A 2017 systematic review and meta-analysis evaluated the efficacy and safety of tamsulosin for the treatment of lower urinary tract symptoms (LUTS) in women. A total of 6 randomized controlled trials (RCTs) were included (N= 764 female patients). International Prostate Symptom Score (IPSS), quality-of-life (QoL) score, and Overactive Bladder Questionnaire (OAB-q) were among the scales used to compare outcomes. Total IPSS improvement was evaluated in two RCTs. Compared to placebo, tamsulosin was found to be significantly more effective in improving total IPSS, with a pooled estimate of standardized mean difference (SMD) of -4.08 (95% confidence interval [CI] -5.93 to -2.23, p<0.00001). For the IPSS storage symptom score, two RCTs again demonstrated the superiority of tamsulosin compared to placebo, with an SMD of -3.16 (95% CI -4.47 to -1.85). Both of these comparisons included significant heterogeneity (I2= 57%, p= 0.13 and I2= 94%, p<0.0001, respectively). Only one RCT included IPSS voiding symptom score, finding improvement with tamsulosin when compared to placebo, with a MD of -2.40 (95% CI -3.71 to -1.09). No significant differences were demonstrated when comparing tamsulosin vs. solifenacin or tolterodine combined with tamsulosin for any IPSS scores. [1]
For QoL score, two RCTs demonstrated the superiority of tamsulosin compared to placebo, with a pooled estimate of SMD of -2.1 (95% CI -2.67 to -1.71), again with significant heterogeneity (I2= 84%, p= 0.01). Similar to previous comparisons, no significant difference was revealed between tamsulosin compared to solifenacin or tolterodine combined with tamsulosin. Only one included RCT evaluated OAB-q, finding a significant improvement in QAB-q with tamsulosin compared to placebo (MD -5.60 [95% CI -6.59 to -4.61]), but not between tamsulosin and solifenacin. Results from a voiding diary were evaluated in one RCT, demonstrating significant improvement in voiding volume with tamsulosin vs. placebo (MD -7.50 [95% CI -10.26 to -4.74]), but with no difference for the daily number of voids, incontinence episodes per day, urgency episodes, and nocturia episodes between the two groups. Significant improvement with tamsulosin was found in some urodynamic parameters as evaluated in 3 RCTs. Compared to prazosin, tamsulosin was found to boost average flow rate (MD -1.78 [95% CI -3.32 to -0.24]), and compared to tamsulosin combined with tolterodine, tamsulosin alone was found to improve post-void residual volume (PVR; MD 24.30 [95% CI 16.34 to 32.26]). The presented data suggest tamsulosin to be an effective treatment option for LUTS in women, however, larger, adequately-powered RCTs are still required to further solidify its efficacy. [1]
A 2018 systematic review focused on the safety of tamsulosin in women and children. Ultimately, 49 studies were found including a mix of men and women, 4 studies with only women, and 3 studies with children. Cumulatively, 725 women and 290 children were included. In studies specific to women participants (age 18 to 70 years, treated for LUTS or overactive bladder), adverse events reported included headache, orthostatic hypotension, incontinence, lethargy, dizziness, drowsiness, asthenia, dry mouth, constipation, nausea, abdominal pain, and dyspepsia; no serious adverse events were reported in these studies. In pediatric studies (mean age range 7.3 to 8.2 years, treated for neuropathic bladder or ureteral stones), nasal congestion, somnolence, and headache were reported. One pediatric death was also reported, considered potentially related to the study drug. In general, the most common adverse events documented in this review, including in women and children, were consistent with known adverse events of tamsulosin reported among men with LUTS secondary to benign prostatic hyperplasia. [2]
A 2019 systematic review evaluated the efficacy and use of finasteride in women with a focus on dosage, length of treatment, and conditions that can benefit from finasteride therapy. A total of 65 studies (published RCTs, prospective cohort studies, retrospective studies, and case reports) involving 2,683 patients were included in the final analysis. The majority of the female patients included in the studies were treated with finasteride for hirsutism (48.7%). The efficacy of finasteride use on female pattern hair loss (FPHL) was assessed in 34.7% of RCTs; while other forms of hair loss such as alopecia, lichen planopilaris, and frontal fibrosing alopecia were studied, no RCTs that evaluated finasteride therapy for those conditions were identified. The analysis of other prospective and retrospective studies demonstrated that finasteride may improve hair loss in women with FPHL or frontal fibrosing alopecia. Evidence from RCTs suggested that finasteride treatment can improve hirsutism scores in women with hirsutism or idiopathic hirsutism secondary to polycystic ovarian syndrome. In general, the doses of oral finasteride ranged from 0.5 to 5 mg/day in females between the age of 6 to 88 years with the length of treatment ranging from 6 to 12 months (57.6%). Monotherapy was used in 88.9% of included finasteride patients and a continuous frequency of use was implemented in 96.4% of finasteride patients. Several recommendations regarding finasteride use in women along with the corresponding references were made by the authors and are summarized in Table 5. [3]
A 2015 Cochrane systematic review investigated interventions for hirsutism in women with polycystic ovary syndrome, idiopathic hirsutism, or idiopathic hyperandrogenism. Two included studies suggested a difference in reduction of Ferriman‐Gallwey hirsutism assessment scores for finasteride 5 mg to 7.5 mg daily compared to placebo (MD ‐5.73, 95% CI ‐6.87 to ‐4.58), however, the authors determined this very low quality of evidence was unlikely to be clinically meaningful. Two studies were also included comparing finasteride vs. spironolactone, finding similar effectiveness (MD 1.49, 95% CI ‐0.58 to 3.56 vs. MD 0.40, 95% CI ‐1.18 to 1.98). This was also considered to be low-quality data, and ultimately the authors determined that finasteride showed inconsistent results, precluding any firm conclusions. [4]
Another 2018 systematic review and meta-analysis compared pharmacologic treatments for hirsutism in women. A total of 43 RCTs were analyzed and six drug classes or combination of classes were used, including oral contraceptive pills (OCPs), antiandrogen, insulin sensitizer, OCPs plus antiandrogen, OCPs plus insulin sensitizer, and antiandrogen plus insulin sensitizer. When compared with placebo, antiandrogen monotherapy with finasteride presented with a significant reduction in hirsutism with an overall effect size of −1.48 (95% CI −2.18 to −0.78, p<0.05). While antiandrogen monotherapy with flutamide, finasteride, and spironolactone was demonstrated to be more effective than placebo, all these agents had similar efficacy when compared to each other. A combination of OCPs with finasteride demonstrated superior efficacy in comparison with placebo with an effect size of −1.64 (95% CI −2.72 to −0.55). It should be noted that the risk of bias in the included trials was high. Furthermore, as many of the studies had important methodological limitations, the precision of the results remains limited, and the interpretation of data should be done with caution. [5]