Response to “A comparative study of alpha-1a blockers (tamsulosin) versus estrogens in the treatment of lower urinary tract symptoms in perimenopausal females”
Anant Patil
Department of Pharmacology, Dr. DY Patil Medical College, Navi Mumbai, Maharashtra, India
Correspondence Address:
Dr. Anant Patil
Department of Pharmacology, Dr. DY Patil Medical College, Nerul, Navi Mumbai - 400 706, Maharashtra
India
Source of Support: None, Conflict of Interest: None
CheckDOI: 10.4103/ijp.IJP_439_20
Sir,
I read with interest the article “A comparative study of alpha-1a blockers (tamsulosin) versus estrogens in the treatment of lower urinary tract symptoms in perimenopausal females” published recently.[1] The study is unique from two aspects. First, references cited in the article, as well as literature search of MEDLINE database using PubMed till date, indicate that there are no head-to-head comparative trials between tamsulosin versus estrogen, and second, tamsulosin is currently used as off-label treatment of this indication. Considering this, the report has a potential for being used by clinicians as an important reference while selecting an option for the treatment of perimenopausal females as well as useful reference while developing guidelines for the treatment of specific patient population. In the study performed by Maiti et al.,[1] tamsulosin outperformed topical estrogen for efficacy in the treatment of lower urinary tract symptoms in the studied population.
Some studies have explored potential of using tamsulosin in the treatment of lower urinary tract symptoms in perimenopausal females. After carefully reading the article by Maiti et al.,[1] few important points related to methodology and results that caught attention are summarized below.
As assignment of the patient to a particular treatment could be a source of bias, blinding and randomization to two treatment groups might have helped to avoid this bias. Another important aspect in comparative trials is matching the patient groups for baseline characteristics. Classification of patients into different severity types (mild, moderate, or severe) can provide understanding about similarity or difference in the severity in the treatment groups at baseline.
Patients in one group received fixed dose, i.e., tamsulosin 0.4 mg once daily, whereas other group received topical estrogen therapy 0.5%–1% twice daily. Method of dose titration and information about number of patients receiving 1% twice daily treatment are also useful information. As tamsulosin As tamsulosin is used off-label in this indication, exact dose is unknown. Some studies have used tamsulosin 0.2 mg,[2],[3] whereas others[4] used same dose as in the study by Maiti et al.[1]
In the discussion section, authors have mentioned that topical estrogen offers advantage of lesser side effects. However, in this study, investigators did not report incidence of adverse events in two treatment groups. Although tamsulosin is generally well tolerated,[2] adverse effects are possible. A study evaluating 8-week treatment with tamsulosin 0.2 mg reported dizziness in three patients and some other adverse events were reported in five patients.[3] In this study, discontinuation rate in the tamsulosin group was 20% (eight out of 40 patients discontinued), whereas in the topical estrogen group, discontinuation rate was 15% (six out of 40 patients discontinued). Numerically, more patients discontinued in the tamsulosin group; statistical significance is unknown. Discontinuation could be because of loss to follow-up, lack of efficacy, safety reasons, or other causes. According to the results of systematic review, primary reasons for discontinuation of tamsulosin are adverse events or insufficient response.[5] The reasons for the discontinuation of patients in this study are not known. In such case, separate analysis of intention-to-treat population and per protocol population may provide better understanding of the results.
Financial support and sponsorship
Nil.
Conflicts of interest
There are no conflicts of interest.
References
留言 (0)