Table 7, Clinical evidence summary: Dose A [10mg/5mg HC] vs Dose B [10mg/5mg/5mg HC] - Routine pharmacological management of secondary and tertiary adrenal insufficiency

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Table 7Clinical evidence summary: Dose A [10mg/5mg HC] vs Dose B [10mg/5mg/5mg HC]

Outcomes	№ of participants (studies) Follow-up	Certainty of the evidence (GRADE)	Relative effect (95% CI)	Anticipated absolute effects
SF-36 - Physical sum scale Scale from: 0 to 100 follow-up: 4 weeks (higher is better)	18 (1 RCT)	⨁◯◯◯ Very low^a^,^b	-	The mean SF-36 - Physical sum scale was 40.7 points	MD 3.2 points higher (4.66 lower to 11.06 higher)
SF-36 - Psychological sum scale Scale from: 0 to 100 follow-up: 4 weeks (higher is better)	18 (1 RCT)	⨁◯◯◯ Very low^a^,^c	-	The mean SF-36 - Psychological sum scale was 46.4 points	MD 0.1 points lower (7 lower to 6.8 higher)
BSI Global Severity Index Scale from: 0 to 100 follow-up: 4 weeks (lower is better)	18 (1 RCT)	⨁◯◯◯ Very low^a^,^d	-	The mean BSI Global Severity Index was 58.1 points	MD 0.2 points lower (8.15 lower to 7.75 higher)
Satisfaction with medication assessed with: 100 mm visual analog scale Scale from: 0 to 100 follow-up: 4 weeks (lower is better)	18 (1 RCT)	⨁◯◯◯ Very low^a^,^e	-	The mean satisfaction with medication was 56.6 points	MD 5.4 points lower (25.22 lower to 14.42 higher)
Sleepiness score 0700 assessed with: Stanford Sleepiness Scale Scale from: 0 to 7 follow-up: 4 weeks (lower is better)	18 (1 RCT)	⨁◯◯◯ Very low^a^,^f	-	The mean sleepiness score 0700 was 2.3 points	MD 0.2 points higher (0.02 lower to 0.42 higher)
Sleepiness score 1200 assessed with: Stanford Sleepiness Scale Scale from: 0 to 7 follow-up: 4 weeks (lower is better)	18 (1 RCT)	⨁◯◯◯ Very low^a^,^g	-	The mean sleepiness score 1200 was 1.7 points	MD 0 points (0.17 lower to 0.17 higher)
Sleepiness score 1500 assessed with: Stanford Sleepiness Scale Scale from: 0 to 7 follow-up: 4 weeks (lower is better)	18 (1 RCT)	⨁◯◯◯ Very low^a^,^h	-	The mean sleepiness score 1500 was 1.8 points	MD 0 points (0.17 lower to 0.17 higher)
Sleepiness score 1800 assessed with: Stanford Sleepiness Scale Scale from: 0 to 7 follow-up: 4 weeks (lower is better)	18 (1 RCT)	⨁⨁◯◯ low^a^,ⁱ	-	The mean sleepiness score 1800 was 2.1 points	MD 0.4 points lower (0.57 lower to 0.23 lower)
Sleepiness score 2200 assessed with: Stanford Sleepiness Scale Scale from: 0 to 7 follow-up: 4 weeks (lower is better)	18 (1 RCT)	⨁⨁◯◯ low^a^,^j	-	The mean sleepiness score 2200 was 3.4 points	MD 0.7 points lower (0.99 lower to 0.41 lower)

Outcomes

№ of participants (studies) Follow-up

Certainty of the evidence (GRADE)

Relative effect (95% CI)

Anticipated absolute effects

Risk with Dose B [10mg/5mg/5mg HC]

Risk difference with Dose A [10mg/5mg HC]

SF-36 - Physical sum scale

Scale from: 0 to 100

follow-up: 4 weeks (higher is better)

(1 RCT)

⨁◯◯◯

Very low^a^,^b

The mean SF-36 - Physical sum scale was 40.7 points

MD 3.2 points higher

(4.66 lower to 11.06 higher)

SF-36 - Psychological sum scale

Scale from: 0 to 100

follow-up: 4 weeks (higher is better)

(1 RCT)

⨁◯◯◯

Very low^a^,^c

The mean SF-36 - Psychological sum scale was 46.4 points

MD 0.1 points lower

(7 lower to 6.8 higher)

BSI Global Severity Index

Scale from: 0 to 100

follow-up: 4 weeks (lower is better)

(1 RCT)

⨁◯◯◯

Very low^a^,^d

The mean BSI Global Severity Index was 58.1 points

MD 0.2 points lower

(8.15 lower to 7.75 higher)

Satisfaction with medication assessed with: 100 mm visual analog scale

Scale from: 0 to 100

follow-up: 4 weeks (lower is better)

(1 RCT)

⨁◯◯◯

Very low^a^,^e

The mean satisfaction with medication was 56.6 points

MD 5.4 points lower

(25.22 lower to 14.42 higher)

Sleepiness score 0700 assessed with: Stanford Sleepiness Scale

Scale from: 0 to 7

follow-up: 4 weeks (lower is better)

(1 RCT)

⨁◯◯◯

Very low^a^,^f

The mean sleepiness score 0700 was 2.3 points

MD 0.2 points higher

(0.02 lower to 0.42 higher)

Sleepiness score 1200 assessed with: Stanford Sleepiness Scale

Scale from: 0 to 7

follow-up: 4 weeks (lower is better)

(1 RCT)

⨁◯◯◯

Very low^a^,^g

The mean sleepiness score 1200 was 1.7 points

MD 0 points

(0.17 lower to 0.17 higher)

Sleepiness score 1500 assessed with: Stanford Sleepiness Scale

Scale from: 0 to 7

follow-up: 4 weeks (lower is better)

(1 RCT)

⨁◯◯◯

Very low^a^,^h

The mean sleepiness score 1500 was 1.8 points

MD 0 points

(0.17 lower to 0.17 higher)

Sleepiness score 1800 assessed with: Stanford Sleepiness Scale

Scale from: 0 to 7

follow-up: 4 weeks (lower is better)

(1 RCT)

⨁⨁◯◯ low^a^,ⁱ

The mean sleepiness score 1800 was 2.1 points

MD 0.4 points lower

(0.57 lower to 0.23 lower)

Sleepiness score 2200 assessed with: Stanford Sleepiness Scale

Scale from: 0 to 7

follow-up: 4 weeks (lower is better)

(1 RCT)

⨁⨁◯◯ low^a^,^j

The mean sleepiness score 2200 was 3.4 points

MD 0.7 points lower

(0.99 lower to 0.41 lower)

: Explanations
a: Downgraded by 2 increments for risk of bias (potential for measurement bias in patient-reported outcome, little information provided on deviations from intended interventions).
b: Downgraded by 2 increments as confidence interval crossed both MIDs (+/− 2)
c: Downgraded by 2 increments as confidence interval crossed both MIDs (+/− 3)
d: Downgraded by 2 increments as confidence interval crossed both MIDs (+/− 6.45)
e: Downgraded by 2 increments as confidence interval crossed both MIDs (+/− 13.65)
f: Downgraded by 1 increment as confidence interval crossed 1 MID (+/− 0.16)
g: Downgraded by 2 increments as confidence interval crossed both MIDs (+/− 0.145)
h: Downgraded by 2 increments as confidence interval crossed both MIDs (+/− 0.12)
i: no imprecision MID (+/− 0.15)
j: no imprecision MID (+/− 0.25)

From: Routine pharmacological management of secondary and tertiary adrenal insufficiency

Cover of Routine pharmacological management of secondary and tertiary adrenal insufficiency

Routine pharmacological management of secondary and tertiary adrenal insufficiency: Adrenal insufficiency: identification and management: Evidence review G.

NICE Guideline, No. 243.

London: National Institute for Health and Care Excellence (NICE); 2024 Aug.

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