Table 3.
Intention to treat analysis: unadjusted effect of laughter exercise on clinical signs of dry eye disease at eight weeks
| Laughter exercise group | 0.1% hyaluronic acid group | Between group difference in change (95% CI)§ | |||||||
|---|---|---|---|---|---|---|---|---|---|
| Baseline† | Week 8 | Change (95% CI)‡ | Baseline† | Week 8 | Change (95% CI)‡ | ||||
| Secondary outcomes | |||||||||
| Proportion of decrease in OSDI total score of ≥10 (percentage points), (n=299 people) | NA | NA | 49.3 (41.0 to 57.5) | NA | NA | 47.3 (39.3 to 55.3) | 1.96 (−9.53 to 13.5) | ||
| Clinical signs of dry eye disease, (n=598 eyes): | |||||||||
| Non-invasive tear break up time | 7.95 (3.65) | 11.2 (5.95) | 3.21 (2.43 to 4.00)*** | 7.91 (3.69) | 8.82 (4.38) | 0.92 (0.29 to 1.54)** | 2.30 (1.30 to 3.30)*** | ||
| TMH (µm) | 0.19 (0.05) | 0.21 (0.06) | 0.02 (0.01 to 0.03)*** | 0.19 (0.05) | 0.20 (0.06) | 0.005 (−0.002 to 0.010) | 0.014 (0.002 to 0.025) | ||
| CFS score | 0.76 (1.56) | 0.57 (1.44) | −0.19 (−0.42 to 0.04) | 0.59 (1.27) | 0.53 (1.41) | −0.06 (−0.27 to 0.15) | −0.13 (−0.43 to 0.17) | ||
| Psychological outcomes, (n=299 people): | |||||||||
| SAS score | 42.7 (9.15) | 39.7 (10.1) | −3.05 (−4.39 to −1.71)*** | 41.3 (7.94) | 39.3 (8.42) | −1.98 (−3.14 to −0.82)*** | −1.07 (−2.84 to 0.70) | ||
| SDS score | 45.8 (10.8) | 42.8 (11.4) | −2.95 (−4.40 to −1.50)*** | 43.7 (10.4) | 42.0 (11.1) | −1.68 (−2.95 to −0.41)** | −1.26 (−3.19 to 0.66) | ||
| SHS score | 4.46 (1.24) | 4.56 (1.18) | 0.09 (−0.06 to 0.24) | 4.42 (1.23) | 4.52 (1.15) | 0.10 (−0.05 to 0.25) | −0.003 (−0.21 to 0.21) | ||
| PSQI score | 6.49 (3.01) | 6.63 (2.90) | 0.14 (−0.23 to 0.60) | 6.67 (2.63) | 6.84 (2.88) | 0.17 (−0.25 to 0.59) | −0.04 (−0.66 to 0.59) | ||
| SF-36 score: | |||||||||
| Physical health subscale | 92.6 (9.66) | 94.0 (8.76) | 1.46 (−0.04 to 2.95) | 91.0 (11.6) | 92.5 (11.2) | 1.48 (0.11 to 2.84)* | −0.02 (−2.04 to 2.00) | ||
| Mental health subscale | 64.7 (17.7) | 68.0 (19.3) | 3.28 (0.80 to 5.75)** | 67.1 (16.3) | 68.0 (17.0) | 0.89 (−1.06 to 2.85) | 2.39 (−0.78 to 5.55) | ||
| Exploratory outcomes (n=598 eyes) | |||||||||
| Fluorescein tear break-up time | 1.89 (0.94) | 3.70 (1.58) | 1.82 (1.60 to 2.03) | 1.91 (0.94) | 2.23 (1.09) | 0.32 (0.16 to 0.48) | 1.50 (1.23 to 1.76) | ||
| Secretory capacity of meibomian gland | 0.46 (0.68) | 0.22 (0.47) | −0.24 (−0.33 to −0.14) | 0.44 (0.64) | 0.46 (0.64) | 0.01 (−0.07 to 0.10) | −0.25 (−0.38 to −0.13) | ||
| Properties of meibomian glands secretion | 2.20 (0.86) | 1.84 (0.89) | −0.36 (−0.48 to −0.24) | 2.22 (0.83) | 2.35 (0.73) | 0.13 (0.03 to 0.24) | −0.49 (−0.65 to −0.33) | ||
| Meibomian glands secretion property score | 9.67 (5.29) | 5.89 (4.17) | −3.78 (−4.45 to −3.12) | 9.57 (4.94) | 10.7 (4.84) | 1.13 (0.54 to 1.71) | −4.91 (−5.80 to −4.02) | ||
Data are mean (standard deviation) or difference mean (95% CI).
CFS=corneal fluorescein staining; CI=confidence interval; PSQI=Pittsburgh sleep quality index; SAS=self-rating anxiety scale; SDS=self-rating depression scale; SF-36=short form health survey; SHS=subjective happiness scale; TMH=tear meniscus height.
P<0.05, **P<0.01, ***P<0.001, P value for between group difference was adjusted by the Benjamini-Hochberg with a false discovery rate of 0.05 for multiple comparisons. After adjustment, only the difference in non-invasive tear break-up time with P<0.001.
No baseline difference between groups for clinical outcomes by generalised estimated equation (GEE) model with adjusting for intra-eye correlation, and two sample t-test for psychological outcomes.
GEE model with adjusting for intra-eye correlation for clinical signs and paired t-test for psychological outcomes.
GEE model with adjusting for intra-eye correlation for clinical signs and two sample t-test for psychological outcomes.