Rohini Handa

Osteoporosis in developing countries

Osteoporosis poses a huge challenge in developing countries due to demographic transition and aging of the population coupled with limited availability of resources. The exact disease burden is difficult to quantify because of the paucity of data. Ethnicity affects bone density as well as fracture risk. Population-specific normative data for bone density are lacking in large parts of the world. Vitamin D deficiency is common even in sunny countries. The WHO has developed an algorithm for estimation of 10-year fracture risk which may be used even in the absence of bone mineral density.

Dengue haemorrhagic fever in adults : a prospective study of 110 cases

One hundred and ten adult patients hospitalized with dengue haemorrhagic fever (DHF) during the recent outbreak in North India were prospectively studied. Of these, 48 (43.6%) were grade 1, 40 (36.4%) grade II, 10 (9.1%) grade III and 12 (10.9%) grade IV DHF. Dengue shock syndrome (DSS) was seen in 22 (20%) patients. Fever, headache, myalgias and arthralgias were the common symptoms seen in 100%, 80.9%, 76.2% and 52.3% patients, respectively. Spontaneous bleeding was seen in 62 patients (56.4%) with mucocutaneous bleeding being the most common (46 patients). Gastrointestinal bleeding was seen in 38 (34.5%) patients. In as many as 40 patients, the haemorrhagic manifestations occurred after the fever had come down. Fifty-five patients (50%) required platelet transfusions. Twelve patients died, giving a mortality rate of 10.9% in the present study. Prompt recognition and supportive treatment can be lifesaving.

Ayurvedic medicine offers a good alternative to glucosamine and celecoxib in the treatment of symptomatic knee osteoarthritis: a randomized, double-blind, controlled equivalence drug trial

OBJECTIVE To demonstrate clinical equivalence between two standardized Ayurveda (India) formulations (SGCG and SGC), glucosamine and celecoxib (NSAID). METHODS Ayurvedic formulations (extracts of Tinospora cordifolia, Zingiber officinale, Emblica officinalis, Boswellia serrata), glucosamine sulphate (2 g daily) and celecoxib (200 mg daily) were evaluated in a randomized, double-blind, parallel-efficacy, four-arm, multicentre equivalence drug trial of 24 weeks duration. A total of 440 eligible patients suffering from symptomatic knee OA were enrolled and monitored as per protocol. Primary efficacy variables were active body weight-bearing pain (visual analogue scale) and modified WOMAC pain and functional difficulty Likert score (for knee and hip); the corresponding a priori equivalence ranges were ±1.5 cm, ±2.5 and ±8.5. RESULTS Differences between the intervention arms for mean changes in primary efficacy variables were within the equivalence range by intent-to-treat and per protocol analysis. Twenty-six patients showed asymptomatic increased serum glutamic pyruvic transaminase (SGPT) with otherwise normal liver function; seven patients (Ayurvedic intervention) were withdrawn and SGPT normalized after stopping the drug. Other adverse events were mild and did not differ by intervention. Overall, 28% of patients withdrew from the study. CONCLUSION In this 6-month controlled study of knee OA, Ayurvedic formulations (especially SGCG) significantly reduced knee pain and improved knee function and were equivalent to glucosamine and celecoxib. The unexpected SGPT rise requires further safety assessment. TRIAL REGISTRATION Clinical Drug Trial Registry-India, www.ctri.nic.in, CTRI/2008/091/000063.

Quality of Life in Indian Patients with Rheumatoid Arthritis

Purpose of Study: Rheumatoid arthritis (RA) is a multisystem disease with various extra-articular manifestations (EAMs). Health-related quality of life (HRQOL) issues are assuming increasing importance in chronic rheumatic diseases like RA. No data on QOL in RA is available from the Indian subcontinent. There is also a paucity of literature on the impact of EAMs on HRQOL in RA. The objective of this study was to address these lacunae. Methods: The study group comprised 81 patients with RA from a rheumatology clinic in India. Quality of life was estimated by the generic HRQOL measure: World Health Organization quality of life instrument (WHOQOL-Bref). Disease activity in RA was measured by calculating Disease Activity Score-28 (DAS28). Results: The mean HRQOL scores of the patients were 12.0±2.8, 13.2±2.7, 14.4±2.9 and 13.3±2.6 in the physical, psychological, social, and environmental domains of the WHOQOL-Bref respectively. Age, gender, disease duration, educational status, constitutional symptoms, rheumatoid factor positivity, erosions and deformities did not influence HRQOL. Disease activity had a negative influence on the physical and psychological domains. Patients with EAMs had significantly higher DAS28 scores compared to patients without EAMs. Even after adjustment for disease activity, patients with EAMs had lower HRQOL scores than patients without these features (statistically significant for physical domain). Conclusions: The physical domain of HRQOL is most affected in Indian patients with RA. Increasing disease activity and presence of EAMs worsens the quality of life.

Atherosclerosis in Asian Indians with systemic lupus erythematosus

Objectives: Atherosclerosis has emerged as an important late complication of systemic lupus erythematosus (SLE). Asian Indians, as an ethnic group, are known to be metabolically predisposed to development of early atherosclerosis. No data on this aspect of SLE are available from Asia. This study was undertaken to find the frequency of atherosclerosis in Indian lupus patients and the factors affecting such an occurrence. Methods: Carotid artery intimo‐medial thickness (IMT) and plaque were used as markers of atherosclerosis. High‐resolution B‐mode ultrasonography was used to compare carotid IMT and plaque in 50 patients with SLE and 50 age‐ and sex‐matched healthy controls. Results: Patients with lupus (age 31.6±10.05, median 30.5 years; disease duration 52.3±36.7, median 46 months) exhibited a significantly greater IMT than controls (0.417±0.07 vs. 0.362±00.07 mm; p = 0.003). Carotid plaques were seen in seven (14%) cases. None of the control population had plaques (p = 0.006). On bivariate analysis, the IMT was significantly affected by age, systolic blood pressure (SBP), disease duration and menopausal status. On multivariate analysis, the only factor significantly affecting IMT was SBP. The Systemic Lupus International Collaborating Clinics/American College of Rheumatology (SLICC/ACR) score was the sole factor found to significantly affect the occurrence of plaque. Conclusions: Asian Indian lupus patients in our study, despite being relatively young and with shorter disease duration, exhibited premature atherosclerosis in the form of significantly thicker intimo‐media and plaque. The factors found to affect accelerated atherosclerosis in our cohort were age, SBP, disease duration, postmenopausal status and the SLICC/ACR score.

Peripheral vascular disease in systemic lupus erythematosus.

With increasing longevity of lupus patients, peripheral vascular disease (PVD) has become an important cause of morbidity. With no systematic study of PVD in systemic lupus erythematosus (SLE), this study was undertaken to define the frequency and spectrum of PVD in SLE and factors affecting such an occurrence. All medium-sized peripheral arteries of bilateral upper and lower extremities were studied in 50 SLE patients using Doppler ultrasonography. PVD was defined clinically as one or more of intermittent claudication, absent/unequal pulses, gangrene or ischemic ulcers and sub-clinically as asymptomatic patients with Doppler abnormalities, with ≥50% reduction in diameter considered hemodynamically significant. Mean (SD) age of the patients was 31.6 (10.1) years. Forty-one percent were hypertensive. Dyslipidemia was found in 62%. Fifteen (30%) had Raynauds phenomenon. Fourteen (28%) patients had PVD, of whom three had positive markers for antiphospholipid antibody (aPL) and six were asymptomatic. Ischemic ulcers were seen in eight (16%), gangrene in three (6%), femoral artery plaques in two (4%), stenosis in four (8%) and intermittent claudication in none. Dyslipidemia was found to independently affect occurrence of PVD (OR = 5.37, [95% CI 1.05—27.5], P = 0.05). The causes of PVD overlap significantly and further studies are needed to ascertain the relative contribution of each. Lupus (2007) 16, 720—723.

Autonomic dysfunction in systemic lupus erythematosus.

The objectives were to study the frequency and pattern of autonomic dysfunction in systemic lupus erythematosus (SLE). Fifty-one patients of SLE and 30 age- and sex-matched healthy controls were studied prospectively using a standard battery of noninvasive tests. Autonomic symptoms were seen in 37% patients. On laboratory testing incipient dysfunction was seen in 9 (18%) cases and 1 (3%) control, while atypical involvement was seen in 11 (21%) cases and 6 (20%) controls. Autonomic dysfunction did not correlate with disease duration, lupus activity, disease damage, any particular organ involvement or the presence/absence of peripheral neuropathy. Autonomic neuropathy is not uncommon in lupus and may exist independent of peripheral neuropathy. There are no specific clinical predictors. The clinical significance of autonomic dysfunction detected by laboratory testing warrants longitudinal studies.

Fibromyalgia in Indian patients with SLE

One hundred and fifty-eight patients with SLE were prospectively studied at a tertiary referral centre in India to ascertain the prevalence and clinical profile of fibromyalgia (FM) in Indian patients with lupus. An attempt was made to determine whether socio-demographic factors or disease characteristics differ in SLE patients with and without FM. Only 13 patients (8.2%) in our cohort were found to have fibromyalgia. Their clinical profiles were similar to that reported in other series. Corticosteroid withdrawal or dose reduction was the probable precipitating factor in nearly one-third of our patients. Age, sex, marital status, educational level, disease duration, disease activity and the organ involvement in patients with SLE and FM were comparable to those in patients not having FM. Fibromyalgia appears to be distinctly uncommon in Indian patients with lupus. A strong family support system, the virtual lack of disability benefits and/or racial variations in pain threshold could be the likely factors responsible for the low prevalence of the disease observed in Indian patients with SLE.

A Randomized Controlled Exploratory Evaluation of Standardized Ayurvedic Formulations in Symptomatic Osteoarthritis Knees: A Government of India NMITLI Project

The multidisciplinary “New Millennium Indian Technology Leadership Initiative” Arthritis Project was undertaken to validate Ayurvedic medicines. Herbal formulations in popular use were selected by expert consensus and standardized using modern tools. Our clinical strategy evolved from simple exploratory evaluations to better powered statistically designed drug trials. The results of the first drug trial are presented here. Five oral formulations (coded A, B, C, D and E), with a common base of Zingiber officinale and Tinospora cordifolia with a maximum of four plant extracts, were evaluated; with placebo and glucosamine as controls. 245 patients suffering from symptomatic OA knees were randomized into seven arms (35 patients per arm) of a double blind, parallel efficacy, multicentric trial of sixteen weeks duration. The groups matched well at baseline. There were no differences for patient withdrawals (17.5%) or adverse events (AE) of mild nature. Intention-to-treat efficacy analysis, demonstrated no significant differences (P < .05) for pain (weight bearing) and WOMAC questionnaire (knee function); placebo response was high. Based on better pain relief, significant (P < .05) least analgesic consumption and improved knee status, “C” formulation was selected for further development. Controlled exploratory drug trials with multiple treatment arms may be used to economically evaluate several candidate standardized formulations.

Fever of unknown origin : a prospective study

Fever of unknown origin (FUO) is a problem frequently faced by clinicians all over the world. One hundred and twenty-one cases of FUO presenting to a large teaching hospital in northern India were prospectively studied over a period of 2 years. Infections were the commonest cause accounting for 43.8% cases of FUO, with tuberculosis (TB) being the commonest infection encountered. Collagen vascular diseases and tumours accounted for 15.7 and 8.3% cases, respectively. No cause could be found out in a substantial number of cases (19%) even after invasive investigations. Knowledge of the current patterns of FUO is important since many patients present with potentially treatable diseases.