Background Exclusive enteral nutrition (EEN) is an established induction treatment for active Crohn’s disease (CD) with a proposed mechanism of action involving the gut microbiome. We have previously shown that CD-TREAT diet, a food-based diet with similar dietary profile to EEN, improves rat ileitis and replicates the effect of EEN on the gut microbiome of healthy volunteers and animal models. Here, we test the efficacy of CD-TREAT diet to induce clinical remission in active CD. Methods This is an open-label study in children (wPCDAI≥12.5) and adults (HBI≥5) with active CD. Primary outcome was clinical response (wPCDAI fall≥17.5; HBI fall≥3) or clinical remission (wPCDAI< 12.5; HBI<5) after 8 week treatment with CD-TREAT. Secondary outcomes included improvement of quality of life (QoL) and reduction in faecal calprotectin (FC) levels. Since CD-TREAT diet is gluten-free, adherence to treatment was assessed by the detection of the gluten immunogenic peptide (GIP) in faeces. Data are presented with median (IQR). Results 25 children, [age, 14.4 (12.5,15.7) years] and 32 adults, [age, 32.6 (24.2,43.9) years] were treated. 7 (12%) failed treatment and n=10 (18%) dropped out during the first 2 weeks of treatment due to palatability issues. In patients who completed 8 weeks of CD-TREAT course (n=40), 85% and 78% achieved clinical response and remission, respectively. CD-TREAT diet improved QoL in children [IMPACT-III score, baseline: 136 (122,143) vs 8weeks: 148 (133,153), p<0.01] and in adults [sIBDq score, baseline: 30 (26,45) vs 8weeks: 60 (48, 64), p<0.001]. Faecal GIP decreased during treatment [ng/g stool, baseline: 1250 (589, 1250), 4weeks: 0 (0,269), 8weeks: 0 (0,329), mg/mg, p<0.001 for both] showing adherence with the CD-TREAT diet. However, 33% and 40% of the patients had detectable faecal GIP at 4 and 8 weeks, respectively, revealing at least partial non-adherence. 30% of patients who completed CD-TREAT (n=12/40) experienced >50% FC reduction. Median FC levels decreased significantly? in the group of patients (n=22) who had undetectable GIP at 4 or 8 weeks [mg/kg FC, baseline: 1190 (361,1129); 8weeks: 534 (92,1230), p<0.01]. Conclusion CD-TREAT diet improved disease activity indices and QoL in the majority of patients who completed treatment and decreased FC in those who were most likely to be compliant. Future RCT should aim to compare CD-TREAT with other induction treatments and improve meal variety and palatability to improve compliance and reduce drop-out rates.
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.
Background We evaluated whether adjunctive mother tinctures (MTs) to individualized homeopathy (IH) have significant effect beyond IH alone in treatment of chronic obstructive pulmonary diseases (COPD). Methods An open, randomized (1:1; IH + MT versus IH only), two parallel arms, pragmatic trial (n = 60) was conducted at National Institute of Homoeopathy, India. Primary outcomes were forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC), and FEV1/FVC, measured at baseline and 6 months; secondary outcomes were Bengali COPD assessment test (CAT-B) questionnaire and (clinical COPD questionnaire) CCQ-B, measured at baseline, and after 3 and 6 months; and exacerbation frequencies during 6 months. Results Five patients dropped out (IH + MT: 3, IH: 2). Though intragroup changes were significant, intergroup differences of spirometric changes over 6 months were nonsignificant (Mann Whitney U test); FEV1 (P 0–6 = 0.761), FVC (P 0–6 = 0.512), and FEV1/FVC (P 0–6 = 0.741). Over 3 and 6 months, differences of changes in CAT-B (P 0–3 = 0.553 and P 0–6 = 0.900) and CCQ-B (P 0–3 = 0.428 and P 0–6 = 0.953) scores were also nonsignificant. Exacerbation frequencies were nonsignificant between groups over 6 months (p = 1.000). Conclusion Although adjunctive MTs to IH could not produce any treatment benefits in COPD, the trial being underpowered, cautious interpretation is necessary. Trial registration CTRI/2018/04/013394.
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 3 months. 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 3 months (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.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.
hi@scite.ai
10624 S. Eastern Ave., Ste. A-614
Henderson, NV 89052, USA
Copyright © 2024 scite LLC. All rights reserved.
Made with 💙 for researchers
Part of the Research Solutions Family.