Self-care treatment for lymphoedema of lymphatic filariasis using integrative medicine.

BACKGROUND: Lymphatic filariasis (LF) is a neglected tropical disease presenting mainly as lymphoedema (elephantiasis). At present, LF is not effectively treated. Integrative medicine (IM) treatment for lymphoedema uses a combination of Indian traditional medicine, Ayurveda, alongside yoga exercises, compression therapy, antibiotics and antifungal treatments, providing a useful combination where resources are limited and different practices are in use. OBJECTIVES: To assess the effectiveness of the IM in the existing clinical practice of lower-limb lymphoedema management and to determine whether the treatment outcomes align with the World Health Organization (WHO) global goal of LF management. METHODS: Institutional data from electronic medical records of all 1698 patients with LF between 2010 and 2019 were retrospectively analysed using pre- and post-treatment comparisons and the National Institute for Health and Care Excellence guidelines for clinical audit. The primary treatment outcomes evaluated were limb volume, bacterial entry points (BEEPs), episodes of cellulitis, and health-related quality of life (HRQoL). Secondary outcomes included the influence of the patient's sex, duration of illness, education and employment status on volume reduction. Multiple regression analysis, t-test, χ2-test, analysis of variance, Mann-Whitney U-test and the Kruskal-Wallis test were used to assess the association between IM and patients' treatment outcomes. RESULTS: Limb volume reduced by 24.5% [95% confidence interval (CI) 22.47-26.61; n = 1660] following an intensive supervised care period (mean 14.84 days, n = 1660). Limb volume further reduced by 1.42% (95% CI 0.76-2.07; n = 1259) at the first follow-up visit (mean 81.45 days), and by 2.3% between the first and second follow-up visits (mean 231.32 days) (95% CI 1.26-3.34; n = 796). BEEPs were reduced upon follow-up; excoriations (78.4%) and intertrigo (26.7%) were reduced at discharge and further improvements was achieved at the follow-up visits. In total, 4% of patients exhibited new BEEPs at the first follow-up [eczema (3.9%), folliculitis (6.5%), excoriations (11.9%) and intertrigo (15.4%); 4 of 7 BEEPs were recorded]. HRQoL, measured using the disease-specific Lymphatic Filariasis Specific Quality of Life Questionnaire, showed an average score of 73.9 on admission, which increased by 17.8 at the first follow-up and 18.6 at the second follow-up. No patients developed new cellulitis episodes at the first follow-up, and only five patients (5.3%) developed new episodes of cellulitis at the second follow-up. CONCLUSIONS: IM for lower-limb lymphoedema successfully reduces limb volume and episodes of cellulitis, and also reduces BEEPs, leading to improved HRQoL. IM aligns with the LF treatment goals of the WHO and is a low-cost, predominantly self-care management protocol. IM has the potential to change care models and improve the lives of patients with lymphoedema.

Human skin fibrosis: up-regulation of collagen type III gene transcription in the fibrotic skin nodules of lower limb lymphoedema.

OBJECTIVES: To investigate the cellular and molecular pathophysiology involved in the development of fibrotic skin of grade-3 lymphoedema patients with a focus on collagen types. METHODS: Fibrotic and normal skin biopsy samples obtained from grade-3 lymphoedema patients and normal individuals, respectively, were analysed by histopathology, quantitative real-time PCR and immunohistochemistry to examine collagen gene expression. RESULTS: Histopathologic analysis revealed epidermal changes such as orthokeratosis, hypergranulosis and irregular acanthosis in the skin biopsies. The thickened dermis contained nodules of haphazardly arranged thick collagen bundles. Real-time PCR data showed significant (P-value 0.0003) up-regulation of Collagen type I and type III gene transcripts in the fibrotic skin of patients resulting in 38.94-fold higher transcription of Collagen type III alpha-1 gene than of Collagen type I alpha-1 gene. Semi-quantification of the per cent of haematoxylin-DAB-stained area of immunohistochemistry images also showed significant (P < 0.0001) enhancement of both collagen proteins in the fibrotic skin of patients vs. normal human skin. CONCLUSIONS: Gene transcript analysis revealed significant up-regulation of Collagen type III vs. Collagen type I in fibrotic skin of limb nodules from patient biopsies. Histopathological and immunohistochemical analysis also revealed enhancement of Collagen types I and III in fibrotic vs. normal skin. The findings of this preliminary study indicate the potentially significant involvement of Collagen type III in the development of the fibrotic skin of grade-3 lymphoedema patients.

OBJECTIFS: Etudier la physiopathologie cellulaire et moléculaire impliquée dans le développement de la fibrose cutanée chez les patients atteints de lymphœdème de grade 3 en mettant l'accent sur les types de collagène. MÉTHODES: Des échantillons de biopsie cutanée fibrotique et normale obtenus respectivement de patients atteints de lymphœdème de grade 3 et d'individus normaux ont été analysés par histopathologie, par PCR quantitative en temps réel et par immunohistochimie pour examiner l'expression des gènes de collagène. RÉSULTATS: L'analyse histopathologique a révélé des changements épidermiques tels que l'orthokératose, l'hypergranulose et l'acanthose irrégulière dans les biopsies cutanées. Le derme épaissi contenait des nodules de faisceaux de collagène épais disposés au hasard. Les données de PCR en temps réel ont montré une régulation à la hausse significative (P = 0.0003) des transcrits des gènes de collagène de type I et III dans la peau fibrotique des patients, résultant en une transcription 38,94 fois plus élevée du gène alpha-1 du collagène de type III par rapport à celui du gène alpha-1 du collagène de type I. La semi-quantification du pourcentage de zone colorée à l'hématoxyline-DAB des images d'immunohistochimie a également montré une amélioration significative (P < 0.0001) des deux protéines de collagène dans la peau fibrotique des patients par rapport à la peau humaine normale. CONCLUSIONS: L'analyse de transcription génétique a révélé une régulation à la hausse importante du collagène de type III par rapport à celle du collagène de type I dans la peau fibrotique des nodules des membres provenant de biopsies de patients. L'analyse histopathologique et immunohistochimique a également révélé une amélioration du collagène de types I et III dans la peau fibrotique pa rapport à la peau normale. Les résultats de cette étude préliminaire indiquent l'implication potentiellement significative du collagène de type III dans le développement de la peau fibrotique des patients atteints de lymphœdème de grade 3.

Yoga for correction of lymphedema's impairment of gait as an adjunct to lymphatic drainage: A pilot observational study.

INTRODUCTION: Yoga used as a major component of integrative treatment protocol in 14 Indian village camps improved quality-of-life in 425 lymphatic filariasis patients. They experienced better mobility and reduced disability. This paper documents the gait abnormalities observed in lower limb lymphedema patients and the locomotor changes following integrative treatment. MATERIALS AND METHODS: Yoga postures were performed as explained by traditional yoga practice in two sessions: Before ayurvedic oil massage without compression bandages and after the massage with compression bandages. Each yoga posture lasted for 5 min and the whole session ended in 45 min. Throughout each session, we advised patients to do long, diaphragmatic breathing, concentrating on each breath. The flexion of joints was coordinated with exhalation and extension with inhalation. We educated the patients to do longer expiration than inspiration. RESULTS AND DISCUSSION: A total of 98 patients (133 limbs) attending the 6(th) month follow-up were evaluated. The most common gait abnormality was antalgic gait. Structural and functional abnormalities were observed in hip, knee and ankle joints. We found that yoga as an adjunct to other components in integrative treatment improved the gait problems. Long standing lymphedema caused altered gait and joint deformities. This was mostly due to inactivity causing muscle weakness and edema within and around the muscles. Both large and small limbs have shown significant volume reduction (P < 0.01) during follow-up after 6 months. CONCLUSION: There can be a mixed etiology for gait related problems in lymphedema patients. Further studies are recommended to understand the causes of deformities in lymphedema patients and an exact role of yoga.

Literature searches on Ayurveda: An update.

INTRODUCTION: The journals that publish on Ayurveda are increasingly indexed by popular medical databases in recent years. However, many Eastern journals are not indexed biomedical journal databases such as PubMed. Literature searches for Ayurveda continue to be challenging due to the nonavailability of active, unbiased dedicated databases for Ayurvedic literature. In 2010, authors identified 46 databases that can be used for systematic search of Ayurvedic papers and theses. This update reviewed our previous recommendation and identified current and relevant databases. AIMS: To update on Ayurveda literature search and strategy to retrieve maximum publications. METHODS: Author used psoriasis as an example to search previously listed databases and identify new. The population, intervention, control, and outcome table included keywords related to psoriasis and Ayurvedic terminologies for skin diseases. Current citation update status, search results, and search options of previous databases were assessed. Eight search strategies were developed. Hundred and five journals, both biomedical and Ayurveda, which publish on Ayurveda, were identified. Variability in databases was explored to identify bias in journal citation. RESULTS: Five among 46 databases are now relevant - AYUSH research portal, Annotated Bibliography of Indian Medicine, Digital Helpline for Ayurveda Research Articles (DHARA), PubMed, and Directory of Open Access Journals. Search options in these databases are not uniform, and only PubMed allows complex search strategy. "The Researches in Ayurveda" and "Ayurvedic Research Database" (ARD) are important grey resources for hand searching. About 44/105 (41.5%) journals publishing Ayurvedic studies are not indexed in any database. Only 11/105 (10.4%) exclusive Ayurveda journals are indexed in PubMed. CONCLUSION: AYUSH research portal and DHARA are two major portals after 2010. It is mandatory to search PubMed and four other databases because all five carry citations from different groups of journals. The hand searching is important to identify Ayurveda publications that are not indexed elsewhere. Availability information of citations in Ayurveda libraries from National Union Catalogue of Scientific Serials in India if regularly updated will improve the efficacy of hand searching. A grey database (ARD) contains unpublished PG/Ph.D. theses. The AYUSH portal, DHARA (funded by Ministry of AYUSH), and ARD should be merged to form single larger database to limit Ayurveda literature searches.

Comparison of three quality of life instruments in lymphatic filariasis: DLQI, WHODAS 2.0, and LFSQQ.

BACKGROUND: The Global Program to Eliminate Lymphatic Filariasis aims to interrupt transmission of lymphatic filariasis and manage morbidity in people currently living with the disease. A component of morbidity management is improving health-related quality of life (HRQoL) in patients. Measurement of HRQoL in current management programs is varied because of the lack of a standard HRQoL tool for use in the lymphatic filariasis population. METHODOLOGY/PRINCIPAL FINDINGS: In this study, the psychometric properties of three health status measures were compared when used in a group of lymphatic filariasis patients and healthy controls. The World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0), the Dermatology Life Quality Index (DLQI), and the Lymphatic Filariasis Quality of Life Questionnaire (LFSQQ) were administered to 36 stage II and stage III lymphatic filariasis subjects and 36 age and sex matched controls in Kerala, India. All three tools yielded missing value rates lower than 10%, suggesting high feasibility. Highest internal consistency was seen in the LFSQQ (α = 0.97). Discriminant validity analysis demonstrated that HRQoL was significantly lower in the LF group than in controls for the WHODAS 2.0, DLQI, and LFSQQ, but total HRQoL scores did not differ between stage II and stage III lymphedema subjects. The LFSQQ total score correlated most strongly with the WHODAS 2.0 (r = 0.91, p<0.001) and DLQI (r = 0.81, p<0.001). CONCLUSIONS/SIGNIFICANCE: The WHODAS 2.0, DLQI, and LFSQQ demonstrate acceptable feasibility, internal consistency, discriminate validity, and construct validity. Based on our psychometric analyses, the LFSQQ performs the best and is recommended for use in the lymphatic filariasis population.

How knowledgeable are investigators studying therapies of traditional medicines?

CONTEXT: Research methodology in traditional Indian system of medicine. AIM: To determine the knowledge level of investigators conducting clinical trials in traditional medicines (TMs) including Ayurveda. MATERIALS AND METHODS: This was a questionnaire survey conducted for selected researchers trained in any specialty and working in TM. 2087 researchers were selected based on selection criteria. A validated and pretested questionnaire containing the questions regarding regulatory issues, literature search, evidence-based medicine, clinical trial design, patient selection, and study reporting were sent either through E-mail or post. The answered questionnaires were analyzed. The parameters were analyzed based on median and interquartile range (IQR). RESULTS: Forty two responses were received through E-mail and 21 researchers responded through post. Out of 63, six researchers sent incomplete responses. Among the remaining 57 respondents; 34 (59.6%) investigators had postdoctoral degree, 43 investigators (75.4%) did not receive any structured training on research methodology, 23 (40.4%) had two decades of research experience. Thirty three (74%) of investigators who received government funding didn't have any training on research methodology. Ayurveda experts group had better knowledge compared to pharmaceutical sciences and basic science group although they had a dilemma about conducting clinical evaluation of TM within the specific framework of rigorous clinical pharmacological principles without ignoring the Ayurvedic concepts such as Dosha, Prakruti etc., Investigators below 30 years possessed higher knowledge of research methodology when analyzed based on the age. The respondents working in research organizations, government organizations, and academic institutions had lower knowledge compared to those who were in private organizations/practice. CONCLUSIONS: It is recommend that investigators, peer reviewers, and fund managers involved in traditional medicine research need training especially in research methodology.

Navarakizhi and pinda sweda as muscle-nourishing Ayurveda procedures in hemiplegia: double-blind randomized comparative pilot clinical trial.

INTRODUCTION: Hemiplegia and the Ayurvedic description of ardhanga disease presents with comparable clinical features. This pilot trial compared two traditional procedure-based treatments: Navarakizhi, a massage of cooked navara rice in a medicated hot bolus, and pinda sweda, a similar massage made of a different type of rice. This article also describes the steps of a double-blind trial in Ayurveda, which was hitherto considered difficult to perform. METHODS: Eighteen (18) patients suffering from hemiplegia with disease duration of 6 months to 2 years received treatment with navarakizhi or pinda sweda for 7 days. Both groups received the same Ayurvedic oral medications for 14 days. All steps of randomization and blinding of procedure-based therapy in Ayurveda are described. The physiotherapist evaluated muscle tone, muscle strength, tendon reflexes, range of movement, and balance of functional abilities at baseline, 7 days, and 14 days after starting therapy. Both patient and the assessing physiotherapist were blinded. RESULTS: Intraquartile range values showed better range in patients who received navarakizhi than those who received pinda sweda. DISCUSSION: A larger trial is needed to confirm the superiority of navarakizhi over the rice varieties in treating hemiplegia. This study demonstrates that double-blind randomized clinical trials are possible in Ayurvedic settings, ending the long-debated controversy in trial methodology involving procedure-based traditional medicines.

Community level morbidity control of lymphoedema using self care and integrative treatment in two lymphatic filariasis endemic districts of South India: a non randomized interventional study.

BACKGROUND: Currently there is no global program to manage lymphoedema as a result of lymphatic filariasis (LF). The primary aim of this study was to determine the efficacy of a previously proposed integrative treatment protocol, using locally available resources to address the morbidity, in a community village setting. METHODS: Two LF endemic districts of south India, Gulbarga in Karnataka (GK) and Alleppey in Kerala (AK), were selected for the study. All known patients were invited to an LF camp. Patients with grade two late or three lymphoedema were enrolled. All patients were given training in the integrative procedure which involved patient education and the domiciliary protocol. RESULTS: A total of 730 patients (851 limbs) completed the three and half month follow up. There was a statistically significant (1%) reduction up to mid thigh level volume measurement for both small (0.7-1.1 liters) and large (1.8-5.0 liters) limbs, p < 0.000. In AK inflammatory episodes at the three months interval reduced from 37.5% (127 patients) to 28.3% (96 patients) and in GK from 37.6% (147 patients) to 10.2% (40 patients), p < 0.000. All patients had reduced bacterial entry points. There was an overall improvement in quality of life in all domains of LF specific quality of life questionnaire p < 0.000. CONCLUSIONS: Self care and integrative treatment is possible in resource poor Indian village settings. Further work is needed to explore factors leading to better compliance by randomizing the interventions such as washing and emollient compression vs Ayurvedic and yoga interventions before integrative treatment is considered for national health programmes in developing countries.

Evidence-based integrative dermatology.

American recognition for medical pluralism arrived in 1991. The National Center for Complementary and Alternative Medicine was established under the National Institutes of Health in 1998. Following this, patients and researchers began exploring use of integrative medicine. Terence Ryan with Gerry Bodeker in Europe, Brian Berman in America, and the Indian council of Medical Research advocated traditional medicine and integrative medicine. The Institute of Applied Dermatology (IAD), Kerala has developed integrated allopathic (biomedical) and ayurvedic therapies to treat Lymphatic Filariasis, Lichen planus, and Vitiligo. Studies conducted at the IAD have created a framework for evidence-based and integrative dermatology (ID). This paper gives an overview of advances in ID with an example of Lichen Planus, which was examined jointly by dermatologists and Ayurveda doctors. The clinical presentation in these patients was listed in a vikruthi table of comparable biomedical terms. A vikruthi table was used for drug selection in ayurvedic dermatology. A total of 19 patients were treated with ayurvedic prescriptions to normalize the vatha-kapha for 3 months. All patients responded and no side effects were recorded. In spite of advancing knowledge on ID, several challenges remain for its use on difficult to treat chronic skin diseases. The formation of new integrative groups and financial support are essential for the growth of ID in India.

Self care integrative treatment demonstrated in rural community setting improves health related quality of life of lymphatic filariasis patients in endemic villages.

This study assessed impact of community based self care integrative treatment provided through mass camps in villages of three districts of Kerala, India endemic for lymphatic filariasis (LF). Two most endemic Primary Health centres (PHCs) were selected from each of the three districts, where maximum concentration of LF patients is recorded. Fourteen one day LF camps, each attended by 30-40 patients were conducted. Trained Accredited Social Health Activists encouraged LF patients to attend camps. Skin wash and drying, care of bacterial entry points using dermatology drugs, and simple yoga and breathing exercises were demonstrated in these camps. Patients were advised to continue these self care activities daily at home for six months. The quality of life (QoL) of LF patients was determined for Indian life style domains using validated and pretested specific questionnaire (LF-specific QoL questionnaire-LFSQQ). It addressed conditions and state of individuals with reference to LF. The questionnaire had 7 domains and each domain consisted of a series of questions with likert scale (no problem, mild, moderate, severe, most severe). 446 patients attended one day camps to get training on integrative self care treatment. 425 patients (95.3%) were followed up after six months and QoL was reassessed. Each patient's QoL in mobility, self care, usual activity, pain and discomfort and social relationship significantly improved (P value <0.01). Psychological health showed no significant change. The disease burden, for the purpose of the study was measured by asking questions about history of painful redness, swelling and cellulitis of legs (filarial fever), foul smell (odor), itching (eczema/discharge from limb), wound (non healing ulcer) and weight/size of the limb. The difference in disease burden as recorded during the sixth month follow up was measured using dependent t test, reduced significantly (P value <0.01) in 409 (96.2%) patients. 103 (24.2%) patients experienced fever during follow up. Severity of inflammatory episodes reduced from severe problem to no problem, after six months of home based self care. There was significant relation between treatment regularity and QoL status (P value=0.003). The community based one day camps that trained LF patients on skin care and daily yoga and breathing practices improved QoL.

Reporting an alliance using an integrative approach to the management of lymphedema in India.

In India 553 million persons are estimated to live in areas endemic for LF; approximately 21 million have symptomatic filariasis. Of the approximately 16.02 million cases of lymphedema caused by LF globally, 7.44 million (46.4%) are in India. India had seen diethyl carbamizine, and/or albendazole, delivered to whole populations, beginning the project to eliminate the disease. But new populations have developed the infection. In 2003 the need in resource-poor countries for morbidity control of lymphatic filariasis (LF) became clear, prompting the study by the Institute of Applied Dermatology in Kerala, India. Under this study,self help and family members assisted in home-based care, combining compression bandaging, yoga exercises, heat therapy using steaming, and skin care according to Ayurvedic medicine. Lymphedema presents with different patterns in the skin with gross changes in the epidermis, dermis, or subcutaneous tissue. Skilled and time-consuming counselling is important to give patients support. An almost immediate reduction in inflammatory episodes from 80.4% to 8.6% shows up within 2 or 3 weeks, and therefore, intake of antibiotics can be stopped. The second major response is reduction in the size of the limb. Volume reduction for large-sized limbs at 3 months is 39%, with a confidence interval of 4.9 to 5.9 L.

Integrating modern dermatology and Ayurveda in the treatment of vitiligo and lymphedema in India.

BACKGROUND: Globally, governments have recognized the growing popularity of Complementary and Alternative Medicines and the possibility of their combined use with biomedicine. Decisions within the Government of India have led to a conducive environment for conducting clinical studies, to achieve integration of more than one system of medicine, so that their combined benefits can be brought to bear on chronic, difficult-to-treat conditions. AIM: To develop integrative dermatology treatment protocols for patients with long-standing skin diseases who have received treatment from many centers. MATERIALS AND METHODS: A team of doctors from modern dermatology, Ayurveda, yoga therapy, and homeopathy studied recruited patients to develop mutual orientation on each therapeutic system and a working knowledge of approach to their clinical diagnosis. Six-hundred thirty-eight patients affected by lower limb lymphedema requiring skin care as a major part of treatment were treated integrating modern dermatology and Ayurveda. Three-hundred eighty-one vitiligo patients were examined and treated to understand the clinical presentations and treatment options in Ayurveda. RESULTS: A two-step cluster analysis performed by SPSS Version 16 showed average volume reductions of 13.3% and 23% on day 14, 19.7% and 31.1% on day 45, and 23.4% and 39.7% on day 90 of treatment in small and large lymphedematous limbs. Inflammatory episodes before the onset on this treatment was reported by 79.5% of our lymphedema patients, and 9.4% reported this at the end of three months after our treatment. Among vitiligo patients, we found that 39.6% of patients had kapha, 39.8% pitta, 10.8% had vatha and 0.52% has tridoshaja presentation. There are over 100 treatment options available in Ayurveda to treat vitiligo. DISCUSSION: Each system of medicine recognizes the same disease albeit with minor difference in description. Skin care procedures like washing and emollients restore the barrier function and skin health. We have converged Ayurvedic skin care with that of dermatology with an aim of achieving patient management that is better than that achievable by a single system alone. Overload of the lymphatic system due to loss of epidermal barrier function and consequent inflammation from bacteria and soil irritants is responsive to selected Ayurvedic herbal preparations. CONCLUSION: It is evident that integration at the therapeutic level is possible, although the pathological basis is interpreted differently. Irrespective of background understanding of the given disease, a mutually oriented multisystem therapeutic team was able to effectively use medicines from more than one system of medicine and to develop guidelines for their prescription and a patient care algorithm.

Conducting literature searches on Ayurveda in PubMed, Indian, and other databases.

BACKGROUND: Literature searches for articles on Ayurveda provide special challenges, since many of the Indian journals in which such articles appear are not indexed by current medical databases such as PubMed and Cochrane Central Register of Controlled Trials. AIM: The aim of this study was to develop a comprehensive search strategy on Ayurveda topics and to map the existing databases containing Ayurveda journal publications. METHODS: We have developed a literature search procedure that can recover the great majority of articles on any given topic associated with Ayurveda. RESULTS: Our system is formulated in an easily reproducible fashion that all researchers can use. Using the keywords related to Ayurveda and vitiligo, we searched 41 databases that may contain complementary and alternative medicine publications. Only 11 databases yielded results; PubMed contained 9 articles. Each of 14 other databases named in our search procedure averaged 23 articles. International Bibliographic Information of Dietary Supplements, for example, gave 22, of which 1 satisfied our eligibility criteria. "Annotated Bibliography of Indian Medicine" gave 47, of which 7 satisfied eligibility criteria. CONCLUSIONS: This article proposes guidelines enabling comprehensive searches to locate all types of Ayurvedic articles, not necessarily only randomized controlled trials.

A protocol for systematic reviews of Ayurveda treatments.

This protocol is intended primarily for Ayurveda doctors who wish to take up systematic reviews along with an expert who has experience in doing such reviews. We have structured this protocol by incorporating the principles of patient treatment in Ayurveda, within the Cochrane framework, using Vitiligo as a model. The treatment section provides a comprehensive list of classical medicines used in the treatment of the disease. This will help in increasing the search terms. Such a list also helps to determine the needs of individualized treatment principles used in the trial and to assess the confounding factors. The search strategy includes an extensive listing of eastern data bases and hand searching. In Ayurveda, the titles of articles are not in the Population, Intervention, Control, and Outcome (PICO) pattern and sometimes the title and methodology do not tally. Therefore, a search of all types of studies is necessary to pool all the relevant publications. A data extraction form is proposed for use in assessing the quality of Ayurvedic studies. The form provides a template for performing evidence reviews of Ayurvedic interventions.

Evidence-based approaches for the Ayurvedic traditional herbal formulations: toward an Ayurvedic CONSORT model.

This paper considers the problem of evaluating multimodal integrative medicine treatments for complex pathologic conditions. The example is given of evaluation of highly successful treatments of lymphedema using Ayurvedic and Yoga medicine practices together with modern medicine. For a framework to evaluate such a complex intervention, we base our proposal on Consolidated Standards of Reporting Trials (CONSORT) guidelines.