Observational study of homeopathic and conventional therapies in patients with diabetic polyneuropathy

doi:10.1016/j.homp.2008.11.006

Homeopathy

Volume 98, Issue 1, January 2009, Pages 17-25

https://doi.org/10.1016/j.homp.2008.11.006 Get rights and content

Methods

The feasibility and outcomes of homeopathic therapy in a group of type-2 diabetes mellitus patients with diabetic neuropathy were studied in a prospective observational study. Patients were followed from baseline (T0) for 6 months (T1) and for 12 months (T2), treatment was adjusted as necessary. Primary outcome was diabetic neuropathy symptom (DNS) score, secondary outcomes were clinical evolution and short-form-36 (SF-36)-evaluated quality of life (QOL).

Results

Homeopathy was used in 45 patients, 32 of whom completed the observation study, and in parallel the conventional therapy outcomes were observed in 32 patients, 29 of whom completed the study. DNS improved in both groups during the observation period, but the change with respect to baseline was statistically significant only in Homeopathic group at T1 (P = 0.016). Over the course of the observation there was a substantial stability of the electroneurophysiological values, blood pressure and body weight in both groups, a slight decrease of fasting blood glucose and glycated haemoglobin in Homeopathic group. QOL scores showed an improvement in Homeopathic group only. The cost of conventional drugs decreased in Homeopathic group from 114 €/month to 94 €/month at T1.

Conclusion

Complementary homeopathic therapy of diabetic neuropathy was feasible and promising effects in symptom scores and cost savings were observed.

Introduction

Public demand for complementary therapies including particular for homeopathy is increasing, because patients are not completely satisfied with conventional treatments for many conditions. It is therefore necessary to initiate constructive and documented comparison between the different therapies and their possible integration, particularly in situations where conventional medicine is limited. Recent multi-practitioner pilot studies have indicated that systematic recording of clinical data in homeopathy is both feasible and capable of informing future research.1, 2, 3, 4, 5, 6

In this study, diabetic neuropathy in a group of type-2 diabetes mellitus patients was considered. Patients affected with this disease often have polyneuropathies causing pain, functional limitations and worsening of the quality of life (QOL). Diabetes is often (>50% of cases) complicated by peripheral neuropathy: a painful, often debilitating condition, which may be associated with ulcers of the lower limbs and in even death due to autonomic neuropathy.

Unfortunately, in terms of therapy little can be done for the neuropathy. So, while future hopes lie in the advancement of research into potential pharmacological agents, for the present particular emphasis is placed on prevention, especially the early and careful control of glycaemia. It is common experience that most type-2 diabetic patients, besides dietary interventions, receive more than one drug, including oral antidiabetic drugs and insulin; however, good control of glycaemia may be achieved in only about 25% of patients. To obtain better results, the treatment should include multidisciplinary efforts. A simple biochemical-laboratory approach is not sufficient, other mental, emotional and spiritual dimensions also need to be treated.7, 8, 9

Given this, an attempt at treatment based on associating homeopathy with traditional therapy appears justified. On the basis of our previous experience in other chronic and neurological pathologies,1, 10 the hypothesis that justifies the homeopathic approach is that it might bring further improvement in the local symptoms of the disease and in the QOL compared to conventional therapy alone. A first exploratory, observational, study was thus undertaken, taking advantage of the existence of a long-standing collaboration between homeopaths and conventional doctors in the Quarenghi Clinic (Bergamo, I), which has a formal agreement with Lombardia Region of the Italian National Health Service, for care and rehabilitation services. Participation in this observational study was proposed to the patients who came to this medical centre. For ethical reasons and due to the observational nature of the design, the choice whether to take advantage of the homeopathic treatment (free of charge) was left to the patient after he/she had been given adequate information. The study comprised two nonrandomised groups, treated for 1 year either with homeopathic therapy (and conventional therapy when necessary), or with conventional therapy alone.

In addition to the specific symptoms and signs of the pathology, the objectives of the study included evaluation of the changes in QOL, assessed by the short-form-36 (SF-36) questionnaire, which is well validated11, 12, 13, 14 and has been used for studies in non-conventional or complementary medicine.1, 15, 16 Thus documentation of the clinical and psychological evolution and the peculiarity of the homeopathy, which is never directed solely to the removal of a symptom but to the overall treatment of the person, were respected.

Section snippets

Study design

This was a nonrandomised, prospective, observational study, with a follow-up of 12 months, of the clinical evolution and the QOL, in a group of patients receiving homeopathic treatment as complementary care and in another group receiving conventional therapy only. The patients of Homeopathic group were treated according to homeopathic therapy based on criteria of classical (individualized) homeopathy.1, 7 The protocol was approved by the Scientific Technical Committee of the Regione Lombardia

Patients included and drop-outs

45 patients were included in Homeopathic group (homeopathic treatment and conventional treatment) and 32 patients in Conventional group (conventional therapy alone) (Table 1). Patients who withdrew from the study were 13 from the Homeopathic group (6 voluntary unspecified withdrawals, 2 could not be contacted for follow-up, 1 serious heart disease, 1 stroke, 1 cognitive decline, 2 neoplasias) and 3 from the Conventional group (1 deceased, 1 neoplasia, 1 could not be contacted for follow-up).

Discussion

The object of this research was homeopathic therapy in diabetic neuropathy, carried out at professional practice level, in a Clinic where the collaboration with conventional doctors was operative. Through this observational study new knowledge was gained regarding the results of homeopathic therapy and conventional therapy in a serious chronic illness. The study proved to be feasible with little difficulty and the cooperation of the various specialists treating the patients proved to be

Competing interests declaration

Homeopathic medical doctors (R. Pomposelli, MD, C. Andreoni, MD, G. Costini, MD, and E. Tonini, MD) worked on a voluntary basis and did not receive supplementary compensation for the research. The doctors of the Quarenghi Clinic were A. Spalluzzi, MD (Diabetologist), D. Rossi, MD (Neurophysiologist) and C. Quarenghi, MD, (Internist). Dr. V. Piasere, MD, has received a grant from Belladonna Association. P. Bellavite, MD, and M.E. Zanolin are Professors at University of Verona (School of

Acknowledgements

The study was financed by a grant from “Belladonna” Association (Milan, Italy), a medical non-profit cultural association having the statutory purpose of supporting the research in homeopathy, and in part by Italian Ministry of Research (60%). Homeopathic medicines were provided free by Siffra (Strada in Chianti, Italy). We thank Yves Doessant for revision of manuscript.

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Studies have shown homoeopathy to effectively control blood sugar levels and improve quality of life (QOL), though a standard treatment protocol is required.
This study intended to assess the homoeopathic practice, prescription habits, experience, and perception of Indian Homeopathic Practitioners (HPs) in treating DM.
A web-based cross-sectional with a snowball sampling method was conducted between 30th July 2021 and 18th August 2021. A questionnaire to record clinical attributes of Indian HPs in the management of DM was formed after the consensus of the subject experts and pilot testing for feasibility.
Participants were 513 HPs with mean age [Standard Deviation (SD)] of 40.44 years (11.16) and a mean duration of the homoeopathic medical practice of 14.67 years [95% Confidence Interval (CI) = 13.71–15.63]. The majority of HPs made classical homoeopathic prescription (201, 39.2%) though the success in the management of DM was better among HPs who prescribed more than one potentized medicine [vs classical prescription, Odds Ratio (OR) = 2.34, p = 0.032]. As perceived by the HPs, homoeopathic treatment resulted in a major improvement in QOL of the diabetic patients (418, 81.5%) with very few adverse effect (100, 19.5%). The blood sugar level was controlled better when homoeopathy was given alongside conventional medicine (348, 67.8%).
The clinical experience of HPs in this study has shown that homoeopathic treatment can benefit DM patients in preventing complications and improving QOL. It further reported that homoeopathy can be an important adjuvant to conventional treatment in managing DM.
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–53,58 The aggravations were mostly characterized as exacerbation of eczema, psoriasis, atopic dermatitis, varicose eczema, asthma, headache, fever, sickness, allergy, pain, hot flushes, ear infections, aggravation of bulimia, urticarial, and lichen simplex. The control intervention was conventional medicine in sixteen studies38,41–43,49,59,62;(32);(35)36;;(60);(27, 33, 39, 44, 57) and complementary therapy (herbs) in two studies.64,66 Key data are summarized in Table 2 (Table 2).
Almost all health care interventions have the potential to be associated with risk to patient safety. Different terminologies are used to define treatment induced risk to patient safety and a common definition is the term adverse effect. Beyond the concept of adverse effect and specific to homeopathy is the concept of homeopathic aggravation. Homeopathic aggravation describes a transient worsening of the patients’ symptoms, which is not understood as an adverse effect. In order to ensure patient safety within a homeopathic treatment setting, it is important to identify adverse effects, as well as homeopathic aggravations, even though it may be challenging to distinguish between these two concepts. To date there is an obvious lack of systematic information on how adverse effects and homeopathic aggravations are reported in studies. This systematic review and meta-analysis focuses on observational studies, as a substantial amount of the research base for homeopathy are observational.
Eight electronic databases, central webpages and journals were searched for eligible studies. The searches were limited from the year 1995 to January 2020. The filters used were observational studies, human, English and German language. Adverse effects and homeopathic aggravations were identified and graded according to The Common Terminology Criteria for Adverse Effects (CTCAE). Meta-analysis was performed separately for adverse effects and homeopathic aggravations.
A total of 1,169 studies were identified, 41 were included in this review. Eighteen studies were included in a meta-analysis that made an overall comparison between homeopathy and control (conventional medicine and herbs). Eighty-seven percent (n = 35) of the studies reported adverse effects. They were graded as CTCAE 1, 2 or 3 and equally distributed between the intervention and control groups. Homeopathic aggravations were reported in 22,5% (n = 9) of the studies and graded as CTCAE 1 or 2.
The frequency of adverse effects for control versus homeopathy was statistically significant (P < 0.0001). Analysis of sub-groups indicated that, compared to homeopathy, the number of adverse effects was significantly higher for conventional medicine (P = 0.0001), as well as other complementary therapies (P = 0.05).
Adverse effects of homeopathic remedies are consistently reported in observational studies, while homeopathic aggravations are less documented. This meta-analysis revealed that the proportion of patients experiencing adverse effects was significantly higher when receiving conventional medicine and herbs, compared to patients receiving homeopathy. Nonetheless, the development and implementation of a standardized reporting system of adverse effects in homeopathic studies is warranted in order to facilitate future risk assessments.
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The details of the validated scales used (DNS, DNE and NTSS-6), data collection and data management in the study have been published elsewhere.[15] On the basis of earlier observational studies [7,10,11,12], and repertorization of symptoms of DDSP symptoms 15 common homoeopathic medicines were shortlisted, namely Arsenic album, Calcarea carbonica, Carbo vegetabilis, Conium maculatum, Kali carbonicum, Lycopodium, Phosphorus, Pulsatilla, Plumbum metallicum, Mercurius solubilis, Sulphur, Phosphoric acid, Natrum muraticum, Nitric acid and Zincum metallicum. Medicines were procured from a GMP compliant firm.
In course of diabetes, some 20–90% of individuals eventually develop diabetic neuropathy. Looking at the disease burden research studies in Homoeopathy were conducted and have shown positive results. These studies were not robust enough to prove the efficacy of individualized homoeopathy.
To assess efficacy of individualized homoeopathic medicines in management of DDSP.
A multi-centric double-blind, placebo controlled, randomised clinical trial was conducted by the Central Council for Research in Homoeopathy at six centres with a sample size of 84. Based on earlier observational studies and repertorial anamnesis of DDSP symptoms 15 homoeopathic medicines were shortlisted and validated scales were used for evaluating the outcomes post-intervention. Primary outcome measure was change in Neuropathy Total Symptom Score-6 (NTSS-6) from baseline to 12 months. Secondary outcomes included changes in peripheral nerve conduction study (NCS), World Health Organization Quality of Life BREF (WHOQOL-BREF) and Diabetic Neuropathy Examination (DNE) Score at 12 months.
Data of 68 enrolled cases was considered for data analysis. Statistically significant difference (p<0.014) was found in NTSS-6 post intervention in the Verum group. Positive trend was noted for Verum group as per the graph plotted for DNE score and assessment done for NCS. No significant difference was found between the groups for WHOQOL-Bref. Out of 15 pre-identified homoeopathic medicines 11 medicines were prescribed in potencies in ascending order from 6C to 1M.
Further studies must be taken up with larger sample size and defined parameters for NCS to assess the effectiveness of homoeopathy.
Therapeutic Homeopathy
2018, Integrative Medicine: Fourth Edition
Individualized homeopathic treatment in addition to conventional treatment in type II diabetic patients in Hong Kong – a retrospective cohort study
2017, Homeopathy
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However, the expected correlations between treatment effect with age (Pearson correlation = −0.107, p = 0.595), duration of diabetes (Pearson correlation = 0.058, p = 0.772) and number of OAD (Spearman correlation = 0.067, p = 0.756) were all non-significant (Figure 3). The results of the present study were concordant with those of previous studies31,32: FPG was significantly improved 12 months after individualized homeopathic management. The improvement in HbA1c was also concomitant with an improvement in FPG.
Glycaemic goals are not achieved in most patients with type II diabetes mellitus (T2DM), especially in those with long disease duration and taking multiple oral antidiabetic drugs (OAD). We aimed to investigate the effectiveness of individualized homeopathic treatment in glycaemic control.
Retrospective cohort study.
At least 6 months of individualized homeopathic treatment at a private homeopathic centre in Hong Kong.
Twenty-seven adults aged 37–84 years were treated with individualized homeopathic remedies between 2012 and 2015. Published data on 40 T2DM patients under standard conventional treatment in Hong Kong were used as a control.
Change in fasting plasma glucose (FPG) and glycated haemoglobin (HbA1c) at 12-month or the last follow-up, whichever is earlier.
Compared with the conventional treatment only group, the homeopathy group had higher baseline FPG (p = 0.044), and more patients had a long (>20 years) duration of diabetes (p = 0.006), and a history of cardiac events (p = 0.022). The mean difference in FPG in the homeopathy group was significantly greater than in the control after 12 months: −2.24 mmol/L (95% confidence interval [CI]: −3.47 to −1.01) vs 0.16 mmol/L (95% CI: −1.72 to 2.04), p = 0.001. The mean difference in glycated haemoglobin (HbA1c) was also significantly greater, −1.11% (95% CI: −2.17 to −0.05) vs 0.08% (95% CI: −1.37 to 1.53), p = 0.046. Poorer baseline glycaemic control was associated with better outcome (r = −0.750, p < 0.001), but not the duration of diabetes (r = 0.058, p = 0.772). The improvement was robust to sensitivity analyses.
Individualized homeopathic treatment was associated with better glycaemic control compared with standard conventional treatment alone.
A prospective multi-centric open clinical trial of homeopathy in diabetic distal symmetric polyneuropathy
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The peak prevalence of DPN in this study was in the age group of 50 to <60 years which is supported by the findings of Ramachandran et al.27 and Pomposelli et al.28 The male and female patients ratio were similar with several populations based multi-centric such as the National Urban Diabetes Survey (NUDS) and Prevalence of Diabetes in India Study (PODIS).25,29,30 In this study improvement in the intensity of symptoms of DPN with homeopathic medicines was observed, similar to the findings of Pomposelli et al28 where there was no changes in conventional treatment but Homeopathy as add-on therapy bought incremental benefits to DPN patients. Nerve conduction velocity improves only when glycaemic control is aggressively pursued, but symptoms of diabetic neuropathy may not improve.4
To evaluate homeopathic treatment in the management of diabetic distal symmetric polyneuropathy.
A prospective multi-centric clinical observational study was carried out from October 2005 to September 2009 by Central Council for Research in Homeopathy (CCRH) (India) at its five Institutes/Units. Patients suffering from diabetes mellitus (DM) and presenting with symptoms of diabetic polyneuropathy (DPN) were screened, investigated and were enrolled in the study after fulfilling the inclusion and exclusion criteria. Patients were evaluated by the Diabetic Distal Symmetric Polyneuropathy Symptom Score (DDSPSS) developed by the Council. A total of 15 homeopathic medicines were identified after repertorizing the nosological symptoms and signs of the disease. The appropriate constitutional medicine was selected and prescribed in 30, 200 and 1 M potency on an individualized basis. Patients were followed up regularly for 12 months.
Out of 336 patients (167 males and 169 females) enrolled in the study, 247 patients (123 males and 124 females) were analyzed. All patients who attended at least three follow-up appointments and baseline curve conduction studies were included in the analysis.). A statistically significant improvement in DDSPSS total score (p = 0.0001) was found at 12 months from baseline. Most objective measures did not show significant improvement. Lycopodium clavatum (n = 132), Phosphorus (n = 27) and Sulphur (n = 26) were the medicines most frequently prescribed. Adverse event of hypoglycaemia was observed in one patient only.
This study suggests homeopathic medicines may be effective in managing the symptoms of DPN patients. Further studies should be controlled and include the Quality of life (QOL) assessment.

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Original paperObservational study of homeopathic and conventional therapies in patients with diabetic polyneuropathy

Methods

Results

Conclusion

Introduction

Section snippets

Study design

Patients included and drop-outs

Discussion

Competing interests declaration

Acknowledgements

Br Homeopath J

Homeopathy

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Palliat Med

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J Altern Complement Med

The science of homeopathy

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Integr Cancer Ther

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Medicina Naturale

The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection

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Original paper
Observational study of homeopathic and conventional therapies in patients with diabetic polyneuropathy