NHR Jan-Mar 2019: Original Research: Utility of Kent’s repertory in homoeopathic treatment chronic bronchitis: An open, observational clinical trial

Utility of Kent’s repertory in homoeopathic treatment chronic bronchitis: An open, observational clinical trial


Showket Ahmad Bhat*1, Avijit Shee Burman2

  1. Former Postgraduate Trainee, Dept. of Repertory, National Institute of Homoeopathy, Govt. of India
  2. Reader, Dept. of Forensic Medicine and Toxicology, PG Guide, Dept. of Repertory, National Institute of Homoeopathy, Govt. of India

*Correspondence: showketbhat76@gmail.com


ABSTRACT:

Background: Chronic Bronchitis is one of the commonest respiratory diseases affecting a large number of people across the globe with prevalence ranging from 2-22% in men and 1.2-19% in women. This study was aimed to evaluate the effect of individualized homoeopathic medicines selected using Kent’s repertory in reducing the symptom severity and improving the global wellbeing of chronic bronchitis patients.

Methods: An open, non-randomized, prospective clinical study was undertaken at the National Institute of Homoeopathy, in which 31 patients suffering from chronic bronchitis, fulfilling the inclusion and exclusion criteria were enrolled and followed up periodically at minimum of one month interval. Outcome measures were COPD Assessment Test (CAT) questionnaire and Numeric Rating scales (NRS) measuring severity of cough, dyspnoea and global wellbeing at baseline, and after 3 and 6 months. Individualized homoeopathic medicines were prescribed using Kent’s repertory.

Results: Thirty four patients were enrolled, 3 dropped out, 31 completed the trial. Thirty patients showed marked reduction in the outcome scores from baseline to 3 months and 6 months that was statistically significant (p<0.001, paired t test and one way repeated measure ANOVA). Natrum Sulph (16.1%), Arsenic Alb (13%), Hepar sulph (9.7%), Lycopodium (9.7%) and Sulphur (9.7%) were frequently prescribed medicines.

Conclusion: The overall response of individualized homoeopathic medicines selected using Kent’s repertory produced promising treatment effects. However further rigorous trials with spirometry findings as outcome measures are warranted.

Keywords: Chronic bronchitis, COPD Assessment Test, Numerical Rating Scale, Kent’s repertory, Homoeopathy


INTRODUCTION 

Respiratory illness is a one of common health problems in the world. The World Health Organization (WHO) reported the global leading causes of death in the past decade were ischaemic heart disease (7.4 million), stroke (6.7 million), lower respiratory infections and chronic obstructive lung disease (3.1 million each), of which most of them badly affected by the air pollution. The major killer diseases in the world are related to the lungs (8 million) which statistically makes it the top cause of death [1]. Respiratory diseases range from mild and self-limiting such as the common cold, to life-threatening entities like bacterial pneumonia, pulmonary embolism, acute asthma and lung cancer [2]. In general, the top eight respiratory diseases are asthma, chronic obstructive pulmonary disease (COPD), chronic and acute bronchitis, emphysema, lung cancer, cystic fibrosis (75 % were diagnosed two years old), pneumonia (caused by bacteria), and allergies (together with immune system problem) [3].

The Chronic Bronchitis definition used in epidemiologic studies has been variable, but the classic definition is chronic cough and sputum production for at least 3 months per year for two consecutive years [4, 5]. It has numerous clinical consequences, including an increased exacerbation rate, accelerated decline in lung function, worse health-related quality of life (HRQoL), and possibly increased mortality [6-8]. As classified in the International Classification of Disease (ICD) [9], chronic bronchitis is classified into following two types:

  1. Simple chronic: A condition associated with mucous production
  2. Mucopurulent chronic: A condition associated with purulent mucous production in the absence of localized suppurative disease

The reported prevalence estimates have ranged from 2-22% in men and from 1.2-19% in women. As per WHO, 210 million people worldwide suffer from moderate to severe disease. In 2005, COPD contributed to 3 million deaths (5% of deaths globally).  GOLD estimates suggest that COPD will rise from the sixth to the third most common cause of death worldwide by 2020. The anticipated rise in morbidity and mortality from COPD will be greatest in Asian and African countries, as a result of their increasing tobacco consumption [4]. The Burden of Obstructive Lung Disease (BOLD) study is an international, cross-sectional study assessing the prevalence and burden of COPD across different parts of the world. Data from 23,855 males and females from 33 BOLD study sites in 29 countries were analyzed. The proportion of self-reported chronic bronchitis symptoms overall was 3.1%: 3.6% for males and 2.6% for females [12]. In India, chronic bronchitis affects about a third of patients with COPD, but also occurs in individuals with normal lung function, with prevalence estimates varying widely both in population-based studies (2.6-16%) and among COPD patients (7.5%) [10].The recent ‘Indian Study of Asthma, Respiratory Symptoms and Chronic Bronchitis’ (INSEARCH) of 85,105 men and 84,470 women from 12 urban and 11 rural sites reported the prevalence of chronic bronchitis to be 3.5% [10]. Thus India contributes very significantly to mortality from COPD 102.3/100,000 and 6,740,000 DALYs out of world total of 27,756,000 DALYs [11].

The aetiologies include tobacco smoking, airway responsiveness and COPD, respiratory infections, occupational exposures, ambient air pollution, passive, or second-hand, smoking exposure, genetic considerations and growth and nutrition [4]. Clinical features [12] usually appear at the age of 30-40 years and consist of chronic cough with muco-purulent expectoration often referred to as smoker’s cough or winter cough, dyspnoea usually mild which initially present as exertional dyspnoea, occasional haemoptysis, tightness in chest, increased frequency of exacerbations due to worsening airflow obstruction, current smokers having signs of active smoking, including an nicotine order or staining in finger nails, over weight and cyanotic (blue bloaters), chest noisy, with rhonchi invariably present, wheezes are common especially expiratory type, and signs of overt right heart failure termed as cor pulmonale. Suggested investigations include CBC (anaemia or document polycythaemia) [13], α1-antitrypsin [14], chest X-ray (peribronchial and perivascular markings, to rule out cardiac failure, lung cancer, and the presence of bullae) [13], PFT (FEV1 and FEV1/FVC reduced) [14], pulse oximetry [13], sputum examination [15], electrocardiogram [14, 15], arterial blood gas (ABG) analysis [15] and HRCT [13].

OBJECTIVES

  1. To determine/observe the utility of Kent’s repertory in the treatment of chronic bronchitis.
  2. To ascertain and shortlist the most frequently prescribed homoeopathic medicines in the treatment of chronic bronchitis.
  3. To determine the reduction in the symptom severity of chronic bronchitis patients with homoeopathic medicines.
  4. To estimate improvement in quality of life in patients with chronic bronchitis after homoeopathic treatment.

METHODS

Trial design: This open label, prospective, observational, non-randomized, non-controlled clinical trial of pre-post comparison design was conducted at the Repertory outpatient department of National Institute of Homoeopathy, Kolkata, India. The study protocol was approved by the Institutional Ethical Committee (IEC) [Ref. No. 5-023/NIH/PG/Ethical Comm. 2009/Vol. III/ 1963 (A/S); dated March 27, 2017]. The trial protocol (unpublished) and full dissertation was submitted as postgraduate thesis of the corresponding author to The West Bengal University of Health Sciences.

Participants: Inclusion criteria were the patients who have been diagnosed with chronic bronchitis (2018/19 ICD-10-CM diagnosis code J41.0), both sexes, aged between 18 and 65 years, and the patients willing to give written consent to participate in the trial. Exclusion criteria were Chronic bronchitis with adverse conditions complicated with some other pathological conditions like predominant emphysema, pneumonia, bronchial asthma, bronchogenic carcinoma, pneumoconiosis, pulmonary tuberculosis or bronchiectasis patients suffering from any life threatening illness or other systemic disease affecting quality of life or any vital organ failure, congenital anomalies, cases willing for or requiring immediate surgical intervention or already underwent any major shoulder surgery in last 6 months, undergoing homoeopathic treatment for chronic disease within last 6 months, diagnosed cases of unstable psychiatric illness, pregnant and lactating women, self-reported immune-compromised state, substance abuse and/or dependence, and the patients not willing to participate. Patients already taking any standard or other alternative therapy for frozen shoulder were included if agreed to discontinue for at least 1 month.

Intervention: Intervention was planned as administration of indicated homoeopathic medicines in centesimal or 50 millesimal potencies and in individualized dosage, as decided appropriate to the case or condition. In centesimal potencies, each dose consisted of 4 cane sugar globules medicated with a single drop of the indicated medicine, preserved in 90% v/v ethanol. In 50 millesimal potencies, a single medicated cane sugar globule of poppy seed size (no.10) was dissolved in 80 ml distilled water with addition of 2 drops of 90% v/v ethanol, 16 doses were marked on the vial, each dose of 5 ml was instructed to be taken after 10 uniformly forceful downward strokes to the vial in 45 ml normal water in a clean cup, to stir well, to take 5 ml of this liquid orally, and to discard rest of the liquid in the cup. Each dose was directed to be taken orally on clean tongue with empty stomach. Duration of such therapy was 3 months. Medicines were obtained from SBL Pvt. Ltd. and Homoeopathy International® – Good Manufacturing Practice certified firms. Single individualized medicine was prescribed on each occasion taking into account presenting symptom totality, clinical history details, constitutional features, miasmatic expressions, repertorization by Kent’s repertory using RADAR® software when required with due consultation with Materia Medica. Participants were assessed by two homoeopaths at a time. Medicine was selected on each occasion by two homoeopaths. All the homoeopaths involved were affiliated with respective state councils and had experience and expertise of practicing classical homoeopathy.

General management: All the participants were advised to practice breathing exercises and to be present for monthly follow-ups.

Outcomes:

  • Primary outcome measure: COPD Assessment Test (CAT) questionnaire in Bengali language [20, 21].
  • Secondary outcome measure: Numeric rating scales (0-10) measuring severity of cough and dyspnoea, and one similar global well-being scale [22].

Sample size: No relevant data was available on reduction of CAT-B scores by individualized homoeopathic treatment using an open observational study design over 3 and 6 months of intervention. Thus assuming a medium effect size (d) of 0.5, alpha = 0.05 and power of 80%, to detect a significant difference between two dependent means of CAT-B scores by two-tailed paired t test, we would have required a sample size of 34.

Statistical methods: The analysis was carried out with per protocol approach; i.e. only the protocol-compliant sample entered into the final analysis. The baseline descriptive data (categorical and continuous) were presented in terms of absolute values, percentages, means, and standard deviations. Parametric student’s t test and post hoc one way repeated measure ANOVA were planned to be used as inferential statistics comparing dependent observation of continuous outcomes. P values less than 0.05 were considered as statistically significant. No interim and subgroup analyses were planned. SPSS®-IBM® v.20 for Windows was used for analysis of data. Reporting adhered to the CONSORT [16] and RedHot [17] guidelines for reporting trials, Mathie’s criteria for model validity of homoeopathic treatment [18, 19] (MVHT) and Saha’s criteria for reporting quality of homoeopathic individualization in clinical trials [20].

RESULTS

Participant flow: As per the pre-specified inclusion and exclusion criteria, 120 subjects suffering from chronic bronchitis were screened; 86 were excluded on account of various reasons; 34 met the eligibility criteria and were enrolled into the trial. Following that, baseline socio-demographic and outcome data was obtained. After 3 and 6 months of intervention, outcome data was recorded again. During intervention, 3 dropped out; 31 completed the trial. (Figure 1)

Recruitment: Starting from April 2017, follow up of the last enrolled patient was completed by the end of June 2018.

Baseline data: Fourteen variables were studied for the baseline socio-demographic features of the subjects – age, gender,

 

Table 1:  Baseline socio-demographic features (N=31)

Features N (%)
Age (yrs; mean ± sd) 47.1 ± 11.6
Age groups (yrs)

§  18 – 45

§  45 – 60

§  Above 60

16 (51.6)

13 (41.9)

2 (6.5)

Gender

§  Male : Female

18 (58.1) : 13 (41.9)

Residence

§  Urban : Rural

9 (29.0) : 22 (71.0)

Religion

§  Hinduism : Islam

13 (41.9): 18 (58.1)

Duration of suffering (yrs; mean ± sd) 7.0 ± 7.3
Risk factor

§  Smoking

7 (22.6)

Treatment taken

§  Allopathy

§  Homeopathy

§  None

19 (61.3)

11 (35.5)

01 (3.2)

Co-morbidities

§  Allergic conditions

§  Hypertension

§  Cervical spondylosis

§  Anemia

§  Diabetes mellitus

§  Dyslipidaemia

§  Fibroadenoma breast

§  Osteoarthritis knee

2 (6.5)

2 (6.5)

2 (6.5)

1 (3.2)

1 (3.2)

1 (3.2)

1 (3.2)

1 (3.2)

Body Mass Index

§  Underweight

§  Normal

§  Overweight

6 (19.3)

23 (74.2)

2 (6.5)

Marital status

§  Single

§  Married

§  Others

1 (3.2)

29 (93.6)

1 (3.2)

Educational status:

§  10th std or below

§  12th std or above

22 (71.0)

9 (29.0)

Employment status:

§  Self-employed

§  Unemployed

16 (51.6)

15 (48.4)

Family income status:

§  Low

§  Medium

§  High

26 (83.9)

4 (12.9)

1 (3.2)

Values presented as absolute numbers (%)

 Figure 1: Study flow diagram

 

residence, religion, duration of suffering, risk factors, treatment taken, co-morbidities, body mass index (BMI), marital status, educational status, employment status, and family income status. (Table 1)

Numbers analyzed: Outcomes from 31 out of 34 enrolled subjects were complete and only those entered into the final analyses.

Outcomes and estimation:

  1. CAT-B scores: Patient assessed severity of CAT score was reduced from 24.8 (sd 4.6) to 19.7 (sd 4.5) over 3 months of homoeopathic treatment. The reduction [mean 5.1, 95% CI 3.9 to 6.3, t30=8.963, p < 0.001] was statistically significant. Similarly after 6 months of treatment the CAT intensity score was reduced to 15.8 (sd 3.9) and the reduction [mean 9.0, 95% CI 7.7 to 10.4, t30= 13.931, p < 0.001] was also statistically significant. Post hoc one way repeated measure ANOVA comparing the CAT scores obtained longitudinally at different points of time (baseline, 3 months and 6 months) also revealed statistically significant reductions [Wilks’ lambda 0.120, Partial η2 = 0.880, F = 106.620, p < 0.001].
  2. Cough NRS: Patient assessed severity of cough on NRS was reduced from 7.4 (sd 2.3) to 5.0 (sd 1.9) over 3 months of homoeopathic treatment. The reduction [mean 2.3, 95% CI 1.6 to 3.0, t30=6.920, p < 0.001] was statistically significant. Similarly after 6 months of treatment, the NRS cough intensity score was reduced to 3.9 (sd 1.1) and the reduction [mean 3.4, 95% CI 2.7 to 4.2, t30= 9.162, p< 0.001] was also statistically significant. Post hoc one way repeated measure ANOVA comparing the cough severity NRS score obtained longitudinally at different points of time (baseline, 3 months and 6 months) also revealed statistically significant reductions [Wilks’ lambda 0.262, Partial η2 = 0.738, F =40.855, p < 0.001].
  3. Dyspnoea NRS: Patient assessed severity of dyspnoea on NRS was reduced from 7.6 (sd 2.2) to 5.8 (sd 2.4) over 3 months of homoeopathic treatment. The reduction [mean 1.8, 95% CI 1.0 to 2.6, t30=4.675, p < 0.001] was statistically significant. Similarly after 6 months of treatment, the NRS dyspnoea intensity score was reduced to 4.5 (sd 2.4) and the reduction [mean 3.1, 95% CI 2.2 to 3.9, t30 = 7.314, p< 0.001] was also statistically significant. One way post hoc repeated measure ANOVA comparing the dyspnoea severity NRS scores obtained longitudinally at different points of time (baseline, 3 months and 6 months) also revealed statistically significant reductions [Wilks’ lambda 0.333, Partial η2 = 0.667, F = 28.981, p < 0.001].
  4. Global wellbeing NRS: Patient assessed severity of global wellbeing on NRS was increased from 4.6 (sd 2.5) to 6.2 (sd 2.3) over 3 months of homoeopathic treatment. The increase [mean -1.6, 95% CI -2.2 to -1.1, t30 = -6.084, p < 0.001] was statistically significant. Similarly after 6 months of treatment the NRS global wellbeing intensity score was increased to 7.2 (sd 2.2) and the increase [mean -2.6, 95% CI -3.4 to -1.8, t30 = -6.849, p < 0.001] was also statistically significant. Post hoc one way repeated measure ANOVA comparing the global wellbeing severity NRS scores obtained longitudinally at different points of time (baseline, 3 months and 6 months) also revealed statistically significant increase [Wilks’ lambda 0.364, Partial η2 = 0.636, F = 25.318, p < 0.001].
  5. Box and whisker plots showing changes in NRSs: Changes in cough intensity NRS scores over 3 months had median 2.0, inter-quartile range 0.0 to 4.0, min 0.0, max 6.0 and over 6 months had median 4.0, IQR 2.0 to 6.0, min 0.0, max 6.0. Changes in dyspnoea intensity NRS scores over 3 months had median 2.0, inter-quartile range 0.0 to 2.0, min 0.0, max 10.0 and over 6 months had median 4.0, IQR 2.0 to 4.0, min -2.0, max 10.0. Changes in global wellbeing NRS scores over 3 months had median -2.0, inter-quartile  range -3.0 to -1.0, min -5.0, max 2.0 and over 6 months had median -3.0, IQR -5.0 to -1.0, min -5.0, max 4.0.
  6. Box and whisker plots showing changes in CAT score: Changes in CAT intensity scores over 3 months had median of 5.0, inter-quartile range 3.0 to 7.0, min 0.0, max 15.0 and over 6 months, had median 9.0, IQR 6.0 to 11.0, min 0.0, max 17.0.
  7. Assessment of degrees of improvement: A difference or change of 2 or more in CAT suggests a clinically significant difference or change in health status, i,e. the minimal clinically important difference (MCID). Thus patients reporting reduction of CAT score of 2 were considered as ‘improved’ and the rest as ‘not improved’. In this study out of 31 patients, 30 showed significant reduction in CAT score from baseline to 6 months varying from 5 to 17, hence considered as ‘clinically improved’, and the rest as ‘clinically not improved’.

Medicines and potencies prescribed at baseline: Natrum sulph was prescribed to 5 (16.1%) patients, Arsenic alb to 4 (13%), Hepar sulph, Lycopodium, and Sulphur to 3 (9.7% each), Natrum mur and Tuberculinum to 2 (6.5% each), Calcarea carb, Calcarea phos, Drosera, Dulcamara, Graphites, Kali carb, Psorinum, Sepia, and Stannum met to single (3.2% each) patients. Medicines were prescribed in centesimal potencies to 16 (51.6%) and in 50 millesimal potencies to 15 (48.4%).

 

Table 2: Changes in outcomes over 3 and 6 months: pair-wise analysis (N=31)

Outcome measures Baseline After 3

months

After 6

months

Change (0-3);

mean ± sd (95% CI)

Change (0-6);

mean ± sd (95% CI)

NRSs:

§  Cough

§  Dyspnoea

§  Global wellbeing

7.4 ± 2.3

7.6 ± 2.2

4.6 ± 2.5

5.0 ± 1.9

5.8 ± 2.4

6.2 ± 2.3

3.9 ± 1.1

4.5 ± 2.4

7.2 ± 2.2

2.3 ± 1.9 (1.6 to 3.0) ψ

1.8 ± 2.2 (1.0 to 2.6) §

-1.6 ± 1.5 (-2.2 to -1.1) ¥

3.4 ± 2.1 (2.7 to 4.2) ψψ

3.1 ± 2.4 (2.2 to 3.9) §§

-2.6 ± 2.1 (-3.4 to -1.8) ¥¥

CAT score 24.8 ± 4.6 19.7 ± 4.5 15.8 ± 3.9 5.1 ± 3.2 (3.9 to 6.3)* 9.0 ± 3.6 (7.7 to 10.4)**

ψ t30 = 6.920, P< 0.001 (significant); § t30 = 4.675, P< 0.001 (significant); ¥ t30 = -6.084, p < 0.001 (significant); * t30 = 8.963, p < 0.001 (significant)

ψψ t30 = 9.162, P< 0.001 (significant); §§ t30 = 7.314, P< 0.001 (significant); ¥¥ t30= -6.849, p < 0.001 (significant); ** t30 = 13.931, p < 0.001 (significant)

Table 3: Changes in outcomes over time: one-way repeated measure ANOVA (N=31)

Outcome measures Baseline After 3 months After 6 months P value
NRSs:

§  Cough

§  Dyspnoea

§  Global wellbeing

7.4 ± 2.3

7.6 ± 2.2

4.6 ± 2.5

5.0 ± 1.9

5.8 ± 2.4

6.2 ± 2.3

3.9 ± 1.1

4.5 ± 2.4

7.2 ± 2.2

< 0.001ψ

< 0.001§

< 0.001¥

CAT score 24.8 ± 4.6 19.7 ± 4.5 15.8 ± 3.9 < 0.001*

ψ Wilks’ lambda 0.262, Partial η2 = 0.738, F = 40.855, p < 0.001 (significant); § Wilks’ lambda 0.333, Partial η2 = 0.667, F = 28.981, p < 0.001 (significant); ¥ Wilks’ lambda 0.364, Partial η2 = 0.636, F = 25.318, p < 0.001 (significant); *Wilks’ lambda 0.120, Partial η2 = 0.880, F = 106.620, p < 0.001 (significant)

Figure 2: Box and whisker plots showing changes in NRSs over 3 and 6 months (N=31)

 

 Figure 3: Box and whisker plots showing changes in CAT scores over 3 and 6 months (N=31)

 DISCUSSION

Principal findings: This prospective open observational clinical study was carried out at National Institute of Homoeopathy involving 31 patients suffering from chronic bronchitis and was treated with individualized homoeopathic medicines for 6 months. Symptom intensity NRS and CAT questionnaire were used as outcome measures, measured at baseline, and after 3 and 6 months. There was statistically significant reduction in the CAT and NRS scores (all p < 0.001) before and after treatment with individualized homeopathic medicines selected with the help of Kent’s repertory. Natrum sulph, Arsenic alb, Hepar sulph, Lycopodium and Sulphur were the most frequently prescribed medicines. Individualized homoeopathic medicines selected using Kent’s repertory seemed to produce promising treatment effects in chronic bronchitis. Further exploration is necessary.

Main strength of the study: The study was the very first of its kind in homoeopathy; hence exploratory in nature. The methodological strengths of the study include the use of standardized and already validated outcome scales- CAT questionnaire and NRSs for cough, dyspnoea and global wellbeing. This study is representative of individualizing (“classical”) homoeopathic treatment of chronic bronchitis. In a broader interpretation of the law of similar, remedies are selected for symptoms both typical of the diagnoses and outside the predominating pathologies (“constitutional”). Being an observational study, it was important for conceptualization of hypothesis. It might also offer help in calculation of effect size and sample size for controlled trials in future. Though the sample size of this study was small, still was adequately powered to detect changes in the specified outcome measure over 6 months. Actually the sample size was small keeping in mind the feasibility issues and stipulated time frame of postgraduate thesis. All the collected data (hard form) was converted into an analyzable and reproducible master chart (soft copy) where all data was extracted systematically and underwent statistical analysis subsequently. The results were presented using sufficient numbers of both tabular forms and pictorials for easy understanding. Enrolment into the study was prospective; i.e. the protocol was declared prior enrolment of the first patient. The study was transparent in terms of declaration of protocol, ethical conduct and reporting. There was no placebo control and no new drug was experimented; thus ethically less vulnerable. There was no violation of routine homoeopathic practice and the outcome data was gathered at baseline, 3 months and after 6 months of treatment. In all the cases, medicines were prescribed only after due repertorization with Kent’s repertory and after referring standard materia medica books to treat the patient as a whole. The medicines were prescribed in both centesimal and fifty millesimal potencies. Advices on dietary modifications and lifestyle modification were also given as adjunctive to homoeopathic treatment. Prior to enrolment, each patient was provided with a patient information sheet in local vernacular Bengali detailing the study aims and objectives, methods, risks and benefits of participating and confidentiality issues. Subsequent to that, written informed consent was obtained. Thus the study conformed to the every possible ethical standard. Clearance was obtained from the Institutional Ethical Committee (IEC). The statistically significant results were obtained as there was marked reduction in the scores before and after treatment along with reduction in the symptom severity of the patient with improved global wellbeing.

Weakness of this study: The analysis was limited to a small sample of 31 patients only. This sample is too small to come to any generalizable conclusion regarding the efficacy or effectiveness of homoeopathic treatment in the management of chronic bronchitis. Duration of follow-up was one of the major limitations of the study as this disease is progressive in nature with frequent exacerbations and needs regular follow of patient for longer duration. It could have been enhanced and/or the outcomes could have been measured repeatedly to enhance the rigor of the study. On account of feasibility issues, spirometry findings were not taken as outcome measures. This study did not support conclusions as to the efficacy or effectiveness of the homeopathic medicines because no methodology for this purpose (control group, randomization, blinding, multi-center study design, etc.) was built into its design.  Also, simultaneous advices on dietary measures and lifestyle modifications could have overestimated the effect size. Besides, the trial was open; no blinding was used. Thus patient selection bias, evaluation bias, and data analysis bias might have affected the outcomes of the study. The aim of the investigation was to explore the effects of homeopathic medical care in treating patients of chronic bronchitis. Any improvement observed in this study should not be extrapolated to other forms of respiratory diseases. The data may also be helpful in the planning of further research projects on homeopathy. It would require specific instruments for more detailed assessment and effect size comparability, and a longer observation period.

Comparison with other studies: Research regarding the chronic bronchitis in homoeopathy is miniscule and only one clinical trial was conducted by CCRH from October 2005 May 2009 in its Chennai unit on 56 patients with 10 pre-selected homoeopathic medicines. The medicines were prescribed in centesimal potency only, that too in 30 strength. There was significant reduction in the symptom scores of majority of patients along with change in the spirometry findings before and after treatment which were used as outcome measures. No questionnaire or scoring scale was used in that study. It was an open prospective clinical trial and no randomization and control arm was used. However, this study which was also an open prospective clinical trial conducted at National Institute of Homoeopathy was carried on a small sample of 31 patients and for a short duration of time. But in this study CAT questionnaire and NRS – cough, dyspnoea and Global wellbeing scoring scales were used as outcome measures. The patient’s improvement was seen on the basis of reduction in CAT and NRS scores before and after treatment The study was not based on any preselected medicine but only those medicines were prescribed which came after due repertorization with Kent’s repertory and further consultation with standard material medica books. The medicines were prescribed in centesimal and millesimal potencies based on the susceptibility of the patients. There was marked reduction in the scaling score before and after treatment in majority of patients except one who did not show any change in scaling cores before and after treatment. Some new drugs were also seen effective in this condition. However in this study also, no randomization, no control arm were used which are warranted. Also spirometry findings before and after treatments were not used as outcome measures which might have further strengthened this study and are therefore warranted. Indicated medicines in this study were prescribed on the basis of individualization instead of empirically. This may have caused difference in results; however, the results should not be compared. Rather randomized trials should be designed on individualized homoeopathy and only after that, the study results should be matched up to.

Unanswered questions and future research: Study with control groups, more clinical trials and RCT’s with spirometry findings before and after treatment as outcome measure are warranted. Future Research with large sample for longer duration of time is warranted. The data is also helpful in the planning of RCTs of individualized homoeopathic treatment of chronic bronchitis in future.

CONCLUSION

This prospective open clinical trial was carried out at National Institute of Homoeopathy on the patients suffering from chronic bronchitis with individualized homoeopathic medicines selected with the help of Kent’s repertory. Over 3 and 6 months of intervention, there was significant reduction in both CAT and NRS scores. The most frequently prescribed medicines were Natrum sulph, Arsenic album, Hepar sulph, Lycopodium and Sulphur. Further trials of similar design and enhanced methodological rigor are warranted.


Conflict of interest statement: The authors declare that they have no competing interests. The trial was carried out as the postgraduate thesis of the corresponding author under guidance of Dr. Avijit Shee Burman, MD(Hom) who was a teaching faculty of the institute.

Funding: We received no funding for the study. Funding required for the project was borne by the authors themselves.

Authors’ contributions: SAB conceived and designed the study. Data was collected by SAB and ASB. SAB prepared the manuscript. Both the authors reviewed and approved the final manuscript.

Acknowledgements: We thank Dr. Subhranil Saha for statistical analysis. The authors are grateful to the institutional heads of both academic and hospital section for their cooperation. We thank the fellow postgraduate trainees, staff, pharmacists, and the patients for their sincere cooperation and participation in the study.


 

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Cite this article as: Bhat SA, Burman AS. Utility of Kent’s repertory in homoeopathic treatment chronic bronchitis: An open, observational clinical trial. National Homoeo Recorder 2019;15(1):34-45.

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