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

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). 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. 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. 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.

Chand KS ，Manchanda RK ，Mittal R ，Batra S ，Banavaliker JN ，De I ... -  《-》

[Study on the efficacy and safety of short-term treatment including fluoroquinolones anti-tuberculosis drugs for rifampicin resistant pulmonary tuberculosis].

Kang WL ，Xie YG ，Tan WG ，Chu NH ，Li L ，You YH ，Yang YZ ，Wang XM ，Yan XL ，Miao ZP ，Duanmu HJ ... -  《-》

Delamanid, linezolid, levofloxacin, and pyrazinamide for the treatment of patients with fluoroquinolone-sensitive multidrug-resistant tuberculosis (Treatment Shortening of MDR-TB Using Existing and New Drugs, MDR-END): study protocol for a phase II/III, m

Lee M ，Mok J ，Kim DK ，Shim TS ，Koh WJ ，Jeon D ，Lee T ，Lee SH ，Kim JS ，Park JS ，Lee JY ，Kim SY ，Lee JH ，Jo KW ，Jhun BW ，Kang YA ，Ahn JH ，Kim CK ，Shin S ，Song T ，Shin SJ ，Kim YR ，Ahn H ，Hahn S ，Won HJ ，Jang JY ，Cho SN ，Yim JJ ... -  《Trials》

[Characteristics and treatment outcomes of INH-resistant or RFP-resistant tuberculosis].

Saito W ，Nagayama N ，Miyamoto M ，Hara H ，Suzuki J ，Masuda K ，Baba M ，Tamura A ，Nagai H ，Akagawa S ，Kawabe Y ，Machida K ，Kurashima A ，Yotsumoto H ... -  《-》

Efficacy and safety of delamanid in combination with an optimised background regimen for treatment of multidrug-resistant tuberculosis: a multicentre, randomised, double-blind, placebo-controlled, parallel group phase 3 trial.

Delamanid is one of two recently approved drugs for the treatment of multidrug-resistant tuberculosis. We aimed to evaluate the safety and efficacy of delamanid in the first 6 months of treatment. This randomised, double-blind, placebo-controlled, phase 3 trial was done at 17 sites in seven countries (Estonia, Latvia, Lithuania, Moldova, Peru, the Philippines, and South Africa). We enrolled eligible adults (>18 years) with pulmonary multidrug-resistant tuberculosis to receive, in combination with an optimised background regimen developed according to WHO and national guidelines, either oral delamanid (100 mg twice daily) for 2 months followed by 200 mg once daily for 4 months or placebo (same regimen). Patients were centrally randomised (2:1) and stratified by risk category for delayed sputum culture conversion. Primary outcomes were the time to sputum culture conversion over 6 months and the difference in the distribution of time to sputum culture conversion over 6 months between the two groups, as assessed in the modified intention-to-treat population. The trial is registered at ClinicalTrials.gov, number NCT01424670. Between Sept 2, 2011, and Nov 27, 2013, we screened 714 patients, of whom 511 were randomly assigned (341 to delamanid plus optimised background regimen [delamanid group] and 170 to placebo plus optimised background regimen [placebo group]) and formed the safety analysis population. 327 patients were culture-positive for multidrug-resistant tuberculosis at baseline and comprised the efficacy analysis population (226 in the delamanid group and 101 in the placebo group). Median time to sputum culture conversion did not differ between the two groups (p=0·0562; modified Peto-Peto), with 51 days (IQR 29-98) in the delamanid group and 57 days (43-85) in the placebo group; the hazard ratio was 1·17 (95% CI 0·91-1·51, p=0·2157). 501 (98·0%) of 511 patients had at least one treatment-emergent adverse event. 136 (26·6%) of 511 patients had at least one serious treatment-emergent adverse event; the incidence was similar between treatment groups (89 [26·1%] of 341 patients for delamanid and 47 [27·6%] of 170 for placebo). Deaths related to treatment-emergent adverse events were similar between groups (15 [4·4%] of 341 for delamanid and six [3·5%] of 170 for placebo). No deaths were considered to be related to delamanid. The reduction in median time to sputum culture conversion over 6 months was not significant in the primary analysis. Delamanid was well tolerated with a highly characterised safety profile. Further evaluation of delamanid is needed to determine its role in a rapidly evolving standard of care. Otsuka Pharmaceutical.

von Groote-Bidlingmaier F ，Patientia R ，Sanchez E ，Balanag V Jr ，Ticona E ，Segura P ，Cadena E ，Yu C ，Cirule A ，Lizarbe V ，Davidaviciene E ，Domente L ，Variava E ，Caoili J ，Danilovits M ，Bielskiene V ，Staples S ，Hittel N ，Petersen C ，Wells C ，Hafkin J ，Geiter LJ ，Gupta R ... -  《-》