Homoeopathic treatment for lower urinary tract symptoms in men with benign prostatic hyperplasia: an open randomized multicentric placebo controlled clinical trial

Background: Benign Prostatic Hyperplasia (BPH) associated with Lower Urinary Tract Symptoms (LUTS) is the most common condition in ageing men. The epidemiological studies estimate that 90% of men between 45 and 80 years of age suffer some type of LUTS.1 There is paucity of such epidemiological data from India but one study reports the prevalence of BPH among rural elderly of India as 11.8%2. Although LUTS secondary to BPH (LUTS/BPH) is not often a life-threatening condition, the impact of LUTS/BPH and its complications on Quality of Life (QoL) can be significant and should not be underestimated.3 When the effect of BPH-associated LUTS on QoL was studied in a number of community-based populations, for many, the most important motivations for seeking treatment were the severity and the degree of bother associated with the symptoms.4LUTS include storage and/or voiding disturbances common in ageing men. Although voiding symptoms are most common, storage symptoms responsible for daytime frequency, urgency and nocturia interfere the most with life activities. Homoeopathic constitutional treatment is useful in the treatment of a constellation of symptoms due to BPH and LUTS. Along with constitutional medicine homoeopathic practitioners are using organ medicines having special affinity for prostate and urinary bladder with good results. Traditionally the primary goal of treatment is to alleviate bothersome LUTS that result from prostatic enlargement. The literature review indicates that both homoeopathic constitutional medicines as well as organ specific remedies show positive results in relieving the symptoms of BPH but the study was not randomized and there was no control group to show its efficacy. In this backdrop the present study was undertaken to evaluate the storage and voiding symptoms of men having BPH through an internationally validated scale IPSS and the role of homoeopathic intervention, both constitutional and organ remedies on LUTS due to BPH and QoL of the patient. Objectives: The primary objective was to compare the changes in IPSS (International Prostate Symptom Score) within the three groups enrolled for the study (Constitutional remedy/Constitutional + Organ remedy/Placebo). The secondary objectives were to compare the changes in Prostate volume, Post Void Residual Urine (PVRU), Uroflowmetry and in WHOQOL-BREF.5 Material and Methods: The study was done in an open randomized placebo controlled setting at five research centers under Central Council for Research in Homoeopathy. The patients in the age group of 50-80 years presenting with the symptoms of incomplete emptying, frequency, intermittency, urgency, weak stream, straining and nocturia were screened from the general OPD as per ICD-10 Classification Code N40.0 following the predefined inclusion and exclusion criteria. A consultant Urologist was appointed at each center to screen and follow up the enrolled cases. The participants who qualified the inclusion criteria were enrolled in the study after obtaining the ‘Informed Written Consent’. It was a three armed randomized clinical trial where Intervention was administered as per the randomization chart for three groups i.e. homoeopathic constitutional medicine in LM potency (Group 1), homoeopathic constitutional medicine in LM potency with organ remedy in mother tincture and 3X (Group 2) and placebo (Group 3) in 2:2:1 ratio. The patients were followed for six months and the outcome of intervention was assessed monthly for IPSS (Primary objective) and at third and sixth month for prostate volume, post void residual urine, Qmax and Qavg, PSA and WHOQOL-BREF, (Secondary objectives). Internationally validated scales (IPSS &WHOQOL-BREF) were used to assess the outcome. Primary safety endpoint was any adverse event which may be life threatening, requires prolonged hospital stay, results in significant disability, an injury, accident or any other important medical event. 474 patients were screened and 252 patients were enrolled in the study. The analysis of these patients as per protocol and as per intention to treat was carried out using repeated measures ANOVA and paired T test. Results: Out of 254 patients enrolled in the study (HC=103, HC + O = 102 and Placebo = 49), 152 were analyzed as per protocol (HC=71, HC + O = 53 and Placebo = 28) as they completed a follow up period of 6 months whereas, 241 patients were analyzed as per ITT (HC=101, HC + O = 92 and Placebo = 48). 13 patients were excluded from analysis for reasons such as protocol violation and incomplete baseline information. There was statistically significant improvement in all the seven components of IPSS, WHOQOL- BREF and Q max values of uroflowmetry in both per protocol as well as ITT analysis. Discussion: Results from this trial will help in constructing treatment strategy for BPH patients with lower urinary tract symptoms to enable them to make an informed decision about available alternatives for the management of LUTS in BPH. The limitation of the study was that it was not blinded. The inhibition for not making it blinded was the use of mother tinctures of organ specific medicines in liquids of different colors and odours which could not be blinded. Pragmatic trial with longer follow up and a parallel arm comprising of conventional treatment may be undertaken in future to compare their role on LUTS due to BPH on pathological and pathophysiological parameters such as prostatic volume and post void residual urine. Trial Registration: Clinical Trial Registry - India: CTRI/2012/05/002649.

Exploring Heart Rate Variability as a Biomedical Diagnostic Tool for the Disympathetic Dimension of Eight-Constitution Medicine

Background. Eight-Constitution Medicine (ECM), an extension of Traditional Korean Medicine, divides the population into eight groups based on their physiological characteristics. ECM divides these eight groups into two larger groups based on autonomic reactivity: the Sympathicotonic group and the Vagotonic group (herein referred to as the Disympathetic Dimension). Heart Rate Variability (HRV) is a widely used biomedical tool to assess cardiac autonomic function. This raises the question of the utility of using HRV to correctly diagnose ECM constitutions. Methods. A systematic literature review was conducted to evaluate the correlation between HRV and constitutions in Korean Constitutional Medicine, including Eight-Constitution Medicine (ECM) and Sasang Constitution Medicine (SCM). The articles were obtained from both English (Scopus, PubMed, EMBASE, ProQuest, and Medline) and Korean databases (NDSL and RISS), in addition to Google Scholar, without date restriction. 20 studies met the inclusion criteria, and data were extracted against three aspects: (1) correlation between HRV and constitution, (2) HRV reporting and interpretation, and (3) extraneous factors that were controlled in the studies. Results. 386 articles were initially identified, which was reduced to n = 20 studies which met the inclusion criteria. Of these, 19 were SCM studies and 1 was an ECM study. Sample sizes varied from 10 to 8498 men and women, with an age range of 10–80 years. SCM studies explored HRV differences by constitution, measuring HRV at resting, with controlled breathing, before and after acupuncture stimulation, and by other interventions. SCM studies reported either no significant differences (HRV at resting or with controlled breathing studies) or conflicting data (HRV with acupuncture stimulation studies). The single ECM study measured HRV at resting and after acupuncture stimulation but reported no significant differences between the two groups of Sympathicotonia and Vagotonia. Conclusions. Due to inconsistencies in study design, study population, and measures of HRV, there was no consistency in the data to support the use of HRV as a biomedical determinant of ECM constitutions.

A Case of Alopecia and Its Homoeopathic Approach

Hair is an ornament & beauty of every person life. It is an outward filamentous growth made up of keratin protein. It has major cosmetic role along with other sensory & homeostatic function. Homoeopathy has wonderful role to reduce hair fall & re-growth of new hair. This article is an attempt to overview of hair cycle, why hair is fall, homoeopathic approach of hair fall or alopecia with different repertorial rubric analysis & a very interesting case history. Keywords Hair fall; Homoeopathy; Constitutional medicine; Miasm

Investigating the Biomarkers of the Sasang Constitution via Network Pharmacology Approach

Sasang constitutional (SC) medicine classifies people into Soeum (SE), Soyang (SY), Taeeum (TE), and Taeyang (TY) types based on psychological and physical traits. However, biomarkers of these types are still unclear. We aimed to identify biomarkers among the SC types using network pharmacology methods. Target genes associated with the SC types were identified by grouping herb targets that preserve and strengthen the requisite energy (Bomyeongjiju). The herb targets were obtained by constructing an herb-compound-target network. We identified 371, 185, 146, and 89 target genes and their unique biological processes related to SE, SY, TE, and TY types, respectively. While the targets of SE and SY types were the most similar among the target pairs of the SC types, those of TY type overlapped with only a few other SC-type targets. Moreover, SE, SY, TE, and TY were related to “diseases of the digestive system,” “diseases of the nervous system,” “endocrine, nutritional, and metabolic diseases,” and “congenital malformations, deformations, and chromosomal abnormalities,” respectively. We successfully identified the target genes, biological processes, and diseases related to each SC type. We also demonstrated that a drug-centric approach using network pharmacology analysis provides a deeper understanding of the concept of Sasang constitutional medicine at a phenotypic level.

An analytical study on effect of constitutional homeopathic medicines for single arm disability patients in age group of 6-15 years

Learning disability is a disorder of the basic physiological processes involved in using or understanding language written or spoken which manifest itself in imperfect ability to listen, speak, read, write, spell or do mathematical calculations. In this study, homeopathic medicine was prescribed to the 30 children having learning disability of age group 6 to 15. Synthesis repertory was used for repertorisation of cases and to find out constitutional medicine. Single dose of medicine was prescribed to every child at the interval of 10 to 15 days in required potency. Pre-assessment of each child was done with "Is It Dyslexia" free online evaluation by Davis Dyslexia Association. Visual Analogue Scale was used for before and after treatment analysis. Study showed significant result with mild to moderate improvement in 30 patients. Dyslexia and Dysgraphia come under category of specific developmental disorder. Dyslexia is characterized by failure to develop adequate reading skills and delay in learning to read which become apparent between the ages of 6 to 9 years. The clinical feature includes omission, distortions or substitutions of words, long hesitations, reversal of words or simply slow reading, writing difficulties are often coexisted with dyslexia. Clinical features include difficulties with spelling, syntax grammar and composition.

The Association between Self-reported Osteoporosis and Chinese Medicine-Constitution Questionnaire – A Cross-Sectional Taiwan Biobank Study

Background: Constitutional medicine was as an example of earlier medicine evidence of Chinese Medicine (CM). CM-Constitutional Questionnaire (CM-CQ) commonly considered as the observed various phenotypes as phenome. However, the comprehensive associations between self-reported disease outcomes and questionnaires of CM-CQ remained uncertain. Methods: Taiwan Biobank has begun the collection of these cancer-free volunteers, aged 30-70 with these questionnaires, self-reported disease history, clinical examinations, and genetic information from 2012 as baseline enrollment. This community-, cross-sectional study was conducted by part of Taiwan Biobank and compared the associations among CM-CQ, which reflect these constitutional variables as individual markers.Results: The present study conducted by using 1,998 volunteers (2 withdraw) from Taiwan Biobank. Which separately assessed the associations among 32 diseases and 44 items of CM-CQ questions using the binomial logistic regression model. There were 6 CM-CQ questions with a significant association of self-reported osteoporosis in all CM-CQ. Interestingly, we found that these 6 CM-CQ questions shown a significant association with osteoporosis, even which adjusted with false discovery rate (adjusted p <0.05). The Q1, Q22, and Q37 demonstrated with considerably adjusted p-value and the other CM-CQ, which involved in Q14, Q16, and Q21 shown borderline relation to self-reported osteoporosis, which was existed less residual effect with smoking and drinking habits. Conclusion: This study generated real-world evidence of national biobank for clarified associations between clinical symptom and self-reported diseases. The exploration of self-reported disease-related CM-CQ for further companion diagnostic indicators via comprehensive community-based Taiwan Biobank study should be a possibility.