Prathap Tharyan

Rapid tranquillisation in psychiatric emergency settings in Brazil: pragmatic randomised controlled trial of intramuscular haloperidol versus intramuscular haloperidol plus promethazine

Objective To compare the effect of intramuscular olanzapine with intramuscular haloperidol plus promethazine on rapid tranquillisation of agitated or violent people with mental illness. Design Pragmatic, allocation concealed, randomised controlled trial. Setting Emergency services of a general hospital psychiatry department in Vellore, south India. Participants 300 adults with agitated or violent behaviour as a result of mental illness; 150 randomised to intramuscular olanzapine and 150 randomised to intramuscular haloperidol plus promethazine. Interventions Open treatment with intramuscular olanzapine or intramuscular haloperidol plus promethazine. Main outcome measures Primary outcome was proportion of patients who were tranquil or asleep at 15 minutes and 240 minutes. Secondary outcomes were proportion of patients who were tranquil, asleep, restrained, absconding, or clinically improved at 15, 30, 60, 120, and 240 minutes; additional medical interventions and adverse effects over four hours; and compliance with oral drugs and adverse effects over two weeks. Results Of 300 people randomised to receive either intramuscular olanzapine or intramuscular haloperidol plus promethazine, follow-up data were available for primary outcomes for 298 (99%). Both treatments resulted in similar proportions of people being tranquil or asleep at 15 minutes (olanzapine 131/150 (87%), haloperidol plus promethazine 136/150 (91%); relative risk 0.96, 95% confidence interval 0.34 to 1.47) and 240 minutes (olanzapine 144/150 (96%), haloperidol plus promethazine 145/150 (97%); relative risk 0.99, 0.95 to 1.03). However, more people given olanzapine than those given haloperidol plus promethazine required additional drugs over four hours (65/150 (43%) v 31/150 (21%); relative risk 2.07, 1.43 to 2.97). Adverse effects were uncommon with both treatments. Conclusions Intramuscular olanzapine and intramuscular haloperidol plus promethazine were effective at rapidly tranquillising or sedating agitated or violent patients with mental illness but the combination resulted in fewer additional medical interventions within four hours of intervention. Trial registration Clinical trials NCT00455234.

Coping with the Asian tsunami: Perspectives from Tamil Nadu, India on the determinants of resilience in the face of adversity

The Asian tsunami of December 26, 2004 wreaked havoc along the southeastern coast of India and resulted in devastating losses. The high rates of long-term mental health consequences in adult survivors predicted immediately after the disaster have not been borne out by recent surveys. This qualitative study explored the psychological impact of the tsunami on survivors with a view to gaining insights into the ethno-cultural coping mechanisms of affected communities and evaluating resilience in the face of incomprehensible adversity. We conducted focus group discussions 9 months after the tsunami with two groups of fishermen, two groups of housewives, a group of village leaders and a group of young men in four affected villages of Nagapattinam district in Tamil Nadu, India. In spite of incomplete reconstruction of their lives, participants reconstructed meaning for the causes and the aftermath of the disaster in their cultural idiom. Qualitative changes in their social structure, processes and attitudes towards different aspects of life were revealed. Survivors valued their unique individual, social and spiritual coping strategies more than formal mental health services. Their stories confirm the assertion that the collective response to massive trauma need not necessarily result in social collapse but also includes positive effects. The results of this study suggest that interventions after disaster should be grounded in ethno-cultural beliefs and practices and should be aimed at strengthening prevailing community coping strategies.

National and multinational prospective trial registers

Clinical trials are an essential source of scientifi c evidence on the safety and eff ectiveness of health interventions. Prospectively registering information about a trial before enrolling participants, tracking changes to that information via a publicly accessible audit trail, and reporting results on completion of the trial helps protect against reporting biases and over-optimistic conclusions about treatment benefi ts. Open-access registries should decrease wasteful duplication of research, promote more effi cient allocation of research funds, and ensure trial information is disseminated and incorporated into the appropriate body of evidence for clinical, funding, and ethical decision-making. The increased commitment to prospective trial registration and the establishment of trial registers has the potential to increase the number of duplicate registrations (panel). It has been argued that if duplicate trial registration is left unchecked, the integrity of trial registries may be compromised, which would falsely over-infl ate the number of trials and confuse users. Limiting the number of registries has been proposed as a possible mechanism to prevent duplicate trial registration. Despite these concerns, there are several compelling reasons why both national and multinational registers are important. National registers are ideally placed to promote, identify, and track clinical trials in a specifi c country. Such registers can fully integrate into local ethics and regulatory processes, which thus ensures complete and comprehensive registration of all trials in their region of infl uence. Such decentralised trial registration is essential to achieve a comprehensive global register of all clinical trials. A philosophical reason underpinning the need for national registers is that most national registers have been developed within specifi c political frameworks and policy makers value them as a source of national pride. It may therefore not be politically expedient to dismiss these registers or undermine their legitimacy. Multinational registers can be especially important in resource-poor settings where individual countries do not have the necessary resources to establish national registers. Such registers serve the needs of several neighbouring countries, usually with similar disease burdens. By sharing technical and operational resources, costs to individual countries can be reduced and promotion of registration can be streamlined across countries (eg, by working with established regulatory or inter-government organ isations, such as WHO/AFRO in Africa or the Pan American Health Organisation in Latin America). There is an urgent need, particularly in resource-poor countries, to improve the ability of researchers to do high-quality clinical trials. National and multi national registers are able to identify and meet the needs of these researchers, by ensuring that information on various aspects of study design is collected and checked on registration. At an operational level, national and multinational registers can customise the registration process to suit the needs of their particular users (eg, displaying information in the local language). It is essential that WHO’s International Clinical Trial Registry Platform continues to work closely with governments and multinational bodies that have the necessary

Non-specialist health worker interventions for mental health care in low- and middle- income countries

This is the protocol for a review and there is no abstract. The objectives are as follows: OVERALL OBJECTIVE In order to assess the impact of delivery by non-specialist health workers (NSHWs) and other professionals with health roles (OPHRs) on the effectiveness of mental healthcare interventions in low- and middle- income countries (LMICs), we will specifically analyse the effectiveness of NSHWs and OPHRS in delivering acute mental health interventions; as well as the effectiveness of NSHWs and OPHRs in delivering long term follow-up and rehabilitation for people with mental disorders; and the effect of the detection of mental disorders by NSHWs and OPHRs on patient and health delivery outcomes. For each of these objectives we will examine the current evidence for the impact of delivery by NSHWs and OPHRs on the resource use and costs associated with mental healthcare provision in LMICs.

The Dilemma of Unmodified Electroconvulsive Therapy: (Commentary)

Chittaranjan Andrade, M.D.; Nilesh Shah, D.P.M., M.D., D.N.B.; and Prathap Tharyan, M.D., M.R.C.Psych. “It’s a small, small world.” Although it has been many years since I first heard that Disney staple, never before has it been as true as in the current era of rapid transportation and instant communication. On a lecture tour last year to India with Max Fink, M.D., I became aware of an Indian Supreme Court case involving electroconvulsive therapy (ECT). Unequaled in efficacy for the treatment of severe and psychotic depression, catatonia, and other psychotic disorders, ECT remains mired in controversy throughout the world. The following commentary by Dr. Chittaranjan Andrade and coauthors is thoughtful and illuminating. East meets West. —A.J.G.

Effects of stimulus intensity on the efficacy and safety of twice-weekly, bilateral electroconvulsive therapy (ECT) combined with antipsychotics in acute mania: a randomised controlled trial

OBJECTIVES To examine differences in speed of improvement and remission in people with mania undergoing bilateral, brief-pulse, twice-weekly electroconvulsive therapy (ECT) at stimulus intensities administered just above and 2.5 times their individually titrated seizure threshold. METHODS Consecutive, eligible subjects with mania, prescribed ECT, were randomised to receive treatments at stimulus doses either just above or 2.5 times their individually titrated seizure thresholds. Main outcomes were the speed of improvement and remission as measured by the Young Mania Rating Scale (YMRS) and the Clinical Global Impressions-Improvement scale (CGI-I) and cognitive side effects assessed by the Mini-Mental State Exam, the Wechsler Memory Scale, and a scale for autobiographical memory. RESULTS A total of 24/26 subjects (92.3%) given threshold ECT and 22/24 subjects (91.7%) given suprathreshold ECT were significantly improved [CGI = 2; odds ratio (OR) = 1.1, 95% confidence interval (CI): 0.1-8.4; p = 1.0] at the end of ECT. A total of 88% of the sample had remitted [YMRS < 10; threshold 23/26 (88.5%) versus suprathreshold 21/24 (87.5%)], with no significant differences between interventions (OR = 1.1, 95% CI: 0.2- 6.0; p = 1.0). The interventions did not differ significantly in the time or number of ECT treatments required for improvement or remission. Both interventions were equally safe. CONCLUSIONS Bilateral, twice-weekly ECT delivered at stimulus intensities just above individually titrated seizure threshold was as effective and safe as ECT administered at stimulus intensities 2.5 times seizure threshold in rapidly resolving the symptoms of acute mania.

Atypical anti‐psychotics in Delusional Parasitosis: a retrospective case series of 20 patients

Background  Delusional Parasitosis (DP) is a relatively uncommon condition wherein there is a fixed belief that one is infested with living organisms despite a lack of medical evidence of such infestation. Pimozide has been mooted as specific for the treatment of this condition. Atypical anti‐psychotics have received attention in recent years.

Prevalence of HIV infection in psychiatric patients attending a general hospital in Tamil Nadu, South India

An anonymous, unlinked study was conducted to detect antibodies to HIV-1 or HIV-2 infections in 1,160 consecutive, newly registered, adult psychiatric outpatients at a general hospital in South India to determine whether psychiatric patients presenting to general hospitals are a population at high risk for HIV infection and should be routinely screened. The seroprevalence of HIV infection (12/1160; 1.03%; 95% CI=0.4-1.6%) did not approximate rates expected of a high-risk group compared to the national (0.7%) or regional community (1.8%) prevalence. It did not differ significantly from HIV seroprevalence in non-psychiatric patients (233/35450; 0.7%; 95% CI=0.57-0.74%) who were systematically screened (relative risk=1.57; 95% CI=0.88-2.80) during the same period, but was greater than the seroprevalence in healthy blood donors (0.5%; p=0.02; relative risk=2.15 95% CI=1.17-3.95). Non-psychiatric patients were also more likely to be HIV infected than blood donors (p=0.02; relative risk=1.37; 95% CI=1.05-1.78). These findings have implications for HIV testing policies among psychiatric and non-psychiatric patients presenting to general hospitals in India.

Bibliometric and content analysis of the Cochrane Complementary Medicine Field specialized register of controlled trials

BackgroundThe identification of eligible controlled trials for systematic reviews of complementary and alternative medicine (CAM) interventions can be difficult. To increase access to these difficult to locate trials, the Cochrane Collaboration Complementary Medicine Field (CAM Field) has established a specialized register of citations of CAM controlled trials. The objective of this study is to describe the sources and characteristics of citations included in the CAM Field specialized register.MethodsBetween 2006 and 2011, regular searches for citations of CAM trials in MEDLINE and the Cochrane Central Register of Controlled Trials (CENTRAL) were supplemented with contributions of controlled trial citations from international collaborators. The specialized register was ‘frozen’ for analysis in 2011, and frequencies were calculated for publication date, language, journal, presence in MEDLINE, type of intervention, and type of medical condition.ResultsThe CAM Field specialized register increased in size from under 5,000 controlled trial citations in 2006 to 44,840 citations in 2011. Most citations (60%) were from 2000 or later, and the majority (71%) were reported in English; the next most common language was Chinese (23%). The journals with the greatest number of citations were CAM journals published in Chinese and non-CAM nutrition journals published in English. More than one-third of register citations (36%) were not indexed in MEDLINE. The most common CAM intervention type in the register was non-vitamin, non-mineral dietary supplements (e.g., glucosamine, fish oil) (34%), followed by Chinese herbal medicines (e.g., Astragalus membranaceus, Schisandra chinensis) (27%).ConclusionsThe availability of the CAM Field specialized register presents both opportunities and challenges for CAM systematic reviewers. While the register provides access to thousands of difficult to locate trial citations, many of these trials are of low quality and may overestimate treatment effects. When including these trials in systematic reviews, adequate analysis of their risk of bias is of utmost importance.

Prospective registration of clinical trials in India: strategies, achievements & challenges.

Objective This paper traces the development of the Clinical Trial Registry‐India (CTRI) against the backdrop of the inequities in healthcare and the limitations in the design, conduct, regulation, oversight and reporting of clinical trials in India. It describes the scope and goals of the CTRI, the data elements it seeks and the process of registering clinical trials. It reports progress in trial registration in India and discusses the challenges in ensuring that healthcare decisions are informed by all the evidence.