Skip to main content
. 2017 Nov 23;2017(11):CD010496. doi: 10.1002/14651858.CD010496.pub2

Yang 2009.

Methods Randomized controlled study.
Setting: People's Hospital of Wuhai City, Wuhai, Inner Mongolia, China.
Study period: January 2007 to December 2007.
Participants Inclusion criteria: first episode of curd‐like vaginal discharge associated with any of the following symptoms and signs: vulvar itching, vulvar or vaginal burning, dyspareunia and vaginal mucosa hyperemia; vaginal samples positive for Candida species, hyphae or pseudohyphae by microscopic examination method. Sexual activity during treatment not allowed and they used condoms during follow‐up.
Exclusion criteria: pregnant, lactating, diabetes, allergic responses to azole drugs, positive for trichomoniasis or mycoplasma infection.
Number enrolled: 86 enrolled and randomized.
Numbers per group: clotrimazole + probiotic: 44; clotrimazole alone: 42.
Age (mean): 36 years (range 25‐48 years). Separate age data per group not available.
Interventions Clotrimazole + probiotic group: 1 vaginal tablet of clotrimazole 500 mg on day 1 and day 4 + 1 vaginal capsule of Lactobacillus delbrueckii subsp. Lactis DM8909 (each capsule contained 0.25 × 106 colony forming units), QD from day 1 to day 10.
Clotrimazole alone group: 1 vaginal tablet of clotrimazole 500 mg on day 1 and day 4.
Outcomes Follow‐up: 7‐10 days and 1 month after completion of treatment, clinical and laboratory symptoms were re‐evaluated.
Outcomes:
  • clinical cure rate (7‐10 days after completion of treatment);

  • mycological cure rate (7‐10 days after completion of treatment);

  • relapse rate (1 month after completion of treatment, visited participants who were mycological cured 7‐10 days after completion of treatment);

  • rate of adverse events.

Notes Study obtained written consent from all participants and had ethical clearance from review committee of hospital.
No funding source or declaration of interest reported.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk We contacted the author and found that they used a draw method (all participants were numbered on individual pieces of paper, then took the paper relevant to participant out of a container without seeing what was written on it).
Allocation concealment (selection bias) High risk No allocation concealment.
Blinding of participants and personnel (performance bias) 
 All outcomes High risk No blinding.
Blinding of outcome assessment (detection bias) 
 All outcomes High risk No blinding.
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk Reported no withdrawals, but there was not enough information for us to judge "yes" or "no" in intention‐to‐treat analysis (per protocol analysis) and consequences.
Selective reporting (reporting bias) Unclear risk No information available to make a judgment.
Other bias Unclear risk No available data on baseline characteristics for the 2 groups to judge the balance. (We contacted the original author and they reported no significant differences in baseline characteristics, but provided no detailed data.)