Safety and cost-effectiveness of Ganoderma lucidum (Reishi mushroom) compared to Ceratonia siliqua in patients with Fibromyalgia: a double-blind, randomised, pilot trial.

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12614001201662
• Date of registration: 14/11/2014
• Prospective Registration: No
• Primary sponsor: Francesco Pazzi
• Public title: Safety and cost-effectiveness of Ganoderma lucidum (Reishi mushroom) compared to Ceratonia siliqua in patients with Fibromyalgia: a double-blind, randomised, pilot trial.
• Scientific title: Safety and cost-effectiveness of Ganoderma lucidum (Reishi mushroom) compared to Ceratonia siliqua in patients with Fibromyalgia: a double-blind, randomised, pilot trial.
• Date of first enrolment: 28/10/2014
• Target sample size: 66
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12614001201662.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Safety/efficacy;
• Phase: Not Applicable

Countries of recruitment

Spain

Contacts

• Name: A/Prof Jose Carmelo Adsuar

• Name: Mr Francesco Pazzi

Key inclusion & exclusion criteria

Inclusion criteria: 1. Be diagnosed with fibromyalgia;
2. Be able to communicate effectively with study staff;
3. Be aged more than 18 years;
4. Give written informed consent.
Exclusion criteria: 1. Be pregnant;
2. Change the daily life habits during the six weeks of treatment;
3. Take immunosuppressive;
4. Suffer diabetes;
5. Participating in other studies;
6. Take C vitamin supplementation;
7. Take anticoagulants;
Patients may abandon the trial if some circumstances happen: they withdraw informed consent, the researcher or their general practitioner feel that they should withdraw from the study for reasons of safety and the patient does not comply with the treatment for more than 80% of the dose.

Age minimum: 18 Years
Age maximum: No limit
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Neurological - Other neurological disorders

Fibromyalgia;
Fibromyalgia

Musculoskeletal - Other muscular and skeletal disorders

Alternative and Complementary Medicine - Herbal remedies

Intervention(s)

The sample will be divided in two groups by one author that does not participate directly neither in the assessment nor in statistic analyses. The groups will be two: the Ganoderma lucidum (GL) group and the Ceratonia siliqua (CS) group. Patients will know that there are two groups and they can be in any of them, but they will not know the group they belong. Given that, the current trial is a double-blind study, neither the patient nor the researcher will know the group the patient has been assigned.

The GL group will take the micromilled GL. The dose will consist on 6g daily for six weeks. The intakes will consist of 3 grams of GL for two times a day, one intake during or immediately after breakfast and one during or immediately after dinner. The administration will be dissolved in warm water and orally ingested. The GL will be provided by the company “MundoReishi” and will be analyzed by the Chair of Mycology of the University of Valladolid, Spain.

The CS group will receive a daily dose of CS flour, which consist on 6g of powder coming from Carob tree (CS). This substance looks very similar to the micromilled GL. The administration will be exactly the same than the other group.

Primary Outcome(s)

Health-related quality of life (HRQoL) through four different questionnaires:
a) 15D: It is a generic instrument for measuring HRQoL among adults. It comprises 15 dimensions: mobility, vision, hearing, breathing, sleeping, eating, speech, elimination, usual activities, mental function, discomfort and symptoms, depression, distress, vitality, and sexual activity. The score can be represented as a single utility score, which ranges from 0 (death) to 1 (full health). This score can be used to perform cost-effectiveness analysis.
b) SF-12v2: It is a generic instrument for assessing HRQoL covering physical and mental aspects of health. It is an abbreviated version of the SF-36, which consist in 12 items. It comprises 6 dimensions: physical functioning, role limitations, social functioning, pain, mental health, and vitality. A single utility score, specific of the Spanish population, can be calculated for cost-effectiveness analysis from this questionnaire.
c) EQ-5D-5L: It is a generic utility-based instrument for assessing HRQoL. It comprises five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and five levels of severity in each dimension. The current health state of the patients (the health state felt the day of the evaluation) is assessed through a Visual Aanalogue Sscale (VAS) from 0 (worst imaginable health status) to 100 (best imaginable health status).
d)Health Utilities Index Mark 3 (HUI3): It is a generic utility-based instrument for assessing HRQoL. It comprises 8 dimensions.[Before the treatment, six weeks after the intervention started, and three weeks after the end of the intervention. ]

Pain:
Pain perception will be evaluated by a previous trained researcher. It will be measured through the digital palpation of the 18 specified tender points with a pressure of 4kg/cm2 made by an stimulator like Ten FDX (Wagner Instrument). Patients must also fill out a VAS twice a day, where they write the pain that they feel at this moment (when they wake up and when they go to bed).
[Before the treatment, six weeks after the intervention started, and three weeks after the end of the intervention. ]

Functional capacity:
It is a composite primary outcome. In order to perform a complete evaluation of the participants´ functional capacity, the battery from Exercise Looks After You (ELAY) study was selected and other tests from different batteries were added. As result, the following fitness outcomes will be measured:
- Upper body strength: Bi-handgrip strength will be measured by using a grip-strength dynamometer (TKK 5401 Model).
- Upper body flexibility: It will be assessed using the back scratch test.
- Lower body flexibility: It will be measured using the “Chair Sit-and-Reach”.
- Balance and agility: dynamic balance will be measured using the three meter version of the Timed Up-and-Go test (TUG).
- The 30-Second Chair Stand Test.
- Aerobic endurance: It will be measured by using the Six Minutes Walk Test.
- Upper body strength: It will be assessed using the “Arm Curl Test”.
- Velocity: The time needed to walk 10m is recorded in the modificated Brisk Walking Test as a measure of velocity.
- Balance: It will be measured using Biodex Balance System. This device measures, in degrees, the tilt about each axis during static and dynamic conditions and calculates a mediolateral stability index, an anteroposterior stability index, and an overall stability index.
- Trunk endurance: It will be assessed by using the method proposed by Ito, Shirado.[Before the treatment, six weeks after the intervention started, and three weeks after the end of the intervention. ]

Secondary Outcome(s)

Covariables:
- Sociodemographic variables: gender, age, education level, profession, income level, religiosity, postal code and familiar situation.
- Other diseases.
- Current treatment and therapies, years since diagnosis of FM and years since the first symptoms.
- Current pain “at today”.

All these variables will be assessed by direct interview.[Before the treatment]

Depression:
Depressive symptoms are frequent in Fibromyalgia patients. The Geriatric Depression Scale (GDS) has been used on Fibromyalgia research because it is less focus on somatic symptoms than other depression questionnaires and could therefore be a more accurate assessment of depressive symptoms in Fibromyalgia patients independently of their health complaints.
[Before the treatment, six weeks after the intervention started, and three weeks after the end of the intervention.]

Work absence:
Self-reported work absence will be assessed. A single question about the number of days that the participants did not go to work because of their FM symptoms in the last six weeks will be asked.
[Before the treatment, six weeks after the intervention started, and three weeks after the end of the intervention.]

Drug treatment costs:
A list of the drugs that they are taking will be asked to the participants. The treatment costs of each participant will be calculated in order to perform cost-effectiveness analysis. In addition, participants will be asked for another kind of therapies, such as physiotherapy, acupuncture, psychological therapy or massages.
[Before the treatment, six weeks after the intervention started, and three weeks after the end of the intervention.]

Visits to the health care system:
A list of the visits to hospitals, health care centers or any other place of the health care system will be asked in order to perform cost-effectiveness analysis.
[Before the treatment, six weeks after the intervention started, and three weeks after the end of the intervention.]

Falls and fear of falling:
Numbers of falls in the past year, six months and six weeks and visual analogic scale where 0 means "no fear to falling" and 10 means "extreme fear to falling"
[Before the treatment, six weeks after the intervention started, and three weeks after the end of the intervention.]

Happiness:
It will be assessed by using the General Happiness Scale and the Satisfaction with Life Scale (SWLS). In Spanish adults, the SWLS was validated by Vazquez, Duque.
[Before the treatment, six weeks after the intervention started, and three weeks after the end of the intervention.]

Primary outcome.

Impact of fibromyalgia:

Two questionnaires will be utilized to assess the impact of FM. The Fibromyalgia Impact Questionnaire (FIQ) is a 10-item, self-administered instrument that covers three domains: function, overall impact and symptoms. A consensus version for Spanish population was developed by Esteve-Vives, Rivera Redondo.

The FIQ was revised in 2009, originating a new questionnaire called Revised Fibromyalgia Impact Questionnaire (FIQ-R). It has the same three domains but differs in some points. The dimension “function” was reduced from 10 to 9 items and modified. The overall impact domain was completely revised to better reflect the overall impact on functional ability and on the perception of reduced function. Four additional items were added to the dimension “symptoms”: tenderness, memory, balance and environmental sensitivity. The validation of the Spanish version of FIQ-R was developed by Salgueiro, Garcia-Leiva.
[Before the treatment, six weeks after the intervention started, and three weeks after the end of the intervention.]

Sleep quality:
The Spanish version of the Pittsburgh Sleep Quality Index (PSQI) will be utilized to assess the sleep quality and the sleep disorders. Its reliability and validity for Spanish Fibromyalgic patients was developed by Hita-Contreras, Martinez-Lopez.
[Before the treatment, six weeks after the intervention started, and three weeks after the end of the intervention.]

Blood parameters: Blood pressure and blood lipids and glucose.

The systolic and diastolic blood pressure will be assessed by a professional nurse in the health care center. Blood main lipids and glucose will be assessed by direct blood analysis on the healthcare center before the treatment starts and six weeks after the treatment. Reagent strips will be used if the analyses cannot be done by the health care system.
[Before the treatment, six weeks after the intervention started, and three weeks after the end of the intervention.]

Body composition and anthropometric measures:
After measurement of the height, different variables of body composition will be evaluated by using a bioelectrical impedance analysis (Tanita BC-418) that allows segmental body analysis. This devices measure the weight, body mass index, fat mass, muscle mass, total body water and free fat mass. The waist-to-hip ratio will be assessed too.
[Before the treatment, six weeks after the intervention started, and three weeks after the end of the intervention.]

Healthy habits:
The healthy habits questionnaire will be used to assess the healthy habits of the participants. This instrument comprises several dimensions. Due to the aims of the current study, only the dimensions “life habits” and “physical exercise” will be considered.
[Before the treatment, six weeks after the intervention started, and three weeks after the end of the intervention.]

Secondary ID(s)

None

Source(s) of Monetary Support

MundoReishi will provide the reishi free of charge.

Fitness and Quality of Life Lab. (AFYCAV) Faculty of Sport Sciences University of Extremadura

Ethics review

Status: Approved
Approval date:
Contact:

Comision de Bioetica y de Bioseguridad de la Universidad de Extremadura