantial number of new available drug treatments, adherence to therapy and adverse drug reactions (ADRs) are the major constraint in the management of this disease. We evaluated the use, the adherence, and the safety of antidiabetic drugs in patients with T2DM. Methods: We performed an observational, retrospective, multicenter study on medical records of outpatients referred to general practitioners in Catanzaro (Calabria, Italy). Drug adherence was measured considering the packages of antidiabetic drugs prescribed at the time of admission, after three months, and 1 year later. ADRs were evaluated using the Naranjo probability scale. Collected data were analyzed using the Statistical Package for the Social Sciences. Results: During the study, we evaluated 12,170 medical records of seven general practitioners. The most prescribed drug was metformin alone (28.4%) or with other oral antidiabetics (19.6%) and then insulin (n: 354; men 190, women 164). Logistic regression showed an association between T2DM less than or equal to 5 years and low adherence (p = 0.023). During the study, we recorded 26 ADRs that were correlated with sex (women) and insulin treatment. Conclusions: this real-life study shows that patients with T2DM have a high adherence, probably related to their having a low number of ADRs.

Introduction: Type 2 Diabetes mellitus (T2DM) is a common disease burdened with significant morbidity and mortality. Despite the substantial number of new available drug treatments, adherence to therapy and adverse drug reactions (ADRs) are the major constrain in the management of this disease. We evaluated the use, the adherence and the dsaftey of antidiabetic drugs in patients with T2DM. Methods: we performed an observational, retrospective, multicenter study on medical records of outpatients referred to general practitioners. Drug adherence was measured in agreement to the European Society for Patient Adherence, Compliance and Persistence Medication Adherence Reporting Guideline. ADRs were evaluated using the Naranjo probability scale. Collected data were analyzed using the Statistical Package for the Social Sciences. Results: During the study we evaluated 12,170 medical records of 7 general practitioners. The most prescribed drug was metformin alone (28.4%) or with other oral antidiabetics (19.6%) and then insulin (n: 354; men 190, women 164). Enrolled patients were stratified as high (35%), medium (41%) and low (24%) adherence. Logistic regression showed an association between T2DM less than or equal to 5 years and low adherence (P = 0.023). During the study we recorded 26 ADRs that was correlated with sex (women) and insulin treatment. Conclusion: this real-life study shows that patients with T2DM have high adherence probably related dto a low number of ADRs

This prospective, open-label clinical study was carried out to evaluate both the efficacy and safety of intramuscular paravertebral injections of an oxygen–ozone (O₂–O₃) mixture in patients with cervicobrachial pain. We enrolled 540 subjects affected by cervicobrachial pain referred to the Ozone Therapy Ambulatory at the Mater Domini Hospital of Catanzaro (Italy) and to the Center of Pain in Taurianova (Reggio Calabria, Italy). All the subjects (n = 540) completed the treatment and the follow-up visits. The subjects received a mean of 11 cervical intramuscular treatments with an O₂–O₃ mixture (5 mL) with an O₃ concentration of 10 μg/mL bis a week. The improvement of pain was measured by a change in the mean of the Visual Analog Scale (VAS) score from baseline to the end of treatment and during follow-ups. Patient satisfaction was assessed at the end of treatment using the SF-36 Questionnaire. The development of adverse drug reactions was recorded. The mean (±standard deviation) VAS pain score at baseline, at the end of treatment, and during follow-ups showed a significant reduction in pain over time (p < 0.001). All the patients who were enrolled (n: 540) were pain-free after one year. According to the pain distribution, all subjects showed a significant reduction in pain over time in each group (p < 0.05). No significant differences were observed with respect to sex or age. No adverse events were observed during the study. In conclusion, we documented that the intramuscular injection of an O₂–O₃ mixture is an effective and safe treatment option for patients with cervicobrachial pain.

Benign prostatic hyperplasia (BPH) is a common cause of male lower urinary tract symptoms (LUTS) that can reduce quality of life. Even if several drugs can be used in its treatment, the development of adverse drug reactions (ADRs) represents the most common cause of low adherence. In the present study, we evaluate both the efficacy and the safety of a new nutrient fixed combination of Pollen Extract plus Teupolioside, named Xipag^®, in patients with LUTS. We conduct a pilot single center open label clinical study between 1 March 2020 and 30 June 2020 in patients with BPH referred to general practitioner’s ambulatories. Male patients > 45 years, sexually active, with clinical symptoms of LUTS and with a diagnosis of HPB were enrolled and received one tablet/day of Xipag^® (T0), for three months (T1: end of treatment). The IPSS and IIEF-5 questionnaires were carried out at T0 and T1 and represent the first end point, whereas the primary safety end point was considered the absence of ADR or of drug–drug interactions related to Xipag^® administration. During the study period, 25 subjects aged 43 to 76 years (mean 62.7 ± 9) were enrolled and completed the study. The clinical evaluation in T1 documented that Xipag^® induced a statistically significant improvement (p < 0.01) in symptoms, as documented by the IPSS questionnaire (range 22.7–88.9; mean 55.2 ± 23.6), without the development of ADRs. In conclusion, this is the first real-world study that showed the efficacy and the safety of Xipag^® in the BPH patients with LUTS.

SARS-CoV-2 is a betacoronavirus, which induced a severe pandemic infectious disease around the world. Even if several drugs have been suggested for its treatment, to date, the only strategy to reduce the severity of disease is represented by the use of vaccine. However, the lack of pre-marketing evidence in frail patients suggests the necessity of the real-world study of a vaccine benefit–risk profile. In this study, we evaluated the efficacy and the safety of SARS-CoV-2 vaccination in a cohort of 33 patients treated with an immunosuppressant after solid organ transplant. Both CLIA and LS/MS analysis were used to evaluate the levels of immunoglobulin (Ig)G anti SARS-CoV-2 and the therapeutic drug monitoring of immunosuppressant drugs. We documented that SARS-CoV-2 vaccination induced a dose- and gender-related serological response. In particular, in 63.6% of the enrolled patients, we documented a significant serological response at T2, and after a time related decrease, the booster dose induced a serological response in 72.7% of enrolled patients. In conclusion, the vaccine anti SARS-CoV-2 is immunogenic in patients under immunosuppression, and is not related to the development of ADRs. We also suggest that the booster dose could be used to increase the efficacy of the vaccination, particularly in women.