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. 2018 Apr 5;2018(4):CD008509. doi: 10.1002/14651858.CD008509.pub3

Alizadeh 2014.

Methods
  • Study design: RCT.

  • Study duration: June 2007 until July 2008.

  • Follow‐up: 4 weeks.

Participants
  • Country: Iran.

  • Setting: single centre.

  • Patients with distal ureteral stones and UVJ stones 3 to 6 mm; 18‐60 years; diagnosed with KUB and US.

  • Number: treatment group: 50; control group: 46.

  • Age limits, years: treatment group: 20‐50; control group: 19‐54.

  • Sex, M/F: treatment group: 21/29; control group: 14/32.

  • Exclusion criteria: radiolucent stone on KUB; acute hydronephrosis (grades 2 and 3) on sonography; presence of UTI; history of peptic ulcer disease; systolic blood pressure < 100; consumers of calcium antagonist drugs; solitary kidney; diabetes mellitus; pregnancy; previous distal ureteral surgery; creatinine over 1.4 for males and 1.2 for females; pain resistant to conservative treatment; NSAID intolerance or adverse events of tamsulosin during the study; participant withdrawal from the study at any time; occurrence of any unforeseen complications during the study.

Interventions Control group
  • Standard pain medication (indomethacin).


Treatment group
  • Tamsulosin 0.4 mg once daily.


Researchers emphasised that all participants should drink 2 L of water daily.
Outcomes
  • Stone expulsion time.

  • Stone expulsion rate.

  • Mean stone size.

  • Stone location.

  • Amount of analgesic consumption.

  • Possible complications caused by stones during the study period.

  • Possible side effects from medications or intolerance recorded and used for statistical analysis.

Funding sources None stated.
Declarations of interest None stated.
Notes Follow‐up was every 2 weeks with KUB, US, or CT.
Not all abbreviations were explained in the text.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: “patients were randomly assigned to a control group (n = 46) and study group (n = 50).”
Comment: Randomisation was stated but no information on method used was available; therefore selection bias was considered to have unclear risk.
Allocation concealment (selection bias) Unclear risk No quotes available. Insufficient information to permit judgement.
Comment: Owing to insufficient information, allocation concealment was considered to have unclear risk of bias.
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk No quotes available. No blinding described.
Comment: Owing to insufficient information, risk of performance bias was considered to be unclear.
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk No quotes available. No blinding of outcome assessments described.
Comment: Owing to insufficient information, risk of detection bias was considered to be unclear.
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk No quotes available. No intention‐to‐treat analysis.
Comment: Owing to lack of intention‐to‐treat analysis, risk of attrition bias was considered to be unclear.
Selective reporting (reporting bias) High risk No quotes available.
Comment: Results on pain episodes were not reported; therefore risk of reporting bias was considered to be high.
Other bias Low risk No quotes available. Study appears to be free of other sources of bias.
Comment: No other sources of bias could be found; therefore we considered risk of other bias to be low.