Article

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

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Abstract

Purpose: To determine the effectiveness of adding Ganoderma lucidum (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. Materials and methods: 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. Results: 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. Conclusions: 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.

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... It has exhibited suppressive effects on tumor necrosis factor-α (TNF-α), IL-1β, IL-12, and IL-6, which are pathogenic cytokines associated with SLE [274,275]. The authors of the present study could not find a clinical trial on the efficacy of the G. lucidum on SLE, but there are several trials investigating the efficacy of this mushroom on some other conditions such as rheumatoid arthritis [276], fibromyalgia [111,277], neurasthenia [278], cancers [279], cardiovascular risk factors of metabolic syndrome [280], lower urinary tract symptoms (LUTS) [281], etc. Moreover, in a clinical trial, β-glucans of G. lucidum were reported as safe and well-tolerated immunomodulator supplements for children [282]. ...
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Ganoderma lucidum (Ling Zhi) is a basidiomycete white-rot macrofungus that has been used as a tranquilizing agent (i.e., An-Shen effect) for the treatment of restlessness, insomnia, and palpitation in China for hundreds of years. The present study aimed to investigate whether Ganoderma lucidum extract (GLE) influences the sleep of freely moving rats and the potential mechanism. Ganoderma lucidum extract was extracted from fruiting bodies of Ganoderma lucidum. Rats were treated with GLE orally for 3 days, and on the third day, electroencephalographic and electromyographic recordings were made for 6h from 9:00 p.m. to 3:00 a.m. in freely moving rats. Sleep parameters were analyzed using SleepSign software. Tumor necrosis factor-α (TNF-α) levels were measured using the enzyme-linked immunosorbent assay. Three-day administration of GLE significantly increased total sleep time and non-rapid eye movement (NREM) sleep time at a dose of 80 mg/kg (i.g.) without influencing slow-wave sleep or REM sleep in freely moving rats. TNF-α levels were significantly increased concomitantly in serum, the hypothalamus, and dorsal raphe nucleus. The hypnotic effect of GLE (80 mg/kg, i.g.) was significantly inhibited by intracerebroventricular injection of TNF-α antibody (2.5 μg/rat). Co-administration of GLE (40 mg/kg, i.g.) and TNF-α (12.5 ng/rat, i.c.v.), both at ineffective doses, revealed an additive hypnotic effect. These results suggest that GLE has hypnotic effects in freely moving rats. The mechanism by which the extract promoted sleep remains unclear, but this effect appears to be primarily related to the modulation of cytokines such as TNF-α. Furthermore, these data at least partially support the ethnomedical use of Ganoderma lucidum.
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To obtain an updated FIQ consensus version for patients in Spain, the Cuestionario de Impacto de la Fibromialgia (CIF). The CIF elaboration was carried out with the participation of all the groups of researchers in the 4 previous FIQ Spanish versions, and taking into account the recent updated version of the original FIQ. The CIF was completed by a sample of fibromialgia patients to explore how comprensible its items are and to compare its global score with 2 fibromialgia composite severity indexes, one semi-objective and one subjective. The corresponding Spearman correlation coefficients were determined The main modifications introduced in the questionnaire are shown. Some patients were confused in their responses to subitem "j" and item 3, but not with regard to the remaining items or subitems. Correlation coeficients between the CIF and the semi-objective and subjective fibromialgia severity indexes were 0.57 and 0.76 respectively (P<001). The CIF is proposed as an updated Spanish version of the FIQ.
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The Medical Outcomes Study Short-form 36 (SF-36) provides numerical measurement of patient health, but does not include preferences for health states and cannot be used directly in cost-effectiveness analyses. By contrast the Euroqol EQ-5D can be used for cost-effectiveness analyses. The EQ-5D has rarely been used in systemic lupus erythematosus (SLE). We compared SF-36 and EQ-5D values across rheumatic diseases. We studied 1316 patients with SLE, 13,722 with rheumatoid arthritis (RA), 3623 with non-inflammatory rheumatic disorders (NIRD), and 2733 with fibromyalgia (FM). The mean EQ-5D, physical (PCS) and mental (MCS) component summary scores were 0.72, 36.3, and 44.3, respectively, in SLE. There was essentially no difference among EQ-5D and PCS scores for patients with SLE, RA, or NIRD. MCS was lower in SLE compared with RA and NIRD (44.3, 49.1, 50.8, respectively). All scores were more abnormal in FM (0.61, 31.9, 41.9). Within SF-36 domains, physical function was better, but general health, vitality, social function, role-emotional, and mental health were more impaired in SLE compared with RA and NIRD. In SLE, quality of life (QOL) was predicted by damage, comorbidity, income, education, and age. Fifteen percent of patients with SLE were very satisfied with their health, and their QOL scores (0.84, 45.4, 50.1) were similar to those found in the US population for EQ-5D and MCS, but were slightly reduced for PCS. EQ-5D and PCS are at the same levels in SLE as in RA and NIRD, but are more abnormal in SLE in the MCS and mental health domains. EQ-5D values allow preference-based comparisons with other chronic conditions.
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The Fibromyalgia Impact Questionnaire (FIQ) is a disease-specific composite instrument that measures the effect of problems experienced by patients with fibromyalgia (FM). Utilization of the FIQ in measuring changes due to interventions in FM requires derivation of a clinically meaningful change for that instrument. Analyses were conducted to estimate the minimal clinically important difference (MCID), and to propose FIQ severity categories. Data from 3 similarly designed, 3-month placebo-controlled, clinical treatment trials of pregabalin 300, 450, and 600 mg/day in patients with FM were modeled to estimate the change in the mean FIQ total and stiffness items corresponding to each category on the Patient Global Impression of Change. FIQ severity categories were modeled and determined using established pain severity cutpoints as an anchor. A total of 2228 patients, mean age 49 years, 93% women, with a mean baseline FIQ total score of 62 were treated in the 3 studies. Estimated MCID on a given measure were similar across the studies. In a pooled analysis the estimated MCID (95% confidence interval) was 14% (13; 15) and for FIQ stiffness it was 13% (12; 14). In the severity analysis a FIQ total score from 0 to <39 was found to represent a mild effect, >or= 39 to <59 a moderate effect, and >or=59 to 100 a severe effect. The analysis indicates that a 14% change in the FIQ total score is clinically relevant, and results of these analyses should enhance the clinical utility of the FIQ in research and practice.
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In this study, we have investigated the analgesic and anti-arthritic effects of a traditional Chinese medicine (TCM) combination of Lingzhi and San Miao San (SMS) in a rat model of arthritis induced by Freund's complete adjuvant (FCA). Sprague-Dawley rats were induced with monoarthritis by single unilateral injection of FCA into the knee joint. The TCM combination was administered to the rats daily by intraperitoneal injection (50mg/(kgday)) or via oral administration (500mg/(kgday)) for 7 days before induction of arthritis and 7 days after. Extension angle that provoked struggling behavior, and size and blood flow of the rat knees were measured to give indexes of allodynia, edema, and hyperemia, respectively. The extent of cell infiltration, tissue proliferation, and erosions of joint cartilage provided additional indexes of the arthritis condition. FCA injection produced significant allodynia, edema, hyperemia, immune cell infiltration, synovial tissue proliferation, and erosions of joint cartilage in the ipsilateral knees compared with the contralateral saline-injected knees. Intraperitoneal injection of the TCM combination (50mg/(kgday)) suppressed allodynia, edema, and hyperemia in the inflamed knees, and oral administration (500mg/(kgday)) suppressed edema and hyperemia. Histological examination showed that the TCM administered by either route reduced immune cell infiltration and erosion of joint cartilage. These findings suggest the Lingzhi and SMS formulation has analgesic and anti-inflammatory effects in arthritic rat knees, and concur to previous clinical studies that showed the TCM combination reduced pain in rheumatoid arthritis patients, and extends its possible benefit to suppression of inflammatory symptoms in these patients.
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The antinociceptive effects 134 extracts prepared from 45 species of mushrooms were examined by the acetic acid-induced writhing method. From the CH2Cl2 extract of Ganoderma lucidum among the active extracts, ganoderic acids A, B, G and H and compound C6 were isolated as the antinociceptive components.
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Administration of hot water soluble extracts of Ganoderma lucidum (GI) (36 to 72 g dry weight/day) decreased pain dramatically in two patients with postherpetic neuralgia recalcitrant to standard therapy and two other patients with severe pain due to herpes zoster infection.
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Cancer-induced weight loss is associated with poor outcomes and is common in pancreatic cancer. The aims were to determine whether stabilising weight loss for patients with unresectable pancreatic cancer was associated with improved survival and quality of life (QoL) and to identify determinants of weight stabilisation. A post hoc analysis was performed using data from 107 patients in a multicentre trial. Patients were categorised as weight losing (> 1 kg lost) or weight stable (< or = 1 kg lost) after an 8 week nutrition intervention period. Group survival duration (Kaplan Meier) and QoL (EORTC QLQ-C30) were compared. Predictors of weight stability were determined using logistic regression analysis. Patients with weight stabilisation survived longer from baseline (log rank test 5.53, P = 0.019). They also reported higher QoL scores (P = 0.037) and a greater mean energy intake (P <0.001) at Week 8 than those who continued to lose weight. The absence of nausea and vomiting (OR 6.5, P =0.010) and female gender (OR 5.2, P = 0.020) were independent determinants of weight stabilisation. Weight stabilisation over an 8 week period in weight-losing patients with unresectable pancreatic cancer was associated with improved survival duration and QoL.
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The SF-6D and EQ-5D are both preference-based measures of health. Empirical work is required to determine what the smallest change is in utility scores that can be regarded as important and whether this change in utility value is constant across measures and conditions. To use distribution and anchor-based methods to determine and compare the minimally important difference (MID) for the SF-6D and EQ-5D for various datasets. The SF-6D is scored on a 0.29-1.00 scale and the EQ-5D on a -0.59-1.00 scale, with a score of 1.00 on both, indicating 'full health'. Patients were followed for a period of time, then asked, using question 2 of the SF-36 as our anchor, if their general health is much better (5), somewhat better (4), stayed the same (3), somewhat worse (2) or much worse (1) compared to the last time they were assessed. We considered patients whose global rating score was 4 or 2 as having experienced some change equivalent to the MID. This paper describes and compares the MID and standardised response mean (SRM) for the SF-6D and EQ-5D from eight longitudinal studies in 11 patient groups that used both instruments. From the 11 reviewed studies, the MID for the SF-6D ranged from 0.011 to 0.097, mean 0.041. The corresponding SRMs ranged from 0.12 to 0.87, mean 0.39 and were mainly in the 'small to moderate' range using Cohen's criteria, supporting the MID results. The mean MID for the EQ-5D was 0.074 (range -0.011-0.140) and the SRMs ranged from -0.05 to 0.43, mean 0.24. The mean MID for the EQ-SD was almost double that of the mean MID for the SF-6D. There is evidence that the MID for these two utility measures are not equal and differ in absolute values. The EQ-5D scale has approximately twice the range of the SF-6D scale. Therefore, the estimates of the MID for each scale appear to be proportionally equivalent in the context of the range of utility scores for each scale. Further empirical work is required to see whether or not this holds true for other utility measures, patient groups and populations.
Article
To examine the efficacy of popular Chinese herbs used in a traditional Chinese medicine (TCM) combination of Ganoderma lucidum and San Miao San (SMS), with purported diverse health benefits including antioxidant properties in rheumatoid arthritis (RA). We randomly assigned 32 patients with active RA, despite disease-modifying antirheumatic drugs, to TCM and 33 to placebo in addition to their current medications for 24 weeks. The TCM group received G lucidum (4 gm) and SMS (2.4 gm) daily. The primary outcome was the number of patients achieving American College of Rheumatology (ACR) 20% response and secondary outcomes included changes in the ACR components, plasma levels, and ex vivo-induced cytokines and chemokines and oxidative stress markers. Eighty-nine percent completed the 24-week study. Fifteen percent in the TCM group compared with 9.1% in the placebo group achieved ACR20 (P > 0.05). Pain score and patient's global score improved significantly only in the TCM group. The percentage, absolute counts, and CD4+/CD8+/natural killer/B lymphocytes ratio were unchanged between groups. CD3, CD4, and CD8 lymphocyte counts and markers of inflammation including plasma interleukin-18 (IL-18), interferon-gamma (IFNgamma)-inducible protein 10, monocyte chemoattractant protein 1, monokine induced by IFNgamma, and RANTES were unchanged. However, in an ex vivo experiment, the percentage change of IL-18 was significantly lower in the TCM group. Thirteen patients reported 22 episodes (14 in placebo group and 8 in TCM group) of mild adverse effects. G lucidum and San Miao San may have analgesic effects for patients with active RA, and were generally safe and well tolerated. However, no significant antioxidant, antiinflammatory, or immunomodulating effects could be demonstrated.
El Ganoderma lucidum mejora la condició n física en mujeres con fibromialgia
  • D Collado Mateo
  • F Pazzi
  • Dominguez Munoz
  • Martin Martinez
  • J P Olivares
  • P R Gusi
  • N Adsuar
Collado Mateo D, Pazzi F, Dominguez Munoz FJ, Martin Martinez JP, Olivares PR, Gusi N, Adsuar JC: El Ganoderma lucidum mejora la condició n física en mujeres con fibromialgia. Nutricion Hospitalaria 32: 2126-2135, 2015.