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Study flow diagram

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Figure 1

Study flow diagram

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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 2

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

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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 3

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

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Summary of findings 1. Ghrelin compared to placebo for cachexia associated with cancer

Ghrelin compared to placebo for cachexia associated with cancer

Patient or population: people with cachexia associated with cancer

Settings: hospital
Intervention: ghrelin
Comparison: placebo

Outcomes

Anticipated absolute effects* (95% CI)

Relative effect
(95% CI)

№ of participants
(studies)

Quality of the evidence
(GRADE)

Comments

Risk with placebo

Risk with ghrelin

Food intake

Not known

Not known

Not known

7
(1 RCT)

⊕⊝⊝⊝
Very low1,2

The study reported, "31% increase in energy intake with ghrelin infusion"

Too few data to be meaningful

Body weight

No data

No data

No data

No data

⊕⊝⊝⊝
Very low3

Not reported. No data available.

No evidence to support or refute the use of ghrelin in people with cancer cachexia

Adverse events

Study population

Not estimable

7
(1 RCT)

⊕⊝⊝⊝
Very low1,4

The study reported, "No side effects were observed"

Too few data and number of events too small to be meaningful

0 per 1000

0 per 1000
(0 to 0)

*The risk in the intervention group (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

GRADE Working Group grades of evidence
High quality: we are very confident that the true effect lies close to that of the estimate of the effect
Moderate quality: we are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different
Low quality: our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect
Very low quality: we have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect

1Downgraded once for study limitations due to high risk of attrition bias and biases confounded by small size.
2Downgraded twice for imprecision due to sparse data and low participant numbers.
3Downgraded three times: in circumstances where there were no data reported for an outcome, we reported the level of evidence as very low with no evidence to support or refute the use of ghrelin in people with cancer cachexia.
4Downgraded twice for imprecision due to sparse data, low participant numbers and number of events too small to be meaningful.

Figuras y tablas -
Summary of findings 1. Ghrelin compared to placebo for cachexia associated with cancer
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Summary of findings 2. Ghrelin compared to alternative experimental treatment modality for cachexia associated with cancer

Ghrelin compared to alternative experimental treatment modality for cachexia associated with cancer

Patient or population: people with cancer cachexia

Settings: hospital
Intervention: ghrelin
Comparison: alternative experimental treatment modality (like appetisers, nutritional supplements, etc.)

Outcomes

Anticipated absolute effects* (95% CI)

Relative effect
(95% CI)

№ of participants
(studies)

Quality of the evidence
(GRADE)

Comments

Risk with alternative experimental treatment modality

Risk with ghrelin

Food intake

No data

No data

No data

No data

⊕⊝⊝⊝
Very low1

Not reported. No evidence to support or refute the use of ghrelin in people with cancer cachexia.

Body weight

No data

No data

No data

No data

⊕⊝⊝⊝
Very low1

Not reported. No evidence to support or refute the use of ghrelin in people with cancer cachexia.

Adverse events

No data

No data

No data

No data

⊕⊝⊝⊝
Very low1

Not reported. No evidence to support or refute the use of ghrelin in people with cancer cachexia.

*The risk in the intervention group (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

GRADE Working Group grades of evidence
High quality: we are very confident that the true effect lies close to that of the estimate of the effect
Moderate quality: we are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different
Low quality: our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect
Very low quality: we have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect

1In circumstances where there were no data reported for an outcome, we report the level of evidence as 'very low' with no evidence to support or refute the use of ghrelin in people with cancer cachexia.

Figuras y tablas -
Summary of findings 2. Ghrelin compared to alternative experimental treatment modality for cachexia associated with cancer
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Summary of findings 3. Ghrelin in combination with other treatments compared to ghrelin treatment alone for cachexia associated with cancer

Ghrelin in combination with other treatments compared to ghrelin treatment alone for cachexia associated with cancer

Patient or population: people with cancer cachexia

Settings: hospital
Intervention: ghrelin in combination with other treatments
Comparison: ghrelin treatment alone

Outcomes

Anticipated absolute effects* (95% CI)

Relative effect
(95% CI)

№ of participants
(studies)

Quality of the evidence
(GRADE)

Comments

Risk with ghrelin treatment alone

Risk with ghrelin in combination with other treatments

Food intake

No data

No data

No data

No data

⊕⊝⊝⊝
Very low1

Not reported. No evidence to support or refute the use of ghrelin in people with cancer cachexia.

Body weight

No data

No data

No data

No data

⊕⊝⊝⊝
Very low1

Not reported. No evidence to support or refute the use of ghrelin in people with cancer cachexia.

Adverse events

No data

No data

No data

No data

⊕⊝⊝⊝
Very low1

Not reported. No evidence to support or refute the use of ghrelin in people with cancer cachexia.

*The risk in the intervention group (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

GRADE Working Group grades of evidence
High quality: we are very confident that the true effect lies close to that of the estimate of the effect
Moderate quality: we are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different
Low quality: Our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect
Very low quality: we have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect

1In circumstances where there were no data reported for an outcome, we report the level of evidence as 'very low' with no evidence to support or refute the use of ghrelin in people with cancer cachexia.

Figuras y tablas -
Summary of findings 3. Ghrelin in combination with other treatments compared to ghrelin treatment alone for cachexia associated with cancer
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Summary of findings 4. Higher‐dose ghrelin compared to lower‐dose ghrelin for cachexia associated with cancer

Higher‐dose ghrelin compared to lower‐dose ghrelin for cachexia associated with cancer

Patient or population: people with cancer cachexia

Settings: hospital
Intervention: higher‐dose ghrelin
Comparison: lower‐dose ghrelin

Outcomes

Anticipated absolute effects* (95% CI)

Relative effect
(95% CI)

№ of participants
(studies)

Quality of the evidence
(GRADE)

Comments

Risk with lower‐dose ghrelin

Risk with higher‐dose ghrelin

Food intake

See comment

See comment

N/A

40
(2 RCTs)

⊕⊝⊝⊝
Very low1 2

Too few data to be meaningful

Because of the differences in study design and diversity in the treatment provided we did not pool results in a meta‐analysis

Body weight

No data

No data

No data

No data

⊕⊝⊝⊝
Very low3

Not reported. No evidence to support or refute the use of ghrelin in people with cancer cachexia.

Adverse events

Study population

Not estimable

40
(2 RCTs)

⊕⊝⊝⊝
Very low1 2

Too few data to be meaningful

See comment

See comment

*The risk in the intervention group (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 N/A: not applicable

GRADE Working Group grades of evidence
High quality: we are very confident that the true effect lies close to that of the estimate of the effect
Moderate quality: we are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different
Low quality: our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect
Very low quality: we have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect

1Downgraded once for study limitations due to high risk of attrition bias and biases confounded by small size.
2Downgraded twice for imprecision due to low participant numbers.
3In circumstances where there were no data reported for an outcome, we report the level of evidence as 'very low' with no evidence to support or refute the use of ghrelin in people with cancer cachexia.

Figuras y tablas -
Summary of findings 4. Higher‐dose ghrelin compared to lower‐dose ghrelin for cachexia associated with cancer
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Table 1. Summary of results of individual studies: primary outcomes

Primary outcome

Lundholm 2010

Neary 2004

Strasser 2008

Higher‐dose ghrelin group

Lower‐dose ghrelin group

Ghrelin group

Placebo group

Higher‐dose ghrelin group

Lower‐dose ghrelin group

Food intake

Baseline:

32.5 ± 94 (SEM) kcal/kg/day

At 8 weeks: 28.2 ± 3.8 (SEM) kcal/kg/day

According to 4‐day schedule

Baseline: 24.1 ± 3.0 (SEM) kcal/kg/day

At 8 weeks: 25.5 ± 4.5 (SEM) kcal/kg/day

According to 4‐day schedule

Mean energy intake: 9270 kJ

(95% CI 3249 to 15,290 kJ)

As assessed by 24‐h food diary

Mean energy intake: 6854 kJ

(95% CI 3634 to 10,070 kJ)

As assessed by 24‐h food diary

Nutritrional intake at lunch compared to baseline

Ghrelin: 251 kcal

Placebo: 230 kcal

Nutritrional intake at lunch and rest of the day compared to baseline

Ghrelin: 244 kcal

Placebo: 156 kcal

Monitored daily

Nutritrional intake at lunch compared to baseline

Ghrelin: ‐105 kcal

Placebo: ‐17 kcal

Nutritrional intake at lunch and rest of the day compared to baseline

Ghrelin: 145 kcal

Placebo: 228 kcal

Monitored daily

Body weight

Not reported

Not reported

Not reported

Not reported

Not reported

Not reported

Adverse events

Nil

Nil

Nil

Nil

Ghrelin: 17 (increased bowel activity: 5; abdominal pain: 5; dry mouth: 3; worsening of pre‐existing neuropathy: 1; asthenia: 1; diarrhoea: 1; nausea: 1)

Placebo: 6 (increased bowel activity: 3; dry mouth: 1; dizziness: 1; diarrhoea: 1)

Ghrelin: 7 (increased bowel activity: 3; shortness of breath: 1; sweating: 2; vomiting: 1)

Placebo: 12

(increased bowel activity: 5; shortness of breath: 1; nausea: 1; increased stool frequency: 1; apoplectiform deafness: 1; vomiting: 2; constipation: 1)

SEM: standard error of mean

Figuras y tablas -
Table 1. Summary of results of individual studies: primary outcomes
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Table 2. Summary of results of individual studies: secondary outcomes

Secondary Outcomes

Lundholm 2010

Neary 2004

Strasser 2008

Higher‐dose ghrelin group

Lower‐dose ghrelin group

Ghrelin group

Placebo group

Higher‐dose ghrelin group

Lower‐dose ghrelin group

Survival

Not reported

Not reported

Not reported

Not reported

Not reported

Not reported

Body composition (lean body mass)

Baseline: 44.8 ± 2.9 (SEM) kg

At 8 weeks: 47.8 ± 2.9 (SEM) kg

Difference over time:

2.24 ± 0.71 (SEM)

Baseline: 44.3 ± 2.2 (SEM) kg

At 8 weeks: 45.1 ± 2.8 (SEM) kg

Difference over time:

0.86 ± 1.18 (SEM)

Not reported

Not reported

Not reported

Not reported

Mean difference 1.38 kg (95% CI ‐1.32 to 4.08)

Body composition (fat mass)

Baseline: 15.1 ± 1.9 (SEM) kg

At 8 weeks: 13.5 ± 1.9 (SEM) kg

Difference over time:

‐1.3 ± 0.7 (SEM)

Baseline: 16.3 ± 3.0 (SEM) kg

At 8 weeks: 12.6 ± 2.4 (SEM) kg

Difference over time:

‐3.7 ± 0.8 (SEM)

Not reported

Not reported

Not reported

Not reported

Mean difference 2.40 kg (95% CI 0.32 to 4.48

Plasma ghrelin

Baseline: 563 ± 90 (SEM) ng/L

At 8 weeks: 1229 ± 501 (SEM) ng/L

Baseline: 3418 ± 2570 (SEM) ng/L

At 8 weeks: 3817 ± 2997 (SEM) ng/L

0 min (pre‐breakfast): 531 ± 83 (SEM)

90 min (at the start of infusion): 505 ± 90 (SEM)

150 min (60 min after the start of infusion): 1718 ± 169 (SEM)

180 min (90 min after the start of infusion): 1840 ± 221 (SEM)

0 min (pre‐breakfast): 545 ± 58 (SEM)

90 min (at the start of infusion): 440 ± 59 (SEM)

150 min (60 min after the start of infusion): 509 ± 97 (SEM)

180 min (90 min after the start of infusion): 490 ± 63 (SEM)

Not reported

Not reported

Baseline imbalances between the two groups

Mean difference 1209.00 pmoL/L (95% CI 827.08 to 1590.92)

Quality of Life

HADS anxiety

Baseline: 4.6 ± 1.07 (SEM)

At 8 weeks: 5.4 ± 1.6 (SEM)

HADS anxiety

Baseline: 8.6 ± 1.6 (SEM)

At 8 weeks: 8.8 ± 1.3 (SEM)

Not reported

Not reported

Not reported

Not reported

Baseline imbalances between the two groups

HADS depression

Baseline: 5.7 ± 0.9 (SEM)

At 8 weeks: 6.8 ±1.2 (SEM)

HADS depression

Baseline: 7.6 ±1.4 (SEM)

At 8 weeks: 9.3 ± 1.9 (SEM)

Not reported

Not reported

Not reported

Not reported

Mean difference ‐2.50 (95% CI ‐6.90 to 1.90)

SF‐36 PCS

Baseline: 30 ± 3 (SEM)

At 8 weeks: 27 ± 3 (SEM)

SF‐36 PCS

Baseline: 35 ± 3 (SEM)

At 8 weeks: 30 ± 2 (SEM)

Not reported

Not reported

Not reported

Not reported

Mean difference ‐3.00 (95% CI ‐10.07 to 4.07)

SF‐36 MCS

Baseline: 40 ± 3 (SEM)

At 8 weeks: 41 ± 3 (SEM)

SF‐36 MCS

Baseline: 30 ± 2 (SEM)

At 8 weeks: 34 ± 4 (SEM)

Not reported

Not reported

Not reported

Not reported

Baseline imbalances

CI: confidence interval
HADS: Hospital Anxiety and Depression Scale

SEM: standard error of mean
SF‐36 MCS: 36‐item Short Form Health Survey Mental Component Scale
SF‐36 PCS: 36‐item Short Form Health Survey Physical Component Scale

Figuras y tablas -
Table 2. Summary of results of individual studies: secondary outcomes
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