Citrus aurantium for respiratory support -
One concern of simply relying on subjective sleep improvement is that an underlying sleep disorder may go undiagnosed and untreated. Although this treatment with bitter orange aromatherapy did bring the PSQI down significantly after the 4 weeks of treatment, the score was still above the cut-off for disrupted sleep, at 5.
This indicates the participants still have clinically significant sleep disruption. Therefore, in a clinical setting, it would be appropriate to do further screening and assessment for all 60 sleep disorders, followed by treatment.
Given the high number of people with subjective sleep complaints and the ease of inhalation aromatherapy, this is a welcome addition to the clinical tool kit. The bitter orange aromatherapy could be used for subjective relief while other sleep disorders are being ruled out. Catherine Darley, ND , is the director of The Institute of Naturopathic Sleep Medicine in Seattle.
Her clinical work focuses on the treatment of sleep disorders in adults and children using behavioral and naturopathic medicine. Additionally she regularly trains corporate employees and first responders on a variety of sleep, performance, and safety issues.
Darley is adjunct faculty at Bastyr University and National University of Natural Medicine in Portland, Oregon, and has served on the Board of the Washington Association of Naturopathic Physicians. You can learn more about her work at www.
In her personal time she likes to be outside in nature with her loved ones. July 6, Bitter Orange: Another Tool to Improve Sleep.
Findings from a randomized, controlled study. Catherine Darley. Postmenopausal women with sleep disturbances found better slumber through aromatherapy with Citrus aurantium oil 5 minutes, twice daily, 4 days a week.
Reference Abbaspoor Z, Siahposh A, Javadifar N, Faal Siahkal S, Mohaghegh Z, Sharifipour F. Study Objective To determine whether inhalation of Citrus aurantium bitter orange daily over 4 weeks would improve the sleep of postmenopausal women Key Takeaway Inhalation of Citrus aurantium for 5 minutes, twice daily, 4 days a week for 4 weeks resulted in a significant improvement in sleep for postmenopausal women.
Design Randomized, controlled study in which both the participants and the researchers were blinded to the treatment condition Participants Eighty postmenopausal women, aged 45 to 60 years, participated in this study. Intervention Participants placed 2 drops of oil on their forearm and inhaled the aroma from a distance of 30 cm away with normal breathing for 5 minutes twice daily 10 am and 10 pm.
Study Parameters Assessed The Pittsburgh Sleep Quality Index was the single outcome measure. Primary Outcome This study determined whether sleep improved subjectively with bitter orange inhalation treatment.
Key Findings The postmenopausal women who used the Citrus aurantium oil had a statistically significant improvement in their subjective sleep, with the PSQI dropping from Transparency The research center at Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran funded this study.
Zhong Y, Zheng Q, Hu P, et al. Sedative and hypnotic effects of compound Anshen essential oil inhalation for insomnia. BMC Complement Altern Med. Acquavella J, Mehra R, Bron M, Suomi JMH, Hess GP. Prevalence of narcolepsy and other sleep disorders and frequency of diagnostic tests from in insured patients actively seeking care.
No effects on body weight were reported. This study represents the highest dose of p -synephrine for the longest period of time that has been reported. The study was presented at a scientific meeting but never published. The product Ripped Fuel Extreme Cut TM contained 21 mg p -synephrine and mg caffeine, as well as other ingredients including herbal extracts of green tea, ginger root, cocoa seed, willow bark, and wasabi.
The product or placebo was taken one hour prior to 30 min of moderately intense exercise. No significant treatment-related differences in systolic blood pressure, heart rate or body temperature were observed.
Product-related increases in diastolic blood pressure 8. Exercise was perceived as being less strenuous after consumption of the product. Due to the poly-alkaloidal and protoalkaloidal nature of this product, the factor or factors responsible for the effects on blood glucose and diastolic blood pressure cannot be determined.
Seifert et al. The product contained 13 mg p -synephrine as Advantra Z ® , mg caffeine as guarana , and The study involved 14 females and 9 males in a placebo-controlled, crossover design.
Subjects ingested one capsule with each of three meals on day one of treatment, and one more capsule on the morning of the second day. Data were collected 60 min after the last administration of the product. No differences were observed in heart rate or blood pressure following treatment.
This was an acute study which did not provide information on long-term effects, but did demonstrate an increase in energy expenditure. Stohs et al. The study was a randomized, placebo-controlled, double blind design with the vehicle for the p -synephrine being one ounce of tomato juice.
The amount of p -synephrine in the product was verified by independent analysis. Measurements were taken at baseline prior to consuming the product and at 75 min. At this time point, a 6. No significant effects were observed with respect to blood pressure or heart rate, nor were there any significant differences in responses to a 10 item self-report questionnaire which addressed such issues as nervousness, tension, anxiety, hunger, energy, headache, general discomfort, and sleepiness.
Longer term safety and efficacy studies involving p -synephrine alone are warranted. The amount of p- synephrine in the capsules was determined by high pressure liquid chromatographic analysis. Electrocardiograms, blood pressures, heart rates, blood chemistries and blood cell counts with differentials were determined at baseline, 30 min, 60 min, 90 min, 2 hours, 4 hours, 6 hours and 8 hours, as well as after 5, 10 and 15 days.
Blood samples were drawn after 2 hours after the first dose as well as at 5, 10 and 15 days to measure p -synephrine levels to ensure compliance. p -Synephrine had no significant effect on heart rate, blood pressure, blood chemistries, or blood cell counts, and caused no cardiovascular abnormalities.
Bloomer et al. Methyl-synephrine is purported to occur in nature, does not occur in bitter orange extract, and is of synthetic origin in this product and other products that have been marketed. For the sake of completeness, the results of these studies will be summarized, but these results will not be incorporated into the general discussion of bitter orange extract and p -synephrine provided below.
Both studies examined the effects of the product on metabolic rate, and plasma free fatty acids, glycerol, norepinephrine and epinephrine levels. The initial study [ 38 ] measured changes over a 90 min time frame in 10 healthy male subjects. The second study [ 39 ] measured the same parameters over a six hour time frame in 10 healthy male and 10 healthy female subjects.
Increases in each of the parameters were observed, with a It is also important to note that significant increases in heart rate as well as systolic and diastolic blood pressure occurred in both studies in response to the consumption of the product.
The authors note that the product may be useful in healthy, normotensive, closely monitored individuals. However, it is not a product that should be recommended to the general public.
In a study similar to those reported by Bloomer et al. Over a three hour time period following ingestion of the product significant increases in resting oxygen uptake and caloric expenditure were occurred.
However, increases in heart rate, systolic blood pressure, tension and confusion were also observed, confirming the highly undesirable properties of this synthetic product. Stohs [ 41 ] has reviewed and assessed the 22 FDA adverse event reports AERs from April through October associated with bitter orange C.
aurantium -containing products, as well as 10 clinical case reports published during this time interval regarding the possible involvement of bitter orange-containing weight management products with cardiovascular incidents and other adverse events.
In all reported AERs and case cases, the products involved were poly-herbal, poly-alkaloidal and poly-protoalkaloidal. Adverse events that have been purported in conjunction with the published clinical case reports included: acute lateral-wall myocardial infarction, exercise-induced syncope associated with QT prolongation, ischemic stroke, ischemic colitis, vasospasm and stroke, variant angina, coronary vasospasm and thrombosis, exercise induced rhabdomyolysis, ST segment myocardial infarction, and ventricular fibrillation [ 41 ].
In one case report it was suggested that a bitter orange-containing dietary supplement may have masked bradycardia and hypotension while exacerbating weight loss in an individual with anorexia nervosa, although no evidence was provided that an adverse event had actually occurred.
Although the products consumed were all multi-ingredient, in each case reference was specifically made to C. aurantium, bitter orange or p -synephrine as the most likely causative agent.
A more probable culprit for at least some of these effects may have been the high caffeine intake associated with the products in question. Another factor to be considered is the occurrence of up to mg p -synephrine per quarter liter of various Citrus juices [ 42 , 43 ] which are widely consumed without the report of adverse events.
Millions of individuals ingest p -synephrine and bitter orange-containing food products as orange juices and marmalades as well as dietary supplements on a daily basis. Therefore, although these case reports should raise the level of awareness with regard to the use of complex weight management products, it is not possible to extrapolate the cause of these adverse effects to the p -synephrine which may have been present in the products.
No evidence showing a direct link between bitter orange extract and the adverse events is provided [ 41 ]. A total of 23 published and unpublished studies involving a total of approximately total human subjects were reviewed.
The authors located information regarding the unpublished studies through presentations at scientific meetings and availability of research reports on the internet, as well as information from the investigators involved in the studies.
Seven of the studies were not published in peer reviewed journals [ 17 - 20 , 25 , 33 , 37 ] Table 2. However, six of these studies were presented at national meetings [ 18 - 20 , 25 , 33 , 37 ], and one of these six studies is in the process of being submitted for consideration for publication [ 37 ].
As noted in the references, information including presentations and final reports are available on the internet regarding these unpublished studies. The results associated with these unpublished studies Table 2 in general are consistent with the results of the published studies Table 1. Five published studies [ 6 , 24 , 27 , 31 , 36 ] and two unpublished studies [ 33 , 37 ] reported no cardiovascular effects when using p -synephrine bitter orange only containing products.
The published studies involved a total of subjects with a total of 31 subjects in the two unpublished studies. However, in one of these studies [ 24 ] consisting of 12 subjects it is not clear that effects on heart rate and blood pressure were specifically examined, with the authors simply reporting that no adverse effects were observed.
Five published studies [ 15 , 21 , 22 , 26 , 30 , 35 ] using p -synephrine in combination with other ingredients reported no cardiovascular effects. A total of 88 subjects were involved in these studies. Small cardiovascular effects were reported by Bui et al.
Small cardiovascular effects were reported for three studies that involved subjects consuming p -synephrine plus caffeine [ 28 , 32 , 34 ]. reported an increase in heart rate [ 28 ] and diastolic blood pressure [ 34 ] 10 subjects.
Upon careful review, the study of Haller et al. p -Synephrine Advantra Z ® alone had no effect on systolic or diastolic blood pressure. The authors reported an increase in heart rate six hours after treatment.
The half-life of p -synephrine is two to three hours [ 28 , 34 , 45 ]. As a consequence, an increase in heart rate after two to three half-lives when the p- synephrine blood levels will have dropped to one-fourth to one-eighth the peak blood levels would not be expected.
Furthermore, a major complicating factor is that all subjects consumed a meal three hours after ingesting the p -synephrine The cardiovascular and thermic effects of food are well known [ 31 ], and an increase in heart rate in the control group was also observed.
Thus, it is not plausible to attribute the increase in heart rate to p -synephrine, or an increase in heart rate and blood pressure to a product that contained very little p -synephrine 5. This study did show that the commercial product Xenadrine EFX® which contained only 5.
This product was reported to also contain 5. aurantium extracts are either devoid of octopamine or contain only trace amounts [ 3 ], thus the product being used [ 28 ] appears to have been adulterated. Hansen et al. These doses represent over 13 times the usual daily dose for p -synephrine and the equivalent of the caffeine in about three cups of coffee given together as a single bolus dose to these animals.
When caffeine was added, increases in heart rate and blood pressure were observed [ 46 ]. These studies indicate that in rats at very high doses of p -synephrine the combination with caffeine may result in cardiovascular effects.
However, due to the highly inequivalent dosing between this study in rats and typical dosing in humans, the results of this study in rats cannot be directly extrapolated to humans.
A dose of 3. Various studies indicate that the lipolytic activity of p -synephrine is due to binding to β-3 adrenergic receptors in adipose tissues [ 10 ].
These same β-3 adrenergic receptors are also associated with cardiovascular tissues, and their activation results in a down-regulation of cardiovascular stimulation [ 48 , 49 ].
Thus, p -synephrine stimulation of β-3 adrenoreceptors in the cardiovascular system does not result in an increase in blood pressure or heart rate but may exhibit a modulating rather than a stimulatory effect.
This cardiovascular receptor response may explain why an increase in heart rate or blood pressure is not seen in most cases when p -synephrine is used alone or in combination with caffeine in dietary supplements, in spite of the fact that caffeine alone may produce modest increases in these parameters under some conditions [ 50 , 51 ].
Approximately half of the clinical studies involved the use of commercial products. In only one case [ 28 ] was the actual amount of p -synephrine and other protoalkaloids determined, while in the remaining studies involving commercial products the reported amounts of p -synephrine and caffeine were simply based on label claim.
The amount of p -synephrine was independently determined in two studies in which bitter orange extract was used as a single ingredient product [ 36 , 37 ]. Various studies have shown that there are not always good correlations between the label claim of marketed products or the product data sheet and the amount of p -synephrine shown to be present by independent analysis [ 52 - 56 ].
Therefore, the actual amount of p -synephrine consumed in the majority of the studies was not verified. Finally, nine studies involving the administration of bitter orange extract alone or in combination with other constituents have demonstrated an increase in metabolic rate without an increase in heart rate or blood pressure [ 18 - 20 , 26 , 30 - 32 , 35 , 36 ].
These results suggest that bitter orange extract and p -synephrine may be beneficial in weight management. The results involving both published and unpublished clinical studies indicate that p -synephrine alone or in combination with caffeine does not appear to produce significant adverse cardiovascular effects or pose a risk to human health at doses commonly ingested orally.
No adverse effects have been directly attributable to bitter orange extract or p- synephrine. The results indicate that bitter orange extract and p -synephrine increase metabolism and energy expenditure. The data accumulated to date do not support hypothesized concerns regarding potential adverse effects of p -synephrine particularly with respect to the cardiovascular system due to a paucity of binding to α-, β-1 and β-2 adrenergic receptors while exhibiting modest binding to β-3 adrenergic receptors.
All authors have served as consultants for Nutratech, Inc. Nutratech Inc. provided some of the unpublished research reports. Chen JK, Chen TT. Zhi Shi Fructus Aurantii Immaturus. Chinese Medical Herbology and Pharmacology. City of Industry, CA USA: Art of Medicine Press.
Stohs SJ, Shara M. A review of the safety and efficacy of Citrus aurantium in weight management. In: ed. Bagchi D, Preuss HG. Obesity: Epidemiology, Pathophysiology, and Prevention.
Boca Raton, FL, USA: CRC Press. Pellati F, Benvenuti S. Chromatographic and electrophoretic methods for the analysis of phenethylamine alkaloids in Citrus aurantium. J Chromatog A. Sander LC, Putzbach K, Nelson BC.
et al. Certification of standard reference materials containing bitter orange. Analyt Bioanalyt Chem. Evans RL, Pho AN, Roman MC, Betz JM.
Penzak SR, Jann MW, Cold JA. Seville sour orange juice: synephrine content and cardiovascular effects in normotensive adults. J Clin Pharmacol. Bent S, Padula A, Neuhaus J. Safety and efficacy of Citrus aurantium for weight loss.
Amer J Cardiol. Nasir JM, Durning SJ. Exercise-induced syncope associated with QT prolongation and ephedra-free Xenadrine. Mayo Clinic Proceed. Stephensen TA, Sarlay JrR. Ventricular fibrillation associated with use of a synephrine containing dietary supplement.
Military Med. Stohs SJ, Preuss HG, Shara M. A review of the receptor-binding properties of p -synephrine as related to its pharmacological effects. Oxid Med Cell Long. Stohs SJ, Preuss HG. Stereochemical and pharmacological differences between naturally occurring p -synephrine and synthetic p -synephrine.
J Funct Foods. McGuffin M. Media spins numbers on bitter orange AERs based on erroneous information from FDA. The Safety of bitter orange Citrus aurantium and its primary protoalkaloid p -synephrine. The safety of Citrus aurantium bitter orange and its primary protoalkaloid p -synephrine.
Phytother Res. Colker CM, Kalman DS, Torina GC, Perlis T, Street C. Effects of Citrus aurantium extract, caffeine, and St.
John's wort on body fat loss, lipid levels, and mood states in overweight healthy adults. Curr Therap Res. The extract under assessment should be considered as irritant to skin, eyes and the respiratory tract, and as a skin sensitiser.
The use of the extract in animal feed under the proposed conditions was not expected to pose a risk for the environment.
Bitter orange extract was recognised to flavour food. Since its function in feed would be essentially the same as that in food, no further demonstration of efficacy was considered necessary.
An official EU website. An official website of the European Union. Other sites EFSA Open EFSA EFSA Journal Connect. fruit bitter orange extract for use in all animal species FEFANA asbl.
We include products we think are rrespiratory for Thermogenic supplements for enhanced thermogenic effect readers. If you buy resipratory links on this page, we may earn a small commission. Healthline only shows you brands and products that we stand behind. Essential oils are concentrated oils that are derived from plants. Several types of oils are produced from citrus species, including oranges, lemon, and grapefruit. Sugar level check strips of the International Citrus aurantium for respiratory support of Sports Nutrition Citrus aurantium for respiratory support 15Article aurantim 34 Cite this article. Metrics details. Ten fod active males After consumption, sup;ort were monitored throughout a min ingestion period, then completed a repeated Wingate protocol, and were then monitored throughout a min recovery period. Cardiac autonomic function Heart Rate HR and Heart Rate Variability HRV and plasma epinephrine E and norepinephrine NE were taken at four different time points; Ingestion period: baseline I1post-ingestion period I2 ; Recovery period: immediately post-exercise R1post-recovery period R2. Heart rate variability was assessed in 5-min increments.
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