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Meta-Analysis
. 2013 Mar 28;2013(3):CD004310.
doi: 10.1002/14651858.CD004310.pub3.

Megestrol acetate for treatment of anorexia-cachexia syndrome

Vicente Ruiz Garcia  1 , Eduardo López-Briz, Rafael Carbonell Sanchis, Jose Luis Gonzalvez Perales, Sylvia Bort-Marti
Affiliations
Meta-Analysis

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.

PubMed Disclaimer

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

Update of

References

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References to studies excluded from this review

Aguilera 2001 {published data only}
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