Council For Research In Homoeopathy Research Articles

English

Introduction Homoeopathy seems scientifically implausible and is the most controversial form of complementary and alternative medicine therapies. This review aims to summarise the treatment effects of homoeopathy in osteoarthritis. Materials and methods Relevant studies from 1980 to 2013 were identified by a comprehensive literature search in electronic databases, reference list of relevant papers and contacts with experts. Clinical trials comparing homoeopathic treatment strategy with controls (placebo or conventional therapies) were eligible. Information on patients, interventions and comparators, outcomes, study designs and results was extracted in a standardised manner, and quality was assessed using the Jadad scoring and Cochrane bias minimisation criteria. Trials providing sufficient data were summarised and tabulated systematically. Results A total of eight controlled clinical trials involving 1444 patients were included in the analysis. None of the studies used individualised homoeopathy, rather tried ‘complex homoeopathy’ and ‘combination formulae’. Methodological quality of the trials was variable. Conclusion Overall results of our review show that homoeopathic complexes have a clear advantage in the treatment of osteoarthritis. However, the evidence is not convincing to arrive at a definite conclusion because of methodological inconsistencies and insufficient trial reporting. Further replications are warranted, provided the trials are rigorous, systematic and, above all, individualised. Introduction Osteoarthritis (OA) is a heterogeneous group of degenerative joint disease of multi-factorial origin, characterised by defective integrity and progressive loss of articular cartilage, subchondral bone remodelling, joint space narrowing and bone spur formation, as well as synovial inflammation1. Pain and functional impairment are the key domains of the burden of suffering experienced by people with OA that is of primary concern, and that burden can be significant, and taken together they often exert a significant reduction in quality of life2,3. Since the last decade, recommendations for managing OA have focused persistently on relieving pain and stiffness and improving physical function as important goals of therapy4,5. However, conventional drug therapy for OA successfully relieves pain only, alongside producing adverse gastrointestinal and cardiovascular effects, especially with long-term use6. Rheumatologic problems are among the most common disease conditions encountered by CAM practitioners7,8. Many patients use CAM therapies including homoeopathy to prevent, control and manage the pain of rheumatologic conditions9,10. However, scientific research has so far not provided evidences solid enough to support the effectiveness of CAM as treatment options for rheumatologic conditions including OA and has remained ambiguous11. Reviews have remained contradictory in conclusions12–18. Few low-potency homoeopathic complexes in the randomised controlled trials seemed to posses significant effects in OA19, but the potential of individualised homoeopathy remained untested. Hence, based on small-to-moderate effect sizes for the wide range of symptomatic treatments, conventional medicine in individualised approach still remains the mainstay of treatment20,21. The aim of this systemic review was to identify, evaluate and summarise the findings of all relevant individual studies, thereby making the available evidence more accessible to decision makers. Materials and Methods Protocol and registration A specific protocol (03/2013-14/ CRU(H)/Slg/MTA/SS; version 1.1, 1 June 2013) was developed for conducting this systematic review. The protocol was registered vide CRD42013004970, 1 July 2013 with the PROSPERO International prospective register of systematic reviews, Centre for Reviews and Dissemination, the University of York, National Institute of Health Research, York, UK. PRISMA guidelines22 were followed in structuring this review. Eligibility criteria Trials were eligible for this review if they compared homoeopathy applied for treatment of OA with placebo or H om eo pa th y * Corresponding author Email: dr.mkoley@gmail.com 1 Clinical Research Unit (Homoeopathy), Siliguri, India (under Central Council for Research in Homoeopathy, Government of India) 2 Naturopathic Private Practitioner, Adelaide Hills, South Australia (registered with Australian traditional Medicine Society)

A multi-centric double-blind homoeopathic pathogenetic trial of Cyclosporin

Objective : To elicit the pathogenetic response of the drug Cyclosporin in homoeopathic potencies on apparently healthy human beings. Material and Methods : The drug Cyclosporin was proved by the Central Council for Research in Homoeopathy through double-blind placebo-controlled trial. The study was conducted in two centres. The drug was proved in two potencies (6C and 30C) on 50 apparently healthy volunteers who were selected after conducting pre-trial medical examinations by the medical specialists and routine laboratory investigations. In the first phase the volunteers were given 56 doses (4 doses per day for 14 days) of placebo. In the next two phases, 56 doses (4 doses per day for 14 days) of each potency or placebo were consumed. The symptoms generated during the trial period were noted by the volunteers and elaborated by the proving masters. The data obtained from the two centers were compiled at proving-cum-data processing cell at Central Council for Research in Homoeopathy (CCRH) headquarters after decoding. Results : Out of 50 provers, 33 were on actual drug trial and 17 were on placebo. Eleven provers manifested symptoms. The drug was able to produce symptoms in each potency in most parts of the body. Conclusion : The pathogenetic responses elicited during the proving trial expands the scope of use of the drug Cyclosporin and will benefit the research scholars and clinicians. These symptoms will carry more value when verified clinically.

Effect of homoeopathic LM potencies in acute attacks of haemorrhoidal disease: A multicentric randomized single-blind placebo-controlled trial

Background and Objectives: Anecdotal data on the usefulness of homoeopathic medicines in acute haemorrhoids shows grade V evidence. So, the efficacy of individualized homoeopathic medicines in LM potencies, in Acute Haemorrhoidal Attacks (AHAs), was investigated in this study against placebo. Material and Methods: In a multicenter randomized controlled single-blind parallel group trial conducted at six centers under the Central Council for Research in Homoeopathy, patients who presented with any symptom such as bleeding, pain, discharge, heaviness, and itching were included. The patients were randomized to receive either individualized homoeopathic medicine or placebo for a period of 90 days. Changes in haemorrhoidal symptoms were the main outcome measures. Results: Two hundred and seventy-eight patients (Homoeopathy: n = 140, placebo: n = 138) were analyzed. After 90 days of treatment, a significant difference (P = 0.0001) was found in the median area under the curve (AUC) for bleeding {difference: −64.0 [95% confidence interval (CI): −90.0, −31.4]}, pain [−243.0 (−280.9, −202.4)], heaviness [−208.0 (95% CI: −245.5, −174.9)], and itching [−198.5 (−246.4, −158.5)] between the Homoeopathy and placebo groups. Significant differences (P Conclusion: In this study, homoeopathic intervention relieved acute haemorrhoidal symptoms early compared to the placebo group. Randomized controlled trials with double blinding are suggested further.

Homoeopathic management in depressive episodes: A prospective, unicentric, non-comparative, open-label observational study

Objective: To evaluate the role of homoeopathic medicines in the management of depressive episodes. Material and Methods: A prospective, non-comparative, open-label observational study was carried out from October 2005 to September 2010, by the Central Council for Research in Homoeopathy (CCRH) (India), at - the Central Research Institute CRI (H), Kottayam. Patients who were 20-60 years of age, suffering from mood disorders were screened for inclusion and exclusion criteria. Homoeopathic medicines were prescribed in 30, 200 and 1M potencies, after repertorising the symptoms and signs and final consultation with the Materia Medica. The internationally accepted scales - Hamilton Depression Rating Scale (HDRS), Beck Depression Inventory (BDI) and Clinical Global Impression (CGI) - were used to assess the symptoms at each visit and measure the outcome. The follow up of 12 months included six months of observation period. Analysis was done as per the intention-to-treat (ITT) principle using SPSS version 20. Results: Eighty-three patients (35 males and 48 females), who fulfilled the inclusion and exclusion criteria were enrolled in the study. Out of these, 67 patients completed the follow-up, 16 patients did not attend the Outpatient Department (OPD) for varying periods. The ITT principle was applied for the analysis considering their last observations. A statistically significant (P = 0.0001, P < 0.05) difference in the mean scores of HDRS, using the paired t-test, was observed. The mean scores at baseline and at end were 17.98 ± 4.9 and 5.8 ± 5.9, respectively. Statistically significant differences were also observed in the BDI and CGI scales. The most frequently used medicines were: Natrum muriaticum (n = 18), Arsenicum album (n = 12), Pulsatilla nigricans (n = 11), Lycopodium clavatum (n = 7) and Phosphorus (n = 6). Conclusion: A course of six months of homoeopathic treatment is associated with significant benefits in patients suffering from depressive episodes, as measured by HDRS. Further controlled studies are needed to assess the efficacy .

Effect of individualized homoeopathic treatment in influenza like illness: A multicenter, single blind, randomized, placebo controlled study

Background: In the past decade the upsurge of influenza throughout the globe was significant and in recent years this has resurfaced showing failures of all the preventive and therapeutic measures against it. Thus, this study was undertaken to evaluate the effect of homoeopathic medicines in the treatment of Influenza like illness (primary objective) and to compare the complication rate among patients receiving homoeopathic medication as compared to the patients receiving placebo and also to compare the efficacy of LM potency vis-ΰ-vis Centesimal potency (secondary objective). Material and Methods: This was a multicenter, prospective, randomized, triple arm placebo controlled trial conducted at nine Institutes and Units of Central Council for Research in Homoeopathy (CCRH) from June 2009 to December 2010. The patients fulfilling the inclusion criteria were randomized to LM, Centesimal and Placebo groups. Homoeopathic interventions were given as per the principles of homoeopathy. Symptoms of Influenza like illness (ILI) were assessed as per validated scales. Data analysis was done using statistical package of SPSS 20.0 version. Each symptom was compared for 10 days among the allocated groups by using Kruskal wallis test and bonferroni correction for the multiple comparisons. Results: Out of 739 screened cases, 447 cases were eligible for enrolment comprising of LM (n=152), (n=147) and placebo (n=148) cases. There was a significant difference in temperature from 2 nd day onwards in LM and Centesimal groups. The significant improvement was observed in headache and myalgia on 1 st day in both the treatment groups. Likewise, significant improvement was noted in malaise on 2 nd day in both the groups; sore throat on 1 st day in LM and 2 nd day in Centesimal; fatigue on 2 nd day in LM and on 3 rd day in Centesimal group; nasal complaints on 2 nd day in LM and 1 st day in Centesimal group; chill on 3 rd day in LM group and 1 st day in Centesimal group and in sweat on 1 st day in the treatment groups. Cough improved significantly from 3 rd day in both the groups. Conclusion: The study revealed the significant effect of individualized homoeopathic treatment in the patients suffering from ILI with no significant difference between LM and Centesimal groups. The complication/sequel rate was also significantly less in the intervention groups.

A multi-centric double-blind randomized homoeopathic pathogenetic trial of Gymnema sylvestre

Objective: To elicit the pathogenetic response of Gymnema sylvestre in homoeopathic potencies on apparently healthy human volunteers. Methodology: Gymnema sylvestre was proved by the Central Council for Research in Homoeopathy through double-blind placebo-controlled method. The study was carried out at four centers. The drug was proved in two potencies (6C and 30C) on 63 apparently healthy volunteers who were selected after conducting pre-trial medical examination by the medical specialists and routine laboratory investigations. In the first phase volunteers were given 56 doses (04 doses per day for 14 days) of placebo. In the next two phases 56 doses (04 doses per day for 14 days) of each potency or placebo were consumed. The symptoms generated during the trial period were noted by the volunteers and elaborated by the proving masters. The data obtained from all the four centers was compiled at proving-cum-data processing cell at CCRH headquarters after decoding. Results: Out of 37 provers who were on actual drug trial, 16 manifested symptoms. The drug was able to produce symptoms in each potency in most of the parts of the body. Conclusion: The pathogenetic responses elicited during the drug proving trial expand the scope of use of the drug Gymnema sylvestre and will benefit the research scholars and clinicians. The generated symptoms of the drug will carry more meaning when verified clinically.

Homoeopathic individualized LM-potencies versus Centesimal potencies for pain management of cervical spondylosis: A multicenter prospective randomized exploratory clinical study

Objective:Primary objective was to assess the feasibility for a further definite study to compare the effectiveness of LM-vs-CM homoeopathic potencies in reducing pain due to cervical spondylosis. Method:A multi center prospective randomized clinical pilot study was conducted by Central Council for Research in Homoeopathy at its three centers during June 2009 - June 2010. Out of 148 patients screened, 56 patients were enrolled and randomized as per the pre-set inclusion criteria. However 54 patients, LM group (n=28) and CM group (n=26) were analyzed. Pain was assessed using visual analog scale. The primary end point for pain from 1 to 60 days was calculated using Area under the curve method. Secondary outcome was to assess the quality of life using WHO QoL Bref questionnaire. Medicines were prescribed to the enrolled patients on the basis of their totality of symptoms and according to principles of homeopathy. Results:AUC for pain was significantly less in the LM group [Median (IQR): 112 (86 to 299); p= 0.007] after the prescription of homeopathic medicines. Overall quality of life of the patients after homeopathic medication showed significant improvement in the WHO-BREF domains: Physical, psychological, and Environmental only. Conclusion:Homeopathic medicines in LM potencies are better than CM potencies for pain management of cervical spondylosis. Further blinded RCT can be conducted for validation of the results.

A multicentric, double-blind randomized, homoeopathic pathogenetic trial of Caesalpinia bonducella

Objective:To elicit the pathogenetic response of Caesalpinia bonducella in homoeopathic potencies on healthy human volunteers. Methodology:The drug Caesalpinia bonducella was proved by the Central Council for Research in Homoeopathy (CCRH) through randomized, double-blind, placebo-controlled design. The proving was conducted at three centres. The drug was proved in 6 & 30 centesimal potencies on 50 apparently healthy volunteers, declared eligible after their pre-trial medical examinations by the medical specialists and routine laboratory investigations. In first phase of proving, provers were given 56 doses of placebo divided in 04 doses per day for 14 days. In next two phases, 56 doses of pre-selected potencies or placebo as per the randomization were administered in divided doses same as in first phase. The symptoms manifested during the trial period were noted down by the provers and elaborated by the Proving Masters. The generated data of the drug from all three centres were compiled at provingcum- data processing cell of CCRH headquarters after de-coding. Observations:Out of 34 provers who were on actual drug trial, only 12 manifested symptoms. Drug was able to manifest symptoms in both the potencies, in more or less every part of the body. Conclusion:The pathogenetic response elicited during the proving trial, expands the scope of use of the drug Caesalpinia bonducella and will benefit the research scholars and clinicians. The generated symptoms of this drug will carry more value when verified clinically.

A multi-centric, double-blind randomized, homoeopathic pathogenetic trial of Buxus sempervirens

Objective:To elicit the pathogenetic response of Buxus sempervirens Linn. in homoeopathic potencies on healthy human volunteers. Methodology: Buxus sempervirens drug was proved by the Central Council for Research in Homoeopathy (CCRH) through randomized, double-blind, placebo-controlled method. The proving was conducted at three centres during 2007-08. The drug was proved in 6 & 30 centesimal potencies on 57 apparently healthy volunteers, declared eligible after their pre-trial medical examination by the medical specialists and routine laboratory investigations. In its first phase of proving, volunteers were given 56 doses of placebo divided in 4 doses per day for 14 days. In the next two phases, 56 doses of pre-selected potencies or placebo as per the randomization were consumed in divided doses same as in first phase. The symptoms generated during the trial period were noted down by the volunteers and elaborated by the Proving Masters. The generated data of the drug from all three centres was compiled at the proving-cum-data processing cell at CCRH headquarters after de-coding. Observations:Out of 40 provers who were on actual drug trial, only 23 manifested symptoms. The drug was able to generate symptoms in both the potencies to every part of the body. Conclusion: The pathogenetic response elicited during the proving trial, expands the scope of use of the drug Buxus sempervirens and will benefit the research scholars and clinicians. The generated symptoms of this drug will carry more value when verified clinically.

Role of homoeopathic medicines in treating uterine fibroid: A prospective observational study

Background & objective: Uterine fibroids (UF) or leiomyomas are found in 25% to 35% women of reproductive age. It is one of the most common indications for hysterectomy further leading to complications. The present observational study on UF was undertaken to arrive at a group of useful homoeopathic medicines for the treatment of the same. Methods: A prospective observational study was conducted at Princess Durru Shehvar Children′s and General Hospital, Hyderabad in coordination with its Extension Unit of Drug Standardization Unit (Hyderabad) of Central Council for Research in Homoeopathy during September 2006 - August 2009. One hundred and thirty eight patients with UF were screened as per the pre-set criteria and 103 patients were enrolled. Homoeopathic Medicines were prescribed to the enrolled patients on the basis of repertorization of the symptom totality. The improvement of the patients was assessed subjectively through the clinical symptoms and objectively through USG pelvis. Results: Out of 103 patients enrolled, follow up of 71 patients was completed as per protocol and their data was analyzed. In 12 patients, fibroids resolved completely. There was statistically significant reduction in some of the symptoms/signs as well as in size of fibroid(s) (p= <0.05). Calcarea carbonica (n=16), Pulsatilla (n=14), Phosphorus (n=7), Lycopodium (n=5), Sulphur (n=3) and Kali carbonica (n=2) were found to be most useful among the prescribed homoeopathic medicines. Limitations: This was an observational study with no control arm, with the duration of follow up being only 8 months. Conclusion: This study has shown positive results in terms of reduction and resolution of UFs with homoeopathic treatment. Further RCTs with long follow ups need be conducted for definite conclusions.

A prospective observational study to ascertain the role of homeopathic therapy in the management of diabetic foot ulcer

Background:The risk for lower extremity amputation (LEA) in patients with diabetic foot ulcer is high, and high recurrence rates of foot ulcers pose a risk that the amputations will be repeated. While the incidence rates of diabetic foot ulcers are often poorly documented, such as is the case in India, the heavy strain of the disease on health care budgets can easily be felt the world over. The high cost of the treatment of foot ulcers causes many patients to neglect needed care, resulting in amputations. The present observational study of diabetic foot ulcer was undertaken for the purpose of deriving a group of useful homeopathic medicines for the treatment of this condition, hopefully revealing a cost effective means of reducing the incidence of foot amputations. Method: A prospective observational study was conducted by the Central Council for Research in Homoeopathy at its Drug Standardization Extension Unit, Hyderabad, from October 2005 to September 2009. One hundred and fifty-six (156) patients with diabetic foot ulcer in the age group of above thirty years from both sexes were screened and eighty-one patients were enrolled as per the pre-set inclusion and exclusion criteria. Out of eighty-one cases enrolled only sixty-three cases completed the follow up. The remainder of the cases were excluded. Homeopathic medicines prescribed to the enrolled patients were limited to a group of fifteen pre-defined trial medicines. The improvement of the cases was assessed basing upon the diabetic foot ulcer assessment score, before and after treatment, on a prescribed format devised by the council (Table 1) and by periodic photographs. Results:The difference in the mean of the ulcer assessment score was found to be statistically significant (P=0.000, <0.05) after the treatment with trial medicines. In only one case, the ulcer assessment score showed no significant improvement from the baseline. Silicea (n=22), Sulphur (n=11), Lycopodium (n=10), Arsenic album (n=8), Phosphorus (n=8) were found to be the most useful among the fifteen pre-identified trial medicines. Conclusion:This was an observational study with positive results; however, it is difficult to attribute the positive results to homeopathic therapy alone as the dressing of the ulcer and ancillary measures of themselves often eventuate in ulcer resolution. Further RCT corroboration is recommended for validation of the results.

Staphylococcinum - A multicenter clinical verification study

Introduction:Clinical verification is an ongoing research programme of the Central Council for Research in Homoeopathy, under which many Indian and rarely used drugs in Homoeopathy have been Clinically Verified. Staphylococcinum is a nosode, prepared from the bacterial endotoxins of staphylococcus pyogenes aureus. In India, the medicine is prepared as per the direction of preparation of nosodes of N-I group of Homoeopathic Pharmacopoeia of India (HPI). The Council had under taken an observational study on Staphylococcinum from 2005-2010, to determine its therapeutic effects through Clinical Verification. Objectives:The study had two objectives. The primary objective was to clinically verify the symptomatology of Staphylococcinum as observed during its proving conducted by Council on this drug and the secondary objective was to ascertain the additional clinical symptoms, if any. Materials and Methods:In this multi-center study, a total of 411 patients from all age groups & both sexes were enrolled from the OPDs of the institutes and units of the Council adhering to the inclusion, exclusion criteria as per protocol. The informed written consent was obtained from each patient before the enrolment in the studies. The presenting signs and symptoms were recorded in a predefined case recording proforma. On repertorising the symptoms of each patient, if Staphylococcinum was found to be the simillimum or very closely similar to the symptoms of the patient, the patient was included in the study. The medicine was prescribed in different potencies, viz. 30C, 200C and 1M in ascending order, as per the need of the case, in accordance with homoeopathic principles. The progress was noted in a follow up sheet to determine the effects of the medicine. Result:It was observed that many of the symptoms of Staphylococcinum obtained during the proving of this drug, (conducted by the Council) were present in the patients, which were relieved after administration of Staphylococcinum in this study. Thus the study verifies the symptoms of Staphylococcinum obtained earlier during proving of this medicine. The study, in addition, reveals few additional clinical symptoms not obtained in the proving. Conclusion:Staphylococcinum can be considered as an important medicine for acidity, acne, aphthae, arthritis, dermatitis, fever, headache, toothache and urinary tract infection. In the study, 24 symptoms of Staphylococcinum were clinically verified and 13 clinical symptoms were evolved. All the verified symptoms confirm the scope of its therapeutic action.

Homeopathy in chronic sinusitis: a prospective multi-centric observational study

The primary objective was to ascertain the therapeutic usefulness of homeopathic medicine in the management of chronic sinusitis (CS). Multicentre observational study at Institutes and Units of the Central Council for Research in Homoeopathy, India. Symptoms were assessed using the chronic sinusitis assessment score (CSAS). 17 pre-defined homeopathic medicines were shortlisted for prescription on the basis of repertorisation for the pathological symptoms of CS. Regimes and adjustment of regimes in the event of a change of symptoms were pre-defined. The follow-up period was for 6months. Statistical analysis was done using SPSS version 16. 628 patients suffering from CS confirmed on X-ray were enrolled from eight Institutes and Units of the Central Council for Research in Homoeopathy. All 550 patients with at least one follow-up assessment were analyzed. There was a statistically significant reduction in CSAS (P=0.0001, Friedman test) after 3 and 6months of treatment. Radiological appearances also improved. A total of 13 out of 17 pre-defined medicines were prescribed in 550 patients, Sil. (55.2% of 210), Calc. (62.5% of 98), Lyc. (69% of 55), Phos. (66.7% of 45) and Kali iod. (65% of 40) were found to be most useful having marked improvement. 4/17 medicines were never prescribed. No complications were observed during treatment. Homeopathic treatment may be effective for CS patients. Controlled trials are required for further validation.

Homeopathy and Heart Rate Variability: Clarification About Concerns and Issues

The Journal of Alternative and Complementary MedicineVol. 18, No. 1 Letters to the EditorHomeopathy and Heart Rate Variability: Clarification About Concerns and IssuesNirupama Mishra, K. Charan Muraleedharan, Akalpita Srinivas Paranjpe, Devendra Kumar Munta, Hari Singh, and Chaturbhuja NayakNirupama MishraRegional Research Institute for Homoeopathy (CCRH Government of India), Navi Mumbai, India.Search for more papers by this author, K. Charan MuraleedharanRegional Research Institute for Homoeopathy (CCRH Government of India), Navi Mumbai, India.Search for more papers by this author, Akalpita Srinivas ParanjpeBhabha Atomic Research Centre, Mumbai, India (Retired).Search for more papers by this author, Devendra Kumar MuntaRegional Research Institute for Homoeopathy (CCRH Government of India), Navi Mumbai, India.Search for more papers by this author, Hari SinghCentral Council for Research in Homoeopathy, Department of AYUSH, New Delhi, India.Search for more papers by this author, and Chaturbhuja NayakCentral Council for Research in Homoeopathy, Department of AYUSH, New Delhi, India.Search for more papers by this authorPublished Online:23 Jan 2012https://doi.org/10.1089/acm.2011.0757AboutSectionsView articleView Full TextPDF/EPUB ToolsPermissionsDownload CitationsTrack CitationsAdd to favorites Back To Publication ShareShare onFacebookTwitterLinked InRedditEmail View article"Homeopathy and Heart Rate Variability: Clarification About Concerns and Issues." , 18(1), pp. 4–5FiguresReferencesRelatedDetails Volume 18Issue 1Jan 2012 InformationCopyright 2012, Mary Ann Liebert, Inc.To cite this article:Nirupama Mishra, K. Charan Muraleedharan, Akalpita Srinivas Paranjpe, Devendra Kumar Munta, Hari Singh, and Chaturbhuja Nayak.Homeopathy and Heart Rate Variability: Clarification About Concerns and Issues.The Journal of Alternative and Complementary Medicine.Jan 2012.4-5.http://doi.org/10.1089/acm.2011.0757Published in Volume: 18 Issue 1: January 23, 2012PDF download

Bacopa monnieri - A multicentric, randomized, double-blind homoeopathic pathogenetic trial

Objective: To elicit the pathogenetic response of the drug Bacopa monnieri in homoeopathic potencies on healthy human beings. Methodology: Drug Bacopa monnieri was proved by the Central Council for Research in Homoeopathy through randomized, double-blind, placebo-controlled method. The study was conducted at two centers. The drug was proved in three potencies (6C, 30C and 200C) on 32 apparently healthy volunteers who were selected after conducting pre-trial medical examination by the medical specialists and routine laboratory investigations. In the first phase volunteers were given 56 doses (04 doses per day for 14 days) of placebo. In the next three phases 56 doses (04 doses per day for 14 days) of each potency or placebo were consumed. The symptoms generated during the trial period were noted by the volunteers and elaborated by the Proving Masters. The data obtained from both the centers was compiled at provingcum- data processing cell at CCRH headquarters after de-coding. Observations: Out of the 20 provers who were on actual drug trial, 07 manifested symptoms. Drug was able to produce symptoms in all three potencies more or less related to every part of the body. Conclusion: The pathogenetic responses elicited during the proving trial expands the scope of use of the drug Bacopa monnieri and will benefit the research scholars and clinicians. These symptoms will carry more value when verified clinically.

Management of Distress During Climacteric Years by Homeopathic Therapy

The purpose of this study was to ascertain the usefulness of homeopathic therapy in the management of distressing symptoms encountered during climacteric years in women (primary objective) and also the changes brought about in the levels of follicle-stimulating hormone (FSH) and lipid profile in these women after homeopathic treatment (secondary objective). An open, multicenter, prospective, observational study was carried out to ascertain the usefulness of homeopathic treatment in distress during climacteric years (DDCY). Patients were enrolled from the general outpatient department of the six Institutes/Units of Central Council for Research in Homoeopathy (CCRH) and were required to complete a follow-up period of 1 year as per the protocol designed by the CCRH. A uniform questionnaire assessing 15 predefined symptoms of menopause was adopted, with assessment of each symptom at every visit. Levels of serum FSH and lipid profile were monitored at entry and at completion. Effect size of the study was also calculated. CARA Software was used for repertorization of the presenting symptoms of menopause along with the characteristic attributes of each patient to arrive at a simillimum. The selected medicine was prescribed in a single dose as per the homeopathic principles. The assessment of the results was made through statistical analysis using the Wilcoxon signed rank test on Statistical Package for Social Sciences (SPSS) comparing symptom score at entry and completion of 1 year of treatment and t test for analyzing improvement in laboratory findings. Homeopathic therapy was found to be useful in relieving menopausal distressing symptoms such as hot flashes, night sweats, anxiety, palpitation, depression, insomnia, and so on. Influence on serum levels of FSH, high-density lipoprotein, and low-density lipoprotein was not significant but serum levels of cholesterol, triglycerides, and very-low-density lipoprotein decreased significantly. Effect size of the study was found to be large. The medicines found to be most frequently indicated and useful were Sepia, Lachesis, Calcarea carb., Lycopodium, and Sulphur. This study proves the usefulness of homeopathic medicines in relieving DDCY.

Asclepias currasavica- A multicentric, randomized, double-blind homoeopathic pathogenetic trial

Methodology: Drug Asclepias currasavica was proved by the Central Council for Research in Homoeopathy through randomized, double-blind, placebo-controlled method. The study was conducted at four centers. The drug was proved in two potencies (6C and 30C) on 67 apparently healthy volunteers who were selected after conducting pre-trial medical examination by the medical specialists and routine laboratory investigations. In the first phase volunteers were given 56 doses (04 doses per day for 14 days) of placebo. In the next two phases 56 doses (04 doses per day for 14 days) of each potency or placebo were consumed. The symptoms generated during the trial period were noted by the volunteers and elaborated by the Proving Masters. The data obtained from all the four centers was compiled at proving-cum-data processing cell at CCRH headquarters after decoding. Observations: Out of the 44 provers who were on actual drug trial, 21 manifested symptoms. Drug was able to produce symptoms in both the potencies more or less related to every part of the body. Conclusion: The pathogenetic responses elicited during the proving trial expands the scope of use of the drug Asclepias currasavica and will benefit the research scholars and clinicians. These symptoms will carry more value when verified clinically.

Alfalfa - A multicentric clinical verification study

Introduction: Clinical verification programme is an ongoing research programme of the Central Council for Research in Homoeopathy since its inception, under which many Indian and rarely used drugs in Homoeopathy have been undertaken. Alfalfa is a flowering plant and known for its use as a medicine in toning up the appetite and digestion and favorably influencing nutrition. Disorders like anorexia, nervousness, insomnia, diabetes, lethargy and malnutrition are mainly within its therapeutic range. The Council had undertaken an observational study on Alfalfa from October 2005 to March 2010, to determine its therapeutic effect through clinical verification. Objectives: The primary objective was to clinically verify the symptomatology of Alfalfa as observed during the proving conducted by the Council on this drug and the secondary objective was to ascertain the clinical symptoms. Methods: In this multicentre study, a total of 169 patients from all age groups and both sexes were enrolled from the OPDs of respective institutes and units of the Council following the exclusion and inclusion criteria as per protocol. The informed written consents from the patients were also taken. Their presenting signs and symptoms were recorded in a predefined case recording proforma. Thereafter, on repertorising the symptoms of each patient, if Alfalfa was found to be the similimum or very closely similar to the symptoms of the patient, then the case was enrolled. The medicine was prescribed in different potencies like 6c, 30c and 200c in ascending order, as per the need of the case and in accordance with homoeopathic principles. The progress was noted in follow up sheets to determine the effect of the medicine. Result: The result obtained from the enrolled patients was analysed after the conclusion of the study. It was found that many of the symptoms obtained by proving of the drug (conducted by the Council) were present in the patients clinically and thus stood verified. Apart from these, some clinical symptoms (symptoms which were not exhibited during the proving of the Alfalfa, but got cured in the sick, after the administration of the medicine) were also emerged during the study, exploring the wider area of the medicine for its therapeutic use. Fifty five symptoms of Alfalfa, including its proving symptoms (obtained by the Council), were verified during the study and most of these symptoms were of gastrointestinal system, respiratory & nervous system, head, back and sleep. The essence of the medicine lies in its properties like digestive, antiinflammatory, neurotic and antipyretic. Conclusion: Alfalfa may be considered as a remedy for various clinical conditions like anorexia, coryza, depression, dry cough, fever, headache, irritability, lethargy, sleeplessness, sneezing, cervical pain and weakness. Since Fifty five proving symptoms of the drug were verified during the study, it may be concluded that the drug symptoms were amply verified.

A multicentre observational study to ascertain the role of homoeopathic therapy in Urolithiasis

Study was aimed to ascertain the role of homoeopathic medicines in Urolithiasis. A prospective, multicentre observational study was conducted by Central Council for Research in Homoeopathy (CCRH) from October 2005 to January 2010 to find the usefulness of homoeopathic medicines in cases of Urolithiasis. 901 cases were screened, out of which 311 cases were enrolled and 220 cases were analyzed in this study. The symptoms pertaining to urolithiasis were assessed before and after treatment. Pain, Dysuria and Haematuria were graded from 0-3 as per severity of complaints. Calculi were graded as per Number, Size and Position of calculi. The difference between the scores was assessed by using ′Wilcoxon sign rank test′ in SPSS software (ver. 16). Out of 220 cases, there was expulsion of calculi in 106 cases (single calculus in 76 cases, multiple calculi in 30 cases) and in 114 cases, calculi remained but the symptom score reduced, indicating improvement in the case. The symptom score at baseline and after treatment was analysed and found statistically significant (P<0.005). The medicines found most useful were Lycopodium clavatum in 40.9% (n=90) cases; Sulphur in 12.3% (n=27) cases; Pulsatilla nigricans in 8.2% (n=18) cases; Nux vomica in 6.2% (n=14) cases and Cantharis vesicatoria in 5.9% (n=13) cases. Treatment with homoeopathic medicines showed positive response in dissolution/expulsion of calculi. Further validation of these results is needed by conducting randomized clinical trial.

Andrographis paniculata - A multicentric, randomized, double-blind homoeopathic pathogenetic trial

Objective: To elicit the pathogenetic response of the drug Andrographis paniculata in homoeopathic potencies on healthy human beings. Methodology: Drug Andrographis paniculata was proved by the Central Council for Research in Homoeopathy through double-blind, randomized, placebo-controlled method. The study was conducted at three centers. The drug was proved in two potencies (6C and 30C) on 39 apparently healthy volunteers who were selected after conducting pre-trial medical examination by the medical specialists and routine laboratory investigations. In the first phase volunteers were given 56 doses (04 doses per day for 14 days) of placebo. In the next two phases 56 doses (04 doses per day for 14 days) of each potency or placebo were consumed. The symptoms generated during the trial period were noted by the volunteers and elaborated by the Proving Masters. The data obtained from all the three centers was compiled at proving-cum-data processing cell at CCRH headquarters after de-coding. Observations: Out of the 23 provers who were on actual drug trial, 06 manifested symptoms. Drug was able to produce symptoms in both the potencies more or less related to every part of the body. Some of the symptoms have been reproved which are mentioned in different literatures after the fragmentary proving. Conclusion: New and reproved pathogenetic responses elicited during the proving trial expands the scope of use of the drug Andrographis paniculata and will benefit the research scholars and clinicians. These symptoms will carry more value when verified clinically.