Table 2 Change from baseline to week 4 in hot flush symptoms and quality of life.

From: Open-label placebos for menopausal hot flushes: a randomized controlled trial

Outcomes, metric

Baseline (observed)

Mean change from baseline to treatment end (week 4) (estimates)

OLP (N = 50)

No-treatment (N = 50)

OLP

No-treatment

Group difference [95% CI]

p

Cohen’s d

M

SD

M

SD

M

M

Log-transformed hot flush score (diary)a

2.75

0.49

2.85

0.51

− 0.52

− 0.20

− 0.32 [− 0.43; − 0.21]

< 0.001***

0.86

Problem rating (HFRS)b

6.45

1.24

7.12

1.20

− 1.86

− 1.43

− 0.43 [− 1.01; 0.15]

0.24

0.23

Hot flush frequency (Diary)

8.58

3.90

8.95

3.73

− 2.90

− 1.77

− 1.12 [− 1.81; − 0.43]

0.02*

0.51

QoL overall (MRS-II)c

18.06

9.25

18.86

7.87

− 1.75

0.78

− 2.53 [− 4.17; − 0.89]

0.02*

0.49

QoL Anxiety and Depression (WHQ)d

75.67

21.59

75.43

16.22

2.22

0.86

1.37 [− 1.82; 4.56]

0.50

0.14

QoL Well-being (WHQ)

80.78

16.48

80.33

14.16

− 2.01

− 1.00

− 1.01 [− 4.73; 2.71]

0.67

0.09

QoL Somatic symptoms (WHQ)

69.47

20.39

69.60

15.60

3.18

− 1.73

4.92 [0.05; 9.98]

0.05

0.39

QoL Memory/concentration (WHQ)

55.56

29.78

50.67

24.81

4.70

1.78

2.92 [− 1.63; 7.49]

0.31

0.20

QoL Sleep problems (WHQ)

42.33

26.77

43.33

30.12

5.38

1.33

4.05 [− 2.00; 10.09]

0.29

0.20

  1. Baseline values were obtained from the observed means and standard deviation. The mean change from baseline to week 4 was obtained from estimates of linear mixed models.
  2. OLP Open-label placebo, HFRS Hot Flush Rating Scale, QoL Quality-of-Life, MRS-II Menopause Rating Scale II, WHQ Women’s Health Questionnaire, PGIC Patient Global Impression of Change.
  3. *p < 0.05, ***p < 0.001.
  4. aHot flush score is a composite scale of frequency × severity (1 = mild, 2 = moderate, 3 = severe).
  5. bScale range: 1–10.
  6. cScale range: 0–55. Higher scores indicate severe menopausal symptoms and great impact of such symptoms on quality of life.
  7. dScale range of all WHQ subdomains: 0–100. Higher scores indicate better health.
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