Open Observational Trial Research Articles

Homeopathic Treatment of Rheumatoid Arthritis: An Open, Observational Trial

Abstract Background Rheumatological complaints including rheumatoid arthritis (RA) are frequently encountered conditions in homeopathy practice. On account of progressive destruction and disability of the joints, and troublesome side effects and dissatisfaction with the mainstream therapies, homeopathy remains one of the most sought-after therapies; however, it remained under-researched systematically. Aim of this trial was to evaluate the possible role of homeopathic treatment in RA by determining changes in severity of complaints and quality of life. Materials and Methods An open observational trial was performed on 50 patients suffering from RA (classified as per 2010 ACR/EULAR criteria) at National Institute of Homoeopathy, Kolkata and were assessed over 4 months of treatment. Disease Activity Score-28 (DAS28) and Rheumatoid Arthritis Disease Activity Index (RADAI) were used as the primary and secondary outcome measures respectively. Individualised medicines were prescribed on the basis of homeopathic principles. Results Six patients dropped out; 44 completed the trial. Intention-to-treat sample (n = 50) was analysed in the end. There were statistically significant reductions in both DAS28 score (6.8 ± 1.0 vs. 6.1 ± 1.2; mean reduction 0.7, 95% CI: 0.4–0.9, p < 0.001) and RADAI score (6.6 ± 1.8 vs. 5.2 ± 1.9; mean reduction 1.4, 95% CI: 1.0–1.9, p < 0.001) over 4 months of individualised homeopathic treatment. Conclusion Individualised homeopathic medicines seemed to produce promising treatment effects by reducing DAS28 and RADAI scores significantly over 4 months. Further randomised trials are warranted with enhanced methodological rigor (Trial registration: CTRI/2017/06/008848).

The role of homoeopathic treatment in women suffering from post-caesarean backache: An open observational clinical trial

Context: An open observational trial was carried out at National Institute of Homoeopathy, India, to assess the possible effects of individualised Homoeopathy in individuals suffering from post-caesarean backache. Aim: The aim of the study was to find the role of homoeopathic treatment in individuals suffering from post-caesarean backache. Methods: Fifty subjects were enrolled. The Short-Form McGill Pain Questionnaire (SF-MPQ) and Oswestry Low Back Pain Disability Questionnaire (ODQ) were used as the outcome measures, assessed at baseline and after 3 months of treatment. Medicines prescribed followed homoeopathic principles. Non-parametric Wilcoxon signed rank test was applied to compare the dependent observations. P

An open observational trial evaluating the role of individualised homoeopathic medicines in the management of nocturnal enuresis

Context: Nocturnal enuresis is a widespread and distressing condition that can have a deep impact on the subject's behavioural, emotional and social life. Aim: We intend to evaluate the role of homoeopathic treatment in nocturnal enuresis. Materials and Methods: A prospective, single arm, pre-post comparison, non-randomised, open-label, observational trial on individuals of 5–18 years of age presenting with nocturnal enuresis at the outpatient department of The Calcutta Homoeopathic Medical College and Hospital was carried out. A total of 34 individuals were enrolled. A scoring scale was developed; scores were measured at baseline, after 2nd and 4th month. The intention to treat population was statistically analysed in the end. Results: The mean age of the patients was 8.71 ± 2.73 years; gender distribution was 1:1. Compared to baseline, scores reduced significantly over 2 months (11.6 ± 1.9 vs. 9.6 ± 3.5; mean difference: 2.0 ± 2.5 [95% confidence interval (CI): 1.2, 2.9]; t = 4.748; P

Bengali questionnaire validation among geriatric population visiting homeopathic hospital and subsequent open observational trial evaluating effectiveness of homeopathic treatment

AimsThe authors intend to develop translated Bengali questionnaires measuring depression, stress, mindfulness and quality of life among geriatric population seeking homeopathic care and to examine effectiveness of homeopathic treatment subsequently in the said conditions by an open, observational trial. MethodsA mixed method bi-phasic study – a cross-sectional validation study in the first phase, followed by open, observational trial in the second phase was conducted using 4 translated questionnaires – Geriatric Depression Scale, Perceived Stress Questionnaire, Mindfulness Attention Awareness Scale, and Quality of Life Scale. Hamilton’s Anxiety Scale was physician-administered; hence translation, further validation and testing cross-cultural adaptability was unnecessary. ResultsTotal 110 geriatric patients were enrolled; 60 suffered from depression, 86 from stress, 59 from anxiety. Exploratory principal component analysis using varimax rotation provided indications for construct validity. Questionnaires were internally consistent (Cronbach’s α 0.745–0.926); with acceptable concurrent validity (Pearson’s r 0.552–0.884). After the questionnaires were found valid by psychometric evaluation, the subsequent open observational trial for 3 months demonstrated individualized homeopathic treatment to be effective for the said conditions by changing the questionnaire scores significantly (P<0.001; Cohen’s d 0.568–1.499). ConclusionThe questionnaires appeared valid and reliable. Effect sizes were promising, forming basis of up-taking efficacy trials. Limited generalizability of treatment effects necessitates cautious interpretation. Trial registration: CTRI/2015/06/005927.

Effectiveness of the Austrian disease management programme “Therapie Aktiv” for type 2 diabetes regarding the improvement of metabolic control, risk profile and guideline adherence: 2 years of follow up

We evaluated the disease management programme (DMP) "Therapie Aktiv" for diabetes mellitus type 2 during the first year of implementation in a cluster-randomised controlled trial (RCT), which revealed an improvement of process quality, but only insignificant effects on HbA1c. To further analyse the effects of the DMP we followed up participants of the RCT for another year. After completion of the RCT, the study was continued as an open observational trial. By patient's choice, three groups were formed. Group 1 (DMP/DMP): interventions of the RCT (DMP), who remained in the DMP; group 2 (Control/DMP): controls of the RCT (usual care), who participated in the DMP during the second year; group 3 (Control/Control): controls of the RCT (usual care), who remained as controls. HbA1c. BMI, lipids, blood pressure and measures of process quality. Only 801 of 1,489 RCT participants completed the study (53.8 %). Group 1: n = 355; group 2: n = 335; group 3: n = 111. After 2 years, pre-post-analysis revealed a significant reduction of HbA1c (0.37 %, p < 0.001) in both DMP groups, and a reduction of only 0.03 % (p = 0.975) in the control group. However, the difference between the groups was not significant (p = 0.065). There was a significant improvement of process quality in the DMP groups compared with controls. The DMP clearly enhances process quality. Furthermore, the DMP yields a reduction of HbA1c within groups after 2 years, but significance is lost in between-group analysis. We conclude that the DMP has only a minor effect on metabolic control.

The results of open observational trial DIAMOND

Aim. DIAMOND (DIAMicrON in Daily practice) is an open non-randomized observational trial aimed to estimate the efficacy and safety of gliclazide(Diamicron MB) in routine clinical practice. Materials and methods. 394 patients with poor control of type 2 diabetes mellitus (T2 DM), previously treated with diet or one of oral antidiabeticdrug (OAD), were switched to Diamicron MB. Previous therapy was left unchanged, except for a sulfonylurea or glinide that were canceled. Results. After 6 months of Diamicron MB therapy (30% monotherapy, 70% combined therapy) target HbA1c

Evaluating algorithm-guided treatment for depression: The German Algorithm Project (GAP)

The introduction of algorithms in the treatment of patients suffering from major depressive disorder (MDD) is considered as an important instrument in avoiding and overcoming treatment-resistant depression. The multiphasic German Algorithm Project has evaluated algorithm-guided treatment of inpatients with MDD. Phase I (open observational trial) showed a moderate acceptance but good clinical effectiveness of a standardized stepwise drug treatment regimen (SSTR). Phase II (randomized controlled trial) demonstrated a higher probability of achieving remission for SSTR patients compared to patients with treatment as usual (TAU). Phase III was a recently finished randomized controlled multi-center trial within the German Research Network on Depression which compared an SSTR and a computerized documentation and expert system (CDES) with TAU. Within the SSTR we compared three different second-step strategies in the case of non-response to an initial antidepressant monotherapy (SSTR1: lithium augmentation, SSTR 2: dose escalation, SSTR 3: switch to other compound). Preliminary analyses show a faster remission for algorithm-treated patients compared to TAU (F=3.045; p=0.18) with SSTR1 showing the greatest difference to TAU (p=0.02). TAU was associated with a higher average rate of residual symptoms at the end of treatment. Algorithm-guided treatment of depression may lead to a faster remission and reduce hospitalization times, particularly with an SSTR including lithium augmentation.

Surgical management of cornual-isthmic tubal obstruction

Objective: To examine the efficacy of microsurgical tubal anastomosis among patients having failed attempts to correct cornual-isthmic tubal obstruction by hysteroscopic tubal catheterization. Design: An open observational trial. Setting: A tertiary referral reproductive medicine practice. Patient(s): Forty-three patients with laparoscopically confirmed bilateral cornual-isthmic obstruction and otherwise normal fallopian tubes. Thirty-three control patients with a history of elective sterilization presenting for tubal anastomosis. Intervention(s): All patients with bilateral cornual-isthmic obstruction underwent attempted hysteroscopic tubal cannulation. Those unsuccessfully catheterized proceeded with microsurgical resection and anastomosis. Candidates for reversal of sterilization underwent microsurgical repair in standard layered technique. Main Outcome Measure(s): Mean time to achieve pregnancy, as well as cumulative pregnancy rates for all three groups using life-table analysis, were calculated. Result(s): Cumulative pregnancy rates for patients with successful tubal catheterization, for those requiring microsurgical repair, and for reversal of elective sterilization were 0.68%, 0.56%, and 0.29%, respectively, at 12 months. Mean duration to achieve pregnancy was similar for both cornual-isthmic blockage-treated groups and was shorter than that for the sterilization-reversal group. Conclusion(s): Patients with cornual-isthmic obstruction and otherwise normal fallopian tubes who are treated successfully by either tubal catheterization or resection and microsurgical anastomosis demonstrate high pregnancy rates, short interval to achieve pregnancy, and similar obstetric outcome. If no pregnancy is achieved within 1 year of surgery, reevaluation and consideration for possible IVF and ET is indicated.

Long-Term Follow-up of Gonadotrophin-Releasing Hormone Analog Treatment for Recurrent Endometrial Cancer

To test the antitumor effect of gonadotrophin-releasing hormone (GnRH) analogs, 32 consecutive patients with recurrent endometrial cancer that had progressed through conventional treatments were entered into an open observational trial of treatment with this class of compounds. Patients recruited had progressive, symptomatic, and measurable disease. Treatment was with monthly subcutaneous injections of GnRH analog. Measurements of gonadotrophins, sex hormones, and tumor dimensions were made together with repeat biopsy when possible to assess response to treatment. An objective response was seen in nine patients (28%, 95% CI 13–43%). Responses were seen within the first 2 months of treatment and included pelvic as well as distant sites of recurrence. Significantly greater response rates were seen in previously irradiated sites when compared with nonirradiated sites of recurrence (0.01 >P> 0.001). There was no significant difference between the response in patients with G3 lesions compared with patients with G1/G2 lesions (P> 0.5). Response did not correlate with previous progestogen exposure. No evidence of disease flare or drug toxicity was observed. GnRH analogs have a significant and durable antitumor effect in recurrent endometrial cancer which warrants further examination in comparison with progestogens.

The incidence of fallopian tube patency after transcervical resection of the endometrium including rollerball diathermy to the tubal ostia

To evaluate the incidence of tubal patency as well as the shape of the endometrial cavity after transcervical resection of the endometrium. An open observational trial. The obstetrics and gynecology unit at a district hospital in Norway. Fifty consecutive patients who had undergone treatment for menorrhagia and metrorrhagia by resection of the endometrium and coagulation of the tubal ostium were included in the study. A hysterosalpingogram was performed with a semistiff catheter and injection of 20 mL contrast dye 5 to 12 months after transcervical resection of the endometrium and fibroids. Tubal patency and uterine cavity morphology. Forty-four patients showed total occlusion of the fallopian tubes, and the uterine cavity showed fibrosis and narrowing of the cavity. Three patients showed bilateral and three patients unilateral tubal patency. Shrinkage and fibrosis of the uterine cavity occur after endometrial resection. A significant number of women after transcervical resection of the endometrium have patient tubes (13%) despite coagulation of the tubal ostia.