Perilla Extract improves gastrointestinal discomfort in a randomized placebo controlled double blind human pilot study

BMC Complementary and Alternative Medicine

Christiane Schoen³  Claudia Reule³  Hajime Fujii¹  Sybille Buchwald-Werner² 

[1] Amino Up Chemical Co., Ltd., 363-32 Shin-ei Kiyota, Saporo, Japan;Vital Solutions GmbH, Hausingerstrasse 6, Langenfeld 40764, Germany;BioTeSys GmbH, Schelztorstrasse 54-56, Esslingen D-73728, Germany

关键词: Feeling of fullness;    Rumbling;    Passage of gas;    Bowel movement;    Human study;    Abdominal discomfort;    Bloating;    Perilla frutescens;    Gastrointestinal discomfort;   

Others  :  1220134
DOI  :  10.1186/1472-6882-14-173

 received in 2013-07-11, accepted in 2014-05-06,  发布年份 2014

【 摘 要 】

Background

Gastrointestinal (GI) discomfort, e.g. bloating or rumbling, is a common symptom in otherwise healthy adults. Approximately 20% of the population, particularly women suffer from gastrointestinal discomfort and this affects quality of life. Recent studies discovered a link between the body and mind, called the gut-brain axis. Psychosocial factors, such as e.g. daily stress may cause altered gut physiology leading to ileum contractions and consequently gastrointestinal symptoms. In vitro and ex vivo studies clearly showed that a Perilla frutescens extract combines prokinetic, antispasmodic and anti-inflammatory effects. The aim of the intervention was to investigate the effects of the proprietary Perilla extract on GI discomfort in healthy subjects with gastrointestinal discomfort and reduced bowel movements in comparison to a placebo product.

Methods

The pilot study was performed according to a double-blind, randomized, placebo-controlled parallel design. Fifty healthy subjects with gastrointestinal discomfort and reduced bowel movements, 30-70 years, documented their GI symptoms, stool frequency and consistency daily during a 2-week run-in phase and a 4-week intervention phase with Perilla frutescens extract or placebo. GI symptoms were assessed on a 5-point scale daily and average scores over 14 days intervals were calculated.

Results

All GI symptoms were significantly improved over time by Perilla frutescens extract during the intervention phase (bloating: -0.44 ± 0.56, p = 0.0003; passage of gas: -0.30 ± 0.66, p = 0.0264; GI rumbling: -0.55 ± 0.87, p = 0.0014; feeling of fullness: -0.36 ± 0.72, p = 0.0152; abdominal discomfort: -0.54 ± 0.75, p = 0.004), whereas in the placebo group only abdominal discomfort was significantly improved (-0.31 ± 0.55, p = 0.0345). In the subgroup of women results were strengthened and a subscore out of bloating and abdominal discomfort was significantly improved against placebo (95%CI 0.003 to 0.77; p = 0.048).

Conclusion

The demonstrated effects of Perilla frutescens extract to improve GI complaints offer very promising results, taking into consideration the challenging set up of a nutritional human study with healthy subjects and in the area of digestive health, which is known for high placebo effects.

Trial registration number

NCT01931930 at ClinicalTrials.gov, Registration date 23^rd August 2013.

【 授权许可】

   
2014 Buchwald-Werner et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

Figure 2.

Figure 3.

Figure 4.

Figure 5.

【 参考文献 】

• [1]Tuteja AK, Talley NJ, Joos SK, Tolman KG, Hickam DH: Abdominal bloating in employed adults: prevalence, risk factors, and association with other bowel disorders. Am J Gastroenterol 2008, 103:1241-1248.
• [2]Jiang X, Locke GR III, Choung RS, Zinsmeister AR, Schleck CD, Talley NJ: Prevalence and risk factors for abdominal bloating and visible distention: a population-based study. Gut 2008, 57:756-763.
• [3]Garrigues V, Galvez C, Ortiz V, Ponce M, Nos P, Ponce J: Prevalence of constipation: agreement among several criteria and evaluation of the diagnostic accuracy of qualifying symptoms and self-reported definition in a population-based survey in Spain. Am J Epidemiol 2004, 159:520-526.
• [4]Health-novartis-consumer-health. Progressive Grocer 2013. Ref Type: Electronic Citation: http://www.progressivegrocer.com/%25cat%25category-captain-digestive-health-novartis-consumer-health webcite
• [5]Drossman DA: The functional gastrointestinal disorders and the Rome III process. Gastroenterology 2006, 130:1377-1390.
• [6]Yu H, Kosuna K, Haga M: Perilla: The Genus Perilla. London: Harwood Academic Publisher; 1997.
• [7]Verspohl EJ, Fujii H, Homma K, Buchwald-Werner S: Testing of Perilla frutescens extract and Vicenin 2 for their antispasmodic effect. Phytomedicine 2013, 20:427-431.
• [8]Buchwald-Werner S: Investigation of a Perilla frutescens special extract, anti-inflammatory and immune-modulatory properties. Agro FOOD Inductry Hi Tech 2012, 23:38-41.
• [9]EFSA Panel on Dietetic Products NaA: Guidance on the scientific requirements for health claims related to gut and immune function. EFSA Journal 2011, 1-9.
• [10]Veldhuyzen van Zanten SJ, Cleary C, Talley NJ, Peterson TC, Nyren O, Bradley LA, Verlinden M, Tytgat GN: Drug treatment of functional dyspepsia: a systematic analysis of trial methodology with recommendations for design of future trials. Am J Gastroenterol 1996, 91:660-673.
• [11]Spiller RC: Problems and challenges in the design of irritable bowel syndrome clinical trials: experience from published trials. Am J Med 1999, 107:91S-97S.
• [12]Lewis SJ, Heaton KW: Stool form scale as a useful guide to intestinal transit time. Scand J Gastroenterol 1997, 32:920-924.
• [13]Slappendel R, Simpson K, Dubois D, Keininger DL: Validation of the PAC-SYM questionnaire for opioid-induced constipation in patients with chronic low back pain. Eur J Pain 2006, 10:209-217.
• [14]Marquis P, De La LC, Dubois D, McDermott A, Chassany O: Development and validation of the Patient Assessment of Constipation Quality of Life questionnaire. Scand J Gastroenterol 2005, 40:540-551.
• [15]Fliege H, Rose M, Arck P, Walter OB, Kocalevent RD, Weber C, Klapp BF: The Perceived Stress Questionnaire (PSQ) reconsidered: validation and reference values from different clinical and healthy adult samples. Psychosom Med 2005, 67:78-88.
• [16]Lampe JW, Wetsch RF, Thompson WO, Slavin JL: Gastrointestinal effects of sugarbeet fiber and wheat bran in healthy men. Eur J Clin Nutr 1993, 47:543-548.
• [17]Castiglia-Delavaud C, Verdier E, Besle JM, Vernet J, Boirie Y, Beaufrere B, De Baynast R, Vermorel M: Net energy value of non-starch polysaccharide isolates (sugarbeet fibre and commercial inulin) and their impact on nutrient digestive utilization in healthy human subjects. Br J Nutr 1998, 80:343-352.
• [18]Bouhnik Y, Flourie B, Riottot M, Bisetti N, Gailing MF, Guibert A, Bornet F, Rambaud JC: Effects of fructo-oligosaccharides ingestion on fecal bifidobacteria and selected metabolic indexes of colon carcinogenesis in healthy humans. Nutr Cancer 1996, 26:21-29.
• [19]Moore N, Chao C, Yang LP, Storm H, Oliva-Hemker M, Saavedra JM: Effects of fructo-oligosaccharide-supplemented infant cereal: a double-blind, randomized trial. Br J Nutr 2003, 90:581-587.
• [20]Vogelsang H, Brenner F: Wirkung von Caricol beim Reizdarmsyndrom. Jpournal für Ernährungsmedizin 2009, 11:19.
• [21]Buchwald-Werner S: Benegut- beneficial effects for digestively- stressed consumers. NutraCos Anno 2012, 2012:18-21.
• [22]Guyonnet D, Naliboff B, Rondeau P, Mayer E, Chassany O: Gastrointestinal well-being in subjects reporting mild gastrointestinal discomfort: characteristics and properties of a global assessment measure. Br J Nutr 2013, 110:1263-1271.
• [23]Irvine EJ, Whitehead WE, Chey WD, Matsueda K, Shaw M, Talley NJ, Veldhuyzen van Zanten SJ: Design of treatment trials for functional gastrointestinal disorders. Gastroenterology 2006, 130:1538-1551.
• [24]Moody GA, Eaden JA, Bhakta P, Sher K, Mayberry JF: The role of complementary medicine in European and Asian patients with inflammatory bowel disease. Public Health 1998, 112:269-271.
• [25]Joos S, Rosemann T, Szecsenyi J, Hahn EG, Willich SN, Brinkhaus B: Use of complementary and alternative medicine in Germany - a survey of patients with inflammatory bowel disease. BMC Complement Altern Med 2006, 6:19. 19 BioMed Central Full Text