Original Research Paper
The use of Benincasa hispida for the treatment of uninvestigated dyspepsia: Preliminary results of a non-randomised open label pilot clinical trial

https://doi.org/10.1016/j.aimed.2015.09.003Get rights and content

Abstract

Background

Dyspepsia is becoming a common health problem for which an individual seeks medical help. The approach to the management of dyspepsia is complex with high treatment costs and possible adverse effects.

Methods

A prospective pilot study was designed to assess the effectiveness of the fruit juice of Ash Gourd (Benincasa hispida) on twenty dyspeptic subjects, who were followed up for 45 days. Measures of retrosternal pain, post-prandial fullness, bloating, sour belching, nausea, vomiting and changes in bowel habits were taken at three times periods (baseline, 30 days and 45 days).

Results

Statistically significant improvements were seen in several parameters, including pain (p < 0.001), retrosternal burning (p < 0.001), nausea (p < 0.001), belching (p < 0.001) and bowel habits (p < 0.05), which are considered as the classical symptoms of dyspepsia. Bloating, though not a common symptom also improved (p < 0.001) over time.

Conclusion

The trial drug is an effective remedy for uninvestigated dyspepsia. Randomised controlled trials are further needed to confirm the pharmaco-dynamics of the trial drug for anti-ulcer, acid suppression, H2 receptor antagonistic, anti-cholinergic properties.

Introduction

Dyspepsia is a common health problem with estimates of 20.8% of people in the community reporting chronic or recurrent dyspeptic symptoms each year which varied across nations (1.8–57%) [1]. Incidence of dyspepsia range from 21 to 24% in Europe alone every year [2]. Less than half of dyspepsia sufferers in Europe and the USA seek medical help for their complaint [3], yet it is a major cause of morbidity and economic loss in the community [4] and can have a significant impact on patient quality of life.

Dyspepsia is defined as a medical condition characterised by chronic or recurrent pain in the upper abdomen associated usually with fullness (postprandial fullness), bloating, belching, feeling full earlier than expected when eating (early satiety), nausea or heartburn [5], [6]. The typical approach for the patient with uninvestigated dyspepsia starts empirically with an anti-secretory agent or prokinetic agent as they are better tolerated and are effective in treating the underlying gastro-oesophageal reflux/peptic ulcer. Proton pump inhibitors (PPI) are regarded as the first line agents at present and are superior to H2 receptor antagonists in providing relief from reflux symptoms and ulcer healing [7]. The duration of empiric PPI therapy for relief from heartburn and other symptoms of dyspepsia is around 4–8 weeks with no effect on subsequent relapse which is rapid in most patients [8]. Alarm symptoms such as weight loss, recurrent vomiting, dysphagia, bleeding/anaemia, prompt the physician to advocate investigational procedures like endoscopy and urea breath test [9].

Symptoms of dyspepsia can result from a multitude of aetiological factors. Etiologies like gastroesophageal reflux (with or without esophagitis) and medications (calcium antagonists, nitrates, NSAIDs) result in retrosternal burning, belching and recurrent pain whereas functional dyspepsia, also called as non-ulcer dyspepsia, has no organic cause. Symptoms vary according to the aetiology and hence the management strategies.

Diagnosis and management of dyspepsia can be challenging as most of the biochemical and endoscopic procedures do not point to underlying organic disturbances leading to the symptoms of dyspepsia in majority of the cases. A retrospective study on one thousand four hundred subjects reporting dyspeptic symptoms scheduled for upper GI endoscopy revealed normal findings in 65% of subjects (mean of 43years of age) suggesting the fact that significant endoscopic lesions are not found in majority of endoscopies done for dyspepsia [10]. Endoscopy, though considered an accurate diagnostic tool, is not indicated unless the patient is aged over forty five years and accompanied by alarm symptoms like unexplained weight loss, progressive dysphagia, recurrent vomiting, anaemia, bleeding or an abdominal mass.

It has been previously reported that people with dyspepsia have sought out alternative forms of treatment such as complementary and alternative medicines (CAM) [11], [12], [13]. Nearly one-third of people in the United States (42%) and Australia (49%) seek CAM treatments/therapies, including Ayurveda, for chronic ailments including dyspepsia [14]. Ayurveda is a traditional healing system that originated in India. In Sanskrit, Ayu means “Life” and Veda means “knowledge or science.” Thus, Ayurveda can be interpreted as a life science which incorporates herbal medicines and holistic mind body interventions for the management of physical and mental ailments. Ayurveda describes a clinical condition called Amlapitta, which is characterised by pain, postprandial fullness, bloating, sour belching, nausea, burning sensation especially retrosternal, and/or vomiting.

Management of dyspepsia in Ayurveda includes various herbal formulations, the dosage form of which depends on the severity of the problem and tolerability of the patient. The most common dosage form advocated is the fresh juice of an herb. Selection of a particular herbal drug or formulation chiefly depends on the symptomatology. For example if heartburn is dominant then herbs like Indian gooseberry, ash gourd are used [15] whereas if pain is dominant, then herbs like ginger, piper longum are used [16]. The aetio-pathology of dyspepsia is complex and so is the herbal formulation selected for management [17].

Though there are ample number of researches reporting improvement in dyspepsia symptoms with the use of herbal medicines mentioned in Ayurveda [18], [19], there is no conclusive evidence as to how the drug acts since the drugs used are a complex mixture of multiple herbs most of the times [20].

To date, any relevant randomised controlled trials conducted have had inadequate sample sizes or thus have been unable to conclusively determine the exact mode of action of herbal medicines. To date, any relevant trials conducted have had inadequate sample size or non-blinded and most of the times not a randomised controlled trial. However, a Meta analysis to determine the effectiveness of various herbal formulations advocated in non-ulcer dyspepsia concluded that there are several herbal medicines, including ginger, St John's wort, turmeric and Indian gooseberry, with anti-dyspeptic activity and encouraging safety profiles and advises further research to establish their therapeutic value in the treatment of dyspepsia [21].

Considering the growing evidence of the potential for Ayurveda treatments of dyspepsia, we conducted a study to evaluate a single herb Benincasa hispida belonging to cucurbitaceae family for its anti-dyspeptic activity on patients of dyspepsia.

Section snippets

Design and methods

The trial was designed based on TREND (Transparent Reporting of Evaluations with Nonrandomized Designs) guidelines for reporting standards of behavioural and public health intervention evaluations involving nonrandomized designs. The study was a before-and-after design, conducted at Shri Dharmasthala Manjunatheshwara (SDM) Hospital of Ayurveda, Hassan, Karnataka, India after obtaining ethical clearance from the Institutional Review Board (IRB). Twenty-five participants fulfilling the

Study subjects and recruitment

The study followed the guidelines of the Declaration of Helsinki and Tokyo for humans. Patients visiting SDM Hospital of Ayurveda were either referred to the study by the physician in charge or by patients volunteering after seeing the poster advertising the study displayed in the hospital. A total of 20 patients were recruited into the study. The inclusion criteria were patients aged between 18 and 45 years, diagnosed as having dyspepsia based on diagnostic parameters including retrosternal

Diagnostic criteria and assessment

A diagnostic criterion was framed for the study based on symptoms of dyspepsia as outlined in Western medical literature and Ayurveda as follows. The diagnostic criteria include pain, post-prandial fullness, bloating, sour belching, nausea and retrosternal burning. Table 1 shows the assessment scales for these criteria.

Intervention

Subjects received the following interventions. Fresh and cleaned fruit of B. hispida was taken and its skin and seeds were separated, cut into small pieces and pound well. It was strained well through a clean cloth to get fresh juice of B. hispida. It was administered as a single dose of 200 ml to the patient every morning in empty stomach for thirty days. No specific dietary restriction was imposed on the study subjects to avoid influence of co-variants on the test results.

Outcomes measures

The study subjects were assessed on day zero, day thirty and day forty-five through self-report of behavioural data using a face-to-face interviewer-administered questionnaire. Primary outcomes of the study include improvement in the classical symptoms of dyspepsia (Amlapitta), that is, retrosternal pain, post-prandial fullness, bloating, sour belching, nausea and vomiting which were graded based on a scale outlined in Table 1. The symptom severity is graded from zero to four wherein zero

Statistical methods

The results of the study were analysed using descriptive statistics. Pair wise changes over time (i.e. 0–45 days) were assessed using ANOVA and changes in between groups were assessed using paired t-test with a confidence interval 95% and the relevant time point was 30 days. Statistical significance was set at 0.05. All analyses were conducted using the statistical software SPSS v12.

Results

The average age of the subjects was 37.3 (SD = 7.8), with 40% being male and 60% female. All 20 subjects who commenced the study were able to complete the study with measurements taken at day 0, day 30 and day 45. No adverse events were reported during the intervention and also up to about 45 days after completion of treatment.

The mean and standard deviation of all assessment parameters, measured at day 0, day 30 and day 45 are presented in Table 2. The mean burning sensation decreased from 2.40

Discussion

Dyspepsia is a common health issue in the present era of lifestyle disorders and the condition has a multitude of etiological factors and symptoms which vary from individual to individual. This study reports the first examination of the effectiveness of fruit juice of B. hispida in relieving the common symptoms of dyspepsia.

Our analyses revealed significant improvements in a number of common symptoms of dyspepsia, including retrosternal burning, pain, nausea, bloating, belching, and bowel

Conclusion

Our novel pilot study revealed that the use of ‘B. hispida’ reduced the classical symptoms of dyspepsia. Randomised controlled trials are further needed to confirm the pharmaco-dynamics of the trial drug for anti-ulcer, acid suppression, H2 receptor antagonistic, anti-cholinergic properties. B. hispida has the potential to become a safe, cost effective treatment for an uninvestigated case of dyspepsia as a first line of treatment.

Authors contribution

All research done by the authors

Financial support

Self-funded.

Conflict of interest

None declared.

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