A prospective multi-centric open clinical trial of homeopathy in diabetic distal symmetric polyneuropathy

Nayak, Chaturbhuja; Oberai, Praveen; Varanasi, Roja; Baig, H; Ch, Raveender; Reddy, G Ravi Chandra; Devi, P. Gayathri; Bhubaneshwari, S; Singh, Vikram; Singh, Huidrom Lokhendro; Shitanshu, Shashi Shekhar

doi:10.1016/j.homp.2013.02.004

Cited by 14 publications

(12 citation statements)

References 15 publications

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“…The results of the present study were concordant with those of previous studies 31 , 32 : FPG was significantly improved 12 months after individualized homeopathic management. The improvement in HbA1c was also concomitant with an improvement in FPG.…”

Section: Discussionsupporting

confidence: 92%

“…The improvement in HbA1c was also concomitant with an improvement in FPG. The magnitude of the observed difference was less in the previous studies despite the larger sample size because only patients with good glycaemic control were included (HbA1c <8%) 32 by the eligibility criteria. The larger treatment effect that was found in those with poorer glycaemic control could be understood intuitively, as there is little room for improvement for those with good glycaemic control.…”

Section: Discussionmentioning

confidence: 84%

“…A 12-month observational study was available for individualized homeopathic treatment in 2008, n = 45 in the homeopathic group and n = 32 in the conventional treatment group, a significant improvement was found in the diabetic neuropathy symptoms score ( p = 0.016), and a non-significant decrease in fasting plasma glucose (FPG) and HbA1c were observed. 31 A much larger (n = 336) prospective, multi-centric, clinical observational study on individualized homeopathic treatment on diabetic polyneuropathy published in 2013 32 showed a significant improvement in the total symptom score ( p = 0.0001) in patients with good diabetic control (HbA1c < 8.0), a reduction in FPG (mean reduction = 0.5 mmol/L, p = 0.0001) and post-prandial plasma glucose (mean reduction = 1.5 mmol/L, p = 0.0001) in 1-year follow-up.…”

Section: Introductionmentioning

confidence: 99%

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Individualized homeopathic treatment in addition to conventional treatment in type II diabetic patients in Hong Kong – a retrospective cohort study

To¹,

Fok

Chong

et al. 2017

Homeopathy

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Section: Discussionsupporting

confidence: 92%

Section: Discussionmentioning

confidence: 84%

Section: Introductionmentioning

confidence: 99%

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Individualized homeopathic treatment in addition to conventional treatment in type II diabetic patients in Hong Kong – a retrospective cohort study

To¹,

Fok

Chong

et al. 2017

Homeopathy

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“…of India, has conducted many observational studies in primary health care settings to describe and investigate homeopathic health care strategies under primary care conditions and to get data to evaluate the usefulness of the therapy (e.g. for climacteric symptoms, 28 chronic sinusitis, 29 diabetic neuropathy, 30 depression, 31 schizophrenia 32 and many other disease conditions).…”

Section: Types Of Observational Studies Cohort Studiesmentioning

confidence: 99%

Recommendations for Designing, Conducting and Reporting Observational Studies in Homeopathy

et al. 2020

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Background Randomized placebo-controlled trials are considered to be the gold standard in clinical research and have the highest importance in the hierarchical system of evidence-based medicine. However, from the viewpoint of decision makers, due to lower external validity, practical results of efficacy research are often not in line with the huge investments made over decades. Method We conducted a narrative review. With a special focus on homeopathy, we give an overview on cohort, comparative cohort, case-control and cross-sectional study designs and explain guidelines and tools that help to improve the quality of observational studies, such as the STROBE Statement, RECORD, GRACE and ENCePP Guide. Results Within the conventional medical research field, two types of arguments have been employed in favor of observational studies. First, observational studies allow for a more generalizable and robust estimation of effects in clinical practice, and if cohorts are large enough, there is no over-estimation of effect sizes, as is often feared. We argue that observational research is needed to balance the current over-emphasis on internal validity at the expense of external validity. Thus, observational research can be considered an important research tool to describe “real-world” care settings and can assist with the design and inform the results of randomised controlled trails. Conclusions We present recommendations for designing, conducting and reporting observational studies in homeopathy and provide recommendations to complement the STROBE Statement for homeopathic observational studies.

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“…13 Two multicenter studies have suggested a promising role for homeopathic treatment in diabetic distal symmetric polyneuropathy. 14,15 This randomized controlled trial (RCT) was the first attempt at exploring the efficacy of IHMs in individuals with PD in comparison with placebos.…”

Section: Introductionmentioning

confidence: 99%

A Double-Blind, Randomized, Placebo-Controlled Clinical Trial to Evaluate the Efficacy of Individualized Homeopathic Medicines in Pre-diabetes

et al. 2023

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Background Pre-diabetes (PD) contributes importantly to the disease burden worldwide and is a precursor to stroke, cardiovascular diseases, as well as type-2 diabetes mellitus. Objective In this project, the efficacy of individualized homeopathic medicines (IHMs) was explored against placebos in the treatment of PD. Methods A 6-month, double-blind, randomized, placebo-controlled trial was conducted at the outpatient departments of a homeopathic medical college and hospital in India. Sixty participants with PD were randomized to receive either IHMs (n = 30) or identical-looking placebos (n = 30). Concomitant care measures were advised to both groups of participants in terms of dietary advice, yoga, meditation and exercise. The primary outcome measures were fasting blood sugar (FBS) and the oral glucose tolerance test (OGTT); the secondary outcome was the Diabetes Symptom Checklist-Revised (DSC-R) score. All the outcomes were measured at baseline and after 3 and 6 months of treatment. Inter-group differences and effect sizes (Cohen's d) were calculated using two-way repeated measures analysis of variance models after adjusting baseline differences using analysis of co-variance on the intention-to-treat data. Results Between-group differences in FBS were statistically significant, favored IHMs against placebos (F 1,58 = 7.798, p = 0.007) but not for OGTT (F 1,58 = 1.691, p = 0.199). The secondary outcome, DSC-R total score, favoring IHMs significantly compared with placebos (F 1,58 = 15.752, p < 0.001). Calcarea Carbonicum, Thuja occidentalis and Sulphur were the most frequently prescribed medicines. No harm or serious adverse events were recorded from either of the participant groups. Conclusion IHMs produced significantly better results than placebos in FBS and in DSC-R scores but not in OGTT. Independent replications with larger sample sizes are warranted to substantiate the findings. Trial registration CTRI/2019/10/021711

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A prospective multi-centric open clinical trial of homeopathy in diabetic distal symmetric polyneuropathy

Abstract: 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.

Cited by 14 publications

References 15 publications

Individualized homeopathic treatment in addition to conventional treatment in type II diabetic patients in Hong Kong – a retrospective cohort study

Individualized homeopathic treatment in addition to conventional treatment in type II diabetic patients in Hong Kong – a retrospective cohort study

Recommendations for Designing, Conducting and Reporting Observational Studies in Homeopathy

A Double-Blind, Randomized, Placebo-Controlled Clinical Trial to Evaluate the Efficacy of Individualized Homeopathic Medicines in Pre-diabetes

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