Respiratory Insufficiency in Postmenopausal Women: Study Design

In: Respiratory

27 Aug 2014

Respiratory Insufficiency in Postmenopausal Women: Study DesignStudy Design
The 12-week study was a placebo-controlled single-blind trial. Seven days after the baseline measurements, all patients started with placebo treatment for 14 days. The placebo measurements were made in the morning after the last evening placebo dose. After a 7-day interval, MPA treatment for 14 days was started, and the MPA measurements were made as after placebo treatment. The washout measurements were similarly done in the morning, 3 and 6 weeks after cessation of MPA (Fig 1).
Thirty milligrams of oral MPA (Lutopolar; Orion; Espoo, Finland) was administered twice in the evening, at 9 and 11 pm. MPA reaches its peak serum concentration within 1 to 3 h and declines quite sharply thereafter. MPA was divided in two doses given 2 h apart because we wanted sufficient MPA concentrations from falling asleep to waking up. Identical placebo tablets for the placebo treatment were also provided by Orion. Compliance was assessed by tablet counts, patient interviews, and measurements of serum MPA concentrations. The visit protocol was performed five times at 3-week intervals: at baseline, after 14 days on placebo, after 14 days on MPA, and after 3- and 6-week washout periods. order antibiotics online

Visit protocol: Body weight, BP, arterial blood gases, serum MPA, and flow-volume spirometry (Vitalograph Compact II; Vitalograph Ltd; Buckingham, England) were assessed. BP was measured in the morning by the same individual, using the auscultatory method in seated subjects. Arterial blood samples were obtained with a single arterial puncture in patients lying awake in supine position. Blood hemoglobin and hematocrit were measured at 3-week intervals except during placebo treatment.
Questionnaires: Dyspnea was evaluated with the visual analog scale during each visit. Patients completed a structured daily diary card with 20 separate items concerning their symptoms and possible adverse events of MPA for 14 days before each visit. The diary before baseline was not used for data collection but served as a training period to ensure appropriate reporting.

Figure 1. Study design.

Figure 1. Study design.


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