|Year : 2013 | Volume
| Issue : 1 | Page : 9-14
Usefulness of polyherbal Unani formulations on Lequesne Algo-Functional Index of knee osteoarthritis: A pretest and posttest evaluation study
Asfia Tarannum1, Arshiya Sultana2, Khaleequr Rahman3
1 Department of Moalajat (General Medicine), MIJ Unani Medical College, and HARK Hospital, Varsova, Mumbai, Maharashtra, India
2 Department of Amraze Niswan wa Ilmul Qabalat (Obstetrics and Gynecology), National Institute of Unani Medicine, Bangalore, Karnataka, India
3 Department of Ilmus Saidla (Pharmacy), National Institute of Unani Medicine, Bangalore, Karnataka, India
|Date of Web Publication||23-May-2013|
Flat No.002, 6 and 7 Ranganatha Regency, 12th Cross, 2nd Main, Annapoorneshwari Nagar, Bangalore - 560 091, Karnataka
Source of Support: None, Conflict of Interest: None
| Abstract|| |
Objectives: To evaluate the usefulness of a selected polyherbal Unani formulation on Lequesne Algo-Functional Index (AFI) of knee Osteoarthritis (OA). Materials and Methods: Patients (n = 23) diagnosed with OA were recruited from the Nizamia General Hospital, Hyderabad to conduct a prospective, pre- and post-evaluation study. A combination of Unani herbs was given internally twice daily i.e., 3 g powder of Asgandh (1 g), Gule baboona (2 g), Bozidan (1 g), and Suranjan shireen (2 g). Topically, the paste of powdered Suranjan talkh (7 g) along with Roghane baboona (20 ml) was applied over the affected knee-joint, one-hour-twice for 40 days. The main outcome measure was to observe significant reduction in modified Lequesne AFI for knee OA after using the Unani formulations. Results: The mean Lequesne AFI Score pre- and post-test was 9.9 (1.58) and 2.05 (2.06) respectively (P < 0.0001). The mean percentage reduction of Lequense AFI score was 79.29%. Conclusion: The present study, demonstrates that the Unani herbal approach selected for this study are effective in ameliorating the severity of pain and improving knee function in patients suffering with knee OA.
Keywords: Knee osteoarthritis, Lequesne Algo-Functional severity Index, polyherbal Unani formulation
|How to cite this article:|
Tarannum A, Sultana A, Rahman K. Usefulness of polyherbal Unani formulations on Lequesne Algo-Functional Index of knee osteoarthritis: A pretest and posttest evaluation study. ASL Muscuskel Dis 2013;1:9-14
|How to cite this URL:|
Tarannum A, Sultana A, Rahman K. Usefulness of polyherbal Unani formulations on Lequesne Algo-Functional Index of knee osteoarthritis: A pretest and posttest evaluation study. ASL Muscuskel Dis [serial online] 2013 [cited 2020 Aug 14];1:9-14. Available from: http://msd.ancientscienceoflife.org/text.asp?2013/1/1/9/107798
| Introduction|| |
Osteoarthritis (OA) is a chronic degenerative disorder of multi-factorial etiology characterized by loss of articular cartilage, hypertrophy of bone at the margins, sub-chondral sclerosis and range of biochemical and morphological alterations of the synovial membrane and joint capsule.
It is the second most common rheumatological problem and frequent joint disease with prevalence of 22-39% in India.
This is the most common cause of locomotor disability in the elderly. OA is regarded as a complex disease, whose root cause is not completely understood. Furthermore, effective biomarkers, diagnostic aids and imaging technologies are not available to assist in the management of OA. There are also several areas, where information such as epidemiology, pathophysiology, environmental risk factors, genetic predisposition and lifestyle factors are still lacking. It poses a substantial and increasing burden on individuals and the society as a result of population dynamics, impaired health-related quality of life and the socio-economic impact. Radiologic changes occur late in OA and there is limited correlation between changes seen on X-ray and the presence of symptoms such as pain and impaired function. Hence, OA represents a major cause of morbidity and disability, as well as a significant economic burden on patients and health-care resources. Although OA was previously thought to be a progressive, degenerative disorder, it is now known that spontaneous arrest or reversal of the disease can occur.
The humoral imbalance is ascribed as the major cause of all arthritic pains in classical Unani text; OA (Tahajjarul Mafasil) is explained under the title of "Wajaul mafasil." As the joints are empty and subjected to movement and activity, when the morbid matter is redirected from the vital organs towards the joints, it amassed in it. Furthermore, the joints lie in the extremities far away from the heart and have cold temperament. Hence, this matter becomes thick and hard like a lime stone, especially, if the Akhlat (humors) are immature, and retained.
The current treatment of OA is mainly palliative management and includes physical, pharmacological, and surgical approaches and does not aim at cure. Most drug treatments have been developed to alleviate the symptoms of OA, mainly by reducing inflammatory processes and pain. There are two categories of symptomatic drugs for OA; the first is non-specific and rapidly acting such as analgesics and non-steroidal anti-inflammatory drugs (NSAIDs), whereas, the second is specific and slow acting with a delayed onset of action (symptom-modifying agents). Conventional medications are often effective for symptom relief, but they can also cause significant side effects and do not slow the progression of the disease. Several natural substances have been shown to be at least as effective as NSAIDs at relieving the symptoms of OA, and preliminary evidence suggests some of these compounds may exert a favorable influence on the course of the disease. The rationale for using symptom-modifying drugs such as chondroitin sulfate (CS) as a treatment for OA disease was in part empirical based on the observation that CS decreased with aging and OA. Though randomized, placebo-controlled, clinical trials confirmed the efficacy of oral glucosamine sulphate on arthritis controversies regarding the therapeutic efficacy prevail. Therefore, it is important to identify new chondroprotective drugs and nutraceuticals. There is historical evidence suggesting that herbal medicines have been used to treat OA since the earliest recorded times.
Some of the Unani herbs such as Gule baboona (Matricaria chamomilla), Asgandh (Withania somnifera), Bozidan (Pyrethrum indicum), Suranjan shireen (Meriandra persica), and Suranjan talkh (Colchicum autumnale) are having Musakkin (analgesic), Muhallil (anti-inflammatory), Muqawwie (tonic), and Mudir baul (diuretic) properties. Therefore, these drugs are in use to manage OA. Moreover, Withania somnifera, and Matricaria chamamilla are pharmacologically proven to have cyclo-oxygenase inhibiting activity., Hence, present study aims to evaluate the efficacy of polyherbal Unani formulations for treating knee AO.
| Material and Methods|| |
Our hypothesis was that the Unani polyherbal formulations will reduce or not reduce the modified Algo functional index in Knee OA. The research question was whether polyherbal Unani treatment was effective in reducing the modified Lequesne Algo-Functional Index (AFI) in knee OA.
A prospective, single center, open-labeled, pre- and post-evaluation study was carried out to assess the efficacy of polyherbal Unani formulations that included both internal and external interventions. The study was approved by the Institutional ethical committee and a written consent was obtained.
In the study, diagnosed patients (n = 23) of OA were recruited from the Outpatient Department of General Medicine, Government Nizamia General Hospital, Hyderabad between the years 2000 and 2002. Patients aged between 35 and 70 years of either sex having clinical and radiologic (X-ray) finding of a unilateral or bilateral knee OA were included, whereas, patients with systemic or metabolic disorders, any joint deformity, congenital deformity or disease, and secondary OA were excluded.
At first visit, detail history of the participants, which included socio-demographic data (age, sex, marital status, education level, habits, temperament, total income and marital status), past history, and symptoms (tender joint count, grip strength, inactivity stiffness) were obtained. The general and systemic examination, including Lequesne AFI, laboratory (erythrocyte sedimentation rate, complete blood picture, complete urine examination) and radiologic investigations were incorporated at baseline Careful clinical examination of joints, movements, Lequesne AFI scoring were performed at baseline and at the end of the treatment sessionsto assess improvement or any untoward effects of the medicine. The patients were recalled fortnightly for two follow-ups to observe recurrence of any symptoms such as pain, stiffness, etc., after the completion of trial.
All the participants who met the inclusion criteria were advised to take a polyherbal Unani formulation internally, twice daily, which was as follows; 3 g powder of Asgandh (Withania somnifera) (1 g), Gule baboona (Matricaria chamomilla) (2 g), Bozidan (Pyrethrum indicum) (1 g) and Suranjan shireen (Meriandra persica) (2 g). Additionally, a paste of powdered Suranjan talkh (7 g) mixed with Roghane baboona (20 ml) was advised as an external application over the affected joint for one-hour-twice daily for 40 days. Patients, who were using NSAIDs as rescue remedy, were advised to stop and contact the study personnel, if the pain was unbearable for a possible referral to an orthopedician or exclusion from the trial.
The main outcome measure in the study was to evaluate the effectiveness of poly herbal Unani formulations in reducing the modified Lequesne AFI for knee OA. The test-retest reliability of this functional index has been reported to be high (intra-class correlation coefficient = 0.95).
According to the response, the patients were categorized as relieved (R) if the mean percentage reduction of AFI (Index of severity for OA for the knee [ISK]) was more than 50%, the mean percentage reduction of Algo Functional Index was calculated as
The results of pre- and post-test were analyzed statistically using Graph Pad Instat version 3.00 for window (Graph Pad Software, San Diego, CA, USA) at completion of the study taking into account the reduction of AFI score and alleviating the symptoms. The descriptive statistical analysis has been used and results were presented in mean (SD/SEM) for continuous measurements. The results on the categorical measurements were presented in percentages. The cut-off point for level of significance was 5% with 95% confidence interval. The Wilcoxon matched test has been used to find the pre- and post-test change in Lequesne AFI score, because the population was not normally distributed.
| Results|| |
A total of 53 patients were screened, out of which 15 refused to participate in the study, nine did not review for the treatment after counseling, six were excluded [diabetes mellitus (n = 3), rheumatic arthritis (n = 2), traumatic arthritis (n = 1)] and 23 patients were eligible and agreed to provide written informed consent. Of the 23 participants that were enrolled, three dropped out as they did not complete the trial. The statistical analysis was done on the data obtained from 20 participants.
Baseline socio-demographic data
The mean age of the patients was 47.6 (±2.55) years. Majority of patients were aged 36-45 years. Eighteen (90%) patients were non-vegetarian and 10 (50%) patients were from low-socioeconomic status. The females 13 (65%) were more than males 7 (35%) in our study sample [Table 1].
Duration of illness
The duration of illness was more than one year in 17 (85%) patients [Table 2].
| Lequesne Algo-Functional Index Score|| |
The mean percentage reduction in Lequesne AFI was 79.29%. The pre- and post-test mean score (SD) of AFI score was 9.9 (1.58) and 2.05 (2.06) respectively (P < 0.0001) [Table 3].
Severity of knee Osteoarthritis assessed by Algo-Functional Index
The severity of knee OA was assessed by the AFI. At pretest, 15 (75%), 4 (20%) and 1 (5%) patients had 8-10 (severe), 11-13 (very severe) and ≥ 14 (extremely severe) severity score respectively. At post-test, 2 (10%) patients had 0 (none) score, 16 (80%) patients had at 1-4 score (mild), whereas 1 (5%) patient each had 5-7 (moderate) and 8-10 (severe) score respectively, and none of the patients had very severe or extreme severity score [Table 4].
|Table 4: Severity of osteoarthritis assessed by Algo-Functional Index Score|
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| Discussion|| |
Patients were mainly diagnosed on basis of clinical examination and radiologic finding. The routine investigations were normal in all the patients.
| Main Outcome|| |
Lequesne Algo-Functional Index Score
AFI decreased significantly by 79.29%. The pre- and post-test evaluation was found statistically extremely significant showing that the Unani treatment was effective in reducing the AFI score (P < 0.0001).
Uebelhart and co-workers in their randomized placebo-controlled trial conducted in patients suffering with knee OA reported that AFI decreased significantly by 36% in the chondrotin sulfate group after 1 year as compared to 23% in the Placebo group. The pre- and post-test AFI was 9 (2.8) and 5.8 (3.6) respectively. In our study, AFI decreased significantly by 79.29% and post-test mean AFI was 2.05, which is not in total agreement with their finding. In this study, poly herbal formulations had good effect than chondrotin sulfate.
Kulkarni et al., in their double-blind, placebo-controlled cross-over clinical trial proved that an herbal formula containing Withania somnifera reduced the severity of pain and disability score. The study was conducted on 42 patients with OA who were randomly assigned to receive, Ayurvedic preparation (Articulin-F) or a placebo for three months, and then the alternate treatment for an additional three months. Articulin-F contains (per capsule) 450 mg of Withania somnifera root, 100 mg of Boswellia serrata stem, 50 mg of Curcuma longa rhizome, and 50 mg of a zinc complex. The dosage was two capsules 3 times per day, after meals.
In another study (n = 20), the authors of this study have demonstrated usefulness of Unani treatment with 3.5 g powder of Asarum europeaum (2 g), A. graveolens (2 g), and Piper longum (3 g) administered orally twice daily combined with an external application made out of, the concoction of flowers of Matricaria chamomilla (20 g) and Butea frondosa (40 g) made in 1 L was poured over the affected knee, daily once for 40 days in 20 participants. The study with the above mentioned herbs were conducted simultaneously with the present study but data were analyzed and reported separately, which showed that AFI decreased significantly by 71.09% and pre- and post-test mean AFI was 10.55 (1.70) and 3.05 (2.30) respectively. Some of the herbs used in the present study, such as Withania somnifera are having anti-inflammatory, immune-modulator, anti-stress, antioxidant, adoptagenic as well as chondroprotective properties and chamomile is also having anti-inflammatory properties.
In classical literature, it is mentioned that drugs having Muhallil (anti-inflammatory), Musakkin (analgesic), Muqawwi (tonic), Mushil (purgative) and Mudir (diuretic) properties are to be used in OA. Anti-inflammatory property is observed in Matricaria chamomilla, Withania somnifera, Meriandra persica, and Suranjan talkh. Matricaria chamomilla, Meriandra persica, and Suranjan talkh are having Musakkin property. Matricaria chamomilla is also having diuretic property, hence, it is suggested that these drugs eliminated the morbid humors from the body. Nervine tonic property was noted in Matricaria chamomilla, and Withania somnifera, which is presumed to have strengthened the nerves, increased the muscle tone and power of the muscles thus, preventing peri-articular muscle wasting and making the joints stable. It is assumed that these poly herbal formulations played a significant role in ameliorating signs and symptoms of knee OA because of the above said properties.
Additionally, some of the herbs are pharmacologically and clinically proven to have anti-inflammatory, anti-oxidant and analgesic properties.
Scientifically, the effectiveness of Withania somnifera in a variety of rheumatologic conditions is attributed to its anti-inflammatory property, which has been reported by Anbalagan et al., Begum et al., and Hindawi et al. These studies reported that it decreases the glycosaminoglycans content in the granuloma tissue, α2-glycoprotein, α2-macroglobulin and acute phase protein found only in inflamed rat serum to undetectable levels. Begum et al., found in their study that Asgandh uncoupled the oxidative phosphorylation by significantly reducing the ADP/O ratio in mitochondria of granuloma tissue. It increased the Mg2+ dependent-ATPase enzyme activity and also reduced the succinate dehydrogenase activity in the mitochondria of the granuloma tissue. Another study observed that Withania somnifera caused significant reduction in both paw swelling and degenerative changes as observed by radiological examination. Few other studies have been conducted on the mechanism of action for the anti-inflammatory properties of Withania somnifera. These studies suggested cyclo-oxygenase inhibition may be involved in the mechanism of action of this drug. Another study reported that this herb acts as an anti-inflammatory agent through inhibition of complement, lymphocyte proliferation, and delayed-type hypersensitivity. It is also proven to be have immune-modulator, anti-stress, antioxidant, and adoptagenic properties. Moreover, Sumantran et al., in their study reported that Withania somnifera root powder extracts had a statistically significant, short-term chondroprotective effect on damaged human osteoarthritic cartilage matrix in 50% of the patients tested and caused a significant and reproducible inhibition of the gelatinase activity of collagenase type 2 enzyme in vitro.
A study conducted by Hormann and Korting showed that in vitro, chamomile extract inhibited both cyclo-oxygenase and lipo-oxygenase, and consequently prostaglandins and leukotrienes. Anti-inflammatory effects of it was thought to occur via the influence of azulenes (chamazulene, prochamazulene, and guaiazulene) on the pituitary and adrenals, increasing cortisone release and reducing histamine release. Another study also proved Matricaria chamomilla, and Withania somnifera plants possessed varying degrees of anti-inflammatory activity.
Evidence indicates that continuous exposure to oxidants contributes to the development of many common age-related diseases, including OA. Furthermore, chondrocytes are potent sources of reactive oxygen species, which may damage cartilage collagen and synovial fluid hyaluronate, the macromolecule that accounts for the viscosity of the synovial fluid. Since, antioxidants provide defense against tissue injury, intake of these could be postulated to protect against OA and may reduce the risk of cartilage loss and disease progression in people with OA. Withania somnifera  is also proven to have antioxidant property. As an antioxidant, its active constituents' sitoindosides VII-X and withaferin A (WA) have been proven to increase the levels of endogenous superoxide dismutase, catalase, and ascorbic acid, while decreasing lipid peroxidation.
During the follow-up after treatment, two patients who had moderate and severe pain were referred to the orthropedican. It was also observed that the Algo-Functional Score was same in the patients who had mild pain after two follow-ups.
This study has several limitations such as lack of control group, small sample size, lack of statistical power, no standard control and WOMAC score was not used. But the strength of this study is the herbs used in these formulations had both anti-inflammatory, as well as chondroprotective effect. Hence, these formulations are more beneficial than herbs of other group and chondrotin sulfate. Additionally, these herbs are cost effective, easily available and the compliance of the patients was good.
Further, double-blind, randomized controlled trial in larger number of patients for longer duration is to be conducted to evaluate the efficacy of this formulation in the OA using WOMAC OA Index.
| Conclusion|| |
In the present study, the poly herbal Unani formulations administered to patients showed promising results and hence demands a closer inquiry into this formula with larger well-designed randomized controlled clinical trials in the future.
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[Table 1], [Table 2], [Table 3], [Table 4]