ABSTRACT
Introduction:
Functional bowel disorders (FBD) are chronic, recurrent, debilitating disorders affecting the mid or lower gastrointestinal tract with no identifiable underlying pathology. There is a dearth of Indian studies focusing on treatment awareness and prescription evaluation in FBD. Due to chronic course, patients tend to self-medicate. The study was planned to evaluate disease and drug treatment awareness, self-medication practices, and prescription patterns in FBD patients.
Materials and Methods:
A cross-sectional, single-center, questionnaire-based study was carried out on FBD patients after getting clearance from the Institutional Ethics Committee. The patients were administered two questionnaires, i.e. disease/drug awareness and self-medication questionnaire. Prescriptions were analyzed based on World Health Organization prescribing indicators.
Results:
A total of 118 FBD patients were enrolled and the common disorder was functional constipation (94/118, 79.7%). Number of males (77/118, 65%) was greater than females (41/118, 34%). In disease awareness (98/118, 83%), patients opined that FBD occurs frequently and agreed that medications can treat FBD. In treatment awareness (106/118, 90%), patients were aware about the importance of drug compliance, but only (10/118, 9%) knew the adverse effects. In prescription patterns, a total of 311 medications were prescribed. A total of 173 medications were primary drugs for FBD. Laxatives were the common class (98/138, 68.9%) prescribed with polyethylene glycol (77/138, 55.7%) as the most common drug prescribed for functional constipation. A total of 28/118 (23.7%) patients’ self-medicated prior to visiting the current OPD.
Conclusions:
FBD patients were aware of the dosing schedule and consulted their treating doctor but awareness regarding drug name, and adverse effects was poor among the patients. Laxative-polyethylene glycol was the common drug prescribed. Only less than 1/4th of patients resorted to self-medication commonly with herbal remedies.
KEY WORDS: Abdominal pain, constipation, diarrhea, polyethylene glycol, questionnaire
Introduction
Functional bowel disorders (FBDs) are chronic, recurrent, frequently debilitating disorders affecting the mid or lower gastrointestinal tract with no identifiable underlying pathology.[1] It is characterized by a typical constellation of symptoms for a duration of at least 3 months and the exclusion of other diseases that could adequately account for the symptoms.[2]
Prevalence of FBD is 4.4–4.8% for irritable bowel syndrome (IBS), 7.9–8.6% for functional constipation, and 3.6–5.3% for functional diarrhea.[3] Studies show that the prevalence of FBDs in India ranges from 2.7% to 21.7%, with conditions like functional constipation and IBS being common.[4] FBD occurs due to a complex interplay between biological, psychological, and social factors.[5]
Diarrhea and constipation are the most common symptoms seen in FBD. The treatment strategy of FBD depends on the severity of the disease which involves psychosocial, psychological, and lifestyle support like reassurance, education, dietary advice, and drug therapy with antispasmodics, antidiarrhoeals, bile acid binders, newer gut serotonin modulators, osmotic agents like polyethylene glycol, probiotics, rifaximin.[6,7] Adherence to pharmacological/nonpharmacological treatment is crucial to control the disease symptoms of FBD (constipation or diarrhea) and ensure that the patient is symptom-free with better quality of life. Lack of awareness regarding lifestyle measures and drug treatment affects adherence. There is a dearth of Indian studies focusing on treatment awareness in these FBD patients.[8] Apart from a prescription evaluation study by Trinkley et al.,[9] no other Indian studies on drug use patterns in FBD patients exist. In addition, FBD has a chronic course, and sometimes due to the patient’s dissatisfaction or unresponsiveness to drugs; these patients have a tendency to self-medicate and consume nonspecific drugs in their attempt to manage symptoms.[10,11] This study was planned to evaluate patient awareness of disease and drug treatment, prescription patterns, and self-medication practices in patients of FBD.
Materials and Methods
This cross-sectional, single-center, and questionnaire-based study was conducted by the Department of Pharmacology and Therapeutics in collaboration with the Gastroenterology Department at a tertiary care teaching hospital. The study was carried out from January 2020 to June 2021. Permission from the Institutional Ethics Committee was obtained, and the study was registered with the Clinical Trials Registry of India prior to the enrollment of patients. Patients of either gender between the age group of 18–65 years attending gastroenterology OPD for treatment of FBD diagnosed as per Rome IV criteria were included. Patients carrying treatment records (of at least 3 months) and providing written informed consent were enrolled in the study. Newly diagnosed and treatment-naive patients or patients admitted in the gastroenterology IPD/emergency department were excluded. Patients with a concomitant history of peptic ulcer, inflammatory bowel disorders, or a history of substance dependence or abuse were also excluded. Patients were selected using the convenience-based sampling technique. Taking into account the general load of FBD patients in the weekly gastroenterology OPD at the study center, approximately 5 to 6 FBD patients per month visited the gastroenterology OPD. Thus, using a convenient sampling technique based on duration of study (18 months) the study was expected to enroll 90 to 108 FBD patients in that time period.
The demographic details of the patients, including age, gender, occupation, education, and socioeconomic status (as per Kuppuswamy scale), were recorded in the case record form (CRF). Prescriptions were scrutinized for completeness and incompleteness of data in terms of dose, dosage form, frequency, duration (weeks/month), or dosage instructions. The patients were then asked questions sequentially from two prevalidated questionnaires, i.e., the disease and drug awareness questionnaire and a self-medication questionnaire, which were developed by the study team. The questionnaires were validated by eight experts (n = 6 from the pharmacology department, n = 1 from the community medicine department, and n = 1 from the general medicine department).[12] The mean content validity ratio (CVR, according to Lawshe’s rule, with eight experts, the CVR must be >0.75) of the self-medication questionnaire as a whole was 1, the drug awareness questionnaire was 1, and the disease awareness questionnaire was 0.97. The awareness questionnaire for patients consisted of two parts. Part A was on disease awareness consisting of nine questions out of which five were yes/no type questions, and four were MCQ type, grouped under five domains (i.e., 1 – Occurrence of disease, 2 – Fear/Concern regarding FBD, 3 – Etiology, 4 – Symptom, 5 – Treatment). Part B was on drug awareness, which consisted of 13 questions with responses as Yes/No/Cannot say. These 13 questions were grouped under six domains (i.e., 1 – Current prescription, 2 – Factors affecting drugs and their doses, 3 – Dosing schedule and its importance, 4 – Importance of doctor–patient interaction, 5 – Side effects, 6 – Long-term treatment). These questions were scored as + 1 for ‘Yes’ answer and ‘No/cannot say’ answer was scored as 0. Self-medication questionnaire consisted of 17 questions out of which eight were Yes/No type response questions and nine were multiple options response type.
The data obtained from CRF and questionnaires were entered in Microsoft Excel and analyzed using descriptive statistics with IBM SPSS software, version 26. The categorical data expressed as proportions and quantitative data was expressed as mean with standard deviation (SD). A correlation analysis was performed between the drug treat awareness score, socioeconomic status and education. All the patients answered the questions of the questionnaires asked by the investigators; hence, there was no missing data. The prescriptions were analyzed based on the World Health Organization prescribing indicators. Prescribed daily dose/defined daily dose (PDD/DDD) calculation was performed for all the prescribed FBD drugs as per the WHO criteria.
Results
A total of 118 patients were enrolled in this study. The number of males (77/118, 65%) was greater than the number of females (41/118, 34%). Mean age of the patients was 42.82 ± 12.86 years (Mean ± SD). According to Modified Kuppuswamy Scale, majority of patients belonged to the upper lower (62/118, 52.5%) and lower middle (34/118, 28.8%) socioeconomic status. Majority patients had completed middle school education (40/118, 33.9%) followed by the patients who had completed high school education (31/118, 26.3%).
The most common type of FBD was functional constipation, i.e., 94/118 patients (79.7%) followed by IBS, i.e., in 14/118 (11.9%) patients, and 10/118 (8.5%) patients were diagnosed with functional diarrhea. A total of 38/94 (40.4%) patients of functional constipation and 3/10 patients of functional diarrhea had concomitant symptom of functional dyspepsia.
The responses for disease awareness in FBD patients were as follows: Domain I (Occurrence of Disease): 98/118, (83%) patients opined that FBD occurs frequently. Domain II (Fear/Concern regarding FBD): 63/118 (53.3%) patient stated symptoms of FBD once developed will remain lifelong while 60/118 (50.8%) patients mentioned that it increases risk of colon/rectum cancer. A total of 58/118 (49.2%) patients opined that FBD shortens the life span. Domain III (Etiology): 102/118 (86.4%) patients agreed that dietary factors are a cause of FBD, while only 34/118 (28.8%) agreed to genetic factors as cause. A total of 58/118 (49.2%) patients stated anxiety/depression as cause of FBD, while 47/118 (40%) patients attributed FBD to environmental exposure. Domain IV (Symptom): 47/118 (39.8%) patients stated that abdominal pain is most common complaint followed by constipation in 41/118 (34.7%) patients. Domain V (Treatment): 98/118 (83%) patients agreed that medications can treat FBD, while only 35/118 (29.7%) agreed counseling is important for treatment of FBD. A total of 117/118 patients agreed that it is important to consult a doctor for FBD of which 63/118 (53%) patients preferred a specialist doctor for consultation, while 54 (46%) patients preferred general practitioner), while only one patient disagreed.
The drug treatment awareness questionnaire – domain-wise and item-wise responses of the patients have been depicted in Table 1. A total of 75/118 patients answered correctly about the number of medicines prescribed to them. On questioning further, only 12/45 (26.6%) patients could correctly tell the names of all medicines. Most common side effect that patients were aware about included dizziness (n = 4), dry eyes and mouth (n = 3), abdominal pain and discomfort, bloating, constipation, and kidney failure (n = 1 each). Mean score of the 118 patients who were administered the treatment awareness questionnaire was 10.55 ± 2.49. No significant co-relation with demographic variables (gender r = 0.2, P = 0.45; socioeconomic status r = 0.6, P = 0.18; and education r = 0.4, P = 0.24 using spearman correlation test) and awareness score was detected. Total treatment awareness score and domain-wise awareness score are depicted in Table 2.
Table 1.
FBD patients’ responses to various items of the treatment awareness questionnaire
| Sr. No. | Treatment awareness questionnaire item | Total patients (n=118) | ||
|---|---|---|---|---|
|
| ||||
| Yes | No | Cannot say | ||
| Domain I Current prescription | Do you know about the medicines that have been written on the prescription today? | 76 (64.4%) | 42 (35.5%) | 0 |
| 1.1. | Do you know the number of medicines that have been written on the prescription today? | 76 (64.4%) | 42 (35.5%) | 0 |
| 1.2. | Do you know the names of medicines that have been written on the prescription today? | 45 (38.1%) | 73 (61.8%) | 0 |
| 1.3. | Do you know the reason for which you have been given each of these medicines? | 66 (55.9%) | 52 (44%) | 0 |
| 1.4. | Do you know the dosing frequency of medicines prescribed to you today? | 72 (61%) | 46 (38.9%) | 0 |
| Domain II Factors affecting drugs/doses | 2. Do you continue to take the medicines after your symptoms get improved? | 58 (49.1%) | 58 (49.1%) | 2 (1.6%) |
| 3. | Do you continue to take the same dose of drugs if your symptoms/disease get severe? | 27 (23%) | 80 (67.7%) | 11 (9.3%) |
| 4. | Do you continue to take the medicines for functional bowel disorder in the presence of other illness? | 104 (88.1%) | 10 (8.4%) | 4 (3.3%) |
| 5. | Is it important to consult your doctor before taking any concurrent medications? | 117 (99.1%) | 0 | 1 (0.8%) |
| Domain III Dosing schedule importance | 6. Is it important to follow a dosing schedule? | 116 (98.3%) | 2 (1.6%) | 0 |
| 7. | Have you skipped your medication in the past 1 month? | 92 (77.9%) | 26 (22%) | 0 |
| Domain IV Doctor–patient interaction | 8. Do you know when is your next follow -up? | 99 (83.9%) | 19 (16.1%) | 0 |
| 9. | Is it important to keep a regular follow-up with the consulting physicians? | 107 (90.6%) | 4 (3.3%) | 7 (5.9%) |
| Domain V Side effects | 10. Can drugs given to you cause undesired side effects? | 11 (9.3%) | 107 (90.7%) | 0 |
| 11. | If you experience side effects, will you report the side effects to your doctor? | 110 (93.2%) | 2 (1.7%) | 6 (5.1%) |
| 12. | Do you know that you may need separate treatment to manage the side effects? | 105 (89%) | 7 (5.9%) | 6 (5.1%) |
| Domain VI Requirement of long-term treatment | 13. Do you know that you may need to take medications for a long time? | 58 (49.2%) | 39 (33.1%) | 21 (17.8%) |
Table 2.
Drug treatment mean scores obtained on the FBD patient drug awareness questionnaire (n=118)
| Domains (minimum score to maximum score) | Mean score obtained by patients (mean±standard deviation) |
|---|---|
| Domain I: Current prescription domain (0 to 5) | 2.19±1.75 |
| Domain II: Factors affecting drugs and their doses (0 to 4) | 2.44±0.84 |
| Domain III: Dosing schedule and its importance (0 to 2) | 1.76±0.42 |
| Domain IV: Importance of doctor–patient interaction (0 to 2) | 1.74±0.57 |
| Domain V: Side effects domain (0 to 3) | 1.91±0.57 |
| Domain VI: Long-term treatment required in Functional Bowel Disorder (0 to 1) | 0.49±0.5 |
| Overall questionnaire score (0 to 17) | 10.55±2.49 |
The analysis of prescription pattern is depicted in Table 3. A total of 311 medications were prescribed in 118 prescriptions. Among the 311 medications, 173 medications were primary drugs prescribed for FBD, while 138 medications were concomitant drugs. Out of these 173 drugs for FBD, 138 drugs were prescribed for patients of functional constipation (n = 94), 25 drugs in IBS patients (n = 14), and 10 drugs for patients with functional diarrhea (n = 10)
Table 3.
Analysis of prescriptions of FBD patients using WHO prescribing indicators
| Prescribing indicators | Results |
|---|---|
| Number of prescriptions | 118 |
| Total drugs prescribed | 311 |
| Average number of drugs per encounter | 2.41±0.77 (Mean±SD) |
| Total number of drugs for FBD | 173 |
| Percentage of drugs prescribed by generic name | 89.4% |
| Percentage of drugs prescribed from the national essential drugs list | 37.3% |
| Percentage of drugs prescribed from the WHO essential drugs list | 22.2% |
Laxatives (95/138, 68.8% with polyethylene glycol 77/138, 55.8% being the most prescribed laxative) were the most common class of drugs prescribed for functional constipation patients. Similarly, Loperamide (4/10) was the most common drug prescribed for functional diarrhea patients. Loperamide (7/25.28%) and Amitriptyline (7/25.28%) were the most common drugs prescribed for IBS patients. The distribution of drugs prescribed in functional constipation, IBS, and functional diarrhea are depicted in Table 4. Common concomitant drugs prescribed were pantoprazole (60/138, drugs 43.9%) followed by rabeprazole (35/138, 25%) and multivitamin (11/138,7.7%).
Table 4.
Class-wise distribution of drugs prescribed in FBD patients
| Drug class prescribed in patients with functional constipation | Drugs prescribed in patients with functional constipation | Frequency (%) of the drug prescribed (138 drugs prescribed in 94 patients) |
|---|---|---|
| Laxatives | Polyethylene glycol | 77/138 (55.8) |
| Lactulose | 7/138 (5.1) | |
| Liquid paraffin | 4/138 (2.9) | |
| Bisacodyl | 3/138 (2.2) | |
| Ispaghula | 2/138 (1.4) | |
| Lactitol monohydrate | 2/138 (1.4) | |
| Serotonin Receptor Agonist | Prucalopride | 20/138 (14.5) |
| Antidepressants | Escitalopram | 13/138 (9.4) |
| Antispasmodics | Drotaverine hydrochloride | 6/138 (4.3) |
| Mebeverine | 3/138 (2.2) | |
| Diltiazem | 1/138 (0.7) | |
|
| ||
| Drug class prescribed in patients with IBS | Drugs prescribed in patients with IBS | Frequency (%) of drug prescribed (25 drugs prescribed in 14 IBS patients) |
|
| ||
| Antidepressant | Amitriptyline | 7/25 (28) |
| Antidiarrheal agents | Loperamide | 7/25 (28) |
| Laxatives | Ispaghula | 3/25 (12) |
| Polyethylene glycol | 2/25 (8) | |
| Antispasmodics | Mebeverine | 3/25 (12) |
| Drotaverine | 1/25 (4) | |
| Antibiotics | Albendazole | 2/25 (8) |
|
| ||
| Drug class prescribed in patients with functional diarrhea | Drugs prescribed in patients with functional diarrhea | Frequency of drugs prescribed (10 drugs prescribed in 10 patients with functional diarrhea) |
|
| ||
| Antimotility agents | Loperamide | 4 |
| Probiotics | Lactobacillus supplement | 3 |
| Antibiotics | Rifaximin+Metronidazole | 3 |
Majority of the prescriptions (74/118, 62.71%) were complete. Among 44/118 incomplete prescriptions, 33 prescriptions were incomplete in terms of instructions related to diet, lifestyle modification, and how to take the medication, five prescriptions for frequency of dosage (11.4%), and in six prescriptions, duration was missing. PDD/DDD ratio was found to be highest for lactulose (1.49) and lowest for Loperamide (0.2). The ratio was found to be 1 for Bisacodyl, Lactitol Monohydrate, Albendazole, Escitalopram, Prucalopride.
Regarding self-medication practices in patients of FBD, 28/118 (23.7%) patients had self-medicated prior visiting the current OPD. Out of the 28 self-medicated patients, 13 patients had self-medicated only once, while seven patients did not remember the number of times they self-medicated. A total of 22 patients self-medicated for constipation, two patients for bloating, and four patients for diarrhea. The details of self-medicating drugs have been stated in Table 5. In 21 patients, the most common reason for self-medication was ‘convenience’, followed by ‘lack of trust on prescribing doctor’ in six patients. Only one patient answered ‘cost saving’ being the reason for self-medication. When asked about source of information about the dose of self-medicated drugs, six patients answered that they received information from the consulting pharmacist and internet, while five patients have guessed the dose by themselves. Majority of patients (25/28, 89.2%) stopped self-medicating after few days regardless of symptoms. A total of 9/28 (32.1%) patients experienced adverse effects (acidity = 7, diarrhea = 2). Out of 28 patients, 27 patients responded that self-medication is not acceptable practice. Out of 28 patients, 16 patients were not sure about self-treatment for FBD, while 11 patients answered that they cannot treat themselves.
Table 5.
Self-medicated drugs by FBD patients
| Category | Name of the self-medicated drug | Frequency (%) n=28 |
|---|---|---|
| Ayurvedic n=15 (53.6%) | Churan | 5 (17.9%) |
| Abhipath Churan | 2 (7.1%) | |
| Ram dev baba churan | 2 (7.1%) | |
| Triphala Churan | 2 (7.1%) | |
| Vaidyanath Kadha | 4 (14.2%) | |
| Ayurvedic + Allopathy n=5 (17.9%) | Tb. Pantoprazole + Domperidone (Enteric coated sustained release) + Kayam Churan | 2 (7.1%) |
| Tb. Ranitidine + Kayam Churan | 3 (10.7%) | |
| Allopathy n=4 (14.2%) | Tab. Pantoprazole Domperidone + Aluminum hydroxide, magnesium hydroxide, and dimethicone. | 1 (3.5%) |
| Tb. Ranitidine | 1 (3.5%) | |
| Ispaghula | 2 (7.1%) | |
| Home remedy n=3 (10.7%) | Castor oil (Ricinus oil) | 3 (10.7%) |
| Don’t remember n=1 (3.5%) | - | 1 (3.5%) |
Discussion
FBD is a chronic and debilitating disorder with high non-responders to the treatment. Our study showed a male preponderance, in contrast to the studies conducted in the west where prevalence of IBS has been found to be more in females.[13] However, early studies conducted in India and Asia found a predominance of men over women because of male predominant society favoring easier access to medical services and cultural factors and also heterogeneity in number of available studies in different parts of world.[14,15]
In our study, functional constipation was found to be the most common subtype of FBD followed by IBS and functional diarrhea.
Our study depicts certain concerns and fear about the disease that affected the patient’s well-being. About half of the patients agree that FBD shortens the life span and increases the risk of colon cancer and symptoms once developed will never go away. Two European studies conducted by Caballero-Plasencia et al.[16] and van Dulmen et al.[17] reported that patients have similar concerns. More than 75% patients rely on medications and dietary changes as only treatment of FBD. Study by Brian E. Lacy et al.[8] and Linda Bjork Olafsdottir et al.[18] found that more than 50% patients believed that dietary changes could improve their symptoms, while 66% agreed that drug therapy is necessary, while only 27% agreed counseling as important part of treatment. Hence, there is need to educate people regarding benefits of counseling and finding an appropriate mental health professional to decrease health care cost as it will increase the patient adherence to treatment and improve the quality of life of these patients.
FBD patients were aware about the importance of follow-up and maintaining dosing schedule, but there was lack of awareness in terms of adverse effect of drugs and factors affecting drugs and their doses. Unawareness about adverse effects can refrain patients from continuing the drugs leading to non-adherence to therapy. While communicating the prescription, the patients are given significant information with regards to drug dosing, side effects, and follow-up, but patients may tend to forget this important information. Implementation of reinforcing strategies by the physicians which will help them to remember the entire drug schedule and help minimization of adverse effects is essential. Emphasis should be made on proper patient counseling by the treating physicians, and patient-oriented educational programs should be designed to alleviate the fears and concerns among these patients.
Our study found that greater number of drugs were from the national essential drugs list while lesser number of drugs were from the WHO essential drugs list. This may be because, the WHO list is not extensive enough to include all effective, latest and each and every medicine required in a given country and defines only the minimum needs for a basic health system.[19] Among the incomplete prescriptions, the incompleteness was in the terms of instructions regarding diet, exercise, and use of laxative powder followed by dose and duration. It is a common practice in the OPD to verbally instruct the patients and not possible to write everything on the prescription, given the time constraints and patient load. Among the concomitant medications proton pump inhibitors and multivitamins were most prescribed. This could be because of associated symptoms of dyspepsia in many patients in our study. Due to shared pathophysiologic mechanisms between the functional gastrointestinal disorders (FGIDs), patients with one FGID may also complain of corresponding symptoms of other FGIDs.[20] Evidence shows that there is high prevalence of overlap that is almost equal to 13–87% between functional dyspepsia and IBS.[21]
Our study also showed that the PDD/DDD ratio was less than 1 for antidepressants and antispasmodics. This is because the recommended daily dose of tricyclic antidepressants is below the psychiatric range to be effective in IBS.[22] Antispasmodics need to be prescribed for abdominal pain, and majority patients were of functional constipation which was best treated by laxatives; hence, antispasmodics were under prescribed. The ratio was found to be more than 1 for only lactulose. This can be explained by the fact that medium and high dose of lactulose is used routinely for treatment of constipation while low dose is used as prebiotic to stimulate the growth of bacteria in the gastrointestinal tract.[23]
It may be assumed that patients suffering from FBD may have a higher tendency to self-medicate, but in our study, it was found to be lesser. A study conducted in Iran found that patients with functional dyspepsia self-medicate more as compared to IBS which could be the reason for lesser self-medication practice in our study.[10] Ayurvedic drugs were most commonly self-medicated while, few patients used allopathic drugs like Ispaghula powder, Pantoprazole, and Ranitidine. This indicated that patients sought inappropriate medications like antacids for symptoms of constipation/bloating. This could be due to the lack of knowledge about the disease leading to inappropriate drug selection, thus increasing the risk of disease severity and potential adverse effects.[24] Hence, during every visit, reassurance, reinforcement of the instructions regarding prescribed drugs and counseling to avoid self-medication are crucial in FBD management.
Limitations: The study was conducted at the gastroenterology OPD of single tertiary care center; during the COVID pandemic; hence, generalizability of the results may be limited due to smaller sample size. The responses to both the questionnaires are based on the recall memory of the patients and hence possibility of recall bias exists.
Finally, to conclude, this study highlighted that FBD patients were aware that medications have to be taken regularly and but awareness regarding the adverse effects of drugs was very poor. Prescription patterns showed 62% (74/118) were complete prescriptions, with common medications varying by disorder type. Self-medication, driven mainly by convenience, predominantly involved Ayurvedic remedies as the self-medicating drug. Evaluation of interventions such as patient education programs to reinforce information about drug regimens and their adverse effects, avoidance of self-medication, and promotion of adherence is needed in the future.
Ethics committee approval
Permission from the Institutional Ethics Committee (EC/53/2019) of Seth GS Medical College and KEM Hospital, Mumbai was obtained, and the study was registered with Clinical Trials Registry of India [CTRI/2020/02/023661].
Conflicts of interest
There are no conflicts of interest.
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