Journal presentation homoeopathy .pptx

Journal presentation homoeopathy

1. COMPARING THE EFFECTIVENESS OF HYDRASTIS CANADENSIS MOTHER TINCTURE AGAINST CONSTITUTIONAL HOMOEOPATHIC MEDICINES IN TREATMENT OF PEDIATRIC CONSTIPATION: AN OPEN-LABEL, RANDOMIZED, EXPLORATORY, EQUIVALENCE, PILOT TRIAL Presented by, NAKUL GAUTAM & NIDHIKA Department of paediatrics ( 2023 – 2026 ) Presented on – 27 th may 2024

2. JOURNAL PRESENTATION COORDINATORS DR. MEENAKSHI AMBWANI (HOD DEPARTMENT OF PHARMACY) DR, VIJAYA GOSWAMI (ASSISTANT PROFESSOR DEPT. OF POM) DR. NEHA (ASSISTANT PROFESSOR, DEPT. OF ORGANON OF MEDICINE) DEPARTMENT OF PEDIATRICS UNDER THE GUIDANCE OF DR. PUNEET GARG (PROFESSOR- DEPT. OF PEDIATRICS) DR. RITU GONTIYA (ASSISTANT PROF. - DEPT OF PEDIATRICS) DR. AJAY BHATI (ASSISTANT PROF. - DEPT. OF PEDIATRICS)

3. SOURCE – National Homoeo Recorder YEAR October to December 2018 VOLUME XIV ISSUE IV PAGE NO 25 to 33 Kapil Kumar Shaw, Gautam Ash, Rajib Purkait AUTHORS

4. ABSTRACT Structured abstract

5. Constipation is a common problem, that affects the child’s activity and behavior. Hydrastis canadensis (HC) mother tincture (ϕ) has its probable effect in pediatric constipation, but its action has not yet been evaluated systematically. We aimed to compare the effectiveness of pre-decided HC ϕ against constitutional homoeopathic medicines (CH) in treatment of pediatric constipation. BACKGROUND

6. METHOD An open-label, randomized, two parallel arms, exploratory, pilot pragmatic trial was conducted on 40 children suffering from constipation, as defined by the Rome III diagnostic criteria for functional constipation. Constipation severity transformed percentage scores and physician plus parent assessed global status (‘improved’ or ‘not improved’) were the primary and secondary outcomes respectively, assessed at baseline, and 3 and 6 months after treatment . Comparative analysis was done on the protocol-compliant sample to detect group differences.

7. RESULTS Out of 84 screened, 44 were enrolled and randomized, 2 dropped out in each group, 40 completed the trial . Groups were comparable at baseline (all P > 0.01). After 3 and 6 months of intervention, both the outcome measures changed significantly in both the groups (all P < 0.01) without any significant group differences (all P > 0.01). CONCLUSION HC ϕ and CH – both the therapies seemed to be equally effective in treatment of pediatric constipation.

8. KEY WORDS Homoeopathy Hydrastis canadensis Paediatrics Randomised controlled trial Constipation 04. 05. 01. 02. 03.

9. Clinical trials have been the main tool used by the health sciences community to test and evaluate interventions. Trials fall into two broad categories: PRAGMATIC and EXPLANATORY -- PRAGMATIC TRIALS are designed to evaluate the effectiveness of interventions in real-life routine practice conditions. TRIAL

10. EXPLANATORY TRIALS aim to test whether an intervention works under optimal situations. Exploratory trials include a small number of patients or healthy subjects and expose them (over a short period of time) to a low dose of an investigational medicinal product. OPEN LABEL A type of study in which both the health providers and the patients are aware of the drug or treatment being given.

11. A pilot study is defined as “ A small-scale test of the methods and procedures to be used on a larger scale” A pilot experiment/ pilot study/ pilot test/ pilot project is a small-scale preliminary study conducted to evaluate feasibility, duration, cost, adverse events, and improvement upon the study design prior to performance of a full-scale research project.

12. RANDOMISED CONTROLLED TRIAL (RCT) A randomized controlled trial (RCT) is a trial in which subjects are randomly assigned to one of two groups: one (the experimental group) receiving the intervention that is being tested , and the other (the comparison group or control) receiving an alternative (conventional) treatment.

13. PARALLEL ARM STUDY In this design, subjects are randomized to one or more study arms and each study arm will be allocated a different intervention . After randomization each participant will stay in their assigned treatment arm for the duration of the study.

14. EQUIVALENCE It shows that new treatment intervention and the control condition are equivalent (equally effective) or ‘similar’. Example – whether one drug used is equally effective with the other drug used in the study.

15. CONSTIPATION

16. CONSTIPATION is defined as a delay or difficulty in defecation, present for 2 or more weeks OR infrequent passage of hard stools and sufficient to cause significant distress to the patient. It is increasingly being recognized as a very common problem in children. Patients may also complain of straining, a sensation of incomplete evacuation and either perianal or abdominal discomfort.

17. The normal stool frequency decreases from 4 or more per day during infancy to once per day at 4 yr of age. A stool frequency of <2/week is considered abnormal for all ages . Constipation can be divided into two groups : 1. functional 2. organic. In a study of 135 Indian children with constipation, 85% had functional constipation and 15% had an organic etiology (most commonly, Hirschsprung disease, cerebral palsy and meningomyelocele )

18. EPIDEMIOLOGY The prevalence varies according to age groups. prevalence ranging from 0.5 to 32.2% in children aged 0 to 18 years. The peak incidence of constipation occurs between 2 and 4 years , when the potty training starts. A recent systematic review found that the median prevalence of constipation in children was 12%. The incidence of constipation reported in infants varies between 0.05% and 39.3% , but based on expert consensus the prevalence is estimated at 15% . At this age. feeding is a major contributing factor.

19. CAUSES OF CONSTIPATION GASTROINTESTINAL CAUSES Dietary Lack of fibre and or fluid Motility Slow transit constipation IBS Chronic intestinal pseudo – obstruction Structural Colonic carcinoma Diverticular disease Hirschsprung's disease Defecation Anorectal disease ( Crohn's, fissures, haemorrhoids) Obstructed defecation NON – GASTROINTESTINAL CAUSES Drugs Neurological multiple sclerosis Cerebo vascular accidents Spinal cord lesions Parkinsonism Metabolic/ endocrine Diabetes mellitus Hypercalcaemia Hypothyroidism Pregnancy Others Any serious illness with immobility, especially in the elderly. Depression

20. FUNCTIONAL CONSTIPATION The increase in intake of low residue diet and sedentary lifestyle is responsible for the increase in functional constipation in children. Functional constipation is defined by the presence of at least 2 or more of the following criteria: (i) 2 or fewer defecations in the toilet per week. (ii) At least 1 episode of fecal incontinence per week. (iii) History of retentive posturing or excessive volitional stool retention. (iv) History of painful or hard bowel movements. (v) Pre- sense of a large fecal mass in the rectum. (vi) History of passage of large diameter stools that may obstruct the toilet.

21. Children with functional constipation pass large or hard stools and display: 1. stool withholding behavior 2. Characterized by stiffening of whole body 3. screaming in infants 4. To walking on tiptoes 5. Tightening of buttocks in older children This is often misunderstood by parents as if the child is trying to defecate. Often an acute illness, change in diet, coercive toilet training or nonavailability of clean toilet leads to non passage of stools.

22. The stools become hard and cause pain on passage which leads to association of defecation with pain and withholding . This further increases stool size and hardness with more pain on defecation and a vicious cycle of constipation is initiated. Children with functional constipation often have: 1. Abdominal pain (10-70%) 2. Anorexia (10-25%) 3. Enuresis or urinary tract infections (30%) 4. And psychological problems (20%)

23. APPROACH The following details should be asked for : Pattern of stooling Time of first passage of meconium (in infants) Presence of blood in stools Diet Stressful life events Drug intake Previous surgeries

24. A complete physical and neurological examination is essential: Examination for features of spina bifida (pigmentation or tuft of hair on lower back), Power in lower limbs Perianal sensation Voluntary contraction and tone of anal sphincter Amount and consistency of stool in rectum Presence of 'red flags ’ should be acknowledged: Failure to thrive Blood in stools Recurrent fever with loose stools (enterocolitis) Recurrent vomiting, lump in abdomen Recurrent chest infections Features of hypothyroidism

25. CLINICAL ASSESEMENT The onset, duration and characteristics are important; A neonatal onset suggests Hirschsprung's disease . A recent change in bowel activity in middle age should raise the suspicion of organic disorders such as colonic carcinoma . Symptoms suggestive of irritable bowel syndrome , a history of childhood constipation and emotional distress. Neurological disorders, especially spinal cord lesions, should be sought.

26. INVESTIGATIONS Initial visit Digital rectal examination proctoscopy and sigmoidoscopy (to detect anorectal disease) routine biochemistry including serum calcium and thyroid function tests and a full blood count If these are normal, a 1-month trial of dietary fiber and/or laxatives is justified .

27. Next visit If symptoms persist, then examination of the colon by barium enema or colonoscopy is indicated to look for structural disease. Further investigation If no cause is found and disabling symptoms are present, then specialist referral for investigation of possible dysmotility may be necessary. Intestinal marker studies Anorectal manometry Electrophysiological studies and Defecating proctography

28. MANAGEMENT X-ray abdomen may be done to document constipation. willing impaction management for in- a per are select rectal disimpaction situation. Disimpaction is required in patients who have a rectal impaction , i.e. presence of a large hard mass of faeces on per rectal examination . Rectal impaction is responsible for progressive dilatation of the rectum over time.

29. The maintenance phase is to promote regular stooling and prevent re-impaction. Passage of 1-2 soft stools per day and no soiling . It includes the following components: i. BEHAVIORAL TRAINING: involves establishing a positive routine of sitting on toilet for passing stools after meals regularly (2-3 times per day for 5-10 min) and documenting all stool passage. Embarrassment or punishment should be avoided. ii. DIETARY CHANGES: A nutritious diet with fruit/vegetables and adequate fluids is given. A short trial of milk and milk product free diet may be done in cases suspected to have milk allergy.

30. iii. MEDICATION : Regular and tailor-made (as per response) laxative use is the key to success and this should be explained to the family. Prokinetics like cisapride are not recommended. In infants, mineral oil and stimulant laxatives should not be used. Glycerin suppository is preferred over enema for impaction in infants. Premature withdrawal of medications is a very common cause of relapse .

31. Hirschsprung Disease Thia disease is characterised by constipation and colonic disease and colonic dilatation (megacolon) due to congenital absence of ganglion cells in the large intestine . The incidence is approximately 1:5000 Patients have a positive family history and in these families, the disease is inherited in an autosomal dominant manner. About 50% of familial cases and 15% pf sporadic cases have mutations affecting the RET protooncogene , which is also implicated in multiple endocrine neoplasm (MEN) type 2 and 3 . This disease is caused by loss of function mutations.

32. PATHOPHYSIOLOGY - Ganglion cells are absent from nerve plexuses , most commonly in a short segment of the rectum or sigmoid colon . - As a result the internal anal sphincter fails to relax . CONSTIPATION ABDOMINAL DISTENTION VOMITING - These usually develop immediately after birth but a few cases do not present until childhood or adolescence. - The rectum is empty on physical examination .

33. HYDRASTIS CANADENSIS Commonly known by the names Goldenseal, Orange Root and Yellow Root . family – Ranunculaceae The thick, yellow rhizome of the herb is used to extract the medicine. It is indigenous to the United States and Canada. It is also widely grown in India. Spheres of action - respiratory tract, gastrointestinal tract, ears, and female organs.

34. MOUTH: Peppery taste. Tongue white, swollen, large, flabby, slimy; shows imprint of teeth (Merc); as if scalded; stomatitis. Ulceration of tongue, fissures toward the edges. STOMACH: Sore feeling in stomach more or less constant. Weak digestion. Bitter taste. Pain as from a hard-cornered substance . Gone feeling. Pulsation in epigastrium. Cannot eat bread or vegetables. Atonic dyspepsia. Ulcers and cancer. Gastritis. ABDOMEN: Gastro-duodenal catarrh. Liver torpid, tender. Jaundice. Gallstones. Dull dragging in right groin with cutting sensation into right testicle.

35. RECTUM: Prolapsed; anus fissured. Constipation, with sinking feeling in stomach, and dull headache. During stool, smarting pain in rectum . After stool, long-lasting pain (Nit ac). Haemorrhoids; even a light flow exhausts. Contraction and spasm. DOSE: Tincture , to thirtieth attenuation. Locally colorless. Hydrastis, mother tincture, or fluid extract.

36. CONSTITUTIONAL REMEDIES USED CALCAREA CARBONICA STOOL - Crawling and constriction in rectum. Stool large and hard (Bry); whitish, watery, sour. Prolapse ani, and burning, stinging hemorrhoids. Diarrhea of undigested, food, fetid, with ravenous appetite. Children's diarrhea. Constipation; stool at first hard, then pasty, then liquid. MAGNESIUM MURIATICUM STOOL - Constipation of infants during dentition; only passing small quantity; stools knotty, like sheep's dung, crumbling at verge of anus . Painful smarting haemorrhoids.

37. GRAPHITES STOOL - Constipation; large, difficult, knotty stools united by mucus threads. Burning haemorrhoids. Prolapse, diarrhoea; stools of brown fluid, mixed with undigested substance, very fetid, sour odour. Smarting, sore anus, itching. Lump stool, conjoined with threads of mucus . Varices of the rectum. Fissure of anus ( Ratanhia ; Paeonia). SULPHUR STOOL - Itching and burning of anus; piles dependent upon abdominal plethora. Frequent, unsuccessful desire; hard, knotty, insufficient . Child afraid on account of pain. Redness around the anus, with itching. Morning diarrhea, painless, drives out of bed, with prolapsus recti. Hemorrhoid's, oozing and belching

38. METHODS Study setting Paediatric out patient departments of NATIONAL INSTITUE OF HOMOEOPATHY (NIH). TRIAL DESIGN Open label, randomised, exploratory, pilot, pragmatic, two parallel arms clinical trial Institutional Ethical Committee (IEC) approved the protocol [Ref. No. 5-023/NIH/PG/Ethical Comm. 2009/Vol. III/1976 (A/S); dated March 27, 2017]. The trial protocol dissertation (unpublished) full was submitted as the postgraduate thesis of the corresponding author to The West Bengal University of Health Sciences.

39. STUDY DURATION M ay A pril 2017 2018

40. Children suffering from constipation as diagnosed by the Rome III diagnostic criteria of functional constipation (ICD 10 code K59.00) Symptomatic for at least last month Age 1-18 years , both sexes Guardians willing to make their children participate in the study and giving written informed consent. PARTICIPANTS INCLUSION CRITERIA

41. It is a process by which a participant / legal guardian voluntarily confirms their willingness to participate in a particular research project, after being informed of all aspects of the research that are relevant to the subject's decision to participate. Consent may be given only by someone who is legally able to provide consent. When the participant is a child under the age of 18, the parent or legal guardian provides consent. Assent is an agreement by an individual not competent to give legally-valid informed consent to participate in research. example - A child aged 7-17 or cognitively-impaired person. CONSENT ASSENT

42. EXCLUSION CRITERIA Congenital abnormalities and cases of extensive morbid pathologies , where surgical intervention were indicated or required. Children who were too unwell to take part, inability to read patient information sheets and/or denied consent to take part. Diagnosed cases of developmental disorders. Uncontrolled hypothyroidism Unstable psychiatric complaints or other systemic diseases affecting quality of life Currently receiving homoeopathic treatment for any chronic condition(s). Self-reported immune compromised conditions , Substance abuse and/or dependence.

43. INTERVENTION Each standardized dose was consisted of 15 drops of the HC ϕ in 20 ml of distilled water. The medicine was obtained from a Good Manufacturing Practice (GMP) certified firm – SBL Pvt. Ltd . The medicine was directed to be taken twice daily orally on clean tongue with empty stomach for 7 consecutive days followed by placebo and repeated as and when necessary. Such intervention continued for 6 months.

44. The participants were assessed by the two homoeopaths every month in every follow up. Irrespective of the allocated codes, provision was kept for prescribing acute medicines ‟ based on acute totality ‟ to meet adverse or serious adverse events as per homoeopathic principles.

45. Control was planned as administering individualized homoeopathic medicines in centesimal scale potencies as detailed above and in individualized dosage , as decided appropriate to the case or condition. As in the experimental arm, instructions were given to take each dose orally on clean tongue with empty stomach . Duration of treatment was 6 months . On each occasion, single individualized medicine was prescribed considering symptom totality , clinical history details, constitutional traits, miasmatic features, repertorization as and when required , consultation with Materia Medica, and agreement among the two prescribing homoeopaths. CONTROL

46. Subsequent prescriptions were produced in accord with Kent's observations and Hering’s law. Medicines used in the CH group: The most frequently indicated medicines in the CH group were; 1. Calcarea carbonica (n=7, 35%) 2. Graphites (n=5, 25%) 3. Magnesium muriaticum (n=4 each, 20%) 4 . Sulphur (n=4 each, 20%)

47. Distribution of socio demographics features including age group, gender, residence, religion, and body mass index were similar between the HC ϕ and CH group (all P > 0.01) ensuring comparability of the two groups. BASELINE DATA

48. Socio – demographic features of the participants at baseline ( N = 40 ) Chi-square test; P values two-tailed less than 0.01 considered as statistically significant

49. RANDOMISATION Intervention (HC ϕ) or comparator (CH) was implemented as per the random number chart created by using the random number generator at StatTrek.

50. STATISTICAL ANALYSIS

51. CHI-SQUARE TEST / PEARSON’S CHI SQUARE TEST P earson’s chi-square test  is a  statistical test  for categorical data. For eg - weight ( numerical data ) can be categorized in to underweight & overweight. It is used to determine whether your data are significantly different from what you expected. SYMBOL –  (χ2) O = Observed Value E = Expected Value

52. Gender and colour are dependent. ( null hypothesis rejected )

53. ANALYSIS OF VARIANCE (ANOVA) This test was developed by Ronald A. Fisher . ANOVA is used to compare the means of 3 or more groups. These groups must be mutually exclusive. Types of ANOVA: one way ANOVA Two way ANOVA Three way ANOVA

54. REPEATED MEASURE ANOVA Repeated measures ANOVA is similar to one way ANOVA , except for one additional calculation we must perform to account for this shared variability. It can be used in 2 situations: The dependent variable is measured repeatedly upon same subject at different points of time in their follow up. The dependent variable is measured repeatedly upon same subjects but under different circumstances at each occasion. i.e. independent variable change at each occasion.

55. f- table

56. 7. State conclusion The 3 conditions differed significantly on anxiety levels.

57. STUDENT T–TEST Named after - William Sealy Gossett ( pen name - "Student") T -TEST is a statistical test procedure ​used ​to analyze if there is a significant difference between the means of two groups​. TYPES One sample T-test  ​ Independent or unpaired t – test  ​ Paired t-test ​

58. 1. Formulation of hypothesis Null hypothesis(Ho): The Null Hypothesis is the assumption that the event will not occur . A null hypothesis has no bearing on the study's outcome unless it is rejected. H0 is the symbol for it, and it is pronounced H-naught . ​ ​ Alternative Hypothesis (H1): The Alternate Hypothesis is the logical opposite of the null hypothesis . The acceptance of the alternative hypothesis follows the rejection of the null hypothesis.  H1 is the symbol for it. 2. Data collection 3. Calculating the difference 4. Calculate the mean of the differences 5. Calculate the standard deviation of the difference

59. PAIRED T-TEST

60. UNPAIRED T-TEST

61. OUTCOMES PRIMARY OUTCOME: The primary outcome measure was the constipation severity scores , derived from the items mentioned in Rome III diagnostic criteria. The main reason for developing this scoring system was the absence of any pre validated outcome scales on pediatric constipation. SECONDARY OUTCOME: The secondary outcome measures were physician-rated and parent rated global health status improved or not improved. Both the outcome measures were assessed at baseline, and after 3 and 6 months.

62. OUTCOMES AND ESTIMATION

63. DISCUSSION Empirically selected HC ϕ seemed to be non inferior and equally effective to CH in treatment of pediatric constipation , as evidenced from constipation severity score and physician and parent assessed wellbeing score.

64. MERITS AND DEMERITS One of the major strength of the study was randomization . No placebo control was used; rather all the randomized patients received medicine – either HC ϕ or CH . Hence, ethically the study was less vulnerable. Effect size could not be calculated on account of absence of any previous studies; hence sample size was based on assumption only. The trial was open; no blinding was used. Besides, our analysis was restricted to protocol-compliant sample only, intention to treat to analysis would have generated more proper results than this.

65. This trial was carried out at NIH, India on 40 children suffering from constipation. Over 3 and 6 months of intervention, symptom severity and health status improved significantly in both the HC ϕ group and CH group without any significant differences in between, suggesting HC ϕ as an equally effective treatment option as that of CH in pediatric constipation. However, being an underpowered trial, results should be interpreted cautiously and further independent research in multi-centric design is required on larger sample size before making any firm recommendations . CONCLUSION

66. The authors declare that they have no competing interests. CONFLICT OF INTEREST Funding required for the project was borne by the authors themselves FUNDING

67. KKS conceived and designed the study. KKS and GA collected data. RP ran the statistical analyses and interpreted the data. KKS prepared the manuscript. All the authors reviewed and approved the final manuscript . AUTHOR’S CONTRIBUTIONS We thank Dr. Subhranil Saha, the institutional heads of both academic and hospital section for their cooperation. We thank the fellow PG trainees, staff, pharmacists, and the patients for their sincere participation in the study. ACKNOWLEDGEMENTS

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69. THANK YOU.