|Year : 2016 | Volume
| Issue : 4 | Page : 227-231
Clinical efficacy of certain Unani herbs in knee osteoarthritis: A pretest and post-test evaluation study
Asfia Tarannum1, Arshiya Sultana2, Khaleeq Ur Rahman3
1 Department of Moalajat (General Medicine), HARK Hospital, M.I.J. Unani Medical College, Mumbai, Maharashtra, India
2 Department of Amraze Niswan wa Ilmul Qabalat (Obstetrics and Gynecology), National Institute of Unani Medicine, Bengaluru, Karnataka, India
3 Department of Ilmul Saidla (Pharmacy), National Institute of Unani Medicine, Bengaluru, Karnataka, India
|Date of Web Publication||10-Aug-2016|
Flat No. 002, 6 and 7 Ranganatha Regency, 12th Cross, 2nd Main, Annapoorneshwari Nagar, Bengaluru - 560 091, Karnataka
Source of Support: None, Conflict of Interest: None
Objectives: This study was conducted to evaluate the efficacy of preparations of certain Unani herbs on Lequesne Algo-Functional Index of knee osteoarthritis (OA).
Materials and Methods: A prospective, pre- and post test evaluation study was conducted on 20 diagnosed patients of OA recruited from the Nizamia General Hospital, Hyderabad. Internally, a combination (formula) of Unani herbs was administered, which was as follows: 3.5 g powder of Asarun (2 g), Tukhme karafs (2 g), and Filfil daraz (3 g) was administered internally twice daily. Externally, the concoction of Gule baboona (20 g) and Gule tesu (40 g) made in 1 l water was poured over the affected knee, daily once for 40 days. The primary outcome was to assess the efficacy of Unani test drugs with the modified Lequesne Algo-Functional Index for knee OA.
Results: The mean percentage reduction of Lequesne Algo-Functional Index score was 71.09%. The mean and standard deviation was 10.55 (1.70) and 3.05 (2.30) before treatment and after treatment, respectively. The pre- and post test evaluation showed reduction in Lequesne Algo-Functional Index score (P < 0.0001).
Conclusion: In this study, the Unani treatment module was found to be effective in reducing the severity of disease in patients with osteoarthritis of knees.
Keywords: Knee osteoarthritis, Lequesne Algo.-Functional Index, randomized comparative study, Unani medicine
|How to cite this article:|
Tarannum A, Sultana A, Ur Rahman K. Clinical efficacy of certain Unani herbs in knee osteoarthritis: A pretest and post-test evaluation study. Ancient Sci Life 2016;35:227-31
| Introduction|| |
Osteoarthritis (OA) is a chronic degenerative, progressive, musculoskeletal disease with multifactorial etiology. It is primarily a non-inflammatory disorder of movable joints  characterized by joint destruction, cartilage loss, and occasionally gross derangement of the joint's integrity. This disease is an enigmatic, homogeneous, ubiquitous condition related to age.
OA is the most frequent form of arthritis and joint disorder worldwide. In India, it is the second most common joint disease with a prevalence rate of 22%–39%. It is estimated that 11% individuals of age 65 years or more have symptoms of OA, while <1% of individuals of age of 25–34 years experience knee OA. It strikes mainly weight-bearing joints, such as knee and hip joints. In that, Knee arthritis alone accounts for 30%–40%. Eighty percent patients suffering from OA have some degree of limitation of movements and 25% can't perform normal activities of their life. With progression of the disease, working abilities of the individual get affected resulting in dependence and segregation from productive life. Hence, OA is emerging as a major cause of work loss. The metabolic and structural changes of OA are currently viewed as adaptive response of synovial joints to a variety of genetic, constitutional, and biomechanical insults.
In most of the authentic Unani literature, OA is described as “Tahajjar-ul-Mafasil ”under the heading of “Waja-ul-Mafasil .” The cause of all arthritic pains is described to be humoural imbalance. When the morbid matter is diverted from the vital organs toward the joints, it accumulates in the joints, as they are empty and subjected to movement and activity. Moreover, they have cold temperament and lie in the extremities far away from the heart (the center of heat production). Hence, this matter becomes thick and hard, especially if the akhlat (humours)are immature, and retained.
According to the Unani scholars, the predisposing factors of OA is accumulation of ghair tabayi akhlat (abnormal humour), such as dominance of damavi (sanguine), or safravi (choleric), or balghami (phlegmatic), or saudavi (melancholic) khilt (humour), or a mixture of any two ghair tabayi akhlat or reeh (gases). The other predisposing factor is sue mizaj (abnormal temperament) that can be either sue mizaj saada (without any morbid matter) or sue mizaj maddi (with morbid matter). The exciting factors are old age, chronic diseases, congenital weakness of the organ, emotional upsets, alcoholism, insomnia, sedentary life, menstrual disturbances in women, trauma, heredity, and so on.,
The main goal in the management of OA is to control pain, to improve the movements, and minimize morbidity. The American College of Rheumatology guidelines recommends the use of nonsteroidal anti-inflammatory drugs (NSAIDs) to relieve pain in OA. However, long-term use of NSAIDs is associated with gastrointestinal side effects and nephrotoxicity. In Unani, drugs such as Asarun (Asarum europeaum ), Tukhme karafs (Apium graveolens ), Filfil daraz (Piper longum ), Gule baboona (Matricaria chamomilla ), and Gule teesu (Butea frondosa ) have been in use to manage OA. These drugs have musakkin (analgesic), muhallil ( anti-inflammatory), muqawwie (nervine tonic), and mudir boul (diuretic) properties. In this study, an effort is made to evaluate the efficacy of preparations of certain Unani herbs which are currently used in the management of OA, in view of scarce documentation and validation of their efficacy.
| Materials and Methods|| |
In this study, the research question was whether the Unani treatment module was effective in reducing the modified Lequesne Algo-Functional Index in knee OA. We hypothesized that the Unani treatment (as proposed in this study) will reduce the pain in knee OA.
To evaluate the usefulness of a Unani treatment that included both internal and external interventions, a prospective, single center, open-labeled, pre- and post test evaluation study was conducted. The intervention was for 40 days. The study was approved by the Institutional ethical committee. The data were analyzed and compared from the baseline after completion of the treatment.
Twenty diagnosed patients of OA were recruited in this study from the Outpatient Department of General Medicine, Government Nizamia General Hospital, Hyderabad, between the years 2000 and 2002. The inclusion criteria were patients aged 35–70 years, of either sex having clinical and radiologic (X-ray) finding of unilateral or bilateral knee OA. Patients who had systemic or metabolic disorders, joint deformities, concomitant disease, congenital deformity or disease, and secondary OA were excluded.
All details of the participants and informed consent were obtained at their first visit. A history including 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 evaluated. The general and systemic examination, including Lequense Algo-Functional Index, laboratory (erythrocyte sedimentation rate, complete blood picture, and complete urine examination) and radiologic investigations were integrated in the case record form. All the patients were reviewed every 10th day during the treatment. A careful clinical examination of joints, movements, Lequesne Algo-Functional Index, and so forth, were carried out for assessing the effectiveness or any untoward effects of the medicine. After the completion of the trial, the patients were recalled fortnightly for two follow-ups to observe the reccurrence of any symptoms such as pain, stiffness, and so on.
The patients (n = 20) who met the inclusion criteria were selected. Internally, a combination (formula) of Unani herbs was given to all the participants. The dosage was as follows: 3.5 g powder of Asarun (Asarum europeaum) (2 g), Tukhme karafs (Apium graveolens) (2 g), and Filfil daraz (Piper longum) (3 g) was administered orally twice daily. Externally, the concoction of Gule baboona (Matricaria chamomilla) (20 g) and Gule tesu (Butea frondosa) (40 g) made in 1 l water was poured over the affected knee, daily once for 40 days. The patients were restricted from any other treatment apart from the trial formulation.
The primary outcome was to assess the efficacy of Unani test drugs with the well-validated modified Lequesne Algo-Functional Severity Index for knee OA. The test–retest reliability of this severity index was excellent (intra-class correlation coefficient = 0.95).
According to the response, the patients were categorized as relieved (R) if the mean percentage reduction of Algo-Functional Index (ISK or Index of severity for OA for the knee) was more than 50%, whereas not relieved if it was less 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 Windows (Graph Pad Software, San Diego, CA, USA) and Vassar stat at completion of the study taking into account the relief of symptoms and reduction of Lequense Algo-Functional index score.
The descriptive statistical analysis has been carried out in the present study. Results on continuous measurements are presented in mean (Standard Deviation/Standard Error Mean) and results on the categorical measurements were presented in number (%) with 5% level of significance and 95% confidence interval. The Wilcoxon matched test has been used to find the intragroup comparison for change in Lequense Algo-Functional Index Score as it did not pass the normality test.
| Results|| |
The various baseline characteristics are summarized in [Table 1]. The mean age with standard deviation of the patients was 52.6 (2.41). Out of 20 patients, 14 (70%) were females and 6 (30) males. Low socioeconomic status was found in 13 (65%) patients, Obesity was seen in 8 (40%) female and 4 (20%) male patients [Table 1].
The duration of illness was more than 1 year in 18 (90%) patients [Table 2].
Lequesne Algo-functional index
The mean score (SD) and P value before treatment and after treatment are summarized in [Table 3]. The mean percentage reduction in Lequesne Algo-Functional index was 71.09% [Table 4].
|Table 4: Severity of osteoarthritis assessed by algofunctional index score|
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Severity of knee osteoarthritis assessed by Algo-functional index
The severity of knee OA was assessed by the Algo-Functional Index. All the patients had a score > 8–10 before treatment. After treatment, one (5%) patient had no pain, 16 (80%) patients had mild pain, whereas 1 (5%) and 2 (10%) had moderate and severe pain, respectively, and none of the patients had very severe or extreme pain [Table 3].
| Discussion|| |
Patients were mainly diagnosed on basis of clinical examination and radiological finding, as it has been reported that no laboratory studies are diagnostic for OA. The routine investigations were normal in all the patients.
Lequesne Algo-functional index score
The intragroup comparison was found statistically extremely significant (P < 0.0001) showing that the treatment was effective in reducing the Lequense Algo-Functional Index Score. The mean percentage of reduction of pain was 71.09%.
According to the Unani , drugs having muhallil (anti-inflammatory), musakkin (analgesic), muqawwi (tonic), mushil (purgative), and mudir (diuretic) properties are used in OA. Piper longum and Matricaria chamomilla have anti-inflammatory property. Matricaria chamomilla also has analgesicproperty. Asarum europeaum, Apium graveolens and Matricaria chamomilla , have diuretic property, and hence these drugs eliminate the morbid humours from the body. Asarum europeaum and Matricaria chamomilla have muqawwie asab (nervine tonic) property, and therefore strengthen nerves, increases the muscle tone and power of the muscles, thus preventing periarticular muscle wasting and make the joints stable. It is hypothesized that these above-mentioned properties of the trial drugs played an important role in alleviating signs and symptoms of knee OA.
Moreover, some of the trial drugs are pharmacologically and clinically proven to have anti-inflammatory, antioxidant, and analgesic properties. A study conducted by Hormann and Korting showed that in vitro , chamomile (Matricaria chamomilla) 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.Apium graveolens is proven to have anti-nociceptive and anti-inflammatory effects. Another study also proved Apium graveolens and Matricaria chamomilla plants possessed varying degrees of anti-inflammatory activity.
Piper longum root is proven to have weak opoid analgesic effect but potent NSAIDs type of analgesic 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 the drugs could be postulated to protect against OA and may reduce the risk of cartilage loss and disease progression in people with OA. Some of the test drugs such as Piper longum  and Apium graveolens  are proven to have antioxidant property. Hence it is hypothesized that the test drugs were effective in reducing the Lequense Algo-Functional Index Score.
The strength of this study is that it is the first of its kind where Lequesne Algo-Functional index was used in the interventional study to evaluate the efficacy of Unani herbs. The compliance of the patients was good, and this formulation is cost-effective and easily available.
The limitations of the study are (a) small sample size, (b) lack of statistical power, (c) no standard control and e. WOMAC score was not used. Therefore, double-blind, randomized controlled trial in larger number of patients for longer duration is to be conducted to evaluate the efficacy of the test drugs in OA using WOMAC Osteoarthritis Index.
| Conclusion|| |
OA is a common condition with significant impact on the quality of life of affected individuals. The present study suggests that the Unani treatment module administered to patients with osteoarthritis who enrolled in the study was effective. It is recommended that long-term prospective, randomized standard controlled clinical studies be conducted with more sophisticated parameters and health-related quality of life questionnaire in the evaluation of OA.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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