Nazari 2013.
| Methods | Randomised, placebo‐controlled, double‐blind trial | |
| Participants | Setting: inpatient, treatment services operated by non‐government organisations, Tehran, Iran. Participants: 90 opioid dependent by DSM‐IV, using opium (93%), opium extract (42%), heroin (29%), and crack (74%). Use by injection reported by 20%. Group sizes: 30 in each. Group characteristics similar. Age: 25to 40 years All male. |
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| Interventions | (1) Hab‐o Shefa, preparation of plant extracts used in traditional Iranian medicine, 3 g/day in 4 divided doses, tapered from day 8. (2) Clonidine, 0.2 to 0.4 mg days 1 to 2, 0.6 mg days 3 to 18, 0.4 to 0.2 mg days 20 to 21. (3) Placebo (sugar). Group (1) not considered for this review. All participants received an assisted self help intervention (behavioural therapy and the 12‐step principles). Scheduled duration of treatment 21 days. Naloxone challenge test on day 21 |
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| Outcomes | Overall average scores for withdrawal, craving, depression, side effects and graphs of daily mean withdrawal scores | |
| Notes | Withdrawal assessed with Subjective (13 items, possible scores 0 to 13), Objective (16 items, possible scores 0 to 64), and Clinical (11 items, possible scores 0 to 48) Opiate Withdrawal Scales. Craving assessed by visual analogue scale. Depression assessed with Beck and Hamilton scales. Side effects rates by investigator as present or absent. Source of funds not reported |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "computerized random numbers" (Materials and Methods) |
| Allocation concealment (selection bias) | Low risk | Quote: Medication "in unit size capsules packed in the boxes that were encoded ... for each patient individually and were distributed by a third person who had no contact with ... the investigator [or] the patients". (Materials and Methods) |
| Blinding (performance bias and detection bias) Subjective outcomes ‐ intensity of withdrawal, adverse effects | Low risk | Double‐blind stated. Quote: "A physician ... who ... was blind to capsules content, performed all the clinical assessments". (Materials and Methods, Setting and Ethics) |
| Blinding (performance bias and detection bias) Objective outcomes ‐ duration of treatment, completion of treatment | Low risk | Double‐blind stated |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Missing data replaced by last observation carried forward. Analysis of variance applied for two‐way comparisons |
| Selective reporting (reporting bias) | Unclear risk | Average side effects score reported but no details of nature of side effects experienced. Stated that all participants completed the study, but it is not specifically stated whether this meant that all stayed in treatment for 21 days |
| Other bias | Low risk | None apparent |