ABSTRACT – This comparative analysis tries to investigate the methodological and conceptual disparities between clinical trials conducted in Homoeopathy and Conventional Medicine. Highlighting the fundamental differences in principles, trial design, and evaluation metrics, the study explores the distinct approaches used in respective fields. Emphasizing the contrasting ideologies of individualized remedies of Homoeopathy versus treatments of Conventional Medicine. The investigation aims to shed light on the unique features, challenges, and implications in designing and executing clinical trials in these divergent medical practices, providing insights into the evaluation of their respective efficacy and outcomes.
KEYWORDS – Homoeopathy, Clinical trials, Comparative analysis, Conventional medicine, Methodology, Efficacy, Individualized remedies, Outcome evaluation, Medical practices, Healthcare research
INTRODUCTION – Homoeopathy and Conventional Medicine are two very different approaches to healthcare all over the world. Homeopathy, founded by Dr. Christian Friedrich Samuel Hahnemann in the late 18th century. Homoeopathy is a holistic system of medicine that is based on the principle “Similia Similibus Curentur” which means “Let Likes be Cured by Likes.” Dr. Samuel Hahnemann proposed that substances causing symptoms in healthy individuals could treat similar symptoms in the sick. Homoeopathy uses highly diluted substances to stimulate the body’s natural healing response and treat a variety of disease conditions.
On the other hand, Conventional Medicine, also known as Modern or Western Medicine, has its roots in ancient civilizations like Egypt, Mesopotamia, and Greece. But it has no active principles to work and it relies totally on drugs and surgery to treat disease. Despite their differences, both Homoeopathy and Conventional Medicine are subject to rigorous scientific testing. Clinical trials are research studies that are conducted to test the safety and efficacy of medicines and are considered as the gold standard for medical research for different methods of treatments.
In recent years, especially after the pandemic of COVID-19 Homoeopathy has become more popular and has been praised for its efficacy. There has been a growing interest regarding Homoeopathy in people due to which some critics criticized it on the topic of clinical trials. So comparing Homoeopathic clinical trials to Conventional Medicine trials will provide a comparative analysis and deep and clear knowledge on this topic.
Clinical Trials in Homoeopathy – Clinical trials is a process for acquiring the knowledge of instruments intended for the cure of the natural disease. It is a systematic and orderly way of Investigating the pathogenetic power of medicine on healthy people which is also known as the curative power of the drug.
Clinical trials are randomized double blind placebo controlled with duration of 6 months to 1 year. In the cycle of clinical trials, each cycle consists of proving of Investigational Proving Substance (IPS) in one potency followed by IPS in the next higher potency. The Homoeopathic drug is always proved in ascending potencies. For each potency a batch is prepared. The provers will be enrolled following a pre-trial medical examination. Subsequent to a run-in period of 1 week the study medication will be prescribed to the prover.
Intervention arms are IPS and placebo and duration of administration is 3 days per batch with maximum 12 doses. Number of batches varies depending on the number of potencies in which the drug will be proved. Each batch of the drug will have 12 doses; each dose of 4 pills (Globules size 30). The prover is asked to take 4 doses in a day (4 hourly) for 3 days from the prescribed batch of the coded drug. After the completion of the batch, one month washout period will be maintained in all provers, before the next batch is initiated.
The study medication is coded and blinding is maintained during the study period with the Principal Investigator (PI). The code is broken at the research center after the study period is completed and data is analyzed.
An analysis to extract dependable homeopathic prescribing indications from a drug proving is required to contain the following dimensions:
- 1st dimension: All symptoms occurring during the proving
- 2nd dimension: Proving symptoms with relative characterizing assessment
- 3rd dimension: Characteristic symptoms (a highly individualized subset)
In the data analysis, the proving symptoms is identified and segregated from the symptoms
produced in a placebo group. The proving symptoms will form the drug pathogenesis.
The inclusion criteria are the characteristics that participants must have in order to be eligible for the clinical trial which are:
- Age between 18 – 60 years
- Both males and females
- Healthy individuals with no apparent disease and normal routine laboratory parameters during screening
- Intelligent enough to record carefully the facts, subjective and objective symptoms generated by the drug during proving
- Able to be informed of the nature of the study and willing to give written informed consent
The exclusion criteria are the characteristics that disqualify participants from enrolling in the clinical trial which are:
- Any disease or condition which might compromise the hematopoietic, renal, endocrine, pulmonary, central nervous system, cardiovascular, immunological, dermatological, gastro-intestinal or any other body system
- Persons with color blindness
- Persons who have undergone surgery in the last two months
- Planned medical or dental treatment during the proving period including herbal or dietary supplements, procedures, or medications that are likely to interfere with, or substantially alter, responsiveness to the proving substance
- Volunteers on regular medication of Allopathic, Ayurvedic, Homoeopathic, Naturopathic, Unani, etc. for any acute or chronic disease
- Participant must not be on any Homoeopathic remedy in the preceding one month and have had no significant change in health status in last one month
- Emotionally disturbed, hysterical or anxious persons
- Persons having known history of allergies, food hypersensitivity, etc.
- Women during pregnancy, puerperium and while breast-feeding and women who have undergone hysterectomy
- Smokers who smoke more than 10 cigarettes per day
- Recent history of alcoholism or drug addictions or unlikely to refrain from excessive alcohol consumption or drug intake during the study period
- Participation in another clinical or proving trial during the last 6 months
Clinical Trials in Conventional Medicine – Clinical trial is a prospective ethically designed investigation in human subjects to objectively discover/verify/compare the results of two or more therapeutic measures. Clinical trials are designed to answer one or more precisely framed questions about the value of treating equivalent groups of patients by two or more modalities (drugs, dosage regimens, other interventions). Clinical trials may be conducted in healthy volunteers or in volunteer patients.
Clinical trials are randomized single or double blind placebo controlled with a wide time duration depending on the type of trial, the disease or condition being studied, and the drug or device being tested. However, in general, clinical trials can take several years to complete. The clinical trial process is typically divided into four phases:
- Phase I: The main objective of Phase I trials is to assess the safety and tolerability of a new drug in a small group of healthy volunteers (usually 20-100 people). It takes a time duration of 6-12 months.
- Phase II: Phase II trials involve a larger group of participants (usually 100-500 people) and are designed to assess the efficacy of the drug in treating a specific disease or condition. This phase also helps to further characterize the drug’s safety profile. It takes a time duration of 1-2 years.
- Phase III: Phase III trials are the largest and most comprehensive clinical trials. They involve hundreds or even thousands of participants and are designed to definitively establish the efficacy and safety of the drug in a large population of patients. It takes a time duration of 3-5 years.
- Phase IV: Phase IV trials are conducted after a drug has been approved for marketing. These trials are used to monitor the long-term safety and efficacy of the drug in real-world settings. The trials can continue for many years after a drug has been approved for marketing.
The dose of the investigational drug administered in clinical trials is also determined by the route of administration. For example, drugs that are administered orally are typically given at higher doses than drugs that are administered intravenously. The dose of an investigational drug given in clinical trials of conventional medicine are given as follows:
- Phase I: The trials typically start with very low doses and gradually increase the dose until the maximum tolerated dose (MTD) is reached. The MTD is the highest dose of the drug or device that can be safely administered without causing unacceptable side effects.
- Phase II: Once the MTD has been established clinical trials can be conducted to assess the efficacy of the drug at the MTD and at lower doses.
- Phase III: It is typically large-scale trials that compare the investigational drug to a standard of care treatment. The trials are designed to definitively establish the efficacy and safety of the drug in a large population of patients.
The dose and frequency of administration of the investigational drug or device may vary depending on the specific disease or condition being studied, the drug being tested, and the goals of the clinical trial. Clinical trial participants are closely monitored for any side effects that they experience. If a participant experiences unacceptable side effects, the dose of the investigational drug or device may be reduced or the participant may be withdrawn from the trial.
The inclusion criteria are the characteristics that participants must have in order to be eligible for the clinical trial which are:
- Age 18-65 years
- Male or female
- Diagnosis of non-small cell lung cancer
The exclusion criteria are the characteristics that disqualify participants from enrolling in the clinical trial which are:
- Pregnant or breastfeeding women
- History of other malignancies within the past 5 years
- Uncontrolled diabetes or hypertension
- Active infection
- Allergic to the investigational drug
Analysis is typically conducted using a variety of statistical methods. The specific methods used will depend on the type of trial, the disease or condition being studied, and the primary and secondary endpoints of the trial. The analysis can be complex, and there are a number of factors that can affect the results of the analysis.
RESULTS AND DISCUSSION – Homeopathic and Conventional Medicine clinical trials differ in a number of ways.
- Duration: Homeopathic clinical trials are typically shorter and take less time than Conventional Medicine clinical trials. Homoeopathic clinical trials last for 6-12 months while Conventional Medicine clinical trials last for 3-5 years. This is because Homoeopathic trials focus on assessing the safety and efficacy of a single remedy in a small group of participants, while Conventional Medicine trials typically compare multiple treatments in a large group of participants.
- Patient Population: Homeopathic clinical trials typically involve only healthy volunteers, while Conventional Medicine clinical trials involve patients with a specific disease or condition. This is because Homoeopathic trials are designed to assess the pathogenesis of a remedy, while Conventional Medicine trials are designed to assess the efficacy of a treatment in a specific patient population.
- Endpoints: Homoeopathic clinical trials typically use subjective endpoints, such as patient-reported symptoms and well-being, to measure efficacy. Conventional Medicine clinical trials typically use objective endpoints, such as lab results and imaging data, to measure efficacy.
- Blinding: Homoeopathic clinical trials are typically double-blind and placebo-controlled, meaning that neither the participants nor the researchers know who is receiving the Homoeopathic remedy and who is receiving the placebo. Conventional Medicine clinical trials may be single-blind, double-blind, or open-label, depending on the type of trial and the treatment being tested.
Despite these differences, both Homoeopathic and Conventional Medicine clinical trials are important for assessing the safety and efficacy of new treatments.
CONCLUSION – Homoeopathic and Conventional Medicine clinical trials differ in a number of ways, including duration, patient population, endpoints, and blinding. However, both types of clinical trials are important for assessing the safety and efficacy of new treatments.
In Homoeopathy, clinical trials are always done on the mentally and physically healthy humans who don’t have any kind of addiction. The number of doses of the medicine and its repetition is also limited under certain boundaries and even the size of the globules to be used during clinical trials is fixed. Homoeopathic clinical trials work in three dimensions .i.e. from getting symptoms to getting highly individualized symptoms. Homoeopathic clinical trials usually take 6 months to 1 year to complete.
In Conventional Medicine, clinical trials are done on humans either healthy or not. It also does not focus on mental health or addiction in prover. Also the number of doses of medicine and its repetition is also not fixed, it continues till it shows any adverse effects on prover. Conventional Medicine clinical trials work in 4 phases which are time taking around 3-5 years.
In Homoeopathy, accidental proving and clinical proving is also a part of clinical trials in some cases which is not seen in the case of Conventional Medicine.
REFERENCE –
- A Treatise on Organon of Medicine (Part-1) by Dr. Asok Kumar Das, reprint edition March 2018, published by Souvik Homoeo Publication.
- A Text Book of Homoeopathic Pharmacy by Mandal Pratim Partha, B. Mandal, 3rd edition 2012, published by New Central Book Agency (P) Ltd.
- Essentials of Medical Pharmacology by K. D. Tripathi, 8th edition 2019, published by Jaypee Brothers Medical Publishers (P) Ltd.
- Drug Proving Protocol, October 2014 issue, by Central Council for Research in Homoeopathy India (CCRH India)
- Website of Central Drugs Standard Control Organization (CDSCO)
- Schedule Y amendment to the Drugs and Cosmetics Act, 1945.
- Health Topics on Clinical Trials, by the World Health Organization.
ABOUT THE AUTHOR –
- Dr. Preeti Jha,
Assistant Professor Department of Forensic Medicine and Toxicology, Parul Institute of Homoeopathy and Research, Parul University, Vadodara, Gujarat.
- Shaikh Mohammed Hamza Jamaluddin,
Student of 3rd BHMS, Parul Institute of Homoeopathy and Research, Parul University, Vadodara, Gujarat.
