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ORIGINAL ARTICLE
Year : 2013  |  Volume : 1  |  Issue : 1  |  Page : 15-21

Effectiveness of an integrative whole-system approach to the treatment of Gṛdhrasi: An observational study


1 Centre for Clinical Research, Institute of Trans-Disciplinary Health Sciences and Technology (IHST-FRLHT), Bangalore, Karnataka, India
2 Swami Vivekananda Yoga Anusandhana Samsthana, Bangalore, Karnataka, India
3 I AIM Health care Centre (IHC), Institute of Ayurveda and Integrative medicine, Bangalore, Karnataka, India

Date of Web Publication23-May-2013

Correspondence Address:
Gopinath G Gangadharan
Additional Director, Institute for Ayurveda and Integrative Medicine (I AIM) 74/2, Jarakabande Kaval, Attur Post, Yelahanka, Bangalore - 560 106
India
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Source of Support: None, Conflict of Interest: None

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   Abstract 

Background: Gṛdhrasi correlates with "Lumbago with Sciatica." Disease complexity suggests that integrative whole-system Āyurvēda treatment combining external and internal therapies will optimize patient care. Objectives: The aim was to evaluate the effectiveness of an integrative whole-system Āyurvēda treatment approach to the management of pain and disability in Gṛdhrasi patients. Study Design: An observational study using standard monitoring procedures. Materials and Methods: Fifty-four Gṛdhrasi patients (age range 41.53 ± 1.71 years, M: F 27:27, mean duration of illness 18.51 ± 4.36 months) receiving individualized treatments at the Integrative Healthcare Center were recruited. Subjects were assessed at the outset, and after each period of treatment using visual analog scale (VAS), straight leg-raising test (SLR), and Roland Morris disability questionnaire (RMDQ). Statistical analysis used Microsoft Excel and SPSS 16.0. Results: Following initial consultations, 16 subjects dropped out. Of the 38 remaining, 68.4% showed significant improvements in pain and disability, 18.4% were borderline non-responders, and 13.2% failed to respond to treatment. There was a statistically significant reduction in the pain (VAS) (F = 62.53, P < 0.0001) and measures of disability (RMDQ) (F = 17.14, P = 0.018). Leg-raising as assessed by SLR also improved significantly for both the legs (P < 0.001). Conclusion: The results of the current observational study are encouraging despite the small size of the group; further clinical trials using a similar integrative whole-system approach for the management of Gṛdhrasi are warranted.

Keywords: Āyurvēda, Gdhrasī, integrative whole-system approach, lumbago with sciatica


How to cite this article:
Shruthi C, Sriranjini JS, Alex H, Vivek Sanker KM, Gangadharan GG. Effectiveness of an integrative whole-system approach to the treatment of Gṛdhrasi: An observational study. ASL Muscuskel Dis 2013;1:15-21

How to cite this URL:
Shruthi C, Sriranjini JS, Alex H, Vivek Sanker KM, Gangadharan GG. Effectiveness of an integrative whole-system approach to the treatment of Gṛdhrasi: An observational study. ASL Muscuskel Dis [serial online] 2013 [cited 2017 Mar 27];1:15-21. Available from: http://msd.ancientscienceoflife.org/text.asp?2013/1/1/15/111929


   Introduction Top


Gṛdhrasī, an Āyurvēda disease category, is characterized by severe pain originating in the katī pradēśa (lumbosacral region) and radiating toward the pratyaṅgulī (toes) of the affected leg, resulting in a typical gait resembling that of a gṛdhra (vulture). On the basis of these signs and symptoms, Gṛdhrasī is correlated to Lumbago with Sciatica caused by a disorder of the sciatic nerve root[1] and having a prevalence ranging from 1.2% to 43%.[2]

In general, cost effective, efficacious management of Gṛdhrasī/sciatica and its associated conditions like lower back pain (LBP), remains a major challenge to modern healthcare systems.[3] Chronic symptoms like these are seldom satisfactorily addressed by Western biomedicines, hence patients often seek complementary therapies.[1] According to the US 2007 National Health Interview Survey, back pain and related conditions are top reasons for use of complementary and alternative medicine (CAM), in which several specialized systems for treating back problems exist.[4] Since LBP and its complications are so common, an immense amount of research is published on various treatments, including major reviews of conservative treatment,[5] bed rest,[6] and keeping the patient active.[7] Evaluating the potential of integrative Āyurvēda therapies in this area is therefore of value to medical practice worldwide.

Few studies have been conducted on Āyurvēda management of Gṛdhrasī, all focused on single treatments like matrāvasti, katīvasti, and agnikarma.[8],[9],[10] From these, it is evident that no effective Āyurvēda therapy for degenerative pathologies like Gṛdhrasī can consist of a single treatment. The complexity and multidimensional nature of the pathology necessitates appropriate combinations of treatments based on the patients' presentation and can be expected to produce greater benefit than any single therapy.[3] In addition, routine Āyurvēda clinical practice utilizes personalized combinations of internal medication and external therapies, precisely tailored to meet the needs of the individual.[11] However, the effects of such individualized combinations are seldom reported, partly because the ascendancy of randomized controlled clinical trials (RCTs) in recent decades has changed the expected clinical reporting. RCT designs, although considered a gold standard for evaluating the effect of single-component interventions, severely limit an overall assessment of Āyurvēda as practiced in real-life clinical situations.[12] The insistence on such prospective trials has also undermined observational therapeutics. Observational studies, however, are very appropriate for Āyurvēda and would provide a wealth of information if conducted rigorously.[13]

With this in mind, the current study was undertaken to evaluate the effectiveness of an integrative whole-system Āyurvēda approach to the management of pain and disability in Gṛdhrasī being followed at our Integrative Healthcare Center (IHC). Integrative at our institute is defined as Āyurvēda being the crux of the treatments, ably supported by allied systems like allopathy, yoga, and physiotherapy; but, in the current study, no allopathic intervention was used. The study observed a relatively small group of Gṛdhrasī patients and monitored their changes in symptoms like pain, range of movement of affected limb, and quality of life measures.


   Materials and Methods Top


Study design

An observational study wherein measures were repeated after individualized treatment period.

Setting

The OP and IP departments of the IHC between May 2011 and February 2012.

Subjects

Patients diagnosed to have clinical symptoms of Gṛdhrasī/sciatica.

Inclusion criteria

Agreement to participate and sign informed consent forms.

Intervention

The internal medications and external therapies administered varied between the patients based on the consulting physicians' opinion. In addition, all patients received physiotherapy. The aim was to monitor them for a minimum period of 30 days.

Measured variables

Pain level measured by visual analog scale (VAS),[14] level of domestic disabilities assessed by the Roland Morris disability questionnaire (RMDQ),[15] and the range of motion, as measured by the straight leg-raising (SLR) test.[16]

Blinding

The observer/rater was not involved in the treatment prescribed for each patient.

Sample size calculation

Being the first study of its kind undertaken at the Center, a formal sample size calculation was not possible. It was therefore planned a priori to include all patients who consented to repeat observations over the study period.

Statistical analysis

An intent to treat analysis of recorded measurements with the last observation carried forward (LOCF) protocol was adopted. Repeated measures of analysis of variance (RMANOVA) with Bonferroni's adjustment was used to work out the changes in clinical variables. Microsoft Excel and SPSS 16.0 were used for the analysis. Values are presented as Mean ± SEM.


   Results Top


Fifty-four patients were selected for the study and were given consultations by concerned physicians at the center. Of these, 10 did not report back and another 6 were unrecorded and therefore treated as dropouts. The remaining 38 patients were included for analysis. Of these, 22 patients completed the minimum recommended 30 days of treatment; of the remaining patients, 11 did not report back for further treatments, reasons for the same is unknown and 5 patients were lost at follow-up due to the lack of internal communication to the concerned researcher [Figure 1]. Mean age of the patients was 41.53 ± 1.74 years, the numbers of male and female patients were equal (-27 each). Duration of illness ranged from 0.25 to 108 months (mean 18.51 ± 4.36 months), mean duration of first and second periods of treatment were 17.50 ± 1.13 and 22.60 ± 1.37 days, respectively. Highly skewed statistics on duration of disease required us divide patients into acute (<6 months, 21 patients) and chronic (>6 months, 17 patients) groups. For acute patients, the mean duration of illness was 2.08 ± 0.39 months, for chronic patients, it was 38.82 ± 7.17 months. Patients were also classified as “responders” to treatment (decreased VAS score > 3 units, 26 patients) and “non-responders” (decreased VAS score ≤ 3 units, 12 patients).
Figure 1: Participant flow-chart

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Prescribed medications were either classical Āyurvēda formulations cited in the Ayurvedic Formulary of India (AFI)[17] or various Āyurvēda company products. All patients were treated with both internal and external medications.[18] The most prescribed external therapies and internal medication have been presented as [Figure 2]a and b. Physiotherapy was administered as advised by the consulting therapist and mainly included electrotherapy (interferential therapy, transcutaneous electrical nerve stimulation, shortwave diathermy), ultrasonic therapy, exercise therapy, and traction.
Figure 2: Most common Āyurvēda treatment modalities used a) SK ‑ Sahacarādi ka?āya, GHT ‑ Gandharvahastādi taila, ST ‑ Sahacarādi taila, GK ‑ Guggulu kalpa, CT ‑ Cincādi taila, BA ‑ Balāriṣṭa, REK ‑ Rāsnaeraṇdādi ka?āya; b) Ab ‑ Abhyaṅ ga, PPS ‑ Patra piṇḍ a sveda, KB ‑ Kaṭ ī vasti, DD ‑ Dhānyāmladhara, Pi ‑ picu, AB ‑ Anuvāsana basti, SSPS ‑ Ṣaṣṭika?āli piṇḍa sveda

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Clinical results

Improvements in VAS pain scores were statistically significant: Mean score before treatment (BT) (8.03 ± 0.21) reduced to 4.79 ± 0.35 and 3.58 ± 0.31 at the end of first (F1) and second (F2) follow-up, respectively, with RMANOVA F value of 62.53 and P < 0.0001. Post hoc analysis with Bonferroni's adjustment indicated significant differences across all time points (BT vs. F1 - t = 3.24, BT vs. F2 - t = 4.53, F1 vs. F2 - t = 1.29; P < 0.05). Significant results were obtained even on classifying the patients based on the duration of illness as acute and chronic [Figure 3]a.

Significant improvement in RMDQ scores was also observed. Mean score before treatment of 16.82 ± 0.54, which was reduced to 12.39 ± 0.84 and 10.82 ± 0.83 at the end of F1 and F2 follow-up, respectively, with F value of 17.14 and P = 0.018. Post hoc analysis with Bonferroni's adjustment indicated significant differences at two time points (BT vs. F1 - t = 4.16, BT vs. F2 - t = 5.65; P < 0.05). Here, the improvements were significant in both the acute and chronic groups [Figure 3]b.
Figure 3: Effect of integrative Āyurvēda treatment modalities on clinical variables: a) visual analog scale (VAS); b) Roland Morris disability questionnaire (RMDQ); c) straight leg raising (SLR) right leg; d) straight leg raising (SLR) left leg; BT   Before treatment, F1 – Follow up 1, F2 – Follow up 2, Ac   Acute, Ch  Chronic

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The SLR test was affected on the right for 26 patients and left for 19 patients, with a mean angle of 44° for the right leg and 46° for the left leg approximately. After the first period of treatment, these had significantly improved to 62° for the right (P < 0.0001) and 66° for the left leg (P < 0.0001). Small improvements were also seen over the later periods of treatment, although not very significant [Figure 3]c and d.

In view of the acute/chronic differences, the patients were split up into the four categories: acute responders (n = 11), chronic responders (n = 15), acute non-responders (n = 10), and chronic non-responders (n = 2). Observations of interest on non-responders were as follows:

  1. Most (n = 10) patients belonged to the acute group (10/21), while only 2 belonged to the chronic group (2/17), the contingency table of these two ratios has a significance of P = 0.0336 (Fisher's Exact test), therefore we can safely say that treatments were more effective for the chronic group.
  2. Seven of the 12 patients were only borderline non-responders and recorded moderate decreases in both VAS and RMDQ scales. Only 3 non-responders had two courses of treatment; their decreases in VAS scores were 5 to 2 (60%), 8 to 5 (37.5%), and 7 to 5 (28%), respectively.
  3. Of the 9 non-responders who completed one course of treatment, only one recommended 30-days treatment, and his decrease in VAS score was 3 (43%).
  4. Reclassifying non-responders as < 33% reduction in VAS score reduced their numbers to six. Only one was a borderline non-responder; none of the remaining five completed the recommended 30-days treatment.


To summarize, only one patient who completed the prescribed 30-days treatment had a reduction in VAS score of < 33%.


   Discussion Top


The current study observed a group of patients undergoing a wide variety of Āyurvēda treatment options for Gṛdhrasī and reported the rates of success/failure for different subgroups. Previously, 3 studies of 4 specific Āyurvēda treatments for Gṛdhrasī have been published (PubMed database).[8],[9],[10] While these studies represent a good beginning, they do not do justice to the richness of treatment options in Āyurvēda for Gṛdhrasī nor to the multiplicity of treatments typically used in each case in actual practice. From our study, it was observed that by averaging over a larger variety of Āyurvēda treatments, a better estimate of outcome measure for the treatment of Gṛdhrasī was possible.

The study provides clear clinical evidence for Āyurvēda, demonstrating that scientifically useful clinical data can be obtained in the course of normal Āyurvēda practice. It thus emphasizes that data on effectiveness of Āyurvēda treatment modalities is not difficult to generate. The study, though novel to Āyurvēda research, was limited by shortcomings in design and became apparent while conducting the study. E.g., sample size evaluation was not possible, it included all patients registering for treatment, so there were no exclusion criteria; being just an observational study, also, treatment duration varied from patient to patient. Finally, many patients were lost to follow-up for various reasons. The diagnosis was restricted to clinical evidence of sciatica alone and more robust imaging techniques to evaluate the presence/extent of disc herniation were not adopted.

A perusal of Āyurvēda studies published on PubMed showed that single treatment options have been tested for their effectiveness on Gṛdhrasī patients. Bali et al.,[10] conducted an RCT on 40 Gṛdhrasī patients comparing the effectiveness of katīvasti with the pain-relieving procedure of agnikarma (pañcadhātu śalāka). They found that agnikarma gave better results in pain relief (80%) and SLR (95%). Babita et al.,[9] conducted a comparative study on different types of agnikarma śalāka on 22 patients and found tāmradhātu śalāka to be more effective (57%) than two other types. Mumtaz et al.,[8] compared the effect of śamana therapy alone with śamana therapy and matrā basti for 17 patients and 50 patients, respectively. The addition of matrā basti was found to improve results of treatment, which the authors suggested was due to its efficacy against vāta aggravation, of which pain is a symptom.

In our study, it was observed that two periods of treatment were sufficient to significantly reduce the pain in most patients completing them. Patients with lower response in one period generally responded more in the other period, so that the distribution of overall reduction in pain points was satisfactory. Similarly, the treatment survey identified 7 medications and 7 modalities of treatment most commonly used in as many combinations as patients studied [Figure 2]a and b. This contrasts strongly with previous kinds of clinical study. A possible evaluation of the mechanism of action of the treatments involved has been attempted based on available literature from Āyurvēda classics and contemporary research. Samprāptivighaṭana or disrupting the pathogenesis is the crux of Āyurvēda treatments. In contemporary medicine also, compression, inflammation, and immune factors are considered as part of the pathogenesis of sciatica,[19] and treatments are multidisciplinary in nature.[20] Gṛdhrasī involves aggravated vāta dōṣa, either alone or together with kapha, demonstrating symptoms like pain, stiffness, and weakness. The effectiveness of the therapies is due to its multipronged nature whereby it possibly (a) reduces pain (śῡla)[22] and (b) promotes strength[23] (balya) of affected structures (Refer Appendix 1[Additional file 1]).

Until date, Āyurvēda has been dogged by paucity of credible published evidence. Inappropriateness of RCT's to evaluate individualized treatments poses Āyurvēda the challenge of developing effective clinical trial designs that can evaluate the efficacy of its treatments. The present approach offers a solution that promises to provide clinicians with a greater choice of evidence-based treatments and thus more robust management strategies. The current study is, to the best of our knowledge, the first to evaluate effectiveness of multimodal personalized Āyurvēda treatment strategies in a true clinical setting. Since it was not possible at this stage to identify reasons for failure by individual patients to respond to treatment, this should be investigated in future. Reasons why those totally cured responded so well and were treated successfully, also needs investigation. Such studies will enable treatment to be optimized and ensure that pain and disability are better reduced in more patients. Encouraging patients who feel discouraged by lack of instant results may well be an important factor in such a program.

Central questions when conducting clinical trials included “What percentage of patients obtain benefits?,” and “How much benefit can be expected?” For Āyurvēda, which habitually uses individualized multiple treatments, these questions are better answered by the kind of observation and analysis given in this study, than by many RCT's on individual therapies that only form a part of total treatments. This paper presents a new kind of analysis of evidence for the effectiveness of Āyurvēda treatments, which can assess overall effects of an intervention without setting fixed primary or secondary endpoints,[21] as a means to frame outcomes and judge them. Previously, there has been a relative poverty of published clinical evidence in Āyurvēda, but this study demonstrates that, if normal clinical records are kept for each patient, the data can be scientifically useful. It can result in studies that simultaneously evaluate the effectiveness of multiple treatment regimes, and thus generate valuable clinical evidence for Āyurvēda as a system of medicine.


   Conclusion Top


Almost every Gṛdhrasī patient who completed the prescribed course of treatment following the integrative treatment approach experienced a significant lowering of pain and increased number of abilities relevant to life at home. Some patients made spectacular improvements, showing total reduction in pain and disability. Failure to respond to full treatment recommended was only 5%. From these results, it follows that patients need to be encouraged to continue treatment. Individualized, integrative Āyurvēda treatment is therefore effective against Gṛdhrasī. The results are encouraging and warrant further well-designed observational studies using similar integrative whole-system approaches, and, to further substantiate the findings, carefully designed RCTs with larger study populations may be conducted.

 
   References Top

1.Pinto RZ, Maher CG, Ferreira ML, Ferreira PH, Hancock M, Oliveira VC, et al. Drugs for relief of pain in patients with sciatica: Systematic review and meta-analysis. BMJ 2012;344:e497.  Back to cited text no. 1
    
2.Konstantinou K, Dunn KM. Sciatica: Review of epidemiological studies and prevalence estimates. Spine (Phila Pa 1976) 2008;33:2464-72.  Back to cited text no. 2
    
3.Maiers MJ, Westrom KK, Legendre CG, Bronfort G. Integrative care for the management of low back pain: Use of a clinical care pathway. BMC Health Serv Res 2010;10:298.  Back to cited text no. 3
    
4.Kohatsu W. In: Rakel D, editor. Integrative Medicine. Philadelphia: WB Saunders; 2007. p. 687-96.  Back to cited text no. 4
    
5.Vroomen PC, de Krom MC, Slofstra PD, Knottnerus JA. Conservative treatment of sciatica: A systematic review. J Spinal Disord 2000;13:463-9.  Back to cited text no. 5
    
6.Hagen KB, Jamtvedt G, Hilde G, Winnem MF. The updated cochrane review of bed rest for low back pain and sciatica. Spine (Phila Pa 1976) 2005;30:542-6.  Back to cited text no. 6
    
7.Hagen KB, Hilde G, Jamtvedt G, Winnem MF. The cochrane review of advice to stay active as a single treatment for low back pain and sciatica. Spine (Phila Pa 1976) 2002;27:1736-41.  Back to cited text no. 7
    
8.Ali M, Shukla VD, Dave AR, Bhatt NN. A clinical study of Nirgundi Ghana Vati and Matra Basti in the management of Gridhrasi with special reference to sciatica. Ayu 2010;31:456-60.  Back to cited text no. 8
[PUBMED]  Medknow Journal  
9.Bakhashi B, Gupta SK, Rajagopala M, Bhuyan C. A comparative study of Agni karma with Lauha, Tamra and PanchadhatuShalakas in Gridhrasi (Sciatica). Ayu 2010;31:240-4.  Back to cited text no. 9
[PUBMED]  Medknow Journal  
10.Bali Y, Vijayasarathi R, Ebnezar J, Venkatesh B. Efficacy of Agnikarma over the padakanistakam (little toe) and Katibasti in Gridhrasi: A comparative study. Int J Ayurveda Res 2010;1:223-30.  Back to cited text no. 10
    
11.Sumantran VN, Tillu G. Insights on personalized medicine from ayurveda. J Altern Complement Med 2012.  Back to cited text no. 11
    
12.Patwardhan B. Ayurveda GCP Guidelines: Need for freedom from RCT ascendancy in favor of whole system approach. J Ayurveda Integr Med 2011;2:1-4.  Back to cited text no. 12
    
13.Vaidya R. Observational therapeutics: Scope, challenges, and organization. J Ayurveda Integr Med 2011;2:165-9.  Back to cited text no. 13
    
14.Scott J, Huskisson EC. Graphic representation of pain. Pain 1976;2:175-84.  Back to cited text no. 14
    
15.Roland M, Morris R. A study of the natural history of back pain. Part I: Development of a reliable and sensitive measure of disability in low-back pain. Spine (Phila Pa 1976) 1983;8:141-4.  Back to cited text no. 15
    
16.Speed C. Low back pain. BMJ 2004;328:1119-21.  Back to cited text no. 16
    
17.The Ayurvedic Formulary of India. New Delhi: Department of Indian Systems of Medicine and Homeopathy, Ministry of Health and Family Welfare, Government of India; 2003.  Back to cited text no. 17
    
18.Vaidya HS. Ayurvediya Panchakarma Vijnana. 5. Nagpur: Sri Baidyanath Ayurveda Bhavan; 1997.  Back to cited text no. 18
    
19.Stafford MA, Peng P, Hill DA. Sciatica: A review of history, epidemiology, pathogenesis, and the role of epidural steroid injection in management. Br J Anaesth 2007;99:461-73.  Back to cited text no. 19
    
20.Koes BW, van Tulder MW, Peul WC. Diagnosis and treatment of sciatica. BMJ 2007;334:1313-7.  Back to cited text no. 20
    
21.Herman PM, Craig BM, Caspi O. Is complementary and alternative medicine (CAM) cost-effective? A systematic review. BMC Complement Altern Med 2005;5:11.  Back to cited text no. 21
    
22.Acharya Charaka, Acharya Drdhabala, Acharya Chakrapanidatta. The Charaka samhita of Agnivesha. Varanasi: Munshiram Manoharlal Publishers Pvt. Ltd; 1992.  Back to cited text no. 22
    
23.Acharya Sushruta, Acharya Dalhanacharya, Acharya Gayadasacharya. Sushruta samhita. Varanasi: Krishnadas Academy; 1998.  Back to cited text no. 23
    


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