Reliability of Ayurvedic Diagnosis for Knee Osteoarthritis Patients: A Nested Diagnostic Study Within a Randomized Controlled Trial.

Background: Ayurveda is a traditional Indian system of medicine. The customized Ayurvedic approach consists of a combination of several diagnostic procedures and subsequent individualized therapeutic interventions. Evaluation of inter-rater reliability (IRR) of Ayurvedic diagnoses has rarely been performed. The aim of this study was to evaluate IRR of Ayurvedic diagnosis for patients with knee osteoarthritis. Methods: A diagnostic reliability study of 30 patients and 4 Ayurvedic experts was nested in a randomized controlled trial. Patients were diagnosed in a sequential order by all experts utilizing a semistructured patient history form. A nominal group technique as consensus procedure was performed to reach agreement on the items to be diagnosed. An IRR analysis using Fleiss' and Cohen's kappa statistics was performed to determine a chance-corrected measure of agreement among raters. Results: One hundred and twenty different ratings and 30 consensus ratings were performed and analyzed. While high percentages of agreement for main diagnostic entities and the final Ayurveda diagnosis (95% consensus agreement on main diagnosis) could be observed, this was not reflected in the corresponding kappa values, which largely yielded fair-to-poor inter-rater agreement kappas for central diagnostic aspects such as prakriti and agni (κ values between 0 and 0.4). Notably, agreement on disease-related entities was better than that on constitutional entities. Conclusions: This is the first diagnostic study embedded in a clinical trial on patients with knee osteoarthritis utilizing a multimodality whole systems approach. Results showed a contrast between the high agreement of the consented final diagnosis and disagreement on certain diagnostic details. Future diagnostic studies should have larger sample sizes and a methodology more tailored to the specificities of traditional whole systems of medicine. Equal emphasis will need to be placed on all core diagnostic components of Ayurveda, both constitutional and disease specific, using detailed structured history taking forms.

The Effect of a Complex Multi-modality Ayurvedic Treatment in a Case of Unknown Female Infertility.

BACKGROUND: Treatment of female infertility has been growing globally in recent years. In spite of improvements in medical strategies and the improved outcomes for infertile couples, treatment attempts remain largely unsuccessful. A growing number of patients pursue complementary and alternative medicine treatment options like Ayurveda that offers a variety of inpatient and outpatient treatments for infertility. CASE REPORT: A case of a 38 year-old woman with infertility of unknown origin is presented. She received 18 conventional fertility treatments in 5 different fertility centers and 3 different countries. After several complications, the patient quitted conventional treatment and admitted to an Ayurvedic outpatient clinic where she received a complex Ayurvedic treatment, which included botanicals, dietary and lifestyle advice, manual therapy, yoga, and spiritual elements. The patient then became pregnant and gave birth to a healthy boy in 2012. CONCLUSIONS: Ayurveda may be a useful complementary option in the case of futile conventional treatment attempts in female infertility. Nevertheless, the evidence base for Ayurvedic interventions remains weak and requires well-designed clinical trials. This case raises some questions, such as whether the exposure to a large number of assisted reproduction procedures can lead to more health problems than health benefits. The Ayurvedic approach to fertility strives first to improve the health of the patient leading to a higher likelihood of pregnancy. As this is a case report, we are not able to exclude temporal factors stimulating the pregnancy. However, the chronology suggests that this approach might have been an important factor in the eventual pregnancy.

[Integrative management using Ayurvedic medicine in a patient with advanced malignant mixed Muellerian tumor - a case report]. / Integratives Management unter Einsatz von Ayurveda-Medizin bei einer Patientin mit fortgeschrittenem Malignen Müllerschen Mischtumor - ein Fallbericht.

BACKGROUND: Carcinosarcoma of the uterus is a rare malignant tumor with an extremely poor prognosis. Because there are just a few cases described, there is little evidence on possible treatment options. An improvement in the overall unsatisfactory therapeutic situation is required. CASE REPORT: The management of an advanced stage uterine carcinosarcoma, at the time of primary diagnosis in FIGO stage 4, in a 67-year-old woman is described, including multiple surgical interventions, radiotherapy, chemotherapy, and the complementary use of elements of Ayurvedic medicine. To this date, the 3-year follow-up revealed no evidence of distant metastasis. A high quality of life could be ensured continuously. CONCLUSION: Even with poor prognosis, tumor entities can be controlled by using all the available medical resources, enabling a satisfactory quality of life over a longer period of time. For this reason, the complementary use of the traditional medical system Ayurveda could be helpful.

Comparative effectiveness of a complex Ayurvedic treatment and conventional standard care in osteoarthritis of the knee--study protocol for a randomized controlled trial.

BACKGROUND: Traditional Indian Ayurvedic medicine uses complex treatment approaches, including manual therapies, lifestyle and nutritional advice, dietary supplements, medication, yoga, and purification techniques. Ayurvedic strategies are often used to treat osteoarthritis (OA) of the knee; however, no systematic data are available on their effectiveness in comparison with standard care. The aim of this study is to evaluate the effectiveness of complex Ayurvedic treatment in comparison with conventional methods of treating OA symptoms in patients with knee osteoarthritis. METHODS AND DESIGN: In a prospective, multicenter, randomized controlled trial, 150 patients between 40 and 70 years, diagnosed with osteoarthritis of the knee, following American College of Rheumatology criteria and an average pain intensity of ≥40 mm on a 100 mm visual analog scale in the affected knee at baseline will be randomized into two groups. In the Ayurveda group, treatment will include tailored combinations of manual treatments, massages, dietary and lifestyle advice, consideration of selected foods, nutritional supplements, yoga posture advice, and knee massage. Patients in the conventional group will receive self-care advice, pain medication, weight-loss advice (if overweight), and physiotherapy following current international guidelines. Both groups will receive 15 treatment sessions over 12 weeks. Outcomes will be evaluated after 6 and 12 weeks and 6 and 12 months. The primary endpoint is a change in the score on the Western Ontario and McMaster University Osteoarthritis Index (WOMAC) after 12 weeks. Secondary outcome measurements will use WOMAC subscales, a pain disability index, a visual analog scale for pain and sleep quality, a pain experience scale, a quality-of-life index, a profile of mood states, and Likert scales for patient satisfaction, patient diaries, and safety. Using an adapted PRECIS scale, the trial was identified as lying mainly in the middle of the efficacy-effectiveness continuum. DISCUSSION: This trial is the first to compare the effectiveness of a complex Ayurvedic intervention with a complex conventional intervention in a Western medical setting in patients with knee osteoarthritis. During the trial design, aspects of efficacy and effectiveness were discussed. The resulting design is a compromise between rigor and pragmatism. TRIAL REGISTRATION: NCT01225133.