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    Clinical Trial Results:
    Pilot Study of Homeopathic Treatment of Fibromyalgia Syndrome (HOFS)

    Summary
    EudraCT number
    		 2005-004511-29
    Trial protocol
    		 GB  
    Global end of trial date
    07 Jul 2007

    Results information
    Results version number
    		 v1(current)
    This version publication date
    08 Oct 2021
    First version publication date
    08 Oct 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    resgov/8nov05/01
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Barnsley Hospital NHS Foundation Trust
    Sponsor organisation address
    Research and Development, Block 14, Barnsley Hospital, Gawber Road, Barnsley, United Kingdom, S75 2EP
    Public contact
    Barnsley Hospital NHS Foundation Trust, Barnsley Hospital NHS Foundation Trust, barnsley.research@nhs.net
    Scientific contact
    Barnsley Hospital NHS Foundation Trust, Barnsley Hospital NHS Foundation Trust, barnsley.research@nhs.net
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    30 Apr 2009
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    07 Jul 2007
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the comparative effectiveness of a homeopathy intervention relative to usual care
    Protection of trial subjects
    No specific measures were put in place
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Jan 2006
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 47
    Worldwide total number of subjects
    47
    EEA total number of subjects
    47
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    47
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Diagnosis of FMS (ACR criteria)

    Period 1
    Period 1 title
    Overall Trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Usual Care
    Arm description
    		 -
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Usual care plus adjunctive care by a homeopath
    Arm description
    		 -
    Arm type
    		 Intervention

    Investigational medicinal product name
    individually tailored homeopathic medicines
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    The homeopath care group received usual care plus an initial one hour in depth interview followed by up to four 30 min in depth interviews (4–6 weeks apart) with individually tailored homeopathic medicines prescribed at each interview.

    Number of subjects in period 1
    		Usual Care Usual care plus adjunctive care by a homeopath
    Started
    24
    23
    Completed
    16
    20
    Not completed
    8
    3
         Consent withdrawn by subject
    -
    2
         Emigrated
    -
    1
         Lost to follow-up
    8
    -

    Baseline characteristics

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    End points

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    End points reporting groups
    Reporting group title
    Usual Care
    Reporting group description
    		 -

    Reporting group title
    Usual care plus adjunctive care by a homeopath
    Reporting group description
    		 -

    Primary: Difference in the Fibromyalgia Impact Questionnaire (FIQ) total scores

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    End point title
    		 Difference in the Fibromyalgia Impact Questionnaire (FIQ) total scores
    End point description
    End point type
    Primary
    End point timeframe
    22 weeks
    End point values
    		 Usual Care Usual care plus adjunctive care by a homeopath
    Number of subjects analysed
    16
    20
    Units: Fibromyalgia Impact Questionnaire (FIQ)
        number (not applicable)
    16
    20
    Statistical analysis title
    		 FIQ score
    Comparison groups
    Usual Care v Usual care plus adjunctive care by a homeopath
    Number of subjects included in analysis
    36
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.82
    Method
    		 Mixed models analysis
    Confidence interval

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    24 hours for SAEs
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    12
    Frequency threshold for reporting non-serious adverse events: 5%
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: There were no reported adverse events

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/19358959
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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