Pulmonology · Medical Literature
Clinical pharmacist-led intervention improves anxiety, depression and inhaler technique in budesonide/glycopyrronium/formoterol-using patients: A single-center prospective randomized cohort study.
Abstract
Chronic respiratory disease (CRD) patients using budesonide/glycopyrronium/formoterol (BGF) inhalers often face anxiety, depression and incorrect inhaler technique, which impair treatment outcomes. This study aimed to evaluate the effects of clinical pharmacist-led intervention on anxiety, depression, inhaler technique, adverse drug reactions (ADR) and body mass index (BMI) in BGF users. A prospective randomized cohort study enrolled 100 BGF users from July 2023 to December 2023 at a public tertiary hospital and randomized them 1:1 to either the experimental or control group. Among these, 48 experimental patients and 45 control patients completed this study, which comprised an initial and three follow-up visits. The control group received routine care, whereas the experimental group received supplementary care led by a clinical pharmacist alongside conventional treatment. Outcomes included Self-Rating Anxiety Scale (SAS), the Self-Rating Depression Scale (SDS), Inhaler technique scores, Adverse drug reaction (ADR) and Body mass index (BMI) were assessed at 1-, 3- and 6-months post-intervention. The experimental group had lower SAS scores at 3/6 months (p<0.05), lower moderate-to-severe anxiety rate at 6 months (68.75% vs. 93.33%, p<0.05) and lower SDS scores at 3/6 months (p<0.05). Inhaler technique scores were higher in the experimental group at all follow-ups (p<0.05). ADR incidence was lower (2 vs. 5 cases) and BMI slightly increased (p=0.312). Pharmacist-led intervention alleviates anxiety/depression, improves inhaler technique and reduces ADR in BGF users. These findings support the adoption of pharmacist-led integration into comprehensive BGF management.
Clinical relevance
Does a clinical pharmacist-led intervention, added to routine care, improve anxiety, depression, inhaler technique, adverse drug reactions, and body mass index in patients with chronic respiratory disease using a budesonide/glycopyrronium/formoterol (BGF) fixed-dose combination inhaler? __SNAPSHOT__ {"studyDesign":"Prospective randomized cohort study (single-center, open-label; labeled 'randomized cohort' by authors — not a blinded RCT)","setting":"Single public tertiary hospital, Putian City, China; prospectively registered in the Chinese Clinical Trials Registry (ChiCTR2400090585)","sampleSize":"n=100 enrolled (1:1 randomization); 93 completed (experimental: n=48, control: n=45); 7 did not complete (attrition not reported by group)","population":"Adults with chronic respiratory disease (CRD) actively using a BGF metered-dose inhaler; specific inclusion/exclusion criteria and CRD subtypes (e.g., COPD, asthma) not detailed in available abstract","intervention":"Clinical pharmacist-led supplementary care (content of intervention — counseling, education, technique training, monitoring schedule — not fully detailed in available abstract) added to conventional treatment, with assessments at baseline, 1, 3, and 6 months","comparator":"Routine care without pharmacist-led supplementary intervention","primaryOutcome":"Not explicitly designated as a single primary endpoint; outcomes assessed included Self-Rating Anxiety Scale (SAS), Self-Rating Depression Scale (SDS), inhaler technique score, adverse drug reactions (ADR), and body mass index (BMI) at 1, 3, and 6 months post-intervention","followUp":"6 months (visits at 1, 3, and 6 months post-baseline)","fundingSource":"Not reported"}
Key findings
The experimental group demonstrated statistically significantly lower SAS scores at 3 and 6 months (p<0.05) and lower SDS scores at 3 and 6 months (p<0.05); differences at 1 month were not reported as significant in the available abstract. The proportion of patients with moderate-to-severe anxiety was lower in the experimental group at 6 months (68.75% vs. 93.33%, p<0.05), representing an absolute risk reduction of approximately 24.6% (calculated) and a number needed to treat of approximately 4 (calculated). Inhaler technique scores were statistically significantly higher in the experimental group at all three follow-up time points (p<0.05). ADR incidence was numerically lower in the experimental group (2 cases vs. 5 cases); formal statistical testing for this comparison was not reported in the available abstract, and this difference may not be statistically significant given the small event counts. BMI increased slightly in the experimental group but the between-group difference was not statistically significant (p=0.312). Absolute values (mean ± SD) for SAS, SDS, and inhaler technique scores at each time point, as well as effect sizes, confidence intervals, and formal NNT/NNH, are not reported in the available abstract.
Practice implications
This study suggests that adding clinical pharmacist-led care to conventional treatment for BGF-using CRD patients may reduce anxiety and depression scores and improve inhaler technique over a 6-month period, with a statistically significant reduction in the proportion of patients with moderate-to-severe anxiety at 6 months. The ADR reduction (2 vs. 5 events) is clinically plausible but cannot be interpreted statistically with such small event counts. BMI did not differ significantly between groups, suggesting no meaningful nutritional benefit from the intervention over this timeframe. Critically, the study does not define a single pre-specified primary endpoint, raising concerns about multiple comparisons and inflated Type I error. The findings apply to Chinese tertiary-hospital CRD patients on BGF; generalizability to other healthcare systems, inhaler types, or CRD subtypes (COPD vs. asthma not differentiated) is uncertain. Blinding of patients and assessors was not feasible for this intervention type, introducing performance and detection bias, particularly for subjective self-report scales (SAS, SDS). The magnitude of symptom scale score changes and their clinical meaningfulness (minimal clinically important difference on SAS/SDS) cannot be evaluated from the abstract alone. Practice should not change on the basis of this single-center, open-label study with a small sample; however, results are consistent with the broader literature supporting pharmacist roles in inhaler education and chronic disease management. Note: this summary is based on the abstract only; full-text review may reveal additional outcome data, statistical details, and methodological safeguards not available here. __LIMITATIONS__ Single-center design at a Chinese tertiary hospital substantially limits generalizability to other healthcare systems and patient populations.,No single pre-specified primary endpoint; assessment of five outcome domains across three time points creates a significant multiple comparisons problem without reported correction (e.g., Bonferroni).,Open-label design with no blinding of patients, pharmacists, or assessors introduces performance bias and detection bias, particularly for subjective self-report instruments (SAS, SDS).,Small sample size (n=93 completers) is underpowered to detect meaningful differences in low-frequency outcomes such as ADR (2 vs. 5 events); no formal sample size calculation or power analysis is reported in the available abstract.,7 patients did not complete the study (dropout ~7%); attrition by group and reasons for withdrawal are not described in the abstract, limiting intent-to-treat analysis assessment.,CRD subtypes (e.g., COPD, asthma, asthma-COPD overlap) are not differentiated, preventing subgroup-level inference.,The specific components and intensity of the pharmacist-led intervention are not described in the available abstract, limiting reproducibility.,Funding source is not reported, introducing unquantifiable sponsorship bias risk.,No patient-reported quality-of-life measures, lung function data, or hospitalization/exacerbation endpoints are reported; all outcomes are intermediate or surrogate in nature.,Short 6-month follow-up is insufficient to establish durability of benefit or impact on hard clinical outcomes (exacerbations, mortality).,The journal (Pakistan Journal of Pharmaceutical Sciences) has a low JCR impact factor (0.6 in 2024), which may reflect limitations in peer-review rigor. __BOTTOM_LINE_CATEGORY__ promising_but_preliminary __BOTTOM_LINE__ This small, single-center, open-label Chinese study found that pharmacist-led supplementary care was associated with statistically significant reductions in anxiety and depression scores and improved inhaler technique in BGF-using CRD patients at 3 and 6 months, with a clinically notable reduction in moderate-to-severe anxiety prevalence (NNT ≈ 4, calculated). However, the absence of a single pre-specified primary endpoint, lack of blinding, small sample, single-center design, and failure to report effect sizes or confidence intervals prevent definitive conclusions; replication in larger, multicenter, methodologically rigorous trials is required before recommending routine adoption of this model.