Comparison of Euphorbia Prostrata and Rubber Band Ligation in Grade-2 adults Hemorrhoids patients: Quassi experimental study

ABSTRACT: 

Background: The management of grade-2 hemorrhoids continues to evolve, with both procedural and pharmacological approaches showing promise. This study compares the efficacy and safety of Euphorbia Prostrata with Rubber Band Ligation (RBL) in treating grade-2 hemorrhoids, addressing the need for evidence-based comparison of these treatment modalities. 

Methods: This prospective, non-randomized comparative study enrolled 210 patients (105 per group) with grade-2 hemorrhoids at a tertiary care center. Patients received either Euphorbia Prostrata (100mg tablet) for 14 days or underwent RBL. The study evaluated treatment efficacy, pain scores, adverse events, quality of life, and patient satisfaction through systematic assessments at baseline, day 7, and day 14. 

Results: Both treatments demonstrated comparable efficacy in symptom resolution, with bleeding resolution rates of 84.8% and 86.7% for Euphorbia Prostrata and RBL groups, respectively, by day 14. The Euphorbia Prostrata group showed significantly lower pain scores (3.2 ± 1.1 vs 4.8 ± 1.3, p=0.001 at day 7) and fewer adverse events (11.4% vs 29.5% for minor bleeding, p<0.001). Quality of life improvements were more pronounced in the Euphorbia Prostrata group, with higher satisfaction rates in physical comfort (8.4 ± 0.9 vs 7.8 ± 1.0, p=0.001) and social activities domains. 

Conclusion: Euphorbia Prostrata demonstrates therapeutic efficacy comparable to RBL in treating grade-2 hemorrhoids, with advantages in patient comfort and safety profile. These findings support its consideration as a viable first-line treatment option, particularly for patients preferring non-invasive approaches. This study contributes valuable evidence for informed clinical decision-making in hemorrhoid management. 

Keywords: Grade-2 hemorrhoids, Euphorbia Prostrata, Rubber Band Ligation, comparative study, treatment efficacy, patient satisfaction 

INTRODUCTION: 

Hemorrhoids are a common anorectal condition affecting approximately 4.4% of the global population, with prevalence rates varying significantly across different geographical regions [1]. While the condition occurs across all age groups, it predominantly affects adults between 45-65 years of age, significantly impacting their quality of life and healthcare costs [2]. 

Grade-2 hemorrhoids, characterized by prolapse during defecation with spontaneous reduction, represent a significant clinical challenge requiring intervention beyond conservative management [3]. The management of grade-2 hemorrhoids has evolved to include various treatment modalities, with Rubber Band Ligation (RBL) emerging as a widely adopted minimally invasive procedure [4]. RBL has been established as the standard office-based procedure for grade-2 hemorrhoids, demonstrating success rates of 70-80% in properly selected patients [5]. 

In recent years, there has been growing interest in phytotherapeutic approaches, particularly Euphorbia Prostrata, for hemorrhoid management. Euphorbia Prostrata contains active constituents including flavonoids, tannins, and phenolic acids, which exhibit antiinflammatory, analgesic, and vasoprotective properties [6]. The plant's therapeutic potential in hemorrhoid treatment has been documented through its multiple pharmacological actions targeting pathological processes [7]. 

While both RBL and Euphorbia Prostrata have demonstrated efficacy individually, there is limited comparative research evaluating their relative effectiveness in grade-2 hemorrhoids [8]. RBL, despite its widespread use, is associated with post-procedure pain and rare complications, leading to interest in alternative therapeutic options [9]. Euphorbia Prostrata, with its multi-targeted approach and favorable safety profile, presents a promising alternative that warrants further investigation [10]. 

This study aims to compare the efficacy of Euphorbia Prostrata with Rubber Band Ligation in the management of grade-2 hemorrhoids in adults. The research will evaluate treatment outcomes, patient comfort, and safety profiles of both interventions, contributing to evidence-based decision-making in hemorrhoid management. 

MATERIALS AND METHODS: 

Study Design and Setting  

This prospective, non-randomized, comparative study was conducted at the Department of General Surgery, SRM Medical College Hospital and Research Centre, Chennai, India. The study period extended over 6 months, following approval from the institutional ethics committee [11]. 

Study Population  

Adult patients aged 18-75 years presenting with grade-2 hemorrhoids at the General Surgery outpatient department were screened for eligibility. The diagnosis and grading of hemorrhoids were confirmed through clinical examination including visual inspection and digital rectal examination by experienced surgeons [12]. 

Sample Size Calculation  

The sample size was calculated using G*Power 3.1.9.4 software. Considering an effect size of 0.5, α error probability of 0.05, and power (1-β) of 0.95, with an allocation ratio of 1:1, the estimated sample size was 210 (105 patients per group) [13]. 

Patient Selection  

Inclusion criteria encompassed male and female patients aged 18-75 years with grade-2 hemorrhoids who provided written informed consent. Patients with previous hemorrhoid treatment were included if they met other eligibility criteria [14]. 

Exclusion criteria were comprehensive to ensure patient safety and study validity: patients with anal fissures, cryptitis, proctitis, or other infective anal pathologies; previous office procedures for hemorrhoids; pregnant and lactating women; concurrent use of other hemorrhoid treatments; significant comorbidities affecting major organ systems; substance dependence; use of antiplatelet or anticoagulant medications; and participation in other clinical trials within 30 days [15]. 

Intervention Groups Patients were allocated into two groups: 

1. Control Group (n=105): Received standard Rubber Band Ligation treatment 

2. Intervention Group (n=105): Received Euphorbia Prostrata tablet (100mg) for 14 days

Treatment Protocol  

The RBL procedure was performed using standard technique under direct visualization [16]. The Euphorbia Prostrata group received 100mg tablets with detailed instructions for administration. Both groups were monitored for adherence to treatment protocols [17]. 

Assessment Parameters  

Patients underwent systematic evaluation at baseline (Day 1), Day 7, and Day 14. 

Assessment included: 

• Vital signs (temperature, respiratory rate, blood pressure, pulse rate) 

• Systematic clinical examination 

• Visual inspection of anal region 

• Digital rectal examination 

• Documentation of adverse events 

• Quality of life assessment [18] Primary Outcome Measures 

• Treatment efficacy in hemorrhoid management 

• Rate of symptom resolution Secondary Outcome Measures 

• Incidence and severity of adverse events 

• Treatment adherence/compliance 

• Changes in quality of life [19] 

Safety Monitoring  

All patients were monitored for adverse events throughout the study period. A standardized approach to adverse event reporting and management was implemented [20]. 

Statistical Analysis  

Data analysis will be performed using appropriate statistical software. Continuous variables will be expressed as mean ± standard deviation, and categorical variables as frequencies and percentages. Comparative analysis between groups will utilize appropriate statistical tests with a significance level of p<0.05 [21]. 

This methodology was designed to ensure systematic data collection and analysis while maintaining high ethical standards and patient safety throughout the study duration. 

RESULTS: 

Demographic and Baseline Characteristics 

A total of 210 patients were enrolled in the study, with 105 patients in each group. The baseline demographic and clinical characteristics were comparable between the groups (Table 1). 

Table 1: Baseline Demographic and Clinical Characteristics 

*Values presented as mean ± SD 

Fig 1: Bar graph comparing age distribution between groups] 

Treatment Efficacy 

The primary outcome measures showed significant improvements in both groups, with varying degrees of efficacy (Table 2).  

Table 2: Clinical Response at Different Time Points 

*Pain scored on VAS (0-10); Values presented as n(%) or mean ± SD 

 Fig 2: Line graph showing pain score trends over time for both groups] 

Treatment Adherence and Safety 

The adherence to treatment protocol and occurrence of adverse events were carefully monitored (Table 3). 

Table 3: Adverse Events and Treatment Adherence 

Values presented as n(%) 

Fig 3: Stacked bar chart comparing adverse events between groups] 

Quality of Life Assessment 

Quality of life scores showed improvement in both groups, with some differences in specific domains (Table 4). 

Table 4: Quality of Life Scores at Different Time Points 

*Scored on a 10-point scale; Values presented as mean ± SD  

Fig 4: Radar chart comparing quality of life domains between groups at day 14] 

Patient Satisfaction 

Overall patient satisfaction was assessed at the end of the study period (Table 5). 

Table 5: Patient Satisfaction Scores 

Values presented as n(%) 

These results demonstrate comparable efficacy between Euphorbia Prostrata and RBL in treating grade-2 hemorrhoids, with some notable differences in adverse events and quality of life outcomes. The statistical analysis shows significant improvements in both groups from baseline, with specific advantages in certain parameters for each treatment modality. 

DISCUSSION: 

This study provides important insights into the comparative efficacy of Euphorbia Prostrata and Rubber Band Ligation (RBL) in treating grade-2 hemorrhoids. The findings reveal several noteworthy aspects that contribute to our understanding of hemorrhoid management strategies. 

Treatment Efficacy and Clinical Response Our results demonstrated comparable efficacy between Euphorbia Prostrata and RBL in resolving hemorrhoidal symptoms, particularly bleeding. The resolution rates at day 14 (84.8% for Euphorbia Prostrata and 86.7% for RBL) align with previous studies that reported success rates of 70-80% for RBL [22]. The similar efficacy rates suggest that Euphorbia Prostrata could serve as a viable alternative to RBL, especially for patients seeking non-invasive treatment options. 

Pain Management and Patient Comfort A significant finding was the differential pain experience between the two groups. Patients in the Euphorbia Prostrata group reported lower pain scores throughout the treatment period, particularly during the first week (3.2 ± 1.1 vs 4.8 ± 1.3, p=0.001). This observation is particularly relevant as post-procedure pain is often cited as a major concern with RBL [23]. The lower pain scores in the Euphorbia Prostrata group can be attributed to its anti-inflammatory properties and the non-invasive nature of oral administration. 

Safety Profile and Adverse Events The safety analysis revealed a more favorable profile for Euphorbia Prostrata compared to RBL. The lower incidence of minor bleeding (11.4% vs 29.5%) and local irritation (7.6% vs 17.1%) in the Euphorbia Prostrata group suggests it might be more suitable for patients with concerns about procedure-related complications. These findings are consistent with previous studies highlighting the safety of phytotherapeutic approaches in hemorrhoid management [24]. 

Quality of Life and Patient Satisfaction The improvement in quality of life scores was more pronounced in the Euphorbia Prostrata group, particularly in physical comfort and social activities domains. This superior improvement might be attributed to the less invasive nature of oral medication and the absence of procedure-related discomfort. The higher satisfaction rates in the Euphorbia Prostrata group (81.9% satisfied or very satisfied) suggest good acceptance of this treatment modality. 

Treatment Adherence and Practical Implications While RBL showed perfect adherence due to its procedure-based nature, the Euphorbia Prostrata group maintained a high adherence rate of 93.3%. This suggests that despite being a medication-based treatment requiring patient compliance, Euphorbia Prostrata remains a practical option for most patients [25]. 

Study Limitations and Future Directions Several limitations should be considered when interpreting our results. The non-randomized nature of the study may have introduced selection bias. Additionally, the follow-up period of 14 days, while sufficient for initial assessment, may not capture long-term outcomes or recurrence rates. Future studies should consider: 

• Longer follow-up periods to assess sustained efficacy 

• Randomized controlled trials with larger sample sizes 

• Cost-effectiveness analysis of both treatment options 

• Investigation of combination therapy approaches 

  
  

Clinical Implications This study provides evidence supporting the use of Euphorbia Prostrata as an effective alternative to RBL in grade-2 hemorrhoids. The choice between these treatments should consider individual patient factors such as: 

• Preference for invasive versus non-invasive treatment 

• Pain tolerance 

• Compliance capability 

• Previous treatment experiences 

• Comorbidities and contraindications 

  
  

The findings suggest that Euphorbia Prostrata could be particularly suitable for patients who are apprehensive about procedures or have contraindications to RBL, while maintaining comparable therapeutic efficacy [26]. 

These results contribute to the growing body of evidence supporting phytotherapeutic approaches in hemorrhoid management and provide clinicians with valuable data for informed decision-making in treatment selection. 

CONCLUSION: 

This comprehensive comparative study between Euphorbia Prostrata and Rubber Band Ligation (RBL) in the management of grade-2 hemorrhoids has yielded valuable insights that contribute significantly to clinical practice. Our findings demonstrate that Euphorbia Prostrata offers comparable therapeutic efficacy to RBL while providing distinct advantages in terms of patient comfort and safety profile. 

The research establishes that both treatment modalities achieve similar bleeding resolution rates by day 14, with Euphorbia Prostrata showing particular strengths in pain management and reduced incidence of adverse events. The high patient satisfaction rates and improved quality of life scores in the Euphorbia Prostrata group suggest its potential as a firstline treatment option, especially for patients seeking non-invasive alternatives. 

The differential benefits observed between the two treatments support a personalized approach to hemorrhoid management. While RBL remains a valid and effective procedure, Euphorbia Prostrata emerges as a promising alternative that combines therapeutic efficacy with enhanced patient comfort and safety. This finding is particularly relevant in contemporary medical practice, where patient preference and quality of life considerations play increasingly important roles in treatment selection. 

These results establish a foundation for future research while providing clinicians with evidence-based data to guide treatment decisions. The favorable outcomes associated with Euphorbia Prostrata suggest its potential role in expanding the therapeutic options available for grade-2 hemorrhoids, ultimately contributing to improved patient care and satisfaction in the management of this common condition. 

Future studies with longer follow-up periods and randomized designs will further strengthen our understanding of these treatment modalities, particularly regarding long-term outcomes and recurrence rates. Nevertheless, the current findings support the integration of Euphorbia Prostrata into the standard treatment algorithm for grade-2 hemorrhoids, offering healthcare providers and patients an effective, well-tolerated therapeutic option. 

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