Dr Vrushita Girishbhai Vaghela
Dr Jalpa Atri
ABSTRACT
Background –Homoeopathic system of medicine is known for its holistic cure with remedies. Homoeopathic remedies collectively form Materia medica which is updated time to time with addition of new verified remedies. Quillaya saponaria is one of the remedies that need verification to be included in materia medica. So, a study was done with aim to study clinical indications of Quillaya Saponaria with objective to understand the curative and preventive action of this medicine in upper respiratory tract infection.
Materials and methods– 30 cases were selected according to inclusion and exclusion criteria prepared for study. Quillaya saponaria 6c was given in cases according to its indications. Where pre and post treatment scoring was done for estimating improvement and its statistical analysis was done with the help of paired t test.
Observation and result– The study reveals that Quillaya saponaria was efficacious in diseases of younger age group(46.7%) with Female preponderance19(63%). Most of cases show the Moderate improvement 13(43%). Paired t test shows marked difference between mean value of pre and post treatment score.
Conclusion– Quillya Saponaria medicine is effective in prevention and cure of upper respiratory tract infection which is acute in nature but more sample size and clinical trials are need to explore more about this medicine.
Keywords– Homoeopathy, Quillaya Saponaria, Verification, Curative, Prevention
INTRODUCTION
A variety of viruses and bacteria can cause upper respiratory tract infections. These cause a variety of diseases including rhinosinusitis, pharyngitis, otitis media, epiglotitis, tonsillitis, adenoiditis. URTI, amongst the most common acute condition, is an important cause of morbidity and economic loss globally. Disease transmission occurs via inhalation route and direct contact. Viruses are the most frequently implicated aetiological causes but, URTI due to primary bacterial infection or super-infection are also frequently encountered. Conditions like common cold and influenza, rhinitis, pharyngitis, sinusitis, etc comes under heading of URTI. Upper respiratory tract involves the nose, sinuses, pharynx, larynx and large airways.
Common cold continues to be a large burden on society, economically and socially. URTI accounts for an estimated 10 million outpatient appointments a year. Relief of symptoms is the main reason for outpatient visits amongst adults during the initial couple of weeks of sickness, and a majority of these appointments results with physician’s needless writing of antibiotic prescriptions. Adult obtain a common cold around 2-3 times yearly whereas pediatric can have upto 8 times yearly. URTI are accountable for greater than 20 million days of work lost, thus generating a large economic burden.
Homoeopathy is system of medicine which is founded by Dr. Samuel Hahnemann. Homoeopathy is derived from two Greek words, homoes meaning similar and pathos meaning suffering. Homoeopathy simply means treating diseases with medicines, prescribed in minute doses and on the basis of law of similia , that is “ similia similibus curentur” , means “lets like cure by like” . Homoeopathy is based on idea that if a substance triggers the symptoms of an illness, then the use of the identical substance may cure it, if given in smaller doses. The more dilute a homoeopathic medication is, the greater its potency is thought to be.
Many homoeopathic medicines have been verified clinically that are efficient in relieving symptoms of acute URTI like Arsenic alb., belladonna, dulcamara, hepar sulph. etc according to symptom similarity. One among such remedy is Quillaya Saponaria which is also known as chile soap bark. The medicine produces and cures signs of acute inflammation in the mucous membrane of nose and throat, in the irritation of the nose and start of running nose, keeping a check on further advancement. It treats cold with a sore and dry throat and cough with difficulty in expelling the sputum.
Due to insufficient data related to verification of this remedy, it is not widely used by Homoeopathic Physician. So, this study helps us to add data related to verification of this remedy which ultimately increases one laurel of Homoeopathic dispensary to fight against various ailments.
Materials and methods:
In this study, following were research question and research hypothesis.
Research Question:Will the verification of Quillaya saponaria in case of URTI helpful in homeopathic Practice?
Research Hypothesis: Null hypothesis : There will be no usefulness Quillaya saponaria in case of URTI Alternative hypothesis : There will be usefulness of Quillaya saponaria in case of URTI. The study was conducted at the O.P.D. of Government Homoeopathic Medical college and Hospital, Dethali, Tal. Siddhpur; Dist. Patan. Peripheral camps conducted by Government Homoeopathic Medical college and Hospital, Dethali, Tal. Siddhpur; Dist. Patan
Study duration :- 6 months. It was Prospective, randomized clinical verification study
Selection of samples :- Sampling method : Consecutive Random Sampling Sample size : 30 [screening was done with 50 patients] In this study, Inclusion criterias were as following, All age group and both sexes will be included in study irrespective of occupation, ethnic group and socio economic status, Cases with clear diagnostic indications of Upper respiratory tract infection [Rhinitis including allergic rhinitis, pharyngitis, tonsillitis], Cases with reversible pathological conditions, Cases with systemic disorders along with acute URTI, Cases with history of medication for complain of URTI, Cases with some allergic conditions related to respiratory tract, Chronic cases of respiratory system with acute exacerbation, Cases with totality of symptoms that indicates Quillaya Saponaria. Exclusion criterias were Cases with lower respiratory tract involvement and Cases with irreversible pathological conditions. Withdrawal Criteria was Cases which will not maintain regular followups. To conduct this study tools were Case Record (specially prepared) O.P.D, Source books for verifying corresponding totality of Quillaya saponaria in case of URTI. MYMOP2(Measure Yourself Medical Outcome Profile) scoring form. Microsoft excel for Symptom Scoring and statistical analysis
Data collection :-Data collection method :- Personal interview. Quillaya saponaria was prescribed to all cases of URTI where it indicated through its totality of symptoms mentioned in source book, after excluding other similar medicines on therapeutic basis
Potency :- According to study, 6c potency was prescribed.
Frequency and Repetition :- As per need of case during treatment on the basis of guidelines given in the Organon of medicine 6th edition Medicine Dispensing:- Dispensing in globule form (size 30) From dispensing unit of Government Homoeopathic Medical College and Hospital, Dethali, Tal. Siddhpur, Patan.
Follow Up:- Follow up Prescription on CTP as per requirement of case
Data analysis: Data analysis was done using Microsoft excel sheet on the basis of symptom score before treatment and after treatment using MYMOP2 Scoring system.
Criteria for Results:- The result will be analyzed. Significantly improved:- Pre and Post score difference about 6 or 5 at 24 hours [after starting treatment] indicates significant improvement. Moderately improved:-Pre and Post score difference about 4 or 3 at 24 hours [after starting treatment] indicates moderate improvement. Status Quo/not improved:- Pre and Post score difference 0 at 24 hours [after starting treatment] indicates status quo/not improved case.
Statistical Techniques: Data was analyzed on the basis of t test (paired t test) of statistical technique using Microsoft Excel Office 2007. To compare pre and post treatment scores of all the patients in the study. Paired t test was applied for Pre and Post MYMOP Scores.(level of significance (p value-≤0.05)
Ethical Aspect-Ethical guidelines were followed as mentioned in the Declaration of Helsinki [revision 2008] and ICMR [2006]. No harm produced to any human being during this study. Consent form was prepared in English as well as in Gujarati to make patient aware about the aim and methods of study. Privacy and confidentiality were fully respected during study. Change of medicine or treatment method was allowed during this study as per patient’s preference and health status.
PROBABLE ERRORS AND MEASURE TO MINIMISE THAT ERRORS
| SAMPLING ERROR | Random Sampling technique was selected for study to exclude selection and sampling error as well as other biases |
| INTERVIEWER BIAS | One observer was always there in case taking to minimize this error.
Researcher and guide turn by turn plays role of observer during case taking. |
BRIEF OF PROCEDURE:
Case taking according to 6th edition of Organon of Medicine was performed at Project sites then 50 Cases meeting inclusion and exclusion criteria were included in the study.
Quillaya saponaria 6c was Prescribed for study cases and According to need of cases, Follow up on Case Taking Performa every 15 minutes, 1 hr, 2 hrs, 12 hrs, 24 hrs , 3/7/15 days as per need of case.
Difference of Pre and Post treatment scoring at 24 hrs after first prescription decided improvement level in case.
After 24 hrs if case needed further management it was managed with further Homoeopathic/Allopathic or other treatment as per Demand of Patient.
After Intervention on the basis of: – Follow up On Case Taking Performa and Assessing Scoring System Criteria, Outcome assessment was done with statistical analysis
ANALYSIS OF DATA:
- The Pre treatment and Post treatment score of To study indications of quillayasaponaria 6c in acute URTI using MYMOP2 scale- Randomised, Non control Prospective Study are mentioned in the following table:
| Case No. | Pre-T/t Score
(µ1) |
Post -T/t Score
(µ2) |
D=(µ1 -µ2) Or X=(µ1 -µ2) |
(X-Ẋ) |
(X-Ẋ)2 |
| 1 | 3 | 1 | 2 | -1.1 | 1.21 |
| 2 | 2 | 2 | 0 | -3.1 | 9.61 |
| 3 | 4 | 0 | 4 | 0.9 | 0.81 |
| 4 | 4 | 0 | 4 | 0.9 | 0.81 |
| 5 | 3 | 1 | 2 | -1.1 | 1.21 |
| 6 | 4 | 2 | 2 | -1.1 | 1.21 |
| 7 | 4 | 2 | 2 | -1.1 | 1.21 |
| 8 | 4 | 0 | 4 | 0.9 | 0.81 |
| 9 | 4 | 0 | 4 | 0.9 | 0.81 |
| 10 | 4 | 1 | 3 | -0.1 | 0.01 |
| 11 | 5 | 3 | 2 | -1.1 | 1.21 |
| 12 | 4 | 1 | 3 | -0.1 | 0.01 |
| 13 | 4 | 0 | 4 | 0.9 | 0.81 |
| 14 | 4 | 0 | 4 | 0.9 | 0.81 |
| 15 | 5 | 0 | 5 | 1.9 | 3.61 |
| 16 | 4 | 2 | 2 | -1.1 | 1.21 |
| 17 | 5 | 0 | 5 | 1.9 | 3.61 |
| 18 | 4 | 1 | 3 | -0.1 | 0.01 |
| 19 | 3 | 0 | 3 | -0.1 | 0.01 |
| 20 | 4 | 1 | 3 | -0.1 | 0.01 |
| 21 | 5 | 0 | 5 | 1.9 | 3.61 |
| 22 | 5 | 0 | 5 | 1.9 | 3.61 |
| 23 | 4 | 2 | 2 | -1.1 | 1.21 |
| 24 | 4 | 4 | 0 | -3.1 | 9.61 |
| 25 | 5 | 1 | 4 | 0.9 | 0.81 |
| 26 | 6 | 6 | 0 | -3.1 | 9.61 |
| 27 | 6 | 1 | 5 | 1.9 | 3.61 |
| 28 | 5 | 1 | 4 | 0.9 | 0.81 |
| 29 | 5 | 1 | 4 | 0.9 | 0.81 |
| 30 | 5 | 2 | 3 | -0.1 | 0.01 |
| Total | 128 | 35 | ∑D or ∑X = 93 | ∑(X-Ẋ)2 =62.7 |
- Here in this test, p value is 0.00013 which is smaller than 0.05 and this result suggest the strong probability to reject null hypothesis. This result supports the result of theoretical testing.
- Null hypothesis: (REJECTED)
- Alternative hypothesis: (ACCEPTED)
- So, here Null hypothesis is rejected and Alternative hypothesis is selected to apply further statistical calculations.
- So, with acceptance of Alternative Hypothesis we can apply Student t test for further analysis.
| t-Test: Paired Two Sample for Means | ||
| PRE-T/T | POST- T/T | |
| Mean | 4.266666667 | 1.366666667 |
| Variance | 0.754022989 | 2.722988506 |
| Observations | 30 | 30 |
| Pearson Correlation | 0.266319909 | |
| Hypothesized Mean Difference | 0 | |
| Df | 29 | |
| t Stat | 9.642069511 | |
| P(T<=t) one-tail | 7.49512E-11 | |
| t Critical one-tail | 1.699126996 | |
| P(T<=t) two-tail | 1.49902E-10 | |
| t Critical two-tail | 2.045229611 |
- Here, Means of Pre- and Post- treatment scores are respectively 4.26 and 1.3. So, Mean difference between this variable(Pre and Post Treatment Score is as follows,
- Mean difference of Pre Score – Mean Difference Of Post Score
- i.e. 4.26- 1.3 = 2.96 (Mean Difference)
Inference:
- Value of Mean Difference in Pre and Post treatment Score shows that the decreased in Post treatment value due to action of Homoeopathic medicines. Result of p value and t test also support the alternative Hypothesis. These all data suggest, To study indications of quillayasaponaria 6c in acute URTI using MYMOP2 scale- Randomised, Non control Prospective Study.
DISCUSSION-
- The study reveals that Quillaya saponaria was efficacious in diseases of younger age group with Female preponderance.
- Most of cases show the Moderate improvement..
- The study was statistically analyzed with Pre treatment and Post Treatment data of Subjective Scoring System MYMOP used in this study.
- Statistically Student’s t- test was applied and shows the Usefulness of verification of Symptomatology of quillayasaponaria in Homoeopathy.
- Cases with sensation as if coryza will occur and incipient cold show significant and moderate improvement status reveals role of quillaya as homoeopathic prophylaxis in upper respiratory tract infections.
- The following Some Special observations were seen during study which help us to prepare a qualitative prescribing totality of Quillaya Saponaria.
| § Coryza with watery discharge |
| § Dull headache during cold |
| § Appetite decreased during cold |
| § Thirst increased during cold |
| § Sleep disturb during cold |
Limitation of study
Small sample size- this become one of the limitations to verify maximum number of symptomatology of Quillaya Saponaria
Further recommendations:
As this was a Small sample sized consequtive Sampling study, so study with More Sample Size with Control trial will be more effective to explore the more verified Symptoms of Quillaya Saponaria.
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CONFLICT OF INTEREST– None
ACKNOWLEDGEMENT– We are grateful to institute Government Homoeopathic Medical College and Hospital to provide opportunity for carried out this study. We would like to thank Principal & Superintendent of hospital (Dr. R.P.Sharma) and other hospital Staff and College’s Teaching and Non- teaching staff for providing guidance and encouragement.
Dr. Vrushita Girishbhai Vaghela
Intern doctor (Batch 2022-2023) at Government Homoeopathic Medical College, Dethali, Siddhpur, Patan, Gujarat
Dr. Jalpa Atri
Assistant Professor, Community Medicine Department, Government Homoeopathic Medical College, Dethali, Siddhpur, Patan, Gujarat
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