Correction to “Efficacy of the Enteroadsorbent Silicol®gel in Adults with Irritable Bowel Syndrome Subtypes IBS-D or Mixed: Observational Open-Label Study”

Background Irritable bowel syndrome (IBS) is a common chronic gut-brain interaction disorder with limited effective treatment options. Intestinal adsorbents have a high adsorption capacity for gut irritants and may provide nonpharmacological alternatives. Objectives This post marketing study is aimed at providing up-to-date evidence to support the safety and efficacy in normal use of an established medical device for IBS treatment. Methods In this open-label, observational study, adults with IBS with predominant diarrhoea (IBS-D) or IBS with mixed bowel habits (IBS-M), according to Rome IV criteria, received 4 weeks of treatment with the enteroadsorbent Silicol®gel, a CE-certified, licenced, medical device containing colloidal silicic acid. Eligible participants were assessed at baseline (visit 1; in-clinic) and after 1 (visit 2; telephone), 2 (visit 3; telephone), and 4 (visit 4; in-clinic) weeks of treatment. The primary endpoint was the proportion of participants with an overall reduction in the IBS severity scoring system (IBS SSS) > 50, representing clinically meaningful improvement. Key secondary endpoints were a reduction in common IBS symptoms and improved quality of life (QoL). Results Among the 67 treated participants (IBS-D: 37; IBS-M: 30), 65 completed the study. At visit 4, 83.6% (56/67) of participants achieved a reduction in IBS SSS > 50. The mean (standard deviation [SD]) IBS SSS was 323.4 (55.7) at visit 1 and 160.3 (90.3) at visit 4 (overall change: -163.1 (101.7); 95% confidence interval [CI] 138.3, 187.9, p < 0.001). Compared with visit 1, significant reductions in the severity of all key IBS symptoms and overall improvement in QoL were observed at visit 4 (p < 0.001), with improvements observed from visits 1 and 2. Conclusions In this open-label study of participants with IBS-D and IBS-M, Silicol®gel provided clinically significant improvement in IBS symptoms, demonstrating that enteroadsorbents may be clinically beneficial in this population.

Skin aging is a biological process leading to visible skin alterations. The mechanism of action, clinical efficacy and tolerance of a novel anti-wrinkle technology were evaluated in two skin care products formulated for different skin types. Two single-arm monocentric, open-label observational clinical studies, which were 56 days long, evaluated a cream-gel (n = 30) and a cream (n = 33) on the face and neck. Morphometric analyses of five types of wrinkles were performed at 0, 7, 28 and 56 days. Structural changes in extracellular matrix (ECM) including collagen, elastin and hyaluronic acid (HA) were visualized and quantified by histochemical imaging after daily treatment of skin explants for 6 days. Protein and gene expression related to barrier and hydration were analyzed using ELISA and qRT-PCR, respectively, in a reconstituted human skin model treated daily for 48 h. A decrease in wrinkle dimensions was found in the majority of parameters after 28 days of treatment. Collagen, elastin, HA, procollagen type I, hyaluronan synthases, HAS2 and HAS3 were all stimulated. Based on significant and consistent changes in our investigations, we conclude that the underlying mechanism of action of the novel anti-wrinkle technology could be the remodeling of dermal ECM, and both the test formulations were efficacious and well tolerated.

Purpose Efficacy, tolerability and safety of the novel preservative‐free prostaglandin tafluprost 0.0015% were investigated. Methods Data were collected in a non‐interventional prospective multi‐center observational open label study. IOP readings were recorded for each eye at baseline (prior therapy or untreated) and 12 weeks after changing or initiating treatment with preservative‐free tafluprost. Change in IOP was evaluated over the study period for all patients and for specific pre‐treatment subgroups. Local comfort was measured using a 5 step scale. All adverse events were recorded. Results Data from 2123 patients with glaucoma or ocular hypertension were eligible for the final evaluation. In all patients preservative‐free tafluprost lowered IOP from 19.5+4.4 mmHg at baseline to 16.4+2.9 mmHg after 12 weeks. Preservative‐free tafluprost also lowered IOP significantly in all monotherapy‐subgroups: Naϊve patients (N=440): 22.6+3.9 mmHg to 16.7+2.7mmHg; betablockers (N=307): 20.3+3.5 mmHg (baseline) to 16.7+2.6 mmHg (week 12); CAI’s (N=158): 19.0+3.6 mmHg to 16.0+2.6 mmHg; PG’s (N=447): 16.8+2.9 mmHg to 15.8+2.6 mmHg. Local comfort was rated as 'very good' or 'good' by 85.6% of patients at the final visit. Only few adverse events occurred during the treatment period. Conclusion Preservative‐free tafluprost was effective, well tolerated and safe in a broad patient population. Local comfort and patient satisfaction improved after change of medical treatment in the vast majority of patients. Commercial interest

The effect of fecal microbiota transplantation on psychiatric symptoms among patients with irritable bowel syndrome, functional diarrhea and functional constipation: An open-label observational study

Objectives: To evaluate the usefulness of homoeopathic intervention in Schizophrenia, in untreated cases and antipsychotic treatment resistant cases, to verify indications of medicines, and to assess relapse, if any. Materials and Methods: A prospective, non-comparative, open-label observational study was carried out from October 2005-September 2010 by CCRH at Central Research Institute (H), Kottayam, Kerala, India. Patients between 20 and 60 years of age, presenting with symptoms of Schizophrenia were screened for inclusion and exclusion criteria. The patients who were on antipsychotic drugs were allowed to continue the same along with homoeopathic medicine, the dose of antipsychotics was monitored by the Psychiatrist. The symptoms of each patient were repertorized, and medicine was initially prescribed in 30C potency after consulting Materia Medica. Patients were followed up for 12 months. Outcome of treatment was assessed with Brief Psychiatric Rating Scales (BPRS). Analysis was done using Statistical Package for the Social Sciences SPSS Version 20.0. Results: Out of 188 enrolled patients, 17 cases did not complete the baseline information. Total 171 patients were analysed as per modified Intention to Treat Principle. Significant difference (P = 0.0001, P Conclusion: The study reflects the positive role of homoeopathic medicines in the management of patients suffering from schizophrenia as measured by BPRS.

Objective Depressive disorders have an overall prevalence of 12.1%, which is clinically very significant. This study is taken up to understand the concept of the causes of depressive disorders, to understand the miasmatic state of depressive disorders and to determine the efficacy of homoeopathic medicines in the management of depressive disorders. Methods A prospective, non-comparative, open-label observational study was done at Multi-Specialty Clinic and Research Centre of The Andhra Pradesh Homoeopathic Association from 2009 to 2012. Patients aged between 15 and 30 years, presenting with symptoms of depressive disorders, were screened for inclusion and exclusion criteria and a total of 207 cases were enrolled for the study. The characteristic symptoms of the patients were recorded, repertorised, miasmatic diagnosis done and medicines prescribed based on individualisation of patient, with the help of materia medica. Hamilton depression rating scale (HAM-D) was used to assess the treatment. The parameter of improvement was - Marked improvement - 75% and above; outcome. Moderate improvement - 50% and above; Mild improvement - 25%. Results Out of 207 enrolled patients, 32 cases were dropout, while total 175 cases were analysed. The significant difference (p = 0.0001, p &lt; 0.05) in the mean scores of HAM-D using paired t-test was observed at the end of the study; marked improvement was seen in 39 cases; moderate improvement was seen in 76; mild improvement was seen in 34 cases; no improvement was seen in 26 cases. Remedies such as Ignatia, Nat mur, Nux vomica, Staphysagria, Arsenicum album and Lycopodium were found to have a positive role. Conclusion The study showed positive and encouraging results of homoeopathic intervention in the management of patients suffering from depressive disorders as measured by HAM-D scale.

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 .

BackgroundMany patients with cluster headache (CH) are inadequately controlled by current treatment options. Non-invasive vagus nerve stimulation (nVNS) is reported to be effective in the management of CH though some studies suggest that it is ineffective.ObjectiveTo assess the safety and efficacy of nVNS in chronic cluster headache (CCH) patients.MethodWe prospectively analysed data from 40 patients with refractory CCH in this open-label, observational study. Patients were seen in tertiary headache clinics at the National Hospital for Neurology and Neurosurgery and trained to use nVNS as preventative therapy. Patients were reivewed at one month and then three-monthly from onset. The primary endpoint was number of patients achieving ≥50% reduction in attack frequency at 3 months. A meta-analysis of all published studies evaluating the efficacy of nVNS in CCH was also conducted. We searched MEDLINE and EMBASE for all studies investigating the use of nVNS as a preventive or adjunctive treatment for CCH with five or more participants. Combined mean difference and responder proportions with 95% confidence intervals (CI) were calculated from the included studies.Results17/40 patients (43%) achieved ≥50% reduction in attack frequency at 3 months. There was a significant reduction in monthly attack frequency from a baseline of 124 (±67) attacks to 79 (±63) attacks in month 3 (mean difference 44.7; 95% CI 25.1 to 64.3; p < 0.001). In month 3, there was also a 1.2-point reduction in average severity from a baseline Verbal Rating Scale of 8/10 (95% CI 0.5 to 1.9; p = 0.001). Four studies, along with the present study, were deemed eligible for meta-analysis, which showed a responder proportion of 0.35 (95% CI 0.07 to 0.69, n = 137) and a mean reduction in headache frequency of 35.3 attacks per month (95% CI 11.0 to 59.6, n = 108), from a baseline of 105 (±22.7) attacks per month.ConclusionThis study highlights the potential benefit of nVNS in CCH, with significant reductions in headache frequency and severity. To better characterise the effect, randomised sham-controlled trials are needed to confirm the beneficial response of VNS reported in some, but not all, open-label studies.

To assess long-term safety and efficacy of stiripentol as an antiepileptic medication for people with Dravet syndrome. A prospective, observational open-label study (2003-2015) of the efficacy and long-term safety of stiripentol in patients with Dravet syndrome and ongoing seizures. Frequency of generalized tonic-clonic seizures, focal seizures, status epilepticus, and adverse events were recorded. Forty-one patients started stiripentol, with median age at enrolment 5 years 7 months (range 11mo-22y) and median duration of treatment 37 months (range 2-141mo). Twenty out of 41 patients had greater than or equal to 50% long-term reduction in frequency of generalized tonic-clonic seizures. Frequency of focal seizures was decreased by greater than or equal to 50% in 11 out of 23 patients over the long-term. Frequency of status epilepticus was decreased by 50% or more in 11 out of 26 patients. The most common adverse events were anorexia, weight loss, sedation, and behavioural changes. One patient had worsening of absence and myoclonic seizures. Another developed recurrent pancreatitis on concurrent valproate. Stiripentol improves long-term seizure frequency in approximately 50% of patients with Dravet syndrome, when used as part of unrestricted polytherapy. Long-term use appears safe. In more than 40% of patients, episodes of status epilepticus markedly decrease after stiripentol initiation. What this paper adds Frequency of status epilepticus is reduced in 40% of patients with Dravet syndrome after stiripentol initiation. Stiripentol is effective for generalized tonic-clonic and focal seizures. Stiripentol can be safely used with a range of antiepileptic drugs.

Hepatic cirrhosis is one of the leading causes of death worldwide, especially if complicated by ascites. This chronic condition can be related to the classical disease entity jalodara in Traditional Indian Medicine (Ayurveda). The present paper aims to evaluate the general potential of Ayurvedic therapy for overall clinical outcomes in hepatic cirrhosis complicated by ascites (HCcA). In form of a nonrandomized, uncontrolled, single group, open-label observational clinical study, 56 patients fulfilling standardized diagnostic criteria for HCcA were observed during their treatment at the P. D. Patel Ayurveda Hospital, Nadiad, India. Based on Ayurvedic tradition, a standardized treatment protocol was developed and implemented, consisting of oral administration of single and compound herbal preparations combined with purificatory measures as well as dietary and lifestyle regimens. The outcomes were assessed by measuring liver functions through specific clinical features and laboratory parameters and by evaluating the Child-Pugh prognostic grade score. After 6 weeks of treatment and a follow-up period of 18 weeks, the outcomes showed statistically significant and clinically relevant improvements. Further larger and randomized trials on effectiveness, safety, and quality of the Ayurvedic approach in the treatment of HCcA are warranted to support these preliminary findings.

BackgroundOmalizumab is a non-steroidal medication indicated for the treatment of poorly controlled moderate-to-severe allergic asthmatics. This observational study examines the “real world” effectiveness of omalizumab in this population.MethodsThis is a one year open-label observational study that compared clinical outcomes including total oral corticosteroid use, exacerbation history, measures of quality of life and inflammation in patients with moderate-to-severe allergic asthma, who were prescribed omalizumab as part of their treatment with the year prior to therapy.ResultsA total of 99 patients were enrolled at 25 sites in Canada. During the study period, the mean total annual OCS dose was reduced from 2301.5 mg (prednisone equivalents) in the year prior to omalizumab to 1130.0 mg (p<0.0001). There was a 71% reduction in asthma exacerbations and 56% of patients on omalizumab remained exacerbation free when compared to the year prior to study entry. Associated with this was reduced health care utilization. There were significant improvements in the Asthma Control Questionnaire (ACQ) and Asthma Quality of Life questionnaire (AQLQ) Patients with an elevated FeNO at baseline showed a better response to treatment. No new safety issues were identified during the study period.ConclusionOur study demonstrates that in “real world” clinical practice, after initiating omalizumab, there is a reduction in total OCS use and exacerbation frequency in patients with moderate-to-severe allergic asthma. Patients on treatment reported improved asthma control and quality of life. FeNO may be a useful biomarker to identify patients who may benefit with omalizumab treatment.

Comparison of tandospirone and escitalopram as a symptomatic treatment in Multiple System Atrophy-cerebellar ataxia: An open-label, non-controlled, 4 weeks observational study

Vitamin D supplementation versus combined calcium and vitamin D in older female patients - an observational study.

Molluscum contagiosum (MC) is a common viral skin infection primarily affecting children which is difficult to treat using available therapeutic approaches. The sulfated polysaccharide named calcium spirulan (Ca-SP) has demonstrated antiviral effects against herpes simplex virus in keratinocytes in vitro, and a cream containing 1.5% Ca-SP and 1% of a defined microalgae extract (Spiralin®) effectively prevented herpes labialis in a trial with susceptible individuals. This observational study aimed to show antiviral effects of a similar formulation (Spirularin® VS) against MC in children. Children with active MC lesions were treated with Spirularin® VS cream twice daily on affected skin over several months and asked to return for follow-up visits after 1 to 3 months. Clinical status of MC infection was documented at baseline and follow-up visits. Of the 31 children enrolled in the study, 26 completed treatment and returned for control visits. Spirularin® VS cream was applied twice daily over a period of 1 to 9 months (mean treatment duration 3.9 months). 19/26 (73.1%) children achieved complete clearance of MC lesions with no clinical evidence of bacterial skin infection during treatment. No irritative skin reactions or unpleasant symptoms were observed or reported. This open-label observational study suggests that a cream formulation containing 1.5% Ca-SP and 1% Spiralin® may be an effective and safe treatment option for children with active MC lesions. The high rate of complete clearance of MC lesions and lack of adverse reactions warrant further investigation in larger, controlled trials.

Objective: to evaluate the impact of therapy with chondroitin sulfate (CS) and glucosamine (GA) on the clinical manifestations of low back pain (LBP). Subjects and methods. A multicenter open-label observational prospective study was conducted in 22 cities of Russia (46 centers) to investigate the efficacy of a combination of CS and GA in the outpatient treatment of nonspecific LBP. A total of 9761 patients were enrolled in the study that was completed by 8546 patients. Therapeutic efficiency was evaluated from changes in pain intensity during movement and at rest, by using the visual analogue scale. The Oswestry disability index, an global physician and patient assessment of therapeutic efficiency, and a daily need for nonsteroidal anti-inflammatory drugs (NSAIDs) were taken into account as additional criteria for efficiency evaluation. Results and discussion. The multicenter open-label observational study established the efficacy of a combination of CS and GA in treating nonspecific LBP: relief in pain during movement and at rest, functional improvement, and a reduction in the daily need for NSAIDs. The patients and physicians highly assessed therapeutic efficiency. The combination of CS and GA was also noted to be well tolerated. The findings may suggest that this combination may be a promising tool to treat LBP and gives proof to the expediency of its use in randomized placebo-controlled studies.