Methods |
Random allocation. Blinding not reported. |
Participants |
160 opioid dependent by ICD‐10; Group sizes (1) 78 (2) 82. Duration of drug abuse 15 months to 11 years. 79% using by inhalation. 91% male, mean age 30. |
Interventions |
Naloxone 0.03mg/kg iv followed by naltrexone 0.6mg/kg by nasogastric tube under anaesthesia with propofol, midazolam and (1) ketamine or (2) tramadol. Anaesthesia maintained for 3 hours, iv tranquillizers for 2 hours. Inpatient treatment, general hospital. |
Outcomes |
Heart rate and blood pressure before and after anaesthesia, after each dose of naloxone, and after naltrexone. Main withdrawal symptoms before and after treatment. |
Notes |
Ten signs and symptoms of withdrawal assessed; scoring method not reported. Country: China |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Adequate sequence generation? |
Unclear risk |
Quote: "...volunteers were divided at random into two groups". Method of sequence generation not reported. |
Allocation concealment? |
Unclear risk |
Method not reported. |
Blinding?
Subjective outcomes ‐ intensity of withdrawal, adverse effects |
High risk |
No blinding reported. |
Blinding?
Objective outcomes ‐ duration of treatment, completion of treatment |
Low risk |
These outcomes not reported, and considered unlikely to be affected by lack of blinding. |
Incomplete outcome data addressed?
All outcomes |
Low risk |
No drop out reported. |
Free of selective reporting? |
Low risk |
None apparent |
Free of other bias? |
Low risk |
None apparent |
Other bias: Selection of comparison cohort |
Low risk |
Experimental and comparison groups drawn from same population. |
Other bias: Comparability of cohorts |
Unclear risk |
Comparability of group demographics not reported. |
Other bias: Representativeness of exposed cohort |
Unclear risk |
Participants described as volunteers, but means of recruiting participant and source population not reported. |
Other bias: Ascertainment of exposure |
Low risk |
Data collection established by study protocol. |