Li 2002.
Methods | Randomised controlled trial. Participants allocated at ratio of 1.5:1 for Qigong relative to other 2 groups. Blinding not able to be maintained, but each study group unaware of others. No dropouts; participants in mandatory treatment | |
Participants | Setting: residential treatment, China. Participants: 86 heroin users, dependent by DSM‐III‐R, urine positive for morphine. Group sizes: (1) n = 26, (2) n = 34, (3) n = 26. No significant difference in baseline data of groups. Mean age: 32 years. 100% men. 79 using by injection, 7 by sniffing; mean 5.5 years of drug use; mean 27 hours between last use and entry to treatment centre |
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Interventions | (1) Symptomatic medications. (2) Qigong ‐ traditional Chinese health practice. (3) Lofexidine, 0.4 mg twice day 1, 0.6 mg 3 times/day for 3 days, then tapered to cease after day 10. Only groups (1) and (3) considered for this review. Scheduled duration about 10 days |
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Outcomes | Graph of daily withdrawal scores; Hamilton Anxiety Rating Scale scores days 0, 5, and 10; days to achieve morphine‐negative urine | |
Notes | Withdrawal rated by observers, 5 levels, 23 symptoms. Source of funds not reported | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "Participants were randomly assigned ..." (abstract) and "Qualified subjects were assigned into one of three groups according to the order in which they entered the treatment centre." Comment: Method of sequence generation not reported |
Allocation concealment (selection bias) | Unclear risk | Method not reported |
Blinding (performance bias and detection bias) Subjective outcomes ‐ intensity of withdrawal, adverse effects | Unclear risk | Study established with observers blind, but authors noted the blind was difficult to maintain. Blinding of participants was not possible, but participants were not aware of other treatment groups |
Blinding (performance bias and detection bias) Objective outcomes ‐ duration of treatment, completion of treatment | Low risk | These outcomes unlikely to be affected by lack of blinding, but were confounded by treatment being mandatory. These outcomes not used for this review |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No dropouts |
Selective reporting (reporting bias) | Low risk | None apparent |
Other bias | High risk | Rates of completion of withdrawal confounded as participants were in mandatory treatment |