Research-Oriented Homoeopathic Approach: Need of the Hour

Abstract:Since the inception of homoeopathy by Dr. Hahnemann who himself “re-searched” into the history to prove the theories he discovered, there are several research papers published in homoeopathy. Currently, the greatest weaknesses in homoeopathic research are the variety of unreplicated studies and the small sample sizes. Hence, there is a need for use of appropriate research methodology, following guidelines for conducting research, use of validated tools and Multi-site research studies with larger sample sizes.

Key words: Research orientation, Homoeopathy, HOM-CASE

Abbreviations: RCT- randomised controlled trial, HPT- homoeopathic pathogenetic trial

Introduction

The homoeopathic sector has begun to realise the need for scientific research. Research orientation is what we need today, as we talk of scientific evidence-based medicine.

An authoritative paper concluded that ‘the evidence of the effectiveness of homoeopathy for specific clinical conditions is scant, is of uneven quality, and is generally of poorer quality than research done in allopathic (mainstream) medicine.’ Nevertheless ‘when only high-quality studies have been selected… a surprising number show positive results’ although ‘even the best systematic reviews cannot disentangle components of bias in small trials.’ These authors conclude that ‘more and better research is needed, unobstructed by belief or disbelief in the system.’ ^[1]

Despite 200 years of practise of homoeopathy and several recent studies documenting homoeopathic treatment effects under double-blind conditions, the medical and scientific community has generally dismissed these findings because of a lack of a plausible mechanism for the observed effects. ^[2]

The report states that clinical trials done for evaluation of homoeopathy, taken in their totality, are most consistent with nonspecific effects and placebo responses. ^[3]

This can be, as the success of any clinical trial depends on the prescriber, the skills to individualise and prescribe the simillimum, i.e. the individualised medicine in homoeopathy. Prescriptions without justifications in clinical trials lead to questionable results.

So now, trial designs must be revisited in homoeopathy. The focus must be being laid on personalized medicine ^[4] and scientific tools for assessing the reliability and validity of homoeopathic trials ^[5]

Emphasis must be made on selecting the research study.

1. Descriptive study
   1. Case study / case report

Case reports are considered the first step to demonstrate evidence-based medicine. A case report should be a unique clinical experience in terms of diagnosis, investigations, or management that widens the scope of homoeopathy.

Each peer-reviewed journal in homoeopathy has a section where case reports are included. The Indian Journal of Homoeopathy has given a template for Case Reports.

For Example, A 15-mm urinary calculus expelled with homoeopathic medicine – A case report by Rai S and Vineetha K R published in Indian J Res Homoeopathy 2021;15:155-61 ^[6]

CARE guidelines had been evolved for writing case reports. Van Haselen, using the Delphi technique with a panel of 19 homoeopathic experts, suggested modifications in the CARE case report guidelines for writing homoeopathic case reports. He has recommended using these HOM-CASE guideline extensions to improve the quality of homoeopathic case reports. ^[7]

1. Case series

A case series (also known as a clinical series) is a type of medical research study that tracks subjects with a known exposure, such as patients who have received a similar treatment, ^[8] or examines their medical records for exposure and outcome. Case series may be consecutive ^[9] or non-consecutive, ^[10] depending on whether all cases presenting to the reporting authors over a period were included, or only a selection.

For example, Homoeopathic management of wrist ganglion: A Case series published in Indian J Res Homoeopathy 2021; by Nath and Palit DK. ^[11]

1. Cross-sectional survey

 A cross-sectional survey collects data to make inferences about a population of interest (universe) at one point in time. ^[12] 

For example, An online cross-sectional survey on knowledge, attitudes, practices, and perspectives of homoeopathic practitioners towards COVID-19 by Taneja D and Khurana A published in Indian J Res Homoeopathy 2020;14:90-9.^[13]

• Analytical study
  • Observational studies: The three classical types of observational studies in research are –  
    • Cohort studies: In cohort studies, a cohort, i.e., a group of people with some similarity, e.g., in treatment, diagnosis, or location, is followed up and systematically observed within a given timeframe.
      • Prospective cohort study: The study begins with a baseline assessment at the starting time point and progresses into the future with follow-up assessments of data.
      •  Retrospective cohort study: The data are collected only from already extant records. The outcome has already occurred and is assessed retrospectively.

For Example, A cohort study by Witt et al, which included nearly 4000 new patients undergoing homoeopathic case taking and followed up this cohort for 8 years. This study allowed observation of who consulted a homoeopathic physician, how frequently the consultations took place, which remedies and potencies were prescribed, the intensity of complaints and quality of life changed over time. ^{[14, 15]}

1. Case-control: The researcher identifies an existing health problem (“cases”) and a similar group without the problem (“controls”) and then compare them retrospectively concerning exposure. ^[16]

For example, A study trying to show that people who smoke (the attribute) are more likely to be diagnosed with lung cancer (the outcome), the cases would be persons with lung cancer, the controls would be persons without lung cancer (not necessarily healthy), and some of each group would-be smokers.^[16]

There are guidelines and tools relevant for homoeopathy that help to improve the quality of observational studies, such as the STROBE Statement, RECORD, GRACE, and the ENCePP Guide. ^[17]

• Interventional studies

Interventional study designs, also called experimental study designs, are those where the researcher intervenes at some point throughout the study.

1. Control trial: Controlled trials allow discrimination of the patient outcome from an outcome caused by other factors (such as natural history or observer or patient expectation). The different types of control trials are:
2. Placebo control helps to discriminate outcomes due to intervention (new product) from outcomes due to other factors. This design is used to demonstrate superiority or equivalence. There are many homoeopathic research papers published using placebo control trials. While conducting a homoeopathic pathogenetic trial (HPT), a placebo control trials can be used to elicit the pathogenetic effects of the homoeopathic preparation vs placebo. ^[18]
3. “No treatment” concurrent control – No intervention will be administered in the control arm in this design. Study endpoints must be objective in this design.
4. Active treatment concurrent control – This design involves the comparison of a new drug to a standard drug or compare a combination of new and standard therapies vis a vis standard therapy alone.
5. Historical control (external and non-concurrent) – sources of controls are external to the present study and were treated at an earlier time (earlier therapeutic gold standard) or in a different setting. ^[19,20]

1. Randomized control trial: In randomised controlled trials, trial participants are randomly assigned to either treatment or control arms.
2. Parallel group trial design: In this design, subjects are randomized to one or more study arms and each study arm will be allocated a different intervention. After randomization, each participant will stay in their assigned treatment arm for the duration of the study.

• Cross over design: In this design, some participants start with drug A and then switch to drug B (AB sequence) in one trial arm, while subjects in other trial arm start with drug B and then switch to drug A (BA sequence). An adequate washout period must be given before crossover to eliminate the effects of the initially administered intervention. Outcomes are then compared within the same subject (effect of A vs. effect of B). This study has a limitation, as it is difficult to decide the washout period of Homoeopathic medicine. 

Blinding in randomised controlled trial if withholding the treatment arm from individuals involved in the study. Blinding within randomised controlled trial includes patient blinding, provider blinding, or assessor blinding. ^{[19, 20]}

For example:

1. A randomized controlled trial in the management of alcohol dependence: Homoeopathic vs. standard Allopathic treatment, conducted by Central Council for Research in Homoeopathy, published in Indian J Res Homoeopathy 2014;8:187-93 ^[21]
2. Effects of individualized homoeopathic intervention in Stage I essential hypertension: A single-blind, randomized, placebo-controlled trial, conducted by Dr. Roja Varanasi and others, published in Indian J Res Homoeopathy 2020;14:3-14 ^[22]

There are standards and guidelines to systematize and elevate the quality of interventional research design, execution, and reporting, such as CONSORT.

The main problem of randomised controlled trial in homoeopathy is that it is not personalised and personalised medicine is the essence of homoeopathy.

1. Systematic reviews and meta-analysis

Systematic reviews, as the name implies, typically involve a detailed and comprehensive plan and search strategy derived a priori, intending to reduce bias by identifying, appraising, and synthesising all relevant studies on a particular topic. ^[23]

Meta-analysis

Meta-analysis is a quantitative, formal, epidemiological study design used to systematically assess previous research studies to derive conclusions about that body of research. ^[24]

For Example

1. Veterinary Homoeopathy: Systematic Review of Medical Conditions Studied by Randomised Placebo-Controlled Trials, by Mathie RT, Clausen J, published in The Veterinary Record, Volume 175, Issue 15, 2014, Pages 373-381. ^[25]
2. Randomised Placebo-Controlled Trials of Individualised Homoeopathic Treatment: Systematic Review and Meta-Analysis, by Mathie RTet.al., published in Systematic Reviews, Volume 3, Issue 1, 2014, Page 142.^[26]

Meta‑analysis conducted using these Randomized Control Trails is criticized for ‘cherry‑picking’ of studies, disputed selection criteria and purposeful exclusion of studies. ^[27]

Problem with meta-analysis in homoeopathy: It reflects the point of view that the treatment with a specific remedy could be administered in a particular disease. However, homoeopathy aims to treat the whole person, rather than the diseases and each case has to be treated individually with an individualized remedy. Furthermore, the commonly known events during the course of homoeopathic treatment, such as “initial aggravation” and “symptom-shift” were not considered in almost all the studies. Thus, only few trials were eligible for meta-analyses, if at all. ^[28]

There are standard guidelines for reporting systematic reviews and meta-analysis such as   PRISMA, ^[27]

Conclusion

There is a need for “re-search” and “re-validation” of the existing work, by following the guidelines given for each research study and using validated tools.

Research studies must be taken on a larger sample size and at multi-centric levels.

There must be a Centralized database of research activities accessed globally, Observational studies, Systematic reviews and High-quality clinical trials and verification must be encouraged.

References

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About the author

Dr Neha Patel , MD, Assistant Professor, Smt C.M.P. Homoeopathic Medical College.