Lin 2006.
Methods | Randomized controlled study. Setting: People's Hospital of Meizhou City, Meizhou, Guangdong Province, China. Study period: July 2005 to October 2005. |
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Participants | Inclusion criteria: first episode of curd‐like vaginal discharge associated with any of the following symptoms and signs: vulvar or vaginal itching, vulvar burning and vaginal mucosa hyperemia; vaginal samples positive for Candida species, hyphae or pseudohyphae by microscopic examination method. They received no systemic or intravaginal antibiotic during the treatment and follow‐up. Sexual activity during treatment not allowed and they used condom during follow‐up. Exclusion criteria: pregnant, lactating, diabetes, diseases of the liver and kidney system, allergic responses to azole drugs. Number enrolled: 105 women enrolled and randomized. Number per group: clotrimazole + probiotic: 53; clotrimazole alone: 52. Age (mean): 30 years (range 20‐44 years). Separated age data per group not available. |
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Interventions | Clotrimazole + probiotic group: 1 vaginal suppository of clotrimazole 150 mg, QD from day 1 to day 7, and then 1 vaginal Lactasin capsules of Streptococcus faecalis (each capsule contained 6 × 107 colony forming units), QD from day 8 to day 14. Clotrimazole alone group: 1 vaginal suppository of clotrimazole 150 mg, QD from day 1 to day 7. |
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Outcomes | Follow‐up: 7 days 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 original 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 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 of baseline characteristics for the 2 groups to judge the balance. (We contacted the original authors and they reported no significant differences in baseline characteristics, but provided no detailed data.) |