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Functional constipation (FC) is common with 14.3% estimated prevalence in Hong Kong, but treatment for this condition in conventional medicine is suboptimal. Complementary and alternative medicines, especially Chinese herbal medicine (CHM) are used frequently by patients with FC, but there is little research evidence about these commonly used CHM. The purpose of the study is evaluate the efficacy and safety of CHM, as well as determining the optimal dosage.
Functional constipation (FC) is a common complaint in clinical practice, with the estimated prevalence 14.3% in Hong Kong, as nearly affecting 1 million Hong Kong People in different extent. It is comparable with western population, which is 15% in North America. By the definition of Rome II criteria, FC comprises a group of functional disorders, which presents as persistent difficult, infrequent or seemingly incomplete defecation.
Constipation is often perceived to be benign, easily treated condition with short-term treatment being relatively straightforward. However, the fact is the management of FC is perplexed as some subjects complain of constipation more than decade. Moreover, chronic constipation can develop into more serious bowel complaints, such as faecal impaction, incontinence and bowel perforations. There is also accumulating evidence shown that constipated subjects have significantly higher anxiety and depression scores and lower quality of life. Therefore, the demand of effective agents to normalize bowel function is extremely large.
Conventional treatment for constipation mainly relies on dietary fibre and laxatives. Although there is no credible evidence that any serious problem is associated with their prolonged use, the treatment of it has been suboptimal. First, a recent systematic review pointed out that there were paucity of trials for many commonly used agents, therefore, their use might not be well validated. Second, many patients with severe constipation do not respond adequately or lose of effectiveness after a short period of time. Third, many patients who intake dietary fibre complain of flatulence, distension, bloating and poor taste. As a result, the compliance is low as about 50%. Fourth, the use of osmotic laxatives, such as polyethylene glycol, become increasingly popular due to fewer side effects and better taste, however, the prices are much more expensive than other medications. Many constipation sufferers seek help from alternative medicine, especially from Chinese herbal medicine. For example, according to a telephone survey in Hong Kong, more than 85% of constipated subjects seek for coping strategies, such as asking for medical consultations, taking prescribed medicine and seeking for alternative therapy, involving Chinese medicine.
Traditional Chinese medicine (TCM) is particularly attractive as their effectiveness in treating functional disorders and retaining balance of body functions. The CHM used in study is derived from classic text of Chinese medicine (Shang Han Lun, Discussion of Cold-induced Disorders), which can "moisten the intestines, drain heat, promote the movement of qi and unblock the bowel".
It is well known that randomized controlled trial (RCT) is the gold standard to test the efficacy of intervention, thus in this project, we attempt to follow the basic requirements of RCT to testify the efficacy and safety of CHM on FC, as well as to determine the optimal dosage. We believe such study will benefit the advancement of CHM, or even as the foundation of research study in future.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MaZiRenWan (MZRW) Low dose | Experimental | MaZiRenWan (MZRW) Low dose 2.5g sachet by mouth, twice daily for 8 weeks |
|
| MaZiRenWan (MZRW) Median dose | Experimental | MaZiRenWan (MZRW) Median dose 5.0g sachet by mouth, twice daily for 8 weeks |
|
| MaZiRenWan (MZRW) High dose | Experimental | MaZiRenWan (MZRW) High dose 7.5g sachet by mouth, twice daily for 8 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MaZiRenWan (MZRW) Low dose | Drug | Dissolved MaZiRenWan (MZRW) granule (2.5g/sachet) in 150 ml hot water, take orally twice daily for 8 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Responder for Complete Spontaneous Bowel Movement (CSBM) | Participants with a mean increase of CSBM>=1 movement per week compared with the last 14 days of the run-in period were defined as responders.CSBM referred to the feeling that defecation led to complete passage of stool rather than partial or incomplete evacuation without the use of any laxative or enema within 24 hours. | Week3-10 |
| Measure | Description | Time Frame |
|---|---|---|
| Responder for Complete Spontaneous Bowel Movement (CSBM) | Participants with a mean increase of CSBM>=1 movement per week compared with the last 14 days of the run-in period were defined as responders. CSBM referred to the feeling that defecation led to complete passage of stool rather than partial or incomplete evacuation without the use of any laxative or enema within 24 hours. | Week11-18 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| ZhaoXiang Bian, PhD | Hong Kong Baptist University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hong Kong Baptist University Chinese Medicine Clinic | Hong Kong | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21045817 | Result | Cheng CW, Bian ZX, Zhu LX, Wu JC, Sung JJ. Efficacy of a Chinese herbal proprietary medicine (Hemp Seed Pill) for functional constipation. Am J Gastroenterol. 2011 Jan;106(1):120-9. doi: 10.1038/ajg.2010.305. Epub 2010 Nov 2. |
| Label | URL |
|---|---|
| Abstract | View source |
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177 patients were screened; of these 80 patients were excluded due to not meeting inclusion criteria (68 cases), refused to participate (6 cases) and lost to follow up (6 cases).
All constipated patients (aged 18-65) who presented to the Chinese Medicine Clinics of School of Chinese Medicine, Hong Kong Baptist University from October 2006 to May 2007 were refered.
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| ID | Title | Description |
|---|---|---|
| FG000 | Low Dose Group | MaZiRenWan (MZRW) 2.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks. |
| FG001 | Median Dose Group | MaZiRenWan (MZRW) 5.0g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks. |
| FG002 | High Dose Group | MaZiRenWan (MZRW) 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Low Dose Group | MaZiRenWan (MZRW) 2.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks. |
| BG001 | Median Dose Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Responder for Complete Spontaneous Bowel Movement (CSBM) | Participants with a mean increase of CSBM>=1 movement per week compared with the last 14 days of the run-in period were defined as responders.CSBM referred to the feeling that defecation led to complete passage of stool rather than partial or incomplete evacuation without the use of any laxative or enema within 24 hours. | Statistical analysis was performed on the population being randomized and receiving allocated intervention. Missing values were imputed by the method of last observation carried forward. | Posted | Number | participants | Week3-10 |
|
18 weeks
Within the whole study period
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Low Dose Group | MaZiRenWan (MZRW) 2.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain/cramping or bloating | Gastrointestinal disorders | Other | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. Zhao-xiang Bian | Hong Kong Baptist University | (852) 3411 2905 | bzxiang@hkbu.edu.hk |
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| ID | Term |
|---|---|
| D003248 | Constipation |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000591093 | ma zi ren wan |
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|
| MaZiRenWan (MZRW) Median dose | Drug | Dissolved MaZiRenWan (MZRW) granule (5.0g/sachet) in 150 ml hot water, take orally twice daily for 8 weeks |
|
|
| MaZiRenWan (MZRW) High dose | Drug | Dissolved MaZiRenWan (MZRW) granule (7.5g/sachet) in 150 ml hot water, take orally twice daily for 8 weeks |
|
|
| Bowel Movement | Baseline(Week1-2), Within treatment(Week3-10) & Within follow-up(Week11-18) |
| Complete Spontaneous Bowel Movement (CSBM) | CSBM referred to the feeling that defecation led to complete passage of stool rather than partial or incomplete evacuation without the use of any laxative or enema within 24 hours. | Baseline(Week1-2), Within treatment(Week3-10) & Within follow-up(Week11-18) |
| Global Symptoms Improvement | Participants were asked to rate their impression of change in constipation by comparing with their baseline (Wk2) at the visits during the treatment (Wk6), end of treatment (Wk10) and end of follow-up (Wk18) with scores from 0 to 6 represented markedly worse or better respectively. The response categories were collapsed to simply "improved" for score 4 to 6, "same" for score 3 or "worse" for score 0 to 2. | Week6, 10 & 18 |
| Severity of Constipation | It was a 7-point ordinal scale from 0=not at all to 6=very severe. | Baseline(Week2), Within treatment(Week6), End of treatment(Week10) & End of follow-up(Week18) |
| Sensation of Straining | It was a 7-point ordinal scale from 0=not at all to 6=very severe. | Baseline(Week2), Within treatment(Week6), End of treatment(Week10) & End of follow-up(Week18) |
| Incomplete of Evacuation | It was a 7-point ordinal scale from 0=not at all to 6=very severe. | Baseline(Week2), Within treatment(Week6), End of treatment(Week10) & End of follow-up(Week18) |
| Sensation of Bloating | It was a 7-point ordinal scale from 0=not at all to 6=very severe. | Baseline(Week2), Within treatment(Week6), End of treatment(Week10) & End of follow-up(Week18) |
| Sensation of Abdominal Pain/Cramping | It was a 7-point ordinal scale from 0=not at all to 6=very severe. | Baseline(Week2), Within treatment(Week6), End of treatment(Week10) & End of follow-up(Week18) |
| Passing of Gas | It was a 7-point ordinal scale from 0=not at all to 6=very severe. | Baseline(Week2), Within treatment(Week6), End of treatment(Week10) & End of follow-up(Week18) |
| Adverse Effects (e.g. Renal and Liver Function Tests) | pre-treatment & post-treatment |
| Blood Urea Level | Pre-treatment(Week2) & Post-treatment(Week10) |
| Blood Creatinine Level | Pre-treatment(Week2) & Post-treatment(Week10) |
| Serum Glutamic Pyruvic Transaminase(SGPT) Level | Pre-treatment(Week2) & Post-treatment(Week10) |
| Serum Glutamic Oxaloacetic Transaminase(SGOT) Level | Pre-treatment(Week2) & Post-treatment(Week10) |
| Lack of Efficacy |
|
| Lost to Follow-up |
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| Withdrawal by Subject |
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| Physician Decision |
|
MaZiRenWan (MZRW) 5.0g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
| BG002 | High Dose Group | MaZiRenWan (MZRW) 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Duration of constipation | Mean | Standard Deviation | years |
|
| Bowel Movement | Mean | Standard Deviation | movements per week |
|
| Complete Spontaneous Bowel Movement (CSBM) | CSBM referred to the feeling that defecation led to complete passage of stool rather than partial or incomplete evacuation without the use of any laxative or enema within 24 hours. | Mean | Standard Deviation | movements per week |
|
| No. of days taking rescue therapy | Any medications, including laxatives, enemas and Chinese herbal medicine, for facilitating bowel movements. | Mean | Standard Deviation | days per week |
|
| Severity of Constipation | It was a 7-point ordinal scale from 0=not at all to 6=very severe. | Mean | Standard Deviation | Units on a scale |
|
| OG001 |
| Median Dose Group |
MaZiRenWan (MZRW) 5.0g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks. |
| OG002 | High Dose Group | MaZiRenWan (MZRW) 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks. |
|
|
|
| Secondary | Responder for Complete Spontaneous Bowel Movement (CSBM) | Participants with a mean increase of CSBM>=1 movement per week compared with the last 14 days of the run-in period were defined as responders. CSBM referred to the feeling that defecation led to complete passage of stool rather than partial or incomplete evacuation without the use of any laxative or enema within 24 hours. | Statistical analysis was performed on the population being randomized and receiving allocated intervention. Missing values were imputed by the method of last observation carried forward. | Posted | Number | participants | Week11-18 |
|
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| Secondary | Bowel Movement | Statistical analysis was performed on the population being randomized and receiving allocated intervention. Missing values were imputed by the method of last observation carried forward. | Posted | Mean | Standard Deviation | movements per week | Baseline(Week1-2), Within treatment(Week3-10) & Within follow-up(Week11-18) |
|
|
|
|
| Secondary | Complete Spontaneous Bowel Movement (CSBM) | CSBM referred to the feeling that defecation led to complete passage of stool rather than partial or incomplete evacuation without the use of any laxative or enema within 24 hours. | Statistical analysis was performed on the population being randomized and receiving allocated intervention. Missing values were imputed by the method of last observation carried forward. | Posted | Mean | Standard Deviation | movements per week | Baseline(Week1-2), Within treatment(Week3-10) & Within follow-up(Week11-18) |
|
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| Secondary | Global Symptoms Improvement | Participants were asked to rate their impression of change in constipation by comparing with their baseline (Wk2) at the visits during the treatment (Wk6), end of treatment (Wk10) and end of follow-up (Wk18) with scores from 0 to 6 represented markedly worse or better respectively. The response categories were collapsed to simply "improved" for score 4 to 6, "same" for score 3 or "worse" for score 0 to 2. | Statistical analysis was performed on the population being randomized and receiving allocated intervention. Missing values were imputed by the method of last observation carried forward. | Posted | Number | participants | Week6, 10 & 18 |
|
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| Secondary | Severity of Constipation | It was a 7-point ordinal scale from 0=not at all to 6=very severe. | Statistical analysis was performed on the population being randomized and receiving allocated intervention. Missing values were imputed by the method of last observation carried forward. | Posted | Mean | Standard Deviation | Units on a scale | Baseline(Week2), Within treatment(Week6), End of treatment(Week10) & End of follow-up(Week18) |
|
|
|
|
| Secondary | Sensation of Straining | It was a 7-point ordinal scale from 0=not at all to 6=very severe. | Statistical analysis was performed on the population being randomized and receiving allocated intervention. Missing values were imputed by the method of last observation carried forward. | Posted | Mean | Standard Deviation | Units on a scale | Baseline(Week2), Within treatment(Week6), End of treatment(Week10) & End of follow-up(Week18) |
|
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| Secondary | Incomplete of Evacuation | It was a 7-point ordinal scale from 0=not at all to 6=very severe. | Statistical analysis was performed on the population being randomized and receiving allocated intervention. Missing values were imputed by the method of last observation carried forward. | Posted | Mean | Standard Deviation | Units on a scale | Baseline(Week2), Within treatment(Week6), End of treatment(Week10) & End of follow-up(Week18) |
|
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| Secondary | Sensation of Bloating | It was a 7-point ordinal scale from 0=not at all to 6=very severe. | Statistical analysis was performed on the population being randomized and receiving allocated intervention. Missing values were imputed by the method of last observation carried forward. | Posted | Mean | Standard Deviation | Units on a scale | Baseline(Week2), Within treatment(Week6), End of treatment(Week10) & End of follow-up(Week18) |
|
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| Secondary | Sensation of Abdominal Pain/Cramping | It was a 7-point ordinal scale from 0=not at all to 6=very severe. | Statistical analysis was performed on the population being randomized and receiving allocated intervention. Missing values were imputed by the method of last observation carried forward. | Posted | Mean | Standard Deviation | Units on a scale | Baseline(Week2), Within treatment(Week6), End of treatment(Week10) & End of follow-up(Week18) |
|
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| Secondary | Passing of Gas | It was a 7-point ordinal scale from 0=not at all to 6=very severe. | Statistical analysis was performed on the population being randomized and receiving allocated intervention. Missing values were imputed by the method of last observation carried forward. | Posted | Mean | Standard Deviation | Units on a scale | Baseline(Week2), Within treatment(Week6), End of treatment(Week10) & End of follow-up(Week18) |
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| Secondary | Adverse Effects (e.g. Renal and Liver Function Tests) | Not Posted | Mean | Standard Deviation | pre-treatment & post-treatment |
| Secondary | Blood Urea Level | Statistical analysis was performed on the population being randomized and receiving allocated intervention. Missing values were imputed by the method of last observation carried forward. | Posted | Mean | Standard Deviation | mmol/L | Pre-treatment(Week2) & Post-treatment(Week10) |
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| Secondary | Blood Creatinine Level | Statistical analysis was performed on the population being randomized and receiving allocated intervention. Missing values were imputed by the method of last observation carried forward. | Posted | Mean | Standard Deviation | μmol/L | Pre-treatment(Week2) & Post-treatment(Week10) |
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| Secondary | Serum Glutamic Pyruvic Transaminase(SGPT) Level | Statistical analysis was performed on the population being randomized and receiving allocated intervention. Missing values were imputed by the method of last observation carried forward. | Posted | Mean | Standard Deviation | U/L | Pre-treatment(Week2) & Post-treatment(Week10) |
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| Secondary | Serum Glutamic Oxaloacetic Transaminase(SGOT) Level | Statistical analysis was performed on the population being randomized and receiving allocated intervention. Missing values were imputed by the method of last observation carried forward. | Posted | Mean | Standard Deviation | U/L | Pre-treatment(Week2) & Post-treatment(Week10) |
|
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|
| 0 |
| 32 |
| 10 |
| 32 |
| EG001 | Median Dose Group | MaZiRenWan (MZRW) 5.0g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks. | 0 | 32 | 10 | 32 |
| EG002 | High Dose Group | MaZiRenWan (MZRW) 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks. | 0 | 32 | 14 | 32 |
| Upper gastro-intestinal discomfort | Gastrointestinal disorders | Other | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | Other | Systematic Assessment |
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| Disturbance of menstruation | Reproductive system and breast disorders | Other | Non-systematic Assessment |
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| Puffy face | Skin and subcutaneous tissue disorders | Other | Non-systematic Assessment |
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| Increase body odor | General disorders | Other | Non-systematic Assessment |
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| Urinary frequency | Renal and urinary disorders | Other | Non-systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | Other | Non-systematic Assessment |
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| Title | Measurements |
|---|---|
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| Wk11-18 |
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| Week11-18 |
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| Title | Measurements |
|---|---|
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| Week6-Worse |
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| Week10-Improved |
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| Week10-Same |
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| Week10-Worse |
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| Week18-Improved |
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| Week18-Same |
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| Week18-Worse |
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| Week10 |
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| Week18 |
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| Week10 |
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| Week18 |
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| Week10 |
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| Week18 |
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| Week10 |
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| Week18 |
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| Week10 |
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| Week18 |
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| Week10 |
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| Week18 |
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