Objective:

2

To evaluate the efficacy and safety of a hospital-made resuscitation pack

a Chinese medicinal herbal compound formula designed to enhance recovery in post-bronchoscopy patients.

Methods:

2

In this randomized

single-blind

placebo-controlled clinical trial

eligible patients were randomly assigned 1:1 to either the treatment or control group. The patients in the treatment group applied the resuscitation pack

which contained aromatic compounded Chinese herbs. The patients in the control group applied a hospital-made

single herb placebo pack. Packs were placed on the Tiantu (CV 22) acupuncture point for 4 h as soon as the bronchoscopy finished. Efficacy indicators

such as recovery time

patients' symptoms including nausea and dizziness

and adverse events (AEs) were observed and compared. The outcome indices were evaluated at baseline

1 and 24 h after the bronchoscopy. Subgroup analysis was further performed by patients' age and depth of sedation.

Results:

2

When applying generalized estimating equations (GEE) to evaluate the intensity of post-bronchoscopy nausea and vomiting

the intensity was lower in the treatment group (163 cases) compared with the control group (162 cases; 95% CI: 0.004

0.099

P

=0.03

]

. Also

significantly lower intensity of nausea was observed in the 60–70 years of age subgroup (95% CI: 0.029

0.169

P

=0.006) and deep sedation subgroup (95% CI: 0.002

0.124;

P

=0.04). There was no significant difference in dizziness between two groups by GEE (95% CI: –0.134

0.297;

P

=0.459). In addition

no serious AEs were observed in either group.

Conclusions:

2

Our study found that the resuscitation pack markedly improved patients' symptoms by reducing nausea and vomiting after bronchoscopy without AEs

compared with placebo in the perioperative period. (Trial registration No. ChiCTR2000038299)