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 Table of Contents  
ORIGINAL ARTICLE
Year : 2018  |  Volume : 12  |  Issue : 3  |  Page : 149-156

An open observational trial evaluating the role of individualised homoeopathic medicines in the management of nocturnal enuresis


1 Department of Organon of Medicine, The Calcutta Homoeopathic Medical College and Hospital, Govt. of West Bengal, Kolkata, West Bengal, India
2 Student, The Calcutta Homoeopathic Medical College and Hospital, Govt. of West Bengal, Kolkata, West Bengal, India
3 Independent Researcher, Shibpur, Howrah, West Bengal, India

Date of Submission08-Apr-2018
Date of Acceptance12-Sep-2018
Date of Web Publication27-Sep-2018

Correspondence Address:
Dr. Sangita Saha
The Calcutta Homoeopathic Medical College and Hospital, 265-266 A. P. C. Road, Kolkata - 700 009, West Bengal, India
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/ijrh.ijrh_25_18

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  Abstract 


Context: Nocturnal enuresis is a widespread and distressing condition that can have a deep impact on the subject's behavioural, emotional and social life. Aim: We intend to evaluate the role of homoeopathic treatment in nocturnal enuresis. Materials and Methods: A prospective, single arm, pre-post comparison, non-randomised, open-label, observational trial on individuals of 5–18 years of age presenting with nocturnal enuresis at the outpatient department of The Calcutta Homoeopathic Medical College and Hospital was carried out. A total of 34 individuals were enrolled. A scoring scale was developed; scores were measured at baseline, after 2nd and 4th month. The intention to treat population was statistically analysed in the end. Results: The mean age of the patients was 8.71 ± 2.73 years; gender distribution was 1:1. Compared to baseline, scores reduced significantly over 2 months (11.6 ± 1.9 vs. 9.6 ± 3.5; mean difference: 2.0 ± 2.5 [95% confidence interval (CI): 1.2, 2.9]; t = 4.748; P < 0.0001 two-tailed; Student's t-test) and 4 months (11.6 ± 1.9 vs. 7.1 ± 4.8; mean difference: 4.5 ± 4.2 [95% CI: 3.1, 6.0]; t = 6.319; P < 0.0001). A post hoc one-way repeated measure ANOVA indicated significant time effect (F[2,32] = 311.286, P < 0.0001). Effect size was considerably large (Cohen's d: 0–2 months = 1.653; 0–4 months = 2.200). The most frequently indicated medicine was Kreosotum (n = 9; 26.5%). Conclusion: Homoeopathic medicines seemed to have a potential treatment effect in nocturnal enuresis. Controlled trials are warranted.

Keywords: Homoeopathy, Nocturnal enuresis, Observational trial


How to cite this article:
Saha S, Tamkeen R, Saha S. An open observational trial evaluating the role of individualised homoeopathic medicines in the management of nocturnal enuresis. Indian J Res Homoeopathy 2018;12:149-56

How to cite this URL:
Saha S, Tamkeen R, Saha S. An open observational trial evaluating the role of individualised homoeopathic medicines in the management of nocturnal enuresis. Indian J Res Homoeopathy [serial online] 2018 [cited 2018 Dec 12];12:149-56. Available from: http://www.ijrh.org/text.asp?2018/12/3/149/242278




  Introduction Top


Nocturnal enuresis is a disorder in which episodes of urinary incontinence occurs during sleep in children ≥5 years of age.[1] More than 85% of children attain complete diurnal and nocturnal control of the bladder by 5 years of age. The remaining 15% gain continence at approximately 15% per year, such that by adolescence only 0.5%–1% children have enuresis.[2] Nocturnal enuresis prevalence rates vary from 3.5% to 56.4% in different geographical regions and countries.[3],[4]DSM-5 criteria for the diagnosis of enuresis are as follows:[5]

  • Repeated voiding of urine into bed or clothes, whether involuntary or intentional.
  • The behaviour either (a) occurs at least twice a week for at least 3 consecutive months or (b) results in clinically significant distress or social, functional or academic impairment.
  • The behaviour occurs in a child who is at least 5-year-old (or has reached the equivalent developmental level).
  • The behaviour cannot be attributed to the physiologic effects of a substance or other medical condition.


Primary enuresis (75%–90%) occurs when a child has never established bladder control. Secondary enuresis (10%–25%) occurs when a person has established bladder control for 6 months, then relapses and begins wetting.[6] Enuresis can be further divided into the following three subtypes on the basis of the time of occurrence: nocturnal (i.e. during sleep), diurnal (i.e. during waking hours) and nocturnal and diurnal.[5] Primary nocturnal enuresis is caused by a disparity between bladder capacity and nocturnal urine production and the child's failure to awaken in response to a full bladder.[7] Factors associated with enuresis include nocturnal polyuria, detrusor instability and an abnormally deep sleep pattern.[8] A variety of medical and psychological disorders is associated with secondary enuresis such as bladder dysfunction, constipation, diabetes mellitus, hyperthyroidism, obstructive sleep apnoea, pinworm infestation and psychological stress.[8],[9] Studies suggest association between sexual abuse and nocturnal enuresis.[10]

Active treatment should be avoided in children before the age of 6 years. The child should be reassured and no punitive measures to be taken as that can affect the child's psychological development adversely. The first line of treatment is usually non-pharmacological comprising motivational therapy and use of alarm devices. Alarm devices are used to elicit a conditioned response of awakening to the sensation of a full bladder. Pharmacotherapy is to be done if enuresis persists despite institution of alarm and regular voiding habits.[2],[6] Desmopressin acetate (DDAVP) is the preferred contemporary medication for treating children with enuresis.[6] However, the common side effects include headache, nausea, upset stomach or stomach pain, diarrhoea or flushing of the face (warmth, redness and tingly feeling). DDAVP can infrequently cause low levels of sodium in the blood, which can be serious and possibly life-threatening.[11]

A randomised, double-blind, double-dummy, controlled trial [12] conducted by Ferrara et al. on 151 children suffering from nocturnal enuresis and treated with complex homoeopathic medicines (homotoxicological remedies) were superior to placebo (P < 0.001) with regard to the number of children attaining 14 consecutive dry nights during treatment, but less effective than standard treatment with Desmopressin. Naude [13] in his randomised, double-blind, placebo-controlled trial used homoeopathic complex remedies and evaluated against placebo; but it was under-reported. In a case series [14] of 27 patients, homoeopathic medicine Equisetum was coupled with a visualisation technique and the results were promising after 2 years of treatment. A Cochrane review [15] in 2011 could not identify any randomised trial of Homoeopathy for nocturnal enuresis in children and hence concluded that efficacy or effectiveness of Homoeopathy was uncertain in this condition. We identified one on-going single arm, open-label observational trial on 50 participants suffering from nocturnal enuresis evaluating the effects of homoeopathic medicine Causticum 200C (ClinicalTrials.gov Identifier: NCT02154152); however, no relevant publication could be identified. Thus, literature on homoeopathic medicines in the treatment of nocturnal enuresis with improvement in the quality of life was insufficient and required more studies for a clinical research decision on enuresis. The objective of this study was to evaluate the role of individualised homoeopathic medicines in the treatment of nocturnal enuresis.


  Materials and Methods Top


Setting and design

A prospective, single arm, pre-post comparison, non-randomised, open-label, observational trial on individuals of 5–18 years of age presenting with nocturnal enuresis was conducted on the patients attending the outpatient departments at The Calcutta Homoeopathic Medical College and Hospital (CHMCH), Kolkata. The protocol was approved from the Institutional Ethical Committee of the institution. A total of 34 patients were included in the study. Each patient was provided with a patient information sheet in local vernacular Bengali detailing the objectives, methods, risks and benefits of participating and confidentiality issues. Before enrolment, written informed consent was taken from either of the parents or guardians of the patients.

Inclusion and exclusion criteria

Individuals of both sexes between 5 and 18 years of age with episodes of involuntary urination at least twice a week for 3 consecutive months, having no organic pathology behind enuresis, no anatomical and/or surgical changes leading to enuresis, and who have not used systemic antibiotics in the past 1 month, were enrolled. Patients whose parents did not give consent and had objection in being involved with the study were not included.

Outcome assessment

On account of the absence of any valid scales on nocturnal enuresis, we developed a nocturnal enuresis symptom severity scoring scale [Table 1]; measured at baseline, and after the 2nd and 4th month were completed by one or both of the parents with the help of the child under the guidance of the investigating physician. The assessment form consisted of ten questions with their respective scores ranging from 0 to 2 relating to the frequency of night wetting, experience of diurnal enuresis, urge for micturition, consciousness about enuresis after voiding and effects due to enuresis.
Table 1: Nocturnal enuresis scoring scale

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Intervention and follow-up

Each enrolled patient was enquired about the complaint according to the predesigned questionnaire. A careful history was obtained regarding whether the enuresis is primary or secondary, whether any daytime symptoms are present and whether any voiding difficulty is present. Enuresis-focused history, physical examination and urinalysis were done before initiation of treatment. Information was obtained to know the onset, duration and severity of enuresis; presence of daytime wetting, constipation, genitourinary symptoms and neurologic symptoms; family history of enuresis; patient medical and psychosocial history and details of previous treatment. Medicines were prescribed after analysis and evaluation of symptom of each case. Cases were repertorised as and when required with the help of RADAR software version 10.0.028 (ck), Archibel 2007, Belgium. The selected medicines in appropriate doses were applied as per the directions in the Homoeopathic Philosophy. Medicines were repeated as per the individual requirement of each case and guidelines of Organon of Medicine. Intervention was given to each enrolled patient and follow up was conducted at least once a month (or earlier as required by the patient) for a timeline of 4 months as per the protocol.

Statistical analysis

Intention to treat analysis was conducted. Student's t- test and post hoc one-way repeated measure ANOVA were used keeping P < 0.05 two-tailed as statistically significant. Statistical Package for the Social Sciences, version 20.0 (IBM Corp., IBM SPSS Statistics for Windows, Armonk, NY: USA) was used for analysis.


  Results Top


A total of 34 patients were enrolled in the study; 4 (11.76%) dropped out and 30 completed the study [Figure 1].
Figure 1: The study flow diagram

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Baseline features

The mean age of the participants was 8.71 ± 2.73 years; gender distribution was 1:1. Maximum number of patients spanned the age group of 8–10 years (47.1%). Among the participants, 55.9% children were studying in Class I to Class V, 64.7% belonged to middle economic status and 70.6% residing mostly in urban areas. Dietary habit was mostly non-vegetarian (91.2%). 70.59% of the parents did not have a history of nocturnal enuresis. Further details of the baseline socio-demographic characteristics are given in [Table 2].
Table 2: Baseline features of the patients (n=34)

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Symptom profile

The frequency of night wetting was found to be daily in 79.4% patients that were subsequently reduced to 33.3% and 13.3% over 2nd and 4th month of homoeopathic intervention, respectively. The problem regarding bedwetting several times, feeling of embarrassment and shyness, sleep and academic disturbances also improved after treatment. Further details are tabulated in [Table 3].
Table 3: Symptom profile at different time points

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Pre-post comparison

  • Over 2 months: Compared to baseline, scores reduced significantly over 2 months (11.59 ± 1.99 vs. 9.56 ± 3.45; mean difference: 2.03 ± 2.49 [95% confidence interval (CI): 1.16, 2.89]; t = 4.748; P < 0.0001 two-tailed; Student's t-test) [Figure 2]
  • Over 4 months: Compared to baseline, scores reduced significantly over 4 months (11.59 ± 1.99 vs. 7.06 ± 4.79; mean difference: 4.53 ± 4.18 [95% CI: 3.07, 5.99]; t = 6.319; P < 0.0001) [Figure 2]
  • Repeated measures over 2 and 4 months: A post hoc one-way repeated measure ANOVA indicated significant time effect {F{2,32} = 311.286, P < 0.0001}. Effect size was considerably large {Cohen's d: 0–2 months = 1.653; 0–4 months 2.200} [Figure 2].
Figure 2: Changes in outcomes over different time-points

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Medicines used

Kreosotum was the most frequently used medicine (n = 9; 26.5%), followed by Calcarea phosphorica (n = 6; 17.6%), Calcarea carbonica (n = 4; 11.7%), Cina and Acidum nitricum (n = 3; 8.8%) and Natrum muriaticum (n = 2; 5.9%). Rest of the medicines, namely Abrotanum, Aloe socotrina, Calcarea iodata, Chamomilla, Equisetum, Rhus toxicodendron and Tuberculinum were used once (n = 1; 2.9%) [Table 4] and [Figure 3]. Indication for Kreosotum was nocturnal enuresis specially in first sleep; the child was difficult to wake up even after bedwetting and dreams of urination as if urinating in the toilet during sleep was noted in one case. Calcarea phosphorica was prescribed for tall slender children with profuse perspiration, pain and stiffness in legs along with enuresis. Obese children with a tendency to easily catch cold, profuse perspiration and constipation reacted well with Calcarea carbonica. Cina was prescribed for children with worm infestation and nocturnal enuresis, especially at first sleep. Very strong offensive urine was a strong indicator for Acidum nitricum.
Table 4: Medicines in first prescription (n=34)

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Figure 3: Medicines used

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  Discussion Top


A prospective, single arm, pre-post comparison, non-randomised, open, observational trial was carried out on 34 individuals of 5–18 years of age presenting with nocturnal enuresis. As no such work on individualised homoeopathic treatment was available on search, the studies available were with complex homoeopathic medicines or with Equisetum or Causticum 200, hence a scoring scale was developed; scores were measured at baseline, after 2nd and 4th month. Compared to baseline, scores reduced significantly over 2 and 4 months Effect size was considerably large. Totally 13 different homoeopathic medicines were used; Kreosotum being the most common. Homoeopathic medicines seemed to have a promising treatment effect in nocturnal enuresis.

This prospective observational study was aimed to reflect the contemporary homoeopathic health care in real practice settings and its outcome in 34 patients suffering from nocturnal enuresis. The methodological strengths of our study include its prospective design, the participation of qualified and experienced homoeopathic physicians schooled in and practicing 'classical' Homoeopathy, and dealing with a challenging condition like nocturnal enuresis.

In the absence of control arm, there is always chance of overestimation of treatment effect sizes. This is attributable to placebo effect, regression effect to the mean and undisclosed use of concurrent therapeutic modalities. This issue could not be addressed in our study. Another limitation was the absence of prevalidated scale to measure the construct. We developed a scoring scale; however, its validity and reliability remained untested.

All the 34 patients were treated with homoeopathic medicines in different outpatient departments of the institution by different visiting physicians. After proper case taking medicines were selected on the basis of individualisation and totality of symptoms. The potency and dose selection for indicated medicine depended on the patient's susceptibilities, seat, nature and intensity and stage and duration of disease, previous treatment of patient and as per directions in Organon of Medicine and Homoeopathic Philosophy. Changes in the medicines, potencies and repetitions were made according to the homoeopathic principles after observing the prognosis of the case, assessment of remedy reaction and changes in the presenting symptoms over 4 months of follow-up. Medicines were dispensed by the pharmacists of CHMCH at Hospital dispensary as per as direction of the physician according to individualised case.


  Conclusion Top


Nocturnal enuresis is a widespread and distressing condition that has a deep impact on the child or young person's behaviour and on their emotional and social life. This prospective observational trial, though preliminary, revealed promising treatment effect of homoeopathic medicines in nocturnal enuresis. The study findings need to be interpreted with caution and further be experimented in randomised placebo-controlled design with enhanced methodological rigor and longer follow-up.

Acknowledgement

For completing the study, deep regards to Dr. Rajat Chattopadhyay (Principal and Administrator of CHMCH, Kolkata) and Dr. Kajal Bhattacharya (Ex-acting Principal and Ex-Administrator of CHMCH, Kolkata) for providing technical co-operation and administrative support from time to time for conducting the study. We acknowledge Dr. Malay Mundle (Professor and HOD, Department of Community Medicine, C.N.M.C, Kolkata) for his constant supervision in preparing the protocol, questionnaire and statistical analysis. A sincere regards to Dr. Rakesh Singh for constant support and co-operation. We acknowledge the Ethical Committee, all the visiting physicians, all hospital staffs and patients for their co-operation that provided an opportunity to complete the study.

Financial support and sponsorship

This study was supported by Central Council for Research in Homoeopathy under Short Term Student Scholarship Scheme.

Conflicts of interest

Non declared.

 
  References Top

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Nevéus T, von Gontard A, Hoebeke P, Hjälmås K, Bauer S, Bower W, et al. The standardization of terminology of lower urinary tract function in children and adolescents: Report from the standardisation committee of the international children's continence society. J Urol 2006;176:314-24.  Back to cited text no. 1
    
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Paul VK, Ghai BA. Essential Pediatrics. 8th ed., Ch. 16. New Delhi: CBS Publishers & Distributers Pvt., Ltd.; 2013. p. 504, 505.  Back to cited text no. 2
    
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Doganer YC, Aydogan U, Ongel K, Sari O, Koc B, Saglam K, et al. The prevalence and sociodemographic risk factors of enuresis nocturna among elementary school-age children. J Family Med Prim Care 2015;4:39-44.  Back to cited text no. 3
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Ferrara P, Marrone G, Emmanuele V, Nicoletti A, Mastrangelo A, Tiberi E, et al. Homotoxicological remedies versus desmopressin versus placebo in the treatment of enuresis: A randomised, double-blind, controlled trial. Pediatr Nephrol 2008;23:269-74.  Back to cited text no. 12
    
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Naude D. The efficacy of homoepathic similimum in the treatment of nocturnal enuresis in children between five and eighteen years who reside in children's homes. Proceedings of the 58th Congress of the Liga Medicorum Homeopathica Internationalis (LMHI) held at Graz, Austria; 22-26 April, 2003. p. 54-5.  Back to cited text no. 13
    
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