| Methods |
Study design: parallel‐group randomised controlled trial. Setting: single centre/Turkey. Dates when study was conducted: May 2005 to February 2008. |
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| Participants |
Inclusion criteria: radiopaque lower ureteral stones 2 to 10 mm in diameter (mean +/‐ SD 6.2 +/‐ 1.1 mm). Exclusion criteria: anatomical abnormalities, previously diagnosed reflux, voiding dysfunction, history of uretal surgery, calcium channel blockers. Diagnostic criteria: US/XR or CT and renal function tests. Total number of participants randomly assigned: 39. Group A (ibuprofen and doxazosin)
Group B (Ibuprofen)
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| Interventions |
Group A (n = 19): ibuprofen 20 mg/kg daily 2 equal doses + doxazosin 0.03 mg/kg daily at night orally, until expulsion or 3 week review. Group B (n = 20): ibuprofen 20 mg/kg daily 2 equal doses orally, duration until expulsion or 3 week review. Co‐interventions: none. |
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| Outcomes |
Stone clearance
Secondary procedures
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| Notes |
Funding Sources: not stated. Declaration of interests: not stated. |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote from publication: 'We randomly divided patients into 2 groups'. Process of randomisation not described. |
| Allocation concealment (selection bias) | Unclear risk | Not described. |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Not described. |
| Blinding of outcome assessment (detection bias) Subjective outcomes | Unclear risk | Not described. |
| Blinding of outcome assessment (detection bias) Objective outcomes | Low risk | Objective outcomes are not likely to be influenced by lack of blinding. |
| Incomplete outcome data (attrition bias) Stone free rate | Low risk | Quote from publication: "All patients completed the study and outcome data available". |
| Incomplete outcome data (attrition bias) Serious adverse events or complications of treatment | Unclear risk | No information given. |
| Incomplete outcome data (attrition bias) Secondary procedures | Low risk | Quote from publication: "All patients completed the study and outcome data available". |
| Incomplete outcome data (attrition bias) Hospital stay | Unclear risk | No information given. |
| Incomplete outcome data (attrition bias) Pain | Unclear risk | No information given. |
| Selective reporting (reporting bias) | High risk | No published protocol available. All of the outcomes were not prespecified. Study author describe that secondary procedures (SWL or ureteroscopic procedures) were applied in participants who could not pass the stone after 3 weeks, but the result was omitted. |
| Other bias | Low risk | Not detected. |