Double-blind, randomized, controlled, pilot study comparing classic ayurvedic medicine, methotrexate, and their combination in rheumatoid arthritis.

OBJECTIVE: To compare classic Ayurveda, methotrexate (MTX), and their combination in a double-blind, randomized, double-dummy, pilot trial in rheumatoid arthritis (RA) for 36 weeks. METHODS: Forty-three seropositive RA patients by American College of Rheumatology (ACR) criteria with disease duration of less than 7 years were assigned to the following treatment groups: MTX plus Ayurvedic placebo (n = 14), Ayurveda plus MTX placebo (n = 12), or Ayurveda plus MTX (n = 17). Outcomes included the Disease Activity Score (DAS28-CRP), ACR20/50/70, and Health Assessment Questionnaire--Disability Index. All measures were obtained every 12 weeks for 36 weeks. Analyses included descriptive statistics, analysis of variance, χ², or Student t test. The unique features of this study included the development of placebos for each Ayurvedic pharmacological dosage form and individualization of Ayurvedic therapy. RESULTS: All groups were comparable at baseline in demographics and disease characteristics. There were no statistically significant differences among the 3 groups on the efficacy measures. ACR20 results were MTX 86%, Ayurveda 100%, and combination 82%, and DAS28-CRP response were MTX -2.4, Ayurveda -1.7, and combination -2.4. Differences in adverse events among groups were also not statistically significant, although the MTX groups experienced more adverse event (MTX 174, Ayurveda 112, combination 176). No deaths occurred. CONCLUSIONS: In this first-ever, double-blind, randomized, placebo-controlled pilot study comparing Ayurveda, MTX, and their combination, all 3 treatments were approximately equivalent in efficacy, within the limits of a pilot study. Adverse events were numerically fewer in the Ayurveda-only group. This study demonstrates that double-blind, placebo-controlled, randomized studies are possible when testing individualized classic Ayurvedic versus allopathic treatment in ways acceptable to western standards and to Ayurvedic physicians. It also justifies the need for larger studies.

Determination of the optimal cut-off value of serum prostate-specific antigen in the prediction of skeletal metastases on technetium-99m whole-body bone scan by receiver operating characteristic curve analysis.

Radionuclide whole-body bone scan is a useful investigation of choice to detect the skeletal metastases in prostate cancer. It is indicated in patients having elevated serum prostate-specific antigen (Sr. PSA) or patients with bone pain. Elevated Sr. PSA levels have high predictive value for skeletal metastases; however, there is no consensus regarding cut-off value of Sr. PSA above which bone scan is indicated. This study was performed to find out the accuracy of Sr. PSA test and to know the optimal cut-off value of Sr. PSA with high sensitivity and specificity in the prediction of skeletal metastases on bone scan in prostate cancer patients. A retrospective analysis of medical records of 307 prostate cancer patients referred to the department of nuclear medicine for bone scan between June 2009 and June 2014 was done. Of 307 patients, 15 cases were excluded due to nonavailability of Sr. PSA. Bone scan was performed 3 h after administration of 20 mCi Tc-99m methylene diphosphonate intravenously. Whole-body sweep imaging was performed and spot views were taken wherever required. Of 292 cases, 174 (59.58%) patients had positive bone scan for metastases and 118 (40.41%) patients had negative bone scan for metastases. Maximum and minimum Sr. PSA levels in positive and negative bone scan patients were 1260 and 0.02 ng/ml and 198.34 ng/ml and 0.01 ng/ml, respectively. On comparison of the mean Sr. PSA levels between positive and negative groups, we found significant Sr. PSA levels (P < 0.05). We used receiver operating characteristic (ROC) curve analyses to find out the accuracy of Sr. PSA test and to know the optimal cut-off value of Sr. PSA with maximum sensitivity and specificity in the prediction of skeletal metastases on bone scan. Area under ROC curve was 0.878 (87%). This indicates that the accuracy of Sr. PSA test in the prediction of skeletal metastases on bone scan was good. The optimal cut-off value of Sr. PSA in the prediction of positive bone scan for skeletal metastases in the management of prostate cancer was 29.16 ng/ml, with sensitivity and specificity of 89.0% and 74.6%, respectively. In this study, we conclude that the accuracy of Sr. PSA test in the prediction of skeletal metastases is good. ROC-derived optimal cut-off value of Sr. PSA for positive skeletal metastases on bone scan is >29.16 ng/ml; thus, the chances of getting positive bone scan for skeletal metastasis are less in prostate cancer patients with Sr. PSA <29.16 ng/ml. ROC-derived sensitivity and specificity of different possible cut-off points of Sr. PSA help reduce the false positive results and increase the diagnostic accuracy of bone scan in the detection of skeletal metastases in prostate cancer patients.

Skeletal Metastases Presenting as Superscan on Technetium 99m Methylene Diphosphonate Whole Body Bone Scintigraphy in Different Type of Cancers: A 5-Year Retro-prospective Study.

The purpose of the study is to find out the overall incidence of superscan among different type of cancers, causes of superscan and its relationship with other parameters such as age, sex, duration of disease, and serum alkaline phosphatase (ALP) levels. This was a retro-prospective study. Records of all previous bone scans and reported patients of superscan were re-evaluated retrospectively. Patients who were diagnosed as having superscan in the preceding 3 years with confirmed histopathological diagnosis were included in the retrospective group. In the prospective group, all the patients who were reported to have superscan appearance over the past 2 years of prospective period were included. Total of 6027 bone scans were examined in a 5-year period and out of which 80 cases were diagnosed as superscan. The overall incidence of superscan in different type of cancers was 1.3% (80/6027). Prostate cancer (46/80) was the most common cause of superscan appearance followed by breast cancer (10/80). Out of 6027 patients referred for bone scan, 307 patients had prostate cancer on histopathological examination. Out of 307 patients with prostate cancer, 46 had superscan appearance. Incidence of superscan in prostate cancer was 14.98% (46/307), and 71.73% (33/46) prostate cancer patients with superscan had Gleason score of 8 and above 8 with mean serum prostate-specific antigen level was 178.42 ng/ml in symptomatic patients and 122 ng/ml in asymptomatic patients. Out of all patients with superscan, 71 patients (88.7%) had elevated serum ALP levels. Overall incidence of superscan in our study was 1.3% in different type of cancer patients, and the most common cause of superscan appearance was prostate cancer. Incidence of superscan appearance in prostatic cancer patients was 14.98%.

Chyawanprash: A review of therapeutic benefits as in authoritative texts and documented clinical literature.

ETHNOPHARMACOLOGICAL RELEVANCE: Chyawanprash (CP), a traditional immune booster recipe, has a long history of ethnic origin, development, household preparation and usage. There are even mythological stories about the origin of this recipe including its nomenclature. In the last six decades, CP, because of entrepreneurial actions of some research Vaidyas (traditional doctors) has grown to industrial production and marketing in packed forms to a large number of consumers/patients like any food or health care product. Currently, CP has acquired a large accepted user base in India and in a few countries out-side India. AIM OF THE STUDY: Authoritative texts, recognized by the Drugs and Cosmetics Act of India, describe CP as an immunity enhancer and strength giver meant for improving lung functions in diseases with compromised immunity. This review focuses on published clinical efficacy and safety studies of CP for correlation with health benefits as documented in the authoritative texts, and also briefs on its recipes and processes. MATERIALS AND METHODS: Authoritative texts were searched for recipes, processes, and other technical details of CP. Labels of marketing CP products (Indian) were studied for the health claims. Electronic search for studies of CP on efficacy and safety data were performed in PubMed/MEDLINE and DHARA (Digital Helpline for Ayurveda Research Articles), and Ayurvedic books were also searched for clinical studies. RESULTS: The documented clinical studies from electronic databases and Ayurvedic books evidenced that individuals who consume CP regularly for a definite period of time showed improvement in overall health status and immunity. However, most of the clinical studies in this review are of smaller sample size and short duration. Further, limitation to access and review significant data on traditional products like CP in electronic databases was noted. CONCLUSIONS: Randomized controlled trials of high quality with larger sample size and longer follow-up are needed to have significant evidence on the clinical use of CP as immunity booster. Additional studies involving measurement of current biomarkers of immunity pre- and post-consumption of the product as well as benefits accruing with the use of CP as an adjuvant are suggested.