Las intervenciones farmacéuticas con Valeriana officinalis o Passiflora incarnata junto con la educación en la higiene del sueño mejoran los síntomas climatéricos y los problemas del sueño en la menopausia

  1. Marcos, Elena 1
  2. Iglesias, Irene 1
  3. Vazquez-Velasco, Miguel 1
  4. Benedi, Juana 1
  1. 1 Department of Pharmacology, Pharmacognosy and Botanical, Faculty of Pharmacy, Universidad Complutense de Madrid, Plaza Ramon y Cajal s/n, Ciudad Universitaria, 28040, Madrid, Spain
Journal:
Journal of Negative and No Positive Results: JONNPR

ISSN: 2529-850X

Year of publication: 2020

Volume: 5

Issue: 12

Pages: 1538-1557

Type: Article

DOI: 10.19230/10.19230/JONNPR.3983 DIALNET GOOGLE SCHOLAR lock_openDialnet editor

More publications in: Journal of Negative and No Positive Results: JONNPR

Sustainable development goals

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.  

Bibliographic References

  • Lee J, Han Y, Cho HH, Kim MR. Sleep disorders and menopause. J Menopausal Med. 2019; 25(2): 83-87.
  • Lampio L, Polo-Kantola P, Polo O, Kauko T, Aittokallio J, Saaresranta T. Sleep in midlife women: effects of menopause, vasomotor symptoms, and depressive symptoms. Menopause 2014; 21(11): 1217-1224.
  • Polo-Kantola P. Sleep problems in midlife and beyond. Maturitas 2011; 68 (3):224-232.
  • de Villiers TJ, Hall JE, Pinkerton JV, Perez SC, Rees M, Yang C, et al. Revised global consensus statement on menopausal hormone therapy. Maturitas 2016; 91: 153-155.
  • Urru SA, Pasina L, Minghetti P, Giua C. Role of community pharmacists in the detection of potentially inappropriate benzodiazepines prescriptions for insomnia. Int J Clin Pharm 2015; 37(6): 1004-1008.
  • Akram M, Daniyal M, Munir N, Mohiuddin E, Sultana S. Medicinal plants combating against insomnia: A green anti-Insomnia approach. J. Nerv Ment Dis 2019; 207(11): 927-935.
  • MacLennan A, Lester S, Moore V. Oral oestrogen replacement therapy versus placebo for hot flushes. Cochrane Database Syst Rev 2001; (1): CD002978.
  • Kargozar R, Azizi H, Salari R. A review of effective herbal medicines in controlling menopausal symptoms. Electron Physician 2017; 9(11): 5826-5833.
  • Taavoni S, Ekbatani N, Kashaniyan M, Haghani H. Effect of valerian on sleep quality in postmenopausal women: a randomized placebo-controlled clinical trial. Menopause 2011; 18(9): 951-955.
  • Kim M, Lim H, Lee H, Kim T. Role identification of Passiflora incarnata Linnaeus: A mini review. J Menopausal Med 2017; 23 (3):156-159.
  • Weil V, Cirigliano M, Battistini P. Perspectives in complementary medicine: Herbal treatments for symptoms of menopause clinical. Hospital Physician 2000; 36(11): 35-44.
  • Lee J, Jung H-Y, Lee SI, Choi JH, Kim S-G. Effects of Passiflora incarnata Linnaeus on polysomnographic sleep parameters in subjects with insomnia disorder: a double-blind randomized placebo-controlled study. Int Clin Psychopharmacol 2020; 35(1): 29-35.
  • Ayala F, Mexicano G. Effect of a medicinal plant (Passiflora incarnata L) on sleep. Sleep Sci 2017; 10(3): 96-100.
  • Merritt S, Gyllenhaal C, Peterson S, Block K, Gochenour T. Herbal remedies: efficacy in controlling sleepiness and promoting sleep. Nurse Pract Forum 2000; 11(2): 87-100.
  • Kashyap KC, Nissen LM, Smith S, Kyle G. Management of over-the-counter insomnia complaints in Australian community pharmacies: a standardized patient study. Int J Pharm Pract 2014; 22(2):125-134.
  • Driot D, Ouhayoun S, Perinelli F, Grezy-Chabardes C, Birebent J, Bismuth M, et al. Non-drug and drug alternatives to benzodiazepines for insomnia in primary care: Study among GPs and pharmacies in a Southwest region of France. Therapie 2019; 74 (5): 537-546.
  • Simpson S, Johnson J, Biggs C. Practice – Based research: lessons from Community Pharmacist Participants. Pharmacotherapy 2001; 21: 731-739.
  • Joshi S. Nonpharmacologic Therapy for Insomnia in the Elderly. Clin Geriatr Med 2008; 24: 107–119.
  • Hilditch J, Lewis J, Peter A, van Maris B, Ross A, Franssen E, et al. A menopause-specific quality of life questionnaire: development and psychometric properties. Maturitas 2008; 61 (1-2):107-121.
  • Macías J, Royuela A. La versión española del índice de la calidad de sueño de Pittsburghh. Inf Psiquátricas 1996; 146: 465-472.
  • Morin C, Belleville G, Belanger L, Ivers H. The Insomnia Severity Index: psychometric indicators to detect insomnia cases and evaluate treatment response. Sleep 2011; 34 (5): 601-608.
  • Chiner E, Arriero J, Signes-Costa J, Marco J, Fuentes I. Validation of the Spanish version of the Epworth Sleepiness Scale in patients with a sleep apnea syndrome. Arch Bronconeumol 1999; 35 (9):422-427.
  • Schmidt S, Vilagut G, Garin O, Cunillera O, Tresserras T, Brugulat P, et al. Reference guidelines for the 12-Item Short-Form Health Survey version 2 based on the Catalan general population. Med Clin (Barc.). 2012; 139(14): 613-625.
  • Atkinson M, Sinha A, Hass S, Colman S, Kumar R, Brod M, et al. Validation of a general measure of treatment satisfaction, the Treatment Satisfaction Questionnaire for Medication (TSQM), using a national panel study of chronic disease. Health Qual Life Outcomes 2004; 2: 12.
  • Green S, Salkind N, editors. Using SPSS for Windows and Macintosh, Books a la Carte. 8th Edition. TX (USA): Pearson; 2016.
  • Aljumah K, Hassali M. Impact of pharmacist intervention on adherence and measurable patient outcomes among depressed patients: a randomised controlled study. BMC.Psychiatry 2015; 15: 219.
  • Shaver J, Woods N. Sleep and menopause: a narrative review. Menopause 2015; 22(8): 899-915.
  • Jenabi E, Shobeiri F, Hazavehei S, Roshanaei G. The effect of Valerian on the severity and frequency of hot flashes: A triple-blind randomized clinical trial. Women Health 2018; 58(3): 297-304.
  • Mirabi P, Mojab F. The effects of valerian root on hot flashes in menopausal women. Iran J Pharm Res Winter 2013; 12(1): 217-222.
  • Fahami F, Asali Z, Aslani A, Fathizadeh N. A comparative study on the effects of Hypericum perforatum and passion flower on the menopausal symptoms of women referring to Isfahan city health care centers. Iran J Nurs Midwifery Res 2010; 15(4):202-207.
  • Ghazanfarpour M, Sadeghi R, Abdolahian S, Roudsari R. The efficacy of Iranian herbal medicines in alleviating hot flashes: A systematic review. Int J Reprod Biomed (Yazd.) 2016; 14(3): 155-166.
  • Agan K, Ozmerdivenli R, Degirmenci Y, Caglar M, Basbug A, Balbay E, et al. Evaluation of sleep in women with menopause: results of the Pittsburg Sleep Quality Index and polysomnography. J Turk Ger Gynecol Assoc 2015; 16(3): 149-152.
  • Pinkerton J, Abraham L, Bushmakin A, Cappelleri J, Komm B. Relationship between changes in vasomotor symptoms and changes in menopause-specific quality of life and sleep parameters. Menopause 2016; 23(10): 1060-1066.
  • Kalmbach D, Cheng P, Arnedt J, Cuamatzi-Castelan A, Atkinson R, Fellman-Couture C, et al. Improving daytime functioning, work performance, and quality of life in postmenopausal women with insomnia: comparing cognitive behavioral therapy for insomnia, sleep restriction therapy, and sleep hygiene education. J Clin Sleep Med 2019; 15 (7): 999-1010.
  • Kok L, Kreijkamp-Kaspers S, Grobbee D, Lampe J, van der Schouw T. Soy isoflavones, body composition, and physical performance. Maturitas 2005; 52 (2):102-110.
  • Riesco E, Choquette S, Audet M, Tessier D, Dionne J. Effect of exercise combined with phytoestrogens on quality of life in postmenopausal women. Climacteric 2011; 14(5): 573-580.
  • Fontvieille A, Dionne I, Riesco E. Long-term exercise training and soy isoflavones to improve quality of life and climacteric symptoms. Climacteric 2017; 20(3): 233-239.
  • Panvelkar P, Saini B, Armour C. Measurement of patient satisfaction with community pharmacy services: a review. Pharm World Sci 2009; 31(5): 525-537.