Methods |
Study design: open RCT
Study duration: 3 weeks
Follow‐up: 6 months
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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)
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Interventions |
Treatment group
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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
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Outcomes |
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Notes |
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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 |