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Prevención primaria de la hemorragia por várices en personas con várices esofágicas debido a cirrosis hepática: un metanálisis en red
Davide Roccarina, Lawrence MJ Best, Suzanne C Freeman, Danielle Roberts, Nicola J Cooper, Alex J Sutton, Amine Benmassaoud, Maria Corina Plaz Torres, Laura Iogna Prat, Mario Csenar, Sivapatham Arunan, Tanjia Begum, Elisabeth Jane Milne, Maxine Tapp, Chavdar S Pavlov, Brian R Davidson, Emmanuel Tsochatzis, Norman R Williams, Kurinchi Selvan Gurusamy | 6 abril 2021

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Temas

Study flow diagram.
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Figure 1

Study flow diagram.

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Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
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Figure 2

Risk of bias summary: review authors' judgements about each risk of bias item for each included study.

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Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
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Figure 3

Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.

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. Trial sequential analysis of the cumulative meta‐analysis of the effect of hormone replacement versus control on bone mineral density measured at proximal femur in women with primary biliary cirrhosis. The diversity‐adjusted required information size (DARIS) of 130 patients is calculated based on a minimal relevant intervention effect (MIREDIF) of 1.6 g/cm² yearֿ¹, a standard deviation of 3.2 g/cm² yearֿ¹, a risk of type 1 error of 5%, a power of 80%, and a diversity of 0%. The cumulated Z‐curve (blue curve) did not cross the trial sequential monitoring boundary (red curve) implying that there is no firm evidence for an effect of 1.6 g/cm² yearֿ¹ decrease in bone mineral density measured at proximal femur when the cumulative meta‐analysis is adjusted for sparse data and multiple testing on accumulating data.
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Figure 4

Figure 4. Trial sequential analysis of the cumulative meta‐analysis of the effect of hormone replacement versus control on bone mineral density measured at proximal femur in women with primary biliary cirrhosis. The diversity‐adjusted required information size (DARIS) of 130 patients is calculated based on a minimal relevant intervention effect (MIREDIF) of 1.6 g/cm² yearֿ¹, a standard deviation of 3.2 g/cm² yearֿ¹, a risk of type 1 error of 5%, a power of 80%, and a diversity of 0%. The cumulated Z‐curve (blue curve) did not cross the trial sequential monitoring boundary (red curve) implying that there is no firm evidence for an effect of 1.6 g/cm² yearֿ¹ decrease in bone mineral density measured at proximal femur when the cumulative meta‐analysis is adjusted for sparse data and multiple testing on accumulating data.

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Comparison 1 Hormone replacement versus placebo or no intervention, Outcome 1 All‐cause mortality.
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Analysis 1.1

Comparison 1 Hormone replacement versus placebo or no intervention, Outcome 1 All‐cause mortality.

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Comparison 1 Hormone replacement versus placebo or no intervention, Outcome 2 Fractures.
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Analysis 1.2

Comparison 1 Hormone replacement versus placebo or no intervention, Outcome 2 Fractures.

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Comparison 1 Hormone replacement versus placebo or no intervention, Outcome 3 Adverse events.
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Analysis 1.3

Comparison 1 Hormone replacement versus placebo or no intervention, Outcome 3 Adverse events.

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Comparison 1 Hormone replacement versus placebo or no intervention, Outcome 4 Change in % of lumbar spine bone mineral density (BMD) per year (g/cm2 year‐1).
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Analysis 1.4

Comparison 1 Hormone replacement versus placebo or no intervention, Outcome 4 Change in % of lumbar spine bone mineral density (BMD) per year (g/cm2 year‐1).

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Comparison 1 Hormone replacement versus placebo or no intervention, Outcome 5 Change in % of proximal femur bone mineral density (BMD) per year (g/cm2 year‐1).
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Analysis 1.5

Comparison 1 Hormone replacement versus placebo or no intervention, Outcome 5 Change in % of proximal femur bone mineral density (BMD) per year (g/cm2 year‐1).

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Comparison 1 Hormone replacement versus placebo or no intervention, Outcome 6 Liver‐related mortality or liver transplantation.
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Analysis 1.6

Comparison 1 Hormone replacement versus placebo or no intervention, Outcome 6 Liver‐related mortality or liver transplantation.

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Comparison 1 Hormone replacement versus placebo or no intervention, Outcome 7 Liver‐related morbidity.
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Analysis 1.7

Comparison 1 Hormone replacement versus placebo or no intervention, Outcome 7 Liver‐related morbidity.

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Comparison 1 Hormone replacement versus placebo or no intervention, Outcome 8 Bilirubin (µmol/L).
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Analysis 1.8

Comparison 1 Hormone replacement versus placebo or no intervention, Outcome 8 Bilirubin (µmol/L).

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Comparison 1 Hormone replacement versus placebo or no intervention, Outcome 9 Number of patients having hormone replacement withdrawn due to adverse events.
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Analysis 1.9

Comparison 1 Hormone replacement versus placebo or no intervention, Outcome 9 Number of patients having hormone replacement withdrawn due to adverse events.

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Summary of findings for the main comparison. Hormone replacement versus placebo or no intervention for osteoporosis in women with primary biliary cirrhosis

Hormone replacement versus placebo or no intervention for osteoporosis in women with primary biliary cirrhosis

Patient or population: women with primary biliary cirrhosis.
Setting: out‐patients.
Intervention: hormone replacement versus placebo or no intervention.

Outcomes

Illustrative comparative risks* (95% CI)

Relative effect
(95% CI)

No of participants
(trials)

Quality of the evidence
(GRADE)

Comments

Assumed risk

Corresponding risk

Placebo or no intervention

Hormone replacement

All‐cause mortality

Study population

RD 0.00 (‐0.11 to 0.11)

49
(2 trials)

⊕⊝⊝⊝
very low1,2

0 per 1000

0 per 1000
(0 to 0)

Fractures

Study population

RD ‐0.08 (‐0.24 to 0.07)

49
(2 trials)

⊕⊝⊝⊝
very low1,2

80 per 1000

0 per 1000
(‐19 to 6)

Adverse events

Study population

RR 5.26
(1.26 to 22.04)

49
(2 trials)

⊕⊝⊝⊝
very low1,2

80 per 1000

421 per 1000
(101 to 1000)

Change in % of lumbar spine bone mineral density (BMD) per year (g/cm2 year‐1)

The mean % change of lumbar spine BMD per year in the intervention groups was
1.25 higher
(0.91 lower to 3.42 higher)

36
(2 trials)

⊕⊝⊝⊝
very low1,2

Change in % of proximal femur bone mineral density (BMD) per year (g/cm2 year‐1)

The mean % change of proximal femur BMD per year in the intervention groups was
2.24 higher
(0.74 higher to 3.74 higher)

36
(2 trials)

⊕⊝⊝⊝
very low1,2

Liver‐related morbidity

Study population

RR 1.07
(0.15 to 7.63)

49
(2 trials)

⊕⊝⊝⊝
very low1,2

40 per 1000

43 per 1000
(6 to 305)

Bilirubin (µmol/L)

The mean bilirubin concentration in the intervention groups was
4.6 higher
(3.42 lower to 12.62 higher)

36
(2 trials)

⊕⊝⊝⊝
very low1,2

*The basis for the assumed risk (eg, the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: Confidence interval; RR: Risk ratio.

GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

1 The main limitations in design were the lack of clarity of the generation of allocation sequence and blinding in one trial.
2 The included trials in our meta‐analysis include few participants and few events indicating that we have little knowledge about the intervention effect, and that further information is needed.

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Summary of findings for the main comparison. Hormone replacement versus placebo or no intervention for osteoporosis in women with primary biliary cirrhosis
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Table 1. Reasons for withdrawals from treatment due to adverse events (Ormarsdottir 2004)

Adverse events

Hormone replacement

Placebo

Temporary spotty vaginal bleeding

1/8

0/10

Slight increase in systolic blood pressure

1/8

0/10

Increase in liver enzymes

1/8

0/10

Increase in bilirubin concentration

0/8

1/10
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Table 1. Reasons for withdrawals from treatment due to adverse events (Ormarsdottir 2004)
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Table 2. Reasons for withdrawals from treatment due to adverse events (Boone 2006)

Adverse event

Hormone replacement

Placebo

Generalised pruritus

1/16

0/15

Pneumonia, pulmonary embolism

1/16

0/15

Abdominal pain, headache

1/16

0/15

Local pruritus at patch site

1/16

0/15

Heavy vaginal bleeding

1/16

0/15

Breast pain, chest pain, generalised pruritus, dysuria

1/16

0/15

Local pruritus at patch site

1/16

0/15

Diffuse painful rash of lower back

0/16

1/15
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Table 2. Reasons for withdrawals from treatment due to adverse events (Boone 2006)
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Table 3. Adverse events (Menon 2003)

Adverse event

Hormone replacement

No intervention

Breast tenderness

1/46

0/46

Vaginal spotting

1/46

0/46

Increase in bilirubin concentration

4*/46

0/46

*In three of the four patients with increase in bilirubin concentration, this was because of worsening liver function, as manifest by worsening ascites and development of oesophageal varices. The remaining patient developed elevations in her serum bilirubin and alkaline phosphatase after stopping ursodeoxycholic acid therapy.

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Table 3. Adverse events (Menon 2003)
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Table 4. Adverse events (Pereira 2004)

Adverse events

Hormone replacement patches

No intervention

Monthly
bleeding

2/21

0/21
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Table 4. Adverse events (Pereira 2004)
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Table 5. Biochemical indices (Ormarsdottir 2004)

Outcome measure (maximum change % from baseline value)

Type of data

Oestrogen + vitD + Ca (median(range))

n = 7

vitD + Ca (median(range))

n = 10

P

Serum alkaline phosphatases (µkat/L)

Continuous

‐4 (‐34 to 29)

‐2 (‐10 to 35)

NS

Serum alanine aminotransferase (µkat/L)

Continuous

‐5 (‐24 to 483)

8 (‐7 to 140)

NS

Albumin (g/L)

Continuous

‐5 (‐12 to 0)

‐5 (‐14 to 5)

NS

µkat/L = 60 U/L
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Table 5. Biochemical indices (Ormarsdottir 2004)
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Comparison 1. Hormone replacement versus placebo or no intervention

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 All‐cause mortality Show forest plot

2

49

Risk Difference (M‐H, Fixed, 95% CI)

0.0 [‐0.11, 0.11]

2 Fractures Show forest plot

2

49

Risk Difference (M‐H, Fixed, 95% CI)

‐0.08 [‐0.24, 0.07]

3 Adverse events Show forest plot

2

49

Risk Ratio (M‐H, Fixed, 95% CI)

5.26 [1.26, 22.04]

4 Change in % of lumbar spine bone mineral density (BMD) per year (g/cm2 year‐1) Show forest plot

2

36

Mean Difference (IV, Fixed, 95% CI)

1.25 [‐0.91, 3.42]

5 Change in % of proximal femur bone mineral density (BMD) per year (g/cm2 year‐1) Show forest plot

2

36

Mean Difference (IV, Fixed, 95% CI)

2.24 [0.74, 3.74]

6 Liver‐related mortality or liver transplantation Show forest plot

2

49

Risk Difference (M‐H, Fixed, 95% CI)

0.0 [‐0.11, 0.11]

7 Liver‐related morbidity Show forest plot

2

49

Risk Ratio (M‐H, Fixed, 95% CI)

1.07 [0.15, 7.63]

8 Bilirubin (µmol/L) Show forest plot

2

36

Mean Difference (IV, Random, 95% CI)

4.60 [‐3.42, 12.62]

9 Number of patients having hormone replacement withdrawn due to adverse events Show forest plot

2

49

Risk Ratio (M‐H, Fixed, 95% CI)

5.26 [1.26, 22.04]
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Comparison 1. Hormone replacement versus placebo or no intervention
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