ABSTRACT
INTRODUCTION: Psoriasis is a chronic inflammatory skin disorder, affecting the trunk and extensor surfaces of the limbs and scalp predominantly. Worldwide prevalence ranges between 0.1 and 11.4%, and in India between 0.4 and 2.8%; this creates a serious health burden. Psoriasis remains a frequently encountered condition in homeopathy practice, but there is a dearth of conclusive efficacy data supporting its use. METHODS: This 6-month, double-blind, randomized trial was conducted on 51 patients suffering from psoriasis at the National Institute of Homoeopathy, India. Patients were randomized to receive either individualized homeopathic medicines (IHMs; n = 25) in LM potencies or identical-looking placebos (n = 26). Psoriasis area and severity index (PASI; primary), psoriasis disability index (PDI), and dermatological life quality index (DLQI; secondary) were measured at baseline and every 2 months, up to 6 months. The intention-to-treat sample was analyzed using a two-way repeated measure analysis of variance. RESULTS: Although intragroup changes were significant in both groups in the outcome measures, improvements were significantly higher in the IHMs group than in placebos in PASI scores after 6 months of intervention (F1, 49 = 10.448, p = 0.002). DLQI daily activity subscale scores also yielded similar significant results favoring IHMs against placebos after 6 months (F1, 49 = 5.480, p = 0.023). Improvement in PDI total (F1, 49 = 0.063, p = 0.803), DLQI total (F1, 49 = 1.371, p = 0.247), and all remaining subscales were higher in the IHMs group than placebos after 6 months, but nonsignificant statistically. Calcarea carbonica, Mercurius solubilis, Arsenicum album, and Petroleum were the most frequently prescribed medicines. CONCLUSIONS: IHMs exhibited better results than placebos in the treatment of psoriasis. Further research is warranted.
Subject(s)
Homeopathy , Psoriasis , Humans , Psoriasis/drug therapy , Double-Blind Method , IndiaABSTRACT
INTRODUCTION: Tinea corporis (TC; ringworm or dermatophytosis) is a superficial skin infection caused by Microsporum, Epidermophyton and Trichophyton genera of dermatophytes. We compared the effects of individualized homeopathic medicines (IHMs) in fifty-millesimal (LM) potencies against placebo in TC. METHODS: A double-blind, randomized, placebo-controlled, two parallel arms trial was conducted on 62 individuals suffering from TC at the National Institute of Homoeopathy, India. Participants were randomized in a 1:1 ratio to receive either IHMs in LM potencies or identical-looking placebos for a period of 3 months. The primary outcome measure was the number of participants showing complete disappearance of skin lesions after 3 months. Secondary outcomes were a numeric rating scale (NRS) measuring intensity of itching and the Skindex-29 questionnaire (overall, and three sub-scales - degree of symptoms, psychological functioning, emotional status). All were assessed at baseline and every month, up to 3 months. The intention-to-treat sample was analyzed to detect inter-group differences using two-way repeated measures analysis of variance after adjusting for baseline differences. RESULTS: The primary outcome revealed no improvement in either of the groups (χ 2 = 0.012, p = 0.999). Inter-group differences in some of the secondary outcomes favored IHMs against placebo - itching NRS (mean group difference after 3 months: -0.7 (95% confidence interval [CI], -1.1 to -0.4; p = 0.001); Skindex-29 overall (mean group difference after 3 months: 3.2 [95% CI, -0.6 to 7.0; p = 0.009]); Skindex-29 degree of symptoms (mean group difference after 3 months: 0.9 [95% CI, -0.2 to 1.9; p = 0.007]); and Skindex-29 psychological functioning (mean group difference after 3 months: 1.7 [95% CI, 0-3.4; p = 0.002]). CONCLUSION: Results were negative on the primary outcome; however, secondary outcomes included some statistically significant results favoring IHMs against placebo after 3 months. TRIAL REGISTRATION: CTRI/2019/11/021999; UTN: U1111-1242-0070.
Subject(s)
Homeopathy , Materia Medica , Tinea , Humans , Homeopathy/methods , Double-Blind Method , Tinea/drug therapy , Materia Medica/therapeutic use , Pruritus/drug therapy , Treatment OutcomeABSTRACT
Objective: The feasibility of a definitive trial was tested to evaluate individualized homeopathic medicines (IHMs) for the treatment of vitiligo. Design: This was a double-blind randomized (1:1) placebo-controlled pilot trial conducted at the National Institute Homeopathy, India. Sixty patients with vitiligo were included in the study. Interventions: IHMs and identical-looking placebos at 50-millesimal (LM) potencies. Outcome measures: Feasibility issues and scores from the Vitiligo Area Scoring Index (VASI), Vitiligo-specific Quality-of-life instrument (VitiQoL), and Dermatology Life Quality Index (DLQI) were measured at baseline and after 3 and 6 months. Results: The recruitment and retention rates were satisfactory. Mean reductions in the outcome measures were higher in the IHM group than placebo. Conclusions: Definitive efficacy trials are warranted. Clinical Trials Registry-India: CTRI/2018/10/016160; secondary identifier UTN: U1111-1221-7704.
Subject(s)
Materia Medica , Vitiligo , Double-Blind Method , Humans , Materia Medica/therapeutic use , Pilot Projects , Treatment Outcome , Vitiligo/drug therapyABSTRACT
A rare case reporting the occurrence of full-thickness macular hole (MH) formation following intravitreal antivascular endothelial growth factor injection in a case of hemicentral retinal vein occlusion and the subsequent management of the case. As described in few other similar case reports in the literature, there are quite a few probabilities of factors causing this pathology. An acute posterior vitreous detachment or sudden decompression of the macular edema can quite possibly lead to the above situation. This case report shares light on the evolution of a MH following intravitreal injection and the subsequent treatment process.
ABSTRACT
BACKGROUND: Chronic rhinosinusitis (CRS) is a common disorder, with up to an estimated 134 million Indian sufferers, and having significant impact on quality of life (QOL) and health costs. Despite the evidence favoring homeopathy in CRS being inadequate, it is highly popular. This trial attempts to study the efficacy of individualized homeopathy (IH) medicines in comparison with placebo in patients with CRS. METHODS: A double-blind, randomized (1:1), placebo-controlled, preliminary trial (n = 62) was conducted at the National Institute of Homoeopathy, West Bengal, India. Primary outcome measure was the sino-nasal outcome test-20 (SNOT-20) questionnaire; secondary outcomes were the EQ-5D-5L questionnaire and EQ-5D-5L visual analog scale scores, and five numeric rating scales (0-10) assessing intensity of sneezing, rhinorrhea, post-nasal drip, facial pain/pressure, and disturbance in sense of smell, all measured at baseline and after the 2nd and 4th months of intervention. Group differences and effect sizes (Cohen's d) were calculated on the intention-to-treat sample. RESULTS: Groups were comparable at baseline. Attrition rate was 6.5% (IH: 1, Placebo: 3). Although improvements in both primary and secondary outcome measures were higher in the IH group than placebo, with small to medium effect sizes, the group differences were statistically non-significant (all p > 0.05, unpaired t-tests). Calcarea carbonica, Lycopodium clavatum, Sulphur, Natrum muriaticum and Pulsatilla nigricans were the most frequently prescribed medicines. No harmful or unintended effects, homeopathic aggravations or any serious adverse events were reported from either group. CONCLUSION: There was a small but non-significant direction of effect favoring homeopathy, which ultimately renders the trial as inconclusive. Rigorous trials and independent replications are recommended to arrive at a confirmatory conclusion. [Trial registration: CTRI/2018/03/012557; UTN: U1111-1210-7201].
Subject(s)
Materia Medica/therapeutic use , Sinusitis/drug therapy , Double-Blind Method , Female , Humans , India , Male , Middle Aged , Placebos , Surveys and Questionnaires , Treatment OutcomeABSTRACT
OBJECTIVES: The quality of management of hyperuricemia has remained sub-optimal owing to unavoidable toxicities, limitations, and dearth of novel advances. Homeopathy has remained under-researched in hyperuricemia. We investigated the clinical effectiveness of three treatment regimens - individualized homeopathy (IH), Urtica urens mother tincture (UUMT), and both (IH + UUMT) along with lifestyle modifications in a sample of 90 patients with hyperuricemia. METHODS: An open, randomized (1:1:1), 3 parallel arms (IH, UUMT, and IH + UUMT), pragmatic trial was conducted at National Institute of Homoeopathy, Kolkata. Outcome measures were serum uric acid (primary), Gout Assessment Questionnaire version 2 (GAQ2, secondary), and Measure Yourself Medical Outcome Profile version 2 (MYMOP2, secondary); all measured at baseline, and after 3 and 6 months. Intention- to-treat sample was analyzed to detect group differences by unpaired t tests. RESULTS: Attrition rate was 8.9% (IH: 3, UUMT: 3, IH + UUMT: 2). Groups were comparable at baseline. Reductions in serum uric acid over 3 months were comparatively higher (p=0.057) in the UUMT group than others, however, the differences were narrowed over 6 months (p=0.119). Per protocol analysis of serum uric acid level revealed similar trend of significantly higher reduction in the UUMT group than the other two (3 months: p=0.001; 6 months: p=0.007). No significant differences existed in reductions of GAQ2 scores among the three groups. Few significant differences were detected in MYMOP scores over 3 months favoring IH against others (symptom 2, p=0.001 and wellbeing score, p=0.002), and also over 6 months favoring IH + UUMT against others (symptom 1, p<0.001). CONCLUSION: Although all three therapies showed similar improvements, the IH + UUMT group had more positive direction of effects than IH or UUMT alone; however, no definite conclusion could be arrived at. Further trials are warranted with larger sample size. Trial registration: CTRI/2018/05/014026.
Subject(s)
Hyperuricemia , Materia Medica , Female , Humans , Hyperuricemia/drug therapy , Materia Medica/therapeutic use , Mothers , Pilot Projects , Treatment Outcome , Uric AcidABSTRACT
OBJECTIVES: Homeopathy remains one of the most sought after therapies for urological disorders. The aim of this paper was to systematically review the available clinical researches of homeopathy in the said conditions. CONTENT: Relevant trials published between Jan 1, 1981 and Dec 31, 2016 (with further extension up to Dec 31, 2017) was identified through a comprehensive search. Internal validity of the randomized trials and observational studies was assessed by The Cochrane Collaboration's tool and methodological index for non-randomized studies (MINORS) criteria respectively, homeopathic model validity by Mathie's six judgmental domains, and quality of homeopathic individualization by Saha's criteria. SUMMARY: Four controlled (three randomized and one sequentially allocated controlled trial) trials were reviewed and 14 observational studies alongside - all demonstrated positive effect of homeopathy. Major focus areas were benign prostatic hypertrophy and renal stones. One of the four controlled trials had 'adequate' model validity, but suffered from 'high' risk of bias. None of the non-randomized studies was tagged as 'ideal' as all of those underperformed in the MINORS rating. Nine observational studies had 'adequate' model validity and quality criteria of individualization. Proof supporting individualized homeopathy from the controlled trials remained promising, still inconclusive. OUTLOOK: Although observational studies appeared to produce encouraging effects, lack of adequate quality data from randomized trials hindered to arrive at any conclusion regarding the efficacy or effectiveness of homeopathy in urological disorders. The findings from the RCTs remained scarce, underpowered and heterogeneous, had low reliability overall due to high or uncertain risk of bias and sub-standard model validity. Well-designed trials are warranted with improved methodological robustness. FUNDING: None; Registration web-link: https://www.crd.york.ac.uk/PROSPERO/display_record.php?ID=CRD42018081624&ID=CRD42018081624.
Subject(s)
Homeopathy/methods , Materia Medica/therapeutic use , Urologic Diseases/drug therapy , Clinical Trials as Topic , Humans , Observational Studies as Topic , Treatment OutcomeABSTRACT
Background Irritable Bowel Syndrome (IBS) is a prevalent gastro-intestinal disorder characterized by recurrent abdominal pain, bloating, altered bowel function and myriad of gastro-intestinal symptoms. Dysentery compound (DC), a 'bowel nosode', is one of the homeopathic medicines to treat IBS, but remained under-researched. We hypothesized that DC would be non-inferior to individualized homeopathy (IH) in treatment of IBS. Method An open, randomized (1:1), parallel arms, pragmatic, non-inferiority, pilot trial was conducted to compare the effectiveness of DC with IH medicines in 60 IBS patients. IBS Quality of Life (IBS-QOL) questionnaire was used as the outcome measure; assessed at baseline and after 3âmonths. Comparative analysis was carried out on the primary outcome to detect non-inferiority by one-tailed t test at alpha=5% with a prefixed margin (Δ) of 1.0 based on assumption. Results Six subjects dropped out. Groups were comparable at baseline (all p>0.01). Though intra-group changes were higher favoring IH over DC, group differences were statistically non-significant (all p>0.01). Non-inferiority was not demonstrated by DC against IH over 3âmonths (mean difference= -3.3, SE=5.2, lower 95% confidence limit -11.9, t= -0.453, p=0.674). No adverse events were reported from either group. Conclusion Non-inferiority of DC against IH in treatment of IBS was not demonstrated though it appeared as safe; still, being a pilot trial, no definite conclusion could be drawn. Further exploration of both efficacy and effectiveness of either of the therapies is necessary by adequately powered trials and independent replications. Trial registration: CTRI/2017/05/008480; UTN: U1111-1196-1004.
Subject(s)
Irritable Bowel Syndrome/drug therapy , Materia Medica/therapeutic use , Adolescent , Adult , Female , Humans , Male , Middle Aged , Pilot Projects , Prospective Studies , Quality of Life , Surveys and Questionnaires , Young AdultABSTRACT
Interferon-γ-induced aminopeptidase ERAP1 trims peptides within the endoplasmic reticulum so that they can be loaded onto MHC class I and presented to the CD8+ T-cells. ERAP1 association and its interaction with HLA-C∗06 is controversial across different populations. We have investigated the association and possible functional role of non-synonymous SNPs at different exons of ERAP1 (rs26653: Arg127Pro, rs30187: Lys528Arg and rs27044: Gln730Glu) and their interactions with HLA-C∗06 in psoriasis. Significant associations of HLA-C∗06 (OR=5.47, P<2.2×10-16), rs30187 (OR 1.35, P=7.4×10-4) and rs27044 (OR=1.24, P=5.8×10-3) were observed. All three ERAP1 SNPs showed significant association only for HLA-C∗06 positive patients, while rs30187 and rs27044 showed significant association only for early onset patients (rs30187: OR=1.47, P=9.6×10-5; rs27044: OR=1.36, P=3.3×10-4). No differential expression of ERAP1 was observed either between paired uninvolved and involved skin tissues of psoriasis patients or between non-risk and risk variants in the involved skin. Significant epistatic interaction was observed between HLA-C∗06 and the SNP (rs27044) located at the peptide-binding cavity of ERAP1. Evolutionary conservation analysis among mammals showed confinement of Lys528 and Gln730 within highly conserved regions of ERAP1 and suggested the possible detrimental effect of this allele in ERAP1 regulation.
Subject(s)
Aminopeptidases/genetics , CD8-Positive T-Lymphocytes/immunology , Minor Histocompatibility Antigens/genetics , Psoriasis/genetics , Adult , Age of Onset , Aminopeptidases/metabolism , Antigen Presentation , Epistasis, Genetic , Evolution, Molecular , Female , Gene Frequency , Genetic Association Studies , Genetic Predisposition to Disease , Genotype , HLA-C Antigens/metabolism , Humans , India/epidemiology , Interferon-gamma/metabolism , Lymphocyte Activation , Male , Middle Aged , Minor Histocompatibility Antigens/metabolism , Polymorphism, Single Nucleotide , Protein Binding , Protein Domains/genetics , Psoriasis/epidemiology , Young AdultABSTRACT
AIM: To compare the photographic screening for retinopathy of prematurity (ROP) using RetCam 120 with binocular indirect ophthalmoscope (BIO), which is the current gold standard. SETTING AND DESIGN: Prospective, comparative study. MATERIALS AND METHODS: A total of 87 RetCam examinations were performed on 27 premature babies. They were stored in a separate file after deleting the identifying information. At the same visit using the BIO with scleral depression, an experienced vitreoretinal surgeon evaluated the fundus in detail. A masked examiner then evaluated the RetCam photographs for presence or absence of ROP, the stage and zone of the disease and the presence or absence of plus disease. These data were then compared with the BIO findings to determine the sensitivity, specificity and the positive and negative predictive values of the method. RESULTS: ROP was detected in 63 of 87 examinations by BIO and in 56 of 87 RetCam examinations. Nine RetCam examinations were false-negative and two were false-positive. Sensitivity of RetCam was 85.71% (54/63) and specificity was 91.66% (22/24). The positive and negative predictive values were 96.43% and 70.97% respectively. CONCLUSION: Nine cases having ROP were missed by the RetCam. All these cases were either in zone 3 or the outer part of zone 2, which later regressed. These were missed mostly because of the restricted mobility of the camera head caused by its size and the barrier caused by the lid speculum arms. No case of threshold ROP was missed. RetCam may replace BIO for screening of ROP.
Subject(s)
Ophthalmoscopy , Retina/pathology , Retinopathy of Prematurity/diagnosis , Vision Screening/methods , Diagnosis, Differential , Humans , Infant, Newborn , Predictive Value of Tests , Prospective StudiesABSTRACT
Serum superoxide dismutase and catalase assays were performed using spectrophotometry in 60 adults and children with benign or malignant tumors and in controls. There was a statistically significant difference in the antioxidative status of children with intraocular tumors (primary retinoblastoma) compared with children without tumors. The difference was not significant in adults. These enzymes may be of value in the early diagnosis of malignant intraocular tumor, especially retinoblastoma.
Subject(s)
Eye Neoplasms/etiology , Oxidants/metabolism , Retinoblastoma/etiology , Adult , Age Factors , Catalase/blood , Child , Eye Neoplasms/enzymology , Eye Neoplasms/metabolism , Female , Humans , Male , Oxidative Stress , Retinoblastoma/enzymology , Retinoblastoma/metabolism , Superoxide Dismutase/bloodABSTRACT
PURPOSE: To analyse the clinical characteristics and treatment outcome of zone 1 Fulminate type of Retinopathy of Prematurity (ROP) and compare it to Conventional ROP. METHODS: Preterm infants from two neonatal intensive care units (NICU) born between July 2002 and November 2003 were screened for ROP. Cases with Conventional ROP were classified according to the International Classification of Retinopathy of Prematurity (ICROP) while that of Fulminate ROP according to Shapiro's classification. Threshold disease was kept the cut off for treatment for Conventional ROP and stage 3A for Fulminate ROP. RESULTS: Of the 54 cases that had treatable ROP, 36 (66.67%) had Fulminate type. The mean gestational age and birth weight was higher in Fulminate ROP compared to Conventional disease (31.75 weeks and 1554 gms vs 31 weeks 1387 gms) whereas the mean postnatal age at laser was lower (4.62 weeks vs 6.3 weeks). The average number of laser spots given was 3036.6 for Fulminate disease. CONCLUSION: Fulminate ROP had an atypical morphology which was difficult to classify according to ICROP classification and we would like to lay stress upon the importance of screening of premature infants from the age of 4 weeks and to start treatment immediately once Fulminate ROP has been diagnosed.
Subject(s)
Laser Therapy , Retinopathy of Prematurity/physiopathology , Retinopathy of Prematurity/therapy , Birth Weight , Gestational Age , Humans , Infant , Infant, Newborn , Retinopathy of Prematurity/pathology , Severity of Illness Index , Treatment OutcomeABSTRACT
Routine ophthalmoscopic screening for retinopathy of prematurity (ROP) from the age of 2 weeks is necessary to detect and treat fulminate ROP.
