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Efficacy of Pumpkin Oil (A Persian Medicine Product) in the Treatment of Chronic Insomnia: a Randomized Double-Blind Clinical Tr

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Efficacy of Pumpkin Oil (A Persian Medicine Product) in the Treatment of Chronic Insomnia: a Randomized Double-Blind Clinical Tr © 2019 Journal of Pharmacy & Pharmacognosy Research, 7 (6), 471-481, 2019 ISSN 0719-4250 http://jppres.com/jppres Original Article | Artículo Original Efficacy of pumpkin oil (a Persian medicine product) in the treatment of chronic insomnia: A randomized double-blind clinical trial [Eficacia del aceite de calabaza (un medicamento persa) en el tratamiento del insomnio crónico: un ensayo clínico aleatorizado doble ciego] Elham Haghjoo1,2, Khosro Sadeghniiat Haghighi3, Fataneh Hashem Dabaghian1,2, Asie Shojaii1,4*, Hoorieh Mohammadi Kenari1,2 1Research Institute for Islamic and Complementary medicine. Iran University of Medical Sciences, Tehran, Iran. 2Department of Traditional Medicine, School of Persian Medicine, Iran University of Medical Sciences, Tehran, Iran. 3Occupational Sleep Research Center, Baharloo Hospital, Tehran University of Medical Sciences, Tehran, Iran. 4Department of Traditional Pharmacy, School of Persian Medicine, Iran University of Medical Sciences, Tehran, Iran. *E-mail: [email protected] Abstract Resumen Context: According to Persian medicine text, there are some topical Contexto: De acuerdo con el texto de la medicina persa, existen algunos herbal remedies for insomnia such as pumpkin oil as a nasal drop. remedios herbales tópicos para el insomnio, como el aceite de calabaza Aims: To evaluate the effect of pumpkin oil (a Persian medicine product) como aplicado como gota nasal. in patients with chronic insomnia. Objetivos: Evaluar el efecto del aceite de calabaza (un producto de Methods: This study was conducted as a randomized double-blind medicina persa) en pacientes con insomnio crónico. clinical trial on pumpkin oil efficacy in 74 patients with chronic Métodos: Este estudio se realizó como un ensayo clínico aleatorizado insomnia. The participants received two drops of intranasal pumpkin oil doble ciego sobre la eficacia del aceite de calabaza en 74 pacientes con or placebo every night for two weeks. The effects of pumpkin oil and insomnio crónico. Los participantes recibieron dos gotas de aceite de placebo on the pattern of sleep and sleep quality were assessed at calabaza intranasal o placebo todas las noches durante dos semanas. Los baseline and at the end of two weeks of treatment by Insomnia Severity efectos del aceite de calabaza y el placebo sobre el patrón de sueño y la Index (ISI) and Pittsburgh Sleep Quality Index (PSQI) questionnaires. calidad del sueño fueron evaluados al inicio y al final de dos semanas de Results: The scores of the ISI questioner were statistically different tratamiento mediante cuestionarios del Índice de Gravedad del between groups after two weeks of intervention and patients in the Insomnio (ISI) y el Índice de Calidad del Sueño de Pittsburgh (PSQI). pumpkin oil group had fewer scores for ISI questioner (p<0.001). The Resultados: Las puntuaciones del interrogador ISI fueron reduction of the total score of the Pittsburgh questioner was 10.08 ± 3.21 estadísticamente diferentes entre los grupos después de dos semanas de in the pumpkin oil group and 0.28 ± 0.98 (p<0.001) in the control group. intervención y los pacientes en el grupo de aceite de calabaza tuvieron Conclusions: Pumpkin oil could have a significant positive effect on the menos puntuaciones para el interrogador ISI (p<0,001). La reducción de quantity and the quality of sleep in patients with chronic insomnia. la puntuación total del interrogador de Pittsburgh fue de 10,08 ± 3,21 en el grupo de aceite de calabaza y 0,28 ± 0,98 (p <0,001) en el grupo de control. Conclusiones: El aceite de calabaza podría tener un efecto positivo significativo en la cantidad y la calidad del sueño en pacientes con insomnio crónico. Keywords: clinical trial; insomnia; oil; nasal drop; Persian medicine; Palabras Clave: aceite; calabaza; ensayo clínico; gota nasal; insomnio; pumpkin. medicina persa. ARTICLE INFO Received: May 22, 2019. Received in revised form: September 23, 2019. Accepted: September 23, 2019. Available Online: October 14, 2019. Declaration of interests: The authors declare no conflict of interest. Funding: This study was supported by School of Persian Medicine and Research Institute for Islamic and Complementary Medicine, Iran University of Medical Sciences, Tehran. Iran (Grant number 26.M.T.95). _____________________________________ Haghjoo et al. Efficacy of pumpkin oil for insomnia INTRODUCTION Persian medicine (PM) is a traditional medical Sleep is a complex and physiological condition system based on humoral medicine with a rich that plays an important role in our body’s function literature about insomnia. In PM, insomnia is and health. Sleep is a vital process and is needed called “Sahar” that is defined as excessive wake for various processes, such as learning, cellular that is out of normal range and is considered as a repair and brain development. It can be impaired temperamental disease, mainly caused by brain by certain factors including noise, stress and sick- dystemperament (Sina, 2005). In PM, temperament ness (many factors such as noise, stress and illness means the dominant quality of the composite ob- can impair it) (Stone et al., 2008, Askari, Rahimi et ject and it is made of the interaction of four basic al., 2016). According to statics, more than 27% of elements hot, cold, wet, and dry. They mention people worldwide have sleep disorders. Chronic that insomnia is caused by dryness in brain (Mo- sleep disturbances can induce memory loss, slower radi et al., 2013). An ideal healthy state of an indi- reaction, emotional disorders and impaired im- vidual is depending on temperament. Dystemper- mune response (Orzeł-Gryglewska, 2010). Clinical- ament, which identified as vulnerability of tem- ly, inadequate sleep can lead to an increased risk perament to alteration, leads to different types of of depression, fatness, dyslipidemia, hypertension diseases such as insomnia (Emtiazy et al., 2012). and type 2 diabetes (Postuma et al., 2009; Mason et The basis of treating insomnia in PM, especially al., 2012). insomnia due to the dryness of brain, is to mois- Different hypnotic drugs have been approved turize the brain, which can be done by nutrition, in order to treat insomnia, including benzodiaze- using spice or massage therapy (Khorasani, 2001; pine receptor (BZR) and melatonin receptor ago- Masoudi, 2008). nists, as well as histamine antagonists (Limandri, According to the theories of humoral medicine, 2018). To some specialists, the benzodiazepine this defect can be resolved by food or drugs with receptor agonists are the best choice and have been wet temperament. Based on PM manuscripts, one used for about 50 years (Roehrs and Roth, 2012). of the most cited and widely recommended medic- However, it has been reported that they possess inal herbs to treat insomnia is Cucurbita spp., which several side effects, including psychomotor retar- can be used in the form of nasal drop (Aghili dation, memory impairment, paradoxical disinhib- Khorasani, 1999; Haghjoo et al., 2019). Nasal route iting, depression and emotional blunting, toler- of drug administration is specifically used in ance and dependence and short-term withdrawal treatments of neurologic disease in PM (Hamedi et symptoms. These effects may be amplified in the al., 2013) and was introduced by Galen (Aghili elderly (Longo and Johnson, 2000; Helft et al., Khorasani, 1999). 2014). Pumpkin (Cucurbita moschata Duchesne), com- It has been demonstrated that some herbal monly known as Gharea, belongs to the family agents are effective in ameliorating insomnia dis- Cucurbitaceae is a medium sized plant grown for its order including Valeriana spp. (Trauner et al., 2008), fruits and edible seeds (Elemo et al., 2002). It has Humulus lupulus (Butterweck et al., 2007), Zizyphus some properties in PM references such as anti- jujube (sour date) (Hajhashemi and Safaei, 2015), depressant, anti-inflammatory effect and treatment Valeriana officinalis (Ziegler et al., 2002), Passiflora of jaundice and insomnia (Noor Mohammadi and incaranta (passion flower) (Grundmann et al., Haji, 2013). Pumpkin contributes to nutrition 2008), Eschscholzia californica (California poppy) though an abundant supply of minerals, vitamins (Rolland et al., 2001), Piper methysticum (Boonen and especially carotene (Gwanama et al., 2001). and Häberlein, 1998) and Lactuca sativa (Yakoot et Seeds are good sources of protein, fats, carbohy- al., 2011). drate and minerals (Bello et al., 2008). Popularity http://jppres.com/jppres J Pharm Pharmacogn Res (2019) 7(6): 472 Haghjoo et al. Efficacy of pumpkin oil for insomnia of pumpkin in various systems of traditional med- each group for observing three score difference icine for several ailments (anti-diabetic, anti- between groups. hypertensive, anti-tumor, immunomodulation, antibacterial, anti-hypercholesterolemia, intestinal Inclusion criteria anti-parasite and anti-inflammation) focused the • Willingness to participation. investigators’ attention on this plant (Caili et al., 2006; Xia and Wang, 2006). • Being 20 to 65 years old. According to PM texts, pumpkin oil has been • Meeting the defined criteria for primary in- suggested for insomnia as nasal drop. Also, it has somnia according to Diagnostic and Statis- showed potentiated pentobarbital hypnosis with- tical Manual of Mental Disorders (DSM- out toxic influence in mice (Baradaran Rahimi et IV)(Association, 2013) for at least three al., 2018). Since there is no study on hypnotic effect nights a week in at least six-month period. of pumpkin oil in clinical trial, the present study
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