Yang 2009.
Methods | Randomized controlled study. Setting: People's Hospital of Wuhai City, Wuhai, Inner Mongolia, China. Study period: January 2007 to December 2007. |
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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. |
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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. |
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Outcomes | Follow‐up: 7‐10 days and 1 month after completion of treatment, clinical and laboratory symptoms were re‐evaluated. Outcomes:
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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. |
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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.) |