A recent randomized, double-blind, placebo-controlled clinical trial found that duloxetine significantly reduced the frequency and sensitivity of refractory chronic cough (RCC) compared with placebo. Patients treated with duloxetine had a marked decrease in objective cough frequency and improvement in cough-related quality of life (measured by the Leicester Cough Questionnaire) versus those receiving a placebo. However, adverse effects such as nausea, dizziness, and somnolence were more common with duloxetine, which may limit its use despite its therapeutic benefit. The study was published in BMC Medicine by Shengyuan W. and colleagues.
Refractory chronic cough (RCC) is a clinical issue that continues to cause difficulties in management despite standard treatment protocols, with implications for quality of life. New evidence indicates that the cough sensitivity mechanism through the action of hyperresponsiveness of sensory nerves is the key mechanism in refractory chronic cough pathophysiology. This was a clinical study with a prospective, randomized, double-blind, placebo-controlled design in the outpatient clinic of Tongji Hospital of Tongji University. The study took place between October 2020 and May 2024.
A total of 98 patients with refractory chronic cough with no diagnosed mood disorder were studied. Participants were randomly allocated in a 1:1 ratio to duloxetine or placebo. All patients were given the study drug for a period of 8 weeks. Thereafter, the patients were monitored for a period of 3 weeks. Patients were given duloxetine as a study drug, while patients in the control arm were given a placebo drug identical in nature to the study drug. The study considered the change in cough frequency, as well as cough-quality-of-life data using the Leicester Cough Questionnaire (LCQ).
Key findings
• Mean coughs per hour decreased from 83.96 ± 28.95 to 33.12 ± 22.99 in the duloxetine group, compared with a smaller reduction from 87.67 ± 31.75 to 80.36 ± 31.75 in the placebo group (P < 0.001 between groups).
• LCQ scores improved significantly with duloxetine, increasing from 12.75 ± 2.44 to 14.88 ± 2.45, while no meaningful improvement was observed in the placebo group (12.17 ± 2.64 to 12.81 ± 2.32; P < 0.001 between groups).
• These benefits were observed after 8 weeks of treatment and were maintained through the follow-up period.
This randomized double-blind study showed conclusively that duloxetine therapy is associated with decreased cough frequency and cough quality of life in refractory chronic cough sufferers; meanwhile, mild side effects do crop up more often with this type of therapy. These findings pave the way for this promising new form of therapy for a condition like RCC.
Reference:
Wang, S., Wu, H., Zhou, Y. et al. The efficacy and safety of duloxetine in treating refractory chronic cough: a randomized clinical trial. BMC Med (2026). https://doi.org/10.1186/s12916-025-04613-x
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