Search JIM Advanced Search

Journal of Integrative Medicine ›› 2014, Vol. 12 ›› Issue (1): 13-19.doi: 10.1016/S2095-4964(14)60009-1

• Research Article • Previous Articles     Next Articles

Developing the criteria for evaluating quality of individualization in homeopathic clinical trialreporting: A preliminary study

Subhranil Sahaa, Munmun Koleya, Subhasish Gangulyb, Prasanta Rathc, Pulak Roy Chowdhuryd, Seikh Intaj Hossaine   

  1. Clinical Research Unit (Homeopathy), Central Council for Research in Homeopathy, Siliguri 734006, West Bengal, India
    Department of Organon of Medicine and Homeopathic Philosophy, D N De Homeopathic Medical College and Hospital, Kolkata 700046, West Bengal, India
    Department of Community Medicine, National Institute of Homeopathy, Kolkata 700114, West Bengal,India
    Upasana Diagnostic Center, Salt Lake City, Kolkata 700064, West Bengal, India
    Paikpari Block Primary Health Center, District Purba Medinipur 721134, West Bengal, India
  • Received:2013-12-04 Accepted:2013-12-20 Online:2014-01-10 Published:2014-01-15


This study describes the development of a preliminary version of an instrument that attempts to assess the quality of reports of individualized homeopathic prescriptions in clinical trials and observational studies. 


A multidisciplinary panel of 15 judges produced an initial version of the instrument through iterative Delphi rounds and pilot-tested the instrument on five clinical trials. Later they assessed, under blind conditions, the individualization quality of 40 randomly-selected research reports. The final version of the instrument included six criteria. These items were scored consistently by all the raters regardless of background. 


The instrument appeared to have adequate face and content validity, acceptable internal consistency or reliability (Cronbach’s α 0.606-0.725), significant discriminant validity (F = 398.7; P < 0.000 1), moderate interrater reliability (Fleiss κ 0.533), agreeable test-retest reliability (Cohen’s κ 0.765-0.934), moderate sensitivity (0.4; 95% confidence interval 0.253-0.566), and high specificity (1.0; 95% confidence interval 0.891-1.000). 


The initial data suggest that this instrument may be a promising systematic tool amendable for further development.

Key words: Clinical trials, Consensus, Delphi, Homeopathy, Individualization, Reliability, Validity

[1] Blackstone V . Single or multiple medicine prescribing-a debate[J]. Br Hom J, 1993,82:37-52
doi: 10.1016/S0007-0785(05)80952-4
[2] Linde K, Melchart D . Randomized controlled trials of individualized homeopathy: a state-of-the-art review[J]. J Altern Complement Med, 1998,4(4):371-388
doi: 10.1089/act.1998.4.371 pmid: 9884175
[3] Klejnen J , Knipschild P, ter Riet G.Clinical trials of homeopathy[J]. BMJ, 1991,302(6772):316-323
doi: 10.1136/bmj.302.6772.316
[4] Linde K, Clausius N, Ramirez G, Melchart D, Eitel F, Hedges LV, Jonas WB . Are the clinical effects of homeopathy placebo effects? A meta-analysis of placebo-controlled trials[J]. Lancet, 1997,350(9081):834-843
doi: 10.1016/S0140-6736(97)02293-9
[5] Mathie RT, Hacke D, Clausen J, Nicolai T, Riley DS, Fisher P . Randomized controlled trials of homeopathy in humans: characterising the research journal literature for systematic review[J]. Homeopathy, 2013,102(1):3-24
doi: 10.1016/j.homp.2012.10.002
[6] Saha S, Koley M . Homeopathic treatment of headaches and migraine: a meta-analysis of the randomized controlled trials[J]. Asian J Pharm Clin Res, 2013,6(Suppl. 3):194-199
[7] Koley M, Saha S, Arya JS, Choubey G, Ghosh S, Purkait R, Mondal R, Kundu B, Mukherjee R . A study on drug utilization and prescription habits of physicians in a government homeopathic hospital in West Bengal, India[J]. J Integr Med, 2013,11(5):305-313
doi: 10.3736/jintegrmed2013048
[8] Brien SB, Harrison H, Daniels J, Lewith G . Monitoring improvement in health during homeopathic intervention. Development of an assessment tool based on Hering’s Law of Cure: the Hering’s Law Assessment Tool(HELAT)[J]. Homeopathy, 2012,101(1):28-37
doi: 10.1016/j.homp.2011.10.002
[9] Harrison H. . The development and use of Hering’s Law Assessment Tool (HELAT) in clinical trials. Homoeopathy Research Institute (HRI) Research Article. 2012; (18). [2012-12-27]. 2012-12-27]. .
[10] Yousuf MI. Using experts’ opinion through Delphi technique. Practical Assessment, Research and Evaluation. 2007; 12(4). [2012-12-12]. THER].Yousuf MI. Using experts’ opinion through Delphi technique. Practical Assessment, Research and Evaluation. 2007; 12(4).2012-12-12]. .
[11] Kalaian SA, Kasim RM. Terminating sequential Delphi survey data collection. Practical Assessment, Research and Evaluation. 2012; 17(5). 2012-12-12]. .
[12] Hsu CC, Sandford BA. The Delphi technique: making sense of consensus. Practical Assessment, Research and Evaluation. 2007; 12(10).[ 2012-12-12]. .
[13] Ferri CP, Prince M, Brayne C, Brodaty H, Fratiglioni L, Ganguli M, Hall K, Hasegawa K, Hendrie H, Huang Y, Jorm A, Mathers C, Menezes PR, Rimmer E, Scazufca M; Alzheimer’s Disease International . Global prevalence of dementia: a Delphi consensus study[J]. Lancet, 2005,366(9503):2112-2117
doi: 10.1007/BF03075138 pmid: 16360788
[14] Landis JR, Koch GG . The measurement of observer agreement for categorical data[J]. Biometrics, 1977,33(1):159-174
doi: 10.2307/2529310
[15] Linstone HA . The Delphi technique. Fowles RB.Handbook of future research[M]. Westport: Greenwood, 1978: 273-300
[16] Chalmers TC, Smith H, Blackburn B, Silverman B, Schroeder B, Reitman D, Ambroz A . A method for assessing the quality of a randomized control trial[J]. ControlIed Clin Trials, 1981,2(1):31-49
doi: 10.1016/0197-2456(81)90056-8 pmid: 7261638
[17] Jadad AR, Moore RA, Carroll D, Jenkinson C, Reynolds DJM, Gavaghan DJ, McQuay HJ. Assessing the quality of reports of randomized clinical trials: is blinding necessary? Controlled Clin Trials. 1996; 17(1):1-12.
doi: 10.1016/0197-2456(95)00134-4 pmid: 872179710001000
[18] Polit DF, Beck CT. Nursing research: generating and assessing evidence for nursing practice. 8th ed. Philadelphia: Lippincott Williams &THER].Polit DF, Beck CT. Nursing research: generating and assessing evidence for nursing practice. 8th ed. Philadelphia: Lippincott Williams &Wilkins. 2008.
doi: 10.1016/j.nepr.2013.04.001
[19] . Rose-Grippa MK, Haber J, LoBiondo-Wood G, Gorney-Moreno MJ. Nursing research: methods, critical appraisal and utilization. 4th ed. St. Louis:Mosby. 1998.
[20] Linstone HA, Turoff M. The Delphi method: Techniques and applications. Reading, MA:Addison-Wesley. 1975.
[21] Dalkey NC, Helmer O. An experimental application of the Delphi method to the use of experts (Report No. RM-727-PR)( Abridged). . Santa Monica, CA: the RAND Corporation. 1962.
[22] Hasson F, Keeney S , McKenna H.Research guidelines for the Delphi survey technique[J]. J Adv Nurs, 2000,32(4):1008-1015
doi: 10.1046/j.1365-2648.2000.t01-1-01567.x pmid: 11095242
[23] Keeney S, Hasson F , McKenna H.Consulting the oracle: ten lessons from using the Delphi technique in nursing research[J]. J Adv Nurs, 2006,53(2):205-212
doi: 10.1111/jan.2006.53.issue-2
[1] Mikhail Teppone. Medicine has always been “Modern” and “Scientific” from ancient times to the present day. Journal of Integrative Medicine, 2019, 17(4): 229-237.
[2] Arthur Yin Fan, Hui Ouyang, Xinru Qian, Hui Wei, David Dehui Wang, Deguang He, Haihe Tian, Changzhen Gong, Amy Matecki, Sarah Faggert Alemi. Discussions on real-world acupuncture treatments for chronic low-back pain in older adults. Journal of Integrative Medicine, 2019, 17(2): 71-76.
[3] Ubiratan Cardinalli Adler, Ana Carolina Acorinte, Fernando Oliveira Calzavara, Adriano Andréda Silva, Amarilys de Toledo Cesar, Maristela Schiabel Adler, Edson Zangiacomi Martinez, José Carlos Fernandes Galduróz. Double-blind evaluation of homeopathy on cocaine craving: A randomized controlled pilot study. Journal of Integrative Medicine, 2018, 16(3): 178-184.
[4] Shubha Singhal, Vandana Roy. Awareness, practice and views about integrating AYUSH in allopathic curriculum of allopathic doctors and interns in a tertiary care teaching hospital in New Delhi, India. Journal of Integrative Medicine, 2018, 16(2): 113-119.
[5] Shahnaz Karkon Varnosfaderani, Fataneh Hashem-Dabaghian, Gholamreza Amin, Mahbubeh Bozorgi, Ghazaleh Heydarirad, Esmaeil Nazem, Mohsen Nasiri Toosi, Seyed Hamdollah Mosavat. Efficacy and safety of Amla (Phyllanthus emblica L.) in non-erosive reflux disease: A double-blind, randomized, placebo-controlled clinical trial. Journal of Integrative Medicine, 2018, 16(2): 126-131.
[6] Salvatore Chirumbolo, Geir Bjørklund. Homeopathic potencies of Arnica montana L. change gene expression in a Tamm-Horsfall protein-1 cell line in vitro model: The role of ethanol as a possible confounder and statistical bias. Journal of Integrative Medicine, 2017, 15(4): 255-264.
[7] Saeed Ahmad, Tayyeba Rehman, Waheed Mumtaz Abbasi. Effects of homoeopathic ultrahigh dilutions of Aconitum napellus on Baker's yeast-induced fever in rabbits. Journal of Integrative Medicine, 2017, 15(3): 209-213.
[8] Jin Yu, Chao-qin Yu, Qi Cao, Li Wang, Wen-jun Wang, Li-rong Zhou, Jing Li, Qiao-hong Qian. Consensus on the integrated traditional Chinese and Western medicine criteria of diagnostic classification in polycystic ovary syndrome (draft). Journal of Integrative Medicine, 2017, 15(2): 102-109.
[9] Jesmin Mondal, Asmita Samadder, Anisur Rahman Khuda-Bukhsh. Psorinum 6× triggers apoptosis signals in human lung cancer cells. Journal of Integrative Medicine, 2016, 14(2): 143-153.
[10] Santu Kumar Saha, Sourav Roy, Anisur Rahman Khuda-Bukhsh. Ultra-highly diluted plant extracts of Hydrastis canadensis and Marsdenia condurango induce epigenetic modifications and alter gene expression profiles in HeLa cells in vitro. Journal of Integrative Medicine, 2015, 13(6): 400-411.
[11] Subhranil Saha​, Munmun Koley, Jogendra Singh Arya, Gurudev Choubey, Shubhamoy Ghosh​, Subhasish Ganguly​, Aloke Ghosh​, Sangita Saha​, Malay Mundle​. Medicine prescription practices of homeopathic undergraduate students in West Bengal, India. Journal of Integrative Medicine, 2014, 12(1): 7-12.
[12] Munmun Koley, Subhranil Saha, Jogendra Singh Arya, Gurudev Choubey, Shubhamoy Ghosh, Rajib Purkait, Ramkumar Mondal, Bapi Kundu, Rajarshi Mukherjee. A study on drug utilization and prescription habits of physicians in a government homeopathic hospital in West Bengal, India. Journal of Integrative Medicine, 2013, 11(5): 305-313.
[13] Christoph A. Doenitz, Ana Anjos, Thomas Efferth , Tobias Greten, Henry J. Greten. Can heat and cold be parameterized? Clinical data of a preliminary study. Journal of Chinese Integrative Medicine, 2012, 10(5): 532-537.
[14] Soumya Sundar Bhattacharyya, Jayeeta Das, Sreemanti Das, Asmita Samadder, Durba Das, Arnab De, Saili Paul, Anisur Rahman Khuda-Bukhsh. Rapid green synthesis of silver nanoparticles from silver nitrate by a homeopathic mother tincture Phytolacca Decandra. Journal of Chinese Integrative Medicine, 2012, 10(5): 546-554.
[15] Santu Kumar Saha, Sreemanti Das, Anisur Rahman Khuda-Bukhsh. Phenotypic evidence of ultra-highly diluted homeopathic remedies acting at gene expression level: A novel probe on experimental phage infectivity in bacteria. Journal of Chinese Integrative Medicine, 2012, 10(4): 462-470.
Full text



[1] Jun Hu, Jian-ping Liu. Non-invasive physical treatments for chronic/recurrent headache. Journal of Chinese Integrative Medicine, 2008, 6(1): 31
[2] Jun Cai, Hua Wang, Sheng Zhou, Bin Wu, Hua-rong Song, Zheng-rong Xuan. Effect of Sijunzi Decoction and enteral nutrition on T-cell subsets and nutritional status in patients with gastric cancer after operation: A randomized controlled trial. Journal of Chinese Integrative Medicine, 2008, 6(1): 37-40
[3] Min Cheng, Qiong Feng, Shu-wen Qian, Hui Gao, Cui-qing Zhu. Preliminary assay of p-amyloid binding elements in heart-beneficial recipe. Journal of Chinese Integrative Medicine, 2008, 6(1): 68-72
[4] Guo-hong Yuan, Xiao-jing Pang, He-chao Ma. Synergic effects of Danggui Buxue Decoction in reducing toxicity of cytoxan in tumor-bearing mice. Journal of Chinese Integrative Medicine, 2008, 6(1): 83-88
[5] Bo Wang , Wei Yan , Li-hui Hou, Xiao-ke Wu. Disorder of Tiangui (kidney essence) and reproductive dysfunction in patients with polycystic ovary syndrome. Journal of Chinese Integrative Medicine, 2010, 8(11): 1018-1022
[6] Bing Hu , Hong-mei An , Ke-ping Shen , Qin Du. Senescence-inducing effects of Chinese herbal medicine Tenglong Buzhong Decoction on human colon carcinoma LS-174-T cells and the mechanism. Journal of Chinese Integrative Medicine, 2010, 8(11): 1048-1052
[7] Ya-bing Zhou, Jian-er Yu, Jie Wu, Li Bai, Li-li Huo, Xin-guang Zhang, Li-qing Li . Effects of Chinese herbal medicine Bushen Gubiao Recipe on toll-like receptor 4 and CD4 +CD25 +foxp3 +regulatory T cells in mice with recurrent respiratory tract infections. Journal of Chinese Integrative Medicine, 2010, 8(11): 1053-1059
[8] Zhao-guo Li . A discussion of English translation of 1995 and 1997 Chinese National Standards of Traditional Chinese Medical Terminologies for Clinical Diagnosis and Treatment. Journal of Chinese Integrative Medicine, 2010, 8(11): 1090-1096
[9] Zhi-mei Wang, Bin Zhang. A study on translation of ellipses in Huangdi Neijing from perspective of hermeneutic theory. Journal of Chinese Integrative Medicine, 2010, 8(11): 1097-1100
[10] Hui-min Liu, Xian-bo Wang, Yu-juan Chang, Li-li Gu. Systematic review and meta-analysis of randomized controlled trials of integrative medicine therapy for treatment of chronic severe hepatitis. Journal of Chinese Integrative Medicine, 2012, 10(11): 1211-1228