Community pharmacy-based interventions with Valeriana officinalis or Passiflora incarnata together with sleep hygiene education improve climacteric symptoms and sleep problems in menopause

Abstract

Introduction. Physiological and endocrine changes occur during menopause that can negatively affect the sleep-wake cycle and contribute to objective and subjective sleep problems. Objective. To assess the effectiveness of a pharmaceutic intervention with two different complementary treatments and sleep hygiene education on climacteric symptoms and sleep domains in menopausal women with sleep disturbance. Material and methods. A sample of 109 women (45-64 years) participated in a 3-month randomized study, 35 received sleep hygiene instructions (SHI), 36 received capsules containing Passiflora incarnata 3 times a ay plus SHI (PI), and 38 received capsules containing Valerian officinalis 3 times a day plus SHI (VO). Participants were evaluated by a) the Menopause Quality of Life (MENQOL) instrument, b) Pittsburgh Sleep Quality Index (PSQI), c) Insomnia Severity Index, d) Epworth Sleepiness Scale, and e) Mental component of SF-12 health survey. Results. MENQOL scores were similar at baseline in the three groups but were reduced (improved vasomotor domain and physical subscale) at the end of the study in the VO group when compared with PI and SHI counterparts (both, p<0.05). The SF-12 mental function showed improvement in the VO group (p<0.05). Global PSQI score was significantly improved by PI and VO treatments at the end of treatment (p=0.046 and p=0.034, respectively). VO group was more effective than PI in alleviating mild insomnia. Change in vasomotor symptoms positively and significantly correlated with changes in all items of PSQI components, except for sleep duration and the association was strongest with sleep latency. Most participants evaluated the pharmaceutical and educational interventions provided as satisfactory. Conclusions. The Valerian officinalis was the preferable treatment for the climateric symptoms and sleep difficulties associated with menopause. This study provided evidence that community pharmacists can play a crucial role in referring menopausal women with symptoms of insomnia to potential medicinal plants therapy and sleep hygiene instructions.