Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress 2023 EHA Congress 2023 ASCO Annual Meeting
Clinical Collections
Advances in Alzheimer’s

Keynote webinar | Spotlight on sleep in brain health

LIVE: Thursday 2nd May 2024, 18:00-19:30 (CEST)

Quality sleep is essential for health. But what happens to our brains when sleep patterns are disturbed? Join our experts to explore the interplay between sleep disruption and neurological diseases, and the questions that you need to be asking your patients to help you prevent the harmful effects of sleep deprivation.
ADVANCED SEARCH
Log in
Top
BMC Complementary Medicine and Therapies
Published in: BMC Complementary Medicine and Therapies 1/2018

Open Access 01-12-2018 | Research article

A poly-herbal blend (Herbagut®) on adults presenting with gastrointestinal complaints: a randomised, double-blind, placebo-controlled study

Authors: Adrian L. Lopresti, Hemant Gupta, Stephen J. Smith

Published in: BMC Complementary Medicine and Therapies | Issue 1/2018

Login to get access

Abstract

Background

To evaluate the efficacy and tolerability of a poly-herbal formulation, Herbagut, for the treatment of gastrointestinal symptoms and its effect on quality of life parameters in patients presenting with self-reported, unsatisfactory bowel habits.

Methods

This was a randomised, double-blind, placebo-controlled trial. Fifty adults with self-reported unsatisfactory bowel habits, primarily characterised by chronic constipation were randomly allocated to take Herbagut or a matching placebo for 28 days. Efficacy of gastrointestinal changes was measured by the completion of a patient daily diary evaluating changes in stool type (Bristol Stool Form Scale), ease of bowel movements, and feeling of complete evacuation; and the Gastrointestinal Symptom Rating Scale (GSRS). Changes in quality of life were also examined using the World Health Organization Quality of Life – abbreviated version (WHOQOL-BREF), and the Patient Assessment of Constipation-Quality of Life (PAC-QOL).

Results

All participants completed the 28-day trial with no adverse events reported. Compared to the placebo, weekly bowel movements increased over time (p < .001), as did self-reported, normal bowel motions (76% vs 4%; p < .001). Self-reported incomplete evacuation was also lower in the Herbagut group compared to placebo (24% vs 76%; p = <.001). GSRS domain ratings for abdominal pain, constipation, diarrhoea, indigestion, and reflux also decreased significantly in people taking Herbagut compared to placebo (p < .001, for all domains). Moreover, quality of life significantly improved in the Herbagut group compared to placebo as indicated by significantly greater improvement in WHOQOL-BREF domain ratings for overall quality of life, social relations, environmental health, psychological health, and physical health (p < .001, for all domains); and PAC-QOL domain ratings for physical discomfort, psychosocial discomfort, worries and concerns, and life satisfaction (p < .001, for all domains). The changes were considered clinically meaningful as evidenced by their large effect sizes.

Conclusion

Herbagut ingestion over a 28-day period resulted in improvements in several gastrointestinal symptoms and overall quality of life. Further investigation utilising larger sample sizes and diverse clinical and cultural populations are needed.

Trial registration

Clinical Trials Registry- India /​2016/​11/​007479. Registered 24 April 2015 (retrospectively registered).
Appendix
Available only for authorised users
Literature
1.
Drossman DA. Functional gastrointestinal disorders: history, pathophysiology, clinical features and Rome IV. Gastroenterology. 150(6):1262–279.
2.
Peery AF, Dellon ES, Lund J, Crockett SD, McGowan CE, Bulsiewicz WJ, Gangarosa LM, Thiny MT, Stizenberg K, Morgan DR, et al. Burden of gastrointestinal disease in the United States: 2012 update. Gastroenterology. 2012;143(5):1179–87. e1171–1173CrossRefPubMedPubMedCentral
3.
Koloski NA, Talley NJ, Boyce PM. The impact of functional gastrointestinal disorders on quality of life. Am J Gastroenterol. 2000;95(1):67–71.CrossRefPubMed
4.
Addolorato G, Mirijello A, D'Angelo C, Leggio L, Ferrulli A, Abenavoli L, Vonghia L, Cardone S, Leso V, Cossari A, et al. State and trait anxiety and depression in patients affected by gastrointestinal diseases: psychometric evaluation of 1641 patients referred to an internal medicine outpatient setting. Int J Clin Pract. 2008;62(7):1063–9.CrossRefPubMed
5.
Shah E, Rezaie A, Riddle M, Pimentel M. Psychological disorders in gastrointestinal disease: epiphenomenon, cause or consequence? Ann Gastroenterol. 2014;27(3):224–30.PubMedPubMedCentral
6.
Alander T, Svardsudd K, Agreus L. Functional gastrointestinal disorder is associated with increased non-gastrointestinal healthcare consumption in the general population. Int J Clin Pract. 2008;62(2):234–40.CrossRefPubMedPubMedCentral
7.
Sanchez MI, Bercik P. Epidemiology and burden of chronic constipation. Can J Gastroenterol. 2011;25(Suppl B):11B–5B.CrossRefPubMed
8.
Chang JY, Locke GR 3rd, McNally MA, Halder SL, Schleck CD, Zinsmeister AR, Talley NJ. Impact of functional gastrointestinal disorders on survival in the community. Am J Gastroenterol. 2010;105(4):822–32.CrossRefPubMedPubMedCentral
9.
Drossman DA. The functional gastrointestinal disorders and the Rome III process. Gastroenterology. 2006;130(5):1377–90.CrossRefPubMed
10.
Mearin F, Ciriza C, Minguez M, Rey E, Mascort JJ, Pena E, Canones P, Judez J. Clinical practice guideline: irritable bowel syndrome with constipation and functional constipation in the adult. Rev Esp Enferm Dig. 2016;108(6):332–63.PubMed
11.
Herz MJ, Kahan E, Zalevski S, Aframian R, Kuznitz D, Reichman S. Constipation: a different entity for patients and doctors. Fam Pract. 1996;13(2):156–9.CrossRefPubMed
12.
Campbell AJ, Busby WJ, Horwath CC. Factors associated with constipation in a community based sample of people aged 70 years and over. J Epidemiol Community Health. 1993;47(1):23–6.CrossRefPubMedPubMedCentral
13.
Chang JY, Locke GR, Schleck CD, Zinsmeister AR, Talley NJ. Risk factors for chronic constipation and a possible role of analgesics. Neurogastroenterol Motil. 2007;19(11):905–11.CrossRefPubMed
14.
Dossett ML, Davis RB, Lembo AJ, Yeh GY. Complementary and alternative medicine use by US adults with gastrointestinal conditions: results from the 2012 National Health Interview Survey. Am J Gastroenterol. 2014;109(11):1705–11.CrossRefPubMedPubMedCentral
15.
Hung A, Kang N, Bollom A, Wolf JL, Lembo A. Complementary and alternative medicine use is prevalent among patients with gastrointestinal diseases. Dig Dis Sci. 2015;60(7):1883–8.CrossRefPubMed
16.
Farzaei MH, Bahramsoltani R, Abdolghaffari AH, Sodagari HR, Esfahani SA, Rezaei N. A mechanistic review on plant-derived natural compounds as dietary supplements for prevention of inflammatory bowel disease. Expert Rev Gastroenterol Hepatol. 2016;10(6):745–58.CrossRefPubMed
17.
Farzaei MH, Bahramsoltani R, Abdollahi M, Rahimi R. The role of visceral hypersensitivity in irritable bowel syndrome: pharmacological targets and novel treatments. J Neurogastroenterol Motil. 2016;22(4):558–74.CrossRefPubMedPubMedCentral
18.
O'Donnell LJ, Virjee J, Heaton KW. Detection of pseudodiarrhoea by simple clinical assessment of intestinal transit rate. BMJ. 1990;300(6722):439–40.CrossRefPubMedPubMedCentral
19.
Kulich KR, Madisch A, Pacini F, Pique JM, Regula J, Van Rensburg CJ, Ujszaszy L, Carlsson J, Halling K, Wiklund IK. Reliability and validity of the gastrointestinal symptom rating scale (GSRS) and quality of life in reflux and dyspepsia (QOLRAD) questionnaire in dyspepsia: a six-country study. Health Qual Life Outcomes. 2008;6:12.CrossRefPubMedPubMedCentral
20.
World Health Organization. Development of the World Health Organization WHOQOL-BREF quality of life assessment. The WHOQOL Group. Psychol Med. 1998;28(3):551–8.CrossRef
21.
Skevington SM, Lotfy M, O'Connell KA, Group W. The World Health Organization's WHOQOL-BREF quality of life assessment: psychometric properties and results of the international field trial. A report from the WHOQOL group. Qual Life Res. 2004;13(2):299–310.CrossRefPubMed
22.
Marquis P, De La Loge C, Dubois D, McDermott A, Chassany O. Development and validation of the patient assessment of constipation quality of life questionnaire. Scand J Gastroenterol. 2005;40(5):540–51.CrossRefPubMed
23.
24.
Hanai H, Iida T, Takeuchi K, Watanabe F, Maruyama Y, Andoh A, Tsujikawa T, Fujiyama Y, Mitsuyama K, Sata M, et al. Curcumin maintenance therapy for ulcerative colitis: randomized, multicenter, double-blind, placebo-controlled trial. Clin Gastroenterol Hepatol. 2006;4(12):1502–6.CrossRefPubMed
25.
Feng W, Wang H, Zhang P, Gao C, Tao J, Ge Z, Zhu D, Bi Y. Modulation of gut microbiota contributes to curcumin-mediated attenuation of hepatic steatosis in rats. Biochim Biophys Acta. 2017;1861(7):1801–12.CrossRefPubMed
26.
Gull I, Saeed M, Shaukat H, Aslam SM, Samra ZQ, Athar AM. Inhibitory effect of Allium sativum and Zingiber officinale extracts on clinically important drug resistant pathogenic bacteria. Ann Clin Microbiol Antimicrob. 2012;11:8.CrossRefPubMedPubMedCentral
27.
Viljoen E, Visser J, Koen N, Musekiwa A. A systematic review and meta-analysis of the effect and safety of ginger in the treatment of pregnancy-associated nausea and vomiting. Nutr J. 2014;13:20.CrossRefPubMedPubMedCentral
28.
Hu ML, Rayner CK, Wu KL, Chuah SK, Tai WC, Chou YP, Chiu YC, Chiu KW, Hu TH. Effect of ginger on gastric motility and symptoms of functional dyspepsia. World J Gastroenterol. 2011;17(1):105–10.CrossRefPubMedPubMedCentral
29.
Butt MS, Pasha I, Sultan MT, Randhawa MA, Saeed F, Ahmed W. Black pepper and health claims: a comprehensive treatise. Crit Rev Food Sci Nutr. 2013;53(9):875–86.CrossRefPubMed
30.
Mukherjee A, Sengupta S, Ray L, Sengupta S. Evaluation of Tinospora cordifolia amylase as a commercial digestive enzyme of plant origin. Journal of Herbs, Spices & Medicinal Plants. 2012;18(1):58–76.CrossRef
31.
Bafna PA, Balaraman R. Anti-ulcer and anti-oxidant activity of pepticare, a herbomineral formulation. Phytomedicine. 2005;12(4):264–70.CrossRefPubMed
32.
Nagappan T, Ramasamy P, Wahid ME, Segaran TC, Vairappan CS. Biological activity of carbazole alkaloids and essential oil of Murraya koenigii against antibiotic resistant microbes and cancer cell lines. Molecules. 2011;16(11):9651–64.CrossRefPubMed
33.
Laxmi A, Siddhartha S, Archana M. Antimicrobial screening of methanol and aqueous extracts of Swertia chirata. Int J Pharm Pharm Sci. 2011;3:142–6.
34.
Santino A, Scarano A, Santis S, Benedictis M, Giovinazzo G, Chieppa M. Gut microbiota modulation and anti-inflammatory properties of dietary polyphenols in IBD: new and consolidated perspectives. Curr Pharm Des. 2017;23(16):2344–51.CrossRefPubMed
35.
Leong RW, Chan FK. Drug-induced side effects affecting the gastrointestinal tract. Expert Opin Drug Saf. 2006;5(4):585–92.CrossRefPubMed
36.
Siris ES, Fan CS, Yang X, Sajjan S, Sen SS, Modi A. Association between gastrointestinal events and compliance with osteoporosis therapy. Bone Rep. 2016;4:5–10.CrossRefPubMed
37.
Rieder R, Wisniewski PJ, Alderman BL, Campbell SC. Microbes and mental health: a review. Brain Behav Immun. 2017;66:9–17.CrossRefPubMed
38.
Hill JM, Bhattacharjee S, Pogue AI, Lukiw WJ. The gastrointestinal tract microbiome and potential link to Alzheimer's disease. Front Neurol. 2014;5:43.CrossRefPubMedPubMedCentral
39.
Poirier AA, Aube B, Cote M, Morin N, Di Paolo T, Soulet D. Gastrointestinal dysfunctions in Parkinson's disease: symptoms and treatments. Parkinsons Dis. 2016;2016:6762528.PubMedPubMedCentral
40.
Sanz Y, Olivares M, Moya-Perez A, Agostoni C. Understanding the role of gut microbiome in metabolic disease risk. Pediatr Res. 2015;77(1–2):236–44.CrossRefPubMed
41.
Li WQ, Han JL, Chan AT, Qureshi AA. Psoriasis, psoriatic arthritis and increased risk of incident Crohn's disease in US women. Ann Rheum Dis. 2013;72(7):1200–5.CrossRefPubMed
42.
43.
Huang R, Wang K, Hu J. Effect of probiotics on depression: a systematic review and meta-analysis of randomized controlled trials. Nutrients. 2016;8(8):483.
44.
Wallace CJ, Milev R. The effects of probiotics on depressive symptoms in humans: a systematic review. Ann General Psychiatry. 2017;16:14.CrossRef
45.
Lopresti AL. Curcumin for neuropsychiatric disorders: a review of in vitro, animal and human studies. J Psychopharmacol. 2017;31(3):287–302.CrossRefPubMed
Metadata
Title
A poly-herbal blend (Herbagut®) on adults presenting with gastrointestinal complaints: a randomised, double-blind, placebo-controlled study
Authors
Adrian L. Lopresti
Hemant Gupta
Stephen J. Smith
Publication date
01-12-2018
Publisher
BioMed Central
Published in
BMC Complementary Medicine and Therapies / Issue 1/2018
Electronic ISSN: 2662-7671
DOI
https://doi.org/10.1186/s12906-018-2168-y

Other articles of this Issue 1/2018

BMC Complementary Medicine and Therapies 1/2018 Go to the issue

Study protocol

Somatic experiencing® for patients with low back pain and comorbid posttraumatic stress disorder – protocol of a randomized controlled trial

Research article

Phytochemical analysis, antioxidant and anti-inflammatory potential of FERETIA APODANTHERA root bark extracts

Research article

Exploring the combination and modular characteristics of herbs for alopecia treatment in traditional Chinese medicine: an association rule mining and network analysis study

Research article

Emotional release and physical symptom improvement: a qualitative analysis of self-reported outcomes and mechanisms in patients treated with neural therapy

Research article

Galega officinalis extract regulate the diabetes mellitus related violations of proliferation, functions and apoptosis of leukocytes

Research article

Radix Paeoniae Rubra stimulates osteoclast differentiation by activation of the NF-κB and mitogen-activated protein kinase pathways