Table 4.
GRADE evidence profile question 4: what is the effect of naltrexone–bupropion (N‐B) on the frequency of discontinuation due to adverse events in overweight and obese subjects?
| Quality assessment | No of patients | Effect | Quality | Comments | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| No of studies | Design | Risk of bias | Inconsistency | Indirectness | Imprecision | Other considerations | N‐B | Placebo | Relative (95% CI) | Absolute | ||
| Overall discontinuation | ||||||||||||
| 4 | Randomised trials | seriousa | No serious inconsistency | No serious indirectness | No serious imprecision | None | 723/3088 (23.4%) | 175/1448 (12.1%) | RR 1.92 (1.65 to 2.24) |
111 more per 1000 (from 79 more to 150 more) |
⊕ ⊕ ⊕Ο MODERATE | NNTD 9 (8 to 13) |
| Gastrointestinal system | ||||||||||||
| 4 | Randomised trials | seriousa | No serious inconsistency | No serious indirectness | seriousb | Very strong associationc | 308/3088 (10%) |
19/1448 (1.3%) |
RR 6.11 (3.87 to 9.65) | 71 more per 1000 (from 37 more to 131 more) | ⊕ ⊕ ⊕ ⊕ HIGH |
NNTD 15 (9 to 27) |
| Nausea | ||||||||||||
| 4 | Randomised trials | seriousa | No serious inconsistency | No serious indirectness | Very seriousd | Very strong associationc | 181/3088 (5.9%) |
3/1448 (0.2%) |
RR 20.59 (7.65 to 55.41) | 41 more per 1000 (from 14 more to 113 more) | ⊕ ⊕ ⊕Ο MODERATE |
NNTD 25 (9 to 73) |
| Vomiting | ||||||||||||
| 4 | Randomised trials | seriousa | No serious inconsistency | No serious indirectness | Very seriousd | Very strong associationc | 31/3088 (1%) | 1/1448 (0.1%) | RR 5.69 (1.57 to 20.69) | 3 more per 1000 (from 0 more to 14 more) | ⊕ ⊕ ⊕Ο MODERATE | NNTD 309 (74 to 2540) |
| Nervous system | ||||||||||||
| 4 | Randomised trials | seriousa | No serious inconsistency | No serious indirectness | No serious imprecision | Strong associatione | 148/3088 (4.8%) | 28/1448 (1.9%) | RR 2.47 (1.56 to 3.91) | 28 more per 1000 (from 11 more to 56 more) | ⊕ ⊕ ⊕ ⊕ HIGH |
NNTD 35 (18 to 92) |
| 1.7% | 25 more per 1000 (from 10 more to 49 more) | |||||||||||
| Headache—nervous system | ||||||||||||
| 4 | Randomised trials | seriousa | No serious inconsistency | No serious indirectness | No serious imprecision | Strong associatione | 51/3088 (1.7%) | 9/1448 (0.6%) | RR 2.47 (1.23 to 4.95) | 9 more per 1000 (from 1 more to 25 more) | ⊕ ⊕ ⊕ ⊕ HIGH | NNTD 109 (41 to 700) |
| 0.6% | 9 more per 1000 (from 1 more to 24 more) | |||||||||||
| Dizziness | ||||||||||||
| 4 | Randomised trials | seriousa | No serious inconsistency | No serious indirectness | seriousb | Strong associatione | 36/3088 (1.2%) | 5/1448 (0.3%) | RR 3.01 (1.22 to 7.47) | 7 more per 1000 (from 1 more to 22 more) | ⊕ ⊕ ⊕Ο MODERATE | NNTD 144 (45 to 1316) |
| 0.4% | 8 more per 1000 (from 1 more to 26 more) | |||||||||||
Settings: Academic and primary care centres; academic medical centres; private or institutional practices; research centres
a
High drop‐out rates; several investigators have financial ties to the study sponsor;
b
wide confidence interval;
c
RR > 5;
d
very wide confidence interval;
e
RR > 2.
CI: confidence interval; RR: risk ratio