Raghunandan 2010.
Methods | A 3‐arm parallel RCT but only 2 arms of the trial were relevant | |
Participants | 50 postmenopausal women with urogenital and sexual dysfunction Age (mean, SD): Group A: 52.16 (7.53); Group B: 51.60 (5.66) Inclusion criteria: postmenopausal women in the age group of 40–65 years with symptoms of urogenital and sexual dysfunction, who have undergone spontaneous amenorrhoea at least 12 months prior to screening or have undergone surgical menopause at least 6 weeks prior, were included in the study. Urogenital disorders included vaginal atropy, vulvitis, urethritis, dyspareunia, recurrent urinary tract infections, and urinary incontinence symptoms. Sexual dysfunction disorders included sexual pain disorder or a problem with sexual desire, arousal, or orgasm that causes distress Exclusion criteria: women with any known contraindication to HRT as well as those using any hormonal product within 6 weeks of screening visit were excluded from the study |
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Interventions |
Group A: local oestrogen cream (n = 25). 25 women were given Premarin cream preparation locally once daily application of 1 gm of cream containing 0.625 mg of conjugated equine oestrogen for 2 weeks followed by twice weekly application for further 10 weeks Group B: non‐hormonal lubricant (n = 25). 25 women were given non‐hormonal lubricant gel locally, once‐daily application of 1 g of gel for 2 weeks followed by twice weekly application for further 10 weeks |
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Outcomes | Adverse event (total events) | |
Notes | Most outcome data were reported in non‐usable form e.g. mean percentage, etc. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Insufficient information on randomisation process |
Allocation concealment (selection bias) | Unclear risk | Insufficient information on method used in allocation concealment |
Blinding (performance bias) | Unclear risk | No information was reported on performance bias |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No information was reported on the blinding of outcome assessor |
Incomplete outcome data (attrition bias) All outcomes | Low risk | It was stated that "All women analyzed at completion of 12 weeks of therapy" |
Selective reporting (reporting bias) | Low risk | All the outcomes specified in the methods section ware reported |
Other bias | Low risk | "All the study parameters in study groups 1 and 2 and in the control group were comparable with each other at the initiation of therapy" |