A number of medicinal plants are traditionally endowed with anxiolytic or sedative properties and, in the context of this revue, both indications are considered since the former may induce a mood conducive to the latter. For any sleep-inducing drug to be effective, a tranquil ambience needs to be established a priori. Thus, physical ailments (i.e. pain), factors interfering with sleep (i.e. noise), psychological conditions causing stress, psychiatric illnesses (i.e. depression) and other drugs that interfere with sleep (i.e. caffeine) need to be controlled, if possible. Kava-kava is a well-established hypnotic drug, with a rapid onset of effect, adequate duration of action and minimal morning after-effects. However, reports of serious hepatotoxicity with this preparation have led to it being banned in most countries worldwide. On the other hand, side-effects with valerian would appear to be bland indeed. However, it's slow onset of effect (2-3 weeks) renders it unsuitable for short-term use (i.e. 'jet-lag'), but it does have profound beneficial effects on sleep architecture (augments deep sleep) that may make it particularly suitable for long-term use and for the elderly. In a personal trial (not double-blind) in stress-induced insomnia, both kava and valerian improved sleep and the ill-effects of stress, and the combination of the two was even more effective for the control of insomnia. Aromatherapy (lavender, chamomile, Ylang-Ylang) would appear to improve sleep, but how practical a form of treatment this may be remains to be determined. The only other plant drug that may have some effect on sleep is melissa, but reports are too scanty to form any opinion about this. Based on animal experiments, passion flower (passiflora) may have a sedative action, but the sedative action of hops has not been investigated in any detail. In conclusion, there is a need for longer-term controlled studies with some of these compounds (particularly valerian). Aromatherapy constitutes a tantalising possibility. In the interpretation of this review, it should be borne in mind that the evidence on which it is based is often incomplete or missing, but that is all that is available. Consequently some conjecture on the part of the author is inevitable and should be appreciated as such.
Up to now, the antidepressant efficacy of the extract of St. John's wort, LI 160, has been compared to imipramine and maprotiline, demonstrating similar antidepressant efficacy in mildly to moderately depressed patients, treated either with LI 160 or the respective synthetic comparator. In the study reported here, LI 160 (total daily dose: 900 mg) was compared with the sedating tricyclic amitriptyline (total daily dose: 75 mg) in a controlled, randomized, multicentre trial. At the end of the 6-week study, the major target variable, the Hamilton Depression Scale response rate, exhibited no statistically significant difference between the groups, although a tendency for a better response rate was seen in the amitriptyline group. The secondary efficacy parameters, decreases in the total Hamilton Depression and Montgomery-Asberg scores, showed a significant advantage for amitriptyline, but only at week 6. With regard to tolerability, LI 160 was clearly superior to amitriptyline, particularly in relation to anticholinergic and Central Nervous System adverse events. Thus, 37% of the LI 160 treated patients reported adverse events, compared to 64% in the amitriptyline group. This considerable superiority in tolerability for LI 160 in relation to amitriptyline, could confer an advantage in improving compliance for antidepressant pharmacotherapy.
ObjectiveTo estimate the rate of combination antiretroviral treatment change and factors associated with combination antiretroviral treatment change among patients recruited in the Australian HIV Observational Database (AHOD). MethodsAnalyses were based on patients in the AHOD who had commenced combination antiretroviral treatment after 1 January 1997. Combination antiretroviral treatment change was de®ned as the addition or change of at least one antiretroviral drug. A random-effect Poisson regression model was used to assess factors associated with increased rates of combination antiretroviral treatment change. ResultsA total of 596 patients in the AHOD were included in the analysis, with a median follow-up of 2.3 years. The overall rate of antiretroviral treatment change in this group was 0.45 combinations per year. In a multivariate analysis, a low CD4 count (, 200 cells/mL) at baseline was associated with an increased rate of treatment change [rate ratio (RR) 1.43; 95% con®dence interval (CI), 1.13, 1.80; P 0.003)]. Combinations including a nonnucleoside reverse transcriptase inhibitor were also associated with slower rates of change than treatment combinations including a protease inhibitor (RR 0.64, 95% CI, 0.51, 0.80, P , 0.001). ConclusionInitiating combination antiretroviral at a CD4 cell count , 200 cells/mL may be associated with poorer patient outcomes. However, the possibility that clinician or patient concerns about low immunological status led to faster rates of treatment change in this group cannot be discounted.
Kava and valerian are herbal remedies, claimed to have anxiolytic and sedative properties respectively, without dependence potential or any appreciable side-effects. In this pilot study, 24 patients suffering from stress-induced insomnia were treated for 6 weeks with kava 120 mg daily. This was followed by 2 weeks off treatment and then, 5 having dropped out, 19 received valerian 600 mg daily for another 6 weeks. Stress was measured in three areas: social, personal and life-events; insomnia in three areas also: time to fall asleep, hours slept and waking mood. Total stress severity was significantly relieved by both compounds (p < 0.01) with no significant differences between them; as was also insomnia (p < 0.01). The proportion of patients with no side-effects was 58% with each drug respectively and the 'commonest' effect was vivid dreams with valerian (16%), followed by dizziness with kava (12% ). These compounds may be useful in the treatment of stress and insomnia but further studies are required to determine their relative roles for such indications.
A triple-blind (investigator, patient, statistician), randomized, placebo-controlled, trial of Ginkgo biloba 240 mg daily was carried out. Following a 1-week control, it was given to 24 patients with sexual impairment due to antidepressant drugs. Efficacy analysis was carried out on eight males and five females on placebo and six males and five females on Ginkgo, completing the full 12 weeks of treatment. Not included were three subjects who dropped out after 6 weeks. A validated, sex (gender)-orientated questionnaire was recorded at - 1, 0, 1, 3, 6, 9 and 12 weeks, and a non-blind follow-up for a further 6-weeks on Ginkgo. Hamilton anxiety and depression ratings were made at 0, 6 and 12 weeks and simple global assessments of alertness and memory. There were some spectacular individual responses in both groups, but no statistically significant differences, and no differences in side-effects.
Kava and valerian are herbal remedies that are claimed to have anxiolytic and sedative properties respectively, without dependence potential or any appreciable side effects. In this pilot study, 24 patients suffering from stress-induced insomnia were treated for 6 weeks with kava (LI-150), 120 mg daily. This was followed by a 2-week 'wash-out' period off treatment, and then, five patients having dropped out, 19 received valerian (LI-156), 600 mg daily, for another 6 weeks. Then there was a further 2-week period off treatment, and a final 6 weeks of treatment of these 19 patients with the two compounds combined (kava + valerian). Stress was measured in three areas: social, personal and life events; insomnia in three areas also: time to fall asleep, hours slept and waking mood. Total stress severity was significantly relieved by both compounds individually (p < 0.01), with no significant differences between them; and there was also improvement with the combination, significant in the case of insomnia (p < 0.05). On direct questioning, 16 patients (67%) reported no side effects on kava, 10 (53%) on valerian and 10 (53%) on the combination. The 'commonest' effect was vivid dreams with kava + valerian (4 cases (21%)) and with valerian alone (3 cases (16%)), followed by gastric discomfort and dizziness with kava (3 cases each (3 %)). These results are considered to be extremely promising but further studies may be required to determine the relative roles of the two compounds for such indications. Copyright 2001 John Wiley & Sons, Ltd.
Volunteers from the membership of the SAD Association took part in a postal survey, before and after eight weeks' treatment with Hypericum (Kira), using an 11-item rating scale. The maximum score is 44 and the mean score in 168 patients using Kira alone was 21.3. This fell to 13 at endpoint (p < 0.001). The corresponding figures for 133 patients using Kira + light therapy were 20.6 and 11.8, respectively (p < 0.001). In both groups, there was significant improvement in anxiety, loss of libido and insomnia. There were no significant between-group differences on any measure except that improvement in sleep was greater in the Kira + light group (p < 0.01). On the results of this survey, Hypericum would appear to be an effective treatment for SAD.
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