The Efficacy of Lacticum Acidum Homaccord in the Treatment of Chronic Tension-type Headaches
Condition: Chronic Tension-type Headaches
MeSH terms: Tension-Type Headache; Headache
Study type: Interventional
Phase: Phase 2

Summary: 
      Chronic tension-type headaches (CTTHs) affect 30-40% of the population and account for a
      number of absences from, and decreased performances at, work and school as well as
      recreational activities. CTTHs typically occur at least 15 times a month or at least every
      second day, and present as an achy or tight sensation that is felt around the head . The pain
      may last from 30 minutes to several days and varies in intensity . Conventional treatment is
      palliative, consisting of analgesics and non-steroidal anti-inflammatory drugs (NSAIDs),
      which may produce adverse effects and analgesic rebound headaches . Lacticum acidum 30CH is a
      homoeopathic remedy that has been shown to have potential benefits in the treatment of CTTHs
      . Homaccords are the preparation of one remedy in multiple increasing potencies in a single
      vehicle . There has been no research done to date on Lacticum acidum Homaccord in the
      treatment of CTTHs.The aim of this study is to determine the efficacy of Lacticum acidum
      Homaccord in the treatment of chronic tension-type headaches, using the modified Headache
      Diary and the Headache Disability Inventory.
    

Detailed description: 
      The study will be a four-week, double-blind, placebo-controlled study which will take place
      at the Homoeopathic Health Centre at the University of Johannesburg (UJ) Doornfontein campus.
      A randomized sample of 30 male and female participants between the ages of 18 and 45 years
      who suffer from CTTHs will be recruited. This will be done by means of purposive sampling via
      advertisements placed on the UJ campuses, with relevant permission given . At the initial
      consultation (day 0), prospective participants will be requested to sign the Participant
      Information and Consent Form . They will then complete the Screening Questionnaire to assess
      their eligibility for participating in the study. Those participants who meet the diagnostic
      criteria for CTTHs, and whose symptoms match at least eight out of the twelve Lacticum acidum
      headache related symptoms, will be eligible to participate. All participants will also be
      requested to complete a Headache Disability Inventory. Participants will be placed into
      matched pairs according to age and gender and will receive one 30 mL bottle of their
      medication. On days 1-28 each participant will be requested to complete the Headache Diary at
      the end of each day and to take 5 pillules of the medication in the morning and in the
      evening. The first follow-up visit will occur on day 14; here participants will complete the
      Headache Disability Inventory, the completed headache diaries will be exchanged with new
      ones, a relevant physical examination including vital signs will be conducted and an
      additional bottle of medication will be given. The final follow-up visit will occur on day
      28, where each participant will complete the Headache Disability Inventory, and a relevant
      physical examination including vital signs will be recorded.

      Collected data will be evaluated using frequencies, descriptive tests and cross tabulation,
      the Shapiro Wilk test, the Independent samples t-test or Mann-Whitney test, and the Friedman
      and Wilcoxon signed ranks tests. A possible outcome is that Lacticum acidum may have an
      ameliorating effect on CTTHs and may provide a possible alternative treatment option for this
      condition, opening up the field for further research.
    

Intervention name(s): Lacticum acidum homaccord; Placebo
Intervention type(s): Other; Other
Intervention description(s): Homeopathic remedy, made using sucrose pillules; Unmedicated sucrose pillules
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Lacticum acidum homaccord; homeopathy; chronic tension-type headaches