An open-label, prospective, pre–post comparison study to evaluate the efficacy of individualized homoeopathic medicines using Kent’s repertory in the treatment of upper respiratory tract infections

INTRODUCTION

Respiratory tract infections are a persistent and pervasive health issue in developing countries, such as India.^[1] It refers to any of the infectious diseases involving the respiratory tract, broadly classified according to the parts of the respiratory tract affected, such as upper respiratory tract infections (URTI) and Lower respiratory tract infections (LRTI). The upper respiratory tract consists of the airway from the nostrils to the vocal cords in the larynx, including paranasal air sinuses and the middle ears.^[2] URTIs included - rhinitis, laryngitis, pharyngitis, laryngopharyngitis, sinusitis, and otitis media.^[2-4] It affects almost all age groups of patients- predominantly children, adolescents, and older adults. A great variety of pathogens are responsible for URTIs, mostly viral-like Influenza A and B viruses, Rhino virus, Adeno virus, Corona virus, Respiratory Syncytial virus, etc.,^[5] along with some bacteria such as Group – A Streptococcus beta-haemolyticus, Haemophilus influenzae, and Moraxella catarrhalis, etc., and fungi are also causing it. Symptoms usually include a runny nose, sneezing, sore throat, general malaise, hoarseness of voice, low-grade temperature at onset, followed by cough and nasal congestion.^[6,7] URTIs are usually a self-limiting disease, and generally recover patients within about 7–10 days but it may also cause various life-threatening complications like pneumonia and other LRTIs,^[2,6] acute glomerulo-nephritis, rheumatic fever, peritonsillar and retro pharyngeal abscess, septicemia, severe acute respiratory distress syndrome, even to death mainly among children and old peoples.^[5] Nowadays, modern systems of medicinal treatment to control URTIs are based on simple case-to-case management to diagnose and treat promptly using pharmaceutical therapies such as antibiotics, antipyretics, anti-inflammatory drugs, expectorants, decongestants, and cough suppressants, either alone or in combination.^[2-6,8-10] Till now, there is no approved specific and safe therapy for URTIs,^[2,5,6] and modern medicines sometimes may lead to adverse drug reactions.^[9] Homoeopathic literature shows the data on the efficacy of homoeopathic medicines in URTIs. There have been various studies done on URTIs in Homoeopathy to date. A trial to investigate the clinical effectiveness of a homoeopathic add-on therapy in a pediatric sub-population with URTIs in a randomised controlled multinational clinical trial by Haselen et al., showing the efficacy of homoeopathic medicine in reducing symptoms over standard modern medicine treatment group.^[6] Another study showing the efficacy of homoeopathic medicine in preventing and treating pediatric acute URTI by Hawke et al.^[2] An international randomized controlled trial by Thinesse-Mallwitz et al. on 523 patients, published in 2015, showed that those taking homoeopathic medications had symptoms alleviated 1–2 days earlier than the standard treatment group.^[9] A recent study was done at the National Institute of Homoeopathy, India, which compared the efficacy of homoeopathic individualised medicines versus homoeopathic specific medicine Sabadilla in the management of URTI in children.^[11] The studies mentioned above mostly focus on paediatric URTIs, neglecting other age groups with URTIs. Some of the studies were conducted in combination with modern medicinal treatments. The efficacy of individualised homoeopathic medicine has not been thoroughly evaluated and requires further study. According to the ‘law of similia’ and the maxim ‘similia similibus curentur’, homoeopathy treats patients with a remedy that is capable of producing similar symptoms in a healthy individual.^[12] Therefore, in homoeopathy, the same disease can be treated with different remedies in different patients through ‘individualisation,’ which depends on the physical, mental and miasmatic symptoms of an individual.^[13] In this study, the patients with acute URTI were being treated with individualised homoeopathic medicines. URTI symptoms were assessed using the Wisconsin upper respiratory symptom survey-21 (WURSS-21), which is a 21-item illness-specific symptom and health related quality of-life questionnaire widely used in different clinical study related to URTI^[14] by using this scoring scale, the condition of the health of the patient was assessed whether the patient was improved or deteriorated or remained as before. In this study, ‘Repertory of the Homoeopathic Materia Medica’ by Dr. Kent^[15] was used to arrive at the similimum. It is a widely used repertoire and effective in different clinical studies and day-to-day practice, with efficacy. According to Dr. Barthel- ‘The Repertory of the Homoeopathic Materia Medica’ by JT Kent^[15] is the most appropriate, most complete and most reliable of all’.^[16] Here, in the study in Kent’s repertory, we have consulted the various rubrics and sub-rubrics on URTIs in each of the cases.

MATERIAL AND METHODS

RESULTS

In the socio-demographic characteristics, it has been found that the mean age of patients suffering from URTIs is 30, and a maximum (23.08%) of the total patients are age group of 05–15 years. The females, 29 (55.77%), were more affected than the males, 23 (44.23%). Maximum (48.08%) of them belong to middle-class socioeconomic status. 40.38% of the patients were students. In this study the maximum number of patients who have been suffering from URTIs were having no addiction (76.92%).

In this study, the outcome measurement was done by the WURSS-21 score, comparing at the baseline and various follow-ups, mainly the 1^st follow-up. In this study, a non-parametric test for WURSS-21 scores was shown. The mean ± standard deviation (SD) values are reduced from 65.48 ± 7.97 –17.17 ± 15.17 to 7.52 ± 12.15 –3.12 ± 6.32 in WURSS-21 total score for baseline, first follow-up, second follow-up and third follow-up, respectively.

WURSS-21 scores

The mean total WURSS-21 score reduced gradually from base line to different subsequent follow ups which was at the baseline was 65.56, at first follow up 17.10, 2nd follow up 7.52 and third follow up reduced to 3.12.

The WURSS-21 Score is represented in Figure 1.

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Figure 1:

Box and Whisker plot showing mean Wisconsin upper respiratory symptom survey-21 (WURSS) 21 symptoms score at baseline and 4^th (±1) day, 8^th (±1) day and on day 15^th (±2) visit of treatment. It is shown that Baseline Scores (blue box) show high symptom burden (median ~65–70). First Follow-Up (orange box) shows a large drop (median ~15). Second and third follow-up (gray and yellow) show further reduction, with the third follow-up nearing 0 in many cases. Outliers decrease over time, indicating less variability and fewer extreme scores, which supports treatment efficacy.

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DISCUSSION

Pre-post-comparison was an open-label, prospective, pre-post-comparison clinical trial conducted at MBHMCH involving 52 patients from the OPD as per the eligibility criteria. The purpose of this study was to show the efficacy of individualised homoeopathic medicines in the treatment of URTIs by using Kent’s repertory. Case taking of the patients was done according to the guidelines of the organisation of medicine, and a standard case taking pro forma was followed. Repertorisation was done using Kent’s Repertory. Frequently consulted rubrics [Table 2] in cases related to URTIs are mentioned along with frequently prescribed medicines [Table 3]. The socio-demographic data from the study are very useful. In this study, non-parametric tests for WURSS-21 scores showed that the mean ± SD values were reduced from 65.48 ± 7.97 –17.17 ± 15.17 to 7.52 ± 12.15 –3.12 ± 6.32 in WURSS-21 total score for baseline, first follow-up, second follow-up and third follow-up, respectively. In the non-parametric Friedman’s ANOVA by Rank test at the Significance

Level of 0.05 in two-tailed hypothesis testing, the χ²r statistic is 147.1904 (df = 3, n = 52). The result is significant at P < 0.05. In a post hoc analysis with baseline and each follow-up using the Wilcoxon signed rank test, the Z-value was higher than the table value, which signifies that in each follow-up the result was significant. The effect size of the study was calculated by using Kendall’s W, where the W-value is 0.944, which represents a stronger agreement.

In the study, we have seen that individualised homoeopathic medicines in cases of URTIs are also more effective than any combination medicines or a specific one. These do not follow the homoeopathic laws and principles that were observed in various previous clinical studies. Hence, it provides enough evidence regarding the efficacy of homoeopathic medicine in reducing the signs and symptoms of URTI after receiving the treatment, and also the practical utility of Kent’s Repertory in the treatment of URTI was observed through a reportorial approach, different important related rubrics that were clinically listed above [Table 2].

CONCLUSION

This was an open-label, prospective, pre-post-comparison study that was conducted on 52 patients suffering from URTI. There was an improvement in symptoms of URTIs as evident from statistically significant differences in the WURSS-21 score. The study suggests that the individually chosen homoeopathic medicines for the cases of URTIs, following the laws and principles of homoeopathy, are much more effective than any specific medicine and/or combinations of it. It also shows that Kent’s repertory is very useful for this kind of acute disease.

The sample size of this study was small, so it is suggested that in the future, a study on large numbers of patients should be conducted along with appropriate investigation. Such a study will help to draw a more definite conclusion. Furthermore, research by a randomised controlled trial is also required. It is expected that this study will create great awareness among patients, the general population, as well as homoeopathic physicians to establish a firm belief that URTIs can be treated effectively through proper individualised homoeopathic medicines.