Khan, Mohammed Taufiq; (1999) Phytochemical and Biological studies of Tagetes erecta and its clinical evaluation in the treatment of hallux abducto valgus and its associated condition, bunion. Doctoral thesis (Ph.D), UCL (University College London).

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Abstract

This study undertakes a botanical investigation, phytochemical analysis, biological tests and clinical evaluation of Tagetes erecta L in the treatment of unilateral hallux abducto valgus and its associated condition, bunion (HAV and ACB). Clinical observation over 25 years in hospitals, podiatric clinics and community health centres revealed a high incidence of HAV and ACB. Surgical intervention can cause a great deal of discomfort as well as postoperative complications. Investigation of medicinal plants for the treatment of podiatric disorders led to clinical pilot studies and two double blind placebo controlled trials. In the first trial over a period of eight weeks, T. erecta fresh leaf and petal preparations with protective pad were tested on thirty patients with hyperkeratotic plantar lesion (Khan, 1993). In the second trial, T. patula fresh leaf and petal preparations were tested over a period of eight weeks on sixty patients with unilateral and bilateral HAV and ACB (Khan, 1995). The results of this trial, which demonstrated total relief of pain and reduction of lesion, led to the present investigation of T. erecta. The clinical features, anatomy, multiple aetiology and pathology of HAV and ACB are described and the advantages and limitations of traditional treatment discussed. In the phytochemical study of T. erecta. leaf and petal (TeL+P) two flavonoids, kaempferitrin from the leaf and quercetagetrin from the petal, were isolated and identified by chromatographic techniques and spectral analysis. In the clinical study, the effect of TeL+P crude extract and fractions in different organic solvents with protective pad were tested in a single blind controlled trial over a period of 12 weeks. Ethical approval was obtained from the director of the research unit at the Royal London Homoeopathic Hospital NHS Trust (RLHH). Fortyfive volunteers meeting the inclusion and exclusion criteria were admitted to the study from a population awaiting podiatric treatment at the RLHH and systematically allocated to nine groups of five each. Test samples were prepared on the basis of the effective dose established in clinical pilot studies of TeL+P at 200mg/ml/dose/week for crude extract and 60mg/ml/dose/week for fractions. The results of the clinical study showed that ethanolic crude extract of TeL+P with protective pad was the most effective in reduction of swollen soft tissue density at a level of significance of p<0.0005. The ethyl acetate fraction of TeL+P with protective pad was shown to be the most effective in reduction of hallux valgus angle at a level of significance of p<0.005. Both crude extract and fraction resulted in total relief of pain. In biological tests, ethyl acetate fraction of TeL+P at 5μg/μl was shown to be non-toxic to human epidermal keratinocytes and at 20μg/ μ1 to have a greater inhibitory effect on human blood platelet aggregations than ethanolic crude extract. The results of the clinical study and biological tests show a close correlation in terms of the safety and efficacy of T. erecta in the treatment of HAV and ACB and indicate the need for further investigation using a larger number of patients over a longer period of time. They also indicate the potential therapeutic benefit to be derived from T. erecta in the treatment of other painful, inflammatory disorders and provide evidence of the value of further investigation of the genus Tagetes which has so far received little clinical attention.

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