Effectiveness and safety of a nutraceutical formulation for the treatment of functional dyspepsia in primary care

2021 ◽  
Vol 16 ◽  
Author(s):  
Antonio Tursi ◽  
Marcello Picchio ◽  
Walter Elisei ◽  
Leonardo Allegretta ◽  
Pierluigi Benedicenti ◽  
...  
Keyword(s):  
Primary Care ◽  
General Population ◽  
Functional Dyspepsia ◽  
Large Study ◽  
Epigastric Pain ◽  
Root Extract ◽  
Efficacy And Safety ◽  
Conventional Drug ◽  
Natural Treatment ◽  
Symptom Scores

Background: Although FD may affect up to 10% of the general population, the therapy for FD is not standard. Recently, ginger-based food supplements have been proposed in order to restore FD symptoms. Our aim was to assess the efficacy of a new nutraceutical formulation containing extract of gingerol and thymus as a possible natural treatment in managing the symptoms of functional dyspepsia (FD). Methods: We retrospectively analyzed the efficacy and safety profiles of a nutraceutical formulation containing Zingiber of¬ficinalis root extract and a standardized Thymus extract. It was adminis¬tered as 1 ml/day twice a day for 90 days. Patients were assessed at baseline and af¬ter 1, 2 and 3 months of treatment, following a month of pharmacological washout by completing a questionnaire reporting the trend of the following symptoms: epigastric pain, epigastric heaviness, early satiety, belching, and regurgitation. Every symptom was assessed by a Visual Analogic Scale (VAS), ranging from 0= absence to 10= maximal severity. Results: We enrolled 272 patients (99 males and 173 females; median IQR age 49.5, 36-64 yrs). Obesity (BMI>30) was present in 28 (12.5%) patients; smokers were 83 (30.5%); and comorbidities were present in 107 (39.3%) patients. Improvement of symptom scores during treatment and one month after its suspension was extremely significant (p<0.000). Conclusion: This large study found that nutraceutical formulation could be one of the tools for an empirical approach to treat patients with FD, especially when a non-conventional drug treatment is preferable for the patient and considered suitable by the physician.

scholarly journals A Randomized Controlled Study of Efficacy and Safety Profile of Levosulpiride and Itopride in Functional Dyspepsia

2020 ◽  
Vol 5 (2) ◽  
pp. 50-56
Author(s):  
Ganesh Narain Saxena ◽  
Saumya Mathur
Keyword(s):  
Functional Dyspepsia ◽  
Safety Profile ◽  
Epigastric Pain ◽  
Randomized Controlled Study ◽  
Controlled Study ◽  
Efficacy And Safety ◽  
Early Satiety ◽  
Postprandial Fullness ◽  
Presenting Symptoms ◽  
Randomized Controlled

ABSTRACT Introduction Dyspepsia is a clinical problem of considerable magnitude for the healthcare system due to the high prevalence and chronic and recurrent nature of symptoms. Earlier dyspepsia was referred to as a heterogeneous group of symptoms in the upper abdomen and retrosternal which are related to ingestion of meals and include heartburn, regurgitation, epigastric pain, epigastric burning, postprandial fullness/distension, early satiety, bloating, belching, anorexia, nausea, and vomiting. This has prompted the search for newer agents with equal efficacy but lower side effect potential such as levosulpiride and itopride. Aim and objectives To evaluate and compare the efficacy of the newer drugs like levosulpiride and itopride in functional dyspepsia. Observations and results The most common presenting symptoms in the present study were epigastric fullness (81%), upper abdominal pain (55%), early satiety (52%), and epigastric burning (45%). Less common symptoms were bloating (27%), belching (11%), heartburn (10%), and nausea (8%). Conclusion Drugs, itopride and levosulpiride, were equally effective in ameliorating different symptoms of functional dyspepsia at the end of 4 weeks of treatment. There was a significant reduction in mean global symptom score (GSS) and mean duration score and mean score of severity in follow-up visits at the 2nd and 4th week from the day of presentation (p value < 0.05). How to cite this article Saxena GN, Mathur S. A Randomized Controlled Study of Efficacy and Safety Profile of Levosulpiride and Itopride in Functional Dyspepsia. J Mahatma Gandhi Univ Med Sci Tech 2020;5(2):50–56.

scholarly journals Dyspepsia: When and How to Test forHelicobacter pyloriInfection

2016 ◽  
Vol 2016 ◽  
pp. 1-9 ◽  
Author(s):  
Maria Pina Dore ◽  
Giovanni Mario Pes ◽  
Gabrio Bassotti ◽  
Paolo Usai-Satta
Keyword(s):  
Primary Care ◽  
Functional Dyspepsia ◽  
Primary Care Physicians ◽  
Epigastric Pain ◽  
Noninvasive Testing ◽  
Medication History ◽  
Breath Testing ◽  
Rome Iii ◽  
History Of ◽  
H Pylori

Dyspepsia is defined as symptoms related to the upper gastrointestinal tract. Approximately 25% of western populations complain of dyspeptic symptoms each year. 70% of them do not have an organic cause and symptoms are related to the so-called functional dyspepsia, characterized by epigastric pain, early satiety, and/or fullness during or after a meal occurring at least weekly and for at least 6 months according to ROME III criteria. In order to avoid invasive procedures and adverse effects, to minimize costs, to speed up diagnosis, and to provide the most appropriate treatments, primary care physicians need to recognize functional dyspepsia. Because symptoms do not reliably discriminate between organic and functional forms of the disease, anamnesis, family history of peptic ulcer and/or of gastric cancer, medication history, especially for nonsteroidal anti-inflammatory drugs, age, and physical examination could help the physician in discerning between functional dyspepsia and organic causes. For patients without alarm symptoms, noninvasive testing forH. pylori, with either carbon-13-labeled urea breath testing or stool antigen testing, is recommended as a first-line strategy. In this review, we provide recommendations to guide primary care physicians for appropriate use of diagnostic tests and forH. pylorimanagement in dyspeptic patients.

scholarly journals Pelargonium sidoides root extract for the treatment of acute cough due to lower respiratory tract infection in adults: a feasibility double-blind, placebo-controlled randomised trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Merlin Willcox ◽  
Catherine Simpson ◽  
Sam Wilding ◽  
Beth Stuart ◽  
Dia Soilemezi ◽  
...  
Keyword(s):  
Primary Care ◽  
Controlled Trial ◽  
Randomised Trial ◽  
Acute Bronchitis ◽  
Antibiotic Prescribing ◽  
Root Extract ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Link Type ◽  
Pelargonium Sidoides

Abstract Background Pelargonium sidoides DC (Geraniaceae) root extract, EPs®7630 or “Kaloba®”, is a widely used herbal remedy for respiratory infections, with some evidence of effectiveness for acute bronchitis. However, it is not yet widely recommended by medical professionals in the UK. There is a need to undertake appropriately designed randomised trials to test its use as an alternative to antibiotics. The aim was to assess the feasibility of conducting a double-blind randomised controlled trial of Pelargonium sidoides root extract for treatment of acute bronchitis in UK primary care, investigating intervention compliance, patient preference for dosage form and acceptability of patient diaries. Study design Feasibility double-blind randomised placebo-controlled clinical trial. Methods We aimed to recruit 160 patients with cough (≤ 21 days) caused by acute bronchitis from UK general practices. Practices were cluster-randomised to liquid or tablet preparations and patients were individually randomised to Kaloba® or placebo. We followed participants up for 28 days through self-reported patient diaries with telephone support and reviewed medical records at one month. Outcomes included recruitment, withdrawal, safety, reconsultation and symptom diary completion rates. We also assessed treatment adherence, antibiotic prescribing and consumption, mean symptom severity (at days 2–4 after randomisation) and time to symptom resolution. We interviewed 29 patients and 11 health professionals to identify barriers and facilitators to running such a randomised trial. Results Of 543 patients screened, 261 were eligible, of whom 134 (51%) were recruited and 103 (77%) returned a completed diary. Overall, 41% (41/100) of patients took antibiotics (Kaloba® liquid group: 48% [15/31]; placebo liquid group: 23% [6/26]; Kaloba® tablet group: 48% [9/21]; placebo tablet group: 50% [11/22]). Most patients adhered to the study medication (median 19 out of 21 doses taken in week 1, IQR 18–21 - all arms combined). There were no serious adverse events relating to treatment. Most patients interviewed found study recruitment to be straightforward, but some found the diary too complex. Conclusions It was feasible and acceptable to recruit patients from UK primary care to a double-blind placebo-controlled trial of herbal medicine (Kaloba®) for the treatment of acute bronchitis, with good retention and low data attrition. Trial registration HATRIC was registered on the ISRCTN registry (ISRCTN17672884) on 16 August 2018, retrospectively registered. The record can be found at http://www.isrctn.com/ISRCTN17672884.

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