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  1. Ng CG, Boks MP, Roes KC, Zainal NZ, Sulaiman AH, Tan SB, et al.
    Eur Neuropsychopharmacol, 2014 Apr;24(4):491-8.
    PMID: 24503279 DOI: 10.1016/j.euroneuro.2014.01.016
    This is a 4 week, randomized, double-blind, placebo-controlled study to examine the effects of methylphenidate as add-on therapy to mirtazapine compared to placebo for treatment of depression in terminally ill cancer patients. It involved 88 terminally ill cancer patients from University of Malaya Medical Centre, Kuala Lumpur, Malaysia. They were randomized and treated with either methylphenidate or placebo as add on to mirtazapine. The change in Montgomery-Åsberg Depression Rating Scale (MADRS) score from baseline to day 3 was analyzed by linear regression. Changes of MADRS and Clinical Global Impression-Severity Scale (CGI-S) over 28 days were analyzed using mixed model repeated measures (MMRM). Secondary analysis of MADRS response rates, defined as 50% or more reduction from baseline score. A significantly larger reduction of Montgomery-Åsberg Depression Rating Scale (MADRS) score in the methylphenidate group was observed from day 3 (B=4.14; 95% CI=1.83-6.45). Response rate (defined as 50% or more reduction from baseline MADRS score) in the methylphenidate treated group was superior from day 14. Improvement in Clinical Global Impression-Severity Scale (CGI-S) was greater in the methylphenidate treated group from day 3 until day 28. The drop-out rates were 52.3% in the methylphenidate group and 59.1% in the placebo group (relative risk=0.86, 95%CI=0.54-1.37) due to cancer progression. Nervous system adverse events were more common in methylphenidate treated subjects (20.5% vs 9.1%, p=0.13). In conclusions, methylphenidate as add on therapy to mirtazapine demonstrated an earlier antidepressant response in terminally ill cancer patients, although at an increased risk of the nervous system side effects.
    Matched MeSH terms: Double-Blind Method
  2. P S L, Miskan MM, Y Z C, Zaki RA
    BMC Anesthesiol, 2017 Oct 11;17(1):137.
    PMID: 29020936 DOI: 10.1186/s12871-017-0430-3
    BACKGROUND: Cough on emergence has been reported as a common adverse reaction with sugammadex reversal. We investigated if staggering the dose of sugammadex will reduce emergence cough in a single-center, randomized, double-blinded study.

    METHODS: A hundred and twenty ASA 1-3 adults were randomly reversed with 1 mg/kg sugammadex prior to extubation followed by another 1 mg/kg immediately after extubation (staggered group), single dose of 2 mg/kg sugammadex (single bolus group) or neostigmine 0.02 mg/kg with glycopyrrolate (neostigmine group).

    RESULTS: We found 70% of patients (n = 28) reversed with single boluses of sugammadex had Grade 3 emergence cough compared to 12.5% (n = 5) in the staggered sugammadex group and 17.5% (n = 7) in the neostigmine group (p 

    Matched MeSH terms: Double-Blind Method
  3. Norhaya MR, Yap TM, Zainudin BM
    Respirology, 1999 Mar;4(1):77-81.
    PMID: 10339734 DOI: 10.1046/j.1440-1843.1999.00153.x
    The effect of adding inhaled salmeterol to inhaled corticosteroids was studied in patients with poorly controlled nocturnal asthma. In a double-blind, cross-over study, 20 patients were randomized to receive either salmeterol 50 micrograms twice daily or placebo via a Diskhaler after a 1-week run-in period. After 4 weeks of treatment, patients were subsequently crossed over to receive the other treatment for a further 4 weeks with a 2-week wash-out period in between. The response to treatment was assessed by peak expiratory flow rates (PEF) measured in the morning and evening, symptom scores of asthma, number of bronchodilators used, forced expiratory volume in one second (FEV1) and forced vital capacity (FVC) at regular intervals. Patients' preference for the Diskhaler or metered-dose inhaler was assessed at the last visit. The results showed that morning PEF was significantly higher while on salmeterol than on placebo (296.9 +/- 70.2 vs 274.6 +/- 77.4 L/min). Evening PEF showed a trend towards a higher value while on salmeterol than on placebo (321.1 +/- 73.4 vs 288.7 +/- 79.4 L/min), but the difference was not significant. There was no statistically significant improvement in symptom scores, number of rescue bronchodilators used and FEV1 or FVC between the two treatment groups. The occurrence of side effects in terms of tremors and palpitations between treatment and placebo were similar. There were more patients who preferred Diskhaler to metered-dose inhaler (70% vs 30%). We conclude that salmeterol 50 micrograms twice daily produces significant improvement in morning PEF and is well tolerated in patients with nocturnal asthma. Diskhaler is a device which is easy to use and preferred to a metered-dose inhaler.
    Study site: Respiratory Clinic, Pusat Perubatan Universiti Kebangsaan Malaysia (PPUKM), Kuala Lumpur, Malaysia
    Matched MeSH terms: Double-Blind Method
  4. Bosch J, Lonn EM, Jung H, Zhu J, Liu L, Lopez-Jaramillo P, et al.
    Eur Heart J, 2021 08 17;42(31):2995-3007.
    PMID: 33963372 DOI: 10.1093/eurheartj/ehab225
    AIMS: Rosuvastatin (10 mg per day) compared with placebo reduced major adverse cardiovascular (CV) events by 24% in 12 705 participants at intermediate CV risk after 5.6 years. There was no benefit of blood pressure (BP) lowering treatment in the overall group, but a reduction in events in the third of participants with elevated systolic BP. After cessation of all the trial medications, we examined whether the benefits observed during the active treatment phase were sustained, enhanced, or attenuated.

    METHODS AND RESULTS: After the randomized treatment period (5.6 years), participants were invited to participate in 3.1 further years of observation (total 8.7 years). The first co-primary outcome for the entire length of follow-up was the composite of myocardial infarction, stroke, or CV death [major adverse cardiovascular event (MACE)-1], and the second was MACE-1 plus resuscitated cardiac arrest, heart failure, or coronary revascularization (MACE-2). In total, 9326 (78%) of 11 994 surviving Heart Outcomes Prevention Evaluation (HOPE)-3 subjects consented to participate in extended follow-up. During 3.1 years of post-trial observation (total follow-up of 8.7 years), participants originally randomized to rosuvastatin compared with placebo had a 20% additional reduction in MACE-1 [95% confidence interval (CI), 0.64-0.99] and a 17% additional reduction in MACE-2 (95% CI 0.68-1.01). Therefore, over the 8.7 years of follow-up, there was a 21% reduction in MACE-1 (95% CI 0.69-0.90, P = 0.005) and 21% reduction in MACE-2 (95% CI 0.69-0.89, P = 0.002). There was no benefit of BP lowering in the overall study either during the active or post-trial observation period, however, a 24% reduction in MACE-1 was observed over 8.7 years.

    CONCLUSION: The CV benefits of rosuvastatin, and BP lowering in those with elevated systolic BP, compared with placebo continue to accrue for at least 3 years after cessation of randomized treatment in individuals without cardiovascular disease indicating a legacy effect.

    TRIAL REGISTRATION NUMBER: NCT00468923.

    Matched MeSH terms: Double-Blind Method
  5. Lee LK, Shahar S, Chin AV, Yusoff NA
    Psychopharmacology (Berl), 2013 Feb;225(3):605-12.
    PMID: 22932777 DOI: 10.1007/s00213-012-2848-0
    RATIONALE: Epidemiological studies have suggested a beneficial effect of fish oil supplementation in halting the initial progression of Alzheimer's disease. However, it remains unclear whether fish oil affects cognitive function in older people with mild cognitive impairment (MCI).

    OBJECTIVES: This study investigated the effects of fish oil supplementation on cognitive function in elderly person with MCI.

    METHODS: This was a 12-month, randomised, double-blind, placebo-controlled study using fish oil supplementation with concentrated docosahexaenoic acid (DHA). Thirty six low-socioeconomic-status elderly subjects with MCI were randomly assigned to receive either concentrated DHA fish oil (n = 18) or placebo (n = 18) capsules. The changes of memory, psychomotor speed, executive function and attention, and visual-constructive skills were assessed using cognitive tests. Secondary outcomes were safety and tolerability of the DHA concentrate.

    RESULTS: The fish oil group showed significant improvement in short-term and working memory (F = 9.890; ηp (2) = 0.254; p 

    Matched MeSH terms: Double-Blind Method
  6. Chan KQ, Stewart C, Chester N, Hamzah SH, Yusof A
    Andrologia, 2021 May;53(4):e14001.
    PMID: 33559971 DOI: 10.1111/and.14001
    Eurycoma longifolia supplementation increases testosterone levels in humans via activation of the hypothalamic-pituitary-gonadal axis and/or the hypothalamic-pituitary-adrenal axis mainly in older adults and nonhealthy populations. This study aimed to assess the impact of Eurycoma longifolia on the hypothalamic-pituitary-gonadal and hypothalamic-pituitary-adrenal axes in healthy young males since this might promote functional testosterone prowess. Thirty-two males (24.4 ± 4.7 years; 1.74 ± 0.07 m; 73.7 ± 8.4 kg) in a placebo-controlled, double-blind, matched-paired study received 600 mg/day Eurycoma longifolia or placebo for two weeks. Blood analysis using repeated measures analysis of variance showed significant interaction and time effects for testosterone (F1,30  = 9.04, p = .005), free testosterone (F1,30  = 7.13, p = .012) and estradiol (F1,30  = 8.07, p = .008) levels in favour of the treatment group, while luteinising hormone, follicle-stimulating hormone and sexual hormone-binding globulin did not. The lack of changes in luteinising hormone and follicle-stimulating hormone levels suggests that a lesser role played by Eurycoma longifolia in activating the hypothalamic-pituitary-gonadal axis in the young adults. The raised testosterone level may be due to a greater rate of hormone production via the hypothalamic-pituitary-adrenal axis. The supplementation of Eurycoma longifolia for two weeks demonstrates steroidogenic effects on young men were dose-related. Consequently, the raised testosterone following Eurycoma longifolia supplementations could benefit muscle and strength gain in young adults.
    Matched MeSH terms: Double-Blind Method
  7. George A, Udani JK, Yusof A
    Pharm Biol, 2019 Dec;57(1):145-153.
    PMID: 30922154 DOI: 10.1080/13880209.2019.1585460
    CONTEXT: Phyllanthus amarus Schumach. and Thonn. (Euphorbiaceae) is traditionally known to improve general liver health. However, its effect on hangover is unknown.

    OBJECTIVE: This study evaluated PHYLLPRO™, a standardized ethanol extract of P. amarus leaves for protection against oxidative stress and recovery from hangover symptoms.

    MATERIAL AND METHODS: Ten days daily oral supplementation of 750 mg/day followed by intoxication was evaluated in a randomized placebo-controlled (containing only excipient), crossover study in 15 subjects (21-50 years old), for oxidative stress, liver damage, alleviating hangover symptoms (Hangover Severity Score: HSS) and mood improvement (Profile-of-Mood-Scores: POMS).

    RESULTS: PHYLLPRO™ was able to remove blood alcohol in the active group while the placebo group still had 0.05% at 12 h post-intoxication (p  0.05) from baseline to hour 22 was reported in the placebo group using POMS. Significant anti-inflammatory group effect favouring the active group, by the upregulation of cytokines IL-8 (p = 0.0014) and IL-10 (p = 0.0492) and immunomodulatory effects via IL-12p70 (p = 0.0304) were observed. The incidence of adverse events was similar between groups indicating the safety of PHYLLPRO™.

    DISCUSSION AND CONCLUSION: Preliminary findings of PHYLLPRO™ in managing hangover, inflammation and liver functions following intoxication, is demonstrated. Future studies on PHYLLPRO™ in protecting against oxidative stress and hangover in larger populations is warranted.

    Matched MeSH terms: Double-Blind Method
  8. Abu Bakar MR, Abdul Kadir A, Abdul Wahab SZ, Abdul Karim AH, Nik Hussain NH, Mohd Noor N, et al.
    PLoS One, 2015;10(7):e0133514.
    PMID: 26222158 DOI: 10.1371/journal.pone.0133514
    AIM: To compare the mean of anteroposterior (AP) measurements of the uterus in longitudinal and oblique transverse planes, and the pulsatility index (PI) and resistive index (RI) of the uterine artery and superficial skin wound artery between patients taking Channa striatus and placebo.

    BACKGROUND: Channa striatus, also known as haruan, is a fresh water snakehead fish consumed in many parts of Southeast Asia. Channa striatus is also normally consumed by women postpartum to promote wound healing as well as to reduce post-operative pain.

    METHODOLOGY: This study is a randomised, double blind, placebo-controlled study conducted in women after Lower Segment Caesarean Section (LSCS). Subjects were randomised to either a Channa striatus or a placebo group and were given a daily dosage of 500 mg of Channa striatus extract or 500 mg maltodextrin, respectively, for six weeks post LSCS. The anteroposterior measurements of the uterus in the longitudinal and oblique transverse planes, and the pulsatility index (PI) and resistive index (RI) of the uterine and superficial skin wound arteries were assessed using pelvic Gray-scale ultrasound and Doppler ultrasound at baseline (Day 3) and at two weeks, four weeks and six weeks post-operatively.

    RESULTS: Sixty-six subjects were randomised into the study with 33 in the Channa striatus group and 33 in the placebo group. No significant differences were detected in terms of the pulsatility index (PI) and the resistive index (RI) of the uterine and superficial skin wound arteries between the Channa striatus and placebo groups. However, in the Channa striatus group, the AP measurements of the uterus on the longitudinal and oblique transverse planes were significantly lower compared to the placebo group (p<0.05 and p<0.001, respectively).

    CONCLUSION: Daily intake of Channa striatus extract results in marked differences compared to placebo in terms of uterine involution and recovery in women post LSCS.

    TRIAL REGISTRATION: www.isrctn.com 11960786.

    Matched MeSH terms: Double-Blind Method
  9. Magosso E, Ansari MA, Gopalan Y, Shuaib IL, Wong JW, Khan NA, et al.
    Nutr J, 2013;12(1):166.
    PMID: 24373555 DOI: 10.1186/1475-2891-12-166
    Nonalcoholic fatty liver disease (NAFLD) is one of the commonest liver disorders. Obesity, insulin resistance, lipid peroxidation and oxidative stress have been identified amongst the possible hits leading to the onset and progression of this disease. Nutritional evaluation of NAFLD patients showed a lower-than-recommended intake of vitamin E. Vitamin E is a family of 8 isoforms, 4 tocopherols and 4 tocotrienols. Alpha-tocopherol has been widely investigated in liver diseases, whereas no previous clinical trial has investigated tocotrienols for NAFLD. Aim of the study was to determine the effects of mixed tocotrienols, in normalising the hepatic echogenic response in hypercholesterolaemic patients with ultrasound-proven NAFLD.
    Matched MeSH terms: Double-Blind Method
  10. Lim R, Liong ML, Leong WS, Khan NA, Yuen KH
    Trials, 2015;16:279.
    PMID: 26093910 DOI: 10.1186/s13063-015-0803-1
    There is currently a lack of randomized, sham-controlled trials that are adequately powered, using validated outcomes, to allow for firm recommendations on the use of magnetic stimulation for stress urinary incontinence. We report a protocol of a multicenter, randomized, double-blind, sham-controlled parallel-group trial to evaluate the efficacy of magnetic stimulation for stress urinary incontinence.
    Matched MeSH terms: Double-Blind Method
  11. Lim R, Liong ML, Leong WS, Karim Khan NA, Yuen KH
    J Urol, 2017 05;197(5):1302-1308.
    PMID: 27871927 DOI: 10.1016/j.juro.2016.11.091
    PURPOSE: Despite significant differences in success rates between surgical and nonsurgical treatments for female stress urinary incontinence, a few cross-sectional surveys showed that most patients still prefer the latter. We evaluated the efficacy of the under studied nonsurgical treatment using pulsed magnetic stimulation for female stress urinary incontinence.

    MATERIALS AND METHODS: This randomized, double-blind, sham controlled study was performed in 120 female subjects at least 21 years old with stress urinary incontinence. Treatment involved pulsed magnetic stimulation for 2 sessions per week for 2 months (16 sessions). After 2 months, subjects could opt for 16 additional sessions regardless of initial randomization. The primary response criterion was a 5-point reduction in the ICIQ-UI SF (International Consultation on Incontinence Questionnaire for Urinary Incontinence-Short Form) score. Key secondary response criteria included objective and subjective cure, supplemented by other secondary criteria. Followups were performed at months 1, 2, 5, 8 and 14.

    RESULTS: At 2 months 45 of 60 subjects (75%) in the active arm vs 13 of 60 (21.7%) in the sham arm were treatment responders (p <0.001). After 2 months 24 subjects (40%) in the active arm and 41 (68%) in the sham arm elected additional active pulsed magnetic stimulation. At 14 months, subjects who received 32 sessions of active pulsed magnetic stimulation had the highest percentage of treatment responders (18 of 24 or 75.0%), followed by those who received 16 sessions (26 of 36 or 72.2% and 28 of 41 or 68.3%) and those who did not receive any active pulsed magnetic stimulation (4 of 19 or 21.1%) (p <0.001).

    CONCLUSIONS: The encouraging long-term response rates show that pulsed magnetic stimulation is an attractive nonsurgical alternative for patients who do not want to undergo surgery.

    Matched MeSH terms: Double-Blind Method
  12. Lim R, Liong ML, Leong WS, Khan NAK, Yuen KH
    Int Urogynecol J, 2018 07;29(7):997-1004.
    PMID: 28744557 DOI: 10.1007/s00192-017-3425-1
    INTRODUCTION AND HYPOTHESIS: We evaluated patients' perception and satisfaction with nonsurgical pulsed magnetic stimulation (PMS) for treatment of female stress urinary incontinence (SUI) in a randomized, double-blind, sham-controlled trial.

    METHODS: Women with SUI (n = 120) were randomized to either active or sham PMS for 8 weeks (twice/week). Patients answered seven questions on their perception and acceptability, each measured on a 5-point Likert scale. Treatment satisfaction was assessed using two parameters: (i) the single-item question "Overall, please rate how satisfied you are with the treatment" and (ii) Patient Global Impression of Improvement (PGI-I). All adverse events were documented.

    RESULTS: A total of 115 patients completed treatments (active: n = 57, sham: n = 58). There were no significant differences between groups in all parameters regarding perception and acceptability (p > 0.05). In terms of treatment satisfaction, a significantly higher proportion of patients in the active group (n = 47/57, 82.4%) were either mostly or completely satisfied compared with those in the sham group (n = 27/58, 46.6%) ((p = 0.001). Similarly, a statistically significantly higher percentage of patients in the active group (n = 39/57, 68.4%) felt much or very much better compared with patients in the sham group (n = 11/58, 19.0%) as measured using the PGI-I (p 

    Matched MeSH terms: Double-Blind Method
  13. Vitamin E in Neuroprotection Study (VENUS) Investigators, Hor CP, Fung WY, Ang HA, Lim SC, Kam LY, et al.
    JAMA Neurol, 2018 04 01;75(4):444-452.
    PMID: 29379943 DOI: 10.1001/jamaneurol.2017.4609
    Importance: Management of painful diabetic peripheral neuropathy remains challenging. Most therapies provide symptomatic relief with varying degrees of efficacy. Tocotrienols have modulatory effects on the neuropathy pathway and may reduce neuropathic symptoms with their antioxidative and anti-inflammatory activities.

    Objective: To evaluate the efficacy of oral mixed tocotrienols for patients with diabetic peripheral neuropathy.

    Design, Setting, and Participants: The Vitamin E in Neuroprotection Study (VENUS) was a parallel, double-blind, placebo-controlled trial that recruited participants from January 30, 2011, to December 7, 2014, with 12 months of follow-up. This trial screened 14 289 patients with diabetes from 6 health clinics and ambulatory care units from 5 public hospitals in Malaysia. A total of 391 patients who reported neuropathic symptoms were further assessed with Total Symptom Score (TSS) and Neuropathy Impairment Score (NIS). Patients 20 years or older with a TSS of 3 or higher and an NIS of 2 or higher were recruited.

    Interventions: Patients were randomized to receive 200 mg of mixed tocotrienols twice daily or matching placebo for 12 months. Patients with hyperhomocysteinemia (homocysteine level ≥2.03 mg/L) received oral folic acid, 5 mg once daily, and methylcobalamin, 500 μg thrice daily, in both groups.

    Main Outcomes and Measures: The primary outcome was patient-reported neuropathy TSS (lancinating pain, burning pain, paresthesia, and asleep numbness) changes at 12 months. The secondary outcomes were NIS and sensory nerve conduction test result.

    Results: Of 391 eligible patients, 300 were recruited (130 [43.3%] male; mean [SD] age, 57.6 [8.9] years; mean [SD] duration of diabetes, 11.4 [7.8] years) and 229 (76.3%) completed the trial. The TSS changes between the tocotrienols and placebo groups at 12 months (-0.30; 95% CI, -1.16 to 0.56; P = .49) were similar. No significant differences in NIS (0.60; 95% CI, -1.37 to 2.65; P = .53) and sensory nerve conduction test assessments were found between both groups. In post hoc subgroup analyses, tocotrienols reduced lancinating pain among patients with hemoglobin A1C levels greater than 8% (P = .03) and normohomocysteinemia (homocysteine level <2.03 mg/L; P = .008) at 1 year. Serious adverse events in both groups were similar, except more infections were observed in the tocotrienols group (6.7% vs 0.7%, P = .04). Results reported were of modified intention-to-treat analyses.

    Conclusions and Relevance: Supplementation of oral mixed tocotrienols, 400 mg/d for 1 year, did not improve overall neuropathic symptoms. The preliminary observations on lancinating pain among subsets of patients require further exploration.

    Trial Registration: National Medical Research Registry Identifier: NMRR-10-948-7327 and clinicaltrials.gov Identifier: NCT01973400.

    Matched MeSH terms: Double-Blind Method
  14. Tan HM, Chin CM, Chua CB, Gatchalian E, Kongkanand A, Moh CL, et al.
    Asian J Androl, 2008 May;10(3):495-502.
    PMID: 18385912 DOI: 10.1111/j.1745-7262.2008.00388.x
    To evaluate the efficacy and tolerability of vardenafil, a phosphodiesterase type-5 (PDE-5) inhibitor, in men of Asian ethnicity with erectile dysfunction (ED).
    Matched MeSH terms: Double-Blind Method
  15. Teng CL, Lim WY, Chua CZ, Teo RS, Lin KT, Yeo JC
    Aust Fam Physician, 2016;45(1):65-8.
    PMID: 27051992
    BACKGROUD: Previous studies have shown that the blood pressure elevating effect of acute caffeine consumption was variable because of the heterogeneity of study participants, dosage of caffeine and study designs.
    OBJECTIVE: This research aimed to examine the effect of a single cup of coffee on the blood pressure of young adults.
    METHODS: Normotensive adults were randomised to receive either a cup of caffeinated drink (intervention group) or a cup of decaffeinated drink (control group). The main outcome measure was mean change in systolic blood pressure (SBP) and diastolic blood pressure (DBP) between intervention and control groups.
    RESULTS: Enrolled participants (n = 104) were randomly assigned to the intervention group (n = 53) or the control group (n = 51). The mean differences in SBP and DBP of the two groups were +2.77 mmHg (P = 0.05) and +2.11 mmHg (P = 0.64), respectively. Therefore, the rise in both SBP and DBP after caffeine consumption was not statistically significant.
    DISCUSSION: Our study confirmed that drinking a single cup of coffee (containing 80 mg of caffeine) does not have a significant impact on the blood pressure of healthy normotensive young adults one hour after the drink.
    Matched MeSH terms: Double-Blind Method
  16. Nakamoto H, Fujita T, Origasa H, Isono M, Kurumatani H, Okada K, et al.
    BMC Nephrol, 2014;15:153.
    PMID: 25233856 DOI: 10.1186/1471-2369-15-153
    Chronic kidney disease (CKD) is public health concern even in Asian countries. TRK-100STP, a sustained release tablet of an orally-active prostacyclin analogue, beraprost sodium, is suggested to suppress worsening of some parameters of renal filtration function, containing in slope of 1/serum creatinine (1/SCr) vs. time in a phase II clinical trial.
    Matched MeSH terms: Double-Blind Method
  17. Taiyeb-Ali TB, Zainuddin SL, Swaminathan D, Yaacob H
    J Oral Sci, 2003 Sep;45(3):153-9.
    PMID: 14650580
    The aim of this randomised, parallel, double-blind study, in which 28 adult patients diagnosed with chronic gingivitis or early stages of chronic periodontitis were recruited, was to evaluate the efficacy of 'Gamadent' toothpaste compared to a placebo toothpaste. 'Gamadent' toothpaste has all the basic constituents of a toothpaste with the addition of a sea cucumber extract (SCE) of the species Stichopus sp. 1 to improve the healing potential of tissues. The placebo has the same basic constituents minus the extract. Out of the 28 patients, 14 were placed in the test group who used the 'Gamadent' toothpaste, and 14 patients were placed in the control group (2 control subjects defaulted and were excluded), who brushed using the placebo toothpaste. The longitudinal study was carried out over a period of 3 months with assessments made at baseline, 1 month, 2 months and 3 months after conventional therapy at the baseline visit. The clinical parameters used during the trial were Plaque Index (PI), Gingival Index (GI), Papilla Bleeding Index (PBI) and Probing Pocket Depth (PPD). A predetermined number of sites on a molar, premolar, canine and an incisor were examined and evaluated in each quadrant. After the baseline assessment, the patients had full mouth scaling and debridement as well as oral hygiene instructions. Patients were instructed to brush their teeth twice a day with the toothbrush provided (Oral-B plus, size 35) and toothpaste (test or control), using the Bass technique. At the 1-month assessment, there were significant mean reductions to baseline mean values in PI (P < 0.005) and GI (P < 0.001) in the test group as compared to the control group. At the end of the 2-month interval, significant reductions were observed in PI, PBI and PPD (P < 0.001). By the end of 3 months, there were significant differences in the mean reduction of all the parameters i.e. PI, PBI, GI and PPD (P < 0.001), between the test and control sites. In conclusion, 'Gamadent' toothpaste provided noteworthy benefits, producing statistically significant improvement in all clinical parameters compared to the placebo during the healing phase after conventional initial therapy.
    Matched MeSH terms: Double-Blind Method
  18. Uebelhack R, Bongartz U, Seibt S, Bothe G, Chong PW, De Costa P, et al.
    J Obes, 2019;2019:3412952.
    PMID: 30863632 DOI: 10.1155/2019/3412952
    Objective: This study was performed to determine the efficacy and tolerability/safety of IQP-AE-103 on body weight reduction in overweight to moderately obese adults.

    Methods: A double-blind, randomized, placebo-controlled trial involved one hundred and eight subjects (BMI between 25 and 35 kg/m2) that were randomly assigned to either the low-dose or the high-dose IQP-AE-103 group, or the placebo group. Following a 2-week run-in period, subjects received two capsules of investigational product after three daily main meals for 12 weeks. Subjects were instructed to maintain a nutritionally balanced hypocaloric diet according to the individual's energy requirement. Body weight, body fat, and waist and hip circumference were measured at baseline, and after 2, 4, 8, and 12 weeks. Subjects also rated their feelings of hunger and fullness using visual analogue scales, and food craving on a 5-point scale at the same time intervals. Blood samplings for safety laboratory parameters were taken before and at the end of the study.

    Results: After 12 weeks of intake, the high-dose IQP-AE-103 group had a significantly greater weight loss compared with the placebo (5.03 ± 2.50 kg vs. 0.98 ± 2.06 kg, respectively; p < 0.001) and the low-dose group (3.01 ± 2.19 kg; p=0.001). The high-dose group experienced a decrease in body fat of 3.15 ± 2.41 kg compared with a decrease of 0.23 ± 2.74 kg for the placebo group (p < 0.001). High-dose IQP-AE-103 also decreased the feeling of hunger in 66% subjects. A beneficial effect of IQP-AE-103 on the lipid metabolism was also demonstrated in the subgroup of subjects with baseline total cholesterol levels above 6.2 mmol/L. No side effects related to the intake of IQP-AE-103 were reported.

    Conclusions: These findings indicate that IQP-AE-103 could be an effective and safe weight loss intervention. This trial is registered with NCT03058367.

    Matched MeSH terms: Double-Blind Method
  19. Bongartz U, Tan BK, Seibt S, Bothe G, Uebelhack R, Chong PW, et al.
    PMID: 31186669 DOI: 10.1155/2019/9178218
    Objective: The purpose of this study was to explore the clinical benefit and tolerability of IQP-AO-101 in healthy subjects with sleep complaints.

    Methods: This double-blind, randomized, placebo-controlled trial involved fifty subjects with sleep complaints. Subjects with a Pittsburgh Sleep Quality Index (PSQI) score between 6 and 15 were randomized to receive either IQP-AO-101 or placebo for 6 weeks, following a run-in period of one week. Sleep parameters were assessed at baseline and after 1, 4, and 6 weeks using the modified Athens Insomnia Scale (mAIS). Subjects were also instructed to wear an activity tracker and keep a sleep diary during the study. Other questionnaires administered were the Frankfurt Attention Inventory (FAIR-2) and the Profile of Mood States (POMS-65). Blood samples for safety laboratory parameters were taken before and at the end of the study.

    Results: After 6 weeks, subjects who consumed IQP-AO-101 reported significant improvements in mAIS scores compared with placebo, including mAIS total score (11.76 ± 6.85 vs 4.00 ± 4.80; p < 0.001); night parameters composite score (5.20 ± 3.80 vs 2.04 ± 3.16; p = 0.001); and day parameters composite score (6.56 ± 4.10 vs 1.96 ± 2.65; p < 0.001). All individual parameters (Items 1 to 8) were also significantly improved from baseline after 6 weeks of IQP-AO-101 intake. Analysis of variance with baseline values as covariates showed statistically significant improvements across all individual parameters for IQP-AO-101 when compared to placebo. The measurements using the activity tracker, sleep diary, FAIR-2, and POMS did not reveal any significant differences between groups. No adverse effects related to the intake of IQP-AO-101 were reported. Tolerability was rated as very good by all the subjects and by the investigator for all cases.

    Conclusions: In this study, IQP-AO-101 was well tolerated and efficacious for promoting sleep and enhancing daytime performance in subjects with moderate sleep disturbances.

    Clinical Trial Registration: This trial is registered with ClinicalTrials.gov, no. NCT03114696.

    Matched MeSH terms: Double-Blind Method
  20. Chan WK, Wong VW
    Lancet Gastroenterol Hepatol, 2019 10;4(10):747-749.
    PMID: 31345779 DOI: 10.1016/S2468-1253(19)30183-9
    Matched MeSH terms: Double-Blind Method
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