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Review
, 2013 (3), CD004310

Megestrol Acetate for Treatment of Anorexia-Cachexia Syndrome

Affiliations
Review

Megestrol Acetate for Treatment of Anorexia-Cachexia Syndrome

Vicente Ruiz Garcia et al. Cochrane Database Syst Rev.

Abstract

Background: This is an updated version of a previously published review in The Cochrane Library (2005, Issue 2) on 'Megestrol acetate for the treatment of anorexia-cachexia syndrome'. Megestrol acetate (MA) is currently used to improve appetite and to increase weight in cancer-associated anorexia. In 1993, MA was approved by the US Food and Drug Administration for the treatment of anorexia, cachexia or unexplained weight loss in patients with AIDS. The mechanism by which MA increases appetite is unknown and its effectiveness for anorexia and cachexia in neoplastic and AIDS (acquired immunodeficiency syndrome) patients is under investigation.

Objectives: To evaluate the efficacy, effectiveness and safety of MA in palliating anorexia-cachexia syndrome in patients with cancer, AIDS and other underlying pathologies.

Search methods: We sought studies through an extensive search of electronic databases, journals, reference lists, contact with investigators and other search strategies outlined in the methods. The most recent search for this update was carried out in May 2012.

Selection criteria: Studies were included in the review if they assessed MA compared to placebo or other drug treatments in randomised controlled trials of patients with a clinical diagnosis of anorexia-cachexia syndrome related to cancer, AIDS or any other underlying pathology.

Data collection and analysis: Two independent review authors conducted data extraction and evaluated methodological quality. We performed quantitative analyses using appetite and quality of life as a dichotomous variable, and analysed weight gain as continuous and dichotomous variables.

Main results: We included 35 trials in this update, the same number but not the same trials as in the previous version of the review. The trials comprised 3963 patients for effectiveness and 3180 for safety. Sixteen trials compared MA at different doses with placebo, seven trials compared different doses of MA with other drug treatments and 10 trials compared different doses of MA. Meta-analysis showed a benefit of MA compared with placebo, particularly with regard to appetite improvement and weight gain in cancer, AIDS and other underlying conditions, and lack of benefit in the same patients when MA was compared to other drugs. There was insufficient information to define the optimal dose of MA, but higher doses were more related to weight improvement than lower doses. Quality of life improvement in patients was seen only when comparing MA versus placebo but not other drugs in both subcategories: cancer and AIDS. Oedema, thromboembolic phenomena and deaths were more frequent in the patients treated with MA. More than 40 side effects were studied.

Authors' conclusions: This review shows that MA improves appetite and is associated with slight weight gain in cancer, AIDS and in patients with other underlying pathology. Despite the fact that these patients are receiving palliative care they should be informed of the risks involved in taking MA.

Conflict of interest statement

No one involved in this review has any conflict of interest.

Figures

1
1
Study flow diagram.
2
2
Risk of bias
3
3
4
4
5
5
6
6
1.1
1.1
Comparison 1 Megestrol acetate versus placebo (ITT), Outcome 1 Appetite improvement.
1.2
1.2
Comparison 1 Megestrol acetate versus placebo (ITT), Outcome 2 Appetite gain.
1.3
1.3
Comparison 1 Megestrol acetate versus placebo (ITT), Outcome 3 Weight improvement.
1.4
1.4
Comparison 1 Megestrol acetate versus placebo (ITT), Outcome 4 Weight gain.
1.5
1.5
Comparison 1 Megestrol acetate versus placebo (ITT), Outcome 5 Quality of life improvement.
1.6
1.6
Comparison 1 Megestrol acetate versus placebo (ITT), Outcome 6 Quality of life gain.
2.1
2.1
Comparison 2 Megestrol acetate versus other drugs (ITT), Outcome 1 Appetite improvement.
2.2
2.2
Comparison 2 Megestrol acetate versus other drugs (ITT), Outcome 2 Appetite gain.
2.3
2.3
Comparison 2 Megestrol acetate versus other drugs (ITT), Outcome 3 Weight improvement.
2.4
2.4
Comparison 2 Megestrol acetate versus other drugs (ITT), Outcome 4 Weight gain.
2.5
2.5
Comparison 2 Megestrol acetate versus other drugs (ITT), Outcome 5 Quality of life improvement.
2.6
2.6
Comparison 2 Megestrol acetate versus other drugs (ITT), Outcome 6 Quality of life gain.
3.1
3.1
Comparison 3 Megestrol acetate versus megestrol acetate (ITT), Outcome 1 Appetite improvement.
3.2
3.2
Comparison 3 Megestrol acetate versus megestrol acetate (ITT), Outcome 2 Weight improvement.
3.3
3.3
Comparison 3 Megestrol acetate versus megestrol acetate (ITT), Outcome 3 Weight improvement 160 mg versus other higher doses.
3.4
3.4
Comparison 3 Megestrol acetate versus megestrol acetate (ITT), Outcome 4 Weight gain.
3.5
3.5
Comparison 3 Megestrol acetate versus megestrol acetate (ITT), Outcome 5 Quality of life improvement.
3.6
3.6
Comparison 3 Megestrol acetate versus megestrol acetate (ITT), Outcome 6 Quality of life gain.
4.1
4.1
Comparison 4 Safety, Outcome 1 Acute decompensation of COPD or pulmonary exacerbation.
4.2
4.2
Comparison 4 Safety, Outcome 2 Serious adverse events (SAE).
4.3
4.3
Comparison 4 Safety, Outcome 3 Any adverse event.
4.4
4.4
Comparison 4 Safety, Outcome 4 Abdominal pain.
4.5
4.5
Comparison 4 Safety, Outcome 5 Abnormal appetite.
4.6
4.6
Comparison 4 Safety, Outcome 6 Amenorrhoea/irregular menses.
4.7
4.7
Comparison 4 Safety, Outcome 7 Bowel obstruction.
4.8
4.8
Comparison 4 Safety, Outcome 8 Constipation.
4.9
4.9
Comparison 4 Safety, Outcome 9 Chest pain.
4.10
4.10
Comparison 4 Safety, Outcome 10 Confusion.
4.11
4.11
Comparison 4 Safety, Outcome 11 Dyspnoea.
4.12
4.12
Comparison 4 Safety, Outcome 12 Depression.
4.13
4.13
Comparison 4 Safety, Outcome 13 Deaths.
4.14
4.14
Comparison 4 Safety, Outcome 14 Diarrhoea.
4.15
4.15
Comparison 4 Safety, Outcome 15 Drowsiness.
4.16
4.16
Comparison 4 Safety, Outcome 16 Elevated transaminase levels.
4.17
4.17
Comparison 4 Safety, Outcome 17 Glucose intolerance.
4.18
4.18
Comparison 4 Safety, Outcome 18 Hallucinations/psychosis.
4.19
4.19
Comparison 4 Safety, Outcome 19 Headaches.
4.20
4.20
Comparison 4 Safety, Outcome 20 Hyperphagia.
4.21
4.21
Comparison 4 Safety, Outcome 21 Heart burn.
4.22
4.22
Comparison 4 Safety, Outcome 22 Heart failure.
4.23
4.23
Comparison 4 Safety, Outcome 23 Hypertension.
4.24
4.24
Comparison 4 Safety, Outcome 24 Impotence.
4.25
4.25
Comparison 4 Safety, Outcome 25 Infections.
4.26
4.26
Comparison 4 Safety, Outcome 26 Inappropriate behaviour.
4.27
4.27
Comparison 4 Safety, Outcome 27 Insomnia.
4.28
4.28
Comparison 4 Safety, Outcome 28 Loss of co‐ordination.
4.29
4.29
Comparison 4 Safety, Outcome 29 Nausea/vomiting.
4.30
4.30
Comparison 4 Safety, Outcome 30 Neoplasma.
4.31
4.31
Comparison 4 Safety, Outcome 31 Oedema.
4.32
4.32
Comparison 4 Safety, Outcome 32 Pneumonia.
4.33
4.33
Comparison 4 Safety, Outcome 33 Pruritus.
4.34
4.34
Comparison 4 Safety, Outcome 34 Pyrosis.
4.35
4.35
Comparison 4 Safety, Outcome 35 Pulmonary embolism.
4.36
4.36
Comparison 4 Safety, Outcome 36 Respiratory failure.
4.37
4.37
Comparison 4 Safety, Outcome 37 Other adverse events.
4.38
4.38
Comparison 4 Safety, Outcome 38 Skin disorder (includes vesiculobullous rash).
4.39
4.39
Comparison 4 Safety, Outcome 39 Sweating.
4.40
4.40
Comparison 4 Safety, Outcome 40 Swelling legs or abdominal.
4.41
4.41
Comparison 4 Safety, Outcome 41 Stroke.
4.42
4.42
Comparison 4 Safety, Outcome 42 Thromboembolic phenomena including thrombophlebitis.
4.43
4.43
Comparison 4 Safety, Outcome 43 Testicular shrinkage.
4.44
4.44
Comparison 4 Safety, Outcome 44 Withdrawals.
5.1
5.1
Comparison 5 Sensitivity analyses, Outcome 1 Appetite improvement treatment duration 6 weeks.
5.2
5.2
Comparison 5 Sensitivity analyses, Outcome 2 Appetite improvement treatment duration 12 weeks.
5.3
5.3
Comparison 5 Sensitivity analyses, Outcome 3 Appetite gain 12 weeks.
5.4
5.4
Comparison 5 Sensitivity analyses, Outcome 4 Weight improvement treatment duration 6 weeks.
5.5
5.5
Comparison 5 Sensitivity analyses, Outcome 5 Quality of life gain.
5.6
5.6
Comparison 5 Sensitivity analyses, Outcome 6 Weight improvement 12 weeks.
5.7
5.7
Comparison 5 Sensitivity analyses, Outcome 7 Weight gain 6 weeks.
5.8
5.8
Comparison 5 Sensitivity analyses, Outcome 8 Weight gain 12 weeks.
5.9
5.9
Comparison 5 Sensitivity analyses, Outcome 9 Blinded versus open‐label appetite improvement.
5.10
5.10
Comparison 5 Sensitivity analyses, Outcome 10 Blinded versus open‐label appetite gain.
5.11
5.11
Comparison 5 Sensitivity analyses, Outcome 11 Blinded versus open‐label weight Improvement.
5.12
5.12
Comparison 5 Sensitivity analyses, Outcome 12 Sensitivity number patients weight improvement.
5.13
5.13
Comparison 5 Sensitivity analyses, Outcome 13 Appetite improvement, study quality.
5.14
5.14
Comparison 5 Sensitivity analyses, Outcome 14 Weight improvement, study quality.
5.15
5.15
Comparison 5 Sensitivity analyses, Outcome 15 Weight gain, study quality.
5.16
5.16
Comparison 5 Sensitivity analyses, Outcome 16 Sensitivity duration oedema.
5.17
5.17
Comparison 5 Sensitivity analyses, Outcome 17 Sensitivity duration thromboembolic phenomena.
5.18
5.18
Comparison 5 Sensitivity analyses, Outcome 18 Sensitivity blinded versus open‐label weight gain.
5.19
5.19
Comparison 5 Sensitivity analyses, Outcome 19 Sensitivity number of patients in trial appetite improvement.
5.20
5.20
Comparison 5 Sensitivity analyses, Outcome 20 Sensitivity number of patients weight gain.
5.21
5.21
Comparison 5 Sensitivity analyses, Outcome 21 Sensitivity appetite improvement cancer.
5.22
5.22
Comparison 5 Sensitivity analyses, Outcome 22 Appetite improvement doses.
5.23
5.23
Comparison 5 Sensitivity analyses, Outcome 23 Weight improvement doses.
5.24
5.24
Comparison 5 Sensitivity analyses, Outcome 24 Sensitivity (cancer/other patients) thromboembolic phenomena.
5.25
5.25
Comparison 5 Sensitivity analyses, Outcome 25 Deaths sensitivity 6 weeks.
5.26
5.26
Comparison 5 Sensitivity analyses, Outcome 26 Deaths sensitivity/pathology.

Update of

  • Megestrol Acetate for the Treatment of Anorexia-Cachexia Syndrome
    EG Berenstein et al. Cochrane Database Syst Rev (2), CD004310. PMID 15846706. - Review
    This review demonstrates that MA improves appetite and weight gain in patients with cancer. No overall conclusion about quality of life (QOL) could be drawn due to hetero …

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