A Review of the Human Clinical Studies Involving Citrus aurantium (Bitter Orange) Extract and its Primary Protoalkaloid p-Synephrine
Open accessAbstract
This review summarizes the published as well as unpublished human studies involving Citrus aurantium (bitter orange) extract and its primary protoalkaloid p-synephrine, providing information and an assessment of the safety and efficacy of these widely used products. The results of over 20 studies involving a total of approximately 360 subjects that consumed p-synephrine alone or in combination with other ingredients are reviewed and critiqued. Over 50 % of the subjects involved in these studies were overweight/obese, and approximately two-thirds of these overweight/obese subjects consumed caffeine (132-528 mg/day) in conjunction with p-synephrine (10-53 mg/day). Bitter orange/p-synephrine containing products were consumed for up to 12 weeks. Approximately 44 % of the subjects consumed a bitter orange/p-synephrine only product, while the remainder consumed a complex product that contained multiple ingredients in addition to p-synephrine. In general, bitter orange extract alone (p-synephrine) or in combination with other herbal ingredients did not produce significant adverse events as an increase in heart rate or blood pressure, or alter electrocardiographic data, serum chemistry, blood cell counts or urinalysis. p-Synephrine alone as well as in combination products were shown to increase resting metabolic rate and energy expenditure, and modest increases in weight loss were observed with bitter orange extract/p-synephrine-containing products when given for six to 12 weeks. Longer term studies are needed to further assess the efficacy of these products and affirm their safety under these conditions.
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No significant changes in blood pressure were found with p-synephrine (12-13 mg) and lower doses of caffeine (150-176 mg).
“Conversely, no significant changes in BP were found with p-synephrine (12-13 mg) and lower doses of caffeine (150-176 mg).”
From Scientific Opinion on the safety of caffeine (2015) · cites this paper as Stohs et al., 2012
Significant increases in systolic and diastolic blood pressure were reported for a combination of 5.5 mg p-synephrine and 5.7 mg octopamine and caffeine (239.2 mg), and a significant increase in diastolic blood pressure but not systolic blood pressure was observed with 21 mg p-synephrine and 304 mg caffeine.
“Significant increases in SBP and DBP were also reported for a combination of 5.5 mg p-synephrine and 5.7 mg octopamine and caffeine (239.2 mg), and a significant increase in DBP, but not in SPB, was observed with 21 mg p-synephrine and 304 mg caffeine.”
From Scientific Opinion on the safety of caffeine (2015) · cites this paper as Stohs et al., 2012
Significant increases in systolic and diastolic blood pressure were reported for p-synephrine from C. aurantium extracts when consumed at doses of 54 mg, but not at lower doses (13.5-50 mg).
“Significant increases in SBP and DBP were reported for p-synephrine from C. aurantium extracts when consumed at doses of 54 mg, but not at lower doses (13.5-50 mg).”
From Scientific Opinion on the safety of caffeine (2015) · cites this paper as Stohs et al., 2012
The Panel notes that none of the available studies has investigated the effects on blood pressure of single doses of caffeine alone, of p-synephrine alone, or of their combination.
“The Panel notes that none of the available studies has investigated the effects on BP of single doses of caffeine alone, of p-synephrine alone or of their combination.”
From Scientific Opinion on the safety of caffeine (2015) · cites this paper as Stohs et al., 2012
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- Authors
- Stohs, S. J., Preuss, H. G., & Shara, M.
- Affiliations
- CHI Health Creighton University Medical Center - Bergan Mercy (US)
- Jordan University of Science and Technology (JO)
- Corresponding author
- Preuss, Harry G.
- Venue
- International Journal of Medical Sciences
- Publisher
- Ivyspring International Publisher
- Published
- 2012
- Volume
- 9
- Issue
- 7
- Pages
- 527-538
- ISSN
- 1449-1907 (ISSN-L)
- PMC
- PMC3444973
- OpenAlex
- W2159553142
- Cited by
- 115
- References
- 51
- Citations by year
- 2026: 4 · 2025: 3 · 2024: 3 · 2023: 6 · 2022: 11 · 2021: 6 · 2020: 11 · 2019: 9 · 2018: 10 · 2017: 12 · 2016: 7 · 2015: 12 · 2014: 9 · 2013: 11
- FWCI
- 1.19
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- cc-by-nc
- Locations
- International Journal of Medical Sciences (publishedVersion, cc-by-nc)
- PubMed Central (publishedVersion, cc-by-nc-nd)
- PubMed (publishedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
- Topics
- Health Sciences › Medicine › Pharmacology › Pharmacology and Obesity Treatment
- Health Sciences › Medicine › Pharmacology › Coffee research and impacts
- Health Sciences › Medicine › Complementary and alternative medicine › Complementary and Alternative Medicine Studies
- Keywords
- Citrus aurantium, p-synephrine, herbal supplements, caffeine, weight loss, resting metabolic rate, energy expenditure, cardiovascular safety, blood pressure, heart rate, overweight and obesity, supplement safety and efficacy
- MeSH terms
- Citrus, Humans, Obesity, Plant Extracts, Synephrine, Overweight
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