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Research report: Faculty of Health Sciences / ABSTRACT Labour induction in an underresourced environment poses a tremendous challenge. While labour induction is a common obstetric procedure, it poses potential hazards for mother and fetus. This is largely dependent on method and agent used and can be expensive on limited resources because of high purchase prices, refrigerated storage, monitoring equipment and manpower. Misoprostol is a unique anti-ulcer agent that has good properties as an induction agent, but as yet not fully evaluated. It is relatively cheap, easily available, simple to store and has a long shelf life, and would amount to considerable cost saving in an underresourced setting if it were proven to be effective and safe for induction of labour. A simple reliable method of administration and appropriate dosage regimen of misoprostol for the purposes of induction of labour is needed. This study was undertaken in two phases; Part A. The clinical trial where an oral misoprostol suspension was given in a stepwise manner for the induction of labour alone or in combination with an inexpensive mechanical method (Foley catheter bulb) is compared with the “standard” method of induction i.e. dinoprostone 2 mg gel in a randomized controlled trial. Altogether 750 patients (250 in each arm) were recruited. Part B. (a) In vitro study to verify if misoprostol has a direct stimulatory effect on gut smooth muscle similar to sihlambezo.1 There is an increase in the incidence of meconium stained liquor in women who have taken sihlambezo or castor oil and misoprostol.2 It is postulated that misoprostol crosses the placenta and stimulates foetal bowel activity directly rather than as a result of asphyxia caused by excessive uterine contractions due to misoprostol. Strips of rat uterine and intestinal smooth muscle were mounted on a strain gauge with a chart recorder in a physiological bath as was done in the Pharmacology department for the original sihlambezo studies. The model was perfused with doubling concentrations of each test substance, and the concentration noted at which the first uterine muscle and the first bowel muscle activity was detected. The test substances were: #1; prostaglandin E2 (Dinoprostone) #1; oxytocin (Syntocinon) #1; misoprostol freshly dissolved in water #1; misoprostol freshly dissolved in a weak hydrochloric acid solution to approximate stomach content pH #1; misoprostol dissolved in water and stored for 2 hours, 6 hours, 24 hours and 1 year. For each substance, the ratio between the minimum stimulatory concentration for uterine to bowel smooth muscle was calculated, and these ratios compared between substances. The absolute minimum stimulatory concentrations were compared between the different misoprostol preparations to determine the effects of storage and acidification. (b) In vitro study to find out if misoprostol dissolved in water is stable and over what duration of time. This has practical importance, because if it is unstable, it may imply that a fresh sample has to be prepared each time the induction agent is given, and this may be several times per patient per induction. This would escalate the cost of the drug, especially in an underresourced setting such as ours, and would mean more manpower i.e. nursing staff, would be required for each case of induction. We also wanted to establish if acidification of the preparation would affect misoprostol stability as was implied to happen when misoprostol is given vaginally3. References 1 Mitri F, Hofmeyr GJ, van Gelderen CJ. Meconium during labor, self medication and other associations. S Afr Med J 1987: 71: 431-433. 2 Hofmeyr GJ, Gulmezoglu AM. Vaginal misoprostol for cervical ripening and labor induction in late pregnancy (Cochrane Review). In: The Cochrane Library, Issue 3, 1999. Oxford: Update Software. 3 Gunalp S, Bildirici I. The effect of vaginal pH on the efficacy of vaginal misoprostol for induction of labour. Acta Obstet Gynaecol Scand 2000; 79(4): 283-5.

Class of 2012 Abstract / Specific Aims: To explore whether publishing requirements for human-centered randomized control trials, particularly the CONSORT criteria, have any relationship to impact as measured by the Journal Citation Reports TM Impact Factor. Methods: A worksheet was used to evaluate a methodically selected list of journals, including types of articles published, requirements of authors for human-focused randomized control trials, JCR Impact Factor and other JCR metrics for each specific journal title. A worksheet was filled out for each journal by each member of the research team and answers combined for consensus. Group means and SDs were calculated and the Student’s t-Test applied to values for selected journals. Main Results: 50 candidate pharmacy journals were identified and 41 met the criteria for publishing human-centered randomized control trials. Journals were grouped according to whether they required CONSORT or had other reporting requirements for human RCTs, or had no requirements for such studies. Few (6; 15%) pharmacy journals required authors to use CONSORT; and additional 15 (37%) journals provided as least some author guidelines similar to CONSORT. Pharmacy journals using CONSORT or other guidelines had a higher average impact factor (3.5; SD = 1.5) than did journals without guidelines (2.4; SD = 0.9; p = 0.007). Conclusions: There appears to be a statistical difference in average JCR metrics between journals which require specific RCT guidelines and those which do not. The use of reporting guidelines, such as CONSORT, by pharmacy journals is associated with increased impact as represented by JCR influence measures.

Increased interest has focused on associations between dietary fatty acids and cardiovascular disease (CVD). Current findings delineating effects of consuming saturated fatty acids (SFA) from dairy on CVD risk remain controversial. The objective of this thesis was to investigate the effects of consuming two types of dairy fat, namely those from cheese and butter on, human plasma and RBC fatty acid profiles, compared with monounsaturated fatty acids (MUFA), polyunsaturated fatty acids (PUFA) and carbohydrate (CHO). A secondary objective was to investigate the association between consuming these dietary fatty acids and endogenous de novo fatty acid synthesis. A randomized, full-feeding, crossover, single-blinded clinical trial was conducted at the Institute of Nutrition and Functional Foods (INAF), Laval University and Richardson Centre for Functional Foods and Nutraceuticals (RCFFN), the University of Manitoba. A total of 92 women and men with abdominal obesity and relative low high density lipoprotein cholesterol (HDL-C) levels were randomized into a series of 5 treatments. The duration of each treatment was 4 weeks and separated by at least 4 weeks washout period. For plasma fatty acid profile, total plasma SFA after cheese treatment was found to be higher (P<0.05) than after MUFA, PUFA and CHO treatments, whereas total plasma SFA after butter treatment was only found to be higher (P<0.05) than after MUFA and PUFA treatments. Total plasma MUFA after MUFA treatment was higher (P<0.05) than after all other treatments, and total plasma PUFA after PUFA treatment was higher (P<0.05) than after all other treatments. Unlike plasma fatty acid profile, RBC total SFA after two dairy treatments were not higher than after CHO and PUFA treatments. Consistent with the plasma fatty acid profile, RBC total MUFA after MUFA treatment were found to be higher (P<0.05) than after all other treatments. Similarly, RBC total PUFA after PUFA treatment were higher (P<0.05) than after all other treatments. We did not detect any differences in de novo palmitic acid synthesis across all treatments in the present study. However, we did see a positive correlation between de novo palmitic acid synthesis and body fat mass. In summary, present results suggest that consuming dairy fats, from cheese or butter, can significantly modulate plasma fatty acids in a manner that increases plasma total SFA, including myristic acid (C14:0), pentadecanoic acid (C15:0), palmitic acid (C16:0) and heptadecanoic acid (C17:0). However, the effect of consuming dairy fats on RBC fatty acid profile is relatively minor. Additionally, the de novo fatty acid synthesis data suggests that the quality of dietary fatty acids does not associate with human endogenous fatty acid synthesis; unlike body fat mass. / May 2017

Recent research has found that subjects learning a list of paired-associates under conditions requiring one-trial learning are capable of learning a list of paired items in as few a number of trials as subject learning similar lists of paired-associates under a condition using repetition.

Thesis (M.Med.(Paediatrics), Faculty of Health Sciences, University of the Witwatersrand, 2009 / Background In settings with a high burden of tuberculosis, children with unrecognised culture-confirmed pulmonary tuberculosis (PTB) may be discharged from hospital before mycobacterial culture results are available; in these cases clinical improvement may have been due to successful treatment of an intercurrent viral or bacterial co-infection. Aim To estimate the burden of tuberculosis in children who were enrolled in a double-blind, placebo-controlled pneumococcal conjugate vaccine (PCV) trial, and to probe for the presence of pneumococcal co-infection in trial participants who had a hospital-based diagnosis of PTB. Methods A retrospective case-finding strategy was adopted in order to define the tuberculosis case load amongst 39 836 children that had been enrolled in a PCV efficacy trial in Soweto, Gauteng Province. The trial follow-up period was 5.3 years. Children with a hospital-based diagnosis of tuberculosis were categorised by strength of evidence for the disease, HIV status and PCV vaccination status. Incidence rates and risk ratio assessments were conducted using standard statistical methods. Results Four-hundred and ninety-two episodes of tuberculosis arose amongst 425 of the 39 836 PCV Study participants. Tuberculosis incidence was 1067 per 100 000 children (95% Confidence Interval [CI], 968 – 1173), with the greatest burden observed amongst HIV-infected children (10 633 per 100 000 children [95% CI, 9411 – 11 969]; Risk Ratio [RR] 27.5 [95% CI, 22.6 – 33.5], P<0.001). The burden of PTB in the cohort was 982 cases per 100 000 children (95% CI, 887 – 1084): 9895 per 100 000 (95% CI, 8718 – 11 187) in the HIV-infected children and 352 per 100 000 (95% CI 294 – 417) in the HIV-uninfected children (RR 28.1; 95% CI, 22.9 – 34.6), P<0.001. PCV recipients exhibited a 44 percent (95% CI, 11 – 65), P=0.010, reduction in incident culture-confirmed PTB compared to placebo recipients; this apparent reduction was demonstrated chiefly in PCV-vaccinated HIV-infected children (RR 0.53; 95% CI, 0.31 – 0.90) compared to HIV-infected placebo recipients, P=0.017. Conclusions A high burden of tuberculosis is carried by children under 5.3 years in the study setting, with HIV-infected children bearing the brunt of the morbidity. Pneumococcal co-infections are common in the context of hospitalised PTB in the study setting.

M.Med. Faculty of Health Sciences, University of the Witwatersrand, 2009 / Purpose To compare the outcomes of primary viscocanalostomy with trabeculectomy augmented with mitomycin C (MMC) in black South African patients with primary open-angle glaucoma (POAG). Method A prospective, randomized study was conducted over a four year period. Fifteen black South African patients with bilateral open-angle glaucoma requiring surgery that met the inclusion criteria and gave informed consent to participate in the trial were randomized to receive either a viscocanalostomy or a trabeculectomy with MMC in the first eye requiring surgery. The fellow eye then received the alternate procedure. Patients were followed up for two years postoperatively. Results There were no significant differences between the two surgical groups preoperatively. Twelve eyes in each group were followed for twenty-four months. In both groups the intraocular pressure (IOP) was significantly reduced post-operatively (p < 0.01) and the average number of medications used per eye was significantly reduced (p < 0.02). At twenty-four months, complete success (IOP less than or equal to 18mmHg without glaucoma medication and with no evidence of glaucoma progression) was seen in 75% of eyes undergoing trabeculectomy with MMC that completed the follow up, but in only 33% of eyes undergoing viscocanalostomy (p = 0.0498). Survival curves for both success and qualified success (IOP less than or equal to 18mmHg with glaucoma medications) in the two surgical procedures confirmed the superiority of trabeculectomy with MMC over viscocanalostomy. Conclusion Viscocanalostomy may offer some advantages because it is less invasive, but intraocular pressure control appears to be superior with trabeculectomy with MMC and this continues to be the filtering procedure of choice for the management of glaucoma in black South African patients.