Table 2 Primary and Secondary Outcomes in the Modified Intention-to-Treat Analysis.

From: The efficacy and cerebral mechanism of intradermal acupuncture for major depressive disorder: a multicenter randomized controlled trial

Variables

SSRIs (n = 36)

SSRIs + SIA (n = 37)

SSRIs + AIA (n = 36)

Inter-group differencesa

Repeatedly measured datab

Between-group comparisons

F

P

F

P

SSRIs + AIA vs. SSRIs

SSRIs + AIA vs. SSRIs + SIA

MD (95% CI)c

Effect sized

MD (95% CI)c

Effect sized

Primary outcome

           

HAMD-17 score changes at week 6, mean (SD)

−4.6 (0.8)

−4.8 (0.8)

−9.6 (0.8)†*#

13.19

<0.001

  

−5.1 (−7.8 to −2.3)

−1.04

−4.9 (−7.6 to −2.2)

−1.03

Secondary outcome

           

HAMD-17, mean (SD)

           

 Week 3

−3.3 (0.6)

−2.8 (0.6)

−5.2 (0.6)†#

4.70

0.011

  

−1.9 (−3.9 to 0.1)

−0.53

−2.4 (−4.4 to −0.4)

−0.71

 Week 10

−7.2 (0.9)

−6.5 (0.9)

−10.6 (0.9)*#

5.84

0.004

  

−3.4 (−6.5 to −0.3)

−0.65

−4.1 (−7.2 to -1.0)

−0.73

SDS, mean (SD)

     

8.61

<0.001

    

 Week 3

−3.6 (7.2)

−4.8 (5.7)

−11.1 (8.3)*#

11.28

<0.001

  

−7.4 (−11.5 to −3.3)

−0.95

−6.2 (−10.3 to -2.2)

-0.88

 Week 6

−4.7 (8.4)

−6.2 (8.6)

−17.0 (10.1)*#

19.76

<0.001

  

−12.3 (−17.4 to −7.1)

−1.32

−10.8 (−16.0 to −5.6)

-1.15

 Week 10

−8.5 (10.1)

−10.2 (11.1)

−18.5 (11.3)*#

8.88

<0.001

  

−10.1 (−16.3 to −3.8)

−0.96

−8.3 (−14.5 to −2.1)

-0.76

PSQI, mean (SD)

     

0.74

0.593

    

 Week 3

−1.6 (3.0)

−1.1 (4.3)

−2.0 (3.2)

0.64

0.529

  

−0.4 (−2.5 to 1.6)

−0.14

-0.9 (-3.0 to 1.1)

−0.25

 Week 6

−2.7 (3.5)

−2.7 (3.5)

−4.1 (3.4)

1.45

0.239

  

−1.4 (−3.7 to 0.9)

−0.40

−1.4 (−3.7 to 0.9)

−0.33

 Week 10

−3.8 (3.4)

−3.5 (4.6)

−4.2 (4.3)

0.32

0.729

  

−0.4 (-2.8 to 1.9)

−0.12

−0.8 (−3.1 to 1.6)

−0.17

  1. SSRIs selective serotonin reuptake inhibitors, SIA sham intradermal acupuncture, AIA active intradermal acupuncture, SDS Zung Self-Rating Depression Scale, PSQI Pittsburgh Sleep Quality Index, MD mean difference.
  2. *P < 0.05 vs. SSRIs group, #P <0.05 vs. SSRIs + SIA group; P < 0.05 for intra-group comparisons.
  3. aInter-group differences were evaluated by the one factorial ANOVA test.
  4. bRepeatedly measured data (10 weeks’ period) were assessed by the two-way repeated measures ANOVA test.
  5. cBetween-group comparisons were adjusted by Bonferroni test.
  6. dEffect size was calculated using Cohen’s d.