Yeh 2000.
| Methods | Double‐blind randomised controlled trial | |
| Participants | 69 patients with geriatric cachexia a) 36 pts = 35 M + 1 F Mean age 76 yrs b) 33 pts = 31 M + 2 F Mean age 76 yrs | |
| Interventions | a) MA 800 mg/d, suspension
b) Placebo, suspension 12 weeks |
|
| Outcomes | Weight
Appetite Sense of well being (SOWB), enjoyment of life, laboratory nutrition parameter and adverse events were measured |
|
| Notes | Follow_up 13 weeks
QS = 3 Cachexia was defined as experienced weight loss > 5% of their usual body weight during the previous 3 months, or had a body weight of 20% below their ideal body weight (based on the tables of the Metropolitan Life Insurance Company and the Gerontology Research Center) |
|
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Insufficient information to permit judgement of low risk or high risk |
| Allocation concealment (selection bias) | Unclear risk | Insufficient information to permit judgement of low risk or high risk |
| Blinding (performance bias and detection bias) All outcomes | Low risk | See below |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | The main outcome was weight. This is a blinded study and the main outcome is not likely to be influenced by lack of blinding |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | The main outcome was weight. This is a blinded study and the main outcome is not likely to be influenced by lack of blinding |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | The withdrawals were balanced |
| Selective reporting (reporting bias) | Low risk | All the results were available |
| Other bias | Unclear risk | Insufficient information to permit judgement of low risk or high risk |
BMI: body mass index COPD: chronic obstructive pulmonary disease d: day DRO: dronabinol EPA: eicosapentaenoic acid F: female FAACT: functional assessment of anorexia/cachexia therapy HAART: highly active antiretroviral therapy KI: Karnofsky Index LASA: linear analogue self assessment M: male MA: megestrol acetate
NCCTG: The North Central Cancer Treatment Group pts: patientsPS: Performance Status QoL: quality of life QS: quality score (Oxford Quality Scale) SD: standard deviation SSA: subjective sense of appetiteTIQ: Therapy Impact Questionnaire
VAS: visual analogue scale yrs: years