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  1. Adinegara LA, Razzak MS
    Med J Malaysia, 2004 Mar;59(1):39-44.
    PMID: 15535334
    A case-control study was carried out in Alor Gajah to determine the socio-economic, dietary and lifestyle factors and the occurrence of pregnancy-induced hypertension. There were a total of 30 cases who were selected from antenatal mothers attending 3 selected health centers in 1998. The control group consisted of 30 antenatal mothers who were matched according to health centre, race and age. The results showed that pregnancy-induced hypertension was significantly associated with obesity (P < 0.05) and being a housewife (P < 0.05).
  2. Thevi T, Abas AL
    Oman J Ophthalmol, 2018 6 23;11(2):113-118.
    PMID: 29930443 DOI: 10.4103/ojo.OJO_220_2016
    BACKGROUND: Cataract surgery is associated with a variety of complications, one of which is vitreous loss. Doctors and policymakers should be aware about the precipitating factors, associations, and expected outcomes of vitreous loss. This study was, therefore, undertaken to set guidelines to improve the visual outcomes of patients.

    MATERIALS AND METHODS: A retrospective 8-year analysis was conducted from 2007 to 2014 using the national eye database. Demographic features, ocular comorbidities, grade of surgeon, type of surgery, and the associations with the occurrence of vitreous loss, and the final visual outcomes of these patients were studied.

    RESULTS: Out of 12,992 eyes, only 3.2% had vitreous loss, mostly aged <40 years. Pseudoexfoliation was the only ocular comorbidity causing vitreous loss. Medical Officers and Gazetting Specialists got more vitreous loss compared to specialists. Intracapsular cataract extraction, phaco convert to extracapsular cataract extraction (ECCE), ECCE, and phaco all had a significant vitreous loss. Vitreous loss was the most significant intraoperative complication causing poor vision and resulted in impaired or poor visual outcome.

    CONCLUSION: Vitreous loss occurred in almost all types of cataract surgeries, especially by junior surgeons, among those aged <40 years and significantly caused poor visual outcome compared to other complications. Pseudoexfoliation had higher occurrence of vitreous loss. Vitreous loss patients had impaired/poor visual outcome due to preexisting comorbidity and astigmatism. Patients at risk and junior surgeons should be closely monitored to improve outcomes. Further studies need to be done to see why and when the vitreous loss occurred.
  3. Thevi T, Abas AL
    Oman J Ophthalmol, 2019 10 11;12(3):160-165.
    PMID: 31902990 DOI: 10.4103/ojo.OJO_238_2018
    INTRODUCTION: Pseudoexfoliation (PXM) is a fibrillar material deposited in the anterior chamber of the eye and can cause disintegration of zonules and make pupillary dilatation difficult. This can make surgery difficult and result in intraoperative and postoperative complications. The aim of this study was to learn about whether the presence of pseudoexfoliation caused significant complications during cataract surgery.

    MATERIALS AND METHODS: We did a secondary data analysis of 12,992 eyes from 2007 to 2014 using the National Eye Database of Melaka Hospital Malaysia on intraoperative and postoperative cataract surgery complications of patients with PXM.

    RESULTS: Patients with PXM were 2.68 times more likely to get intraoperative complications (P < 0.001). They had a higher incidence of lens subluxation, zonular dehiscence, and vitreous loss (P < 0.001). Although posterior capsule rupture (PCR) was the most common intraoperative complication during cataract surgery (4.8%), the presence of pseudoexfoliation was not associated with PCR (P > 0.05). We did not observe any association between patients with pseudoexfoliation and any of the postoperative complications such as corneal decompensation, raised intraocular pressure, and intraocular lens decentration (P > 0.05). Pseudoexfoliation did not cause corneal decompensation (P > 0.05) although corneal decompensation was the highest postoperative complication of cataract surgeries (0.18%).

    CONCLUSIONS: Patients with PXM had a higher rate of intraoperative complications which were mainly vitreous loss and zonular dehiscence and also lens subluxation/dislocation. We observed poorer visual outcomes in those with PXM following cataract surgery. Patients with pseudoexfoliation should be identified and precautions taken to minimize these complications to get better visual outcomes.

  4. Thevi T, Abas AL
    Indian J Ophthalmol, 2017 Oct;65(10):920-925.
    PMID: 29044054 DOI: 10.4103/ijo.IJO_512_17
    Traumatic endophthalmitis is a devastating condition that can occur following an open globe injury and result in loss of vision. The use of prophylactic antibiotics is empirical as most surgeons fear complications associated with the same. No systematic review has been performed in English on the role of intravitreal/intracameral antibiotics in preventing traumatic endophthalmitis. We searched for randomized controlled trials and controlled clinical trials comparing intracameral/intravitreal antibiotics with placebos on PubMed, Google Scholar, Science Direct, and Cochrane Library using keywords open globe/trauma/penetrating/perforating injuries endophthalmitis. The last search was on 5 May 2017. We included patients of all ages with open globe injuries who received intracameral/intravitreal antibiotics, regardless of the dose. Quality of the trials was assessed using Cochrane collaboration tools to assess the risk of bias. The main outcome measures were endophthalmitis and visual acuity. We included three trials. Overall, intravitreal/intracameral antibiotics were noted to significantly reduce the occurrence of endophthalmitis in open globe injuries (relative risk [RR] 0.19, 95% confidence interval [CI] 0.06-0.57). The use of intravitreal/intracameral antibiotics did not have an effect in improving visual acuity (RR 1.17, 95% CI 0.61-2.23). Two trials (Narang 2003; Soheilan 2001) were observed to have no significant effect on visual acuity while another trial (Soheilan 2007) did not list visual acuity as part of its objectives. Intracameral/intravitreal antibiotics reduce the risk of endophthalmitis in open globe injuries; although, there was no improvement in the visual acuity. We, therefore, recommend the use of intravitreal/intracameral injections in open globe injuries to prevent this devastating complication.
  5. Karanth L, Abas AB
    Cochrane Database Syst Rev, 2021 Dec 09;12(12):CD011059.
    PMID: 34881425 DOI: 10.1002/14651858.CD011059.pub4
    BACKGROUND: Bleeding disorders are uncommon but may pose significant bleeding complications during pregnancy, labour and following delivery for both the woman and the foetus. While many bleeding disorders in women tend to improve in pregnancy, thus decreasing the haemorrhagic risk to the mother at the time of delivery, some do not correct or return quite quickly to their pre-pregnancy levels in the postpartum period. Therefore, specific measures to prevent maternal bleeding and foetal complications during childbirth, are required. The safest method of delivery to reduce morbidity and mortality in these women is controversial. This is an update of a previously published review.

    OBJECTIVES: To assess the optimal mode of delivery in women with, or carriers of, bleeding disorders.

    SEARCH METHODS: We searched the Cochrane Cystic Fibrosis and Genetic Disorders Coagulopathies Trials Register, compiled from electronic database searches and handsearching of journals and conference abstract books. We also searched the Cochrane Pregnancy and Childbirth Group's Trials Register as well as trials registries and the reference lists of relevant articles and reviews. Date of last search of the Group's Trials Registers: 21 June 2021.

    SELECTION CRITERIA: Randomised controlled trials and quasi-randomised controlled clinical trials investigating the optimal mode of delivery in women with, or carriers of, any type of bleeding disorder during pregnancy were eligible for the review.

    DATA COLLECTION AND ANALYSIS: No trials matching the selection criteria were eligible for inclusion.

    MAIN RESULTS: No trials matching the selection criteria were eligible for inclusion.

    AUTHORS' CONCLUSIONS: The review did not identify any randomised controlled trials investigating the safest mode of delivery and associated maternal and foetal complications during delivery in women with, or carriers of, a bleeding disorder. In the absence of high quality evidence, clinicians need to use their clinical judgement and lower level evidence (e.g. from observational trials, case studies) to decide upon the optimal mode of delivery to ensure the safety of both mother and foetus. Given the ethical considerations, the rarity of the disorders and the low incidence of both maternal and foetal complications, future randomised controlled trials to find the optimal mode of delivery in this population are unlikely to be carried out. Other high quality controlled studies (such as risk allocation designs, sequential design, and parallel cohort design) are needed to investigate the risks and benefits of natural vaginal and caesarean section in this population or extrapolation from other clinical conditions that incur a haemorrhagic risk to the baby, such as platelet alloimmunisation.

  6. Sonkusare S, Adinegara, Hebbar S
    Med J Malaysia, 2007 Dec;62(5):402-8.
    PMID: 18705476 MyJurnal
    The purpose of this study was to study the determinants of self rated health in the low-risk pregnant women of Melaka Tengah in Malaysia. A total of 387 subjects were analysed. The role of mental health, psychosocial stressors, support from husband, coping skills, socio-economic status and pregnancy characteristics in determining self- rated health were studied. Health items were taken from the Duke Health Profile. Bad obstetric history, poor mental health, stress from the family were found to be significantly associated with poor self - rated health whereas good support from the husband was related to good self - rated health.
  7. Karanth L, Kanagasabai S, Abas AB
    Cochrane Database Syst Rev, 2017 08 04;8:CD011059.
    PMID: 28776324 DOI: 10.1002/14651858.CD011059.pub3
    BACKGROUND: Bleeding disorders are uncommon but may pose significant bleeding complications during pregnancy, labour and following delivery for both the woman and the foetus. While many bleeding disorders in women tend to improve in pregnancy, thus decreasing the haemorrhagic risk to the mother at the time of delivery, some do not correct or return quite quickly to their pre-pregnancy levels in the postpartum period. Therefore, specific measures to prevent maternal bleeding and foetal complications during childbirth, are required. The safest method of delivery to reduce morbidity and mortality in these women is controversial. This is an update of a previously published review.

    OBJECTIVES: To assess the optimal mode of delivery in women with, or carriers of, bleeding disorders.

    SEARCH METHODS: We searched the Cochrane Cystic Fibrosis and Genetic Disorders Coagulopathies Trials Register, compiled from electronic database searches and handsearching of journals and conference abstract books. We also searched the Cochrane Pregnancy and Childbirth Group's Trials Register as well as trials registries and the reference lists of relevant articles and reviews.Date of last search of the Group's Trials Registers: 16 February 2017.

    SELECTION CRITERIA: Randomised controlled trials and all types of controlled clinical trials investigating the optimal mode of delivery in women with, or carriers of, any type of bleeding disorder during pregnancy were eligible for the review.

    DATA COLLECTION AND ANALYSIS: No trials matching the selection criteria were eligible for inclusion MAIN RESULTS: No results from randomised controlled trials were found.

    AUTHORS' CONCLUSIONS: The review did not identify any randomised controlled trials investigating the safest mode of delivery and associated maternal and foetal complications during delivery in women with, or carriers of, a bleeding disorder. In the absence of high quality evidence, clinicians need to use their clinical judgement and lower level evidence (e.g. from observational trials, case studies) to decide upon the optimal mode of delivery to ensure the safety of both mother and foetus.Given the ethical considerations, the rarity of the disorders and the low incidence of both maternal and foetal complications, future randomised controlled trials to find the optimal mode of delivery in this population are unlikely to be carried out. Other high quality controlled studies (such as risk allocation designs, sequential design, and parallel cohort design) are needed to investigate the risks and benefits of natural vaginal and caesarean section in this population or extrapolation from other clinical conditions that incur a haemorrhagic risk to the baby, such as platelet alloimmunisation.

  8. Thevi T, Maizura Z, Abas AL
    Indian J Ophthalmol, 2017 Jan;65(1):24-29.
    PMID: 28300736 DOI: 10.4103/ijo.IJO_452_16
    INTRODUCTION: As in all surgeries, complications during cataract surgery are unavoidable and cause distress to the surgeon and the patient. This study was conducted to know the factors contributing to complications in our settings, to be able to counsel patients about complications and outcomes and to reduce litigations.

    MATERIALS AND METHODS: The secondary data analysis was conducted using the National Eye Database from 2007 to 2014. Demographic features, ocular comorbidities, technique of surgery, grade of surgeons, types of intraoperative complications, and reasons for not obtaining good visual acuity following intraoperative complications were studied. Statistics was done using Statistical Package for Social Sciences version 20.

    RESULTS: Out of 12,992 eyes, 6.1% had intraoperative complications. The highest rate of complications was when more trainees (medical officers [MOs] and gazetting specialists) operated. Posterior capsule rupture (PCR) was the most common complication followed by vitreous loss and zonular dehiscence. Those aged below 40 years had more complications (P < 0.05), and females had more complications. Ethnicity did not affect complications. Pseudoexfoliation was the only comorbidity causing complications (P < 0.05). Phacolytic lenses had 8.118 times the odds of getting intraoperative complications. MOs and gazetting specialists got more complications. Good outcomes were obtained in cases without complications and those operated by specialists. High astigmatism was the main reason for poorer outcomes.

    CONCLUSION: Intraoperative complications were caused mostly by less experienced doctors and had poorer outcomes. Age below 40 years, females, the presence of pseudoexfoliation and phacolytic lenses had more complications. PCR was the most common complication.

  9. Thevi T, Abas AL, Dua HS
    Indian J Ophthalmol, 2024 Sep 10.
    PMID: 39257085 DOI: 10.4103/IJO.IJO_300_24
    Management of nonhealing corneal ulcers is challenging as it can lead to complications such as melting, descemetocele, and perforation, which can be prevented by amniotic membrane graft (AMG). The absence of any review (English language) on AMG for corneal ulcers prompted us to conduct this review. We looked for clinical trials (randomized and controlled) on the effect of AMG combined with other treatments, through various search engines utilizing the terms amniotic membrane and corneal ulcer. All patients who received AMG and/or conventional medication were included. Risk of bias tools derived from Cochrane collaboration were used to ascertain the standard and quality of the trials. Visual acuity and epithelial healing time were the main outcome measures studied. Three trials were finally selected for analysis. AMG was noted to be associated with better uncorrected visual acuity and reduction in neovascularization. There was no difference in best corrected visual acuity, epithelial healing time, and corneal opacity. There is evidence that the use of AMG is associated with improved uncorrected visual acuity as well as reduction in neovascularization of the cornea among patients with corneal ulcers, but there was no improvement in epithelial healing time or corneal opacity. Further multicenter randomized controlled trials are needed to elicit the beneficial effects of the intervention and augment the validity of this review.
  10. Mulimani P, Ballas SK, Abas AB, Karanth L
    Cochrane Database Syst Rev, 2016;4:CD011633.
    PMID: 27103509 DOI: 10.1002/14651858.CD011633.pub2
    Sickle cell disease is the most common single gene disorder and the commonest haemoglobinopathy found with high prevalence in many populations across the world. Management of dental complications in people with sickle cell disease requires special consideration for three main reasons. Firstly, dental and oral tissues are affected by the blood disorder resulting in several oro-facial abnormalities. Secondly, living with a haemoglobinopathy and coping with its associated serious consequences may result in individuals neglecting their oral health care. Finally, the treatment of these oral complications must be adapted to the systemic condition and special needs of these individuals, in order not to exacerbate or deteriorate their general health.Guidelines for the treatment of dental complications in this population who require special care are unclear and even unavailable in many aspects. Hence this review was undertaken to provide a basis for clinical care by investigating and analysing the existing evidence in the literature for the treatment of dental complications in people with sickle cell disease.
  11. Thevi T, Abas AL, Stephanie Yen Li C
    BMC Ophthalmol, 2021 Sep 27;21(1):348.
    PMID: 34579663 DOI: 10.1186/s12886-021-02100-4
    BACKGROUND: We conducted the study to compare the psychometric properties of the English version of the Questionnaire and the Bahasa Malaysia (Malay Language) version regarding the vision-related Quality of Life of patients with cataracts.

    METHODS: The Malay version was translated by two independent translators who were well versed in both languages. We carried out a cross-sectional study collecting data between June 2017 and March 2018 in the pre-operative Eye Clinic of Hospital Melaka with 224 respondents (mean age 66.8 years) and another 204 respondents (mean age 64.3 years) participating in the English version and Malay version of the Questionnaire respectively. Methods used to validate the standard questionnaire included the use of construct validity via factor analysis and the deployment of reliability test through assessment of internal consistency via Cronbach's alpha.

    RESULTS: We observed both English and Bahasa Malaysia versions to have high reliability with Cronbach's alpha values of 0.90 and above in factors on difficulty with activities and responses to vision problems. Exploratory factor analysis performed revealed that the three-factor model fits the data well for the English version of the questionnaire - difficulty with activities (23.81 % of variance), responses to vision problem (22.22 % of variance) and general health and vision (14.68 % of variance). The Bahasa Malaysia version of the questionnaire produced three factors with two of the factors resembling the factors from the original version of the questionnaire - difficulty with activities (24.3 % of variance) and responses to vision problem (23.7 % of variance). Item response theory analysis revealed that these factors for both English and Bahasa Malaysia versions comprised of adequately fitted items.

    CONCLUSION: The present study observed that both the English and Bahasa Malaysia versions of the NEI VFQ-25 have comparable construct validity to the original American version. With high validity and reliability, the tool shall be able to provide health care providers the assessment of impact due to cataract and other ophthalmic conditions on the vision-related quality of life of ophthalmic patients.

  12. Mulimani P, Ballas SK, Abas AB, Karanth L
    Cochrane Database Syst Rev, 2019 Dec 16;12(12):CD011633.
    PMID: 31841224 DOI: 10.1002/14651858.CD011633.pub3
    BACKGROUND: Sickle cell disease is the most common single gene disorder and the commonest haemoglobinopathy found with high prevalence in many populations across the world. Management of dental complications in people with sickle cell disease requires special consideration for three main reasons. Firstly, dental and oral tissues are affected by the blood disorder resulting in several oro-facial abnormalities. Secondly, living with a haemoglobinopathy and coping with its associated serious consequences may result in individuals neglecting their oral health care. Finally, the treatment of these oral complications must be adapted to the systemic condition and special needs of these individuals, in order not to exacerbate or deteriorate their general health. Guidelines for the treatment of dental complications in this population who require special care are unclear and even unavailable in many aspects. Hence this review was undertaken to provide a basis for clinical care by investigating and analysing the existing evidence in the literature for the treatment of dental complications in people with sickle cell disease. This is an update of a previously published review.

    OBJECTIVES: To assess methods of treating dental complications in people with sickle cell disease.

    SEARCH METHODS: We searched the Cochrane Cystic Fibrosis and Genetic Disorders Review Group's Haemoglobinopathies Trials Register, compiled from electronic database searches and handsearching of journals and conference abstract books. Date of last search: 01 August 2019. Additionally, we searched nine online databases (PubMed, Google Scholar, ClinicalTrials.gov, WHO International Clinical Trials Registry Platform, Literature in the Health Sciences in Latin America and the Caribbean database, African Index Medicus, Index Medicus for South East Asia Region, Index Medicus for the Eastern Mediterranean Region, Indexing of Indian Medical Journals). We also searched the reference lists of relevant articles and reviews and contacted haematologists, experts in fields of dentistry, organizations, pharmaceutical companies and researchers working in this field. Date of last search: 07 November 2019.

    SELECTION CRITERIA: We searched for published or unpublished randomised controlled studies of treatments for dental complications in people with sickle cell disease.

    DATA COLLECTION AND ANALYSIS: Two review authors intended to independently extract data and assess the risk of bias of the included studies using standard Cochrane methodologies; however, no studies were identified for inclusion in the review.

    MAIN RESULTS: No randomised controlled studies were identified.

    AUTHORS' CONCLUSIONS: This Cochrane Review did not identify any randomised controlled studies assessing interventions for the treatment of dental complications in people with sickle cell disease. There is an important need for randomised controlled studies in this area, so as to identify the most effective and safe method for treating dental complications in people with sickle cell disease.

  13. Mulimani P, Abas AB, Karanth L, Colombatti R, Kulkarni P
    Cochrane Database Syst Rev, 2023 Feb 02;2(2):CD012969.
    PMID: 36732291 DOI: 10.1002/14651858.CD012969.pub3
    BACKGROUND: Thalassaemia is a quantitative abnormality of haemoglobin caused by mutations in genes controlling production of alpha or beta globins. Abnormally unpaired globin chains cause membrane damage and cell death within organ systems and destruction of erythroid precursors in the bone marrow, leading to haemolytic anaemia. The life-long management of the general health effects of thalassaemia is highly challenging, and failure to deal with dental and orthodontic complications exacerbates the public health, financial and personal burden of the condition. There is a lack of evidence-based guidelines to help care seekers and providers manage such dental and orthodontic complications. This review aimed to evaluate the available evidence on methods for treating dental and orthodontic complications in people with thalassaemia to inform future recommendations. This is an update of a Cochrane Review first published in 2019.

    OBJECTIVES: To assess different methods for treating dental and orthodontic complications in people with thalassaemia.

    SEARCH METHODS: We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group's Haemoglobinopathies Trials Register in September 2022, and we searched nine online databases and trials registries in January 2022. We searched the reference lists of relevant articles and reviews and contacted haematologists, experts in fields of dentistry, organisations, pharmaceutical companies and researchers working in this field.

    SELECTION CRITERIA: We searched for published or unpublished randomised controlled trials (RCTs) that evaluated treatment of dental and orthodontic complications in individuals diagnosed with thalassaemia, irrespective of phenotype, severity, age, sex and ethnic origin.

    DATA COLLECTION AND ANALYSIS: Two review authors independently screened the 37,242 titles retrieved by the search. After deduplication, we identified two potentially relevant RCTs. On assessing their eligibility against our inclusion and exclusion criteria, we excluded one and included the other.

    MAIN RESULTS: We included one parallel-design RCT conducted in Saudi Arabia and involving 29 participants (19 males, 10 females) with thalassaemia. It aimed to assess the effectiveness of photodynamic therapy as an adjuvant to conventional full-mouth ultrasonic scaling for the treatment of gingivitis. The average age of participants was around 23 years. There is very low-certainty evidence from this trial that full-mouth ultrasonic scaling plus photodynamic therapy compared to full-mouth ultrasonic scaling alone may improve gingival index score and bleeding on probing after 12 weeks in people with thalassaemia. We found no studies that assessed other interventions for the various dental or orthodontic complications of thalassaemia.

    AUTHORS' CONCLUSIONS: Although the included study showed greater reduction in gingivitis in the group treated with full-mouth ultrasonic scaling plus photodynamic therapy, the evidence is of very low certainty. The study had unclear risk of bias, a short follow-up period and no data on safety or adverse effects. We cannot make definitive recommendations for clinical practice based on the limited evidence of a single trial. Future studies will very likely affect the conclusions of this review. This review highlights the need for high-quality RCTs that investigate the effectiveness of various treatment modalities for dental and orthodontic complications in people with thalassaemia. It is crucial that future trials assess adverse effects of interventions.

  14. Abas AB, Mohd Said DA, Aziz Mohammed MA, Sathiakumar N
    Am. J. Ind. Med., 2013 Jan;56(1):65-76.
    PMID: 22544443 DOI: 10.1002/ajim.22056
    BACKGROUND: In Malaysia, surveillance of fatal occupational injuries is fragmented. We therefore analyzed an alternative data source from Malaysia's Social Security organization, the Pertubuhan Keselamatan Sosial (PERKESO).
    METHODS: We conducted a secondary data analysis of the PERKESO database comprised of 7 million employees from 2002 to 2006.
    RESULTS: Overall, the average annual incidence was 9.2 fatal occupational injuries per 100,000 workers. During the 5-year period, there was a decrease in the absolute number of fatal injuries by 16% and the incidence by 34%. The transportation sector reported the highest incidence of fatal injuries (35.1/100,000), followed by agriculture (30.5/100,000) and construction (19.3/100,000) sectors. Persons of Indian ethnicity were more likely to sustain fatal injuries compared to other ethnic groups.
    CONCLUSIONS: Government and industry should develop rigorous strategies to detect hazards in the workplace, especially in sectors that continuously record high injury rates. Targeted interventions emphasizing worker empowerment coupled with systematic monitoring and evaluation is critical to ensure success in prevention and control measures.
  15. Than NN, Soe HHK, Palaniappan SK, Abas AB, De Franceschi L
    Cochrane Database Syst Rev, 2019 09 09;9:CD011358.
    PMID: 31498421 DOI: 10.1002/14651858.CD011358.pub3
    BACKGROUND: Sickle cell disease is an autosomal recessive inherited haemoglobinopathy which causes painful vaso-occlusive crises due to sickle red blood cell dehydration. Vaso-occlusive crises are common painful events responsible for a variety of clinical complications; overall mortality is increased and life expectancy decreased compared to the general population. Experimental studies suggest that intravenous magnesium has proven to be well-tolerated in individuals hospitalised for the immediate relief of acute (sudden onset) painful crisis and has the potential to decrease the length of hospital stay. Some in vitro studies and open studies of long-term oral magnesium showed promising effect on pain relief but failed to show its efficacy. The studies show that oral magnesium therapy may prevent sickle red blood cell dehydration and prevent recurrent painful episodes. There is a need to access evidence for the impact of oral and intravenous magnesium effect on frequency of pain, length of hospital stay and quality of life. This is an updated version of the review.

    OBJECTIVES: To evaluate the effects of short-term intravenous magnesium on the length of hospital stay and quality of life in children and adults with sickle cell disease. To determine the effects of long-term oral magnesium therapy on the frequency of painful crises and the quality of life in children and adults with sickle cell disease.

    SEARCH METHODS: We searched the Cochrane Haemoglobinopathies Trials Register, compiled from electronic database searches and handsearching of journals and conference abstract books.Date of last search of the Cochrane Cystic Fibrosis and Genetic Disorders Group's Haemoglobinopathies Trials Register: 03 February 2019.Date of last search of other resources (clinical trials registries): 04 April 2019.

    SELECTION CRITERIA: We searched for published and unpublished randomized controlled studies of oral or intravenous magnesium compared to placebo or no magnesium.

    DATA COLLECTION AND ANALYSIS: Authors independently assessed the study quality and extracted the data using standard Cochrane methodologies.

    MAIN RESULTS: We included five randomized placebo-controlled studies with a total of 386 participants (aged three to 53 years). Of these, two shorter parallel studies (n = 306) compared intravenous magnesium sulphate to placebo (normal saline) for admission to hospital due to a vaso-occlusive crisis, for which we were able to analyse data. The quality of evidence was moderate for studies in this comparison, mainly due to limitations due to risk of bias and imprecision. Two of the three longer-term studies comparing oral magnesium pidolate to placebo had a cross-over design. The third was a parallel factorial study which compared hydroxyurea and oral magnesium to each other and to placebo over a longer period of time; we only present the comparison of oral magnesium to placebo from this study. The quality of evidence was very low with uncertainty of the estimation.The eight-hourly dose levels in the two studies of intravenous magnesium were different; one used 100 mg/kg while the second used 40 mg/kg. Only one of these studies (n = 104) reported the mean daily pain score while hospitalised (a non-significant difference between groups, moderate quality evidence). The second study (n = 202) reported a number of child- and parent-reported quality of life scores. None of the scores showed any difference between treatment groups (low quality evidence). Data from one study (n = 106) showed no difference in length of stay in hospital between groups (low quality evidence). Both studies reported on adverse events, but not defined by severity as we had planned. One study showed significantly more participants receiving intravenous magnesium experienced warmth at infusion site compared to placebo; there were no differences between groups for other adverse events (low quality evidence).Three studies (n = 80) compared oral magnesium pidolate to placebo. None of them reported data which we were able to analyse. One study (n = 24) reported on the number of painful days and stated there was no difference between two groups (low quality evidence). None of the studies reported on quality of life or length of hospital stay. Two studies (n = 68) reported there were no differences in levels of magnesium in either plasma or red blood cells (moderate quality evidence). Two studies (n = 56) reported adverse events. One reported episodes of mild diarrhoea and headache, all of which resolved without stopping treatment. The second study reported adverse events as gastrointestinal disorders, headache or migraine, upper respiratory infections and rash; which were all evenly distributed across treatment groups (moderate quality evidence).

    AUTHORS' CONCLUSIONS: Moderate to low quality evidence showed neither intravenous magnesium and oral magnesium therapy has an effect on reducing painful crisis, length of hospital stay and changing quality of life in treating sickle cell disease. Therefore, no definitive conclusions can be made regarding its clinical benefit. Further randomized controlled studies, perhaps multicentre, are necessary to establish whether intravenous and oral magnesium therapies have any effect on improving the health of people with sickle cell disease.

  16. Htay MNN, Latt SS, Abas AL, Chuni N, Soe HHK, Moe S
    PMID: 30596109 DOI: 10.4103/jehp.jehp_104_18
    INTRODUCTION: Family planning and contraception is the effective strategy to reduce maternal mortality, child mortality, abortion, and unwanted pregnancies. Since the medical students are the future doctors, it is important to have proper knowledge and training on family planning services. This study aimed to explore the effect of teaching-learning process at maternal and child health (MCH) clinics on the students' knowledge, perceptions toward contraception methods, and family planning counselling.

    METHODS: This quasi-experimental study was conducted in the private medical institution in Malaysia. The same questionnaire was used to administer twice, before and after the posting. Moreover, a qualitative question on the issues related to family planning and contraception utilizations in Malaysia was added to the after posting survey. The quantitative data were analyzed using IBM SPSS (version 20) and qualitative data by RQDA software.

    RESULTS: A total of 146 participants were recruited in this study. Knowledge on contraception method before posting was 5.11 (standard deviation [SD] ±1.36) and after posting was 6.35 (SD ± 1.38) (P < 0.001). Thematic analysis of the students' answer revealed four salient themes, which were as follows: (1) cultural barrier, (2) misconception, (3) inadequate knowledge, and (4) improvement for the health-care services.

    CONCLUSIONS: The teaching-learning process at the MCH posting has an influence on their perception and upgraded their knowledge. It also reflects the role of primary health-care clinics on medical students' clinical exposure and training on family planning services during their postings.

  17. Pal S, Dixit R, Moe S, Godinho MA, Abas AB, Ballas SK, et al.
    Cochrane Database Syst Rev, 2020 03 03;3:CD012762.
    PMID: 32124977 DOI: 10.1002/14651858.CD012762.pub2
    BACKGROUND: Sickle cell disease (SCD), one of the most common inherited disorders, is associated with vaso-occlusive pain episodes and haemolysis leading to recurrent morbidity, hospital admissions and work or school absenteeism. The crises are conventionally treated with opioids, non-opioids and other adjuvants with the risk of developing complications, addictions and drug-seeking behaviour. Different non-pharmacological treatments, such as transcutaneous electrical nerve stimulation (TENS) have been used for managing pain in other painful conditions. Hence, the efficacy of TENS for managing pain in SCD needs to be reviewed.

    OBJECTIVES: To assess the benefits and harms of TENS for managing pain in people with SCD who experience pain crises or chronic pain (or both).

    SEARCH METHODS: We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group Haemoglobinopathies Register, comprising of references identified from comprehensive electronic database searches and handsearches of relevant journals and abstract books of conference proceedings. We also searched online trial registries and the reference lists of relevant articles and reviews. Date of the last search: 26 Febraury 2020.

    SELECTION CRITERIA: We included randomised controlled trials (RCTs) and quasi-RCTs, where TENS was evaluated for managing pain in people with SCD.

    DATA COLLECTION AND ANALYSIS: Two review authors independently assessed the eligibility of the trials identified by the literature searches according to the inclusion criteria. Two review authors then independently extracted data, assessed for risk of bias using the Cochrane standard tool and rated the quality of evidence using the GRADE guidelines.

    MAIN RESULTS: One double-blind cross-over RCT with 22 participants with SCD (aged 12 to 27 years) was eligible for inclusion. Following stratification into four pain crises severity grades, participants were then randomised to receive TENS or placebo (sham TENS). The trial was concluded after 60 treatment episodes (30 treatment episodes of each treatment group). There is a lack of clarity regarding the trial design and the analysis of the cross-over data. If a participant was allocated to TENS treatment for an episode of pain and subsequently returned with a further episode of a similar degree of pain, they would then receive the sham TENS treatment (cross-over design). For those experiencing a pain episode of a different severity, it is not clear whether they were re-randomised or given the alternate treatment. Reporting and analysis was based on the total number pain events and not on the number of participants. It is unclear how many participants were crossed over from the TENS group to the sham TENS group and vice versa. The trial had a high risk of bias regarding random sequence generation and allocation concealment; an unclear risk regarding the blinding of participants and personnel; and a low risk regarding the blinding of the outcome assessors and selective outcome reporting. The trial was small and of very low quality; furthermore, given the issue with trial design we were unable to quantitatively analyse the data. Therefore, we present only a narrative summary and caution is advised in interpreting the results. In relation to our pre-defined primary outcomes, the included trial did not report pain relief at two to four weeks post intervention. The trial authors reported that no difference was found in the changes in pain ratings (recorded at one hour and four hours post intervention) between the TENS and the placebo groups. In relation to our secondary outcomes, the analgesic usage during the trial also did not show any difference between groups. Given the quality of the evidence, we are uncertain whether TENS improves overall satisfaction as compared to sham TENS. The ability to cope with activities of daily living was not evaluated. Regarding adverse events, although one case of itching was reported in the TENS group, the site and nature of itching was not clearly stated; hence it cannot be clearly attributed to TENS. Also, two participants receiving 'sham' TENS reported a worsening of pain with the intervention.

    AUTHORS' CONCLUSIONS: Since we have only included one small and very low-quality trial, with a high risk of bias across several domains, we are unable to conclude whether TENS is harmful or beneficial for managing pain in people with SCD. There is a need for a well-designed, adequately-powered, RCT to evaluate the role of TENS in managing pain in people with SCD.

  18. Soe HHK, Abas AB, Than NN, Ni H, Singh J, Said ARBM, et al.
    Cochrane Database Syst Rev, 2020 05 28;5:CD010858.
    PMID: 32462740 DOI: 10.1002/14651858.CD010858.pub3
    BACKGROUND: Sickle cell disease (SCD) is a genetic chronic haemolytic and pro-inflammatory disorder. With increased catabolism and deficits in energy and nutrient intake, individuals with SCD suffer multiple macro- and micro-nutritional deficiencies, including vitamin D deficiency. This is an update of a previous review.

    OBJECTIVES: To investigate the effects of vitamin D supplementation in children and adults with SCD and to compare different dose regimens. To determine the effects of vitamin D supplementation on general health (e.g. growth status and health-related quality of life), on musculoskeletal health (including bone mineral density, pain crises, bone fracture and muscle health), on respiratory health (including lung function, acute chest syndrome, acute exacerbation of asthma and respiratory infections) and the safety of vitamin D supplementation.

    SEARCH METHODS: We searched the Cochrane Haemoglobinopathies Trials Register, compiled from electronic database searches and handsearching of journals and conference abstract books. Date of last search: 19 March 2020. We also searched database such as PubMed, clinical trial registries and the reference lists of relevant articles and reviews. Date of last search: 14 January 2020.

    SELECTION CRITERIA: Randomised controlled trials (RCTs) and quasi-RCTs comparing oral administration of any form of vitamin D supplementation at any dose and for any duration to another type or dose of vitamin D or placebo or no supplementation in people with SCD, of all ages, gender, and phenotypes.

    DATA COLLECTION AND ANALYSIS: Two authors independently extracted the data and assessed the risk of bias of the included studies. They used the GRADE guidelines to assess the quality of the evidence.

    MAIN RESULTS: Vitamin D versus placebo One double-blind RCT (n = 39) compared oral vitamin D3 (cholecalciferol) supplementation (20 participants) to placebo (19 participants) for six weeks. Only 25 participants completed the full six months of follow-up. The study had a high risk of bias due to incomplete outcome data, but a low risk of bias for randomisation, allocation concealment, blinding (of participants, personnel and outcome assessors) and selective outcome reporting; and an unclear risk of other biases. Vitamin D supplementation probably led to higher serum 25(OH)D levels at eight weeks, mean difference (MD) 29.79 (95% confidence interval (CI) 26.63 to 32.95); at 16 weeks, MD 12.67 (95% CI 10.43 to 14.90); and at 24 weeks, MD 15.52 (95% CI 13.50 to 17.54) (moderate-quality evidence). There was little or no difference in adverse events (tingling of lips or hands) between the vitamin D and placebo groups, risk ratio 3.16 (95% CI 0.14 to 72.84) (low-quality evidence). Vitamin D supplementation probably caused fewer pain days compared to the placebo group at eight weeks, MD -10.00 (95% CI -16.47 to -3.53) (low-quality evidence), but probably led to a lower (worse) health-related quality of life score (change from baseline in physical functioning PedsQL scores); at both 16 weeks, MD -12.56 (95% CI -16.44 to -8.69) and 24 weeks, MD -12.59 (95% CI -17.43 to -7.76), although this may not be the case at eight weeks (low-quality evidence). Vitamin D supplementation regimens compared Two double-blind RCTs (83 participants) compared different regimens of vitamin D. One RCT (n = 62) compared oral vitamin D3 7000 IU/day to 4000 IU/day for 12 weeks, while the second RCT (n = 21) compared oral vitamin D3 100,000 IU/month to 12,000 IU/month for 24 months. Both RCTs had low risk of bias for blinding (of participants, personnel and outcome assessors) and incomplete outcome data, but the risk of selective outcome reporting bias was high. The bias from randomisation and allocation concealment was low in one study but not in the second. There was an unclear risk of other biases. When comparing oral vitamin D 100,000 IU/month to 12,000 IU/month, the higher dose may have resulted in higher serum 25(OH)D levels at one year, MD 16.40 (95% CI 12.59 to 20.21) and at two years, MD 18.96 (95% CI 15.20 to 22.72) (low-quality evidence). There was little or no difference in adverse events between doses (low-quality evidence). There were more episodes of acute chest syndrome in the high-dose group, at one year, MD 0.27 (95% CI 0.02 to 0.52) but there was little or no difference at two years, MD 0.09 (95% CI -0.04 to 0.22) (moderate-quality evidence). At one year and two years there was also little or no difference between the doses in the presence of pain (moderate-quality evidence) or forced expiratory volume in one second % predicted. However, the high-dose group had lower values for % predicted forced vital capacity at both one and two years, MD -7.20% predicted (95% CI -14.15 to -0.25) and MD -7.10% predicted (95% CI -14.03 to -0.17), respectively. There were little or no differences between dose regimens in the muscle health of either hand or the dominant hand. The study comparing oral vitamin D3 7000 IU/day to 4000 IU/day (21 participants) did not provide data for analysis, but median serum 25(OH)D levels were reported to be lower in the low-dose group at both six and 12 weeks. At 12 weeks the median serum parathyroid hormone level was lower in the high-dose group.

    AUTHORS' CONCLUSIONS: We included three RCTs of varying quality. We consider that the current evidence presented in this review is not of sufficient quality to guide clinical practice. Until further evidence becomes available, clinicians should consider the relevant existing guidelines for vitamin D supplementation and dietary reference intakes for calcium and vitamin D. Well-designed RCTs of parallel design, are required to determine the effects and the safety of vitamin D supplementation as well as to assess the relative benefits of different doses in children and adults with SCD.

  19. Soe HH, Abas AB, Than NN, Ni H, Singh J, Said AR, et al.
    Cochrane Database Syst Rev, 2017 01 20;1:CD010858.
    PMID: 28105733 DOI: 10.1002/14651858.CD010858.pub2
    BACKGROUND: Sickle cell disease is a genetic chronic haemolytic and pro-inflammatory disorder. The clinical manifestations of sickle cell disease result from the presence of mutations on the beta globin genes that generate an abnormal haemoglobin product (called haemoglobin S) within the red blood cell. Sickle cell disease can lead to many complications such as acute chest syndrome, stroke, acute and chronic bone complications (including painful vaso-occlusive crisis, osteomyelitis, osteonecrosis and osteoporosis). With increased catabolism and deficits in energy and nutrient intake, individuals with sickle cell disease suffer multiple macro- and micro-nutritional deficiencies, including vitamin D deficiency. Since vitamin D maintains calcium homeostasis and is essential for bone mineralisation, its deficiency may worsen musculoskeletal health problems encountered in sickle cell disease. Therefore, there is a need to review the effects and the safety of vitamin D supplementation in sickle cell disease.

    OBJECTIVES: To investigate the hypothesis that vitamin D supplementation increases serum 25-hydroxyvitamin D level in children and adults with sickle cell disease.To determine the effects of vitamin D supplementation on general health such as growth status and health-related quality of life; on musculoskeletal health including bone mineral density, pain crises, bone fracture and muscle health; on respiratory health which includes lung function tests, acute chest syndrome, acute exacerbation of asthma and respiratory infections; and the safety of vitamin D supplementation in children and adults with sickle cell disease.

    SEARCH METHODS: We searched the Cochrane Haemoglobinopathies Trials Register, compiled from electronic database searches and handsearching of journals and conference abstract books. We also searched database such as PubMed, clinical trial registries and the reference lists of relevant articles and reviews.Date of last search: 15 December 2016.

    SELECTION CRITERIA: Randomised controlled studies and quasi-randomised controlled studies (controlled clinical studies) comparing oral administration of any form of vitamin D supplementation to another type of vitamin D or placebo or no supplementation at any dose and for any duration, in people with sickle cell disease, of all ages, gender, and phenotypes including sickle cell anaemia, haemoglobin sickle cell disease and sickle beta-thalassaemia diseases.

    DATA COLLECTION AND ANALYSIS: Two authors independently extracted the data and assessed the risk of bias of the included study. They used the GRADE guidelines to assess the quality of the evidence.

    MAIN RESULTS: One double-blind randomised controlled study including 46 people with sickle cell disease (HbSS, HbSC, HbSβ+thal and HbSβ0thal) was eligible for inclusion in this review. Of the 46 enrolled participants, seven withdrew before randomisation leaving 39 participants who were randomised. Only 25 participants completed the full six months of follow up. Participants were randomised to receive oral vitamin D3 (cholecalciferol) (n = 20) or placebo (n = 19) for six weeks and were followed up to six months. Two participants from the treatment group have missing values of baseline serum 25-hydroxyvitamin D, therefore the number of samples analysed was 37 (vitamin D n = 18, placebo n = 19).The included study had a high risk of bias with regards to incomplete outcome data (high dropout rate in the placebo group), but a low risk of bias for other domains such as random sequence generation, allocation concealment, blinding of participants, personnel and outcome assessors, selective outcome reporting; and an unclear risk of other biases.Compared to the placebo group, the vitamin D group had significantly higher serum 25-hydroxyvitamin D (25(OH)D) levels at eight weeks, mean difference 29.79 (95% confidence interval 26.63 to 32.95); at 16 weeks, mean difference 12.67 (95% confidence interval 10.43 to 14.90); and at 24 weeks, mean difference 15.52 (95% confidence interval 13.50 to 17.54). We determined the quality of the evidence for this outcome to be moderate. There was no significant difference of adverse events (tingling of lips or hands) between the vitamin D and placebo groups, risk ratio 3.16 (95% confidence interval 0.14 to 72.84), but the quality of the evidence was low. Regarding the frequency of pain, the vitamin D group had significantly fewer pain days compared to the placebo group, mean difference -10.00 (95% confidence interval -16.47 to -3.53), but again the quality of the evidence was low. Furthermore, the review included physical functioning PedsQL scores which was reported as absolute change from baseline. The vitamin D group had a lower (worse) health-related quality of life score than the placebo group but this was not significant at eight weeks, mean difference -2.02 (95% confidence interval -6.34 to 2.30). However, the difference was significant at both 16 weeks, mean difference -12.56 (95% confidence interval -16.44 to -8.69) and 24 weeks, mean difference -12.59 (95% confidence interval -17.43 to -7.76). We determined the quality of evidence for this outcome to be low.

    AUTHORS' CONCLUSIONS: We included only one low-quality clinical study which had a high risk of bias with regards to incomplete outcome data. Therefore, we consider that the evidence is not of sufficient quality to guide clinical practice. Until further evidence becomes available, clinicians should consider the relevant existing guidelines for vitamin D supplementation (e.g. the Endocrine Society Clinical Practice Guidelines) and dietary reference intakes for calcium and vitamin D (e.g. from the USA Institute of Medicine). Evidence of vitamin D supplementation in sickle cell disease from high quality studies is needed. Well-designed, randomised, placebo-controlled studies of parallel design, are required to determine the effects and the safety of vitamin D supplementation in children and adults with sickle cell disease.

  20. Than NN, Soe HHK, Palaniappan SK, Abas AB, De Franceschi L
    Cochrane Database Syst Rev, 2017 Apr 14;4:CD011358.
    PMID: 28409830 DOI: 10.1002/14651858.CD011358.pub2
    BACKGROUND: Sickle cell disease is an autosomal recessive inherited haemoglobinopathy which causes painful vaso-occlusive crises due to sickle red blood cell dehydration. Vaso-occlusive crises are common painful events responsible for a variety of clinical complications; overall mortality is increased and life expectancy decreased compared to the general population. Experimental studies suggest that intravenous magnesium has proven to be well-tolerated in individuals hospitalised for the immediate relief of acute (sudden onset) painful crisis and has the potential to decrease the length of hospital stay. Some in vitro studies and open studies of long-term oral magnesium showed promising effect on pain relief but failed to show its efficacy. The studies show that oral magnesium therapy may prevent sickle red blood cell dehydration and prevent recurrent painful episodes. There is a need to access evidence for the impact of oral and intravenous magnesium effect on frequency of pain, length of hospital stay and quality of life.

    OBJECTIVES: To evaluate the effects of short-term intravenous magnesium on the length of hospital stay and quality of life in children and adults with sickle cell disease. To determine the effects of long-term oral magnesium therapy on the frequency of painful crises and the quality of life in children and adults with sickle cell disease.

    SEARCH METHODS: We searched the Cochrane Haemoglobinopathies Trials Register, compiled from electronic database searches and handsearching of journals and conference abstract books.Date of last search of the Cochrane Cystic Fibrosis and Genetic Disorders Group's Haemoglobinopathies Trials Register: 01 December 2016.Date of last search of other resources (clinical trials registries): 29 March 2017.

    SELECTION CRITERIA: We searched for published and unpublished randomized controlled studies of oral or intravenous magnesium compared to placebo or no magnesium.

    DATA COLLECTION AND ANALYSIS: Authors independently assessed the study quality and extracted the data using standard Cochrane methodologies.

    MAIN RESULTS: We included five randomized placebo-controlled studies with a total of 386 participants (aged three to 53 years). Two shorter parallel studies (n = 306) compared intravenous magnesium sulphate to placebo (normal saline) for admission to hospital due to a vaso-occlusive crisis, for which we were able to analyse data. The quality of evidence was moderate for studies presenting this comparison mainly due to limitations due to risk of bias and imprecision. Two of the three longer-term studies comparing oral magnesium pidolate to placebo had a cross-over design. The third was a parallel factorial study which compared hydroxyurea and oral magnesium to each other and to placebo over a longer period of time; we only present the comparison of oral magnesium to placebo from this study. The quality of evidence was very low with uncertainty of the estimation.The eight-hourly dose levels in the two studies of intravenous magnesium were different; one used 100 mg/kg while the second used 40 mg/kg. Only one of these studies (n = 104) reported the mean daily pain score while hospitalised (a non-significant difference between groups, moderate quality evidence). The second study (n = 202) reported a number of child- and parent-reported quality of life scores. None of the scores showed any difference between treatment groups (low quality evidence). Data from one study (n = 106) showed no difference in length of stay in hospital between groups (low quality evidence). Both studies reported on adverse events, but not defined by severity as we had planned. One study showed significantly more participants receiving intravenous magnesium experienced warmth at infusion site compared to placebo; there were no differences between groups for other adverse events (low quality evidence).Three studies (n = 80) compared oral magnesium pidolate to placebo. None of them reported data which we were able to analyse. One study (n = 24) reported on the number of painful days and stated there was no difference between two groups (low quality evidence). None of the studies reported on quality of life or length of hospital stay. Two studies (n = 68) reported there were no differences in levels of magnesium in either plasma or red blood cells (moderate quality evidence). Two studies (n = 56) reported adverse events. One reported episodes of mild diarrhoea and headache, all of which resolved without stopping treatment. The second study reported adverse events as gastrointestinal disorders, headache or migraine, upper respiratory infections and rash; which were all evenly distributed across treatment groups (moderate quality evidence).

    AUTHORS' CONCLUSIONS: Moderate to low quality evidence showed neither intravenous magnesium and oral magnesium therapy has an effect on reducing painful crisis, length of hospital stay and changing quality of life in treating sickle cell disease. Therefore, no definitive conclusions can be made regarding its clinical benefit. Further randomized controlled studies, perhaps multicentre, are necessary to establish whether intravenous and oral magnesium therapies have any effect on improving the health of people with sickle cell disease.

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