Much attention has been directed to the quality of life in stressful societies, communities in which the social pressures, especially in cities, are markedly increased by the accelerated rate of human activities such as advanced high technology processes in the factory or office, rapid transport in crowded areas or on congested high-speed motorways, strained or overpowering interpersonal business relationships in work, entertainment and sport and even family relationships. Unable to slow down or opt out sufferers turn to drug treatments to give a reasonable quality of life and to offset such strains, which are sometimes identified as functional fatigue.
Ginseng has been used as an agent to counter the subtle changes in health (fatigue, lack of energy, anxiety, restlessness, depression, etc.) and improve the quality of life of humans and several authors, using controlled clinical trials, have demonstrated the efficacy of standardised extracts of ginseng in combination with minerals (Tesch et al., 1987; Dorling and Kirchdorfer, 1989; Pieralisi et al., 1991). Such combination therapy has produced improved alertness, better physical activity and a feeling of well-being in both middle-aged persons and the elderly. Nevertheless there has been criticism of the methodology used in many natural product trials, particularly with respect to poorly documented methods, uncontrolled routines, unsatisfactory choice of participating individuals and the short duration of the trials.
The Swedish group of Wiklund et al. (1994) devised two self-administered questionnaires, the Psychological General Well-Being Index and the Sleep Dysfunction Scale, to assess the quality of life in 205 participants taking Gericomplex capsules (=Geriatric Pharmaton, Pharmaton S.A.), capsules containing 40 mg standardised Ginseng Extract G115 and added vitamins, minerals and trace elements, and 185 persons taking identical-looking placebo capsules. Participating volunteers in the test group were aged 43.6±8.4 years and in the placebo group 41.8±8.9 and all worked for a high-technology organisation. Participants took one capsule after breakfast and one after lunch under supervision and the trial lasted 12 weeks. Assessments under 15 headings measured for all participants before and after treatment indicated that the administration of the combined therapy to an apparently healthy population of working people produced significant advantages over placebo treatment in terms of self-assessed feelings of vitality, alertness, relaxation and appetite. Not surprisingly the beneficial results were more pronounced in those whose initial Quality of Life assessment was poorest.
A subsequent trial conducted by the London-based group of Ussher et al. (1995) involved 95 British middle managers in an eight week double-blind placebo controlled study. Results again shewed that dietary supplements including ginseng were most effective for those on a relatively poor diet and revealed the need for further studies on different age groups and on the contributions of ginseng extract on the one hand and vitamins and minerals on the other.
Older people with age-associated memory impairment but not medical or neurological disorders producing cognitive deterioration were tested for psychological well-being and perceived quality of life by the Italian team of Neri et al. (1995). Sixty persons (18 male and 42 female, mean age ca. 61 years (minimum 51, maximum 65 years)) were divided equally into drug-treated and placebo-treated groups. The trial commenced with a 15 day run-in period and then a double-blind treatment period of 9 months. Participants were given two capsules daily, one after breakfast and the other after lunch. The drug-treated group received Gegorvic Pharmaton=Geriatric Pharmaton capsules and the placebo-treated group identical capsules containing an innocuous substitute. Using rating scales indicating Life Satisfaction in the Elderly and Symptom Rating and the Randt Memory Test, data was gathered at the beginning of the run-in period, at the baseline commencement of treatment and then at the end of 3, 6 and 9 months. Statistical analysis revealed that only in the treated group were memory index scores positively and significantly correlated with the quality of life and psychological well-being, indicating the selective action of the ginseng containing drug combination.
Le Gal et al. (1996) developed a method for evaluating complaints reported by patients suffering from functional fatigue. Patients chose the five titles best describing their problems from a list of 20 prepared titles. After treatment with
Pharmaton capsules (standardised ginseng extract G115 formulated with 9 vitamins and 8 minerals) fatigue scores were calculated on the basis of the patients' assessments of their problems. Such scores were calculated at the start of the trial, after 3 weeks and after 6 weeks. In a multicentre, comparative, double blind clinical trial involving 232 patients (117 in the Pharmaton group and 115 in the placebo group) Pharmaton capsules were shewn to be effective in countering functional fatigue, shewing superiority over placebo treatment whilst being equally tolerable.
A retrospective cohort study by Lillo (1998) in Spain embracing the period 1980-1993 involved 1,800 mainly elderly subjects (age range 15-95 years) who, apart from 93 persons, were receiving medical treatment for pathological conditions with drugs such as cerebral vasodilators, cardiac vasodilators, antiarrhythmics, car-diotonics, antihypertensives and nootropics. In addition to their specific prescribed medication other than tonics or vitamins patients received daily Ginseng G115 capsules with added vitamins, minerals and trace elements. Careful monitoring of all patients in the out-patient clinic was maintained for periods of 3 to 21 months (average 10±3.3 months). Data collated included age, sex, life-style, height, body weight, nutrition state, appetite, duration of treatment, health condition and previous and actual pathology. Further data included clinical parameters such as blood pressure, heart rate, electrocardiogram, Karnofsky's index and mental state (SCAG, the Sandoz Clinical Assessment Scale in Geriatrics based on 17 items). At the end of the study the investigator assessed the overall effectiveness of the treatment and concluded that of the 1800 patients 1257 shewed very good response, 426 demonstrated a good response, 96 a moderate response and only 21 patients were considered to offer a poor response. In addition it was reported that just 17 patients reported moderate tolerance to the treatment but it was not necessary to suspend treatment. Improved appetite was reported by 1298 patients although there was minimal deviation in body weight.
Also published in 1998 was a controlled, randomised double-blind study in parallel groups involving 72 senile patients (mean age±standard deviation=67.5± 4.5 years) with compensated non-insulin dependent diabetes and mild cognitive disorders (Della Marchina and Renzi, 1998). After a 15-day run-in period during which all patients received placebo capsules, the participants were divided into two groups, one receiving placebo and the other standardised Ginseng G115 extract with added vitamins and minerals. All patients received one capsule twice daily for 9 months and were assessed with appropriate psychometric and biochemical tests at regular intervals. At the end of the treatment period the improvement of drug treated patients when compared with placebo treated subjects was significant in the areas of memory, Symptoms Rating Test, Randt Memory Test, Global Deterioration Test And Life Satisfaction in the Elderly Scale.
That ginseng is involved in the improvement in the quality of life is clear and this agrees with the ancient use of ginseng as a nutritive and restorative tonic strengthening the debilitated body and encouraging recovery from illness. Nevertheless experiments employing ginseng and vitamin supplements do not indicate the true effect of ginseng extract. Therefore a Mexican research team (Caso Marasco et al., 1996) compared treatment with Pharmaton capsules with added vitamins and trace minerals and treatment with identical capsules without the Ginseng G115 extract. The randomised, double-blind clinical study was completed by 501 patients in the age range of 18 to 65 years. Of these 338 were treated with the ginseng combination and 163 with the multivitamins alone. Patients made 4 monthly visits to participating physicians and data accumulated included physical measurements e.g. weight, blood pressure and heart rate, and questionnaire details concerning the quality of life under 11 headings and assessed on a 6-point scale. Although 625 persons enrolled for the trial, 124 (44 in the ginseng group and 80 in the multivitamins group) were excluded due to non-compliance or voluntary withdrawal. A few patients withdrew because of side effects. It was concluded that the superiority of the Pharmaton capsule treatment over the multivitamin treatment was due to the action of ginseng which produced a significantly improved quality of life. Multivitamin treatment caused an obvious increase in body weight but ginseng treatment had no such effect; this was probably due to the action of ginseng saponins on carbohydrate and lipid metabolism. In addition multivitamin treatment was accompanied by a rise in diastolic blood pressure, a phenomenon not observed with ginseng and suggesting the adaptogen property of ginseng against stress effects. One patient who was taking the ginseng capsules was proved to have the symptoms of brucellosis or undulant fever. The disappearance of the disease state without interference with the trial indicated a probable immunomodulatory function of ginseng. The value of ginseng therapy for high physical and mental stress states and for improvement of the quality of life was again clearly established.
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