Dyspepsia
Conditions
Brief summary
Purpose of the study: To obtain additional data on efficacy and safety of Kolofort in the treatment of patients with functional dyspepsia.
Detailed description
Design: a multicenter double-blind placebo-controlled randomized clinical trial to evaluate the efficacy and safety of the study treatment. The study will enroll the patients of both genders aged 18-45 years old with verified diagnosis of functional dyspepsia according to Rome-IV criteria and intensity of dyspeptic symptoms ≥ 6 according to GIS (Gastrointestinal symptom score). At the screening visit 1 (Visit 1, from -14 to -1 days), after signing patient information sheet (informed consent form) to participate in the clinical trial, complaints and medical history are collected, an objective examination is performed. The investigator evaluates intensity of dyspeptic symptoms according to GIS. The patient undergoes an abdomen ultrasound examination, esophagogastroduodenoscopy (EGDS) , and diagnostic tests for Helicobacter pylori (H. pylori) infection. In case of the previous use of proton pump inhibitors, prokinetics, antispasmodics, antacids, bismuth drugs the investigator evaluates the possibility of canceling these drugs at least 7 days before the patient is randomized. For women of reproductive age, a pregnancy test is performed. On the day of randomization (Visit 2, Day 0) collection of complaints and objective examination are carried out. The investigator evaluates the results of laboratory and instrumental research methods, the severity of dyspepsia symptoms on the GIS scale, registers changes in concomitant therapy. If a patient meets all inclusion criteria and does not have any exclusion criteria, he/she is randomized into one of two groups: patients in Group 1 receive Kolofort for 8 weeks; patients in Group 2 - Placebo on the study drug regimen. The patient completes the Nepean Dyspepsia Index (NDI) and Quality of Life (SF-36) questionnaires. The patient's treatment lasts for 8 weeks, during which 3 visits to the research center are carried out. At Visit 3 (Week 2 ± 3 days), complaints are collected, an objective examination of the patient is performed. The investigator monitors the prescribed and concomitant therapy, evaluates the safety of therapy and the degree of adherence to treatment (compliance). At visit 4 (week 4±3 days) and 5 (week 8±3 days) the investigator collects complaints, registers the physical examination data, monitors the prescribed and concomitant therapy, assesses the safety of the treatment and compliance. Questionnaires GIS, NDI are filled in. Additionally, at Visit 5 the patient fills out the SF-36 scale, the investigator fills out the Clinical Global Impression-Efficacy Index (CGI-EI). The patients will be allowed to take symptomatic therapy and medications for their co-morbidities during the study, except for the medicines listed in Prohibited Concomitant Treatment.
Interventions
DRUGKolofort
Oral administration
DRUGPlacebo
Oral administration
Sponsors
Materia Medica Holding
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
1. Patients of both genders aged 18-45 years old. 2. Diagnosis of functional dyspepsia established according to Rome-IV criteria (2016). 3. Severity of symptoms of dyspepsia ≥ 6 on the GIS scale. 4. Negative test result for H. pylori infection . 5. Availability of signed patient information sheet and informed consent form for participation in the clinical trial. 6. Patients who gave their consent to use reliable contraception during the study
Exclusion criteria
1. Organic diseases of the gastrointestinal tract (gastroesophageal reflux disease (GERD), peptic ulcer, chronic pancreatitis, cholelithiasis, hepatosis, hepatitis, hepatic cirrhosis, etc.) 2. Verified diagnosis of other functional GI diseases, i.e. biliary dyskinesia, irritable bowel syndrome, etc. 3. Discontinuation of proton pump inhibitors, prokinetics, antispasmodics, antacids, bismuth preparations less than 7 days before randomization. 4. H. pylori eradication within 2 months prior to enrollment. 5. Intestinal infection within 2 months prior to enrollment. 6. History/suspicion of oncology of any location. 7. Previously diagnosed cardiovascular diseases with functional class IV (according to the classification of the New-York Heart Association, 1964), hypothyroidism, diabetes mellitus, chronic renal disease С3-5, hepatic diseases with portal hypertension and/or signs of severe decompensation of function (\> 6 points according to the Child-Pugh classification). 8. Any other severe comorbidity that, in the opinion of the investigator, may affect patient participation in the clinical trial. 9. Allergy/intolerance intolerances to any of the components of the study drugs. 10. Pregnancy, breast-feeding. 11. Patients who, from the investigator's point of view, will not comply with the observation requirements of the study or adhere to study drug dosing regimens. 12. Scheduled hospitalization during the study for any diagnostic or therapeutic procedures. 13. Use of drugs or alcohol (more than 2 alcohol units daily), presence of mental diseases. 14. Use of any medications specified in the Prohibited Concomitant Treatment within 1 month prior to inclusion in the study. 15. Participation in other clinical trials in the previous 3 months. 16. Patients who are related to any of the on-site research personnel directly involved in the conduct of the trial or are an immediate relative of the study investigator. 'Immediate relative' means husband, wife, parent, son, daughter, brother, or sister (regardless of whether they are natural or adopted). 17. Patients who work for MATERIA MEDICA HOLDING (i.e. the company's employees, temporary contract workers, appointed officials responsible for carrying out the research or immediate relatives of the aforementioned).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Severity of Functional Dyspepsia Symptoms | On baseline, after 4 and 8 weeks of the treatment | Changes in severity of functional dyspepsia symptoms due to GIS score (Gastrointestinal symptom score) at week 8 from the start of study therapy. The GIS scale includes 10 subscales (symptoms), the severity of each one was evaluated from 0 to 4 points (by Lickert scale).For example, the absence of the mentioned symptom is classified as 0. The most severe is classified as 4. The all 10 subscales were combined to compute a total score. So the total range is a sum of all subscales.The total score is in range from 0 till 40. So the minimum value is 0, the maximum is 40. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients With a Decrease in the Severity of FD Symptoms | After 8 weeks of the treatment | Percentage of patients with a decrease in the severity of FD symptoms on the GIS scale after 8 weeks from the start of study therapy. The GIS scale is composed of 10 points evaluating the extent of manifestation of a wide range of gastroenterological symptoms. The intensity of clinical symptoms will be evaluated based on a 5-point Likert scale from 0 to 4 where 0 = no, 1 = mild, 2 = moderate, 3 = severe and 4 = very severe). |
| Change in the Severity of the Functional Dyspepsia Index NDI (Nepean Dyspepsia Index) | On baseline, after 4 and 8 weeks of the treatment | Change in the severity of the functional dyspepsia index NDI (Nepean dyspepsia index) after 8 weeks from the start of the study therapy. The NDI questionnaire involves the patient's self-assessment of various manifestations of the disease and how much FD affects his life. The range of possible fluctuations in the total score of the Nepean dyspepsia index is from 10 to 50. The scale consists of 10 questions. Each section corresponds to 5 answer options (the lower score is 1, the highest is 5), reflecting the gradation of the severity of the symptom and coded according to the increase in the severity of the symptom or the loss of the ability to perform a certain task in the framework of daily activities. The minimum value is 10, the maximum value is 50. The higher score represents the worst outcome. |
| Changes in the Quality of Life of Patients on the SF-36 (Short Form-36) Health Survey Scale | On baseline and after 8 weeks of the treatment | The scale reflects the general well-being of a person, which is affected by the state of health, and consists of 11 questions. In the composition of the SF-36 dedicated 8 sections:1. Physical functioning,2. Role (physical) functioning 3. Pain.4. General health.5. Vitality.6. Social functioning.7. Emotional functioning. 8. Psychological health.The sections of the scale are combined into 2 total dimensions - the physical component of health (1-4 questions) and mental (5-8 questions). Subscales (questions 1-4) were summed to provide the information about the physical component, subscales (questions 5-8) - about the mental component. Each scale ranges from 0 to 100 so that the lowest and highest possible scores are 0 and 100, respectively. Scores represent the percentage of total possible score achieved. |
| Percentage of Patients Terminating the Study Early | in 8 weeks of the treatment | Percentage of patients terminating the study early due to lack of efficacy of the study therapy. Lack of efficacy of the study therapy is defined as retention or progression of the symptoms of functional dyspepsia resulting in prescription of the products for FD therapy (proton pump inhibitors, prokinetics, spasmolytics). |
| Indicators of Therapeutic and Side Effects, Efficacy Index on CGI-EI (Clinical Global Impression-Efficacy Index) Scale | After 8 weeks of the treatment | Indicators of therapeutic and side effects, efficacy index on the scale of the general clinical impression CGI-EI (Clinical Global Impression Scale - Efficacy Index) after 8 weeks from the start of study therapy. Clinical Global Impression Efficacy Index (CGI-EI) will be filled by the investigator at the final Visit 5 (Week 8±3 days). Evaluation of the response to treatment should take into account both therapeutic efficacy and treatment-related side effects. Side effects value from 1 to 4. Therapeutic effect value as 0,4,8 or 12 points. The efficacy index is a sum. The minimum value is 1, the maximum value is 16. A lower score on the scales is the best outcome. |
Countries
Russia
Participant flow
Pre-assignment details
A total of 370 patients were enrolled in the study and signed informed consent. After undergoing screening procedures, 61 patients were excluded by the investigators because they did not meet the inclusion criteria, or they had non-inclusion criteria. 309 patients were randomized into two groups - 151 into Kolofort group and 158 into Placebo group.
Participants by arm
| Arm | Count |
|---|---|
| Kolofort Tablet for oral use. Dose per administration: 2 tablets. 2 tablets twice daily (4 tablets per day). The tablets should be held in the mouth until complete dissolution, without meal.
Kolofort: Oral administration | 151 |
| Placebo Tablet for oral use. Dose per administration: 2 tablets. 2 tablets twice daily (4 tablets per day). The tablets should be held in the mouth until complete dissolution, without meal.
Placebo: Oral administration | 158 |
| Total | 309 |
Baseline characteristics
| Characteristic | Placebo | Total | Kolofort |
|---|---|---|---|
| Age, Continuous | 29.7 years STANDARD_DEVIATION 7.9 | 30.1 years STANDARD_DEVIATION 7.8 | 30.5 years STANDARD_DEVIATION 7.7 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment Russia | 158 participants | 309 participants | 151 participants |
| Sex: Female, Male Female | 110 Participants | 215 Participants | 105 Participants |
| Sex: Female, Male Male | 48 Participants | 94 Participants | 46 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 151 | 0 / 158 |
| other Total, other adverse events | 13 / 151 | 12 / 158 |
| serious Total, serious adverse events | 0 / 151 | 0 / 158 |
Outcome results
Primary
Changes in Severity of Functional Dyspepsia Symptoms
Changes in severity of functional dyspepsia symptoms due to GIS score (Gastrointestinal symptom score) at week 8 from the start of study therapy. The GIS scale includes 10 subscales (symptoms), the severity of each one was evaluated from 0 to 4 points (by Lickert scale).For example, the absence of the mentioned symptom is classified as 0. The most severe is classified as 4. The all 10 subscales were combined to compute a total score. So the total range is a sum of all subscales.The total score is in range from 0 till 40. So the minimum value is 0, the maximum is 40.
Time frame: On baseline, after 4 and 8 weeks of the treatment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Kolofort | Changes in Severity of Functional Dyspepsia Symptoms | Baseline score | 10.1 score on a scale | Standard Deviation 3.1 |
| Kolofort | Changes in Severity of Functional Dyspepsia Symptoms | Score after 4 weeks | 5.1 score on a scale | Standard Deviation 3 |
| Kolofort | Changes in Severity of Functional Dyspepsia Symptoms | Score after 8 weeks | 2.9 score on a scale | Standard Deviation 2.5 |
| Kolofort | Changes in Severity of Functional Dyspepsia Symptoms | Baseline minus 8 weeks score difference | 7.2 score on a scale | Standard Deviation 3.3 |
| Placebo | Changes in Severity of Functional Dyspepsia Symptoms | Baseline minus 8 weeks score difference | 6.3 score on a scale | Standard Deviation 4.6 |
| Placebo | Changes in Severity of Functional Dyspepsia Symptoms | Baseline score | 10.0 score on a scale | Standard Deviation 3.9 |
| Placebo | Changes in Severity of Functional Dyspepsia Symptoms | Score after 8 weeks | 3.7 score on a scale | Standard Deviation 3.6 |
| Placebo | Changes in Severity of Functional Dyspepsia Symptoms | Score after 4 weeks | 5.2 score on a scale | Standard Deviation 3 |
Comparison: Mean changes of GIS scores after 8 weeks of treatment were compared.p-value: 0.04195% CI: [0.04, 1.85]ANOVA
Comparison: Mean changes of GIS scores after 8 weeks of treatment were compared. Influence of between center variation was estimated.p-value: 0.04195% CI: [0.04, 1.74]Mixed Models Analysis
Secondary
Change in the Severity of the Functional Dyspepsia Index NDI (Nepean Dyspepsia Index)
Change in the severity of the functional dyspepsia index NDI (Nepean dyspepsia index) after 8 weeks from the start of the study therapy. The NDI questionnaire involves the patient's self-assessment of various manifestations of the disease and how much FD affects his life. The range of possible fluctuations in the total score of the Nepean dyspepsia index is from 10 to 50. The scale consists of 10 questions. Each section corresponds to 5 answer options (the lower score is 1, the highest is 5), reflecting the gradation of the severity of the symptom and coded according to the increase in the severity of the symptom or the loss of the ability to perform a certain task in the framework of daily activities. The minimum value is 10, the maximum value is 50. The higher score represents the worst outcome.
Time frame: On baseline, after 4 and 8 weeks of the treatment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Kolofort | Change in the Severity of the Functional Dyspepsia Index NDI (Nepean Dyspepsia Index) | Baseline | 23.5 units on a scale | Standard Deviation 7 |
| Kolofort | Change in the Severity of the Functional Dyspepsia Index NDI (Nepean Dyspepsia Index) | After 4 weeks | 17.1 units on a scale | Standard Deviation 5.6 |
| Kolofort | Change in the Severity of the Functional Dyspepsia Index NDI (Nepean Dyspepsia Index) | After 8 weeks | 14.4 units on a scale | Standard Deviation 5.1 |
| Kolofort | Change in the Severity of the Functional Dyspepsia Index NDI (Nepean Dyspepsia Index) | Baseline minus 8 weeks score difference | 9.1 units on a scale | Standard Deviation 7.1 |
| Placebo | Change in the Severity of the Functional Dyspepsia Index NDI (Nepean Dyspepsia Index) | Baseline minus 8 weeks score difference | 8.5 units on a scale | Standard Deviation 6.6 |
| Placebo | Change in the Severity of the Functional Dyspepsia Index NDI (Nepean Dyspepsia Index) | Baseline | 23.5 units on a scale | Standard Deviation 6.9 |
| Placebo | Change in the Severity of the Functional Dyspepsia Index NDI (Nepean Dyspepsia Index) | After 8 weeks | 14.9 units on a scale | Standard Deviation 6 |
| Placebo | Change in the Severity of the Functional Dyspepsia Index NDI (Nepean Dyspepsia Index) | After 4 weeks | 17.0 units on a scale | Standard Deviation 6 |
Comparison: Mean changes of NDI scores after 8 weeks of treatment were compared.p-value: 0.43595% CI: [-0.93, 2.15]ANOVA
Secondary
Changes in the Quality of Life of Patients on the SF-36 (Short Form-36) Health Survey Scale
The scale reflects the general well-being of a person, which is affected by the state of health, and consists of 11 questions. In the composition of the SF-36 dedicated 8 sections:1. Physical functioning,2. Role (physical) functioning 3. Pain.4. General health.5. Vitality.6. Social functioning.7. Emotional functioning. 8. Psychological health.The sections of the scale are combined into 2 total dimensions - the physical component of health (1-4 questions) and mental (5-8 questions). Subscales (questions 1-4) were summed to provide the information about the physical component, subscales (questions 5-8) - about the mental component. Each scale ranges from 0 to 100 so that the lowest and highest possible scores are 0 and 100, respectively. Scores represent the percentage of total possible score achieved.
Time frame: On baseline and after 8 weeks of the treatment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Kolofort | Changes in the Quality of Life of Patients on the SF-36 (Short Form-36) Health Survey Scale | After 8 weeks (physical score) | 56.3 score on a scale | Standard Deviation 6.5 |
| Kolofort | Changes in the Quality of Life of Patients on the SF-36 (Short Form-36) Health Survey Scale | Baseline (mental score) | 33.6 score on a scale | Standard Deviation 5.7 |
| Kolofort | Changes in the Quality of Life of Patients on the SF-36 (Short Form-36) Health Survey Scale | Baseline minus 8 weeks score difference (mental score) | 3.5 score on a scale | Standard Deviation 6.3 |
| Kolofort | Changes in the Quality of Life of Patients on the SF-36 (Short Form-36) Health Survey Scale | After 8 weeks (mental score) | 37.1 score on a scale | Standard Deviation 4.5 |
| Kolofort | Changes in the Quality of Life of Patients on the SF-36 (Short Form-36) Health Survey Scale | Baseline minus 8 weeks score difference (physical score) | 6.4 score on a scale | Standard Deviation 7.5 |
| Kolofort | Changes in the Quality of Life of Patients on the SF-36 (Short Form-36) Health Survey Scale | Baseline (physical score) | 49.9 score on a scale | Standard Deviation 7.8 |
| Placebo | Changes in the Quality of Life of Patients on the SF-36 (Short Form-36) Health Survey Scale | Baseline minus 8 weeks score difference (mental score) | 2.9 score on a scale | Standard Deviation 6.6 |
| Placebo | Changes in the Quality of Life of Patients on the SF-36 (Short Form-36) Health Survey Scale | Baseline (physical score) | 49.4 score on a scale | Standard Deviation 7.7 |
| Placebo | Changes in the Quality of Life of Patients on the SF-36 (Short Form-36) Health Survey Scale | After 8 weeks (physical score) | 56.2 score on a scale | Standard Deviation 6.3 |
| Placebo | Changes in the Quality of Life of Patients on the SF-36 (Short Form-36) Health Survey Scale | Baseline minus 8 weeks score difference (physical score) | 6.8 score on a scale | Standard Deviation 7 |
| Placebo | Changes in the Quality of Life of Patients on the SF-36 (Short Form-36) Health Survey Scale | Baseline (mental score) | 34.0 score on a scale | Standard Deviation 6.1 |
| Placebo | Changes in the Quality of Life of Patients on the SF-36 (Short Form-36) Health Survey Scale | After 8 weeks (mental score) | 36.9 score on a scale | Standard Deviation 4.9 |
Comparison: Mean changes of SF-36 scores (physical health domain) after 8 weeks of treatment were compared.p-value: 0.65595% CI: [-2, 1.26]ANOVA
Comparison: Mean changes of SF-36 scores (mental health domain) after 8 weeks of treatment were compared.p-value: 0.37595% CI: [-0.79, 2.1]ANOVA
Secondary
Indicators of Therapeutic and Side Effects, Efficacy Index on CGI-EI (Clinical Global Impression-Efficacy Index) Scale
Indicators of therapeutic and side effects, efficacy index on the scale of the general clinical impression CGI-EI (Clinical Global Impression Scale - Efficacy Index) after 8 weeks from the start of study therapy. Clinical Global Impression Efficacy Index (CGI-EI) will be filled by the investigator at the final Visit 5 (Week 8±3 days). Evaluation of the response to treatment should take into account both therapeutic efficacy and treatment-related side effects. Side effects value from 1 to 4. Therapeutic effect value as 0,4,8 or 12 points. The efficacy index is a sum. The minimum value is 1, the maximum value is 16. A lower score on the scales is the best outcome.
Time frame: After 8 weeks of the treatment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Kolofort | Indicators of Therapeutic and Side Effects, Efficacy Index on CGI-EI (Clinical Global Impression-Efficacy Index) Scale | Side effects | 1.09 units on a scale | Standard Deviation 0.31 |
| Kolofort | Indicators of Therapeutic and Side Effects, Efficacy Index on CGI-EI (Clinical Global Impression-Efficacy Index) Scale | Therapeutic effect | 2.67 units on a scale | Standard Deviation 2.96 |
| Kolofort | Indicators of Therapeutic and Side Effects, Efficacy Index on CGI-EI (Clinical Global Impression-Efficacy Index) Scale | Efficacy index | 3.76 units on a scale | Standard Deviation 2.98 |
| Placebo | Indicators of Therapeutic and Side Effects, Efficacy Index on CGI-EI (Clinical Global Impression-Efficacy Index) Scale | Side effects | 1.04 units on a scale | Standard Deviation 0.19 |
| Placebo | Indicators of Therapeutic and Side Effects, Efficacy Index on CGI-EI (Clinical Global Impression-Efficacy Index) Scale | Therapeutic effect | 3.33 units on a scale | Standard Deviation 3.49 |
| Placebo | Indicators of Therapeutic and Side Effects, Efficacy Index on CGI-EI (Clinical Global Impression-Efficacy Index) Scale | Efficacy index | 4.37 units on a scale | Standard Deviation 3.51 |
Comparison: Side effects analysis.p-value: 0.08Wilcoxon (Mann-Whitney)
Comparison: Therapeutic effectp-value: 0.139Wilcoxon (Mann-Whitney)
Comparison: Efficacy index analysis.p-value: 0.251Wilcoxon (Mann-Whitney)
Secondary
Percentage of Patients Terminating the Study Early
Percentage of patients terminating the study early due to lack of efficacy of the study therapy. Lack of efficacy of the study therapy is defined as retention or progression of the symptoms of functional dyspepsia resulting in prescription of the products for FD therapy (proton pump inhibitors, prokinetics, spasmolytics).
Time frame: in 8 weeks of the treatment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Kolofort | Percentage of Patients Terminating the Study Early | 0 Participants |
| Placebo | Percentage of Patients Terminating the Study Early | 1 Participants |
p-value: 1Fisher Exact
Secondary
Percentage of Patients With a Decrease in the Severity of FD Symptoms
Percentage of patients with a decrease in the severity of FD symptoms on the GIS scale after 8 weeks from the start of study therapy. The GIS scale is composed of 10 points evaluating the extent of manifestation of a wide range of gastroenterological symptoms. The intensity of clinical symptoms will be evaluated based on a 5-point Likert scale from 0 to 4 where 0 = no, 1 = mild, 2 = moderate, 3 = severe and 4 = very severe).
Time frame: After 8 weeks of the treatment
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Kolofort | Percentage of Patients With a Decrease in the Severity of FD Symptoms | Reduction ≥ 2 points | 145 Participants |
| Kolofort | Percentage of Patients With a Decrease in the Severity of FD Symptoms | Reduction ≥ 4 points | 133 Participants |
| Kolofort | Percentage of Patients With a Decrease in the Severity of FD Symptoms | Reduction ≥ 3 points | 138 Participants |
| Kolofort | Percentage of Patients With a Decrease in the Severity of FD Symptoms | Reduction ≥ 5 points | 121 Participants |
| Kolofort | Percentage of Patients With a Decrease in the Severity of FD Symptoms | Reduction ≥ 1 point | 150 Participants |
| Placebo | Percentage of Patients With a Decrease in the Severity of FD Symptoms | Reduction ≥ 5 points | 114 Participants |
| Placebo | Percentage of Patients With a Decrease in the Severity of FD Symptoms | Reduction ≥ 1 point | 151 Participants |
| Placebo | Percentage of Patients With a Decrease in the Severity of FD Symptoms | Reduction ≥ 2 points | 141 Participants |
| Placebo | Percentage of Patients With a Decrease in the Severity of FD Symptoms | Reduction ≥ 3 points | 134 Participants |
| Placebo | Percentage of Patients With a Decrease in the Severity of FD Symptoms | Reduction ≥ 4 points | 125 Participants |
Comparison: Test for comparison percentage of patients with reduction ≥ 1 point.p-value: 0.067Fisher Exact
Comparison: Test for comparison percentage of patients with reduction ≥ 2 points.p-value: 0.029Fisher Exact
Comparison: Test for comparison percentage of patients with reduction ≥ 3 points.p-value: 0.082Fisher Exact
Comparison: Test for comparison percentage of patients with reduction ≥ 4 points.p-value: 0.046Fisher Exact
Comparison: Test for comparison percentage of patients with reduction ≥ 5 points.p-value: 0.111Fisher Exact