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

Shen 2007.

Methods
  • Study design: open RCT

  • Study duration: 4 weeks

  • Follow‐up: 3 months

Participants
  • Country: China

  • Setting: Shanghai Hospital of TCM; outpatients

  • Number: treatment group (52); control group (52)

  • Mean age (years): treatment group (65); control group (67)

  • Sex: female

  • Mean duration of disease (years): treatment group (6.3); control group (5.8)

Interventions Treatment group
  • Bai Tou Weng Tang and Er Xian Tang which comprised:

    • Anemone chinensis Bunge (Bai Tou Weng) 15 g, Phellodendron amurense Rupr. (Huang Bai) 15 g, Coptis chinensis Franch. (Huang Lian) 6 g, Fraxinus chinensis subsp. rhynchophylla (Hance) A.E.Murray (Qin Pi) 12 g, Anemarrhena asphodeloides Bunge (Zhi Mu) 15 g, Curculigo orchioides Gaertn. (Xian Mao) 6 g, Epimedium grandiflorum var. thunbergianum (Miq.) Nakai (Xian Ling Pi) 6 g, Angelica sinensis (Oliv.) Diels (Dang Gui) 9 g, Morinda officinalis F.C.How (Ba Ji Tian) 9 g. If participants reported urgency, frequency and pain then Taraxacum mongolicum Hand‐Mazz. (Pu Gong Ying) 15 g, Herba Plantago asiatica L. (Che Qian Cao) 15 g and Herba Scutellaria barbata D.Don (Ban Zhi Lian) 15 g were added

  • 150 mL of this decoction was taken twice daily for 4 weeks


Control
  • Ofloxacin capsule 0.2 g twice daily. If not effective, different antibiotics that had been chosen after testing to ensure microbial sensitivity were used. Treatment was for 4 weeks

Outcomes
  • Effective treatment at 4 weeks

  • Recurrence at 3 months

Notes
  • Funding source not reported

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk A random numbers table was used. Baseline equivalence was established between groups
Allocation concealment (selection bias) Unclear risk Not reported
Blinding of participants and personnel (performance bias) 
 All outcomes High risk It was not possible to blind participants because of the physical differences between a decoction and a pill
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Not reported
Incomplete outcome data (attrition bias) 
 All outcomes Low risk No dropouts or losses to 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
Participant preference bias could exist with regard to whether they wanted to take herbs or antibiotics. This was not assessed
Funding source not reported