Abstract
Background
Although hemorrhoidal disease is common worldwide, real-world evidence on the effectiveness of conservative treatments during the acute phase remains limited.
Objective
We aimed to assess the effectiveness of conservative treatment in improving symptoms and quality of life in patients with acute hemorrhoids in Vietnam.
Patients and methods
This was a prospective, international, observational, longitudinal study based on a subanalysis of the aCute HemORrhoidal disease evALuation International Study conducted from January 2022 to June 2022 at five major hospitals in Vietnam. The present study included adult patients (≥18 years) diagnosed with acute hemorrhoidal disease (≤48 h since onset) who received conservative treatment and did not require surgical intervention.
Results
Among the 202 patients, 53% were male; the mean population age was 40.5 ± 13.7 years, and the mean body mass index was 22.13 ± 2.59 kg/m2. The distribution of hemorrhoid severity was as follows: grade I, 22.3%; grade II, 59.9%; grade III, 12.4%; and grade IV, 5.4%. The mean number of symptoms per patient decreased from 4.6 ± 1.9 at baseline to 1.0 ± 1.5 at week four. At week one, the venoactive drug group showed symptom improvement rates of 63% for pain, 56.8% for discomfort, and 68.2% for bleeding. The Hemorrhoid and Fissure Quality of Life significantly decreased across all domains (p < 0.05). Patient and physician satisfaction with conservative treatment was high, at 88.7% and 87.7%, respectively.
Conclusion
Conservative treatment, particularly micronized purified flavonoid fraction–based therapy, improved the clinical symptoms and quality of life in patients with acute hemorrhoids in Vietnam.
Keywords
Introduction
Hemorrhoidal disease is a common anorectal condition; however, its prevalence is often underestimated due to patients’ reluctance or discomfort in seeking medical attention. According to Lee et al. (2014), the prevalence of hemorrhoidal disease among adults in South Korea was 14.4%. 1 Riss et al. (2012) 2 reported a prevalence of 38.9% in Austria, and a recent study reported a prevalence of 34.7% in Vietnam. 3
Depending on severity, hemorrhoidal disease can be managed through lifestyle modifications (dietary changes, regular exercise, and avoiding straining during bowel movements), conservative treatments (oral and topical medications), minimally invasive procedures (sclerotherapy, rubber band ligation, infrared coagulation, and cryotherapy), and surgical interventions (hemorrhoidectomy, hemorrhoidal artery ligation, and Longo’s procedure). Although numerous studies have focused on invasive treatment methods, there is a lack of research on the effectiveness of lifestyle modifications and conservative treatments on various aspects of hemorrhoidal disease, such as symptom relief and improving quality of life across different grades of the condition. Real-world data on the effectiveness of conservative treatment approaches for hemorrhoidal disease remain limited.
In 2020, the Chronic venous and HemORrhoidal diseases evalUation and Scientific research (CHORUS) study provided updated international data on patients with hemorrhoidal disease in clinical practice, examining the coexistence of hemorrhoids with chronic venous diseases. 4 However, the CHORUS study did not include follow-up data to assess the effectiveness of treatment strategies for hemorrhoidal disease. Moreover, no large-scale studies have been published on real-world conservative treatment approaches for hemorrhoidal disease and their impact on patients’ quality of life in various geographic regions. To address this gap, the aCute HemORrhoidal disease evALuation International Study (CHORALIS) was initiated in 2021–2022. 5 This large-scale, international study aimed to collect real-world clinical data to evaluate the effectiveness of conservative treatment approaches in patients with acute hemorrhoidal disease.
Based on this context, the present study represents a subanalysis of CHORALIS focusing on data from Vietnam aimed to assess the effectiveness of conservative treatment in improving the symptoms and quality of life among patients with acute hemorrhoids.
Patients and methods
Study population
The study included 202 adult patients with symptomatic acute hemorrhoidal disease whose diagnoses were confirmed by an investigator (a healthcare professional). The patients were enrolled from the following five major Vietnamese hospitals: The University Medical Center Ho Chi Minh City, Hanoi Medical University Hospital, Thai Binh University Hospital, Bach Mai Hospital, and Gia Dinh People’s Hospital between January and June 2022.
The inclusion criteria included adults (≥18 years) with symptomatic acute hemorrhoidal disease (≤48 h of symptom onset), confirmed via clinical examination, who were not receiving treatment at the time of the attack and had not undergone any hemorrhoidal procedure within the past 6 months. Patients with ongoing hemorrhoidal treatment, recent anorectal surgery, perianal infections, inflammatory bowel disease, colorectal malignancy, or severe systemic illness were excluded.
Methods
Study design
CHORALIS is an international, prospective, longitudinal, observational study (NCT04578730) conducted across nine countries. 5 The present study represents a subanalysis of CHORALIS data collected from Vietnam. The reporting of this study conforms to the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) guidelines. 6
Data collection and study variables
Investigators were instructed to continue routine patient management and treatment practices. At the baseline visit (visit 0 (V0)), the patients’ demographic, clinical, and lifestyle data were collected, along with medical history and hemorrhoid-related medication use. Patients self-reported the severity of anal pain and discomfort using a Visual Analogue Scale (VAS), with scores ranging from 0 (no pain/discomfort) to 10 (worst pain/discomfort ever experienced). Additional symptoms, including bleeding severity and frequency, swelling, itching, and anal soiling, were recorded. Patients also completed the Hemorrhoid and Fissure Quality of Life (HEMO-FISS QoL) questionnaire. 7 Hemorrhoidal disease severity was graded using the Goligher classification. 8
Follow-up visits were conducted at week one (V1; phone interview) and week four (V2; in-person assessment). Symptom resolution, Patient Global Impression of Change (PGI-C) scores, HEMO-FISS QoL scores, and patient/physician satisfaction were recorded. Overall satisfaction with the prescribed treatment was evaluated on a 5-point Likert scale (ranging from “very dissatisfied” to “very satisfied”). Prescription data for any additional treatments were also documented.
Data analysis
Quantitative variables were reported as mean ± SD. Categorical variables were presented as counts (n) and percentages (%). Differences were assessed using paired t-tests or Wilcoxon signed-rank tests for continuous variables with normal and skewed distributions, respectively. Statistical significance was defined at a p-value of <0.05. All analyses were performed using Statistical Analysis System (SAS®) software, version 9.4 or higher.
Ethical considerations
The study protocol received Institutional Review Board (IRB) approval from the five hospitals mentioned above with the research code DIM-05682-006-INT.
All procedures involving human participants were conducted in accordance with the ethical standards of the institutional and/or national research committee and the principles of the Declaration of Helsinki (as revised in 2024). All patients provided written informed consent prior to study inclusion.
Results
Characteristics of the study population
The study population comprising 202 patients from Vietnam included a slightly higher proportion of males (53%) than females (47%). The mean population age was 40.5 ± 13.7 years, and mean body mass index (BMI) was 22.13 ± 2.59 kg/m2. Most patients (53.2%) reported performing moderate physical activity, 30% led a sedentary lifestyle, and 28.7% reported prolonged sitting during work. Among female patients, 57% had a history of childbirth, with an average of 2.0 ± 0.8 births. Additionally, 36.6% of patients reported drinking <1.5 L of water per day, whereas 41.1% consumed a low-fiber diet (fruits/vegetables constituted less than one-third of their meals). A history of hemorrhoidal disease was reported in 51.7% of patients, 82.2% of whom had experienced an episode in the past 12 months. In 73.9% of cases, previous episodes of hemorrhoidal disease had lasted for <1 week.
A diagnosis of acute hemorrhoidal disease was confirmed via visual inspection in 78.8% of patients, digital rectal examination in 70.7%, and/or anoscopy in 52.7%. According to the Goligher classification, the distribution of hemorrhoids severity was as follows: grade I, 22.3%; grade II, 59.9%; grade III, 12.4%; and grade IV, 5.4%. Constipation, defined according to the Rome IV criteria, was reported by 39.6% of patients, and 44.1% had a Bristol Stool Scale score of 3.
At V0, patients reported an average of 4.6 ± 1.9 symptoms. The mean number of symptoms increased in patients with more severe hemorrhoidal grades; particularly, grade I patients reported 2.6 ± 1.5 symptoms, whereas those with grades II, III, and IV reported 5.2 ± 1.6, 5.5 ± 1.3, and 4.5 ± 1.5 symptoms, respectively.
Pain and discomfort were the most frequently reported symptoms at V0, with prevalence rates of 79.9% and 85.6%, respectively, occurring at moderate intensity (mean VAS score: 3.4 ± 1.9 for pain and 3.7 ± 1.9 for discomfort). Additional common symptoms included itching (49.0%), swelling (61.9%), and bleeding (75.8%). Anal soiling occurred less frequently, reported by 32.0% of patients. All symptoms may appear as early as grade I hemorrhoidal disease, with more advanced grades associated with an increased number of symptoms; higher frequency and intensity of pain and discomfort; and worsening of bleeding, swelling, itching, and anal soiling.
The mean HEMO-FISS QoL total score at V0 was 14.0 ± 12.8, indicating a mild-to-moderate impact of hemorrhoidal disease on the quality of life. More severe grades of hemorrhoidal disease were associated with higher HEMO-FISS QoL scores, reflecting a significantly greater impact on the quality of life; the mean score was 8.6 ± 11.9 for grade I and 36.4 ± 23.1 for grade IV (both p < 0.001). The HEMO-FISS QoL subscores for the physical (10.9 ± 13.7), psychological (8.4 ± 10.5), and sexual (11.0 ± 14.7) domains showed mild-to-moderate effects on the quality of life, whereas the bowel function domain score increased (25.8 ± 23.3), suggesting a considerable impact. Individuals with grade III or IV hemorrhoidal disease had lower quality of life across all four HEMO-FISS QoL domains.
Effectiveness of conservative treatments for hemorrhoidal disease
Disease management
There were 14 attending physicians, including 5 specialized in anorectal care (35.7%), 5 surgeons (7.1% colorectal and 28.6% general surgeons), and 4 gastroenterologists (21.4%).
The most common recommendations for patients with hemorrhoidal disease included increasing fiber intake (98% of physicians), drinking more water (95%), avoiding spicy foods (82%), avoiding prolonged standing or sitting (78%), avoiding straining during bowel movements (73%), maintaining perianal hygiene (71%), increasing physical activity (70%), and reducing weight (61%).
In addition to lifestyle advice and fiber supplementation (98.5%), the most frequently prescribed treatment was oral venoactive drugs (VADs) (n = 187; 92.6%; Figure 1). Among these, 105 patients (56.1%) received micronized purified flavonoid fraction (MPFF) and 75 (40.1%) received diosmin. Topical treatments were prescribed to 133 patients (65.8%), with 67 of these patients (35.4%) receiving oral VADs and topical treatments. Furthermore, 56 patients (27.7%) were prescribed laxatives, and 43 (21.3%) received analgesics.
Distribution of treatment methods at V0 by hemorrhoids grade. V0: visit 0.
Effectiveness of conservative treatment in improving symptoms
In patients treated with oral VADs (MPFF, diosmin, and others), the mean number of symptoms per patient significantly decreased from 4.6 ± 1.9 at V0 to 1.0 ± 1.5 at V2 (p < 0.001). Overall, 57.4% of patients in the VAD-based group reported no hemorrhoidal symptoms at V2.
After V1, most patients reported improvements in all symptoms, particularly pain, discomfort, and bleeding, with improvement rates of 63%, 56.8%, and 68.2%, respectively, in the VAD-based group. Symptoms improved regardless of the hemorrhoids grade. The VAS scores for pain and discomfort significantly decreased between V0 and V2 (3.4 ± 1.9 vs. 2.3 ± 1.6; p < 0.001) in the VAD-based group. Among those who still reported pain at V2, the majority (>80%) experienced pain during defecation, whereas spontaneous pain was less frequent across all treatment groups (p < 0.001 compared with that at baseline). Additionally, the frequency of pain significantly decreased between V0 and V2 across all treatment groups (77.8% vs. 14.8; p < 0.001). Similar trends were observed for the severity and frequency of discomfort (p < 0.05 compared with that at V0).
The bleeding rate significantly decreased during treatment in the VAD-based group (p < 0.001) (Table 1). Over 95% of patients with bleeding at V0 experienced symptom improvement by V2, with the bleeding resolution rate reaching approximately 90%. Among those for whom bleeding persisted at V2, the frequency and severity of bleeding improved across all treatment groups.
Improvement of the symptoms between V0 and V2 in each treatment group.
ap < 0.001 between V2 and V0 (Wilcoxon signed-rank test)
At least one symptom at each visit
VAD: venoactive drug; MPFF: micronized purified flavonoid fraction; V0: visit 0; V2: second follow-up visit.
Similar improvements were observed in swelling, itching, and anal soiling, with symptom prevalence significantly reducing between V0 and V2 across all treatment groups (p < 0.001). Among patients experiencing at least one of these symptoms at V0, over 90% of patients in each treatment group reported improvements at V2, with complete resolution observed in approximately 80%.
Treatment effectiveness based on PGI-C scale
At V1, 97.2% of patients in the VAD-based group reported symptom improvement on the PGI-C scale, with 2.8% reporting no change and 0% reporting worsening of symptoms. By V2, 96.4% reported improvement, 2.4% no change, and 1.2% worsening of symptoms.
As early as V1, 12.9% of patients in the VAD-based group reported feeling “very much better.” By V2, this proportion increased to 34.3%. Reports of worsening were rare (<3% of patients).
The mean time-to-symptom improvement at V1 was 3.5 ± 1.7 days in the VAD-based group.
Treatment effectiveness based on the quality of life (HEMO-FISS QoL scores)
The mean change in the total HEMO-FISS QoL scores from baseline (V0) to V2 was −9.0 ± 12.2, including −6.8 ± 12.8 for the physical domain, −5.9 ± 10.2 for the psychological domain, −17 ± 22.3 for the bowel function domain, and −6.4 ± 13.6 for the sexual domain (all p < 0.05). Changes in the quality of life, as assessed using the mean HEMO-FISS QoL scores, are summarized in Table 2, with significant improvements observed across all treatment groups (VAD-, MPFF-, and diosmin-based treatments). Reductions in the total HEMO-FISS QoL scores and scores for physical, psychological, bowel function, and sexual domains from V0 to V2 were statistically significant in all treatment groups (Table 2).
Changes in the quality of life (according to HEMO-FISS QoL scores) across treatment groups.
HEMO-FISS QoL: Hemorrhoidal Disease and Anal Fissures Quality of Life; MPFF: micronized purified flavonoid fraction; V0: visit 0; V2: second follow-up visit: VAD: venoactive drug.
Text in bold indicates statistically significant improvement/change.
Patient and physician satisfaction
The majority of patients and physicians reported being satisfied or very satisfied with the prescribed treatment for hemorrhoidal disease (Table 3).
Patient and physician satisfaction with treatment.
MPFF: micronized purified flavonoid fraction; VAD: venoactive drug.
Discussion
Characteristics of the study population
CHORALIS is an international, observational, longitudinal study that was designed to assess the effectiveness of conservative treatment methods for acute hemorrhoidal disease. Each participant was followed up for a mean duration of 4.1 ± 0.6 weeks. 5
The findings of this real-world evidence (RWE) study, involving 202 patients, provide detailed insights into the characteristics of patients with hemorrhoidal disease in Vietnam, impact of hemorrhoidal symptoms on their quality of life, and conservative treatment methods used and their effectiveness.
The mean age of the 202 study patients included in the study was 40.5 ± 13.7 years; a higher proportion of the patients were male (53%), consistent with the findings of the CHORUS study. 4 In a study by Hung and Ánh (2023) 3 that involved 925 individuals aged >25 years with awareness of hemorrhoidal disease, the male-to-female ratio was 1.02, and average patient age was 34.9 ± 8.5 years. A United States epidemiological study by Johanson and Sonnenberg (1990) reported that the age group with the highest prevalence of hemorrhoids was 45–65 years, with no significant sex-based differences. 9 Previous studies commonly found no conclusive association of sex with hemorrhoids occurrence. Riss et al. (2012) reported a higher prevalence of hemorrhoids during pregnancy; however, no significant association was identified between hemorrhoids and obstetric history. 2
Our study’s real-world data confirmed a high recurrence rate of hemorrhoidal disease, consistent with previous reports.3,10 A history of hemorrhoids was noted in 51.7% of patients, with 82.2% experiencing a hemorrhoidal episode within the past 12 months.
Pain and discomfort were the most common symptoms at V0, affecting 79.9% and 85.6% of patients, respectively. These findings are consistent with those reported by Hung and Ánh (2023), 3 who reported that 81% of patients with hemorrhoids experienced symptoms, most commonly anal pain or discomfort (50.2%), prolapse (42.1%), and bleeding (36.1%). In our study, the bleeding rate was 75.8%, similar to that reported by Abramowitz et al. (58.0%). 7 Similarly, Sheikh et al. reported that among 499 patients with hemorrhoids, common symptoms included bleeding (80.8%), pain (66.3%), swelling (51.7%), prolapse (28.9%), itching (37.7%), soiling (12%), and fecal incontinence (13.4%). 11
Additionally, our study reported the following factors associated with hemorrhoids occurrence: low-fiber intake (41.1%), low water intake (<1.5 L/day; 36.6%), physical inactivity (30%), and prolonged sitting during work (28.7%). Conditions that increase intra-abdominal pressure and impair venous drainage from the hemorrhoidal plexus are considered key causes of symptomatic hemorrhoids. Important risk factors include excessive straining, constipation, diarrhea, pregnancy, and obesity. 2 Other contributors include pelvic floor dysfunction, genetics, sedentary lifestyle, and low-fiber diets. 2 Prasad et al. (1976) 12 reported that hemorrhoids were more common among individuals with sedentary office jobs.
In our study, 39.6% of patients with hemorrhoids had constipation according to the Rome IV criteria, and 44.1% had a Bristol Stool Scale score of 3. Johanson and Sonnenberg (1994) 9 reported no significant association of hemorrhoids with constipation, aging, cirrhosis, or varices; however, diarrhea (odds ratio (OR), 2.1; 95% confidence interval (CI): 1.2–3.7) and obesity (OR, 1.7; 95% CI: 1.1–2.7) were significantly associated with hemorrhoids occurrence. Tran et al. reported that individuals with constipation were 1.80 times more likely to develop hemorrhoids (p < 0.05). 13 Similarly, Hung and Ánh identified digestive disorders as a risk factor for hemorrhoids development (OR, 1.7; p < 0.001). 3
The mean total HEMO-FISS QoL score at V0 was 14.0 ± 12.8, indicating a mild-to-moderate impact of hemorrhoidal disease on the quality of life. More severe hemorrhoidal grades were associated with higher total HEMO-FISS QoL scores, reflecting a significantly greater negative impact on the quality of life; the mean scores for grade I and grade IV hemorrhoids were 8.6 ± 11.9 and 36.4 ± 23.1, respectively (p < 0.001). The HEMO-FISS QoL scores for the physical (10.9 ± 13.7), psychological (8.4 ± 10.5), and sexual (11.0 ± 14.7) domains showed a mild-to-moderate impact of hemorrhoidal disease on the quality of life. The bowel function domain exhibited the greatest impact, with a mean score of 25.8 ± 23.3. Patients with grade III or IV hemorrhoids experienced lower quality of life scores across all four HEMO-FISS QoL domains. Abramowitz et al. (2018) developed, validated, and applied the HEMO-FISS QoL scale in a study involving 172 patients with hemorrhoids, comprising 7.7% of patients with grade I, 37.1% with grade II, 44.1% with grade III, and 11.2% with grade IV hemorrhoids. Moreover, 24.9% had thrombosed hemorrhoids (external or circumferential in 60.0% of cases). 7 The mean total HEMO-FISS QoL score was 29.1 ± 20.7, with higher scores across the physical (28.7 ± 24.5), psychological (21.5 ± 19.9), sexual (32.9 ± 29.4), and bowel function (44.03 ± 28.5) domains compared with those in our study, potentially due to a higher proportion of grade II–III hemorrhoids cases, representing a patient population with higher prevalence of severe disease. Higher HEMO-FISS QoL scores were noted in cases of patients with thrombosed hemorrhoids, bleeding, and grade III–IV hemorrhoids. 7
The presence of hemorrhoidal symptoms exerted a significant negative effect on the quality of life of the patients in the present study, regardless of disease severity. This is consistent with a previous study, which showed a weak correlation between the health-specific quality of life and hemorrhoids severity, whereas the burden of hemorrhoids symptoms exerted a greater impact on the quality of life. 10 These findings underscore the importance of incorporating patient-reported outcomes when evaluating hemorrhoids treatments because objective clinical data may not adequately capture the impact of this disease on an individual. The significant impact of hemorrhoids on the quality of life and the associated economic burden further highlight the necessity of identifying effective treatment approaches. 11
Effectiveness of conservative treatment
Effectiveness of conservative treatment in improving symptoms
In patients receiving VADs, including MPFF and diosmin, the mean number of symptoms per patient significantly decreased from 4.6 at V0 to 1.0 at V2 (p < 0.001) (Table 1). Regarding hemorrhoids treatment strategies, most patients, in addition to dietary and lifestyle recommendations, were treated using a combination of two or more treatment methods, primarily oral VADs along with topical treatments and/or laxatives and/or analgesics. MPFF was the most frequently prescribed treatment across all grades of hemorrhoids. Oral VAD treatment significantly reduced symptoms (p < 0.001), with >50% of patients reporting no symptoms by V2 (Table 1). VAD treatment was particularly effective in managing symptoms such as pain, discomfort, and bleeding. The benefits of oral VADs, including MPFF, diosmin, hydroxyethylrutosides, and troxerutin, in hemorrhoids treatment have been reported by several studies.4,10,11 MPFF has been shown to improve most hemorrhoidal symptoms, including bleeding, discharge/leakage, and/or itching. 10 Additionally, data from 14 randomized clinical trials indicated that MPFF effectively reduced symptom recurrence. 10 Our current data showed that 93.1% of patients treated with MPFF-based therapy reported no bleeding at V2. This figure was higher than the proportion of patients (80.2%) who reported no anal bleeding after 1 month of MPFF treatment in a randomized controlled trial. 14 Most recent studies provide high-level medical evidence supporting the effectiveness of MPFF in alleviating symptoms, particularly bleeding.14,15 MPFF was the most frequently prescribed VAD in the current study.
Effectiveness of conservative treatment assessed using the PGI-C scale, HEMO-FISS QoL questionnaire, and satisfaction levels
Symptom improvement, as assessed using the PGI-C scale, demonstrated that VAD-based treatments were effective in patients with hemorrhoidal disease. The proportion of patients who reported feeling “much better” was high, 12.9% by V1 and 54.3% by V2. Additionally, the mean time-to-symptom improvement was 3.5 ± 1.7 days. The effectiveness of VAD treatment was also reflected by the high levels of satisfaction reported by patients and physicians.
A key finding of the present study is the improvement in the disease-specific quality of life with conservative treatment of hemorrhoidal disease. The reduction in HEMO-FISS QoL scores indicated an overall better quality of life in patients with hemorrhoids across all treatment groups. A previous study also demonstrated quality of life improvements in adults with hemorrhoidal disease treated with MPFF. 15 Compared with conventional treatment alone (topical therapy/lifestyle modifications), the addition of MPFF to conventional treatment led to significant improvements in the physical and general health as well as total Short Form-12 scores 2 weeks. The bleeding rate also significantly improved in the MPFF group compared with that in the conventional treatment alone group (p = 0.045). 15
In recent years, laser hemorrhoidoplasty (LHP) has emerged as a minimally invasive alternative treatment of grade II–III hemorrhoidal disease, providing comparable symptom control with reduced postoperative pain and faster recovery as conventional excisional hemorrhoidectomy. 16 Although LHP was not assessed in our cohort, its favorable wound-healing ability and lower complication rate support the growing shift toward functional and tissue-preserving approaches for hemorrhoidal disease management.
Furthermore, recent anatomical and functional studies have emphasized the integrated relationship between the pelvic floor, perineum, and abdominal compartments, suggesting that hemorrhoidal symptoms should considered a broader context of pelvic floor dysfunction rather than as an isolated anal pathology. 17 This holistic concept supports the rationale for multimodal, conservative and minimally invasive therapies that aim not only at symptom relief but also at restoration of normal anorectal function.
Conclusion
The findings of this study provide further insights into the real-world outcomes of conservative treatments, including VADs, primarily MPFF, in patients with acute hemorrhoids in everyday clinical practice. In contrast to randomized controlled trials conducted under controlled conditions, RWE studies collect data in practical settings that include diverse patient populations, treatment approaches, and healthcare practices. The strength of this study lies in the fact that data were collected from 202 patients with varied profiles who were treated by physicians from different specialties, including gastroenterology and surgery. This approach offers valuable information for healthcare providers to better understand the practical implications of conservative treatments for hemorrhoids, optimize treatment strategies, and improve patient outcomes. To the best of our knowledge, this is the first and largest prospective observational study performed in Vietnam to evaluate the effectiveness of conservative treatments, benefiting patients and physicians.
Footnotes
Acknowledgments
We extend our gratitude to the authors of the included studies and Servier Global Medical and Patient Affairs.
Author contributions
Nguyen Trung Tin: Conceptualization, data curation, formal analysis, and writing—original draft preparation.
Tran Ngoc Dung: Methodology, project administration, validation, and supervision.
Nguyen Ngoc Anh: Conceptualization, study design, visualization, writing—review and editing, and correspondence (as corresponding author).
Nguyen Cong Long: Data collection and investigation.
Chung Hoang Phuong: Clinical data acquisition and interpretation of results.
Nguyen Thanh Binh: Statistical analysis and critical revision of the manuscript.
Ngo Minh Thu: Funding acquisition, resources, and manuscript coordination.
Data availability statement
Data can be obtained from the corresponding author upon reasonable request.
Disclosures
The authors declare no potential conflicts of interest with respect to the research, authorship, and publication of this article.
Ethics approval statement
Our study has received approval from the relevant ethics committees in Vietnam. All procedures were conducted in accordance with the principles of research ethics. All participants gave written informed consent.
Funding
The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.
