SAGES Magazine
THE SOUTH AFRICAN GASTROENTEROLOGY REVIEW 2022 | VOLUME 20 | ISSUE 1 | 22 3.1. Characteristics of included studies Table 1 provides a summary of the studies included in this review. Six studies, comprising 435 participants were included in this systematic review. Studies were conducted in China (1 study, 84 participants), Israel (2 studies, 115 participants), Sweden (1 study, 68 participants) and the United Kingdom (2 studies, 168 participants). Participants’ age ranged from 18 to 81 years of age, diagnosed with IBS or functional constipation through the Manning and Rome criteria (Rome iterations include Rome I, Rome II and Rome III). Interventions included: 50ml Aloe drink, prescribed four times daily for one month; 60ml Aloe drink prescribed two times daily for five months (followed by a two-week washout period after which placebo and experimental groups would be crossed-over); 105mg Traditional Chinese Medicine capsule, containing Aloe extract; 500mg of celandin, Aloe Vera and psyllium in the ratio of 6:3:1 (i.e. 150mg Aloe Vera), where initial dose was 1 capsule per day and increasing to 3 capsules per day depending on response; and 250mg Aloe Extract + 60mg ascorbic acid effervescent tablets dissolved in water two times daily for one month. Comparison interventions were placebo, matched in appearance and other characteristics. One study 17 incorporated multiple arms, of which those relevant to this study’s inclusion criteria were included. Another study 16 was a crossover RCT, but unfortunately no data was available to include in the meta-analysis. Information on the characteristics of studies included in this systematic review is shown in Table 2. RESEARCH Included Eligibility Screening Identi cation Africa-wide (n=84) CINAHL (n=49) Records identi ed through database searching (n =2,386) Records after duplicates removed (n = 1974) Records excluded (n = 1948) Full-text articles excluded, with reasons (n = 20) 7 = Published reviews/ no primary data provided 5 = Full text articles could not be accessed 4 = Constipation was induced by opioids 2 = Before-and-after (not placebo-controlled) 1 = Previously published duplicate of a selected study 1 = Ethno-botanical study with no primary experimental data Titles & abstracts screened (n =1974) Full-text articles assessed for eligibility (n = 26) Studies included in qualitative synthesis (n = 6) Studies included in quantitative synthesis (meta-analysis) (n = 5) Additional records identi ed through other sources (n =13) Clinicaltrials. gov (n = 1) Cochrane library (n=28) Health source (n=11) Mednar (n=677) PubMed (n=232) Scopus (n=879) Web of Science (n=423) WHOLIS (n=2) Figure 1 PRISMA diagram showing flow of information through the various phases of the systematic review Table 2: Characteristics of included studies Study ID Study design Country Population Population Control group Outcome Davis, Philpott, Kumar & Mendall 2006 [15] RCT UK Patients aged 18-65; diagnosed with IBS by Rome II Patients aged 18-65; diagnosed with IBS by Rome II Matching placebo Improvement of symptoms through global summated score of 500 points with a ≥50 point improvement considered as response to treatment. Patients assessed at end of treatment, and 3 months post treatment. Hutchings et al., 2011 [16] RCT (cross- over) UK. Patients aged 18 and older, diagnosed with IBS by Rome II for at least one year. Patients aged 18 and older, diagnosed with IBS by Rome II for at least one year. Matching placebo Improvement of patient quality of life. Four self- reported quality of life scales were used in the study including EQ5D, GSRS, SF12 and IBSQOL. Response to treatment was not defined by authors. Patients assessed at end of each study cross-over period, each lasting 5 months. Jia et al., 2010 [17] RCT (3-arm study) China Patients aged 18-65. Diagnosed with functional constipation by Rome III Patients aged 18-65. Diagnosed with functional constipation by Rome III Matching placebo for Group C (105mg of placebo). Improvement of symptoms using two rating scales to rate symptoms: main symptoms included stool frequency, consistency and dyschezia, and were rated using 7-point scale. Distension, dry mouth and throat, weakness and hectic fever were scored through 4-point scale. Response to treatment was defined as change in main symptom scores and cumulative symptom scores 2 weeks following treatment.
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