Existing criteria for admission of newborns to the special care nursery, Sarawak General Hospital, resulted in the admission of many neonates with certain risk factors ("at risk" neonates). To test whether such babies could be safely and better cared for in postnatal wards, 392 of these babies were randomly allocated into two groups. One group of 196 was admitted to the special care nursery and the other group of 196 was cared for with their mothers in the postnatal wards. The two groups were compared for mortality, morbidity and breastfeeding. There was no significant difference in mortality and morbidity between the two groups. While in hospital a larger proportion of babies cared for in postnatal wards were breastfed, compared to babies admitted to the special care nursery. In addition, they initiated their breastfeeding earlier. Babies with these risk factors should therefore be cared for with their mothers in the postnatal wards.
This study was conducted to determine the tolerability and efficacy of valsartan (DIOVAN) compared to perindopril (COVERSYL) in Malaysian patients with mild to moderate hypertension. Two hundred and fifty adult Malaysian patients with a mean sitting diastolic blood pressure of more than 95 mmHg and less than 115 mmHg after a 14 day washout period were randomized to receive either valsartan 80 mg once daily (n=125) or perindopril 4 mg daily (n=125) for eight weeks. The primary end point for efficacy was the change in mean sitting systolic and diastolic blood pressure (SiSBP and SiDBP). The primary criteria for evaluation of tolerability was the incidence of adverse events. There were no significant differences between the two groups with respect to sex, age, weight, baseline sitting and standing systolic and diastolic blood pressure. At 0, 4 and 8 weeks the mean SiDBP in the valsartan group were 101.4, 92.8 and 91.0 mmHg respectively. The corresponding BP for the perindopril treated group was 102.6, 93.8 and 93.2 mmHg. (95% CI -1.39 to +3.27). There were no significant differences in the mean BP measurements between the valsartan and perindopril group at 0, 4 and 8 weeks. In each group there were significant differences between the BP at 4 and 8 weeks compared to baseline. A similar pattern was seen with SiSBP. At 4 weeks 28.7% of the valsartan and 25% of the perindopril group had their BP normalized (SiDBP <90 mmHg) The percentages of patients who responded (SiDBP reduction >10 mmHg but SiDBP >90 mmHg) were 21.3 in the valsartan group and 20.8 in the perindopril group. At 8 weeks, 31.1% of the valsartan group and 30.8% of the perindopril group had their BP normalized. The response rate was 27% and 22.5% for valsartan and perindopril respectively. The major adverse event was cough which occurred in 18 patients (14.4%) in the perindopril and 1 (0.8%) in the valsartan group at 4 weeks. At 8 weeks the figures were 24 (19.2%) and 2 (1.6%) respectively. The results indicate that Valsartan is safe and efficacious in the treatment of mild to moderate hypertension. It is equally efficacious to Perindopril and not associated with any major adverse event. It has a better tolerability profile with respect to dry cough.
An open comparative randomised study comparing the performance of hydrocolloid dressings (DuoDERM CGF) to saline gauze dressings in the treatment of pressure ulcers was done to evaluate the overall dressing performance, wound healing and cost effectiveness. Thirty-four subjects were enrolled at the University Hospital, Kuala Lumpur over a 643 days period. Inclusion criteria were Stage II or III pressure ulcers, at least 18 years of age and written informed consent. Only one pressure ulcer per subject was enrolled in the study. Patients with infected pressure ulcers, diabetes mellitus, an immuno-compromised status and known sensitivity to the study dressings were excluded. Subjects who met the enrollment criteria were randomised to one of the two dressing regimes. They were expected to participate in the study for a maximum of eight weeks or until the pressure ulcer healed, which ever occurred first. Overall subject age averaged 58 years and the mean duration of pressure ulcer existence was about 1 month. Twenty-one of the thirty-four ulcers enrolled were stage II and thirteen were stage III. The majority of the ulcers (88%) were located in the sacral area and seventeen subjects (50%) were incontinent. In the evaluation of dressing performance in terms of adherence to wound bed, exudate handling ability, overall comfort and pain during dressing removal; all favoured the hydrocolloid dressing by a statistically significant margin (p < 0.001). Subjects assigned the hydrocolloid dressing experienced a mean 34% reduction from their baseline surface area measurement compared to a mean 9% increase by subjects assigned gauze dressings. This was not statistically significant (p = 0.2318). In cost evaluation of the study products, there was no statistical significance in the total cost of wound management per subject. When only labour time and cost was evaluated, there was a statistically significant advantage towards hydrocolloid dressings.
Twenty-six patients with frozen shoulder syndrome (Stage 2 and 3) were included in this study conducted at Dr. Kariadi General Hospital, Semarang, Indonesia and randomly allocated into 2 groups: 40 mg triamcinolone intra-articular injection and triamcinolone oral tablets. The result showed that triamcinolone intra-articular injection group "cured" rate was 5.8 times higher at week one compared to the triamcinolone tablet group. Sixty-two percent of the cases with triamcinolone intra-articular injection achieved their "cured" condition after one week of therapy, compared with only 14% of the triamcinolone tablets group. We conclude that, intra-articular corticosteroid injection provide faster improvement compared to oral route.
We have studied the antiemetic efficacy of droperidol alone, and in combination with metoclopramide in first trimester termination of pregnancy in day surgery. The aim was to determine whether the addition of metoclopramide could further reduce the incidence of postoperative nausea and vomiting (PONV) but avoid excessive sedation. Group I (control, n = 40) received i.v. droperidol 0.625 mg at induction. Group II (study, n = 40) received i.v. droperidol 0.625 mg and i.v. metoclopramide 10 mg at induction. The incidence of nausea at 1 and 2 hours postoperatively was 23% and 10% in group I, and 5% and nil in group II respectively. The difference in the incidence of nausea was significant at p < 0.05 at one hour but not at two hours postoperatively. No patients vomited. There was no difference in the sedation and pain score between them. We did not observe any significant side effects attributable to either drug. All patients were discharged home within 3 hours. We conclude that in the prevention of PONV, the combination of metoclopramide and droperidol is superior to the use of droperidol alone at one hour but not at two hours postoperatively.
OBJECTIVE AND STUDY DESIGN: A nonrandomized open labeled clinical trial to evaluate the efficacy and tolerability of Dianex (a poly herbal formulation developed by Apex Laboratories [PVT] Chennai, Tamil Nadu, India) in type 2 diabetes mellitus was carried out during a 6-month period.
SETTING/LOCATION: This study was conducted in TMA Pai Hospital, Udupi, South India.
SUBJECTS: A total of 40 patients were recruited for this study. Three patients dropped out of the study leaving a total of 37 patients (11 for monotherapy and 26 for add on therapy).
OUTCOME MEASURES: Eighteen (18) clinical variables were investigated, including liver enzymes, kidney function tests, hematologic parameters, blood glucose, and insulin and lipid profiles.
RESULTS: at the end of 12 weeks it was found that there was a significant decrease in the level of glycated hemoglobin, fasting plasma insulin level, insulin resistance, and systolic and diastolic blood pressure. At the end of 24 weeks results were similar to those at 12 weeks. Dianex did not alter the liver function tests, hematological parameters, or kidney function tests.
CONCLUSION: In this preliminary study, Dainex is found to be an effective adjuvant drug with either oral antidiabetic agents or insulin that can be used in the control of blood sugars in diabetic patients. Dianex is a safe drug that does not cause any clinical, hematological or biochemical alteration in major organ systems.
To describe and determine the possibility of surgical trauma to the external branch of the superior laryngeal nerve and to assess the role of intraoperative neuromonitoring in thyroid surgery.
Ultrasonographic cervical length assessment is increasingly being utilized clinically to identify women at risk for spontaneous preterm delivery. In a randomised prospective longitudinal study involving 200 women, we measured cervical length and internal os diameter by transvaginal scan at 20 - 24 weeks and analysed their ability to predict preterm birth. The risk of spontaneous preterm delivery increased steeply as cervical length decreased. At cut off value of < or = 2.5cm, the cervical length measurements had sensitivity, specificity, positive predictive value and negative predictive value of 77%, 95%, 56% and 98% respectively. However, internal os diameter lacked sensitivity and specificity. Our data suggests that the duration of pregnancy is directly related to length of the cervix: the shorter the cervix, the greater the chance of preterm delivery.
We assessed the effectiveness of an educational intervention in reducing antibiotic prescribing in public primary care clinics in Malaysia. Twenty-nine medical officers in nine clinics received an educational intervention consisting of academic detailing from the resident Family Medicine Specialist, as well as an information leaflet. The antibiotic prescribing rates were assessed for six months - three months before and three months after the intervention. A total of 28,562 prescriptions were analyzed. Among participating doctors, general antibiotic prescribing rates for pre- and post-intervention phases were 14.3% and 11.0% (post-intervention vs pre-intervention RR 0.77, 95% CI 0.72 to 0.83). The URTI-specific antibiotic prescribing rates for pre- and post-intervention phases were 27.7% and 16.6%, respectively (post-intervention vs pre-intervention RR 0.60, 95% CI 0.54 to 0.66). No significant change in antibiotic prescribing rates was observed among primary care practitioners who did not participate in the study. This low cost educational intervention using both active and passive strategies focusing on URTI produced a statistically significant (and clinically important) reduction in antibiotic prescribing.
Study site: Klinik Kesihatan, Negeri Sembilan, Malaysia
Ergot-derived dopamine D2 receptor agonists are the usual treatment of hyperprolactinemia and Parkinson's disease and recently bromocriptine has been approved for the treatment of type 2 diabetes. The aim of this study was the evaluation of short-term effect of cabergoline in poorly controlled diabetic patients with oral agent failure who refused insulin therapy.
This was an open-label, uncontrolled study with the aim of assessing the efficacy and safety of pegylated interferon alfa-2b plus ribavirin in the treatment of chronic hepatitis C. The study was conducted in Island Hospital, Penang beween January 2002 and December 2003. Thirty-three patients were enrolled in this study with ten defaulters. The overall sustained virological response (SVR) (Intention-To-Treat analysis) in naïve patients was 39.10%. However, when the study was adjusted to only include those who completed treatment and follow-up, overall SVR as 52.9%. Side-effects were tolerable in most patients with anaemia occurring in 22 patients (66.7%), leukopenia 23 patients (69.7%) and thrombocytopenia in 15 patients (45.5%). This study showed that pegylated interferon alfa-2b 1.5 mcg/kg/week plus ribavirin > 10.6 mg/kg/day is efficacious and safe to be used in the treatment of: chronic hepatitis C.
We prospectively evaluated the effect of the treatment of lower urinary tract symptoms (LUTS) on sexual function. The patients were assessed by using the International Index of Erectile Function (IIEF-15) inventory at baseline and three months after medical (alpha-blockers) or surgical treatment (transurethral resection of the prostate, TURP). Following treatment, there were improvement in erectile function and intercourse satisfaction while orgasmic, overall satisfaction and sexual drive were relatively unchanged in the medication group. Patients who had surgical treatment suffered retrograde ejaculation, dissatisfaction in sexual intercourse and overall sexual satisfaction compared to patients who were on alpha-blockers.
Study site: Urology ward and clinic, University Malaya Medical Centre (UMMC), Kuala Lumpur, Malaysia
Botulinum toxin is effective in reducing spasticity post stroke. As there are limited data on post stroke spasticity in Asia, we undertake this study to determine the effectiveness and safety of intramuscular injection of botulinum toxin type-A (BTX-A), in the treatment of chronic focal post-stroke hand spasticity, and the impact of BTX-A on the activities of daily living and quality of life, in comparison to placebo, in Malaysian stroke patients. This was a randomized, double-blind, placebo-controlled study to assess the efficacy and safety of BTX-A in 27 subjects with wrist and finger spasticity after a stroke. The outcome measures were assessed with the Modified Ashworth Scale (MAS) to assess spasticity of the flexor muscles, Barthel Index (BI) for activities of daily living and EQ-5D and EQ VAS for quality of life. Assessments were performed at baseline and 1 and 3 months after injection. Compared to placebo, the BTX-A group had greater improvement in the flexor tone of the wrist and fingers (p = 0.001 and p < 0.001, respectively), at first month follow-up visit and sustained the improvement through to three months. Although there was an improvement in the measures of global function and quality of life in the BTX-A group, there was no significant improvement in between the two groups. No serious BTX-A related adverse effects were reported. The results of this study demonstrate that intramuscular injection of botulinum toxin A is safe and effective in the treatment of chronic focal post-stroke spasticity of the hand.
Dysphagia following stroke is common problem and is of particular concern because of its potental for malnutrition. Nasogastric (NG) and percutaneous endoscopic gastrostomy (PEG) tube feeding are recognized methods for nutritional support for patients with persistent neurologic dysphagia. However, the former is associated with tube dislodgement and blockage that might compromise the patients' nutritional status. There have been few randomized prospective studies to date comparing the efficacy and safety of these 2 modes of dysphagia management in stroke patients. The objective of this study was to compare PEG with NG tube feeding after acute dysphagic stroke in terms of nutritional status and treatment failure. This was a randomized prospective clinical trial. A total of 23 consecutive patients who fulfilled the criteria were recruited from the medical wards in Hospital Universiti Kebangsaan Malaysia. The diagnosis of stroke (acute cerebral infarct) was based on clinical and brain computed tomographic (CT scan) findings; and the diagnosis of dysphagia was done clinically by using the 'swallowing test'. At recruitment, upper-arm skin fold thickness (triceps and biceps) and mid-arm circumference were measured; and blood was drawn for serum albumin level. They were then followed up at 4 weeks where the above tests were repeated. A total of 22 patients completed the study (12 patients in the NG group and 10 patients in the PEG group). Serum albumin levels (p = 0.045) were significantly higher in the PEG as compared to the NG group at 4 weeks post-intervention. There were statistically significant improvements in serum albumin level (p = 0.024) in the PEG group; and statistically significant reductions in serum albumin level (p = 0.047) in the NG group 4 weeks after the intervention. However, there were no significant differences in anthropometric parameters between the two groups and no significant changes in these parameters for each group 4 weeks after the intervention. Treatment failure occurred in 5 out of 10 patients (50.0%) in the NG group, but none in PEG group (p = 0.036). PEG tube feeding is more effective than NG tube feeding in improving the nutritional status (in terms of the serum albumin level) of patients with dysphagic stroke. NG tube feeding, in fact, reduced the nutritional status (in terms of the serum albumin level) of the patients.
Post Arthroscopic intra-articular analgesia is a better method to avoid post-operative pain after arthroscopic surgery, thus avoiding the adverse effects of systemic analgesics. In this prospective randomized double blind study conducted on 90 patients, 30 patients in group A received 20 ml of intra-articular saline, 30 patients in Group B received 10 ml of intra-articular saline and 10 ml of 0.25% bupivacaine and 30 patients in Group C received 10 ml of 0.25% bupivacaine, 1 ml (30 mg) of ketorolac and 9 ml of saline intra-articularly. Ambulatory status, duration of analgesia and requirement for supplemented analgesia were compared in these three groups. Patients receiving this intra-articular analgesic combination of bupivacaine and ketorolac required significantly less supplemental postoperative analgesics. This combination significantly prolonged the duration of analgesia. Patients receiving this combination of drugs for intra-articular analgesia ambulated earlier.
This prospective, randomised, controlled trial was performed to evaluate the effectiveness of single-dose antibiotic prophylaxis in decreasing the infectious morbidity following elective caesarean section. Two hundred women undergoing elective caesarean section were randomly assigned to receive either 1.2 g of Augmentin intravenously, or no treatment, just before the start of their caesarean section. The two groups of women were comparable in terms of patient characteristics and operation variables. The overall postoperative morbidity rate was 19% in the Augmentin treated group versus 38% in the group that received no prophylaxis (p < 0.01). The incidence of wound sepsis was 3% in the Augmentin group versus 13% in the control group (p < 0.01). The incidence of febrile morbidity with no identifiable cause was 8% in the Augmentin group versus 18% in the control group (p < 0.05). The duration of hospital stay was significantly shorter in the Augmentin group (p < 0.05). A single-dose of prophylactic Augmentin significantly reduced the postoperative morbidity and duration of hospital stay in women who underwent elective caesarean sections.
Hypertrophy of the inferior turbinates are the major cause of nasal obstruction. CO2 lasers have been used to reduce the size of the inferior turbinates over the last 20 years. However, the many techniques of delivery of the laser show that there is no one standard method reducing the size of the turbinates. We now describe how the laser can be applied directly to the turbinates using a handpiece with a special nasal tip, thus overcoming the disadvantages delivery via arthroscopic devices, microscopes and fibers. This technique is further enhanced by coupling it with Swiftlase which swirls the focused beam in a 3 mm spot thus ablating tissue more quickly. This procedure is done under local anaesthesia. The ablation of the anterior third of the inferior turbinates effectively overcomes nasal obstruction. This new method was compared to the more traditional submucus diathermy. 22 patients were subjected to laser treatment whilst 20 patients were subjected to diathermy. The outcome was evaluated subjectively by the patients themselves at 2 weeks, 3 months and 6 months. At the end of the study, the laser group reported a more significantly improved nasal airway (91% against 75%) and decreased rhinorrhea (72.7% against 35%) when compared to the diathermy group.
Human amniotic membrane as a homograft material was compared to temporalis fascia to close tympanic membrane perforations in 50 patients with chronic otitis media. Human amniotic membrane was used in 20 patients while temporalis fascia was used in the remaining 30. Anatomical closure of the perforation and reduction of the air-bone gap was measured. The graft uptake showed a 65% success rate for the amniotic membrane and 56.7% for the temporalis fascia at 3 months post-operatively. Significant closure of air-bone gap was observed in the human amniotic group. These results indicate comparable outcomes between human amniotic membrane and the temporalis fascia graft.
Fifteen patients with pure lepromatous leprosy were treated for 12 months with DDS at 50 mgm. twice weekly. The drug was fully effective in this dose, and the incidence and severity of ENL were not less than on larger doses