Shift nurses are prone to sleep problems and impaired nighttime alertness, with risk for reduced health status plus decreased performance, handling errors, and workplace accidents. Attention to and improvements in the situation of shift nurses are urgent. Shimian granules (SMG), an improved formula of Jieyuanshen with liver qingre and yangxin
tranquilizing effects, for more than a decade has been used in China as a herbal treatment of
sleep disorders in clinical practice. However, clinical data on SMG have rarely been reported. This double-blinded, randomized, placebo-controlled, pilot clinical trial (ChiCTR-IOR-17013031) aimed to explore whether Shimian granules (SMG) improves sleep and affective state in shift nurses and in association with changes in concentrations of salivary
cytokines. Fifty-three rotating-shift female nurses with a Pittsburgh Sleep Quality Index (PSQI) score ≥8 were orally treated with 10.0 g SMG or placebo 2 times daily (30 min after breakfast and 30 min before bed) for 1 month. The
Insomnia Severity Index (ISI), a psychomotor vigilance task, Hospital Anxiety and Depression Scale (
HADS-A/
HADS-D), and levels of four salivary
cytokines were evaluated by single time-of-day sampling at baseline and after 1 month of treatment. Significantly lower ISI,
HADS,
HADS-A, and
HADS-D scores, but higher 1/mean reaction time (1/mRT) score, were found in shift nurses treated with SMG than in those who received placebo, and these effects were associated with changes in salivary
melatonin, TNF, IL-1β, and
IL-6 levels. These latter findings suggest
melatonin, TNF, and
IL-6 levels may be suitable
biomarkers of ISI score in shift nurses, whereas TNF level may be a suitable
biomarker of 1/mRT score and
IL-6 level a suitable
biomarker of
HADS score in response to SMG treatment. The results of this pilot study suggest SMG can effectively improve sleep, alertness, plus anxiety and depression symptoms in shift nurses in association with changes in salivary
cytokine levels. The results of this study provide an experimental basis for the evaluation of traditional Chinese medicines for the treatment of
insomnia and underlying mechanisms of their actions that require detailed future exploration.