Evaluating the quality of existing research studies on homoeopathic interventions for type 2 diabetes mellitus: A systematic review

Eligibility criteria

A thorough search was conducted for clinical trials on the effectiveness of homoeopathic treatment in T2DM between 1990 and 2024. All the complete and accessible papers in the English language were collected. There was no age restriction. All the items were strictly reported according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines.^[8]

Search strategy

Different electronic bibliographic databases such as PubMed, Google Scholar, Cochrane library, Database of Abstracts of Reviews of Effects, latin american and caribbean health sciences literature (LILACS), Latin American and Caribbean, Health Sciences Literature, central council of research in homoeopathy (CCRH), Campbell Library of Systemic Review and Data Base of Systemic Review and Non-systemic Review of Public Health Intervention were searched for relevant literature. The National Institute for Health and Case Excellence database was also searched; no paper was found related to DM in homoeopathy. The search terms used were ‘Diabetes Mellitus’, ‘Pharmacopoeias, Homeopathic as Topic’, ‘Diabetes Mellitus, Type 2’, ‘Formularies, Homeopathic as Topic’, ‘National Institute of Diabetes and Digestive and Kidney Diseases (U.S.)’, ‘Pharmacopoeia, Homeopathic’, ‘Diabetes Mellitus, Noninsulin-Dependent’, ‘Formulary, Homeopathic’, “Diabetes Mellitus, Noninsulin-Dependent, Type 4’, ‘Materia Medica’, ‘Diabetes Mellitus, Noninsulin-Dependent, 1’, ‘Homeopathy’, ‘Diabetes Mellitus, Noninsulin-Dependent, 2’, ‘Complementary Therapies’, ‘Diabetes Complications’, ‘Traditional Medicine Practitioners’, ‘Prediabetic State’, ‘National Centre for Complementary and Integrative Health (U.S.)’, ‘Medicine, Traditional’, ‘Plants, Medicinal’, ‘Therapeutics’, ‘Disease Management’, ‘Medication Therapy Management’, ‘Practice Management’, ‘Case Management’, ‘Managed Care Programs’, ‘Patients Care Planning’, ‘Practice Management, Medical’ and ‘Patient Care Management’.

Study selection

Studies were limited to prospective control trials, cohort studies, molecular studies, in vitro and in vivo studies and observational studies with homoeopathic intervention only. Prospective control clinical trials and comparative studies of one homoeopathic treatment measured against another homoeopathic drug were also included in the study. There was no restriction regarding the form or mode of application of homoeopathic treatment.

Data extraction and items

Data were extracted by two reviewers (NS and SN) and checked by a third reviewer (KV) with the help of Rayyan software (www.rayyan.ai). The data items were extracted under the following points: type of DM, population demographic (age group and sex), sample size, interventions (homoeopathic medicine) and comparator (or control), outcomes and overall result. The JADAD scoring system was also used to assess the methodological quality of the selected trials on objective criteria of randomisation, blinding method and withdrawal or dropout description.

Standardised data extraction from the controlled clinical trials by the reviewers and blinding among reviewers provided consistency in the review, reduced bias and improved the quality of the study independently. These tools were used to assess the risk of bias in this study.

Charting the data

The data captured were as follows:

• (a) Author,

• (b) Year of publication,

• (c) Patients information (age group, sex)

• (d) Sample size,

• (e) Intervention,

• (f) Control group,

• (g) Result,

• (h) Scoring and

• (i) Comment.

The data were organised systematically in a spreadsheet and were discussed among all authors periodically.

Study selection and characteristics

An intensive search of clinical research manuscripts published between 1990 and 2024 was done. In the beginning, a total of 133 experimental and controlled clinical trials were identified. After complete screening, 83 papers were segregated, and finally, 14 eligible papers were selected for the review. Out of 14 reviewed papers, nine were clinical, four were in vivo and one in vitro paper was present [Figure 1].^[8]

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Figure 1:

Preferred reporting items for systematic reviews and meta-analyses flowchart. DARE: Database of Abstracts of Reviews of Effects, LILACS: Latin American and Caribbean Health Sciences Literature, CCRH: Central Council of Research in Homoeopathy

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All the clinical papers included in the review are arranged and analysed under various headings such as type of DM, age group, sex ratio, sample size and JADAD score in Table 1. In vivo studies are compiled under Table 2. Table 3 discusses the in vitro study included in the review.

A summary of the medicine analysis from different clinical papers is shown in Figure 2. The age group distribution mentioned in the reviewed papers is shown in Figures 3 and 4. The sex distribution of all the nine clinical papers is shown in Figure 5.

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Figure 2:

Medicines used in the studies.

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Figure 3:

Open-class age group.

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Figure 4:

Closed-class age group.

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Figure 5:

Sex analysis.

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Summary of evidence

The extensive examination of clinical investigations concerning homoeopathic interventions for DM, with a particular emphasis on T2DM, yields a sophisticated comprehension of the efficacy of diverse remedies, the characteristics of the patient demographics engaged and the advantages and drawbacks intrinsic to the research methodologies utilised.

Cephalandra indica was identified as the most prevalently administered homoeopathic remedy in the management of T2DM. Its extensive application is primarily described in numerous clinical investigations, notably those undertaken by Dr. Rastogi [Table 1, S. No. 7], who meticulously validated its hypoglycaemic properties. This remedy has demonstrated considerable potential in regulating blood glucose levels and ameliorating associated symptoms, thereby establishing itself as a fundamental component in homoeopathic treatment for DM.

Among other homoeopathic remedies, sulphur is the second-most commonly prescribed, reflecting its extensive applicability across various patient demographics. Natrum muriaticum and Pulsatilla are also frequently utilised for their efficacy in treating specific symptomatology of T2DM. Insulinum, lactic acid and lac defloratum emerged as the predominant remedies within the categories of sarcodes and nosodes, respectively, addressing critical constitutional and miasmatic issues pertinent to chronic conditions like DM.

The demographic analysis indicated that the majority of patients studied are aged 40–60, an age group recognised as particularly susceptible to DM. While inconsistencies in age distribution data were seen across studies, the predominant focus remained on this vulnerable age range in homoeopathic treatment for DM.

Sex representation in the studies was relatively equitable, with male subjects slightly outnumbering the female ones, comprising 52% of the sample. The understanding of homoeopathic treatment effects was noted across sexes, although some studies lacked detailed sex-specific data, which may constrain comprehensive analyses.

Several of the studies examined, including those conducted by Dastagiri,^[9] and Jaiswal and Shakya^[10] [Table 1, S. No. 1, 2], utilised observational or non-randomised methodologies. These investigations nonetheless offered significant insights, especially regarding the efficacy of particular homoeopathic treatments and miasmatic analysis in patients with T2DM. For example, Dastagiri’s research concerning miasmatic analysis indicated notable enhancements in the majority of cases, implying a possible association between miasmatic conditions and the management of DM. However, the absence of control groups and randomization within these studies introduced potential biases and constrained the generalizability of the findings. While these studies enrich the existing body of knowledge, their outcomes should be approached with caution due to the intrinsic limitations of their methodological frameworks.

Beyond the clinical trials, in vivo investigations have significantly contributed to the understanding of the biochemical effects of homoeopathic interventions on diabetic animal models. The studies by Shukla et al. and Maiti et al.^[18,19] [Table 2, S. No. 1, 2] illustrated that homoeopathic formulations, including Gymnema sylvestre and Syzygium jambolanum, can markedly lower blood glucose concentrations and enhance metabolic indicators in rats with Streptozotocin-induced DM. These results hold particular importance as they provide a scientific foundation for the clinical effectiveness observed in human clinical trial studies, thereby endorsing the potential of these remedies in managing DM.

In vitro investigations have yielded additional insights into the underlying mechanisms of action of homoeopathic treatments. For instance, the research conducted by Kishore and Singh [Table 3, S. No. 1] examined the influence of C. indica on advanced glycation end products, sorbitol accumulation and aldose reductase activity. The findings revealed that C. indica contains phenolic compounds that may significantly mitigate oxidative stress, a critical factor in the advancement of diabetic complications. These results imply that homoeopathic remedies could possess a wider therapeutic scope beyond mere glycaemic control, potentially conferring protective benefits against the long-term sequelae of DM.

The evidence assessed underscores the promising potential of homoeopathic remedies in the management of DM, particularly T2DM. Nevertheless, the variability inherent in study designs, patient demographics and methodologies suggests that while the findings are optimistic, they should be interpreted with an awareness of their constraints. There is an unequivocal necessity for more rigorous, large-scale, randomised controlled trials to authenticate these results and comprehensively elucidate the mechanisms through which homoeopathy may exert its effects in managing DM. The incorporation of these remedies into conventional DM management protocols could provide a complementary strategy, yet further investigation is imperative to establish their role more definitively.