The power of the placebo effect in diabetes: A systematic review and meta-analysis.

This review aims to identify the magnitude of the placebo effect in people with type 2 diabetes mellitus. Literature research was conducted Medline, Embase and Virtual Health Library for studies published between the date of inception and June 2021. The eligibility criteria included randomized controlled trials, showing comparison to placebo, having participants with type 2 diabetes mellitus, and having glycated hemoglobin (HbA1c) as the primary outcome. Meta-analysis was conducted with the effect of changing HbA1c in relation to the baseline. Exploration of heterogeneity was performed.The meta-analysis showed an increase in the average of HbA1c compared to the baseline of 0.14% (95% CI: 0.07-0.21). There was a significant difference between follow-up times (p = 0.03) and between administration routes (p = 0.01), with an increase in HbA1c in the oral route [0.15% (95% CI: 0.07-0.23)]. The meta-regression of the year of publication showed a significant downward trend (p = 0.01) of the increase in HbA1c compared to the baseline.In this study, the expected placebo effect of Hba1c reduction was not found; instead, higher Hba1c levels were observed in the control groups, although this effect was reduced over the years. Registration: PROSPERO ID CRD42020172797.

Risedronate-loaded Eudragit S100 microparticles formulated into tablets.

Risedronate, an anti-osteoporotic drug, is associated with low patient compliance due to the upper gastrointestinal side-effects and stringent dosing regimes. This study aimed to prepare and characterize risedronate-loaded Eudragit® S100 microparticles and develop a final dosage form by the compression of microparticles using direct tableting excipients. Microparticles were prepared by spray-drying and presented yield of 54%, encapsulation efficiency higher than 90%, mean diameter of 3.3 µm, moisture content around 8% and exhibited spherical shape and poor flowability. At pH 1.2, 23% of risedronate was released from microparticles in 120 min, while at pH 6.8 the drug took 90 min to reach 99.5%. Microparticles were compressed into tablets using microcrystalline cellulose, magnesium stearate, colloidal silicon dioxide and 2 polyvinylpyrrolidone concentrations (5% and 15%). Tablets presented low variations in weight, thickness and drug content. Besides, the formulations showed sufficient hardness, low friability and disintegrated in less than 15 min. In acid medium, no more than 16% of the drug was released in 120 min, while in intestinal medium the formulations prolonged the risedronate release for 240 min. Finally, the developed tableted microparticles can be considered a promising dosage form for oral risedronate administration.