Table 3. Cochrane Grades of Recommendation, Assessment, Development, and Evaluation (GRADE)[20] assessment of strength of evidence
| Outcome measure | number
of studies (pooled sample) |
heterogeneity | model of
analysis |
total effects | measure
compared |
95% CI | GRADE
result |
||
| I2 | p | Z | p | ||||||
| N/A, not applicable ALT, ratio | alanine aminotransferase | MD, mean difference | SMD, standardized mean difference | RR, risk | |||||
| Weight | 5(341) | 40% | 0.16 | fixed effect | 4.35 | <0.001 | MD=-2.89 | -4.20, -1.59 | moderate |
| Body Mass Index
(BMI) |
4(265) | 0% | 0.83 | fixed effect | 4.5 | <0.001 | MD=-0.81 | -1.16, -0.45 | high |
| Treatment effect | 3(146) | 40% | 0.19 | fixed effect | 1.36 | 0.17 | SMD=-0.23 | -0.56, 0.10 | high |
| Dropout rate | 3(241) | 59% | 0.09 | random
effects |
0.4 | 0.69 | RR=1.48 | 0.21, 10.30 | moderate |
| Any side effects | 2(172) | 0% | 0.75 | fixed effect | 0 | 1 | RR=1.00 | 0.77, 1.30 | low |
| constipation | 2(172) | 0% | 1 | fixed effect | 0.43 | 0.67 | RR=0.86 | 0.42, 1.74 | low |
| sinus tachycardia | 2(172) | 0% | 0.76 | fixed effect | 0.26 | 0.8 | RR=1.13 | 0.46, 2.78 | low |
| weakness | 2(172) | 0% | 0.6 | fixed effect | 0 | 1 | RR=1.00 | 0.39, 2.54 | low |
| ALT elevation | 2(172) | 0% | 0.93 | fixed effect | 0.86 | 0.39 | RR=1.60 | 0.55, 4.69 | low |
| orthostatic hypotension |
2(172) | 0% | 0.67 | fixed effect | 0.72 | 0.47 | RR=0.60 | 0.15, 2.43 | low |
| nausea | 2(172) | 0% | 0.85 | fixed effect | 0.72 | 0.47 | RR=1.67 | 0.41, 6.67 | low |
| dry mouth | 1(72) | N/A | N/A | fixed effect | 0.46 | 0.65 | RR=0.67 | 0.12, 3.75 | very low |
| hypersomnia | 1(72) | N/A | N/A | fixed effect | 0.58 | 0.56 | RR=0.50 | 0.05, 5.27 | very low |