Cost-Utility Analysis of a Six-Weeks <i>Ganoderma Lucidum-</i>Based Treatment for Women with Fibromyalgia: A Randomized Double-Blind, Active Placebo-Controlled Trial

<p><b>Purpose:</b> To determine the effectiveness of adding <i>Ganoderma lucidum</i> (GL) to standard care for patients with fibromyalgia (FM), and to examine the costs per quality-adjusted life year (QALY) gained from this nutritional supplementation.</p> <p><b>Materials and methods:</b> This was a randomised controlled trial with a random allocation of participants to two groups; experimental group and active-placebo controlled group. A total of 26 women with FM participated in the experimental group. These participants were instructed to take 3 g of micromilled GL twice a day for six weeks. EQ-5D-5L was used to obtain the utilities and a non-parametric bootstrap was used to plot the acceptability curve.</p> <p><b>Results:</b> Of the women initially recruited, over 81% completed the experimental treatment. The incremental QALY in the GL group was 0.177, and the incremental QALY in the active placebo group was 0.101. Therefore, the difference in terms of QALYs was 0.076 and the incremental cost-utility ratio was €1348.55/QALYs. The cost-utility acceptability curve showed 90% probability that the addition of GL to the standard care as a nutritional supplement is cost-effective.</p> <p><b>Conclusions:</b> The GL as nutritional supplementation in patients with FM is cost-effective in women with FM. To authors’ knowledge, the current study reports the first cost-utility analysis of GL as a nutritional supplement.</p

Cost-Effectiveness of a Whole-Body Vibration Program in Patients with Type 2 Diabetes: A Retrospective Study Protocol

Background: Type 2 diabetes mellitus (T2DM) is a chronic disorder, with patients exhibiting hyperglycemia in fasting and postprandial states. T2DM has several complications, including loss of sensation in more distal body parts. Good peripheral sensitivity is essential as this affects different parameters related to activities of daily living, such as leg strength and balance. The objectives of this project were to assess the effects of an 8-week whole-body vibration (WBV) training program on (1) vibration perception threshold (VPT), (2) balance, (3) strength, (4) lipidic profile, (5) health-related quality of life, (6) diabetic neuropathy, and (7) body composition in T2DM patients. Methods/Design: A double-blind, randomized controlled study, with WBV and placebo groups, was carried out. Both groups performed 8 weeks of intervention, with 3 sessions per week, completing a total of 24 sessions. There were two groups: the experimental group, i.e., the WBV group, who received WBV therapy; and the placebo group, who completed a simulated training program that was developed on a Galileo Fitness platform, connected to software displayed on a screen. The participant could see the parameters of the simulated vibration training (duration, amplitude, and frequency), but it was the software that controlled the speakers placed inside the vibration platform. Ninety patients with T2DM (56 males and 34 females) were recruited for the intervention. Participants were assigned equally to the WBV (n = 45) and placebo (n = 45) groups. Primary outcome measures were (1) HbA1c and (2) vibration threshold. Secondary measures were (1) health-related quality of life, (2) balance, (3) strength, (4) body composition, (5) blood pressure, (6) diabetic neuropathy, and (7) lipidic profile. Statistical analysis was carried out by treatment intention and protocol. Discussion: This project aimed to investigate the effects of WBV training on HbA1c, vibration threshold, and incremental cost-effectiveness ratio in T2DM patients. In future, guidelines will be provided for the incorporation of the main obtained conclusions into the social-sanitary system and businesses