Shi 2003.
Methods | Randomised, double‐blind, placebo‐controlled trial. Generation of allocation sequence: random number table. Double blind: study personnel and subjects. Withdrawal/dropouts: numbers and reasons reported. Intention to treat analyses: no. | |
Participants | Study country: China. Setting: not stated. 36 male adults of intravenous drug users including HIV‐infected and AIDS patients (18 in herb group and 18 in placebo group). HIV infection and AIDS were diagnosed by CDC criteria in 1993. | |
Interventions | Experiment:
Qiankunning ( extracts from 14 herbs), four tablets orally, three times daily, for consecutive seven months. Control: Placebo, four tablets orally, three times daily, for consecutive seven months. After seven months treatment, all patients received Qiankunning (six tablets, thrice daily) for another three months. During the treatment period, all other drugs were stopped. There is no information about quality standard of the preparations. |
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Outcomes | CD4 cell counts, viral loads, and adverse events. The outcomes were assessed during treatment bimonthly and at the end of the treatment. |
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Notes | Five patients from herb group and one patient from placebo group were lost during treatment because of relocation. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment? | Low risk | A ‐ Adequate |