Homeopathic treatment in addition to standard care in multi drug resistant pulmonary tuberculosis: a randomized, double blind, placebo controlled clinical trial.

BACKGROUND: Multi drug resistant-tuberculosis (MDR-TB) [resistant to Isoniazid and Rifampicin] is a major global public health problem. In India the incidence is rising in spite of implementation of Revised National Tuberculosis Control Program. Standard MDR-TB drugs are second generation antibiotics taken for 24-27 months. The present study was undertaken to evaluate the efficacy of add on homeopathic intervention to the standard MDR-TB regimen (SR). METHODS: A randomized, double blind, placebo controlled study was conducted from 2003 to 2008. 120 diagnosed MDR-TB patients (both culture positive and negative) were enrolled and randomized to receive Standard Regimen + individualized homeopathic medicine (SR + H) or Standard Regimen + identical placebo (SR + P). The medicines have been used in infrequent doses. The outcome measures were sputum conversion, changes in chest X-ray (CXR), hemoglobin, erythrocyte sedimentation rate (ESR), weight gain, and clinical improvement. RESULTS: There was an improvement in all the outcome measures as per intention to treat (ITT) and per protocol (PP) analyses. ITT analyses revealed sputum culture conversion from positive to negative in 23 (38.3%) in SR + H; 23 (38.3%) patients in SR + P group; (p = 0.269) and 27 (55.1); 21 (42.8%), p = 0.225 as PP analyses. The mean weight gain in SR + H group was 2.4 ± 4.9 and in SR + P was 0.8 ± 4.4; [p = 0.071], reduction in ESR in SR + H was -8.7 ± 13.2; SR + P was 3.9 ± 15.4 [p = 0.068]. The mean increase in hemoglobin was by 0.6 ± 1.7 in SR + H & 0.3 ± 2.3 [p = 0.440] in SR + P group at 95% confidence interval. Statistically significant improvement was seen in CXR in 37 (61.7%) in SR + H and 20 (33.3%) patients in SR + P group (p = 0.002). Subgroup analyses of culture positive patients showed statistically significant improvement in CXR (p = 0.0005), weight gain (p = 0.026), increase in hemoglobin (p = 0.017) and reduction in ESR (p = 0.025) with add on homeopathy. The cure rate was 11.4% more in SR + H group as compared to placebo group. Change in sputum culture conversion, was not statistically significant. CONCLUSION: Add on homeopathy in addition to standard therapy appears to improve outcome in MDR-TB. Larger scale studies using a standardized homeopathic treatment regime should be conducted.

Prallethrin poisoning: A diagnostic dilemma.

Pyrethroid insecticides are very widely used in agriculture and household due to their high effectiveness and low toxicity in humans. Despite their extensive worldwide use, there are a few reports of human pyrethroid poisoning. The poisoning has a varied presentation and its symptoms overlap with those of other compounds, which can lead to misdiagnosis. We present a case of poisoning with prallethrin, a pyrethroid compound, commonly available as All-Out.

Incidence and risk factors for extensively drug-resistant tuberculosis in Delhi region.

BACKGROUND: India with a major burden of multidrug-resistant tuberculosis (MDR-TB) does not have national level data on this hazardous disease. Since 2006, emergence of extensively drug-resistant TB (XDR-TB) is considered a serious threat to global TB control. This study highlights the demographic and clinical risk factors associated with XDR-TB in Delhi. METHODS: The study was conducted during April 2007 to May 2010. Six hundred eleven MDR-TB suspects were enrolled from four tertiary care hospitals, treating TB patients in Delhi and the demographic details recorded. Sputum samples were cultured using rapid, automated liquid culture system (MGIT 960). Drug susceptibility testing (DST) for Rifampicin (RIF) and Isoniazid (INH) was performed for all positive M. tuberculosis (M.tb) cultures. All MDR-TB isolates were tested for sensitivity to second-line drugs [Amikacin (AMK), Capreomycin (CAP), Ofloxacin (OFX), Ethionamide (ETA)]. RESULTS/FINDINGS: Of 611, 483 patients were infected with MDR M. tuberculosis (M.tb) strains. Eighteen MDR-TB isolates (3.7%) were XDR M.tb strains. Family history of TB (p 0.045), socioeconomic status (p 0.013), concomitant illness (p 0.001) and previous intake of 2(nd) line injectable drugs (p 0.001) were significantly associated with occurrence of XDR-TB. Only two of the patients enrolled were HIV seropositive, but had a negative culture for M. tuberculosis. 56/483 isolates were pre-XDR M. tuberculosis, though the occurrence of pre-XDR-TB did not show any significant demographical associations. CONCLUSIONS: The actual incidence and prevalence rate of XDR-TB in India is not available, although some scattered data is available. This study raises a concern about existence of XDR-TB in India, though small, signaling a need to strengthen the TB control program for early diagnosis of both tuberculosis and drug resistance in order to break the chains of transmission.

Diagnostic potential of 16 kDa (HspX, α-crystalline) antigen for serodiagnosis of tuberculosis.

BACKGROUND & OBJECTIVES: Tuberculosis (TB) is a public health problem worldwide. Rapid and accurate diagnosis of tuberculosis is crucial to facilitate early treatment of infectious cases and to reduce its spread. The present study was aimed to evaluation of 16 kDa antigen as a serodiagnostic tool in pulmonary and extra-pulmonary tuberculosis patients in an effort to improve diagnostic algorithm for tuberculosis. METHODS: In this study, 200 serum samples were collected from smear positive and culture confirmed pulmonary tuberculosis patients, 30 tubercular pleural effusions and 21 tubercular meningitis (TBM) patients. Serum samples from 36 healthy, age matched controls (hospital staff), along with 60 patients with non-tubercular respiratory diseases were also collected and evaluated. Humoral response (both IgG and IgA) was looked for 16 kDa antigen using indirect ELISA. RESULTS: Sensitivity of detection in various categories of pulmonary TB patients ranged between 73.8 and 81.2 per cent. While in the extra-pulmonary TB samples the sensitivity was 42.8 per cent (TBM) and 63.3 per cent (tubercular pleural effusion). The test specificity in both the groups was high (94.7%). All of the non-disease controls were negative. Among non-tubercular disease controls, five patients gave a positive humoral response against 16 kDa. INTERPRETATION & CONCLUSIONS: Serodiagnostic tests for TB have always had drawbacks of suboptimal sensitivity and specificity. The antigen used in this study gave encouraging results in pulmonary TB only, while in extra-pulmonary TB (tubercular meningitis and tubercular pleural effusion), this has shown a limited role in terms of sensitivity. Further work is required to validate its role in serodiagnosis of TB especially extra-pulmonary TB.

Fibreoptic bronchoscopy without sedation: Is transcricoid injection better than the "spray as you go" technique?

AIM: The aim of the study was to compare transcricoid injection with spray as you go technique for diagnostic fibreoptic bronchoscopy, to perform the procedure without sedation and to record any complication or side effects. METHODS: Sixty patients belonging to the age group 20-70 years, undergoing diagnostic bronchoscopy over a period of 6 months, were randomly selected and divided into two groups alternatively to receive 3 ml of 4% lignocaine by a single transcricoid puncture (group I) or 2 ml of 4% lignocaine instilled through the bronchoscope on to the vocal cords and further 1 ml of 2% lignocaine into each main bronchus (group II). Additional dose of lignocaine as required was given in both the groups. All patients were given intramuscular atropine 0.6 mg, 20 min before the procedure. Nebulisation with 3 ml of 4% lignocaine was given to all patients. The time from nasal insertion of the bronchoscope to reach the carina was recorded, and the total dose of lignocaine required in both the groups was calculated and compared. The cough episodes during the procedure, systolic blood pressure, and pulse rate were compared before the procedure and 5 min after the procedure in both the groups. A0-10 visual analogue scale (VAS) was used to assess discomfort 30 min after the procedure. RESULTS: The time to reach carina was more in group II (P<0.02), and cough episodes were also more in group II (P<0.05) than in group I. The vitals before the procedure were comparable in both the groups, but 5 min after the procedure the vitals were more stable in group I than in group II, and the total dose of lignocaine required in group II was more than in group I (P<0.001). However, the VAS score was comparable in both the groups. CONCLUSION: Transcricoid puncture for diagnostic bronchoscopies without sedation was associated with no complication and discomfort and required lesser dose of local anaesthetic with more stable vitals and good conditions for bronchoscopists.

Use of transcutaneous electrical nerve stimulation as an adjunctive to epidural analgesia in the management of acute thoracotomy pain.

The present randomized study was conducted in our institute of pulmonary medicine and tuberculosis over a period of 1 year. This study aimed to evaluate the effectiveness of transcutaneous electrical nerve stimulation (TENS) as an adjunctive to thoracic epidural analgesia for the treatment of postoperative pain in patients who underwent posterolateral thoracotomy for decortication of lung. Sixty patients in the age group 15-40 years scheduled to undergo elective posterolateral thoracotomy were divided into two groups of 30 each. Patients were alternatively assigned to one of the groups. In group I, only thoracic epidural analgesia with local anaesthetics was given at regular intervals; however, an identical apparatus which did not deliver an electric current was applied to the control (i.e. group I) patients. While in group II, TENS was started immediately in the recovery period in addition to the epidural analgesia. A 0-10 visual analog scale (VAS) was used to assess pain at regular intervals. The haemodynamics were also studied at regular intervals of 2 h for the first 10 h after the surgery. When the VAS score was more than three, intramuscular analgesia with diclofenac sodium was given. The VAS score and the systolic blood pressure were comparable in the immediate postoperative period (P = NS) but the VAS score was significantly less in group II at 2, 4, 6, 8 h (P < 0.01, P < 0.05, P < 0.05, P < 0.05, respectively), and at 10 h the P value was not significant. Similarly, the systolic blood pressure was significantly less in group II at 2, 4, 6 h after surgery, that is P < 0.02, P < 0.01, P < 0.01, respectively, but at 8 and 10 h the pressures were comparable in both the groups. Adding TENS to epidural analgesia led to a significant reduction in pain with no sequelae. The haemodynamics were significantly stable in group II compared to group I. TENS is a valuable strategy to alleviate postoperative pain following thoracic surgery with no side effects and with a good haemodynamic stability; however, the effects are short lasting.