The effect of USM-IAM-based counselling vs standard counselling on insulin adherence, FBS and HbA1c among patients with uncontrolled type 2 diabetes mellitus (T2DM): a randomised controlled trial.

BACKGROUND: Many patients with T2DM on insulin are not optimally controlled despite receiving standard diabetes education counselling. Poor insulin adherence may be a contributing factor. We developed and evaluated a new module [Universiti Sains Malaysia-Insulin Adherence Module (USM-IAM)] on insulin-treated patients with poorly controlled diabetes. METHODS: Eligibility criteria are those diagnosed with T2DM, aged between 18 and 65 years, with HbA1c between 8 and 15% and on insulin therapy for 1 year. Patients were randomly allocated to receive either the USM-IAM-based counselling or the standard counselling (SC) at baseline and the second visit. Patients were instructed to adjust insulin doses based on blood glucose levels. Outcomes were changes in adherence score, FBS and HbA1c levels from baseline to 3 months and baseline to sixth month. RESULTS: Ninety patients were randomised to each group. The baseline sociodemographic and clinical characteristics were homogenous among groups. Ninety patients were analysed for each group. Adherence score changes between baseline to 3 months were - 8.30 (- 11.47, - 5.14) in USM-IAM-based counselling group (USM-IAM) and - 7.64 (- 10.89, - 4.40) in standard counselling group (SCG), between baseline to sixth month were - 10.21 (- 13.40, - 7.03) in USM-IAM and - 10.79 (- 14.64, - 6.97) in SCG. FBS changes between baseline to 3 months were 1.374 (0.25, 2.50) in USM-IAM and 0.438 (- 0.66, 1.54) in SCG, and between baseline to sixth month were 1.713 (0.473, 2.95) in USM-IAM and 0.998 (- 0.02, 2.01) in SCG. HbA1c changes between baseline to 3 months were 1.374 (0.25, 2.50) in USM-IAM and 0.547 (0.12, 0.98) in SCG, and between baseline to sixth month were 1.03 (0.65, 1.41) in USM-IAM and 0.617 (0.20, 1.03) in SCG. Between-subjects effects for all outcomes were not statistically significant. CONCLUSION: Both groups had significant improvements in adherence score and HbA1c with time, with higher improvement in patients receiving the USM-IAM. FBS reductions were significant in the intervention group but not in the control group. TRIAL REGISTRATION: This study protocol is registered with Clicaltrials.gov with ID NCT05125185 dated 17th November 2021.

Development and Validation of USM-Insulin Adherence Module for Patients with Type 2 Diabetes Mellitus.

Background: Many patients with type 2 diabetes mellitus (T2DM) do not achieve the desired glycaemic control despite being treated with insulin. Studies found this due to an improper understanding of insulin function, its intensification process and patients' negative perspective on insulin. We developed an education module to enhance adherence to insulin therapy. Methods: This study applied a mixed design. It was conducted in three phases: i) Phase I: literature search and focus group discussions (FGDs), ii) Phase II: module development and iii) Phase III: content and face validation of Universiti Sains Malaysia-Insulin Adherence Module (USM-IAM). FGDs were used to gather patients' opinions. All researchers repeatedly discussed about the module content and arrangement, the words and images used, and the grammar in producing the final draft. Specialists and target audience performed content and face validation of the module. Results: Thirty-six participants were involved in the FGDs. Data saturation was achieved at the 4th FGD. Three themes emerged from qualitative data analysis and were incorporated into the module. USM-IAM was finalised with five units. The content validity index (CVI) was 0.92, while face validity agreements were between 86% and 97%. Conclusion: The CVI and face agreement for USM-IAM exceed the cut-off point for a sound module. It has good potential to be used as a resource for educating patients in enhancing insulin adherence.

Tai Chi Exercise for Mental and Physical Well-Being in Patients with Depressive Symptoms: A Systematic Review and Meta-Analysis.

Tai Chi is a mindfulness-body practice that has physiological and psychosocial benefits and can be integrated into the prevention and rehabilitation of various medical conditions; however, the effectiveness of Tai Chi in the treatment of depression remains unclear. This review aimed to determine the effects of Tai Chi exercise on mental and physical well-being in patients with depressive symptoms. We searched databases for English language publications that appeared during January 2000-2022. The included trials were RCTs that involved people with depression with no other medical conditions, and included both adolescent and adult samples. A meta-analysis was performed using a random effects model and the heterogeneity was estimated using I2 statistics. The quality of each trial was assessed according to the Grades of Recommendation, Assessment, Development, and Evaluation (GRADE) methodology. The eight trials were divided into two comparisons: (1) a combination of Tai Chi and antidepressants versus standard antidepressants; (2) Tai Chi versus no intervention. The Tai Chi intervention showed improvements in mental and physical well-being as evidenced by the reductions in depression and anxiety and improved quality of life (QOL) of the patients with depressive symptoms. Further well-controlled RCTs are recommended with a precision trial design and larger sample sizes.

Normalisation of human chorionic gonadotrophin (hCG) levels in a patient with partial molar pregnancy with a uterine mass without chemotherapy: impact of using herbal remedies.

OBJECTIVES: Level of ßhCG and the presence of any uterine mass of hydatidiform mole need a careful review or monitoring in order to prevent metastasis, provide an early treatment and avoid unnecessary chemotherapy. CASE PRESENTATION: A 36-year old fifth gravida patient who had a missed abortion was diagnosed as having a molar pregnancy with beta human chorionic gonadotrophin (ßhCG) level of 509,921 IU/L. Her lung field was clear and she underwent suction and curettage (S & C) procedure. However, after six weeks, AA presented to the emergency department with a massive bleeding, although her ßhCG level had decreased to 65,770 IU/L. A trans-abdominal ultrasound indicated the presence of an intra-uterine mass (3.0 × 4.4 cm). Nevertheless, her ßhCG continued to show a declining trend (8,426 IU/L). AA was advised to undergo a chemotherapy but she refused, citing preference for alternative medicine like herbs instead. She opted for an "at own risk" (AOR) discharge with scheduled follow up. Subsequently, her condition improved with her ßhCG showing a downward trend. Surprisingly, at six months post S & C, her ßhCG ameliorated to 0 IU/L with no mass detected by ultrasound. CONCLUSIONS: Brucea javanica fruits, Pereskia bleo and Annona muricata leaves can potentially be useful alternatives to chemotherapy and need further studies.

The effect of a brown-rice diets on glycemic control and metabolic parameters in prediabetes and type 2 diabetes mellitus: a meta-analysis of randomized controlled trials and controlled clinical trials.

BACKGROUND: Brown rice is a whole-grain food that is often assumed to have a lower glycemic index compared to white rice. A few studies have objectively confirmed the effect of a brown-rice diet on glycemic control and metabolic parameters compared to a white-rice diet. The purpose of this study is to determine the effect of brown rice on improving glycemic control and metabolic parameters in prediabetes and type 2 diabetes. The researchers conducted a systematic review and meta-analysis of randomized controlled trials (RCTs) and controlled clinical trials. METHODS: PRISMA guidelines were used as the basis of this systematic review. Relevant studies were identified by searching the following databases: Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE (PubMed), as well as Epistemonikos for randomized controlled trials (RCTs) and controlled clinical trials published not later than January 2021 involving adults with prediabetes and diabetes mellitus who were consuming brown rice compared to those consuming white rice. The primary outcomes measured were glycated hemoglobin (HbA1c) and fasting blood glucose (FBG) levels. The secondary outcomes were body weight, waist circumference, systolic and diastolic blood pressure levels, LDL and HDL-cholesterol levels. The mean differences (MDs) with 95% confidence intervals (CIs) between brown and white-rice-diet groups were calculated using a random-effects model. RESULTS: Seven trials involving 417 adults with prediabetes or type 2 diabetes were included in this study. Brown-rice diet did not improve the glycemic control because it had no effect on the HbA1c level (p = 0.15) and the FBG level (p = 0.95) compared to white-rice diet. Brown-rice diet reduced body weight (p < 0.00001; MD -2.2 kg; 95% CI [-3.13 to -1.26]; I 2 = 0%). However, it had no effect on the waist circumference (p = 0.09), systolic blood pressure (p = 0.60) and diastolic blood pressure level (p = 0.40). HDL-cholesterol level is increased in brown-rice diet (p = 0.01; MD 0.10, 95% CI [0.02 to 0.17]; I 2 = 44%) but it had no effect on the LDL-cholesterol level (p = 0.81). CONCLUSIONS: The available evidence indicated that consuming brown rice in substitute for white rice does not affect glycemic control (HbA1c and FBG levels) in pre-diabetes and type 2 diabetes patients. Brown rice, however, may be used as an alternative for white rice in such patients because it was found to reduce body weight and increase the HDL-cholesterol level. The benefits of a brown-rice diet on glycemic control may not be detected in short-term studies. The obtained evidence in this meta-analysis ranged from low to moderate quality. Thus, more high-quality trials with a larger sample size and a longer follow-up duration are needed to further investigate the effects of a brown-rice diet on diabetes glycemic control with stronger evidence.PROSPERO registration number: CRD42019143266.