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. 2015 Jun 4;2015(6):CD010446. doi: 10.1002/14651858.CD010446.pub2

Luo 2011.

Methods
  • Study design: open RCT

  • Study duration: 3 weeks

  • Follow‐up: 6 months

Participants
  • Country: China

  • Setting: Hubei Provincial Hospital of TCM outpatients

  • Women were selected from those presenting with the traditional syndromes of kidney Yang deficiency and retained damp and toxic heat

  • Number: treatment group (30); control group (30)

  • Mean age (years): treatment group (42); control group (40)

  • Sex: female

  • Duration of disease (range, years): treatment group (0.75 to 23); control group (0.5 to 21)

Interventions Treatment group
  • Treatment combined 1 week of antibiotic treatment (selected after urine culture and microbial sensitivity tests) with two weeks of the Chinese herbal formula Bushen Tonglin Tang administered as a herbal decoction and comprised of the following herbs:

    • Taraxacum mongolicum Hand‐Mazz. (Pu Gong Ying) 15 g, Viola philippica Cav. (Zi Hua Di Ding) 15 g, Phellodendron amurense Rupr. (Huang Bai) 15 g, Dianthus superbus L. (Qu Mai) 15 g and Polygonum aviculare L. (Bian Xu) 15 g, Talcum (Hua Shi) 10 g, Rehmannia glutinosa (Gaertn.) DC. (Sheng Di Huang) 15 g, Atractylodes macrocephala Koidz (Chao Bai Zhu) 15 g, Dioscorea oppositifolia L. (Shan Yao), Glycyrrhiza uralensis Fisch. (Sheng Gan Cao) 5 g.

  • The resultant liquid was split into two doses and taken morning and evening for 14 days


Control group
  • 14 days of antibiotic treatment selected after urine culture and microbial sensitivity tests

Outcomes
  • Cured

  • Evidence of bacteriuria at 4 weeks post‐treatment

  • Safety data were not reported

Notes
  • This study is an unpublished Master's thesis

  • Funding: not reported

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk A computer generated random numbers table was used for randomisation
Allocation concealment (selection bias) Unclear risk Not reported
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Participants could not be blinded because of the physical difference between decoction and antibiotic tablet
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Not reported
Incomplete outcome data (attrition bias) 
 All outcomes Low risk All 60 participants completed the study and provided data at 6 months follow‐up
Selective reporting (reporting bias) Unclear risk Study protocol was unavailable
Other bias Unclear risk No power calculation was performed to determine the required sample size to adequately power the study to detect type 1 and type 2 errors
Outcomes were not internationally validated or available for review in the study report
Funding source not reported